Oxycontin 30 Mg Preço

Tell your doctor or pharmacist if you are taking any of the following medicines, as they may need to adjust your dose:

Oxycontin 30 Mg Preço

OxyContin 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 120 mg prolonged release tablets

2. Qualitative and quantitative composition

Each 5 mg tablet contains 4.5 mg of oxycodone as 5 mg of oxycodone hydrochloride.

Each 10 mg tablet contains 9.0 mg of oxycodone as 10 mg of oxycodone hydrochloride.

Each 15 mg tablet contains 13.5 mg of oxycodone as 15 mg of oxycodone hydrochloride.

Each 20 mg tablet contains 18.0 mg of oxycodone as 20 mg of oxycodone hydrochloride.

Each 30 mg tablet contains 27 mg of oxycodone as 30 mg of oxycodone hydrochloride.

Each 40 mg tablet contains 36.0 mg of oxycodone as 40 mg of oxycodone hydrochloride.

Each 60 mg tablet contains 54 mg of oxycodone as 60 mg of oxycodone hydrochloride.

Each 80 mg tablet contains 72.0 mg of oxycodone as 80 mg of oxycodone hydrochloride.

Each 120 mg tablet contains108 mg of oxycodone as 120 mg of oxycodone hydrochloride.

Excipient with known effect:

Contains lactose monohydrate.

For the full list of excipients, see Section 6.1.

3. Pharmaceutical form

Prolonged release tablet.

The 5 mg tablets are light blue, round, convex tablets marked OC on one side and 5 on the other.

The 10 mg tablets are white, round, convex tablets marked OC on one side and 10 on the other.

The 15 mg tablets are grey, round, convex tablets marked OC on one side and 15 on the other.

The 20 mg tablets are pink, round, convex tablets marked OC on one side and 20 on the other.

The 30 mg tablets are brown, round, convex tablets marked OC on one side and 30 on the other.

The 40 mg tablets are yellow, round, convex tablets marked OC on one side and 40 on the other.

The 60 mg tablets are red, round, convex tablets marked OC on one side and 60 on the other.

The 80 mg tablets are green, round, convex tablets marked OC on one side and 80 on the other.

The 120 mg tablets are purple, round, convex tablets marked OC on one side and 120 on the other.

4. Clinical particulars
4.1 Therapeutic indications

For the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid.

4.2 Posology and method of administration

Adults over 18 years:

OxyContin tablets should be taken at 12-hourly intervals. The dosage is dependent on the severity of the pain, and the patient’s previous history of analgesic requirements.

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with oxycodone in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

OxyContin is not intended for use as a prn analgesic.

Generally, the lowest effective dose for analgesia should be selected. Increasing severity of pain will require an increased dosage of OxyContin tablets, using the different tablet strengths, either alone or in combination, to achieve pain relief. The correct dosage for any individual patient is that which controls the pain and is well tolerated for a full 12 hours. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. If higher doses are necessary, increases should be made in 25% – 50% increments. The need for escape medication more than twice a day indicates that the dosage of OxyContin tablets should be increased.

The usual starting dose for opioid naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 10 mg, 12-hourly. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of side effects. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief.

Conversion from oral morphine:

Patients receiving oral morphine before OxyContin therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasised that this is a guide to the dose of OxyContin tablets required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Transferring patients between oral and parenteral oxycodone:

The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Elderly patients:

A dose adjustment is not usually necessary in elderly patients.

Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that, compared with younger adults, the clearance of oxycodone is only slightly reduced. No untoward adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate.

Paediatric population

OxyContin should not be used in patients under 18 years of age.

Patients with renal or hepatic impairment:

The plasma concentration in this population may be increased. The dose initiation should follow a conservative approach in these patients. The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation.

Use in non-malignant pain:

Opioids are not first-line therapy for chronic non-malignant pain, nor are they recommended as the only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease. The need for continued treatment in non-malignant pain should be assessed at regular intervals.

Method of administration

OxyContin tablets are for oral use.

OxyContin tablets must be swallowed whole and not broken, chewed or crushed.

