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PROPAIN PLUS

Active substance(s): CAFFEINE ANHYDROUS / CODEINE PHOSPHATE / DOXYLAMINE SUCCINATE / PARACETAMOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

PROPAIN PLUSTM
(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

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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.

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

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.

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.

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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.

What you need to know before you take
Propain Plus

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.

• 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.

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.

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.

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;

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:

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Artwork Proof Box
Ref: N059: SPC & PIL update in accordance with Codeine + RFI
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Date prepared:
04/09/2015

Colours:
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Dimensions: 148 x 297 mm

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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.

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.

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

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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.

How to take Propain Plus

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

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

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.

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.

The usual dose is described below.
These tablets are for oral administration. They should be
swallowed with a glass of water.

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.

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

How to store Propain Plus

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.

Keep out of reach and sight of children.

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.

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

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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.

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.

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Possible side effects

Further information

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.

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.

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.

Other more common side effects that have been
reported are listed below
• sedation or drowsiness,

SZ00000LT000

Artwork Proof Box
Ref: N059: SPC & PIL update in accordance with Codeine + RFI
Proof no.
006.1

Date prepared:
04/09/2015

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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