PATIENT INFORMATION LEAFLET PINADONE METHADONE DTF 1MG/ML ORAL SOLUTION SUGAR FREE Methadone hydrochloride

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1 PATIENT INFORMATION LEAFLET PINADONE METHADONE DTF 1MG/ML ORAL SOLUTION SUGAR FREE Methadone hydrochloride Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Pinadone is and what it is used for 2. Before you take Pinadone 3. How to take Pinadone 4. Possible side effects 5. How to store Pinadone 6. Further information 1. WHAT PINADONE IS AND WHAT IT IS USED FOR Pinadone Methadone DTF 1mg/ml Oral Solution Sugar Free is indicated for the relief of pain in conditions where morphine may be a reasonable alternative, such as severe cancer pain. Pinadone Methadone DTF 1mg/ml Oral Solution Sugar Free is also used as part of the treatment of dependence on opium related drugs. 2. BEFORE YOU TAKE PINADONE Do NOT take Pinadone if you: are allergic (hypersensitive) to methadone hydrochloride or any of the other ingredients in the product (see Section 6 and end of Section 2) are having an asthma attack or suffer from any other respiratory problems or a disease of the lungs where air flow is blocked (COPD) have had any head related injuries or increased pressure in the head have ulcerative colitis (inflammation of the bowel) have a heart condition called QT prolongation or have a heart condition which causes irregular heartbeat from birth have severe liver problems are taking monoamine oxidase inhibitors (MAOIs) or have taken them in the past 2 weeks are pregnant or breast-feeding, or in labour. Pinadone is not recommended for use in children. Take special care Before you take Pinadone tell your doctor if you have: any heart problems including unusual heart beats, heart disease or heart failure or are taking drugs that prolong the QT interval. You will need to be monitored carefully an underactive thyroid gland a tumour of your adrenal gland that causes high blood pressure (phaeochromocytoma)

2 liver or kidney problems or problems with your adrenal glands where low levels of the adrenaline hormone is produced (hypoadrenalism) low potassium or magnesium in your blood, or are taking mineral supplements or hormones to control salt levels in your blood low blood pressure have recently had a head injury inadequate blood supply to the heart asthma or breathing problems. Your doctor may carry out liver function and kidney tests before you take this medicine. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, particularly: MAOIs e.g. moclobemide or phenelzine for depression, selegiline for Parkinson s disease - or in the two weeks after you have stopped taking them (see Section 2 Do not take ) life-threatening interactions affecting the central nervous system, respiratory or heart function have been seen tricyclic antidepressants, serotonin re-uptake inhibitors (SSRIs) and antipsychotic medicines some high blood pressure drugs heart rhythm disorder drugs e.g. digoxin and quinidine certain antibiotics or antifungal medicines e.g. erythromycin, clarithromycin, ketoconazole, fluconazole, itraconazole, rifampicin medicines to treat viral infections carbamazepine or phenytoin for epilepsy opioid drugs e.g. codeine, co-proxamol, morphine, diamorphine, pentazocine, pethidine opioid antagonists e.g. naloxone, naltrexone, buprenorphine medicines for stomach ulcers e.g. cimetidine the herbal remedy St. John s wort water tablets e.g. spironolactone, laxatives, or if you are a vegetarian amprenavir, nevirapine or efavirenz for HIV alcohol phenobarbital to help you sleep or calm you down (tranquillisers) dexamethasone for arthritis, skin, blood, kidney, eye, thyroid and intestinal disorders and some cancers telithromycin to treat mild to moderate respiratory infections medicines that make your urine more acidic such as ascorbic acid (vitamin C) phenothiazines e.g. chlorpromazine atracurium - muscle relaxant People sensitive to aspirin may develop allergic reactions to the food colourings used in this medicine. Taking Pinadone with food and drink Do not drink alcohol whilst taking this medicine. Vegetarian diets you should take special care if you are on a vegetarian diet. Speak to your doctor regarding the dose of this medicine. Pregnancy and breast-feeding

