Patient leaflet - IBUPROFEN EFFERVESCENT TABLETS 200 MG, IBUSOLVE 200 MG EFFERVESCENT TABLETS
What is in this leaflet
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1. What Ibuprofen Effervescent Tablets are and what it is used for
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2. What you need to know before you take Ibuprofen Effervescent Tablets
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3. How to take Ibuprofen Effervescent Tablets
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4. Possible side effects
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5. How to store Ibuprofen Effervescent Tablets
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6. Contents of the pack and other information
1. what ibuprofen effervescent tablets is and what it is used for
Ibuprofen Effervescent Tablets belong to a group of medicines called anti-inflammatory pain killers.
They can be used to relieve rheumatic or muscular pain, pain of non-serious arthritic conditions, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.
The active ingredient in Ibuprofen Effervescent Tablets is ibuprofen and each tablet contains 200mg.
What you need to know before you take Ibuprofen Effervescent Tablets
Do not take Ibuprofen Effervescent Tablets
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– if you have ever had a reaction to ibuprofen or anyof the ingredients listed in section 6
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– If you suffer from, or have ever suffered from, peptic ulceration (ulcer in the stomach or duodenum) or bleeding in your digestive tract -if you are sensitive (allergic) to aspirin or other non- steroidal antiinflammatory (NSAIDs), such symptoms may be runny nose or wheezing/breathing difficulties
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– if you are pregnant, planning to become pregnant or breastfeeding. Ibuprofen tablets may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant
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– if you have a condition which increases your tendency to bleed
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– if you have problems with you liver, kidney or heart
Warnings and precautions
Talk to your pharmacist or doctor if:
- You are taking a combination of several NSAID products including aspirin
- You have or have had impaired kidney or liver function, mild to moderate heart failure.
- 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
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- You have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
- You have a history of stomach problems such as ulcers, crohn’s disease or ulcerative colitis
- You have systemic lupus erythematosus and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.
- You have asthma, chronic rhinitis or allergic disease
- You are elderly, the elderly are at an increased risk of adverse reactions due to Ibuprofen.
- You have an infection- please see heading “infections” below.
- 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 Ibuprofen Effervescent Tablets.
Infections
Ibuprofen may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.
Serious skin reactions have been reported in association with Ibuprofen Effervescent Tablets treatment. You should stop taking Ibuprofen Effervescent Tablets and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.
Always aim for the lowest possible dose and shortest possible treatment time to reduce the risk of side effects. It is generally the case that higher than recommended doses can entail risks.
Children and adolescents
Do not give this medicine to children under 12. There is a risk of kidney damage in dehydrated adolescents (age range 12 to 18)
Other medicines and Ibuprofen Effervescent Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Ibuprofen Effervescent Tablets may affect or be affected by some other medicines. For example:
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> anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin,
ticlopidine)
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> medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta- blockers
such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
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> diuretics (Water tablets)
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> other NSAID painkillers or aspirin
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> cardiac glycosides (for heart problems)
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> aminoglycosides (for infection)
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> anti-platelet agents
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> serotonin reuptake inhibitors (for depression)
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> lithium(for bipolar disorder)
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> methotrexate (for cancer, psoriasis, or rheumatism)
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> ciclosporin or tacrolimus (given after transplant surgery, or for psoriasis or rheumatism)
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> cholestyramine (for high cholesterol)
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> mifepristone (for termination of pregnancy)
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> corticosteroids (used for many conditions such as pain, swelling, allergy, asthma, rheumatism
and skin problems)
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> quinolone antibiotics (for infections)
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> sulfonylureas (used to treat diabetes)
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> zidovudine (for HIV infection)
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> herbal extracts such as Ginkgo Biloba
Some other medicines may also affect or be affected by the treatment of Ibuprofen Effervescent Tablet.You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen Effervescent Tablets with other medicines.
Pregnancy, breastfeeding and fertility
If you take this medicine, it may reduce your ability to become pregnant. This effect will be reversed when you stop the medicine. It is unlikely that ibuprofen, used occasionally will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine, if you have problems becoming pregnant. The use of ibuprofen whilst pregnant or breast feeding should be avoided. Ibuprofen should not be used in late (the last three months of) pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.
