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METHADONE LINCTUS BP

Active substance: METHADONE HYDROCHLORIDE

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TEXT FOR NON-MARKETED PACKS
METHADONE LINCTUS 500ml LABEL
PL 00240/6420R
PATIENT INFORMATION LEAFLET
Methadone Linctus BP
(Methadone Hydrochloride 2mg per 5ml)
Read all this leaflet carefully before you start taking this medicine.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet
1.What is the medicine and what does it do?
2.Before you take the medicine
3.How to take the medicine
4.Possible side effects
5.How to store the medicine
6.Further information
1. What is the medicine and what does it do?
The name of your medicine is Methadone Linctus. It is a solution to be swallowed and is intended for adults
over 18 years only.
What is it for?
The product works to help reduce the desire to cough in people with persistent dry cough.
This product is not for opiate addiction.
2. Before you take the medicine
Take special care with Methadone Linctus
Patients suffering from opiate addiction, such as an addiction to heroin, should take special care with this
medicine. Ask your doctor for advice if this applies to you.
Do not take the medicine if you have:
• An allergy to any of the ingredients listed under ‘further information’.
• Shallow breathing or other breathing difficulties. Do not use during an asthma attack.
• Persistent or recurring headache or experienced a recent head injury.
• Taken antidepressants known as Monoamine Oxidase Inhibitors (MAOIs) including moclobenide within
the past two weeks.
• Are at risk of a type of blocked bowel called paralytic ileus following abdominal surgery.
• Are addicted to alcohol.
• Are in labour.
Ask your doctor for advice if any of these apply.
Talk to your doctor or pharmacist if you have any of the following:
• History of drug abuse.
• Heart disease or other heart problems such as angina.
• Liver disease.
• Kidney disease.
• Problems with the thyroid gland.
• Low blood pressure.
• Enlargement of the prostate gland.
• Hormonal problems.
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TEXT FOR NON-MARKETED PACKS
METHADONE LINCTUS 500ml LABEL
PL 00240/6420R
• A family history of sudden death.
• Low levels of potassium or magnesium in the blood.
• Asthma.
• Or if you are elderly, weak, frail or extremely ill, as these people can react differently to this medicine.
• Epilepsy.
• Shock.
• Problems with your adrenal glands.
• Bowel problems.
• Muscle weakness problems called myasthenia gravis.
Talk to your doctor or pharmacist if you are taking any of the following:
These medicines may have a different effect when taken with methadone.
• Alcohol on a regular basis including binge drinking (See Section 3).
• Domperidone, metoclopramide or cisapride for gastro-intestinal conditions.
• Any drugs which affect the heart including mexiletine.
• Drugs which affect the salt levels in the body, including furosemide and spironolactone.
• Desipramine or other drugs for depression.
• Painkillers (other than methadone).
• Sleeping tablets/mixtures or any other tranquillisers.
• Naloxone or naltrexone for drug or alcohol addiction.
• Zidovudine, didanosine or stavudine for the treatment of HIV infections.
The doctor may need to increase the dose of Methadone if taking these medicines:
• Rifampicin for tuberculosis.
• Phenytoin, Phenobarbital or Carbamazepine for epilepsy.
• Some drugs used for the treatment of HIV infections, including Nevirapine, efavirenz and abacavir.
• Drugs which make the urine more acid, including ammonium chloride.
The doctor may need to reduce the dose of methadone if taking these medicines:
• Other Methadone products or buprenorphine.
• Cimetidine for stomach ulcers or heartburn.
• Drugs for the treatment of HIV infection (known as CYP3A4 inhibitors).
• Antibiotics including ciprofloxacin.
• Medicines for fungal infections.
• Drugs which make the urine more alkaline, including potassium citrate.
• Fluvoxamine used to treat depression.
Ask your doctor or pharmacist if you are unsure if any of these apply.
Pregnancy and breast feeding
When pregnant it is especially important that you follow the instruction for treatment given by your doctor.
Do not use this medicine whilst in labour. Talk to your doctor before breast feeding. Use in pregnancy may
cause shallow breathing and withdrawal symptoms in the baby when born. Mothers may develop stomach
problems and risk pneumonia during labour.
Use by children
This product should not be used in children unless the doctor has prescribed its use.
Driving and using machinery
This medicine may make you drowsy. If affected do not drive or operate machinery. People are affected
differently so your doctor will advise you when it is safe to drive again.
Important information about some of the ingredients of this medicine
This medicine contains small amounts of ethanol (alcohol), less than 100mg per 5ml. It contains colouring
agents (E110 and E102) which may cause allergic reactions. It also contains 2.47g of sucrose per 5ml dose.
This should be taken into account in patients with diabetes mellitus.
This medicine contains Methadone and should not be used to treat opiate addiction.

