1 mg / ml, 2 mg / ml and 5 mg / ml oral solution
methadone hydrochloride respectively

What Methadone dne is and what it is used for

Your doctor may have prescribed this medicine for any other use and/or in other doses than those listed in this leaflet. Always use this medicine exactly as your doctor has told you.

Methadone is a synthetic opiate (a morphine-like drug). Methadone dne is used to treat patients who have become addicted to a group of substances called opioids. The treatment with Methadone dne should be given together with medical, psychological, and social follow-up.

Methadone hydrochloride contained in Methadone dne 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 using Methadone dne

Do not use Methadone dne

  • if you are allergic to methadone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
  • if you have severe breathing problems or suffer from respiratory diseases (such as asthma ) that make it difficult to breathe.
  • if you have used or have used monoamine oxidase inhibitors ( MAOIs ) in the last two weeks ( MAOIs are medicines used to treat depression and Parkinson’s disease )

Methadone dne must NOT be given to children.

Warnings and cautions

Talk to your doctor before using Methadone done:

  • if you have acute asthma attacks
  • if you have impaired lung capacity due to any lung disease or have difficulty breathing.
  • if you have kidney problems (including kidney stones and gallstones )
  • if you have liver problems
  • you have an underactive thyroid gland ( hypothyroidism )
  • if you have an enlarged prostate gland or urethral stricture (difficult to urinate)
  • if you have suffered a head injury and the pressure in your brain is higher than it should be (check this with your doctor). You could suffer from severe headaches.
  • you have stomach pain, diarrhea or constipation
  • if you have certain changes in your heart rhythm or other serious heart disease
  • you are taking other opioid-type medicines (painkillers), such as morphine and pentazocine
  • you take medicines that make you relax and help you sleep ( barbiturates and benzodiazepines )

Methadone dne 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.

If any of the above conditions apply to you, talk to your doctor.

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.

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

  • 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.

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 dne

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

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

  • any medicine that affects your mental state (eg risperidone , thioridazine, perfenazine, phenothiazines, haloperidol and sertindole (used to treat psychosis ) and atomoxetine (used to treat ADHD ).
  • medicines for heart disease (verapamil, quinidine , propafenone , flecainide , metoprolol ).
  • the type of antidepressant called monoamine oxidase inhibitors ( MAOIs ), especially if you have been taking them for the last two weeks (see also section “Do not use Methadone dne”).
  • antidepressants (eg imipramine, clomipramine, nortriptyline, desipramine, nefazodone, fluoxetine , fluvoxamine, paroxetine and sertraline ).
  • tamoxifen (a medicine used to treat cancer).
  • anti-inflammatory and immunosuppressive agents (eg dexamethasone and cyclosporine).
  • antiviral drugs, including certain anti- HIV drugs e.g. amprenavir, nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir, lopinavir, saquvinavir, abacavir, didanosine and stavudine).
  • macrolide-type antibiotics (medicines for bacterial infections) such as clarithromycin, telithromycin and erythromycin.
  • cimetidine (a medicine for stomach ulcers ).
  • antifungals (medicines for fungal infections) such as ketoconazole , itraconazole and fluconazole .
  • naloxone (a medicine for breathing difficulties).
  • drugs against drug addiction e.g. naltrexone and buprenorphine.
  • rifampicin (a medicine used to treat tuberculosis or tuberculosis).
  • antiepileptic drugs (eg phenytoin, phenobarbital and carbamazepine).
  • vitamin tablets (contains vitamin C ).
  • medicines for diarrhea (loperamide, diphenoxylate).
  • drugs that make the urine more acidic, such as ammonium chloride.
  • diuretics ( spironolactone ).
  • (traditional) herbal medicines containing St. John’s wort
  • drugs that make you sleepy

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)

Concomitant use of Methadone done and sedatives or medicines for sleep disorders such as benzodiazepines or similar medicines increase the risk of drowsiness, difficulty breathing ( respiratory depression ), coma, and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.

If your doctor prescribes Methadone done at the same time as sedatives, the dose and treatment time should be limited by your doctor.

Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.

