Ibuprofen Effervescent Tablets 200mg
PL 16431/0163
PATIENT INFORMATION LEAFLET
SOLUBLE CUFEN EF, IBUPROFEN EFFERVESCENT TABLETS 200 mg
Please read this leaflet carefully before you start to take Soluble Cufen Ef, Ibuprofen Effervescent Tablets 200 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 200 mg contain the following active ingredient Ibuprofen 200 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 10, 12, 16, 24, 30, 36, 50, 56, 100 or 112 tablets.
MA Holder: Ayrton Saunders Ltd, North Way, Walworth Industrial Estate, Andover, SP10 5AZ
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 200 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.
• 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 renal impairment in dehydrated adolescents (age range: > 12 years to < 18 years)
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 200 mg
For oral use
Adults and Children over 12:
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 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
Stomach ulcers, perforations or bleeding may occur. 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 Oedema (swelling), nausea, vomiting, diarrhoea, flatulence, constipation may occur
Other effects which may occur are hypersensitivity reactions, including difficulty in breathing (a condition called bronchospasm, caused by narrowing of the airways), nonspecific allergic reactions and various skin reactions, e.g. itching and hives.
Other adverse events reported less commonly include: kidney and liver problems, blood disorders, visual disturbances or blurred vision, , headaches, depression, nervousness , tinnitus, dizziness, difficulty sleeping, blood disorders, and drowsiness.
Swelling, high blood pressure and heart failure have been reported with this type of medicine.
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 200 mg after the expiry date shown on the carton.
Soluble Cufen Ef, Ibuprofen Effervescent Tablets 200 mg should be stored in a cool dry place. Keep out of the reach and sight of children.
Leaflet revised: November 2015