Misyo 10 mg Oral Solution

This medicine contains methadone hydrochloride, which belongs to a group of medicines called narcotic analgesics. It is used in the treatment of opiate/opioid addiction in order to reduce withdrawal symptoms. All patients receiving MISYO must be routinely monitored for signs of misuse, abuse, and addiction during treatment.

Do not take MISYO:

• if you are allergic (hypersensitive) to methadone, benzoates or to any of the other ingredients (listed in section 6).
• if you are having an asthma attack. You should not use MISYO during an asthma attack. If you give MISYO to yourself (self - administration), wait until the asthma attack has passed and you are fully recovered.
• if you are addicted to alcohol.
• if you are taking monoamine oxidase inhibitors (MAOIs) used to treat depression or if you have taken MAOI medicine in the past two weeks (See "Taking other medicines").
• if you have lower consciousness (feeling less alert or aware than normal).
• if you have a head injury.
• if you have heart problems relating to the way in which it conducts electricity (QT prolongation).
• if you have severe liver problems.
• if you have difficulty breathing (respiratory depression).
• in children.
• if you are not dependent on opioid substances.
• if you are in labour.
• if you have ulcerative colitis (inflammatory bowel disease).
• if you have problems with your gallbladder and bile duct or suffer from urinary tract spasms.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking MISYO.

Warnings and precautions

Talk to your doctor or pharmacist before taking MISYO. Take special care with MISYO if you:

• have breathing problems or asthma.
• have recently had a head injury.
• have liver or kidney problems.
• have epilepsy.
• have low thyroid function (hypothyroid).
• have problems with your adrenal glands (glands which produce hormones).
• have an enlarged prostate gland.
• have low blood pressure.
• are in shock.
• have a muscle weakness disease called myasthenia gravis.
• have bowel problems.
• have diabetes or difficulty to regulate your blood sugar.

If during treatment you notice that your breathing becomes slow and shallow, stop taking MISYO and see a doctor straight away. These may be signs of respiratory depression (see section 4) and may not be fully apparent for a week or two.

You and your caregiver must be aware of the signs of excessive dosing, as addressed below in section 3, subsection “If you take more MISYO than you should”. Talk to your doctor or pharmacist if you experience any of the following symptoms while taking MISYO: weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of your adrenal glands producing too little of the hormone cortisol, and you may need to take a hormone supplement. Long - term use may cause decreased sex hormone levels and increased levels of the hormone prolactin. Contact your doctor if you experience symptoms such as decreased libido, impotence or absence of menstruation (amenorrhea).

You must only take MISYO by mouth. Under no circumstances should you inject MISYO, as it may cause serious and permanent damage to your body, with the possibility of death. The correct dosage should be extracted from the bottle by using a medicine measure, dispenser, measuring cylinder or syringe. MISYO can also be diluted with purified water, if required. Your doctor will tell you how much MISYO you need to take, and how often you need to take it. It is important that you do not take more than the dose agreed with your doctor.

Adults

The usual starting dose is 20 mg a day. The dose will be slowly increased over a few weeks until you show no signs of withdrawal or intoxication. The usual dose is 60 – 120 mg/day. MISYO is usually taken once daily. Your doctor will decide what dose you need and when to reduce the dose.

Older people and people with other conditions

If you are elderly, are very ill, have liver or kidney problems, have an under active thyroid gland or have prostate problems, your doctor may monitor you more closely and may reduce your dose of MISYO.

Use in children

MISYO is not suitable for use by children.

MISYO can have side effects. Not all side effects reported for MISYO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MISYO, please consult your health care provider for advice.

If any of the following happens, stop taking MISYO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Allergic reaction which may include: swelling of your face, lips, tongue or throat or difficulty breathing or swallowing or severe itching of your skin with raised lumps.
• Heart problems. The signs of this may include changes in the way your heart beats, such as it beating faster or missed heart beats, breathing difficulties and dizziness.
• If your breathing becomes slow and shallow.
• Worsening of the pressure inside your head if you had an injury to your head or have a brain disease. You may experience bad headaches and vomiting.
• Breathing difficulty or respiratory arrest (being unable to breathe).
• If you have asthma and it gets worse.

These are all very serious side effects. If you have them, you may have had a serious reaction to MISYO. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Feeling or being sick
• Water retention
• Feeling high (euphoria)
• Seeing or hearing things that are not real (hallucinations)
• Sleep disturbances
• Feeling sleepy or tired
• Feeling confused
• Headache
• Blurred vision, pin point pupils, dry eyes
• Feeling of dizziness or spinning
• Constipation
• Skin rash
• Sweating
• Reduction of sex drive
• Weight increase

Less frequent side effects:

• Low levels of thyroid hormone (seen in a blood test)
• Feeling down (dysphoria)
• Feeling agitated
• Difficulty sleeping (insomnia)
• Feeling disorientated
• Fainting
• Visual disturbances
• Heart problems – slower heartbeat, feeling your heart beat (palpitations)
• Low blood pressure
• Facial flush (blushing or feeling of warmth in the face)
• Shock

Store at or below 30 °C in the original package to protect from light. After first opening store at or below 25 °C in the original package to protect from light, for not more than 90 days. If diluted, the diluted solution has a shelf life of 14 days when stored in PET bottles at or below 25 °C protected from light. Store this medicine out of the sight and reach of children. Store MISYO in a safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been prescribed for them. Do not use this medicine after the expiry date which is stated on the carton, bottle after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help to protect the environment.