Hedex Ibuprofen Tablets
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HEDEX
nmnsana Ibuprofen
Please read right through this leaflet before you start using this medicine. This medicine is available without prescription, but you still need to use Hedex Ibuprofen Tablets carefully to get the best results from them.
• Keep this leaflet you may need to read it again.
* If you have any further questions, ask your
pharmacist.
In this leaflet:
1. What Hedex Ibuprofen Tablets do
2. Check before you take Hedex Ibuprofen Tablets
3. How to take Hedex Ibuprofen Tablets
4. Possible side effects
5. How to store Hedex Ibuprofen Tablets
6. Further information
1. What Hedex Ibuprofen Tablets do
Hedex Ibuprofen Tablets are used for the relief of headaches including tension headaches and migraine. They can also be used for rheumatic and muscular pains, period pains, backache, neuralgia,
toothache and to relieve the fever and other symptoms of colds and flu.
The active ingredient is ibuprofen, which belongs to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This group of medicines relieve pain, reduce inflammation and lowers temperature when you have a fever.
2. Check before you take Hedex Ibuprofen Tablets
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if you have ever had an allergic reaction to ibuprofen, aspirin or any other NSAID, or to any of the other ingredients (listed in Section 6) if you suffer from liver, heart or kidney problems if you have or have ever had a stomach ulcer, perforation or bleeding of the stomach if you are taking aspirin at doses above 75 mg daily
if you are taking other ibuprofen containing
products known as NSAID medicines, including
drugs known as COX2 inhibitors
if you are in the last 3 months of pregnancy
for more than 10 days at a time unless your
doctor tells you to
if you are under 12 years.
Take special care with Hedex Ibuprofen Tablets
Taking a painkiller for headaches too often or for too long can make them worse.
Do not drive or operate machinery. The tablets may cause drowsiness.
Medicines such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged
treatment.
Ask your doctor or pharmacist before you take this medicine:
if you are elderly
if you have a history of asthma or allergic disease
if you have heart problems, previous stroke or are at risk of these conditions (for example if you have high blood pressure, narrowing of the arteries, diabetes, high cholesterol, or are a smoker)
if you have stomach problems or had recent stomach surgery or bowel problems such as ulcerative colitis, or Crohn's disease if you have Systemic Lupus Erythematosus (SLE) or related mixed connective tissue disease if you have been told you have an intolerance to some sugars
if you are taking aspirin at doses below 75mg.
If you are taking other medicines
Talk to your doctor or pharmacist before taking these tablets If you are taking any other medicines.
Some medicines may affect or be affected by ibuprofen; particularly blood thinning drugs (anticoagulants e.g. warfarin); drugs to prevent clotting (antiplatelet drugs e.g. aspirin); water tablets (diuretics); monoamine oxidase inhibitors (MAOIs) or lithium (to treat depression); methotrexate; zidovudine; drugs for high blood pressure (e.g. captopril, atenolol or losartan); corticosteroids (to treat allergic or inflammatory disorders); sulfonylureas (hypoglycaemic agents); antibiotics (e.g. ciprofloxacin and aminoglycosides such as gentamycin) and mifepristone.
This medicine belongs to a group of medicines which may impair fertility in women. This effect goes away when the medicine is stopped. It is unlikely that this medicine, used occasionally, will affect your chances of becoming pregnant; however tell your doctor before taking this medicine if you have problems becoming pregnant. Do not take Hedex Ibuprofen Tablets if you are in the last 3 months of pregnancy. Speak to your pharmacist or doctor before taking this product if you are in the first 6 months of pregnancy or are breast feeding.
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Filetitle: 9034 HEDI00730812v1 Hedex Ibuprofen Tabs 12s PILv2F
Item No.: 11000000010645 PROSP HEDEX IBUPROFENO UK 1212
Last edit: 26th March 2013
Brand: Hedex
Variant: Ibuprofen 12s
Component: Leaflet Market/s: UK
Dimensions: 210 x 150 (Drawing No. L607D008)
Printer: Santiago Gonzalez
Substrate: Paper
EAN Code: n/a PharmaCode: 825 Replacement number: n/a Manufacturing Site: Alcala No.of colour: 1
Black
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Regulatory Approval:
Sign:............................................................................... Date:.
Name (please print):......................................................................