Duration of treatment

Oxycodone should not be used for longer than necessary.

Discontinuation of treatment

When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4.3 Contraindications

Hypersensitivity to oxycodone or to any of the excipients listed in section 6.1.

Oxycodone must not be used in any situation where opioids are contraindicated: severe respiratory depression with hypoxia, paralytic ileus, acute abdomen, delayed gastric emptying, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, elevated carbon dioxide levels in the blood, moderate to severe hepatic impairment, chronic constipation.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.4 Special warnings and precautions for use

Caution must be exercised when administering oxycodone to the debilitated elderly, patients with severely impaired pulmonary function, patients with impaired hepatic or renal function, patients with myxoedema, hypothyroidism, Addison’s disease, toxic psychosis, prostate hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, hypotension, hypovolaemia raised intracranial pressure, intracranial lesions, head injury (due to risk of increased intracranial pressure), reduced level of consciousness of uncertain origin, sleep apnoea or patients taking benzodiazepines, other CNS depressants (including alcohol) or MAO inhibitors (see section 4.5).

The primary risk of opioid excess is respiratory depression.

Sleep related breathing disorders

Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. Opioids may also cause worsening of pre-existing sleep apnoea (see section 4.8).

Concomitant use of oxycodone and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible.

If a decision is made to prescribe oxycodone concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible (see also general dose recommendation in section 4.2).

The patient should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).

OxyContin tablets must be administered with caution in patients taking MAOIs or who have received MAOIs within the previous two weeks.

OxyContin tablets should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, OxyContin tablets should be discontinued immediately.

OxyContin tablets are not recommended for pre-operative use or within the first 12-24 hours post-operatively.

As with all opioid preparations, oxycodone products should be used with caution following abdominal surgery as opioids are known to impair intestinal motility and should not be used until the physician is assured of normal bowel function.

Patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive OxyContin tablets for 12 hours prior to the intervention. If further treatment with OxyContin tablets is indicated then the dosage should be adjusted to the new post-operative requirement.

OxyContin 60 mg, 80 mg and 120 mg tablets should not be used in patients not previously exposed to opioids. These tablet strengths may cause fatal respiratory depression when administered to opioid naïve patients.

For appropriate patients who suffer with chronic non-malignant pain, opioids should be used as part of a comprehensive treatment programme involving other medications and treatment modalities. A crucial part of the assessment of a patient with chronic non-malignant pain is the patient’s addiction and substance abuse history.

If opioid treatment is considered appropriate for the patient, then the main aim of treatment is not to minimise the dose of opioid but rather to achieve a dose which provides adequate pain relief with a minimum of side effects. There must be frequent contact between physician and patient so that dosage adjustments can be made. It is strongly recommended that the physician defines treatment outcomes in accordance with pain management guidelines. The physician and patient can then agree to discontinue treatment if these objectives are not met.

Drug dependence, tolerance and potential for abuse

Opioid Use Disorder (abuse and dependence)

Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as oxycodone. Iatrogenic addiction following therapeutic use of opioids is known to occur.

Repeated use of OxyContin tablets may lead to Opioid Use Disorder (OUD). Abuse or intentional misuse of OxyContin tablets may result in overdose and/or death. The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders (e.g. major depression, anxiety and personality disorders).

Patients will require monitoring for signs of drug-seeking behaviour (e.g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.

A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.

Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient.

Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.

Patients should be closely monitored for signs of misuse, abuse or addiction.

The clinical need for analgesic treatment should be reviewed regularly.

Drug withdrawal syndrome

Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with oxycodone.

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.

The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

If women take this drug during pregnancy there is a risk that their newborn infants will experience neonatal withdrawal syndrome.

Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain. This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality. Symptoms of hyperalgesia may resolve with a reduction of opioid dose.

OxyContin tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed, or crushed OxyContin tablets leads to a rapid release and absorption of a potentially fatal dose of oxycodone (see Section 4.9).

Concomitant use of alcohol and OxyContin may increase the undesirable effects of OxyContin; concomitant use should be avoided.

Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, such as local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, and valvular heart injury, which may be fatal.

Empty matrix (tablets) may be seen in the stools.

Opioids such as oxycodone hydrochloride may influence the hypothalamic-pituitary-adrenal or – gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.

4.5 Interaction with other medicinal products and other forms of interaction

The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4). Drugs which affect the CNS include, but are not limited to: other opioids, gabapentinoids such as pregabalin, anxiolytics, hypnotics and sedatives (including benzodiazepines), antipsychotics, antidepressants, phenothiazines, anaesthetics, muscle relaxants, antihypertensives and alcohol.

Concomitant administration of oxycodone with serotonin agents, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) may cause serotonin toxicity. The symptoms of serotonin toxicity may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea). Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.

Concomitant administration of oxycodone with anticholinergics or medicines with anticholinergic activity (e.g. tricyclic anti-depressants, antihistamines, antipsychotics, muscle relaxants, anti-Parkinson drugs) may result in increased anticholinergic adverse effects. Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.

MAO inhibitors are known to interact with narcotic analgesics. MAO inhibitors cause CNS excitation or depression associated with hypertensive or hypotensive crisis (see section 4.4). Co-administration with monoamine oxidase inhibitors or within two weeks of discontinuation of their use should be avoided.

Alcohol may enhance the pharmacodynamic effects of OxyContin; concomitant use should be avoided.

Oxycodone is metabolised mainly by CYP3A4, with a contribution from CYP2D6. The activities of these metabolic pathways may be inhibited or induced by various co-administered drugs or dietary elements. Oxycodone doses may need to be adjusted accordingly.

CYP3A4 inhibitors, such as macrolide antibiotics (e.g. clarithromycin, erythromycin and telithromycin), azole-antifungals (e.g. ketoconazole, voriconazole, itraconazole, and posaconazole), protease inhibitors (e.g. boceprevir, ritonavir, indinavir, nelfinavir and saquinavir), cimetidine and grapefruit juice may cause a reduced clearance of oxycodone that could cause an increase of the plasma concentrations of oxycodone. Therefore the oxycodone dose may need to be adjusted accordingly. Some specific examples are provided below:

• Itraconazole, a potent CYP3A4 inhibitor, administered 200 mg orally for five days, increased the AUC of oral oxycodone. On average, the AUC was approximately 2.4 times higher (range 1.5 – 3.4).

• Voriconazole, a CYP3A4 inhibitor, administered 200 mg twice-daily for four days (400 mg given as first two doses), increased the AUC of oral oxycodone. On average, the AUC was approximately 3.6 times higher (range 2.7 – 5.6).

• Telithromycin, a CYP3A4 inhibitor, administered 800 mg orally for four days, increased the AUC of oral oxycodone. On average, the AUC was approximately 1.8 times higher (range 1.3 – 2.3).

• Grapefruit Juice, a CYP3A4 inhibitor, administered as 200 ml three times a day for five days, increased the AUC of oral oxycodone. On average, the AUC was approximately 1.7 times higher (range 1.1 – 2.1).

CYP3A4 inducers, such as rifampicin, carbamazepine, phenytoin and St John’s Wort may induce the metabolism of oxycodone and cause an increased clearance of oxycodone that could cause a reduction of the plasma concentrations of oxycodone. The oxycodone dose may need to be adjusted accordingly. Some specific examples are provided below:

• St John’s Wort, a CYP3A4 inducer, administered as 300 mg three times a day for fifteen days, reduced the AUC of oral oxycodone. On average, the AUC was approximately 50% lower (range 37-57%).

• Rifampicin, a CYP3A4 inducer, administered as 600 mg once-daily for seven days, reduced the AUC of oral oxycodone. On average, the AUC was approximately 86% lower

Drugs that inhibit CYP2D6 activity, such as paroxetine and quinidine, may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations. Concurrent administration of quinidine resulted in an increase in oxycodone Cmax by 11%, AUC by 13%, and t½ elim. by 14%. Also, an increase in noroxycodone level was observed, (Cmax by 50%; AUC by 85%, and t½ elim. by 42%). The pharmacodynamic effects of oxycodone were not altered.

