METHADOSE 10 MG / 1ML ORAL CONCENTRATE - patient leaflet, side effects, dosage

1. What Methadose is and what it is used for

This medicine contains methadone, which is an opioid, which can cause addiction.

You can get withdrawal symptoms if you stop taking it suddenly.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Methadose is and what it is used for

• 2. What you need to know before you take Methadose

• 3. How to take Methadose

• 4. Possible side effects @

The name of your medicine is Methadose 10mg/1ml. It contains methadone hydrochloride.

This medicine has been prescribed for you for opioid drug addiction. It contains the methadone which belongs to a class of medicines called opioids.

This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

2. What you need to know before you take Methadose

Do not take Methadose and tell your doctor if:

• you are allergic to methadone or any other ingredients of this medicine (listed in section 6). An allergic reaction can include a rash, itching or shortness of breath
• you have severe breathing problems or a history of asthma. You must not use this medicine during an asthma attack. If you give this medicine to yourself (selfadministra­tion), wait until the asthma attack has passed and you are fully recovered @

Page 2 95 × 70mm

Page 3 96 × 70mm

Page 4 98 × 70mm

Page 5 97 × 70mm

Page 6 97 × 70mm

Page 7 98 × 70mm

Page 8 96 × 70mm

Page 9 96 × 70mm

Page 10 98 × 70mm

Page 11 100 x70mm

3. How to take Methadose

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your prescriber should discuss your treatment and whether you need to continue taking this medicine at regular intervals. If you and your prescriber decide to stop treatment a plan will be put in place to gradually reduce the dose and stop taking the medicine to minimise the risk of withdrawal effects.

Taking this medicine

• this medicine contains 10mg of methadone in each 1ml
• take this medicine by mouth
• this medicine is intended for use with another liquid to dilute it with (diluent). Your pharmacist or prescriber should dilute the concentrate to provide the appropriate concentration of drug in a 5ml dose.

Adults

• the starting dose is 10mg to 20mg (1ml to 2ml) each day
• the doctor can increase this to 40mg to 60mg (4ml to 6ml) each day.

Older people and very ill people

• if you have to have repeated doses of this medicine, the doctor may want to monitor you more closely.

Use in children

Children must not take this medicine.

If you take more Methadose than you should

• if you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you
• the signs you may notice are difficulty in breathing; feeling very drowsy which may lead to a stupor or coma; very small pupils; cold and clammy skin; a very slow pulse rate; low blood pressure and muscle weakness. In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart attack which could lead to death
• it can result in low blood sugar.

Q3J

If you forget to take Methadose

• if you forget a dose do not take it. Wait until the next dose is due and take only that amount
• do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Methadose

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

Pregnancy

Do not take Methadose if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Methadose during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated. @ If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

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

Stop taking this medicine and see a doctor straight away if you have an allergic reaction to Methadose.

An allergic reaction may include:

• swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
• severe itching of your skin with raised lumps.

Stop taking this medicine and see a doctor straight away if you have any of the following:

• 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 already have this condition following an injury to your brain or brain disease.

ID

Keep taking the medicine but tell your doctor straight away if you get any of the following side effects:

• if you have asthma and it gets worse.

Tell your doctor if you get any of these side effects:

Very common (affects more than 1 in 10 people)

• feeling sick (nausea) or being sick (vomiting).

Common (affects less than 1 in 10 people)

• feeling weak, tired
• weight gain
• water retention
• constipation
• rash, that may appear and disappear
• sweating a lot more than usual
• blurred vision, small pupils, dry eyes
• feeling of dizziness, spinning sensation
• changes in your mood, feeling “high” or over excited, feeling drowsy
• seeing or hearing things that are not there (hallucinations).

06)

Uncommon (affects less than 1 in 100 people)

• feeling dizzy, particularly when standing up. This may be a sign that you have low blood pressure
• headache
• feeling down (dysphoria), agitation, confusion, difficulty sleeping
• itching, rashes
• dry mouth or nose, inflammation of the tongue, facial flushing
• breast growth and production of breast milk
• difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle spasms
• low body heat (hypothermia)
• lower sexual urge or desire
• painful periods or lack of periods
• addiction to this medicine
• build-up of fluid in the lungs
• disorder of the biliary part of the digestive system (bile duct dyskinesis).

Not known (frequency cannot be estimated from the available data)

• reduction in blood platelets, which increase the risk of bleeding or bruising
• high prolactin levels in the blood
• rapid, uncontrollable movements of the eyes
• low blood sugar
• dependence and addiction.

Drug Withdrawal

When you stop taking Methadose, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

The following side effects have also been reported

• loss of appetite
• swollen arms and legs. This may be a sign of your body holding onto more water than

usual

low potassium and magnesium which will be found by blood tests

eye and eyesight problems in babies and young children born to mothers who used methadone during pregnancy

reduction in the body’s normal production of adrenal and sexual hormones.

You may notice that some of the side effects become less severe with time as you get used to the methadone.

08)

When taken for a long period of time, it is possible that you may become dependent on Methadose.

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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Methadose

• Keep out of the sight and reach of children
• Store below 25°C but not in a refrigerator
• Take back to the pharmacy 3 months after you first open it or 3 months after it has

been diluted

Do not use after the expiry date (month, year) stated on the label and carton

If it is out of date or you no longer want it, take it back to the pharmacy

Do not use Methadose if you notice anything wrong with the medicine. Talk to your

pharmacist

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

6. Contents of the pack and other information

What Methadose 10mg/1ml Oral Concentrate contains

• The active ingredient is methadone hydrochloride
• The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), patent blue (E131) and purified water.

What Methadose 10mg/1ml Oral Concentrate looks like and contents of the pack

• Before and after dilution: a blue liquid