PROPAIN Caplets – patient leaflet, side effects, dosage

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

The name of your medicine is Propain Caplets.

The medicine contains Paracetamol, Codeine, Diphenhydramine and Caffeine.

Paracetamol is an analgesic which acts to relieve pain.

Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. 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.

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 effects of the analgesics.

2. What you need to know before you take 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.

! This medicine contains paracetamol. Do not take

anything else containing paracetamol while taking this medicine.

! If you take a painkiller for headaches for more than

three days it can make them worse.

! This medicine can be taken by adults and children

aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take Propain Caplets:

! if you are allergic to paracetamol, codeine,

diphenhydramine, caffeine or any of the other ingredients in this medicine (listed in section 6) ! 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 difficulty breathing

! if you have a blockage between your stomach and

small intestine, or 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 or chronic constipation ! 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 pregnant, or breast-feeding

! if you have a peptic ulcer

! if you have severe liver disease

If the answer to any of the above questions is YES, tell your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking this medicine, you need to know the following: ! This product contains paracetamol.

! Do not take with any other paracetamol containing

products.

During treatment with Propain Caplets, tell your doctor straight away if:

You have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

You experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine.

You experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

Sleep-related breathing disorders

Propain Caplets can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during

sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

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

! You have liver or kidney problems

! You have asthma, bronchitis, or Chronic Obstructive

Pulmonary Disease (COPD)

! 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 or have epilepsy

! You have an enlarged prostate

! You have difficulty urinating

! You have a thyroid disease

! You suffer from myasthenia gravis (abnormal muscle

function)

! You are elderly, particularly if you also suffer from

confusion

! You have liver disease due to alcoholism

! You have narrow angle glaucoma.

! You are or have ever been addicted to opioids, alcohol,

prescription medicines, or illegal substances ! You have previously suffered from withdrawal

symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs

! You feel you need to take more of this medicine to get

the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it

! You have bowel problems, including blockage of your

bowel

! You are taking monoamine oxidase inhibitors (for

depression), or have taken them in the last 14 days ! You have had an operation to remove your gall bladder ! You have experienced a recent head injury or raised

intracranial pressure

! You have Gilbert's Syndrome (familial non-haemolytic

jaundice)

! You have glucose-6-phosphatase dehydrogenase

deficiency

! You have haemolytic anaemia

! You have glutathione deficiency

! You are dehydrated

! You have a poor diet such that the diet causes health

problems

! You weigh less than 50kg

Other important information

Do not drink alcohol (wine, beer, spirits) whilst taking this medicine. Alcohol increases the risk of side effects occurring and may make you feel more drowsy.

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.

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

Other medicines and Propain Caplets

Please tell your doctor or pharmacist if you are taking, have recently taken or might take 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:

! Any other medicine containing paracetamol, ! Colestyramine for reducing blood fat levels, ! Domperidone and metoclopramide (to treat nausea and

vomiting),

! Anti-coagulants such as warfarin and coumarins (drugs

to prevent blood clotting),

! Medicines for epilepsy

! Probenecid for gout and hyperuricemia

! Flucloxacillin (antibiotic), due to a serious risk of blood

and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2) ! Monoamine oxidase inhibitors (MAOIs) for depression

in the last two weeks or substances that make you drowsy (e.g. sedatives, antidepressants or alcohol) or sedated (e.g. benzodiazepines or related medicines) ! Pregabalin and gabapentin to treat epilepsy or pain due

to nerve problems (neuropathic pain). If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies, ! Anti-depressants and anxiolytics e.g Venlafaxine (to

treat depression, anxiety or sleep disorders), ! Anti-psychotics and hypnotics (for mental disorders), ! Cisapride (drugs for stomach movement problems), ! Antacids (for stomach ulcers) e.g. cimetidine, ! Naltrexone –used in the treatment of drug dependence. ! Medicines for the treatment of high blood pressure

(diuretics and antihypertensives),

! Drugs that lower blood lipids,

! Metoprolol (a beta blocker) used to treat high blood

pressure, angina, irregular heartbeat or overactive thyroid,

! Kaolin or Loperamide - for the treatment of diarrhoea, ! Drugs that control frequency of passing urine ('water

tablets'),

! Anti-arrhythmics (heart rhythm problems), ! Antibacterials and antivirals (for infections), ! Other antihistamines including those used on your skin

and in cough and cold medicines,

! Tranquillisers or anxiolytics (sedatives) used to treat

anxiety e.g. diazepam,

! Antimuscarinics which relax smooth muscles and are

used for example in Parkinsons Disease, irritable bowel syndrome and incontinence e.g. procyclidine,

trihexyphenidyl, atropine, oxybutynin, fesoterodine.

