Nurofen Tension Headache
Reckitt Benckiser
0006 00063 380 article 31 ibup
Reads This Way
If you take more Nurofen Tension Headache than you should,
you may feel drowsy or nauseous. You should seek immediate medical advice in the event of an overdose, even if you feel well.
If you forgot to take Nurofen Tension Headache.
Simply refer to the directions above on how to take the medicine and do not take more than is advised.
INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Nurofen Tension Headache carefully to get the best results from it.
Keep this leaflet. You may want to read it again.
If you have any further questions after you have read it, ask your doctor or pharmacist.
You must contact a doctor if your symptoms worsen or do not Improve after 3 days for children and adolescents between 12 and 18 years and after 10 days for adults.
If any side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nurofen Tension Headache is and what it is used for
2. Before you take Nurofen Tension Headache
3. How to take Nurofen Tension Headache
4. Possible side effects
5. How to store Nurofen Tension Headache
6. Further Information
Contains Ibuprofen Lysine
1. What Nurofen Tension Headache Is and what It Is used tar
The active ingredient (which makes this medicine work) is Ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body's response to pain, swelling, and high temperature.
Nurofen Tension Headache is used for the relief of:
• Headaches and migraine pain
2. Before taking Nurofen Tension Headache
Do not take Nurofen Tension Headache if you:
• are allergic to ibuprofen or any of the other ingredients (see section 6) or to aspirin or other painkillers
• have (or have had Iwo or more episodes of) a stomach ulcer, perforation or bleeding
• have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines
• have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non-steroidal anti-inflammatory drugs)
• are taking other NSAID painkillers or more than 75mg aspirin a day
• have severe liver or kidney problems
• have heart problems, high blood pressure or blood coagulation disorder.
• have breathing difficulties
• are in the last 3 months of pregnancy
• are under 12 years old.
Check with your pharmacist or your doctor before taking this
product If you:
• have or have had asthma
• have kidney, heart, liver or bowel problems
• have high cholesterol or previously have had a heart attack or stroke
• have a history of gastrointestinal disease (such as ulcerative colitis, CrohnS disease)
• have Systemic Lupus Erythematosus (a condition of the immune system causing joint pain skin changes and other organ disorders)
• are a smoker
• are in the first 6 months of pregnancy.
Taking other medicines
To reduce the risk of side effects, do not take this product with other NSAID containing producls (e.g, aspirin, ibuprofen...) Nurofen may affect or be affected by some other medicines.
For example:
Avoid taking this product with corticosteroid tablets, quinolone antibiotics or drugs that are prescribed:
• as anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• to stimulate your heart (e.g, glycosides)
• to reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan)
• to help you passing water (diuretics),
• for the temporary suppression of your immune system (e.g, methotrexate, ciclosporine, tacrolimus)
• for mania or depression (e.g., Lithium or SSRIs)
• for pregancy termination (e.g., mifepristone)
• for HIV treatment (e.g., zidovudine)
Some other medicines may also affect or be affected by the treatment of Nurofen. You should therefore always seek the advice of your doctor or pharmacist before you use Nurofen with other medicines.
Other warnings
• Nurofen Tension Headache belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that Nurofen Tension Headache, used occasionally will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.
• Anti-inflammatory/pain-killer medicines such as 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 Nurofen 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-stroke1 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 children and adolescents.
Pregnancy and breast feeding
Do not take in the last 3 months of pregnancy or if you are breastfeeding.
Speak to your doctor if you are in the first 6 months of pregnancy.
3. How to take Nurofen Tension Headache
This product is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms.
Adults, the elderly and children & adolescents between 12 and 18 years:
Take 1 or 2 caplets with water, up to three times a day as required. Leave at least four hours between doses. Do not take more than 6 caplets in 24 hours.
Do not give to children under 12 years.
In children and adolescents between 12 and 18 years:
If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
In adults:
Do not take for longer than 10 days unless your doctor tells you to. If symptoms persist or the pain worsens, or if any new symptoms occur, consult your doctor or pharmacist.
PRINTING
READS
This Way
TDD1022/5
1.3.1 Package Leaflet
Ibuprofen Lysine UK National 342mg
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.gov.uk/yellowcard By reporting side effects, you can help provide more information on the safety of this medicine.
4. Possible side effects
5. How to stare Nurofen Tension Headache
Like all medicines, Nurofen Migraine Pain can cause side effects, although not everybody gets them. Some side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms. If any of the side effects get serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
STOP TAKING the medicine and seek Immediate medical help if you develop:
• signs of intestinal bleeding such as: bright red faeces (stools/motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds.
• signs of serious allergic reaction such as:
- difficulties in breathing or unexplained wheezing
- dizziness or faster heartbeat,
- severe forms of skin reactions such as itchiness, skin rash with redness, peeling, flaking or blistering
(e.g.: Steven-Johnson syndrome)
- swelling of your face, tongue or throat
• signs of kidney problems such as:
- passing less or more urine
- cloudy urine or blood in urine
- pain in the back and/or swelling (particularly in the legs)
• signs of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or disorientation. Patients with autoimmune disorders (lupus, mixed connective tissue disease) may be more likely to be affected.
STOP TAKING the medicine and tell your doctor if you experience the tallowing uncommon side effects:
- indigestion, heartburn or feeling sick
- pains in your stomach (abdomen) or other abnormal stomach problems
TELL YOUR DOCTOR If you have any of the following side effects, they become worse or you notice any effects not listed:
Uncommon
- allergic reactions, such as skin rashes (urticaria), itching, peeling
- headaches Rare
- flatulence (wind), diarrhoea, constipation and vomiting Very rare
- blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and severe exhaustion
- drop in blood pressure
- stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis)
- liver problems
Side effects for which the frequency cannot be estimated from available data:
- worsening of asthma or bronchospasm
- swelling (oedema), high blood pressure, heart failure or attack
- worsening of colitis and Crohn's disease
Medicines such as Nurofen Tension Headache may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. (See Section 2 'Other warnings'.)
Keep all medicines out of the sight and reach of children.
Do not use after the expiry date stated on the carton after EXP The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original pack.
6. Further Information
Each caplet contains the active ingredient Ibuprofen 200mg (as Ibuprofen Lysine 342mg).
Also contains: Povidone, Sodium Starch Glycollate Type A, Magnesium Stearate, Hypromellose, Talc, Opaspray White M-l -7111B (contains Hypromellose and Titanium Dioxide (El 71) and Black Ink (contains shellac, Iron oxide black (El 72) and propylene Glycol).
Nurofen Tension Headache are available in packs of 2,4,6,8, 10,12,16 white, capsule-shaped tablets printed in black with identifying 'N>>' logo.
Not all packs will be marketed.
Licence Holder: Reckitt Benckiser Healthcare (UK) Ltd, Slough, SL1 4AQ.
Manufacturer: Reckitt Benckiser Healthcare International Ltd, NG90 2DB.
Product licence number: PL 00063/0380 Date of revision: September 2015
Page 1
Reads This Way
V