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SOLUBLE CUFEN EF IBUPROFEN EFFERVESCENT TABLETS 400MG

Active substance(s): IBUPROFEN

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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.

PL 16431/0092
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 lowdose 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.

PL 16431/0092

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, 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 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.

PL 16431/0092

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), feel ing 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

PL 16431/0092
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

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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.

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