4.6 Fertility, pregnancy and lactation

OxyContin tablets are not recommended for use in pregnancy nor during labour. There are limited data from the use of oxycodone in pregnant women. Regular use in pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. If opioid use is required for a prolonged period in pregnant women, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.

Administration to nursing women is not recommended as oxycodone may be secreted in breast milk and may cause respiratory depression in the infant.

4.7 Effects on ability to drive and use machines

Oxycodone may impair the ability to drive and use machines. Oxycodone may modify patients’ reactions to a varying extent depending on the dosage and individual susceptibility. Therefore, patients should not drive or operate machinery if affected.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

• The medicine is likely to affect your ability to drive.

• Do not drive until you know how the medicine affects you.

• It is an offence to drive while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).

• This defence applies when:

o The medicine has been prescribed to treat a medical or dental problem; and

o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine.

• Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).”

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law

4.8 Undesirable effects

Adverse drug reactions are typical of full opioid agonists. Tolerance and dependence may occur (see Section 4.4). Constipation may be prevented with an appropriate laxative. If nausea and vomiting are troublesome, oxycodone may be combined with an anti-emetic.

The following frequency categories form the basis for classification of the undesirable effects:

Oxycontin 30 Mg Preço

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 16950/0098, PL 16950/0097, PL 16950/0099, PL16950/0140, PL16950/0141, PL16950/0139 , PL16950/0150, PL 16950/0123.

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OxyContin 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg and 120 mg prolonged release tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

OxyContin® 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg and 120 mg prolonged release tablets

This medicine contains oxycodone which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1. What OxyContin tablets are and what they are used for
2. What you need to know before you take OxyContin tablets
3. How to take OxyContin tablets
4. Possible side effects
5. How to store OxyContin tablets
6. Contents of the pack and other information

1. What OxyContin tablets are and what they are used for

This medicine has been prescribed for you for the relief of moderate to severe pain over a period of 12 hours. It contains oxycodone which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed for you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

2. What you need to know before you take OxyContin tablets
Do not take OxyContin tablets if you:

• are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the tablets (listed in section 6 of this leaflet);
• have breathing problems, such as severe chronic obstructive lung disease, severe bronchial asthma or severe respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;
• have a condition where the small bowel does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen;
• have a heart problem after long-term lung disease (cor pulmonale);
• have increased carbon dioxide levels in the blood. Symptoms may include dizziness, drowsiness, fatigue, shortness of breath and headache;
• have moderate to severe liver problems. If you have other long-term liver problems you should only take these tablets if recommended by your doctor;
• have ongoing problems with constipation;
• have a rare hereditary problem of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption;
• are under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets if you:

• or anyone in your family are or have ever been addicted to opioids, alcohol, prescription medicines or illegal drugs;
• are a smoker
• have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses);
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs;
• feel you need to take more tablets to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever;
• are elderly or weakened;
• have an under-active thyroid gland (hypothyroidism), as you may need a lower dose;
• have myxoedema (a thyroid disorder associated with dryness, coldness and swelling or puffiness of the skin affecting the face and limbs);
• know you are suffering from a brain injury or tumour, or you have a head injury, severe headache or feel sick as this may indicate that the pressure in your skull is increased;
• have low blood pressure (hypotension);
• have low blood volume (hypovolaemia). This can occur due to severe external or internal bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting;
• feel very lightheaded or faint;
• have a mental disorder following use of certain medicines (toxic psychosis);
• have inflammation of the pancreas (which causes severe pain in the abdomen and back);
• have problems with your gall bladder or bile duct;
• have inflammatory bowel disease;
• have an enlarged prostate gland, which causes difficulty in passing urine (in men);
• have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick), for example due to Addison’s disease;
• have severely impaired lung function. Symptoms may include breathlessness and coughing;
• have long term pain unrelated to cancer;
• have a condition where your breathing stops for short periods whilst you are asleep, known as sleep apnoea;
• have kidney or liver problems.

