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PROPAIN PLUS

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

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Sandoz Ltd
Propain Plus

PL 04416/0363

Patient Information Leaflet
19/06/2015

Package leaflet: Information for the user
PROPAIN PLUS™
(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. 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
PIL.0363.007.1d

N060: SPC & PIL update in accordance with MHRA request to optimised
paediatric posology for paracetamol (dosing) + RFI

IS

Sandoz Ltd
Propain Plus

PL 04416/0363

Patient Information Leaflet
19/06/2015

• neuralgia
• muscular aches and pains
• toothache
• rheumatic pain
• headache and tension headache
• period pain
• migraine
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.

2.

What you need to know before you take Propain Plus



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 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.
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:

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.
PIL.0363.007.1d

N060: SPC & PIL update in accordance with MHRA request to optimised
paediatric posology for paracetamol (dosing) + RFI

IS

Sandoz Ltd
Propain Plus




PL 04416/0363

Patient Information Leaflet
19/06/2015

have irregular, fast or slower than usual heart beat (cardiac arrhythmias), your
doctor will tell you if you have this.
suffer from convulsions.

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.

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:
• 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 medicine);
• naltrexone (for drug addiction);
• aspirin;
• phenothiazines (antipsychotics);
• diuretics (used to reduce the amount of water in the body);
PIL.0363.007.1d

N060: SPC & PIL update in accordance with MHRA request to optimised
paediatric posology for paracetamol (dosing) + RFI

IS

Sandoz Ltd
Propain Plus

PL 04416/0363

Patient Information Leaflet
19/06/2015

• 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.
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 tablets every 6 hours as needed for relief. Do not take more than 8
tablets in 24 hours.
Children aged 16 years or above: Take 1-2 tablets every 6 hours, as needed. Do not take
more than 8 tablets in 24 hours.
Children aged 12 years to 15 years: Take one tablet every 6 hours when
necessary up to a maximum of 4 tablets 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.0363.007.1d

N060: SPC & PIL update in accordance with MHRA request to optimised
paediatric posology for paracetamol (dosing) + RFI

IS

Sandoz Ltd
Propain Plus

PL 04416/0363

Patient Information Leaflet
19/06/2015

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

If you take more Propain Plus than you should
If you or someone else swallows a lot of the tablets all together, or if you think a child
has swallowed any of the tablets, 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.
4.
Possible side effects

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, diarrhea or fever.
Allergic (hypersensitivity) reactions such as skin rash may occur.

Other more common side effects that have been reported are listed below
• sedation or drowsiness,
• dizziness,
• stomach troubles,
• blurred vision,
• insomnia,
• nausea,
• constipation,
PIL.0363.007.1d

N060: SPC & PIL update in accordance with MHRA request to optimised
paediatric posology for paracetamol (dosing) + RFI

IS

Sandoz Ltd
Propain Plus

PL 04416/0363

Patient Information Leaflet
19/06/2015

• 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 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
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. By reporting side effects you can
help provide more information on the safety of this medicine.

5.

How to store Propain Plus

Keep out of the sight and reach 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.
Store at or below 25°C in the original package.
PIL.0363.007.1d

N060: SPC & PIL update in accordance with MHRA request to optimised
paediatric posology for paracetamol (dosing) + RFI

IS

Sandoz Ltd
Propain Plus

PL 04416/0363

Patient Information Leaflet
19/06/2015

If you notice any visible signs of deterioration such as broken or chipped tablets 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.

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.
What Propain Plus looks like and contents of the pack
This medicine is a capsule-shaped tablet called a caplet.
The tablets are available in packs of 8, 10, 16, 20 or 32.
Not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Sandoz Ltd, Woolmer Way, Bordon, Hampshire GU35 9QE.

This leaflet was last revised in 12/2016

PIL.0363.007.1d

N060: 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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