Document: Metadon Pharmadone oral solution ENG PL change

• Metadon Pharmadone oral solution PL
• Metadon Pharmadone oral solution ENG PL

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Package leaflet: Information for the user

Metadon Pharmadone 10 mg oral solution

Metadon Pharmadone 15 mg oral solution

Metadon Pharmadone 20 mg oral solution

Metadon Pharmadone 25 mg oral solution

Metadon Pharmadone 30 mg oral solution

Metadon Pharmadone 35 mg oral solution

Metadon Pharmadone 40 mg oral solution

Metadon Pharmadone 45 mg oral solution

Metadon Pharmadone 50 mg oral solution

Metadon Pharmadone 55 mg oral solution

Metadon Pharmadone 60 mg oral solution

Metadon Pharmadone 70 mg oral solution

Metadon Pharmadone 80 mg oral solution

Metadon Pharmadone 90 mg oral solution

Metadon Pharmadone 100 mg oral solution

Metadon Pharmadone 110 mg oral solution

Metadon Pharmadone 120 mg oral solution

Metadon Pharmadone 130 mg oral solution

Metadon Pharmadone 140 mg oral solution

Metadon Pharmadone 150 mg oral solution

Methadone hydrochloride

Read this entire 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 Pharmadone is and what it is used for

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

3. How to take Metadon Pharmadone

4. Possible side effects

6. Content of the pack and other information

Metadon Pharmadone is used for the treatment of opioid-related drug dependency. Methadone blocks the body’s opioid receptor, and supresses the symptoms of withdrawal. Methadone treatment is supposed to take place together with psychological treatment and social follow-up. All methadone treatment shall be according to national guidelines.

Do not take Metadon Pharmadone:

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

- if you are treated with opioid agonists/antagonists.

- if you are taking MAOIs (used to treat depression, Parkinson disease), or have taken them lately.

Metadon Pharmadone should not be given to children.

Take special care with Methadone Pharmadone solution

- if you have acute asthma attack or reduced lung capacity due to any lung diseases.

- if you have reduced kidney function or kidney-/gallstones.

- if you have reduced liver function.

- if you have serious heart problems or problems with cardiac rhythm.

- if you are treated with certain heart medicines.

- if you have inflammatory or obstructive bowel disease.

- if you have an enlarged prostate gland or narrowing of the urethra.

- if you have problems with the thyroid gland.

- if you have head injury.

Children are more sensitive to methadone than adults. Poisoning can take place event at very low dose. To avoid that children mistakenly can take methadone when using it at home, store it in a secure place and keep out of the reach of children.

Co-administration of opioid type drugs, barbiturates, benzodiazepines or other drugs with a strong sedative effect should be avoided as it can increase the effect and side effects of methadone.

Talk to your doctor before taking Metadon Pharmadone.

Other medicines and Metadon Pharmadone

Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines.

It is especially important to tell your doctor if you are taking any of the following:

- drugs used to treat epilepsy (e.g. carbamazepine, phenobarbital, phenytoin).

- certain antibiotics (such as rifampicin, telithromycin, erythromycin).

- herbal medicines containing St John’s Wort.

- antifungals (such as fluconazole, itraconazole, ketoconazole).

- medicines used to treat heart diseases (verapamil, quinidine).

- medicines used to treat depression (imipramine, desipramine, clomipramine, nortriptyline, nefazodon, fluoxetine, fluvoxamine, paroxetine and sertraline).

- anti-inflammatory and immunosuppressant (dexamethasone and cyclosporine).

- diuretic medicines (spironolactone).

- medicines used to treat diarrhoea (loperamid, diphenoxylate).

- medicines used to treat coughing (containing ammonium chloride).

- vitamin tables (containing ascorbic acid).

- medicines used to treat HIV (amprenavir, nelfinavir, efavirenz, delavirdin, nevirapin, lopinavir, ritonavir, saquinavir, didanosine, zidovudine and stavudine).

The above mentioned medicines can affect the way methadone works and/or can be affected by methadone.

Other medicines you may be taking can also affect the heart:

- medicines which affect cardiac rhythm (e.g. sotalol, metoprolol, propafenone, amiodaron, flekainid).

- certain medicines that have an effect on the mental state (thioridazine and perfenazine (phentiazines), haloperidol, risperidone, atomoxetine and sertindole).

- certain medicines used to treat depression (e.g. paroxetine, sertralin).

- certain antibiotics (clarithromycin, erythromycin).

Attention must be shown if you at the same time use:

- strong painkillers.