Taking this medicine regularly, particularly for a long time, can lead to addiction and may result in life threatening overdose. If you have concerns that you may become dependent on OxyContin tablets, it is important that you consult your doctor. Your doctor should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor about your treatment.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your doctor will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Do not inject OxyContin tablets. This can cause serious side effects including tissue death at the site of injection, infection, inflammation of the lungs and damage to the heart which may be fatal.

Sleep-related breathing disorders

OxyContin tablets can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

If you are going to have an operation, or have just had an operation, please tell the doctor at the hospital that you are taking these tablets. Your doctor may adjust your dose.

You may experience hormonal changes while taking these tablets. Your doctor may want to monitor these changes.

Other medicines and OxyContin

Taking OxyContin tablets at the same time as other medicines that slow down the central nervous system can cause slow or difficulty breathing (respiratory depression), severe sleepiness, loss of consciousness and death. These medicines include:

• other medicines used to treat pain known as opioids (such as codeine or morphine);
• medicines used to treat epilepsy (gabapentinoids) such as pregabalin;
• medicines used to treat anxiety;
• medicines used to make you feel sleepy (such as benzodiazepines);
• medicines used to treat psychiatric or mental disorders (such as phenothiazines);
• anaesthetics;
• muscle relaxants;
• medicines used to treat high blood pressure;
• a type of medicine used to treat depression known as monoamine oxidase inhibitors (MAOIs), such as tranylcypromine, phenelzine and isocarboxazid. You should not take OxyContin tablets if you are currently taking this type of medicine, or have taken this medicine in the last two weeks.

Because of this, your doctor will only prescribe OxyContin tablets where there are no other treatment options, and only in small doses for short periods of time. If you or your friends, family or caregivers notice that you are having difficulty breathing or that you have become very sleepy or lost consciousness you (or they) should inform your doctor immediately.

Taking OxyContin tablets with medicines used to treat depression known as Selective Serotonin Re-uptake Inhibitors (SSRIs) or Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs) can cause a condition known as serotonin toxicity. The symptoms of this include agitation, seeing or hearing things that aren’t real (hallucinations), loss of consciousness, a fast heartbeat, blood pressure changes, increased body temperature, muscle twitching, lack of coordination, stiffness, feeling or being sick, or diarrhoea. If you are taking SSRI or SNRI medicines such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline or venlafaxine your doctor may reduce your dose of OxyContin tablets.

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Tell your doctor or pharmacist if you are taking any of the following medicines, as they may need to adjust your dose:

• a type of medicine used to treat depression known as tricyclic antidepressants, such as amitriptyline, clomipramine, imipramine, lofepramine or nortriptyline;
• medicines used to treat allergies, such as cetirizine, fexofenadine or chlorphenamine;
• medicines used to treat Parkinson’s disease;
• antibiotics such as clarithromycin, erythromycin or telithromycin;
• antifungal medicines such as ketoconazole, voriconazole, itraconazole and posaconazole;
• medicines used to treat HIV known as protease inhibitors, such as boceprevir, ritonavir, indinavir, nelfinavir or saquinavir;
• cimetidine, a medicine used to treat stomach ulcers;
• rifampicin, a medicine used to treat tuberculosis;
• medicines used to treat seizures, fits or convulsions such as carbamazepine and phenytoin;
• a herbal remedy used to treat depression known as St. John’s Wort (also known as Hypericum perforatum);
• quinidine, a medicine used to treat an irregular heartbeat.

Taking OxyContin tablets with food, drink and alcohol

Drinking alcohol during your treatment with this medicine may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended that you do not drink alcohol while you are taking OxyContin tablets.

You should avoid drinking grapefruit juice during your treatment with this medicine.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Do not take OxyContin tablets if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby. If you take OxyContin tablets during pregnancy your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Breast-feeding

Do not take OxyContin tablets while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.