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

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 dne with food, drink and alcohol

Do not drink grapefruit juice when you are being treated with methadone, as this may alter the effect of the medicine.

You should be careful if you drink alcohol while being treated with Methadone done.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Methadone dne can affect the fetus.

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; 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

Methadone affects the coordination between the brain and your body until the treatment has stabilized at an appropriate level. Do not drive or use any tools or machines until you have been stable on the treatment and dose one for at least 6 months. The attending physician will advise you when you can start driving. You should not drive or perform hazardous work until you are sure it is safe. Read this information carefully. If you are not sure, ask your doctor or pharmacist.

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 dne contains ethanol

The oral solution contains 2.3% ethanol, which corresponds to the content of alcohol in light beer.

The oral solution also contains the preservative methyl parahydroxybenzoate (E 218) which may cause an allergic reaction (may be delayed).

How to use Methadone dne

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

Dose one is determined by the doctor, who adjusts it individually for you. Your doctor will tell you how much Methadone to take and how often to take it. You mustn’t take more than the dose you and your doctor have agreed upon.

Methadone dne is an oral solution that should be swallowed. Under no circumstances should you inject this medicine, as an injection can cause severe permanent damage to your body and possibly be fatal.

If you have the impression that the effect of Methadone dne is too strong or too weak, talk to your doctor.

Elderly, liver and kidney problems, and sick

You need to be extra careful if you are elderly, ill, or have liver or kidney problems.

Use for children

Methadone dne must NOT be given to children. There is a serious risk of poisoning. Remember to keep the medicine in a safe place, out of the reach of children.

If you take more Methadon dne than you should

If you take more Methadone done than you should, you may experience the following:

  • breathing difficulties
  • extreme drowsiness, fainting or coma
  • pin pupils
  • muscle weakness
  • cool and moist skin
  • slow heart rate , low blood pressure , heart attack or shock
  • low blood sugar level
  • in severe cases, the overdose can lead to death.

If you forget to take Methadone dne

If you miss a dose during a treatment regimen, you must take a dose as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose but only the next dose at the usual time. DO NOT TAKE A DOUBLE DOSE TO COMPENSATE FOR A MISSED DOSE.

Possible side effects

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

The following side effects may occur:

Very common (may affect more than 1 user in 10):

  • nausea
  • vomiting

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

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

Rare: (may affect up to 1 in 1000 people):

  • heart problems
  • slower pulse
  • that you feel how the heart beats (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
  • low blood sugar level.

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

How to store Methadone dne

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton. 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: 1 mg / ml, 2 mg / ml and 5 mg / ml
  • The other ingredients are: methyl parahydroxybenzoate (E 218), ethanol (96%) 24 mg / ml, sodium citrate, anhydrous citric acid, saccharin sodium, masking flavor, flavoring (blackcurrant / apple), purified water.

What the medicine looks like and contents of the pack

Methadone dne is an oral solution (liquid) in brown plastic bottles with a childproof and sealed screw cap.

Pack sizes:

1 mg / ml; 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, 50 ml, 55 ml, 60 ml, 65 ml, 70 ml, 75 ml, 80 ml, 85 ml, 90 ml, 95 ml , 100 ml, 110 ml, 120 ml, 130 ml, 140 ml, 150 ml.

2 mg / ml: 30 ml, 35 ml, 40 ml, 45 ml, 50 ml, 55 ml, 60 ml, 65 ml, 70 ml, 75 ml, 80 ml, 85 ml, 90 ml, 95 ml, 100 ml

5 ml / ml: 14 ml, 16 ml, 18 ml, 20 ml, 22 ml, 24 ml, 26 ml, 28 ml, 30 ml, 32 ml, 34 ml, 36 ml, 38 ml, 40 ml, 42 ml, 44 ml, 46 ml, 48 ml, 50 ml.

Individual bottles or packages of 3 and 7 bottles respectively.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

dne pharma as

Karihaugveien 22, NO-1086 OSLO, Norway

Manufacturer

Pharma Production AS

Karihaugveien 22, NO-1086 OSLO, Norway

Muhammad Nadeem

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