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Active substance(s): IBUPROFEN

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Please read this leaflet before you start to use this product. If you have any questions or
are unsure about anything, ask your doctor or pharmacist.
Soluble Cuprofen Ibuprofen Effervescent Tablets contain the following active ingredient:
Ibuprofen 200mg
In addition they also contain the following inactive ingredients:
Sodium bicarbonate
Sodium carbonate (anhydrous)
Sodium cyclamate 1968
Sodium saccharin BP
Citric acid anhydrous
Docusate sodium
Polyethylene glycol powder 6000
Orange mint flavour 611160E
Mango flav-o-lok 610575E
Ibuprofen belongs to a class of medicines called Non-Steroidal Anti-inflammatory Drugs
(NSAIDs), which have both pain relieving and temperature reducing properties.
Soluble Cuprofen Ibuprofen Effervescent Tablets are available in cartooned strip packs
containing 10, 12, 16, 24, 30, 36, 50, 56, 100 or 112 tablets.
MA holder
Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire,
WA7 1NU.
Cupal Ltd, King Street, Blackburn, Lancashire, BB2 2DX, UK
For the relief of rheumatic or muscular pain, pain of non-serious arthritic conditions,
backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness,
symptoms of colds and influenza.
The following information should be read before using this medicine:

1. Do not use this medicine if you are sensitive (allergic) to ibuprofen or any of the
ingredients listed at the beginning of this leaflet
2. Make sure these tablets are suitable for you to use – ask your doctor or pharmacist
3. Do not take this medicine if you have ever had peptic ulcers or suffer from asthma
4. Do not take this medicine if you have liver, kidney or heart problems
5. Do not take this medicine if you are on a sodium restricted diet
6. Do not take this medicine if you are sensitive (allergic) to aspirin or other nonsteroidal anti-inflammatory (NSAIDs), such symptoms may be runny nose or
wheezing/breathing difficulties
7. Do not take this medicine if you are taking anticoagulants or thiazide diuretics – if in
doubt consult your doctor
8. Consult your doctor before taking Soluble Cuprofen Ibuprofen Effervescent Tablets if
you are currently taking aspirin or other NSAIDs
9. Do not take this medicine if you are pregnant or breastfeeding
10. Undesirable effects may be minimised by using the minimum effective dose for the
shortest possible duration
11. The elderly are at increased risk of the serious consequences of adverse reactions, if
you are worried, consult your doctor before taking Soluble Cuprofen Ibuprofen
Effervescent Tablets
12. Each tablet contains 661mg of sodium and care should be taken if on a sodium
restricted diet.
13. If you suffer from any of the following at any time during your treatment
STOP TAKING the medicine and seek immediate medical help:
Pass blood in you faeces (stools/motions)
Pass black tarry stools
Vomit any blood or dark particles that look like coffee grounds
14. STOP TAKING the medicine and tell your doctor if you experience:
Indigestion or heartburn
Abdominal pain (pains in your stomach) or other abdominal stomach
15. Do not take if you are taking aspirin at doses above 75mg daily. If you are on lowdose aspirin (up to 75mg daily) speak to your doctor, dentist or pharmacist before you
take Soluble Cuprofen Ibuprofen Effervescent Tablets.
16. Soluble Cuprofen Ibuprofen Effervescent Tablets belong to a group of medicines
which may impair fertility in women. This effect is reversible on stopping the
medicine. It is unlikely that Soluble Cuprofen Ibuprofen Effervescent Tablets, used
occasionally, will affect your chances of becoming pregnant, however, tell your
doctor before taking this medicine if you have problems becoming pregnant.
Warnings and Precautions
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small
increased risk of heart attack or stroke, particularly when used at high doses. Do not
exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking
Soluble Cuprofen Ibuprofen Effervescent Tablets if you:

- have heart problems including heart failure, angina (chest pain), or if you have had a
heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of
feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’
or transient ischaemic attack “TIA”).
- have high blood pressure, diabetes, high cholesterol, have a family history of heart
disease or stroke, or if you are a smoker.
There is a risk of kidney damage in dehydrated adolescents (age range 12 to 18)
Other medicines and Soluble Cuprofen Ibuprofen Effervescent Tablets
Soluble Cuprofen Ibuprofen Effervescent Tablets may affect or be affected by some
other medicines. For example:

-medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g.
aspirin/acetylsalicylic acid, warfarin, ticlopidine)
- medicines that reduce high blood pressure (ACE-inhibitors such as captopril, betablockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
Some other medicines may also affect or be affected by the treatment of Soluble Cuprofen
Ibuprofen Effervescent Tablet .You should therefore always seek the advice of your doctor or
pharmacist before you use Soluble Cuprofen Ibuprofen Effervescent Tablets with other

For oral administration
Dosage instructions
Adults, the elderly and children over 12 years:
Initial dose: one or two tablets to be taken. The initial dose may be followed by further
doses of one or two tablets every four hours. Maximum daily dose – six tablets in 24
hours. To be taken preferably after food.
This product is intended for short-term use only. You should take the lowest dose for the
shortest time necessary to relieve symptoms.
Adults aged 18 or over:
You should not take this medicine for longer than 10 days. If symptoms persist or worsen
consult your doctor who may instruct you to continue taking the medicine.

Adolescents (age range 12 to 18)
If this medicine is required for more than 3 days, or if symptoms worsen a doctor
should be consulted.

Not recommended for children under 12 years
The tablets must be dissolved in half a glass of water (100ml). The tablets dissolve more
quickly in warm water, or if stirred.
In the event of accidental or deliberate overdose, seek immediate medical attention from
your doctor or local hospital casualty department.
If you forget to take a dose, do not worry, take the next dose at the right time. Do not
double up on a dose to make up for the one you’ve missed.

Like all medicines, your medicine can cause side effects, although not everybody gets
The following side effects are very rare (less than 1 in 10,000 people), but if you
experience any of the following serious effects then STOP taking the medicine
immediately and contact your doctor or pharmacist:
• Peptic (stomach) ulceration or perforation. Symptoms could include abdominal pain,
vomiting blood or liquid with what looks like coffee grounds, blood in the faeces
(stools/motions) or passing black tarry stools
• Meningitis (inflammation of the brain lining) has occurred in patients with certain autoimmune diseases (such as lupus or connective tissue disease).Symptoms could include
stiff neck, headache, feeling or being sick, fever or feeling disoriented.
• Severe allergic reactions. Symptoms could include fainting, faster heart rate, swelling of
the face, tongue and throat
• Worsening of asthma and wheezing or difficulty breathing
Between 1 in 100 and 1 in 1,000 people may experience the following uncommon side
• Allergic reactions such as hives, skin rashes and itching (or SLE)
• Abdominal (stomach) pain, indigestion, heartburn and feeling sick
• Headache
Between 1 in 1000 and 1 in 10,000 people may experience the following rare side effects:
• Diarrhoea, wind, constipation or being sick
Less than 1 in 10,000 people may experience the following very rare side effects:
• Worsening of colitis (inflammation of the bowel)
• Worsening of Crohn’s disease
• Reduction in blood cells, which can make the skin pale or yellow, cause fever, sore
throat, mild mouth ulcers, flu-like symptoms, severe exhaustion or weakness, easy
bruising, or bleeding from the skin or nose
• Visual disturbance, and dizziness
• Liver problems. Symptoms could include yellowing of the skin or the whites of the eyes
• Kidney problems. Symptoms could include swelling of the ankles
• Severe skin reactions. Symptoms could include blistering and peeling

Other side effects which have been reported with this type of medicine:
• Heart failure
• High blood pressure
• Swelling
Medicines such as this product may be associated with a small increased risk of heart
attack or stroke. Any risk is more likely with high doses and prolonged treatment.
If any of the side effects get serious, or your notice any side effect not listed in the leaflet,
please tell your doctor or pharmacist

This product has a two year shelf life, its expiry date is given on the foil and carton.
Do not use Soluble Cuprofen Ibuprofen Effervescent Tablets after the expiry date shown
on the carton.
Soluble Cuprofen Ibuprofen Effervescent Tablets should be stored in a cool dry place out
of the reach of children.
Date of leaflet revision: February 2016

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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.