Ibuprofen 200mg Tablets
H
IBUPROFEN 200MG TABLETS
PATIENT INFORMATION LEAFLET
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 10 days.
WHAT IS IN THIS LEAFLET
1. What Ibuprofen Tablets are and what they are used for
2. What you need to know before you take Ibuprofen Tablets
3. How to take Ibuprofen Tablets
4. Possible side effects
5. How to store Ibuprofen Tablets
6. Contents of the pack and other information
1. WHAT IBUPROFEN TABLETS ARE AND WHAT THEY ARE USED FOR
This medicine contains Ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which act to relieve pain, reduce inflammation and lowers temperature when you are feverish. It can be used to relieve headaches, rheumatic and muscular pain, backache, migraine, period pain, dental pain, pain of non-serious arthritic conditions, dysmenorrhoea and neuralgia. It can also be used to reduce fever and relieve the symptoms of cold and influenza.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN TABLETS
Do not take these tablets if you:
• are allergic to ibuprofen, aspirin or any of the other ingredients in this medicine (see section 6)
• have an active or a history of recurrent peptic ulcers (more than two).
• have a history of gastrointestinal bleeding or perforation related to the use of NSAIDs.
■ have a history of allergy to ibuprofen, aspirin or NSAIDs, which includes attacks of asthma, swelling of the nose and throat, skin rashes or a runny nose.
• have severe heart, kidney or liver failure.
• are in your last trimester of pregnancy.
Warnings and precautions
Talk to vour doctor, pharmacist or nurse before
you take these tablets if:
• you suffer from asthma or hives,
• you are pregnant or breast-feeding,
• you are taking aspirin or any other non-steroidal anti-inflammatory drugs (NSAIDs)
■ you have been told by your doctor that you have an intolerance to some sugars.
• you suffer from Systemic Lupus Erythematosus (SLE) and mixed connective tissue disorders.
• you suffer from ulcerative colitis or Crohns disease as these conditions may be worsened.
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Other warnings Low dose Aspirin: Do not take if you are taking more than 75mg of aspirin a day. If you are on low-dose aspirin (up to 75 mg daily) speak to your doctor or pharmacist before you take Ibuprofen 200 mg Tablets. 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 Ibuprofen 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. The elderly have an increased frequency of side effects, especially gastrointestinal bleeding. Consult your doctor before taking this medicine. Female fertility: Ibuprofen belongs to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine. It is unlikely that if you only take Ibuprofen occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine. There is a risk of kidney damage in dehydrated children and adolescents. Other medicines and IbuDrofen Tablets | |
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Before you take these tablets, please tell your doctor or pharmacist about ANY other medicines that you are taking, Ibuprofen tablets may affect or be affected by some other medicines. For example: • Any other NSAIDs • Anti-coagulants (medicines that thin the blood/ prevent clotting i.e. aspirin/acetylsalicylic acid, warfarin, ticlopidine) • Medicines that reduce high blood pressure (ACE Inhibitors i.e. captopril, beta-blockers such as atenolol, or angiotensin- II receptor antagonists such as losartan) ■ Lithium (used in the treatment of mania) • Diuretics (water tablets) • Corticosteroids (used to treat hormone problems, inflammation or allergic conditions) • Ciclosporin (used following organ transplants) • Mifepristone (used to induce abortion) • Antibiotics called quinolones (such as Ciprofloxacin) • Selective serotonin reuptake inhibitor (antidepressants such as Prozac) • Cardiac glycosides used in the treatments of congestive heart failure and cardiac arrhythmia • Methotrexate, Tacrolimus and Zidovudine. Some other medicines may also affect or be affected by the treatment of Ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen with other medicines. Preanancv and Breastfeedina | |
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The use of Ibuprofen whilst pregnant should be avoided. Ibuprofen Tablets should not be used in the | |
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Pharmacode Reading Direction
Ibuprofen 200mg Tablets (FPL) P & GSL
Leaflet Size: 165 x 255 mm
PLL9016NO
165 mm
H
sunset yellow (E1101
Securitainer/Pharmapac bottles: Keep the bottle
Each tablet contains the active ingredient Ibuprofen 200mg. The tablets also contain: lactose monohydrate, maize starch, hypromellose, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, sucrose, purified talc, titanium dioxide (E171), carnauba wax, coloring agent (sucrose, titanium dioxide (E171), sunset yellow lake (E110), erythrosine lake (E127), sodium benzoate (E211), hydrochloric acid (E507).
