5 and 10 mg tablets
of methadone hydrochloride

What Methadone Abcur is and what it is used for

Methadone Abcur is a morphine-like drug used for:

  • treatment of severe chronic pain where only opioid analgesics provide sufficient effect
  • withdrawal treatment in opioid-dependent patients, in parallel with medical and psychological treatment and social rehabilitation.

Methadone contained in Methadone Abcur may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before you take Methadone Abcur

Do not take Methadone Abcur

  • if you are allergic to methadone or any of the other ingredients of this medicine (listed in section 6).
  • if you have used or have used monoamine oxidase inhibitors ( MAOIs ) in the last two weeks (medicines used to treat depression and Parkinson’s disease )
  • if you have difficulty breathing, with slow and shallow breathing, or have other acute breathing difficulties ( acute obstructive pulmonary disease ).

Methadone Abcur must NOT be given to children.

Warnings and cautions

Talk to your doctor before taking Methadone Abcur if you:

  • get acute asthma attacks
  • have lung disease or difficulty breathing
  • have heart problems or ischemic heart disease
  • have liver disease or impaired liver function (including gallstones )
  • has impaired kidney function (including kidney stones )
  • has an underactive thyroid gland
  • have skin and tissue diseases
  • have enlarged prostate or narrowing of the urethra
  • have suffered a head injury and the pressure in the brain is higher than it should be (check this with your doctor). You could suffer from severe headaches.
  • being treated for drug dependence or opioid overdose
  • have difficulty urinating
  • have stomach pain, diarrhea or constipation
  • has low oxygen content or high carbon dioxide content in the blood
  • take other opioid-type drugs (painkillers), such as morphine and pentazocine
  • take other medicines that make you relax and help you sleep ( barbiturates and benzodiazepines ). Concomitant use of benzodiazepines and Methadone Abcur may cause breathing difficulties ( respiratory depression ) and coma and may be life-threatening. If your doctor prescribes you benzodiazepines , it may be necessary for your doctor to change the dose or the duration of treatment or to monitor your condition regularly.
  • have low levels of potassium or magnesium in the blood

Methadone Abcur can affect the electrical signals that control the contractions of the heart, especially at high doses. Tell your doctor if you have had heart problems in the past.

Talk to your doctor or pharmacist if you get any of the following symptoms while taking Methadone Abcur:

  • weakness, fatigue, loss of appetite, nausea, vomiting or low blood pressure . This may be a symptom that the adrenal glands are producing too little of the hormone et cortisol , and you may need to take hormone supplements.
  • Prolonged use can lead to decreased levels of sex hormones and increased levels of the hormone et prolactin . Contact a doctor if you experience symptoms such as decreased sex drive, impotence or missed periods.

Risk of addiction/abuse

Talk to your doctor if you, or someone you know, suspect that you are starting to become addicted to this medicine or think you are taking too much medicine regularly.

Older

Elderly patients have an increased risk of low blood pressure and fainting.

Keep out of reach of children

Children are more sensitive to methadone than adults. Therefore, poisoning can occur at very low doses. To prevent children from accidentally ingesting methadone when using it at home, keep it in a safe place out of the reach of children.

Other medicines and Methadone Abcur

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

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

  • medicines that affect your mental state (eg thioridazine, perfenazine, risperidone , haloperidol and sertindole)
  • drugs for the treatment of ADHD (atomoxetine)
  • the type of antidepressant called monoamine oxidase inhibitors ( MAOIs ), especially if you have been taking them for the past two weeks. Also tell your doctor if you are taking other medicines for depression (eg imipramine, nefazodone, fluoxetine , fluvoxamine, paroxetine and sertraline ).
  • other antidepressants called tricyclic antidepressants (eg clomipramine, nortriptyline, desipramine)
  • medicines for heart disease (verapamil, quinidine )
  • antiarrhythmic agents (eg propafenone and flecainide ) and beta -blocker blockers ( metoprolol )
  • breast cancer drug (tamoxifen)
  • anti-inflammatory and immunosuppressive drugs (eg dexamethasone and ciclosporin)
  • antiviral drugs, including certain anti- HIV drugs e.g. nevirapine, zidovudine, efavirenz, nelfinavir, delavirdine, ritonavir, lopinavir / ritonavir combination, ritonavir / saquinavir combination, didanosine and stavudine
  • Macrolide-type antibiotics (medicines for bacterial infections) such as clarithromycin, telithromycin and erythromycin
  • rifampicin (a medicine used to treat tuberculosis or TB)
  • antifungals (medicines for fungal infections) such as ketoconazole , itraconazole and fluconazole
  • cimetidine (medicine for stomach ulcers )
  • naloxone (a medicine for breathing difficulties)
  • drugs against drug addiction e.g. naltrexone and buprenorphine
  • antiepileptic drugs (eg phenytoin , phenobarbital and carbamazepine)
  • vitamin tablets (containing vitamin C )
  • antiarrhythmic drugs (loperamide, diphenoxylate)
  • drugs and products that make the urine more acidic, e.g. ammonium chloride (ammonia)
  • diuretics ( spironolactone )
  • drugs that make you drowsy or drowsy
  • herbal medicine that contains St. John’s wort