Contact email:.................................................................................
Profile Keys:
Copy/Text Free PharmaCode
40
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20 _
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81 Rivington Street Shoreditch London EC2A3AY UK
awk contact:
Phil Hinckley phil@oneagency.co +44 (0)7710 521027 +44 (0)203 008 6041
Marketing Approval:
Sign:................................
Name (please print):. Contact email:.............
3. How to take Hedex Ibuprofen Tablets
This product is intended for shortterm use only. You should take the lowest effective dose for the
shortest time necessary to relieve your symptoms.
Adults and children aged 12 years and over:
Swallow 1 or 2 tablets with water, every 4 to 6 hours as needed.
• Take the tablets with or after food.
• Leave at least 4 hours between doses.
• Do not take more than 6 tablets in
24 hours.
• Do not take more than the
recommended dose.
If your symptoms continue or worsen, see your doctor.
If you take too many tablets
Contact your doctor or casualty department.
4. Possible side effects
Like all medicines, Hedex Ibuprofen Tablets can
have side effects, but not everybody gets them. Older people are more prone to side effects. The following side effects are either very rare (less than 1 in 10,000 people), or occur at a frequency that cannot be established.
STOP taking the medicine and seek immediate medical help if you experience:
• Signs of intestinal bleeding. Symptoms could include abdominal pain, vomiting blood (or dark particles that look like coffee grounds), blood in your stools, or passing black tarry stools
• Severe allergic reactions. Symptoms could include swelling of the face, tongue and throat causing difficulty breathing or breathing problems e.g. unexplained wheezing, shortness of breath, asthma or worsening of asthma, faster heart rate/palpitations, collapsing or low blood pressure
• Inflammation of the brain lining. Symptoms could include a stiff neck, headache, nausea,
vomiting, fever or feeling disorientated, especially if you have an existing autoimmune disorder (e.g. systemic lupus erythematosus)
• A reduction in blood cells that can lead to unexplained bruising or bleeding, flu-like symptoms, fever, sore throat, mouth ulcers and severe exhaustion.
Other Possible Side Effects
Stop taking the medicine and tell your doctor.
Between 1 in a 100 and 1 in 1,000 may experience:
• Skin reactions e.g. skin rashes, itching, urticaria
(hives) which can be severe with blistering and peeling of the skin.
Fewer than 1 in 10,000 people may experience:
• Stomach pain, nausea and digestive problems;
which may cause diarrhoea, constipation, vomiting or flatulence, worsening of existing bowel disease (ulcerative colitis or Crohn's disease).
The following side effects could also occur.
Tell your doctor if you get them.
1 in 10 to 1 in 100 people:
• Headache, drowsiness, dizziness, ringing in the
ears.
In 1 in 1,000 to 1 in 10,000 people:
• Diarrhoea, flatulence, constipation or vomiting. In less than 1 in 10,000 people:
• Liver problems such as hepatitis or jaundice (yellowing of the skin)
• Breathlessness and/or swelling of the legs or
feet
• Blood in the urine, cloudy urine, you pass more
or less urine than normal or you experience pain in the back and/or swelling (particularly in the
legs).
At a frequency that cannot be estimated:
• Heart attack or stroke, fluid retention, high
blood pressure or heart failure.
If you do get any side effects, even those not mentioned in this leaflet, tell your doctor or pharmacist.
5. How to store Hedex Ibuprofen Tablets
Keep out of the reach and sight of children.
Do not use this medicine after the 'EXP' date shown on the pack.
Store below 25°C.
6. Further information
Active ingredient
Each tablet contains Ibuprofen 200 mg.
Other ingredients Maize starch, microcrystalline
cellulose, magnesium stearate, spray dried lactose, colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose and triacetin.
Packs of Hedex Ibuprofen Tablets contain 12
tablets.
The marketing authorisation holder is
Omega Pharma Ltd., 32 Vauxhall Bridge Road, London, SW1V 2SA, United Kingdom and all enquiries should be sent to this address.
The manufacturer is GlaxoSmithKline GmbH & Co. KG, BenzstraBe 25, 71083 Herrenberg, Germany or SmithKline Beecham S.A., Carretera de Ajalvir, Km 2,500, Alcala de Henares, 28806 Madrid, Spain.
This leaflet was last revised in April 2013.
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