PACKAGE LEAFLET: INFORMATION FOR THE USER

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PROPAIN Caplets

(Paracetamol, Codeine, Diphenhydramine, Caffeine)

•    This medicine can only be used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone

•    You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice.

•    This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it.

•    If you take this medicine for headaches for more than three days it can make them worse.

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    This medicine can only be used for migraine, headache, muscular pain, period pain and toothache.

•    You must contact a doctor if your symptoms worsen or do not improve after 3 days.

•    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.

In this leaflet:

1.    What are Propain Caplets and what are they used for

2.    Before you take Propain Caplets

3.    How to take Propain Caplets

4.    Possible side effects

5.    How to store Propain Caplets

6.    Further information

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What are Propain Caplets and what are they used for

The name of your medicine is Propain Caplets.

This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain.

Diphenhydramine is an antihistamine and is used for its ability to reduce feelings of sickness which can be associated with migraine. Caffeine is a stimulant which is used to counteract the possible sedative affects of the analgesics.

due to Obstructive Sleep Apnoea Syndrome.

Use in children with breathing problems Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Do not give to children under the age of 12 without medical advice.

Take special care with Propain Caplets

Before taking this medicine, you need to know the following:

•    This product contains paracetamol.

•    Do not take with any other paracetamol containing products.

Codeine can be used in children over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol, ibuprofen or aspirin alone. This medicine can be used for the treatment of migraine, headache, muscular pain, period pain and toothache.

What you need to know before Propain Caplets

•    This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it.

•    If you take a painkiller for headaches for more than three days it can make them worse.

Do not take Propain Caplets:

•    if you are allergic to paracetamol, codeine, diphenhydramine, caffeine or any of the other ingredients in these caplets

•    if you are taking any other medicines containing paracetamol, codeine, antihistamine or caffeine (without consulting your doctor)

•    if you suffer from alcoholism

•    if you suffer from severe lung disease and difficulty breathing

•    if you are at risk of a blocked intestine

•    if you have raised pressure within your skull

•    if you have suffered a head injury

•    if you have severe stomach pain

•    for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome

•    if you know that you metabolise very rapidly codeine into morphine

•    if you are breastfeeding

If the answer to any of the above questions is YES, tell

your doctor or pharmacist before taking this medicine.

Children and adolescents

Use in children and adolescents after surgery Codeine

should not be used for pain relief in children and

adolescents after removal of their tonsils or adenoids

Talk to your doctor or pharmacist before taking Propain Caplets if:

•    You have liver or kidney problems

•    You have asthma

•    You have severe lung disease and difficulty breathing

•    You have a condition called porphyria (an enzyme disorder)

•    You have low blood pressure (hypotension)

•    You have eye problems (glaucoma)

•    You have seizures (epilepsy)

•    You have prostate or urinary problems

•    You have a thyroid disease

•    You have liver disease due to alcoholism.

Warnings and precautions

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces the effects of codeine and relieves pain. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have bought yourself without a prescription.

In particular you should tell your doctor if you are taking any of the following:

•    Anti-depressants and anxiolytics (to treat depression, anxiety or sleep disorders),

•    Anti-psychotics and hypnotics (for mental disorders),

•    Anti-coagulants such as warfarin and coumarins (drugs to prevent blood clotting),

•    Domperidone and metoclopramide (to treat nausea and vomiting),

•    Drugs that lower blood lipids,

•    Drugs that control frequency of passing urine,

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•    Cisapride (drugs for stomach movement problems),

•    Antacids (for stomach ulcers) e.g. cimetidine,

•    Anti-arrhythmics (heart rhythm problems),

•    Antibacterials and antivirals (for infections),

•    Drugs to treat ringing in the ears.

Taking Propain Caplets with food and drink

You should avoid excessive intake of caffeine-containing drinks (for example tea and coffee). You should not drink alcohol while taking this medicine. Alcohol may increase the sedative effects of this medicine and make you very sleepy. It can increase the risk of some side effects.

Pregnancy and breast-feeding

You should not take this medicine if you are pregnant as it is not recommended during this time. Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machines

Propain Caplets may cause drowsiness. If affected, do not drive or operate machinery.

Important information about some of the ingredients in Propain Caplets

This medicine contains methyl (E218), ethyl (E214), propyl (E216) and butyl parabens which may cause an allergic reaction (possible delayed).

3 How to take Propain Caplets

The usual dose is described below.

These caplets are for oral administration. They should be swallowed with a glass of water.

Dosage instructions

Children aged 12 years of above should take 1 or 2 caplets every 6 hours, as needed. Do not take more than 10 caplets in 24 hours.

This medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, talk to your doctor for advice.

Propain caplets should not be taken by children below the age of 12 years, due to the risk of severe breathing problems.

Codeine addiction

This medicine contains codeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

If you take more Propain Caplets than you should:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Take this leaflet and any remaining caplets with you.

•    Lowering in body temperature

•    Hallucinations (hearing voices and seeing things)

•    Altered mood

•    Reduced sex drive

•    Small pupils

•    Restlessness and irritability after treatment has stopped

•    Stomach upsets

•    Muscle stiffness

•    Jerky or uncoordinated movements

•    Confusion/depression

•    Sleeping problems

•    Fits

•    Tremor

•    Muscle pain

•    Pins and Needles

•    Hair loss

•    Liver problems

•    Headache

•    Nausea and vomiting

•    Dry mouth

•    Blurred vision

•    Blood pressure changes

•    Light sensitivity

•    Stomach/back pain.

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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How do I know if I am addicted?

If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

•    You need to take the medicine for longer periods of time

•    You need to take more than the recommended dose

•    When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again.

5 How to store Propain Caplets

Keep out of the reach and sight of children.

Do not take this medicine after the expiry date printed on the carton. The expiry date refers to the last day of that month.

Do not use this medicine if you notice and visible signs of deterioration. Take the unused product to your pharmacist.

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.

4 Possible side effects

6 Further information

It is very unlikely that you will experience the following

side effects. However, you should stop taking this

medicines and talk to your doctor immediately if you

notice any of the following symptoms:

•    You bruise more easily, have bleeding gums or bleed for longer after cutting yourself or you feel tired or look pale.

•    You seem to be getting more infections than usual or you develop ulcers in your mouth or throat.

•    You have a severe abdominal pain (in the upper middle or upper left part of the belly) usually accompanied by sickness, diarrhoea or fever.

•    Allergic (hypersensitivity) reactions such as skin rash may occur.

Other more common side effects that have been reported are listed below:

•    Constipation

•    Drowsiness

•    Skin rashes

•    Difficulty passing urine

•    Tightness of the chest and difficulty breathing

•    Itching

•    Sweating

•    Flushing of the face

•    Dizziness

•    Faster, slower or more noticeable heart rate

What Propain Caplets contain:

The active ingredients in Propain Caplets are: paracetamol BP 400 mg, codeine phosphate 10 mg, diphenhydramine hydrchloride 5 mg and caffeine anhydrous 50 mg.

The other ingredients are:

magnesium stearate, maize starch, talc, methyl (E218), ethyl (E214), propyl (E216) and butyl parabens, gelatin, quinoline yellow (E104) and erythrosine (E127).

What Propain Caplets look like and contents of the pack

Propain Caplets are yellow compressed capsule shaped tablets with a scored line on one side and ‘Propain’ on the other. Pack sizes are 12, 16, 24 and 32 caplets. Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Sandoz Ltd, Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

This leaflet was last revised in 06/2015.

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