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• Metadon Abcur 40 mg tablet PL
• Metadon Abcur 40 mg tablet ENG PL

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Package leaflet: Information for the user

Metadon Abcur 40 mg tablets

methadone hydrochloride

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.

What is in this leaflet

1. What Metadon Abcur is and what it is used for

2. What you need to know before you take Metadon Abcur

3. How to take Metadon Abcur

4. Possible side effects

6. Contents of the pack and other information

Metadon Abcur is a morphine-like medicinal product which is used for treating severe chronic pain which can be adequately managed only with opioid analgesics.

Do not takeMetadon Abcur:

- if you are allergic to methadone or any of the other ingredients of this medicinal product (listed in section 6).

- if you use or have used a monoamino-oxidase inhibitor (MAO-inhibitor) within the last two weeks (medicine used for depression and Parkinson's disease).

Metadon Abcur MUST not be given to children.

Warnings and precautions

Talk to your doctor before taking Metadon Abcur if you:

- get acute asthma attacks

- suffer from lung disease or breathing difficulties

- have a heart disorder or ischemic heart disease

- have a liver disease or impaired liver function (including gallstones)

- have impaired kidney function (including kidney stones)

- have an underactive thyroid gland

- have skin- or tissue diseases

- have an enlarged prostate or narrowing of the urethra

• have been affected by a head injury and the pressure in the brain is higher than it should be (check this with your doctor). You may be affected by a severe headache.

• are treated for drug addiction or overdosage of opioids

• have difficulties to pass water

• have stomach pains, diarrhoea or constipation

• have a low oxygen level or high carbon dioxide level in the blood

• take other medicines of opioid type (painkillers), such as morphine and pentazocine

• take other medicines which gets you relaxed and help you go to sleep (barbiturates and benzodiazepines)

• have low levels of potassium or magnesium in the blood

Metadon Abcur may affect the electrical signals which operate the heart constrictions, especially at high doses. Tell your doctor if you have a history of heart problems.

Children

Children are more sensitive to methadone than adults. Therefore may poisoning occur at very low doses. In order to avoid children to take methadone by mistake when you use it at home, the methadone should be stored in a safe place, out of reach of children.

Other medicines and Metadon Abcur

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicine.

Tell your doctor if you are taking any of the following medicines:

• any medicine that affects your mental state (eg. thioridazine, phentiazines, haloperidole and sertindole)

• medicines for heart diseases (verapamil, quinidine)

• the type of medicines for depression called monoamine-oxidase inhibitor (MAO-inhibitor), especially if you have taken them within the last two weeks. Also tell your doctor if you are using other antidepressant medicines (eg. imipramine, nefazodone, fluoxetine, fluvoxamine, paroxetine and sertraline).

• the type of medicines for depression called tricyclic antidepressants (eg. clomipramine, nortriptyline, desipramine)

• antipsychotic agents of phenothiazine type (eg. perphenazine, thioridazine)

• antipsychotic agents (risperidone)

• antiarrhythmic agents (Typ 1c eg. propafenone and flecainide)

• medicines for treatment of ADHD (atomoxetine)

• beta receptor blocker (metoprolole)

• medicines for breast cancer (tamoxifen)

• anti-inflammatory and immunosuppressive agents (eg. dexamethasone and ciclosporin)

• antiviral medicines, including certain anti-HIV medicines eg. nevirapine, zidovudine, efavirenz, nelfinavir, delavirdin, ritonavir, combination of lopinavir/ritonavir, combination of ritonavir/saquinavir, didanosine and stavudine

• antibiotics of macrolide type (medicines to treat bacterial infections) such as clarithromycin, telithromycin and erythromycin

• cimetidine (medicine for gastric ulcer)

• antimycotics (antifungal medicines) such as ketoconazole, itraconazole and fluconazole

• naloxone (a medicine for breathing difficulties)

• medicines to treat drug addiction eg. naltrexone and buprenorphine

• rifampicin (a medicine for tuberculosis or TBC)

• medicines for epilepsy (eg. phenytoin, phenobarbital and carbamazepine)

• vitamin tablets (which contains C-vitamin)

• medicines for diarrhoea (loperamide, diphenoxylate)

• medicines that make the urine more acidic such as ammonium chloride (sal ammoniac)

• diuretics (spironolactone)

• medicines that make you sleepy or drowsy

• natural remedies containing St John's wort

Other medicines you may be taken can also affect the heart (eg. sotalol and amiodarone).

You must tell your doctor about all other medicines that you are taking, since they may potentially be dangerous if they are taken with methadone. In such situations your doctor may decides that your heart should be monitored with ECG in the beginning of the treatment to check that no such effects occur. Methadon may also affect certain blood- and urine samples. Tell your doctor that you take methadone before you give any samples.

