PATIENT INFORMATION LEAFLET

SOLUBLE CUPROFEN IBUPROFEN EFFERVESCENT TABLETS

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 Povidone

Orange mint flavour 611160E Mango flav-o-lok 610575E IMS

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.

Manufacturer

Cupal Ltd, King Street, Blackburn, Lancashire, BB2 2DX, UK Uses

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.

BEFORE USING SOLUBLE CUPROFEN IBUPROFEN EFFERVESCENT TABLETS

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

symptoms

15.    Do not take if you are taking aspirin at doses above 75mg daily. If you are on low-dose 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, beta-blockers 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 medicines.

DIRECTIONS FOR USE

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.

Children:

Not recommended for children under 12 years Directions:

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.

SIDE EFFECTS

Like all medicines, your medicine can cause side effects, although not everybody gets them.

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 effects:

•    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

STORAGE

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