Oxycorrell 10 mg/20 mg/40 mg/80 mg Prolonged-Release Tablets

Oxycorrell Once Daily contain the active ingredient oxycodone which belongs to a group of medicines called opioids which are strong analgesics or ‘painkillers’. Oxycorrell Once Daily is used to treat severe pain over a period of 24 hours, which can be adequately managed only with opioid analgesics. Oxycorrell Once Daily is indicated in adults over 18 years.

Do not take Oxycorrell Once Daily

• if you are hypersensitive (allergic) to oxycodone hydrochloride or any of the other ingredients of Oxycorrell Once Daily (listed in section 6)
• if you have breathing problems, such as severe chronic obstructive lung disease, severe bronchial asthma or severely depressed breathing (respiratory depression) with too little oxygen in the blood (hypoxia) and/or too much carbon dioxide (hypercarbia) in the blood. Your doctor would have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected
• if you have gastrointestinal problems, such as a condition where the small bowel does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying), you have severe pain in your abdomen (acute abdomen) or suffer from ongoing problems with constipation
• if you have a heart problem after long-term lung disease (cor pulmonale)
• if you 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
• if you are under 18 years of age.

Warnings and precautions

Tell your doctor or health care provider before being given Oxycorrell Once Daily 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 Oxycorrell Once Daily to gain the same level of pain relief (tolerance)
• are taking a type of medicine known as a monoamine oxidase inhibitor (MAOI) or you have taken this type of medicine in the last two weeks (see Other medicines and Oxycorrell Once Daily)

Do not share medicines prescribed for you with any other person. Always take Oxycorrell Once Daily exactly as your doctor has instructed you. Check with your doctor if you are not sure.

Adults (over 18 years of age)

The usual dose of Oxycorrell Once Daily is one tablet daily. Your doctor will prescribe the exact daily dose required to treat your pain. If you find that you are still in pain whilst taking these tablets, discuss this with your doctor. Take the tablets once daily as advised by your doctor. Your doctor will decide how to control your treatment and will regularly review it with regard to pain relief and other effects in order to achieve the best pain therapy possible for you as well as to be able to treat the side effects and to decide whether treatment should be continued. Your doctor will adjust the dosage depending on the pain intensity and how you respond to the treatment.

Method of administration

Oxycorrell Once Daily tablets are for oral use only. Swallow the tablets whole with a sufficient amount of liquid (half a glass of water) with or without food, preferably at the same time each day. The tablets must be swallowed whole, not chewed, crushed or dissolved. Oxycorrell Once Daily tablets are designed to work properly over 24 hours when swallowed whole. If a tablet is crushed, dissolved or chewed, the entire 24-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an over-dose, which may be fatal (see also section 2, “Warnings and precautions”). 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”).

Opening instruction for the blister

This medicinal product is packed in a child-resistant blister. You cannot press out the prolonged release tablets through the blister. Please observe the following opening instruction for the blister:

1. Tear off a single dose along the perforation line of the blister.
2. Hereby an unsealed area is accessible which is located at the position, where the perforation lines have crossed.
3. Pull at the unsealed "strap" to peel off the cover seal.

Duration of administration

Your doctor will tell you how long your treatment with Oxycorrell Once Daily will last. Do not stop treatment without informing your doctor (see “If you stop taking Oxycorrell Once Daily”). If you have the impression that the effect of Oxycorrell Once Daily is too strong or too weak, tell your doctor or pharmacist.

Children and adolescents

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 Oxycorrell Once Daily than you should

In the event of overdosage, call your doctor or pharmacist immediately. If neither is available, contact the nearest hospital or poison centre immediately.

Oxycorrell Once Daily can have side effects. Not all side effects reported for Oxycorrell Once Daily are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Oxycorrell Once Daily, please consult your health care provider for advice.