Driving and using machines
This medicine may make you feel dizzy, drowsy or tired. You may also experience blurry vision. Do not drive or use tools or machines if you are affected in any way after taking this medicine.
This medicine contains 661 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 33% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you need one or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
How to use Ibuprofen Effervescent Tablets 200mg
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
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
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preferably after food.
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.
If you take more Ibuprofen Effervescent Tablets than you should
In the event of accidental or deliberate overdose, or if children have taken the medicine by accident, seek immediate medical attention from your doctor or local hospital casualty department. The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.
If you forget to take Ibuprofen Effervescent Tablets
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible 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 dizziness or fainting, faster heart rate, swelling of the face, tongue and throat, skin rash, itching or bruising
- Worsening of asthma and wheezing or difficulty breathing
- Severe spreading skin rash (‘Stevens-Johnson Syndrome’, ‘toxic epidermal necrolysis’ and ‘erythema multiforme’, symptoms include severe skin rash, blistering of skin, including inside mouth, nose, and genitals, as well as skin peeling which may be accompanied with symptoms such as aching, headaches, and feverishness)
- A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
- A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
- 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
Medicines such as this product may be associated with a small increased risk of heart attack, heart failure or stroke. Any risk is more likely with high doses and prolonged treatment.
Kidney problems such as reduced kidney function, fluid retention (oedema), inflammation of the kidney and kidney failure. Liver problems such as inflammation of the liver, reduced liver function and yellowing of the eyes and/or skin (jaundice) or severe skin reactions may occur rarely with ibuprofen.
Medicines such as Ibuprofen Tablets have in exceptional cases been associated with severe skin problems for patients with chicken pox or shingles
Other possible side effects
Common : (may affect up to 1 in 10 people)
- Headache
- Dizziness or tiredness
- Diarrhoea, wind, constipation
- Feeling or being sick
- Abdominal (stomach) pain, indigestion
- Rash
Uncommon: (may affect up to 1 in 100 people)
- Sneezing, blocked, itchy or runny nose (rhinitis)
- Difficulty sleeping
- Feeling anxious
- Feeling a tingling sensation or ‘pins and needles’
- Visual disturbances
- Hearing problems
- Ringing in ears (tinnitus)
- Sensation of spinning (vertigo)
- Mouth ulcers
- Feeling sleepy
- Skin becomes sensitive to light
Rare : (may affect up to 1 in 1,000 people)
- Feeling depressed or confused
- Swelling
- Loss of vision
Very rare: (may affect up to 1 in 10,000 people)
- High blood pressure
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Inflammation of the pancreas
Not known : (frequency cannot be estimated from the available data)
- Worsening of colitis (inflammation of the bowel)
- Worsening of Crohn’s disease
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme a or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. how to store ibuprofen effervescent tablets
Keep this medicine out of the sight and reach of children.
This product has a two year shelf life, its expiry date is given on the foil and carton.
Do not use Ibuprofen Effervescent Tablets after the expiry date shown on the carton. The expiry date refers to the last day of the month.
Ibuprofen Effervescent Tablets should be stored in a cool dry place.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist to throw away any medicines you no longer use.
6. Content of the pack and other information
What Ibuprofen Effervescent Tablets contains
Ibuprofen Effervescent Tablets contain the following active ingredient:
Ibuprofen 200mg
In addition they also contain the following 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
What Ibuprofen looks like and contents of the pack
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Soluble Cuprofen Ibuprofen Effervescent Tablets are available in cartooned strip packs containing 10, 12, 16, 24, 30, 36, 50, 56, 100 or 112 tablets.
Marketing authorisation holder and manufacturer
MA Holder: Kent Pharmaceuticals Limited, The Bower, 4 Roundwood Avenue,
Stockley Park, Heathrow, United Kingdom, UB11 1AF
Manufacturer: Cupal Ltd, King Street, Blackburn, Lancashire, BB2 2DX, UK
PL number: PL 08215/0111
Date of leaflet revision: November 2021
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