Oxycontin 40mg Film-Coated Prolonged-Release Tablets
S1058-61 LEAFLET Oxycontin 20160428
PACKAGE LEAFLET: INFORMATION FOR USER OxyContin® 10mg film-coated prolonged-release tablets OxyContin® 20mg film-coated prolonged-release tablets OxyContin® 40mg film-coated prolonged-release tablets OxyContin® 80mg film-coated prolonged-release tablets (oxycodone hydrochloride)
Your medicine is known as above but will be referred to as OxyContin tablets throughout the following leaflet.
Please note that information regarding other strength of OxyContin tablets is also present in the below leaflet.
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
These tablets have been prescribed for you by your doctor to relieve moderate to severe pain over a period of 12 hours. They contain the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or ‘painkillers'.
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');
• 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 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;
• are under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking these tablets if you:
• are elderly or weakened;
• have an under-active thyroid gland (hypothyroidism), as you may need a lower dose;
• have myxoedema (a thyroid disorder with dryness, coldness and swelling [‘puffiness'] of the skin affecting the face and limbs;
• 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 happen with severe external or internal bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting;
• have a mental disorder as a result of an infection (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), e.g. Addison's disease;
• have breathing problems such as severe pulmonary disease. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing;
• have kidney or liver problems;
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs;
• are or have ever been addicted to alcohol or drugs or have a known opioid dependence;
• have an increased sensitivity to pain;
• need to take increasingly higher doses of OxyContin to gain the same level of pain relief (tolerance).
If you are going to have an operation, please tell the doctor at the
hospital that you are taking these tablets.
Other medicines and OxyContin
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. If you take these tablets with some other medicines, the effect of these tablets or the other medicine may be changed.
Tell your doctor or pharmacist if you are taking:
• a type of medicine known as a monoamine oxidase inhibitor or you have taken this type of medicine in the last two weeks;
• medicines to help you sleep or stay calm (for example tranquillisers, hypnotics or sedatives);
• medicines to treat depression (such as paroxetine);
• medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptic drugs);
• other strong analgesics (‘painkillers');
• muscle relaxants;
• medicines to treat high blood pressure;
• quinidine (a medicine to treat a fast heart beat);
• cimetidine (a medicine for stomach ulcers, indigestion or heartburn);
• antifungal medicines (such as ketoconazole, voriconazole, itraconazole and posaconazole);
• antibiotics (such as clarithromycin, erythromycin or telithromycin);
• medicines known as ‘protease inhibitors' to treat HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir or saquinavir);
• rifampicin (to treat tuberculosis);
• carbamazepine (a medicine to treat seizures, fits or convulsions and certain pain conditions);
• phenytoin (a medicine to treat seizures, fits or convulsions);
• a herbal remedy called St. John's Wort (also known as Hypericum perforatum);
• antihistamines;
• medicines to treat Parkinson's disease.
Also tell your doctor if you have recently been given an anaesthetic. Taking OxyContin tablets with food, drink and alcohol
Drinking alcohol whilst taking OxyContin tablets 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 not to drink alcohol while you're taking OxyContin tablets.
You should avoid drinking grapefruit juice during your treatment with this medicine.
Pregnancy and breastfeeding
Do not take these tablets if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines
These tablets may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 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. If you are affected you should not drive or use machinery.
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it 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:
• 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 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.
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. 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.
Children
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 straight away. 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
You should not suddenly stop taking these tablets unless your doctor tells you to. If you want to stop taking your tablets, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, palpitations, shaking or sweating may occur if you suddenly stop taking these tablets.
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.
The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression). Tell your doctor immediately if this happens to you As with all strong painkillers, there is a risk that you may become addicted or reliant on these tablets.
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 or wheezing, shortness of breath, decreased cough reflex.
• Rash.
• Sweating.
Uncommon side effects
(May affect up to 1 in 100 people)
• Difficulty in swallowing, belching, hiccups, wind, a condition where the bowel does not work properly (ileus), inflammation of the stomach, changes in taste.
• A feeling of dizziness or ‘spinning', hallucinations, mood changes, unpleasant or uncomfortable mood, a feeling of extreme happiness, 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 vision, fainting, unusual muscle stiffness or slackness, involuntary muscle contractions.
• Difficulty in passing urine, impotence, decreased sexual drive, low levels of sex hormones in the blood (‘hypogonadism', seen in a blood test).
• Fast, irregular heart beat, 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, muscle spasm, 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.
• A feeling of ‘faintness' especially on standing up.
• Hives (nettle rash).
Frequency not known
(Frequency cannot be estimated from the available data)
• 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.
• 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, diarrhea 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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE OXYCONTIN TABLETS
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Accidental overdose by a child is dangerous and may be fatal.
• Do not store above 25°C.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What OxyContin tablets contain
• OxyContin 10mg tablets- Each film-coated, prolonged release tablet contains 10mg oxycodone hydrochloride, equivalent to 9mg oxycodone.
• OxyContin 20mg tablets- Each film-coated, prolonged release tablet contains 20mg oxycodone hydrochloride, equivalent to 18mg oxycodone.
• OxyContin 40mg tablets- Each film-coated, prolonged release tablet contains 40mg oxycodone hydrochloride, equivalent to 36mg oxycodone.
• OxyContin 80mg tablets- Each film-coated, prolonged release tablet contains 80mg oxycodone hydrochloride, equivalent to 72mg oxycodone.
• OxyContin tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, ammoniomethacrylate copolymer, povidone, stearyl alcohol, talc, triacetin, hypromellose (E464), macrogol and titanium dioxide (E171).
• In addition the tablet coatings also contain the following: 10mg tablet contains hydroxypropylcellulose; 20mg and 40mg tablets contain polysorbate 80 and iron oxide (E172); 80mg tablet contains hydroxypropylcellulose, iron oxide (E172) and indigo carmine (E132).
What OxyContin tablets looks like and contents of the pack
• OxyContin 10mg tablets are white tablet with a white core marked ‘10' on one side and ‘OC' on the other.
• OxyContin 20mg tablets are round pink tablet with a white core marked ‘20' on one side and ‘OC' on the other.
• OxyContin 40mg tablets are round yellow tablet with a white core marked ‘40' on one side and ‘OC' on the other'.
• OxyContin 80mg tablets are round green tablet with a white core marked ‘80' on one side and ‘OC' on the other'
• OxyContin tablets are available as blister packs of 28, 56 or 98 tablets.
• OxyContin tablets are also available in a bottle of 50 tablets. Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Bard Pharmaceuticals Ltd, Cambridge Science Park, Milton Rd, Cambridge CB4 0GW U.K.
|POM |
PL 19488/1058 OxyContin 10mg film-coated prolonged- release tablets
PL 19488/1059 OxyContin 20mg film-coated prolonged- release tablets
PL 19488/1060 OxyContin 40mg film-coated prolonged- release tablets
PL 19488/1061 OxyContin 80mg film-coated prolonged- release tablets
Leaflet revision date: 28 April 2016
® OxyContin is a registered trade mark of Napp Pharmaceutical Holdings Limited.
S1058-61 LEAFLET Oxycontin 20160428