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PROPAIN CAPLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

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
due to Obstructive Sleep Apnoea Syndrome.

1

What are Propain Caplets and what are
they used for

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.

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.

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

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.

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.

2

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.

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.

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.

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

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,

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

Continued on the next page >>

Artwork Proof Box
Ref: N029: SPC & PIL update in accordance with Codeine Art. 31 referral
Proof no.
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Date prepared:
19/06/2015

Colours:
Black
Dimensions: 148 x 297 mm

Font size:
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Fonts:
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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

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 to take Propain Caplets

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.

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.

5

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.

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.

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

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.

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.

Possible side effects

6

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:

Further information

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).

• 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 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.

SZ00000LT000

Artwork Proof Box
Ref: N029: SPC & PIL update in accordance with Codeine Art. 31 referral
Proof no.
007.0

Date prepared:
19/06/2015

Colours:
Black
Dimensions: 148 x 297 mm

Font size:
7pt
Fonts:
Helvetica

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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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