Concomitant use of methadone and sedative drugs, such as benzodiazepines or similar drugs, increases the risk of drowsiness, difficulty breathing ( respiratory depression ), and coma and can be life-threatening. Due to this, concomitant use should only be considered by your doctor when other treatment options are not possible.

If your doctor prescribes Methadone Abcur at the same time as sedatives, the dose and duration of treatment should be limited.

The risk of side effects is increased if you use methadone at the same time as antidepressants (eg citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, and nortriptyline). Contact a doctor if you get symptoms such as:

  • effects on mental health (eg agitation , hallucinations or coma )
  • fast heartbeat, unstable blood pressure or fever
  • excessive reflexes, impaired coordination, muscle stiffness
  • gastrointestinal symptoms (eg nausea, vomiting or diarrhea)

Tell your doctor about all the sedative medicines you are taking and carefully follow your doctor’s dose recommendations. It can be good to inform friends or relatives about the risks described above. You must contact your doctor if you get these symptoms.

Other medicines you take may also affect your heart (eg sotalol and amiodarone ).

You must tell your doctor about all the other medicines you are taking, as they may be dangerous if you take them with methadone. In such situations, your doctor may decide that your heart needs to be monitored using an ECG at the beginning of treatment to check that no such effects occur. Methadone can also affect certain blood and urine samples. Tell your doctor that you are taking methadone before leaving any samples.

Methadone Abcur with drink and alcohol

You must not drink alcohol while taking Methadone Abcur as it can cause serious side effects. Do not drink grapefruit juice while you are being treated with Methadone Abcur, as it may alter the effect of the medicine.

Pregnancy, breastfeeding and fertility

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

It is recommended not to use Methadone Abcur during labor.

Talk to your doctor if you are breastfeeding or planning to breastfeed while taking methadone as it may affect your baby. Monitor your child for abnormal signs and symptoms such as increased drowsiness (more than usual), difficulty breathing, or muscle weakness. Contact a doctor immediately if you notice any of these symptoms.

Fertility: Impotence in men has been reported with long-term use of methadone.

Driving and using machines

Methadone affects the coordination between brain and body movements, so the ability to drive or use machines can be severely affected until your medication has stabilized at a certain dose level. You should therefore not drive or use machines during the initial period of treatment. How long it takes before you can drive a car or use machines are very individual, so you should decide together with your doctor.

Even if the doctor assesses your psychomotor ability, you are at the same time responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Methadone Abcur contains lactose

Methadone Abcur contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Methadone Abcur

Always take Methadone Abcur exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will tell you how much Methadone Abcur to take and how often to take it. You mustn’t take more than the dose you and your doctor have agreed upon. The individual needs may be different. Modification or discontinuation of treatment should only be done in consultation with a physician.

This product is for oral use only, and must not be injected.

In case of drug addiction

Adults

The doctor adjusts the dose to your needs.

The usual starting dose is 10-30 mg daily. In patients with high opioid tolerance, the starting dose is 25-40 mg. Thereafter, the dose is increased gradually for 3 weeks.

The usual maintenance dose is 60-120 mg daily, but some patients may need higher doses.

The maximum dose should not exceed 150 mg daily in the treatment of drug dependence.

Methadone Abcur is usually given once a day.

