PACKAGE LEAFLET: INFORMATION FOR THE USER

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PROPAIN PLUS™

(Paracetamol, Doxylamine, Caffeine, Codeine)

•    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 backache, neuralgia, muscular aches and pains, toothache, rheumatic pain, headache and tension headache, period pain, migraine and pain following operations and dental surgery.

•    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 Plus and what are they used for

2.    Before you take Propain Plus

3.    How to take Propain Plus

4.    Possible side effects

5.    How to store Propain Plus

6.    Further information

What are Propain Plus and what are they used for

The name of your medicine is Propain Plus.

This medicine contains paracetamol, an analgesic (pain killer). Doxylamine is an antihistamine, caffeine is a mild stimulant which also acts to help the effectiveness of paracetamol. Codeine is an analgesic.

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 to relieve:

•    backache

•    neuralgia

•    muscular aches and pains

•    toothache

•    rheumatic pain

•    headache and tension headache

•    period pain

•    migraine

This medicine can also be used to relieve pain following operations and dental surgery.

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

What you need to know before you take Propain Plus

•    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 Plus

•    If you are allergic to paracetamol, codeine, caffeine, doxylamine succinate, antihistamines or to any of the other ingredients in this medicine.

•    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.

Take special care with Propain Plus

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

•    Contains paracetamol.

Do not take anything else containing paracetamol while

taking this medicine.

Talk to your doctor or pharmacist before taking this

medicine if you:

•    suffer from asthma.

•    have kidney or liver disease.

•    are an elderly person.

•    have had recent gastrointestinal surgery.

•    have a history of drug abuse.

•    have emotional problems.

•    have or suffer from: high blood pressure, bowel disorder, abdominal conditions, thyroid gland problems, adrenal gland disease, prostate problems, shock or gallstone.

•    have irregular, fast or slower than usual heart beat (cardiac arrhythmias), your doctor will tell you if you have this.

•    suffer from convulsions.

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.

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 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.

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:

•    anticholinergic agents such as atropine;

•    sedatives or tranquillizers;

•    cimetidine (for stomach ulcers);

•    antidepressants (tricyclic or MAOI’s);

•    quinidine, mexiletine (used to correct heart rhythm);

•    opioid and narcotic analgesics (for pain relief);

•    ergot alkaloids (for migraine);

•    enzyme-inducing agents such as alcohol or anti-epileptic medicines;

•    naloxone (used to counter the effects of an opioid overdose);

•    coumarins (to thin the blood);

•    phenylbutazone, indometacin (anti-inflammatory medicines);

•    naltrexone (for drug addiction);

•    aspirin;

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•    phenothiazines (antipsychotics);

•    diuretics (used to reduce the amount of water in the body);

•    central nervous system depressants including alcohol;

•    colestyramine (used to lower Cholesterol);

•    antihypertensives (used to reduce blood pressure);

•    barbiturates (to help you sleep or treat epilepsy);

•    metoclopramide, cisapride, domperidone (used to help stop nausea and vomiting);

•    antidiarrhoeals (such as loperamide);

•    hypnotics (to help you sleep);

•    anxiolytics (to help with anxiety).

Taking Propain Plus with food and drink

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 use this medicine during pregnancy as it is not recommended for use at 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 medicine.

Driving and using machines

This medicine may cause drowsiness and impaired concentration. If you are affected, do not drive or operate machinery.

3 How to take Propain Plus

The usual dose is described below.

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

Dosage instructions

Adults: Take 1-2 caplets every 6 hours as needed for relief. Do not take more than 8 caplets in 24 hours.

Children aged 12 years or above: Take 1-2 caplets every 6 hours, as needed. Do not take more than 8 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 Plus 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 Plus than you should

If you or someone else swallows a lot of the caplets all together, or if you think a child has swallowed any of the caplets, contact your nearest hospital casualty department or doctor immediately.

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

•    dizziness,

•    stomach troubles,

•    blurred vision,

•    insomnia,

•    nausea,

•    constipation,

•    vomiting,

•    gastric ulcers,

•    headache,

•    tinnitus (ringing in the ears),

•    extreme feelings of happiness or depression,

•    restlessness or excitement,

•    irritability,

•    nightmares,

•    loss of appetite,

•    difficulty passing water,

•    dryness of the mouth,

•    tightness of the chest,

•    tingling,

•    heaviness or weakness of the hands,

•    muscle tremors,

•    high blood pressure (hypertension),

•    fast or irregular heartbeat.

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

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.

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How to store Propain Plus

Keep out of reach and sight of children.

Do not use this medicine after the expiry date on the container. The expiry date refers to the last day of that month.

Store at or below 25°C in the original package.

If you notice any visible signs of deterioration such as broken or chipped caplets please take this medicine 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

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Further information

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

It is very unlikely that you will experience the following side effects. However, you should stop taking this medicine 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

•    sedation or drowsiness,

What Propain Plus contains

The active ingredients in this medicine are paracetamol 450 mg, doxylamine succinate 5 mg, caffeine anhydrous 30 mg and codeine phosphate 10 mg.

The other ingredients are maize starch, povidone, magnesium stearate, colloidal silicon dioxide, and microcrystalline cellulose. The film coat contains hypromellose, hydroxypropylcellulose, glycerol and carnauba wax.

What Propain Plus looks like and contents of the pack

This medicine is a capsule-shaped tablet called a caplet. The caplets are available in packs of 8, 10, 16, 20 or 32. 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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