OxyContin

Patient Information Leaflet

OxyContin 5 mg, 10 mg, 20 mg, 40 mg, 80 mg, prolonged-release tablets

Oxycodone hydrochloride
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OxyContin is and what it is used for

OxyContin is a potent analgesic (painkiller) and belongs to the group of opioid medicines.
OxyContin is used in adults and adolescents aged 12 years and older to relieve severe pain,
which can only be adequately managed with opioid analgesics.

2. What you should know before taking OxyContin

Do not take OxyContin if you:

• are allergic (hypersensitive) to oxycodone or to any of the other ingredients of this medicine (listed in section 6), or if you have previously experienced an allergic reaction to another strong analgesic or painkiller (such as morphine or other opioids);
• have breathing problems, such as severe chronic lung obstruction, severe bronchial asthma, or severe respiratory depression. Symptoms may include shortness of breath, cough, or slower and weaker breathing than expected;
• have a head injury causing severe headache or malaise. This is because these tablets may worsen such symptoms or mask the severity of the head injury;
• suffer from a condition in which the intestine does not function properly (paralytic ileus), if your stomach empties more slowly than it should (delayed gastric emptying), or if you have sudden severe abdominal pain (acute abdomen);
• have heart problems caused by long-term lung diseases (cor pulmonale).

Warnings and precautions:
Inform your doctor or pharmacist before using these tablets if:

• you are elderly or debilitated;
• you have reduced thyroid function (hypothyroidism);
• you suffer from myxedema (a thyroid disorder characterized by dry, cold, and swollen skin, affecting the face and legs);
• you suffer from severe headache or malaise, which may indicate increased intracranial pressure;
• you have low blood pressure (hypotension);
• you or a family member have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction");
• you are a smoker;
• you have ever had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses;
• you suffer from inflammation of the pancreas (which may cause severe abdominal or back pain) or disorders of the gallbladder or bile duct;
• you suffer from intestinal blockage or inflammatory bowel disorders;
• you suffer from abdominal pain or colic-like abdominal disorders;
• you suffer from an enlarged prostate gland that may cause difficulty in passing urine (in men);
• you have reduced adrenal gland function (your adrenal glands do not work as they should), such as in Addison's disease;
• you have respiratory problems such as severe impairment of lung function, chronic obstructive airway disease, serious lung problems, or reduced respiratory capacity. Symptoms may include shortness of breath and cough;
• you have kidney or liver problems;
• you suffer from withdrawal symptoms such as restlessness, anxiety, palpitations, tremors, or sweating that occurred after stopping alcohol or medication;
• you suffer from epileptic attacks, seizures, or convulsions;
• you suffer from mental confusion or fainting;
• you need to take a higher dose of OxyContin to achieve the same level of pain relief (tolerance);
• you have increased sensitivity to pain;
• you are taking medicines known as monoamine oxidase inhibitors (such as tranilcipromine, phenelzine, isocarboxazid, moclobemide, and linezolid), or have taken such medicines within the last two weeks;
• you suffer from constipation.

Sleep-related breathing disorders
This medicine may cause sleep-related breathing disorders, such as nocturnal apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to gasping for breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. The doctor may consider reducing the dose.
If you are undergoing surgery, inform the hospital doctor that you are taking these tablets.
You may experience hormonal changes while taking these tablets. Your doctor may wish to monitor these effects.
The tablets must never be crushed or injected, as this may lead to serious adverse effects that could be fatal.
Opioids are not the first-line treatment for non-cancer-related pain and are not recommended as the sole treatment. Other medicines should be used together with opioids in the management of chronic pain. Your doctor must monitor you closely and make necessary dose adjustments while you are taking OxyContin to prevent dependence and abuse.

Tolerance, dependence, and abuse
This medicine contains oxycodone, which is an opioid. It may cause dependence and/or tolerance.
This medicine contains oxycodone, which is an opioid medicine. Repeated use of opioid painkillers may reduce the effectiveness of the medicine (you become accustomed to the medicine, a phenomenon known as tolerance). Repeated use of OxyContin may lead to dependence, abuse, and tolerance, which may result in potentially fatal overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.
Dependence or abuse may make you feel that you no longer have control over how much medicine you take or how often you take it. You may feel the need to continue taking the medicine, even when it does not help relieve pain.
The risk of becoming dependent or tolerant varies from person to person. You may have a higher risk of becoming dependent or tolerant to OxyContin if:

• you or a family member have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction");
• you are a smoker;
• you have had mood disorders (depression, anxiety, or personality disorders) or have been treated by a psychiatrist for other mental illnesses.