Driving and using machines

These tablets may cause a number of side effects such as drowsiness or dizziness which could affect your ability to drive or use machinery (see section 4 ‘Possible side effects’ for a full list of side effects). These are usually most noticeable when you first start taking the tablets, or when changing to a higher dose.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However you would not be committing an offence if:
  • The medicine has been prescribed to treat a medical or dental problem and;
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and;
  • It was not affecting your ability to drive safely.

  Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

  OxyContin tablets contain lactose

  These tablets contain lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

  3. How to take OxyContin tablets

  Always take these tablets exactly as your doctor has told you. The label on your medicine will tell you how many tablets to take and how often.

  Your doctor should have discussed with you how long the course of OxyContin tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

  Adults (over 18 years of age)

  The usual starting dose is one 10 mg tablet every 12 hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these tablets, discuss this with your doctor.

  Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.

  Swallow your tablets whole with water. Do not crush, dissolve or chew them.

  OxyContin tablets are designed to work properly over 12 hours when swallowed whole. If a tablet is broken, crushed, dissolved or chewed, the entire 12-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal.

  You should take your tablets every 12 hours. For instance, if you take a tablet at 8 o’clock in the morning, you should take your next tablet at 8 o’clock in the evening.

  You must only take the tablets by mouth. The tablets should never be crushed or injected as this may lead to serious side effects, which may be fatal (see section 2 ‘Warnings and precautions’).

  Children and adolescents under 18 years of age should not take the tablets.

  Patients with kidney or liver problems

  Please tell your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition.

  If you take more OxyContin tablets than you should or if someone accidentally swallows your tablets

  Call your doctor or hospital immediately. People who have taken an overdose may feel very sleepy, sick or dizzy, or have hallucinations. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you to show to the doctor.

  If you forget to take your OxyContin tablets

  If you remember within 4 hours of the time your tablet was due, take your tablet straight away.

  Take your next tablet at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten tablet.

  If you stop taking OxyContin tablets

  Do not suddenly stop taking this medicine. If you want to stop taking this medicine discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

  If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  4. Possible side effects

  Like all medicines, these tablets can cause side effects, although not everybody gets them.

  All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body. These may be signs of a serious allergic reaction.

  The most serious side effect is a condition where you breathe more slowly or weakly than usual (respiratory depression) and can lead to severe sleepiness and loss of consciousness. This side effect may affect up to 1 in 100 people and is more likely to occur when taking certain other medicines (see section 2 ‘Other medicines and OxyContin tablets’). Tell your doctor immediately if this happens to you. You may wish to ask your friends, family or caregivers to monitor you for these signs and symptoms.

  When you stop taking OxyContin tablets you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

  How do I know if I am addicted?

  If you notice any of the following signs whilst taking OxyContin tablets it could be a sign that you have become addicted.

  • You need to take the medicine for longer than advised by your prescriber;
  • You feel you need to use more than the recommended dose;
  • You are using the medicine for reasons other than prescribed;
  • When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.

  If you notice any of these signs it is important you talk to your doctor.

  Very common side effects

  (May affect more than 1 in 10 people)

  • Constipation (your doctor can prescribe a laxative to overcome this problem);
  • Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem);
  • Drowsiness (this is most likely when you start taking your tablets or when your dose is increased, but it should wear off after a few days);
  • Dizziness;
  • Headache;
  • Itchy skin.

  Common side effects

  (May affect up to 1 in 10 people)

  • Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea;
  • Confusion, depression, a feeling of unusual weakness, shaking, lack of energy, tiredness, anxiety, nervousness, difficulty in sleeping, abnormal thoughts or dreams;
  • Difficulty in breathing, wheezing, shortness of breath, decreased cough reflex;
  • Rash;
  • Sweating.

