10 mg / ml solution for injection
methadone hydrochloride

What Methadone Meda is and what it is used for

Methadone Meda contains methadone hydrochloride which has a strong analgesic effect.

Methadone Meda is used for severe pain.

Methadone contained in Methadone Meda 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 receive Methadone Meda

Do not use Methadone Meda

  • if you are allergic to methadone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
  • if you have a lot of mucus and severe breathing problems,
  • if you are usually worried when you have drunk alcohol or taken sleeping pills.

However, never stop taking this medicine without consulting your doctor.

Warnings and cautions

Talk to your doctor or nurse before using Methadone Meda.

There is a risk of habit formation with Methadone Meda.

Tell your doctor

  • if you have asthma ,
  • if you have any head injuries,
  • if you have impaired liver or kidney function
  • if you have any heart disease
  • if you are at risk of having a heart rhythm disorder called QT prolongation, (for example, if you or a close relative has had it, if your fluid and salt balance is affected or when using certain other medicines). Your doctor may check your heart with a so-called ECG if you have a risk of heart rhythm disturbance.

This is because Methadone Meda should be used with caution in these conditions. Always consult your doctor before changing the medication.

Talk to your doctor or pharmacist if you get any of the following symptoms while using Metadon Meda:

  • 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.

Other medicines and Methadone Meda

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

Concomitant use of Methadone Meda and certain medicines increase the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and can be life-threatening. Examples of these drugs are:

  • other strong painkillers (opioids),
  • sedatives, hypnotics and antiepileptic drugs (eg benzodiazepines , certain antihistamines and barbiturates ),
  • anesthetics for anesthesia before e.g. an operation,
  • certain medicines for mental illness (phentiazines),
  • muscle relaxants.

Due to this, the concomitant use of Methadone Meda and the above medicines should only be considered by your doctor when other treatment options are not possible. If your doctor prescribes Methadone Meda at the same time as any of the above medicines, your dose and treatment time should be limited by your doctor. Tell your doctor if you are taking any of the above medicines and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about being aware of the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.

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).

The treatment effect can also be affected if Methadone Meda is taken at the same time as certain other medicines and the doses may need to be adjusted, for example, if you are taking medicines for:

  • infection is (rifampicin, rifabutin),
  • depression (fluvoxamine, fluoxetine , MAO inhibitors ),
  • epilepsy (phenobarbital, phenytoin and carbamazepine),
  • HIV (nelfinavir, amprenavir, nevirapine, efavirenz, lopinavir, ritonavir, zidovudine).
  • pain and fever (metamizole).

The treating physician, therefore, needs to know about other concomitant medication.

Methadone Meda with alcohol

You should not use alcohol while you are being treated with Methadone Meda as the combination may adversely affect your breathing.

Pregnancy and breastfeeding

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.

There is a risk that the fetus is negatively affected, especially if it is used just before birth. Therefore, always consult a doctor before receiving Methadone Meda if you are pregnant.

Talk to your doctor if you are breastfeeding or planning to breastfeed while using 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; if your doctor decides that you can breastfeed during treatment. Contact a doctor immediately if you notice any of these symptoms.

Driving and using machines

During treatment with Methadone Meda, the reactivity may be reduced. This should be taken into account when sharper attention is required, e.g. while driving. You are 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 this regard 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 Meda contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per 1 ml ampoule, ie essentially ‘sodium-free’.

How to get Methadone Meda

Methadone Meda solution for injection is given as an injection into a muscle or under the skin.

The dose is determined by a doctor who adjusts it individually for you and from the pain relief you experience. If you are older or have impaired kidney or liver function, your doctor will give you a lower dose from the beginning.

Possible side effects

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

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

Nausea and vomiting.

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

Decreased sexual desire, fatigue, insomnia and loss of appetite, sweating, dizziness, constipation, impaired breathing, normal agitation, and bile duct cramps. At high doses, fluid may accumulate in the lungs ( edema ).

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

cardiac arrhythmia ( QT prolongation or torsades de pointes )

Has been reported (occurs in an unknown number of users): 

low blood sugar level

How to store Methadone Meda

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

Methadone Meda solution for injection is stored in the outer carton. Photosensitive.

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

Contents of the pack and other information

Content declaration

  • The active substance methadone hydrochloride. 1 ml contains 10 mg.
  • The other ingredients are sodium chloride and water for injections.

What the medicine looks like and contents of the pack

Methadone Meda solution for injection is a clear, colorless solution packaged in a glass ampoule.

Pack size : Glass ampoule is 10 x 1 ml.

Marketing Authorisation Holder

Meda AB

Box 906

170 09 Solna

Phone: 08 – 630 19 00

Muhammad Nadeem

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