If any of the following signs occur while you are taking OxyContin, this may indicate that you have become dependent or tolerant:

• you need to take the medicine for longer than prescribed by your doctor;
• you need to take a higher dose than recommended;
• you are using the medicine for reasons other than those prescribed, for example, "to stay calm" or "to help sleep";
• you have repeatedly tried, without success, to stop or control the use of the medicine;
• when you stop taking the medicine, you feel unwell, and you feel better after resuming it ("withdrawal effects").

If any of these signs occur, consult your doctor to discuss the best treatment approach for you, including when it is appropriate to stop treatment and how to do so safely (see section 3 "If you stop taking OxyContin").
Contact your doctor if you experience severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms associated with inflammation of the pancreas (pancreatitis) and bile ducts.
For athletes: Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and OxyContin
Concomitant use of opioids, including oxycodone, and sedative medicines such as benzodiazepines or related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes OxyContin together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor.
Please inform your doctor of all sedative medicines you are taking and carefully follow the doctor's recommendations regarding dosage. It may be helpful to inform friends or family members to be aware of the signs and symptoms listed above. Inform your doctor if such symptoms occur.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. If you take these tablets together with other medicines, the effect of these tablets or the other medicines may be altered.
The risk of side effects increases if you are taking antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone, and symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movement, restlessness, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C may occur. Inform your doctor if such symptoms occur.
Inform your doctor or pharmacist if you are taking:

• certain types of antidepressants called monoamine oxidase inhibitors, or if you have taken these medicines within the last two weeks (see section 2 "What you should know before taking OxyContin");
• medicines for sleep or to stay calm (e.g., hypnotics or sedatives, including benzodiazepines);
• medicines for depression (e.g., paroxetine or fluoxetine);
• medicines for psychiatric or mental disorders (such as phenothiazines or neuroleptic drugs);
• medicines for epilepsy, pain, and anxiety such as gabapentin and pregabalin;
• other strong analgesics (painkillers);
• muscle relaxants;
• medicines for high blood pressure;
• quinidine (an antiarrhythmic medicine);
• cimetidine (an anti-ulcer medicine for indigestion or heartburn);
• medicines for fungal infections (such as ketoconazole, voriconazole, itraconazole, or posaconazole);
• medicines for bacterial infections (such as clarithromycin, erythromycin, or telithromycin);
• a specific type of medicine known as a protease inhibitor, used for the treatment of HIV (such as boceprevir, ritonavir, indinavir, nelfinavir, or saquinavir);
• rifampicin for the treatment of tuberculosis;
• carbamazepine (a medicine for treating seizures, convulsions, and certain types of pain);
• phenytoin (a medicine for treating seizures, convulsions);
• an herbal remedy called "St. John's wort" (also known as Hypericum perforatum);
• antihistamines;
• medicines for the treatment of Parkinson's disease.

Also inform your doctor if you have recently taken an anaesthetic.

OxyContin with food, drinks, and alcohol
These tablets may be taken with or without food.
Drinking alcohol while taking OxyContin prolonged-release tablets may cause drowsiness or increase the risk of serious adverse effects such as shortness of breath, respiratory depression, and loss of consciousness. It is recommended not to drink alcohol while taking OxyContin tablets. During treatment with OxyContin, you should avoid drinking grapefruit juice.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must not take these tablets during pregnancy and labour unless specifically advised by your doctor. Depending on the dose and duration of oxycodone therapy, newborns may experience slow and shallow breathing (respiratory depression) or withdrawal syndrome.

Breastfeeding
These tablets must not be taken during breastfeeding because the active substance may pass into breast milk.

Driving and using machines
These tablets may cause certain adverse effects, such as drowsiness, which may affect your ability to drive vehicles and operate machinery (see section 4 for a complete list of adverse effects). These effects are usually most relevant when starting treatment with the tablets for the first time or when the dose is increased. If you experience drowsiness, you should avoid driving vehicles or operating machinery.