- medicines used to treat mental disorders.

- sedatives.

- medicines that make you feel sleepy.

- other medicines that have an effect on the brain.

Metadon Pharmadone with food and drink

Metadon Pharmadone can cause reduced breathing and sleepiness which can increase with simultaneous intake of alcohol. Do not drink grapefruit juice while you are taking Metadon Pharmadone as it may alter the effect of the medicinal product.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

The foetus may be affected if methadone is used during pregnancy. Do not use Metadon Pharmadone whilst you are in labour unless prescribed by your doctor.

Methadone passes into breast milk. Do not use Metadon Pharmadone whilst breast feeding unless prescribed by your doctor.

Driving and using machines

Methadone influence on the psychomotoric ability until the dosing is stabilized. You should not drive or operate machinery under dose increasing. The time for driving or operating machines depends individually, and shall be decided together with your doctor.

Important information about some ingredients of Metadon Pharmadone

Sucrose:

Contains 11 g sucrose per dose. The amount of sugar should be taken into account if you have diabetes mellitus. If you cannot tolerate some sugars, tell your doctor before taking this medicine.

Glucose:

If you cannot tolerate some sugars, tell your doctor before taking this medicine.

Methylparahydroxybensate:

May cause allergic reactions (possible delayed).

Always take this medicine exactly as your doctor has told you. The dose is individually determined for you by the doctor. Check with your doctor or pharmacist if you are not sure.

Metadon Pharmadone is an oral solution and must only be taken by mouth. If you feel that the effect of Metadon Pharmadone is too strong or too weak, consult your doctor.

If you take more Metadon Pharmadone than you should:

If you take more of this medicine than you should, always talk to a doctor or go to a hospital.

The signs you may notice if you have taken more medicine than you should, are difficulty in breathing and feeling very drowsy which may lead to coma.

If you forget to take Metadon Pharmadone

Do not take a double dose to make up for a forgotten dose. Contact your doctor or pharmacist for advice.

If you stop taking Metadon Pharmadone

Do not stop taking this medicine abruptly. It may cause withdrawal symptoms as restlessness, drowsiness, anxiety, tremulousness, nausea, vomiting or diarrhoea.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (affects more than 1 in 10 people)

Feeling sick (nausea, vomiting) (mostly patients treated at home).

Common side effects (affects up to 1 in 100 people)

Constipation and sweating. Hallucinations.

Weight increase. Feeling high. Feeling of dizziness or spinning, feeling tired, feeling sleepy. Pin point pupils, blurred vision. Skin rash. Water retention.

After long term use of methadone, the side effects are gradually reduced, but obstipation and sweating remains.

Uncommon side effects (affects up to1 in 1000 people)

Breathing difficulty due to lung oedema. Loss of appetite, inflammation of tongue (glossitis), dry mouth, feeling down, agitation, respiratory depression. Itching, hives, sometimes bleeding hives, other rash, water retention in skin and tissue, Swelling of legs and feet (leg oedema), Bile duct spasm, Facial flush, fainting and low blood pressure. Difficulty in passing urine. Reduced urine production. Reduced libido and/or achieving of maintaining erection and disturbances in menstruation. Weakness, headache, difficulty sleeping, confusion.

Rare side effects (affects up to1 in 10000 people)

Some cases of heart problems have been reported, especially at high doses of methadone.

Unknown side effects (frequency of these side effects is not known)

Deficiency of potassium or magnesium in blood. Lower levels of platelets in blood has been reported for opioid patients with chronic liver inflammation.

When taken for a long period of time, it is possible that you may be morphine type dependent. The withdrawal effects are analogue to that of morphine and heroin, but are less intensive but lasts longer.

If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Metadon Pharmadone

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

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

Do not use Metadon Pharmadone if the cap seal is broken.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Content of the pack and other information

What Metadon Pharmadone contains

• The active substance is methadone hydrochloride

• The other ingredients are sucrose, glucose, raspberry aroma, purified water and methylparahydroxybensate (E218).

What Metadon Pharmadone looks like and contents of the pack

Clear, transparent solution which is available in white plastic bottles, sealed with a children safe, breaking sealed cap. The bottle contains 50 ml oral solution.

Pack sizes: 1 bottle (all strengths) and 7 bottles (1x7) (50 mg, 60 mg, 70 mg, 80 mg, 90 mg, 100 mg, 110 mg, 120 mg, 130 mg, 140 mg and 150 mg).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

<To be completed nationally>

This leaflet was last revised:

2013-08-07