10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190 and 200 mg oral solution
methadone hydrochloride
What Methadone Nordic Drugs are and what they are used for
Methadone is a synthetic opiate (a morphine-like drug) used to treat patients who have developed an opioid addiction. The treatment must be given in parallel with medical and psychological treatment and social rehabilitation.
Methadone contained in Methadone Nordic Drugs 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 taking Methadone Nordic Drugs
Do not take Methadone Nordic Drugs
• if you are allergic to methadone hydrochloride 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 (they are medicines used to treat depression and Parkinson’s disease )
• if you suffer from breathing difficulties
Methadone Nordic Drugs must NOT be given to children
Warnings and cautions
Talk to your doctor or pharmacist before taking Methadone Nordic Drugs if you:
• have acute asthma attacks
• suffers from lung disease or difficulty breathing
• have problems with the liver or kidneys (including kidney and gallstones )
• have heart problems
• has an underactive thyroid gland or skin and tissue diseases
• has an enlarged prostate gland or narrowing of the urethra
• has 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
• treated for drug dependence or overdose of opioid s
• has difficulty throwing water
• have stomach pain, diarrhea, or constipation
• has low oxygen content or high carbon dioxide content in the blood
• take other opioid-type medicines (painkillers) such as morphine and pentazocine
• take medicines that make you relax and help you sleep ( barbiturates and benzodiazepines )
Methadone Nordic Drugs 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.
Talk to your doctor or pharmacist if you get any of the following symptoms while taking Metadon Nordic Drugs:
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.
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 Nordic Drugs
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Pay special attention to:
• medicines that affect your mental state (eg thioridazine, phenothiazines, haloperidol, and sertindole)
• medicines for heart disease (verapamil, quinidine )
• the type of antidepressant called monoamine oxidase inhibitors ( MAOIs ), especially if you have been taking them for the last two weeks
• other antidepressants (eg imipramine, desipramine, nefazodone, fluoxetine, fluvoxamine, paroxetine, and sertraline )
• anti-inflammatory and immunosuppressive agents (eg dexamethasone and cyclosporine)
• antiviral medicines, including certain HIV medicines such as nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir, abacavir, didanosine and stavudine
• Macrolide-type antibiotics (medicines for bacterial infections) such as clarithromycin, telithromycin, and erythromycin
• cimetidine (medicine for stomach ulcers )
• antifungals (medicines for fungal infections) such as ketoconazole , itraconazole and fluconazole
• naloxone (medicine for breathing difficulties)
• drugs for drug addiction, such as naltrexone and buprenorphine
Rifampicin (a medicine used to treat tuberculosis )
• medicines for epilepsy (eg phenytoin, phenobarbital, and carbamazepine)
• vitamin tablets that contain vitamin C.
• medicines for diarrhea (loperamide, diphenoxylate)
• drugs that make the urine more acidic, eg ammonium chloride (ammonia)
• diuretics ( spironolactone )
• medicines that make you drowsy or drowsy
• herbal medicine that contains St. John’s wort
Other medicines you take may also affect your heart (eg sotalol, amiodarone, and flecainide ).
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)
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 Nordic Drugs with food, drink and alcohol
You must not drink alcohol while taking Methadone Nordic Drugs as it can cause serious side effects. Do not drink grapefruit juice when you are being treated with Methadone Nordic Drugs as it may alter the effect of the medicine.
Pregnancy, breastfeeding and fertility
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. You should not take Methadone Nordic Drugs 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; 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 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 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 Nordic Drugs contains sucrose, glucose and methyl parahydroxybenzoate
The content of 11 g sucrose per dose and 2.5 g glucose per dose should be considered in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. May be harmful to teeth.
The preservative methyl parahydroxybenzoate (E 218) may cause an allergic reaction (possibly delayed).
How to take Methadone Nordic Drugs
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
You should only take Methadone Nordic Drugs by mouth. Under no circumstances should you inject this medicine, as an injection can cause severe permanent damage to your body and possibly be fatal.
Your doctor will tell you how much Methadone Nordic Drugs to take and how often to take it. You mustn’t take more than the dose you and your doctor have agreed upon.
Adults
The usual starting dose is 10-30 mg/day. Dose one is increased slowly until you show no signs of withdrawal symptoms ( abstinence ) or drug intoxication. The usual dose is 60-120 mg/day. Your doctor will decide which dose you need and when your dose should be reduced.
Elderly and sick
You need to be extra careful if you are elderly, ill, or have liver or kidney problems.
Children
Methadone Nordic Drugs 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 Metadon Nordic Drugs than you should
If you take more Methadone Nordic Drugs than you should, you may experience the following:
- breathing difficulties
- extreme drowsiness, fainting or coma
- low blood sugar level
- pin pupils
- muscle weakness
- cool and moist skin
- slow heart rate , low blood pressure , heart attack or shock
- in severe cases, the overdose can lead to death
In the event of an overdose, you should seek medical attention immediately, even if you feel well, as you may have suffered from methadone poisoning.
If you forget to take Methadone Nordic Drugs
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, this medicine can cause side effects, although not everybody gets them.
Possible side effects include:
Very common (may affect more than 1 user in 10)
• nausea or vomiting
Common (may affect up to 1 in 10 people)
• weight gain
• accumulation of water in the body
• constipation
• Euphoria _
• to see and/or hear things that are not real (hallucinations)
• a feeling of dizziness or spinning
• Tamsyn
• pin pupils
• drowsiness
• skin 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 )
• or
• difficulty sleeping
• confusion
• decreased sex drive
• headache
• fainting
• low blood pressure
• itching
• hives
• swollen legs
• weakness
• heavy accumulation of water in the body ( edema )
• spasm of the bile ducts (causes stomach pain)
• flushing
• difficulty urinating
• difficulty getting or maintaining an erection
• menstrual disorders
Rare (may affect up to 1 in 1,000 people)
• heart problems
• slower heart rate
• that you feel how the heartbeats (palpitations, palpitation )
No known frequency (occurs in an unknown number of users)
• too low a level of potassium or magnesium in the blood
• reduced number of platelets in the blood
• low blood sugar level
How to store Methadone Nordic Drugs
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle or 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 dose (50 ml) contains 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170 , 180, 190 or 200 mg of methadone hydrochloride.
The other ingredients are sucrose, glucose, methyl parahydroxybenzoate (E 218), raspberry aroma, water.
What the medicine looks like and contents of the pack
Methadone Nordic Drugs is a clear transparent liquid packaged in a plastic bottle with a white child-resistant cork.
The bottle contains 50 ml of solution. Individual bottles or packaging of 7 bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
Apotek Produktion & Laboratorier AB, Box 17, 201 20 Malmö