3 Tell your doctor if you are pregnant, think you may be pregnant or planning to become pregnant. This medicine should not be used during pregnancy unless the doctor has prescribed them due to possible withdrawal symptoms in the newborn. Pinadone must not be used during labour. The active ingredient in this medicine passes into breast milk and may affect your child. Your doctor will advise whether to take this medicine or not. Always ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Pinadone may cause drowsiness. If you are affected, do not drive or operate machinery until you are sure how this medicine affects you. Do not drink alcohol as blurred vision, dizziness or nausea may occur which may affect your ability to drive or operate machinery. Important information about some of the ingredients of this medicine Pinadone Solution contains: maltitol liquid (E965) If you have been told that you have an intolerance to some sugars, contact your doctor before taking this product. Pinadone contains 2.75 g maltitol/5 ml, and may have a mild laxative effect. Maltitol has a calorific value of 2.3 kcal/g. This product does not contain sugar. sunset yellow (E110) which may cause allergic reactions. 3. HOW TO TAKE PINADONE Always take Pinadone exactly as your doctor has told you. Your pharmacist or practitioner will give you the correct amount of Pinadone to take each day. At the weekend the pharmacist will give you the correct amount to take for the weekend. Ask your doctor or pharmacist if you are not sure about the dose you should take. Pain Management The usual initial dose is 5 to 10 mg methadone (daily). However, the dose is adjusted personally for each patient. Opioid Addiction Adults: Pinadone is usually taken by mouth as a single daily dose. The dose is adjusted personally for each patient your doctor will advise you. starting dose: mg daily. The dose is increased by mg (two to four 5 ml spoonfuls) daily until the correct level for each patient is reached. usual dose is mg (eight to twelve 5 ml spoonfuls) per day, which will be gradually reduced by the doctor. Patients with heart, kidney or liver problems: your dose will be reduced and you will be monitored carefully. If your condition is severe you should not be given this medicine. Pregnant women: you will need to stop taking this medicine at least 4 6 weeks before giving birth your doctor will advise you. Children: this medicine is NOT recommended for children. If you take more Pinadone than you should If you, or someone else, have taken too much medicine, contact your doctor immediately or go to your nearest hospital accident and emergency department. Take this leaflet and/or the pack with you.

4 Overdose can cause coma. Medical attention is required urgently and you should go to the nearest hospital emergency or poisons unit. Artificial respiration may be required until medical attention is available. If you forget to take Pinadone If you miss a dose, take one as soon as you remember, unless it is nearly time to take the next one. Take the remaining dose at the correct time. Do not take a double dose to make up for a forgotten dose. If you stop taking Pinadone Do not stop taking this medicine suddenly. Your dose needs to be gradually reduced. Your doctor will advise you. If you stop taking the medicine suddenly you may suffer withdrawal symptoms. Withdrawal symptoms are usually mild, may be observed after discontinuation and include: body aches, diarrhoea, erection of hair on the skin, eating disorders, nervousness or restlessness, sneezing, runny nose, tremors or shivering, abdominal cramps, nausea, sleep disturbance, increase in sweating and yawning, weakness and unexplained fever. Some people may notice that their heart is beating a little faster or more forcefully. With appropriate dose adjustments and gradual withdrawal, these symptoms are usually mild. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Pinadone can cause side effects, although not everybody gets them. STOP taking this solution and seek medical help immediately if you have any of the following which may be signs of an allergic reaction: difficulty breathing or swallowing swelling of the face, lips, tongue or throat severe itching of the skin, with a red rash or raised bumps. Some side effects may be more serious and you should tell your doctor immediately if you experience any of the following: slow or irregular heart beat low body temperature low blood pressure or a fall in blood pressure (associated with dizziness, feeling faint and blurred vision occurring when standing up). Large doses may cause difficulty breathing and dizziness. Very common side effects: (affects more than 1 person in 10) dizziness drowsiness light-headedness. Common side effects: (affects less than 1 in 10 people) nausea, vomiting dry mouth constipation difficulty urinating pain under the right rib cage (biliary spasm). Rare side effects: (affecting more than 1 in 10,000 to less than 1 in 1,000 people)

5 facial flushing slow or irregular heart beat QT prolongation and torsade de pointes faint. Other side effects include: hallucinations, mood changes constriction of the pupil of the eye (dependence miosis) slow or shallow breathing spasms in the kidney itching or skin rash low body temperature sweating weight gain. Prolonged use may cause breast enlargement and impotence in men and possible impaired fertility. Withdrawal abstinence syndrome, see section 3 - withdrawal symptoms. Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: ; Fax: ; Website: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE PINADONE Keep out of the sight and reach of children. Do not store above 25 C. Do not use Pinadone after the expiry date which is stated on the label. The expiry date refers to the last day of that month. The amber glass bottles should be used within 3 months of first opening. 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. FURTHER INFORMATION What this product contains: The active ingredient is 1 mg methadone hydrochloride in each ml. The other ingredients are: maltitol liquid (E965), benzoic acid (E210), propylene glycol, sodium hydroxide, hydroxyethylcellulose, purified water and the colours sunset yellow (E110) and green S (E142). (For further information on some ingredients see end of Section 2). What Pinadone looks like and contents of the pack Pinadone is a clear green oral solution, available in plastic bottles, pack sizes: 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, 50 ml, 55 ml, 60 ml, 500 ml, or 5 litre and amber glass bottles of 100 ml, 500 ml and 1 litre. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PA Number: 281/61/1 This leaflet was last updated in July 2016.