In severe pain

Adults: The usual starting dose is 5 mg 1-3 times daily. Thereafter, dose one can be increased slowly. Patients who have previously taken opioids can start treatment with higher doses, 5-20 mg 2-3 times daily, as previous experience with the opioid treatment is taken into account. If needed, other strengths of Methadone Abcur are available.

Further determination of the daily dose one, the division of the doses, and all dose adjustments during treatment are carried out by the treating physician and depend on the previous dose one.

The maximum dose should not exceed 100 mg daily in the treatment of severe pain.

Elderly: It may be necessary to reduce dose one and you may need more frequent checks when taking Methadone Abdur. Follow your doctor’s instructions.

Hepatic or renal impairment: It may be necessary to reduce dose one or prolong the time between doses. Follow your doctor’s instructions.

If you take more Methadone Abcur than you should

Signs that you have taken too much Methadone Abcur may be:

  • difficulty breathing or short-term respiratory arrest
  • extreme fatigue, fainting or coma
  • small pupils are (pin pupils)
  • muscle weakness
  • cool, moist and pale skin
  • slow heart rate , low blood pressure , heart attack or shock
  • in severe cases, overdose can lead to death
  • low blood sugar levels may occur

Contact a doctor if the above symptoms occur.

Children and the elderly are more sensitive to the effects of this medicine.

If you forget to take Methadone Abcur

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

If you stop taking Methadone Abcur

You should only stop or stop treatment after talking to your doctor. You should not suddenly stop taking Methadone Abcur, as you may experience withdrawal symptoms such as insomnia, runny nose, tearing eyes, loss of appetite, diarrhea, and pain.

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

Possible side effects

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

Very common side effects: may affect more than 1 user in 10

  • nausea or vomiting

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

  • weight gain
  • accumulation of water in the body
  • constipation
  • exhilaration ( euphoria )
  • that you see or hear things that are not real (hallucinations)
  • a feeling of dizziness or spinning
  • dimsyn
  • pin pupils
  • drowsiness
  • rash
  • sweating
  • fatigue

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

  • loss of appetite
  • difficulty breathing (with cough)
  • dry mouth
  • inflammation of the tongue
  • depression ( dysphoria )
  • concern
  • difficulty sleeping
  • confusion
  • decreased sex drive
  • headache
  • fainting
  • itching , hives , skin rash
  • swollen legs
  • weakness
  • accumulation of water in the body
  • bile duct cramps (causes stomach pain)
  • flushing
  • low blood pressure
  • difficulty urinating
  • difficulty getting or maintaining an erection
  • menstrual disorders

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

  • heart problems, slower heart rate , palpitations

Has been reported: occurs in an unknown number of users

  • too low a level of potassium or magnesium in the blood
  • decreased number of platelets in the blood
  • Mood swings
  • drug addiction
  • cardiac arrest
  • irregular heartbeat with symptoms such as too fast or too slow pulse , fluttering sensation in the chest, shortness of breath and chest pain
  • drop in blood pressure when getting up which causes dizziness or fainting
  • sudden death
  • low blood sugar level

How to store Methadone Abcur

Keep out of sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

The medicine 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.

Contents of the pack and other information

Content declaration

  • The active substance is methadone hydrochloride 5 mg or 10 mg.
  • The other ingredients are lactose monohydrate , corn starch, magnesium stearate, talc, povidone (PVP K-25), colloidal anhydrous silica.

What the medicine looks like and contents of the pack

Methadone Abcur 5 mg is a white to off-white round, flat tablet with beveled edges, concave with a notch on one side and embossing “M5” on the other side, tablet size 7 x 2.5 mm. The tablet can be divided into two equal doses.

Methadone Abcur 10 mg is a white to off-white round, flat tablet with beveled edges, with a notch on one side and an embossing “M10” on the other side, tablet size 9 x 3.1 mm.

The tablet can be divided into two equal doses.

Methadone Abcur 5 mg and 10 mg are available in:

Child protection jar: 25, 100, 200 tablets

Blisters: 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Abdur AB

Box 1452

251 14 Helsingborg

Manufacturer

Extractum Pharma Zrt.

6413 Kunfehértó, IV. körzet 6

Hungary

Muhammad Nadeem

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