Tolerance, dependence, and addiction

This medicine contains codeine which is an opioid medicine. It can cause dependence and/or addiction.

Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Propain Caplets can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Propain Caplets if: ! You or anyone in your family have ever abused or been

dependent on alcohol, prescription medicines or illegal drugs ("addiction").

! You are a smoker.

! You have ever had problems with your mood

(depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Propain Caplets, it could be a sign that you have become dependent or addicted:

! You need to take the medicine for longer than advised

by your doctor

! You need to take more than the recommended dose ! You might feel that you need to carry on taking your

medicine, even when it doesn't help to relieve your pain ! You are using the medicine for reasons other than

prescribed, for instance, 'to stay calm' or 'help you sleep'

! You have made repeated, unsuccessful attempts to quit

or control the use of the medicine

! When you stop taking the medicine you feel unwell,

and you feel better once taking the medicine again ('withdrawal effects')

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Propain Caplets).

Propain Caplets with food, drink and alcohol

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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

The medicine can affect your ability to drive as it may make you feel sleepy or dizzy.

! Do not drive while taking this medicine until you know

how it affects you.

! It is an offence to drive if this medicine affects your

ability to drive.

! However, you would not be committing an offence if:

, The medicine has been prescribed to treat a

medical or dental problem and

, You have taken it according to the instructions

given by the prescriber or in the information provided with the medicine and

, It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Propain Caplets contains:

! Methyl (E218), ethyl (E214), propyl (E216) and butyl

parabens. May cause allergic reactions (possibly delayed).

3. How to take Propain Caplets

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

The recommended dose is described below.

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

Dosage instructions

Adults: take 1 or 2 caplets every 4 hours as required, up to a maximum of 10 caplets in 24 hours. The suggested dosage may also be administered to the elderly (in the absence of other contra-indications).

Children aged 16-18 years: take 1 or 2 caplets every 6 hours as required, up to a maximum of 8 caplets in 24 hours.

Children aged 12 years to 15 years: take 1 caplet every 6 hours when necessary up to a maximum of 4 caplets in 24 hours.

Do not take for more than 3 days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist for advice. Propain Caplets should be used for 3 days only to relieve symptoms. If no effective pain relief is achieved while taking the medicine, you should seek the advice of a healthcare professional.

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.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine 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:

! Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

! Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin; mouth ulcers; itching or sweating. ! A serious condition that can make blood more acidic

(called metabolic acidosis), in patients with severe illness using paracetamol (see section 2) ! Severe abdominal pain, dry mouth, nausea and vomiting if you have recently had your gall bladder removed.

If you get any of the following side effects see your pharmacist or doctor:

! 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 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.

Common effects (may affect up to 1 in 10 people) ! Sedation, drowsiness, dizziness, unsteadiness, disturbance in attention

! Dry mouth

! Fatigue.

Other side effects that have been reported are listed below ! Constipation

! Palpitations

! Skin rashes

! Difficulty urinating or inability to pass urine ! Cloudy urine

! Tightness of the chest and difficulty breathing ! Itching

! Sweating

! Flushing of face

! Faster, slower or more noticeable heart rate ! 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

! Blurred vision

! Blood pressure changes

! Light sensitivity

! Stomach/back pain

! Thicker bronchial mucus

! Nervousness (the elderly are more likely to experience these effects)

! Problem affecting a valve in the intestines (sphincter of

Oddi dysfunction).

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: www.mhra.gov.uk/yellowcard 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 Propain Caplets

Keep this medicine out of the sight and reach of children.

Store this medicine 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 intended for them.

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 visible signs of deterioration. Take the unused product to your pharmacist.

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

6. Contents of the pack and other information

What Propain Caplets contain:

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

Ennogen IP Ltd, Unit G4, Riverside Industrial Estate, Riverside Way

Dartford, DA1 5BS, UK

Manufacturer

Sandoz Limited, 37 Woolmer Way, Bordon, GU35 9QE

This leaflet was last revised in: 02/2026

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