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TEXT FOR NON-MARKETED PACKS
METHADONE LINCTUS 500ml LABEL
PL 00240/6420R
3. How to take the medicine
This medicine has been prescribed for you personally. Do not pass it on to others as it may harm
them.
Dose: Always take your medicine as prescribed by your doctor. The usual dose is: Adults over 18 years:
2.5ml– 5ml every 4–6 hours by mouth, reduced to twice daily on prolonged use.
However, the doctor sometimes prescribes different doses to this.
Follow the doctor’s instructions carefully.
If you take too much see a doctor straight away.
Effects when taken with alcohol or illegal substances.
The risk of overdose and serious harm is greatly increased if taken with alcohol, heroin and/or other illegal
substances. Do not mix these with your medicine.
Effects when treatment is stopped.
Stopping this medicine abruptly will cause side effects, possibly severe. Follow the doctor’s instructions
carefully for coming off this medicine gradually.
4. Possible side effects
Like all medicines, Methadone Linctus can have side effects although not everybody gets them.
Important side effects:
If you think you have the following serious side effects or symptoms, stop taking this medicine immediately
and see a doctor straight away.
• Large doses produce shallow breathing. This may lead to unconsciousness and death.
An allergic reaction which may include:
• Swelling of your face, lips, tongue or throat or difficulty breathing or swallowing.
• Severe itching of your skin with raised pink areas surrounded by pale skin and rashes.
Other possible side effects:
• Pinpoint pupils.
• Low blood pressure on standing up, facial flushing, sweating.
• Worsening of existing asthma.
• Nausea, vomiting, constipation and dry mouth.
• Hallucinations, confusion, mood changes, anxiety, restlessness, depression, lower sexual urge or desire.
• Increase in pressure within the head, particularly if pressure is already raised for other reasons,
dizziness/vertigo, headache and drowsiness.
• Difficulty in passing water (urine), passing less water (urine) than usual.
• Reduction in the body's normal production of adrenal hormones.
• Low body heat (hypothermia).
• Abnormal rapid, slow, or irregular heartbeat.
• Pain in the lower back and abdomen caused by muscle spasms.
• When taken for a long period of time, it is possible that you may become dependent on Methadone
Linctus. Long term use may cause irregularities in the make-up of the blood (increased number of white
blood cells, increased protein or antibody levels).
• Erectile function may be reduced in men.
If any of the side effects gets serious or you notice any side effect not included above, please tell your doctor
or pharmacist straight away. They will tell you what to do.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

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TEXT FOR NON-MARKETED PACKS
METHADONE LINCTUS 500ml LABEL
PL 00240/6420R
5. How to store the medicine
Keep out of the sight and reach of children.
Keep the medicine in a locked cupboard if possible.
Do not use the medicine after any expiry date which may appear on the label.
Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to
your pharmacist. These measures will help protect the environment.
6. Further information
What the medicine contains
The active substance is methadone hydrochloride 2mg per 5ml.
The other ingredients are glycerol, tolu flavour solution (benzoic acid E210, cinnamic acid, Ceylon
cinnamon bark oil, ethanol, ethyl cinnamate, sucrose, vanillin), tartrazine compound solution (chloroform,
ethanol, glycerol, tartrazine E102, yellow dye sunset E110), syrup (sucrose) and purified water.
What the medicine looks like
The medicine is a yellow coloured liquid.
Marketing Authorisation Holder and Manufacturer
Thornton and Ross Ltd., Huddersfield, HD7 5QH, England.
This leaflet was last revised in November 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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