  Uncommon side effects

  (May affect up to 1 in 100 people)

  • Withdrawal symptoms (see section ‘Drug withdrawal’);
  • Difficulty in swallowing, belching, hiccups, wind, a condition where the bowel does not work properly (ileus), inflammation of the stomach, changes in taste or unpleasant taste;
  • A feeling of dizziness or spinning (vertigo), hallucinations, mood changes, unpleasant or uncomfortable mood, a feeling of extreme happiness, disorientation, restlessness, agitation, generally feeling unwell, loss of memory, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness, seizures, fits or convulsions, blurred or impaired vision, unusual muscle stiffness or slackness, involuntary muscle contractions or spasms;
  • Difficulty or pain in passing urine, impotence, decreased sexual drive, low levels of sex hormones in the blood (hypogonadism, seen in a blood test);
  • Fast, irregular heartbeat, palpitations, a feeling of lightheadedness, dizziness or fainting, flushing of the skin;
  • Dehydration, thirst, chills, swelling of the hands, ankles or feet;
  • Dry skin, severe flaking or peeling of the skin;
  • Redness of the face, reduction in size of the pupils in the eye, high temperature;
  • A need to take increasingly higher doses of the tablets to obtain the same level of pain relief (tolerance);
  • Colicky abdominal pain or discomfort;
  • A worsening of liver function tests (seen in a blood test).

  Rare side effects

  (May affect up to 1 in 1,000 people)

  • Low blood pressure or feeling faint, especially on standing up;
  • A raised, itchy rash (hives).

  Frequency not known

  (Frequency cannot be estimated from the available data)

  • Dependence and addiction (see section ‘How do I know if I am addicted?’);
  • An increased sensitivity to pain;
  • Aggression;
  • Tooth decay;
  • Absence of menstrual periods;
  • A blockage in the flow of bile from the liver (cholestasis). This can cause itchy skin, yellow skin, very dark urine and very pale stools;
  • Sleep apnoea (breathing pauses during sleep);
  • Long term use of OxyContin during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight.

  You may see the remains of the tablets in your faeces. This should not affect how the tablets work.

  Reporting of side effects

  If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

  5. How to store OxyContin tablets

  Keep this medicine out of the sight and reach of children. Accidental overdose by a child is dangerous and may be fatal.

  Do not use any tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

  Do not store your tablets above 25°C.

  Do not take your tablets if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.

  Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

  6. Contents of the pack and other information
  What OxyContin tablets contain

  The active ingredient is oxycodone hydrochloride. Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg or 120 mg of oxycodone hydrochloride.

  The other ingredients are lactose monohydrate, povidone, ammoniomethacrylate co-polymer, sorbic acid, triacetin, stearyl alcohol, talc, magnesium stearate, hypromellose (E464), titanium dioxide (E171) and macrogol.

  In addition, the tablet coatings contain the following:

  5 mg – brilliant blue (E133)

  10 mg – hydroxypropylcellulose

  15 mg – iron oxide (E172)

  20 mg, 30 mg, 40 mg, 60 mg and 120 mg – polysorbate 80 (E433), and iron oxide (E172)

  80 mg – hydroxypropylcellulose, iron oxide (E172), and indigo carmine (E132)

  What OxyContin tablets look like and the contents of the pack

  The tablets are marked OC on one side and the strength on the other (5, 10, 15, 20, 30, 40, 60, 80 or 120). All strengths are round, bi-convex, film coated tablets.

  The tablets are all film coated in the following colours: 5 mg – light blue, 10 mg – white, 15 mg – grey, 20 mg – pink, 30 mg – brown, 40 mg – yellow, 60 mg – red, 80 mg – green, 120 mg – purple.

  In each box there are 28 or 56 tablets. Not all pack sizes may be marketed.

  Marketing Authorisation Holder
  Napp Pharmaceuticals Limited
  Cambridge Science Park
  Milton Road
  Cambridge
  CB4 0AB
  UK
  Manufacturer
  Bard Pharmaceuticals Limited
  Cambridge Science Park
  Milton Road
  Cambridge
  CB4 0GW
  UK

  This leaflet is also available in large print, Braille or as an audio CD.

  To request a copy, please call the RNIB Medicine Information line (free of charge) on: 0800 198 5000

  You will need to give details of the product name and reference number. These are as follows:

  Product name: OxyContin

  Reference number: 16950/0123

  This leaflet was last revised in March 2022

  ® OxyContin, NAPP and the NAPP device logo are registered trade marks.

  © 2009-2022 Napp Pharmaceuticals Limited.

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