PROPAIN PLUS

Active substance: 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

1









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 pain
relief. 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.

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 MAOIʼs);
• 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:
• This product contains paracetamol.
• Do not take with any other paracetamol containing
products.

Talk to your doctor or pharmacist before taking this
medicine if you:

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Artwork Proof Box
Ref: N057 - Update SPC & PIL in line with Article 31 - RFI
Proof no.
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Date prepared:
13/11/2013

Colours:
Black
Dimensions: 148 x 297 mm

Font size:
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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).









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

























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.

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.

5

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.

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.
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.

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sedation or drowsiness,
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.

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.

6

H

Possible side effects

H

Some people may have side-effects when taking this
medicine. If you have any unwanted side-effects you
should seek advice from your doctor, pharmacist or
other healthcare professional. Also you can help to
make sure that medicines remain as safe as possible by
reporting any unwanted side-effects via the internet at
www.yellowcard.gov.uk; alternatively you can call
Freephone 0808 100 3352 (available between
10am-2pm Monday – Friday) or fill in a paper form
available from your local pharmacy.

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.
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.

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

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.

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

Marketing Authorisation Holder and Manufacturer
Sandoz Ltd, Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, UK.

This leaflet was last revised in 11/2013.

Artwork Proof Box
Ref: N057 - Update SPC & PIL in line with Article 31 - RFI
Proof no.
004.1

Date prepared:
13/11/2013

Colours:
Black
Dimensions: 148 x 297 mm

Font size:
7pt
Fonts:
Helvetica

SZ00000LT000

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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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