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PROPAIN CAPLETS

Active substance(s): CAFFEINE ANHYDROUS / CODEINE PHOSPHATE / DIPHENHYDRAMINE HYDROCHLORIDE / PARACETAMOL / CAFFEINE ANHYDROUS / CODEINE PHOSPHATE / DIPHENHYDRAMINE HYDROCHLORIDE / PARACETAMOL / CAFFEINE ANHYDROUS / CODEINE PHOSPHATE / DIPHENHYDRAMINE HYDROCHLORIDE / PARACETAMOL

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Sandoz Ltd
Propain Caplets

PL 04416/0373

Patient Information Leaflet
08/12/2016

Package leaflet: Information for the user
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
1. 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.

PIL.0373.008.1d V030: SPC & PIL update in accordance with MHRA request to
optimised paediatric posology for paracetamol (dosing) + RFI

IS

Sandoz Ltd
Propain Caplets

PL 04416/0373

Patient Information Leaflet
08/12/2016

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.

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.
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 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.
PIL.0373.008.1d V030: SPC & PIL update in accordance with MHRA request to
optimised paediatric posology for paracetamol (dosing) + RFI

IS

Sandoz Ltd
Propain Caplets

PL 04416/0373

Patient Information Leaflet
08/12/2016

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.

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,
• Cisapride (drugs for stomach movement problems),
• Antacids (for stomach ulcers) e.g. cimetidine,
• Anti-arrhythmics (heart rhythm problems),
PIL.0373.008.1d V030: SPC & PIL update in accordance with MHRA request to
optimised paediatric posology for paracetamol (dosing) + RFI

IS

Sandoz Ltd
Propain Caplets

PL 04416/0373

Patient Information Leaflet
08/12/2016

• 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
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 age 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.
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.
PIL.0373.008.1d V030: SPC & PIL update in accordance with MHRA request to
optimised paediatric posology for paracetamol (dosing) + RFI

IS

Sandoz Ltd
Propain Caplets

PL 04416/0373

Patient Information Leaflet
08/12/2016

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.

4. Possible side effects

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 face
• Dizziness
• Faster, slower or more noticeable heart rate
• Lowering in body temperature
• Hallucinations (hearing voices and seeing things)
PIL.0373.008.1d V030: SPC & PIL update in accordance with MHRA request to
optimised paediatric posology for paracetamol (dosing) + RFI

IS

Sandoz Ltd
Propain Caplets

PL 04416/0373

Patient Information Leaflet
08/12/2016

• 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 sight and reach 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.
PIL.0373.008.1d V030: SPC & PIL update in accordance with MHRA request to
optimised paediatric posology for paracetamol (dosing) + RFI

IS

Sandoz Ltd
Propain Caplets

PL 04416/0373

Patient Information Leaflet
08/12/2016

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.
6. Further Information
What Propain Caplets contain:
The active ingredients in Propain Caplets are: paracetamol BP 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 and Manufacturer
Sandoz Limited, Frimley Business Park, frimley, Camberley, Surrey, GU16, 7SR

This leaflet was last revised in: 12/2016

PIL.0373.008.1d V030: SPC & PIL update in accordance with MHRA request to
optimised paediatric posology for paracetamol (dosing) + RFI

IS

Expand Transcript

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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