OxyContin contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take OxyContin

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The package leaflet indicates how many tablets you should take and how often.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from using OxyContin, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also "If you stop taking OxyContin").
Do not exceed the dose recommended by your doctor.
Swallow the tablets whole with a glass of water.
The tablets must not be chewed, crushed, or dissolved.
Take the tablets every 12 hours. For example, if you take a tablet at 8 a.m., take the next one at 8 p.m.
It is recommended to take this medicine consistently with regard to meal times.
The tablets must not be crushed or injected, as this may cause serious, potentially fatal, adverse effects.
Take the tablets by mouth only.
OxyContin tablets are effective for a period of 12 hours when taken whole. If a tablet is broken, crushed, dissolved, or chewed, the entire dose covering 12 hours may be rapidly absorbed into your body. This can be dangerous and may lead to serious problems such as overdose, which can be fatal.

Adults and adolescents (12 years of age and older)
The usual starting dose is one 10 mg tablet every 12 hours. In some cases, your doctor may prescribe an initial dose of 5 mg to reduce the risk of possible side effects. Your doctor will determine the dose required to treat your pain.
If you continue to feel pain despite treatment with these tablets, discuss this with your doctor.

Children under 12 years of age
The safety and efficacy of OxyContin in children under 12 years of age have not been sufficiently studied. Therefore, treatment with OxyContin is not recommended in children under 12 years of age.

Patients with kidney or liver problems
Inform your doctor if you have kidney or liver problems, so that they can prescribe an alternative medicine or adjust the dose according to your condition.

If you take more OxyContin than you should, or if someone accidentally ingests the tablets, contact your doctor or go to hospital immediately.
An overdose may cause:

• constricted pupils
• slower or weaker breathing than normal (respiratory depression)
• drowsiness or loss of consciousness
• loss of muscle tone (hypotonia)
• reduced heart rate
• low blood pressure
• difficulty breathing due to fluid in the lungs (pulmonary edema)
• a brain disorder (known as toxic leukoencephalopathy).

In severe cases, overdose can lead to unconsciousness and even death. When seeking medical help, bring this leaflet and any remaining tablets with you to show the doctor.
If you have taken too many tablets, do not engage in activities requiring alertness, such as driving a vehicle.

If you forget to take OxyContin
If you remember within 4 hours of the scheduled dose, take it immediately, then take the next dose at the usual time. If more than 4 hours have passed since the missed dose, contact your doctor or pharmacist for advice. Do not take a double dose to make up for the forgotten tablet.

If you stop taking OxyContin
Do not stop taking the tablets abruptly unless instructed by your doctor. If you wish to discontinue treatment, discuss this with your doctor first. Your doctor will advise you on how to stop, usually by gradually reducing the dose, to avoid unpleasant effects. Withdrawal symptoms such as yawning, abnormally dilated pupils, tearing, runny nose, restlessness, anxiety, seizures, difficulty sleeping, palpitations, tremors, or sweating may occur if you suddenly stop taking these tablets.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, these tablets can cause side effects, although not everyone experiences them.
This medicine may cause allergic reactions, although severe allergic reactions are reported rarely.
Inform your doctor immediately if you experience sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, especially if it spreads over your entire body.
The most serious side effect occurs if you breathe more slowly or more weakly than normal (respiratory depression – a typical sign of opioid overdose).
As with other strong analgesics or painkillers, there is a risk of developing physical or psychological dependence on these tablets.

Very common side effects
(may affect more than 1 in 10 people being treated)

• Constipation (your doctor may prescribe a laxative to help prevent this problem).
• Nausea or vomiting (these usually improve within a few days; however, your doctor may prescribe an antiemetic medicine if the problem persists).
• Drowsiness (more likely at the beginning of treatment or after dose increases, but should resolve spontaneously after a few days).
• Dizziness.
• Headache.
• Itching.

Common side effects
(may affect 1 to 10 in 100 people being treated)

• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea.
• Confusion, depression, feeling unusually weak, tremors, lack of energy, fatigue, anxiety, nervousness, difficulty sleeping, abnormal dreams, unusual thoughts.
• Wheezing or difficulty breathing, shortness of breath.
• Difficulty urinating.
• Rash.
• Sweating, increased body temperature.

