PL 16431/0092

PATIENT INFORMATION LEAFLET

SOLUBLE CUFEN EF, IBUPROFEN EFFERVESCENT TABLETS 400 mg

Please read this leaflet carefully before you start to take Soluble Cufen Ef, Ibuprofen Effervescent Tablets 400 mg. It gives you important information about your treatment. If you have any questions, or if you are not sure about anything, ask your doctor or pharmacist.

What is in the pack?

The name of your medicine is Soluble Cufen Ef, Ibuprofen Effervescent Tablets 400 mg contain the following active ingredient Ibuprofen 400 mg. They also contain the following inactive ingredients:

Sodium Bicarbonate Sodium Carbonate (Anhydrous)

Sodium Cyclamate

Sodium Saccharin

Citric Acid Anhydrous

Docusate Sodium

Polyethylene Glycol Powder 6000

Povidone

Orange Mint Flavour 611160E 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 Cufen Ef, Ibuprofen Effervescent Tablets are available in cartoned strip packs containing 12, 24, 48, 96, 112 or 144 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

Uses

For the relief of pain in migraines, menstruation, dental and post-operative pain. For the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis), osteoarthritis, ankylosing spondylitis and other non-rheumatoid arthropathies and non-articular rheumatic conditions.

Indicated in acute periarticular disorders such as bursitis, frozen shoulder, tendonitis, tenosynovitis and low back pain. It may also be used in soft tissue injuries such as sprains and strains.

Before Using Soluble Cufen Ef, Ibuprofen Effervescent Tablets 400 mg

The following information should be read before using this medicine:

•    Have you ever had a reaction after using Soluble Cufen Ef, Ibuprofen Effervescent Tablets or to any of its ingredients?

•    Do aspirin or drugs similar to aspirin bring about the symptoms of asthma, rhinitis (runny nose) or urticaria (rash)?

•    Are you taking any products that contain aspirin or any other non-steroidal antiinflammatory drugs?

•    Do you suffer from, or have ever suffered from, peptic ulceration (ulcer in the stomach or duodenum) or bleeding in your digestive tract?

•    Do you have severe liver disease, kidney problems or heart failure?

•    Are you pregnant or breastfeeding?

•    Are you on a sodium restricted diet?

If the answer is YES to any of the above questions, do not take the medicine.

Talk to your doctor or pharmacist.

•    If you are elderly or have a bleeding disorder, talk to your doctor before taking this medicine as you may be at greater risk of suffering from the serious side effects which are associated with this medicine.

•    If you are taking this medicine, do not take aspirin or any other oral non-steroidal anti-inflammatory drug during your treatment unless your doctor tells you to.

•    Take special care when using this medicine if you suffer from hypertension (high blood pressure), chronic inflammatory intestinal disease (Crohn’s disease and ulcerative colitis) or SLE (systematic lupus erythematosus) or have heart, liver or kidney problems.

•    If you are taking any of the following drugs or types of drugs, please talk to your doctor or pharmacist before taking this medicine:

Anti-hypertensives (drugs for high blood pressure), anticoagulants (drugs to thin your blood), corticosteroids, methotrexate (cytotoxics), mifepristone (within the last 12 days), diuretics (water tablets), quinolone antibiotics (such as ciprofloxacin), digoxin, lithium, ciclosporin, tacrolimus or zidovudine.

•    Each tablet contains 995 mg of sodium and care should be taken if on a sodium restricted diet.

•    Do not take if you are taking aspirin at doses above 75 mg daily. If you are on low-dose aspirin (up to 75 mg daily) speak to your doctor, dentist or pharmacist before you take Soluble Cufen Ef, Ibuprofen Effervescent Tablets.

•    Soluble Cufen Ef, 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 Cufen Ef, 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 Cufen Ef, 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 Cufen Ef, Ibuprofen Effervescent Tablets

Soluble Cufen Ef, 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 Cufen Ef, Ibuprofen Effervescent Tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Soluble Cufen Ef, Ibuprofen Effervescent Tablets with other medicines.

How to take Soluble Cufen Ef, Ibuprofen Effervescent Tablets 400 mg

For oral use

Adults and children over 12 years

The usual recommended dose is as follows: one tablet to be taken three to four times daily. In some cases your doctor may prescribe one tablet two to three times daily. Your doctor may increase this dose depending on your symptoms, but no more than six tablets should be taken in one day.

This product is intended for short-term use only. You should take the lowest dose for the shortest time necessary to relieve symptoms.

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.

Children:

This product should not be taken by children under 12 years of age.

Elderly:

As the risk of side effects is greater in elderly patients, your doctor should prescribe the lowest possible dose, and may wish to monitor you for gastrointestinal bleeding for 4 weeks.

Directions

The tablets must be dissolved in half a glass of water (100 ml). the tablets dissolve more quickly in warm water, or if stirred.

In the event of accidental or deliberate overdose, seek immediate medical attention.

If you forget to take a dose take the missed dose as soon as you remember, unless it is time for your next dose. Never double-up on the dose to make up for the one you have missed.

Side Effects

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 your faeces (stools/ motions) Pass black tarry stools

Vomit any blood or dark particles that look like coffee grounds.

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

The most common side effects relate to the stomach and intestines.

Stomach ulcers, perforation or bleeding may occur. Ulcerative stomatitis, oedema (swelling), feeling sick, being sick, diarrhoea, wind, constipation, indigestion, abdominal pain, and inflammation of the stomach lining. Worsening of colitis (inflammation of the bowel) and Crohn’s disease have been reported. Less frequently, inflammation of the stomach has been observed.

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.

Other common effects which may occur are hypersensitivity reactions, including difficulty in breathing or bronchospasm (a condition called, caused by narrowing of the

airways), non- specific allergic reactions and various skin reactions, e.g. rashes itching, hives, small purple bruises, swelling, severe skin reactions which could include blistering and peeling.

Other adverse events reported less commonly include: kidney problems, including kidney failure and liver problems, including hepatitis and jaundice (yellowing of the skin and whites of the eyes), , visual disturbances, unexpected sensitivity of the skin to the sun, headaches, tingling of the hands and feet, , depression, confusion, hallucinations, tinnitus, vertigo, dizziness, sickness, weakness, tiredness and drowsiness. Reduction in blood platelets, which increases risk of bleeding or bruising, severe reduction in number of white blood cells which makes infections more likely, reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness.

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.

Should you experience any of the above mentioned side effects, or any other unusual effects stop taking the medicine and tell your doctor or pharmacist who will advise you on any necessary action to take.

Storage

This product has a three year shelf life, its expiry date is given on the carton.

Do not use Soluble Cufen Ef, Ibuprofen Effervescent Tablets 400 mg after the expiry date shown on the carton.

Soluble Cufen Ef, Ibuprofen Effervescent Tablets 400 mg should be stored in a cool dry place. Keep out of the reach and sight of children.

Leaflet revised: February 2016