What is in the pack?
last three months of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.
Ibuprofen Tablets contain lactose, sucrose and
These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking these tablets. These tablets contain sunset yellow (E110), which can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.
3. HOW TO TAKE IBUPROFEN TABLETS
They are suitable for adults, the elderly and children over 12 years old:
Take one to two tablets with water to start with, preferably with or after food, followed by one to two tablets every four hours if necessary up to three times a day.
Do not take more than six tablets in any twenty four hour period.
This medicine is for short-term use only.
Take the lowest dose for the shortest time necessary.
Do not take Ibuprofen 200mg tablets for longer than 10 days.
If you do not get better, or get worse, talk to your doctor. They will tell you if it is safe to carry on taking the medicine.
DO NOT GIVE TO CHILDREN UNDER 12 YEARS OLD
4. POSSIBLE SIDE EFFECTS
Most people can take this medicine without any problems but sometimes you may notice some side effects.
Gastrointestinal Effects:
If you get from any of the following at any time during your treatment STOP TAKING and get medical help straight away:
Pass blood in your stools or motions.
Pass black tarry stools or motions.
Vomit any blood or dark particles that look like coffee grounds.
STOP TAKING and tell your doctor if you experience:
Indigestion or heartburn
Pains in your stomach (abdomen) or other
abnormal stomach problems.
Other side effects that could occur include:
Feeling sick, vomiting and peptic ulcer. Diarrhoea, flatulence (wind), constipation and worsening of Crohns disease.
Allergic reactions such as swelling of the face, tongue and throat, skin rashes (urticaria), itching, runny nose, difficulty breathing and, very rarely, skin peeling.
Rarely changes in the blood with symptoms of fever, sore throat, mouth ulcers, tiredness, bleeding and bruising.
Blood in urine, kidney damage or kidney failure has been reported.
Swelling of the heart, heart failure and swelling (oedmea).
• Headache.
• Worsening of asthma or bronchospasm •High blood pressure.
• Liver disorders with symptoms including yellowing of the eyes and skin (jaundice).
» Aseptic meningitis with symptoms of neck stiffness, headache, feeling sick, being sick, fever and loss of consciousness.
Medicines such as Ibuprofen Tablets may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
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 at: www.mhra.aov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE IBUPROFEN TABLETS
Store below 25°C.
Blister packaging: Store in the original package.
tightly closed.
Do not use after the expiry date shown on the package.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What does each tablet contain?
This product contains pink, shiny, biconvex, circular, sugar coated tablets.
Ibuprofen 200 mg Tablets (PL 43461/0004) are available in blister packs of 12 and 16 tablets.
Ibuprofen 200 mg Tablets (PL 43461/0007) are available in blister packs of 12, 16, 24, 48, 84 and 96 tablets. The product is also available in pots of 25, 50 or 1000 tablets.
Marketing Authorisation Holder:
Flamingo Pharma (UK) Ltd,
1st Floor, Kirkland House,
11-15 Peterborough Road, Harrow, Middlesex,
HA1 2AX, UK Manufacturer:
Wave Pharma Ltd.
4th Floor Cavendish House,
369 Burnt Oak Broadway, Edgware,
HA8 5AW, United Kingdom.
If you would like this leaflet in different format information or want to report any side effects please contact marketing authorization holder listed above.
This leaflet was last revised in November 2015,
PL 43461/0007 PLL9016NO
PL 43461/0004 MH/DRUGS/AD-096