Uncommon side effects
(may affect 1 to 10 in 1,000 people being treated)

• A condition in which you breathe more slowly or more weakly than normal (respiratory depression).
• Difficulty swallowing, belching, hiccups, bloating, a condition in which the intestine does not function properly (ileus), inflammation of the stomach, gastrointestinal disorders (e.g. stomach upset), taste disturbances, mouth ulcers, mouth pain.
• A condition causing abnormal production of antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion).
• Feeling dizzy or lightheaded (vertigo), hallucinations, mood swings, euphoria, agitation, general feeling of unwellness, memory loss, difficulty speaking, reduced sensitivity to pain or touch, tingling or numbness, epileptic fit, seizure or convulsions, abnormal gait, depersonalisation, unusual hyperactivity, fainting, reduced level of consciousness, unusual muscle stiffness or floppiness, involuntary muscle contractions.
• Impotence, decreased libido, low levels of sex hormones in the blood (hypogonadism, detectable by blood tests).
• Hot flushes.
• Dehydration, changes in body weight, thirst, swelling of the hands, ankles or feet.
• Dry skin.
• Tear disturbances, blurred vision, reduced pupil size.
• Desire to take increasingly higher doses to achieve the same pain-relieving effect (tolerance).
• Perception of ringing or other sounds in the ears (tinnitus).
• Nasal swelling and irritation, nosebleeds, voice changes.
• Chills.
• Chest pain.
• Inability to completely empty the bladder.
• Worsening of liver function tests (seen in blood tests).
• Withdrawal symptoms (see section 3 “If you stop taking OxyContin”).

Rare side effects
(may affect 1 to 10 in 10,000 people being treated)

• A feeling of faintness, especially when standing.
• Low blood pressure.
• Urticaria (hives).

Frequency not known
(frequency cannot be estimated from the available data)

• Sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, especially when widespread over the body.
• Sleep apnoea (pauses in breathing during sleep).
• Deterioration of teeth.
• Colicky abdominal pain or discomfort.
• A condition affecting a valve in the intestine that may cause severe upper abdominal pain (Oddi sphincter dysfunction).
• Blockage of bile flow from the liver. This may cause itching, yellow skin, very dark urine and very pale stools.
• Absence of menstrual periods.
• Increased sensitivity to pain.
• Aggression.
• Long-term use of OxyContin during pregnancy may cause potentially life-threatening neonatal withdrawal syndrome. Symptoms in the newborn include irritability, hyperactivity and disturbed sleep patterns, high-pitched crying, tremors, restlessness, diarrhoea and failure to gain weight.

You may see remnants of the tablets in your faeces. This should not affect the effectiveness of the tablet.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store OxyContin

Keep this medicine out of the sight and reach of children. Accidental overdose in a child is extremely dangerous and potentially fatal. Store this medicine in a secure place, not accessible to others. It may cause serious harm or be fatal to people for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the blister and on the carton. The expiry date refers to the last day of that month.
For example, Exp. 08 2020 means that the tablets should not be taken after the last day of August 2020.
Do not store above 25°C.
Do not take broken or crushed tablets, as this may be dangerous and cause serious problems such as overdose.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What OxyContin Contains
The active substance is oxycodone hydrochloride. Each tablet contains 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg of oxycodone hydrochloride.
The other components are:

• Lactose monohydrate
• Povidone
• Ammonio methacrylate copolymer dispersion
• Sorbic acid
• Triacetin
• Stearyl alcohol
• Talc
• Magnesium stearate
• Hypromellose (E464)
• Titanium dioxide (E171)
• Macrogol

Additionally, the tablet coating contains:
5 mg – brilliant blue (E133)
10 mg – hydroxypropylcellulose
20 mg & 40 mg – polysorbate 80 (E433) and iron oxide (E172)
80 mg – hydroxypropylcellulose, iron oxide (E172), and indigo carmine (E132).

Description of the Appearance of OxyContin and Contents of the Pack
The tablets are printed with "OC" on one side and the dosage on the other (5, 10, etc.).
All tablets are round and biconvex. Tablets of 5, 10, 20, and 40 mg have a diameter of approximately 7 mm, while the 80 mg tablets have a diameter of approximately 9 mm.
All tablets are coated in the following colours: 5 mg – light blue, 10 mg – white, 20 mg – pink, 40 mg – yellow, 80 mg – green.
The tablets are packaged in blisters and then placed into cartons. Each package contains 10, 28, 30, 56, or 112 tablets.
The tablets are also packaged in polypropylene containers with polyethylene lids. Each container holds 28, 56, or 112 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mundipharma Pharmaceuticals S.r.l.
Viale Restelli 3/7, 20124 Milan, Italy

Responsible Manufacturers for Batch Release
Mundipharma DC B.V.
Leusderend 16
3832 RC Leusden
The Netherlands

This medicinal product is authorized under the name OxyContin in the Member States of the European Community:
Austria
Ireland
Spain
Italy

Date of the Most Recent Authorization of the Package Leaflet