If any of the following happens, stop taking Oxycorrell Once Daily and tell your doctor immediately or go to the casualty department at your nearest hospital:

• depressed breathing (slowed or weaker breathing). This is the most significant risk induced by opioids such as Oxycorrell Once Daily and is most likely to occur in elderly or debilitated patients. As a consequence, in predisposed patients opioids can cause severe drops in blood pressure, coma and death.
• constricted pupils, severe bronchial spasms and spasms in smooth muscles and suppression of the cough reflex
• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting. These are very serious side effects. If you have them, you may have had a serious reaction to Oxycorrell Once Daily. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Frequent side effects
• confusion
• 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
• difficulty in breathing or wheezing, shortness of breath, decreased cough reflex
• constipation, abdominal pain

Less frequent side effects

• dehydration
• dependence (addiction) which is the physical and/or psychological need for the medicine and is likely when using the medicine becomes the focus of your life and interferes with your ability to cope without the medicine
• loss of memory (amnesia), seizures, fits or convulsions, unusual muscle stiffness or slackness (hypertonia and hypotonia), involuntary muscle contractions, fainting (syncope)
• blurred vision
• a feeling of dizziness or ‘spinning’ (vertigo)
• fast, irregular heart beat (palpitations)
• a condition where the bowel does not work properly (ileus) inflammation of the lining of the stomach (gastritis)
• a worsening of liver function tests (seen in a blood test), colicky abdominal pain or discomfort
• severe flaking or peeling of the skin (exfoliative dermatitis) or a rash of round, red welts on the skin that itch intensely, sometimes with dangerous swelling (also called nettle rash, hives or urticaria)
• difficulty in passing urine
• impotence, decreased sexual drive, low levels of sex hormones in the blood (‘hypogonadism’, seen in a blood test)
• medicine withdrawal syndrome with some or all of the following symptoms: restlessness, increased production of tears, runny nose, yawning, sweating, chills, muscle pain, abnormal dilatation of the pupil, sensation of irregular and forceful heartbeat, irritability, anxiety, backache, joint pain, weakness, belly cramps, sleeplessness, being sick, lack of appetite, vomiting, diarrhoea, or increased blood pressure, breathing rate or heart rate

Side effects with frequency unknown

• an increased sensitivity to pain (hyperalgesia)
• 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 Oxycorrell Once Daily 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

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• Frequent side effects
• decreased appetite
• anxiety, depression, difficulty in sleeping, nervousness, abnormal thoughts or dreams
• headache
• lack of energy, shaking, a feeling of unusual weakness, tiredness
• 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)
• dry mouth, indigestion, diarrhoea
• itchy skin, rash and sweating

Less frequent side effects

• agitation, feeling of extreme happiness, hallucinations, disorientation, mood changes, unpleasant or uncomfortable mood, a restlessness, generally feeling unwell
• difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness (‘pins and needles’)
• flushing of the skin and face, low blood pressure, a feeling of ‘faintness’ especially on standing up
• difficulty in swallowing, belching, hiccups, wind, changes in taste
• dry skin
• dehydration, thirst, chills, high body temperature, swelling of the hands, ankles or feet

Tolerance and dependence may develop with chronic use and a withdrawal syndrome may occur upon abrupt cessation of therapy. The withdrawal syndrome is characterised by some or all of the following: restlessness, increased production of tears, runny nose, yawning, sweating, chills, muscle pain, abnormal dilatation of the pupil and sensation of irregular and forceful heartbeat. Other symptoms may also develop, including: irritability, anxiety, backache, joint pain, weakness, belly cramps, sleeplessness, being sick, lack of appetite, vomiting, diarrhoea, or increased blood pressure, breathing rate or heart rate. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Oxycorrell Once Daily.

• Store all medicines out of reach of children.
• Store at or below 25 °C, protected from moisture and light.
• Store in the original packaging until required for use.
• Do not store your medicine in the bathroom.
• Do not use after the expiry date stated on the blister and carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).