10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 55 mg, 60 mg, 70 mg, 80 mg, 90 mg, 100 mg, 110 mg, 120 mg , 130 mg, 140 mg, 150 mg oral solution
Methadone hydrochloride
What Methadone Pharmadon is and what it is used for
Methadone Pharmadone is used to treat patients who have become addicted to a group of substances called opioids. Methadone blocks the body’s opiate receptors and reduces withdrawal symptoms in opiate dependence. The treatment with Methadone Pharmadone should be given together with medical, psychological, and social follow-up.
All treatment with methadone is based on the National Board of Health and Welfare’s regulations.
What you need to know before you use Methadone Pharmadon
Do not use Methadone Pharmadon
- if you are allergic to methadone or any of the other ingredients of this medicine (listed in section 6.)
- if you have severe breathing problems, with slow and shallow breathing, or other acute breathing difficulties.
- if you are being treated with opioid agonists / antagonists
- if you are taking monoamine oxidase inhibitors (called MAO inhibitors and are medicines used to treat depression and Parkinson’s disease ) or have been taking them for the last two weeks
Methadone Pharmadone should not be given to children.
Warnings and cautions
Talk to your doctor before using Methadone Pharmadone:
- if you have an acute asthma attack or impaired lung capacity due to any lung disease, e.g. asthma , chronic obstructive pulmonary disease and decreased lung volume.
- if you have impaired liver or kidney function or kidney / gallstones
- if you have serious problems with your heart, such as poor oxygenation, your heart rhythm or too low levels of potassium and magnesium in your blood.
- if you are being treated with certain heart medicines (See Other medicines and Methadone Pharmadone)
- if you have inflammatory bowel disease or intestinal obstruction with abdominal pain, diarrhea or constipation.
- if you have an enlarged prostate or narrowing of the urethra
- if you have thyroid problems
- If you have a head injury or increased pressure in your head, you may have severe headaches
- if you are older
Talk to your doctor or pharmacist if you get any of the following symptoms while taking Methadone Pharmadone:
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.
Concomitant use of other opioids, barbiturates, benzodiazepines, or other medicinal products with a strong sedative effect should be avoided as it may increase the effect and side effects of methadone.
Children
Children are more sensitive to methadone than adults, so poisoning can occur even 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 Pharmadon
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Pay special attention to:
- any medicine that affects 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 past two weeks.
- anti-inflammatory and immunosuppressive agents (eg dexamethasone and cyclosporine)
- antiviral drugs, including certain anti- HIV drugs e.g. nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir, 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 TB)
- antiepileptic drugs (eg phenytoin , phenobarbital and carbamazepine)
- vitamin tablets (contains vitamin C )
- antiarrhythmic drugs (loperamide, diphenoxylate)
- drugs that make the urine more acidic, e.g. ammonium chloride (ammonia)
- diuretics ( spironolactone )
- drugs that make you sleepy
- (traditional) herbal medicines containing St. John’s wort
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)
Other medicines you take may also affect your heart (eg sotalol, amiodarone, 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 Pharmadon with food, drink and alcohol
You must refrain from drinking alcohol while taking Methadone Pharmadone as it may cause serious side effects.
Do not drink grapefruit juice while taking Methadone Pharmadone, as this may affect the way the medicine works.
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 for advice before using this medicine.
The fetus may be affected if Methadone is used during pregnancy Do not use Methadone Pharmadone during pregnancy unless directed to do so by your doctor.
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.
Methadone Pharmadone contains sucrose, glucose, and methyl parahydroxybenzoate
Sucrose:
Contains 11 g of sucrose per dose . This 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.
Glucose :
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Methyl parahydroxybenzoate :
May cause an allergic reaction (possibly delayed).
How to use Methadone Pharmadon
Always use Methadone Pharmadone exactly as your doctor has told you. Dose one is determined by the doctor, who adjusts it individually for you. Ask your doctor or pharmacist if you are unsure.
Methadone Pharmadone is an oral solution to be swallowed. Dose one is determined by the doctor, who adjusts it individually for you. Your doctor will tell you how much Methadone Pharmadone to take and how often to take it. You mustn’t take more than the dose you and your doctor have agreed upon.
Use for children
Methadone Pharmadone 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 use more Methadon Pharmadon than you should
Signs that you have taken too much Methadone Pharmadone may include small pupils, drowsiness, pallor, damp skin, low body temperature, hearing loss, difficulty breathing, and coma. This can lead to low blood sugar levels. In case of severe overdose, the following symptoms may occur short-term cessation of breathing, low blood pressure, slow heart rate, shock, heart attack, fluid in the lungs, seizures, muscle weakness, kidney failure, irregular heartbeat, and death.
Children and the elderly are more sensitive to the effects of this medicine. Contact a doctor if the above symptoms occur.
If you forget to use Methadone Pharmadon
Do not take a double dose to make up for a forgotten dose. Contact your doctor or pharmacist for information.
If you stop using Methadone Pharmadon
Treatment should not be stopped abruptly; you should only stop or stop treatment after talking to your doctor. If treatment is stopped abruptly, it can lead to withdrawal symptoms such as restlessness, insomnia, anxiety, tremor, nausea, vomiting, or diarrhea.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
As with all medicines, Methadone Pharmadone can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 user in 10):
- Nausea and vomiting (mainly applies to patients in outpatient care)
Common side effects (may affect up to 1 in 10 people):
- Weight gain
- Accumulation of fluid in the body
- Constipation
- Elevation ( euphoria ), seeing or hearing things that are not real (hallucinations)
- A feeling of dizziness or dizziness, tiredness or drowsiness
- Pupil contraction and blurred vision
- Transient rash
- Sweating
With long-term use of methadone, the side effects often diminish over time. However, constipation and sweating often persist.
Uncommon side effects (may affect up to 1 in 100 people):
- Loss of appetite
- Breathing difficulties (with cough)
- Dry mouth
- Inflammation of the tongue
- Depression ( dysphoria ), physical and mental anxiety ( agitation )
- Difficulty sleeping
- Confusion
- Decreased sex drive, difficulty maintaining an erection
- Menstrual disorders
- Headache
- Fainting and low blood pressure
- Itching , hives and in sometimes bleeding hives
- Bile duct cramps ( biliary dyskinesia )
- Blushing of the face
- Difficulty urinating
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 potassium or magnesium levels in the blood
- Decreased number of platelets in the blood
- Low blood sugar level
Prolonged use of methadone can lead to addiction. The withdrawal symptoms are similar to those seen with morphine and heroin, but are less intense, though more long-lasting.
How to store Methadone Pharmadon
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiration date is the last day of the specified month.
Do not use Methadone Pharmadone if the safety seal on the cap is broken.
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.
- The other ingredients are sucrose, glucose , raspberry aroma, purified water, methyl parahydroxybenzoate ( preservative E218).
What the medicine looks like and contents of the pack
Clear, transparent liquid packed in a white plastic bottle closed with a child-protective, break-sealed screw cap. The bottle contains 50 ml of oral solution.
Pack sizes: 1 bottle (all strengths) and 7 bottles (1×7) (50 mg, 60 mg, 70 mg, 80 mg, 90 mg, 100 mg, 110 mg, 120 mg, 130 mg, 140 mg and 150 mg).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Unimedic Pharma AB
Box 6216
102 34 Stockholm
Tel: 010-130 99 50