5 mg and 10 mg Tablets
Methadone hydrochloride

What Methadone 2care4 is and what it is used for

Methadone 2care4 is a morphine-like drug used in adults for:

  • treatment of severe chronic pain where only opioids give a sufficient analgesic effect
  • replacement therapy for opioid-dependent patients in parallel with medical and psychological treatment and social rehabilitation.

Methadone hydrochloride contained in Methadone 2care4 may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Metadon 2care4

Do not use Methadone 2care4

  • 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 impaired breathing with slow and shallow breathing or other acute breathing difficulties ( acute illness that causes narrowing of the airways).

Warnings and cautions

Talk to your doctor or pharmacist before taking methadone if you:

  • get acute asthma attackssuffering from 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 may suffer from severe headaches.
  • treated for drug dependence or opioid overdose
  • have difficulty urinating
  • have stomach pain, diarrhea or constipation, have 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 )
  • have low levels of potassium or magnesium in the blood.

Risk of addiction/abuse

Talk to your doctor if you or anyone else suspects that you are becoming addicted to this medicine or if you notice that you regularly take too much of this medicine.

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

Older

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

Children and young people

Methadone 2care4 must NOT be given to 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 2care4

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Pay special attention to:

  • 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 antidepressants (eg nefazodone, fluoxetine , fluvoxamine, paroxetine and sertraline ).
  • other antidepressants called tricyclic antidepressants (eg clomipramine, nortriptyline, desipramine)
  • medicines for heart disease (verapamil, quinidine )
  • antiarrhythmics (eg propafenone and flecainide ) and beta -blocker blockers ( metoprolol )
  • breast cancer drug (tamoxifen)
  • anti-inflammatory and immunosuppressive agents (eg dexamethasone and cyclosporine)
  • antiviral drugs, including certain anti- HIV drugs , eg nevirapine, zidovudine, efavirenz, nelfinavir, amprenavir, delavirdine, ritonavir, lopinavir / ritonavir combination, ritonavir / saquvinavir combination, didanosine and stavudine
  • Macrolide-type antibiotics (medicines for bacterial infections) such as clarithromycin, telithromycin and erythromycin
  • rifampicin (medicine for tuberculosis , TB)
  • antifungals (medicines for fungal infections) such as ketoconazole , itraconazole and fluconazole
  • cimetidine (medicine for stomach ulcers )
  • naloxone (medicine for breathing difficulties)
  • drugs for drug addiction, such as naltrexone and buprenorphine
  • antiepileptic drugs (eg phenytoin , phenobarbital and carbamazepine)
  • vitamin tablets (containing vitamin C )
  • antiarrhythmic drugs (loperamide, diphenoxylate)
  • drugs that make the urine more acidic, such as ammonium chloride (ammonia)
  • diuretics ( spironolactone )
  • drugs that make you drowsy or drowsy
  • traditional herbal medicines containing St. John’s wort

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 2care4 with food, drink and alcohol

You should not drink alcohol while taking methadone as it can cause serious side effects. Do not drink grapefruit juice when you are being treated with methadone 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.

Methadone 2care4 is not recommended during childbirth. Methadone should not be used during pregnancy and lactation except on the recommendation of your doctor. Breast-feeding may be possible at doses up to 20 mg daily.

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.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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 2care4 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 use Methadone 2care4

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

Your doctor will tell you how much Methadone 2care4 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.

Methadone 2care4 5 mg tablets: The tablet can be divided into two equal doses.

Methadone 2care4 10 mg tablets: The switch is only available to help you split the tablet if you have difficulty swallowing it whole, not to divide the tablet into equal doses.

Drug addiction

Adults: The doctor will adjust the dose to your needs. 

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

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

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

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, taking into account their previous experience with opioid treatment.

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.

Older:

It may be necessary to reduce the starting dose and you may need more careful monitoring when taking Methadone 2care4. Follow your doctor’s instructions.

Hepatic or renal impairment:

It may be necessary to reduce the dose one or extend the dose range. Follow your doctor’s instructions.

Symptoms of methadone overdose may include:

  • difficulty breathing or short-term respiratory arrest
  • extreme tiredness, 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, the overdose can lead to death.

Contact a doctor if the above symptoms occur.

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

Possible side effects

Like all medicines, this medicine 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 )
  • to see or hear things that are not real (hallucinations)
  • a feeling of dizziness or spinning
  • dimsyn
  • small pupils are (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
  • 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 pulse
  • palpitation

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
  • methadone dependent
  • Mood swings
  • heart attack
  • arrhythmia in the heart
  • sudden drop in blood pressure when standing which may cause dizziness or fainting
  • sudden death
  • dangerously low body temperature ( hypothermia ).

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

How to store Methadone 2care4

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

Do not store above 30 ° C.

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.

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.

Contents of the pack and other information

Content declaration

  • The active substance is methadone hydrochloride.
  • The other ingredients are lactose monohydrate , pregelatinized corn starch and magnesium stearate

What the medicine looks like and contents of the pack

Methadone 2care4 5 mg tablets: white to off-white, round and flat tablets, marked with “5” on one side and with a scoreline on the other side (see section 3 How to take Methadone 2care4).

Methadone 2care4 10 mg tablets: white to off-white, round and flat tablets, marked with “10” on one side and with a scoreline on the other side (see section 3 How to take Methadone 2care4).

Methadone 2care4 is available in Al / PVC / PVDC blisters or white HDPE cans with child-resistant lids.

Pack sizes:

10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 and 100 tablets in blisters.

25, 100 and 200 tablets in a jar.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

2care4 Generics ApS

Stenhuggervej 12-14

DK-6710 Esbjerg V

Denmark

Manufacturer

SANTA SA

St. Carpatilor No. 60, objective no. 47, 48, 58, 133

Brasov, Jud. Brasov, cod 500269

Romani

Muhammad Nadeem

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