Using Metadon Abcur with drink and alcohol

You are not allowed to drink alcohol while taking Metadon Abcur since this can give serious side effects. Do not drink grapefruit juice while being treated with Metadon Abcur, since this may change the effect of the medicine.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding you should only take Metadon Abcur after you have talked to your doctor.

You are not recommended to use Metadon during labor.

If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Methadone affects the coordination between the brain and body movements, so the ability to drive or use machines may be severely affected until your medication has been stabilised at a certain dose level. Therefore you should not drive or use machines during the initial treatment period. How long it takes before you can drive or use machines is to a large extent individual, so you should decide this together with you doctor.

Metadon Abcur contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take Metadon Abcur exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor tells how much Metadon Abcur you should take and how often you should take the medicine. It is important that you do not take more than the dose that you and your doctor have agreed upon. The individual need may be different. Modification or discontinuation of treatment should only be done in consultation with your doctor.

Severe pain

Adults: The usual initial dose is 5 mg 1-3 times/day. Thereafter the dose can be increased slowly. Continued determination of the daily dose, the dividing of doses and all dose adjustments during the treatment are done by the attending doctor and depends on the previous dose.

Patients who have taken opioids earlier may start the treatment at higher doses, 5-20 mg 2-3 times/day, since their earlier experience of opioid treatment is considered.

Elderly: It is necessary to decrease the dose. Follow the doctor's advice.

Older people are more sensitive to this medicine and may therefore develop poisoning symptoms even atthe specified dosage. See "If you take more Metadon Abcur than you should".

Impaired renal function:It may be necessary to adjust the dose. Follow the doctor's advice.

Impaired hepatic function:It may be necessary to decrease the dose. Follow the doctor's advice.

Use in children

Metadon Abcur must NOT be given to children. There is a serious risk of poisoning. Remember to store the medicine in a safe place, out of reach of children.

If you take more Metadon Abcur than you should

If you have taken more medicinal product than you should or if for example a child has taken the medicine by mistake, you should seek medical advise.

Signs of overdose of Metadon Abcur may be small pupils, drowsiness, paleness, moist skin, low body temperature, breathing difficulties and coma. At severe overdosage the following symptoms may occur: short respiratory arrest, low blood pressure, slow pulse, shock, heart effects, fluid in the lungs, seizures, muscle weakness, renal failure, irregular heart rhythm and death. Children and elderly are more sensitive to this medicine. Contact your doctor if any of the above symptoms occur.

If your forget to take Metadon Abcur

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Metadon Abcur

You should only discontinue or terminate the treatment after talking with your doctor. You should not suddenly discontinue taking Metadon Abcur, since you may experience abstinence symptoms such as sleeplessness, running nose, tearing, anorexia, diarrhoea and pains.

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

4. Possible side effects

Like all medicines, Metadon Abcur can cause side effects, although not everybody gets them.

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

Common side effects (may affect up to 1 in 10 people):

• Weight increase

• Accumulation of water in the body

• Constipation

• Excitement (euphoria), you see or hear things that are not real (hallucinations),

• A feeling of dizziness or that you are spinning around

• Blurred vision

• Pinpoint pupils

• Drowsiness

• Rash

• Sweatin

• Tiredness.

Uncommon side effects (may affect up to 1 in 100 people):

• Loss of appetite

• Breathing difficulties (with cough)

• Mouth dryness

• Inflammation in the tongue

• Depressed mood (dysphoria)

• Anxiety

• Sleep disturbance

• Confusion

• Decreased sexual drive

• Headache

• Fainting

• Itching, urticarial, rash

• Swollen legs

• Weakness

• Accumulation of water in the body

• Seizure in the bile ducts (gives stomach ache)

• Facial flush

• Low blood pressure

• Difficulties to pass water

• Difficulties in achieving or maintaining erection

• Menstrual disorders.

Rare side effects (may affect up to 1 in 1,000 people):

Not known: frequency cannot be estimated from the available data:

• Too low level of potassium or magnesium in the blood

• Decreased number of blood platelets in the blood.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Metadon Abcur

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.

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.

What Metadon Abcur contains

- The other ingredients are lactose monohydrate, maize starch, magnesium stearate,talc, povidone, colloidal anhydrous silica.

What Metadon Abcur looks like and contents of the pack

Metadon Abcur 40 mg is a white to off-white hexagonal, flat bevelled tablet,

with score line on one side and embossing "M40" on the other side, tablet dimension 9.5 x 3.2 mm. The tablet can be divided into equal doses.

Metadon Abcur 40 mg is available in:

Childproof container: 25 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Abcur AB

Box 1452

251 14 Helsingborg

This leaflet was last revised in 26 February 2015