NUROFCN

TENSION HEADACHE

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Contains Ibuprofen Lysine

Information for the user

jRead 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 jHeadache carefully to get the best results from it.

Keep this leaflet. You may want to read it again.

Ilf 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 hot improve after 3 days for children and adolescents {between 12 and 18 years and after 10 days for adults.

if any side effecls get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

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Jn this leaflet:

'1. What Nurofen Tension Headache is and what it is used for

12. Before you take Nurofen Tension Headache

p. Howto take Nurofen Tension Headache

4. Possible side effects

|5. Howto store Nurofen Tension Headache

|6. Further Information

1. What Nurofen Tension Headache is and what it is used for

;The active ingredient (which makes this medicine work) is llbuprofen. It belongs to a group of medicines known as )ion-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body's response to pain, swelling, and high temperature.

INurofen 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

I ulcer, perforation or bleeding

;• have had a worsening of asthma, skin rash, itchy runny

i 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 I 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

i» have high cholesterol or previously have had a heart attack

! or stroke

;• have a history of gastrointestinal disease (such as ulcerative ! colitis, Crohn's 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...) Some medicines may affect or be affected by treatment with ibuprofen.

Avoid taking this product with corticosteroid tablets, quinolone antibiotics or drugs that are prescribed:

•    to thin your blood or prevent clotting (e.g, warfarin),

•    to stimulate your heart (e.g, glycosides) or treat high blood pressure,

•    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)

Speak to your pharmacist or doctor before taking Ibuprofen 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.

•    Medicines such as Nurofen Tension Headache may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses or prolonged treatment.

Do not exceed the recommended dose.

•    If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, or high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist.

•    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.

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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 caplels 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.

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 fergot 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.

4. Possible side effects

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: j- difficulties in breathing or unexplained wheezing 1- dizziness or faster heartbeat, severe skin reaction (rashes, itchiness, peeling, flaking or i blistering)

!- swelling of your face or throat

Jell your doctor if you experience:

» fever, flu-like symptoms, sore throat, mouth ulcers,

! headache, a stiff neck, vomiting, unexplained bleeding and ; bruising, severe exhaustion.

» indigestion, stomach or abdominal pain, constipation,

I diarrhoea, flatulence or if you feel sick, chest pain or fast,

; irregular heart beat.

i* liver and kidney problems associated with swelling in your ! arms and legs.

jMedicines such as Nurofen Tension Headache may be associated with a small increased risk of heart attack !("myocardial infarction") or stroke. (See Section 2 'Other jwarnings'.)

Reporting of side effects

lit 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.

5. How to store Nurofen Tension Headache

keep all medicines out of the sight and reach of children.

i

|Do not use after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.

bo not store above 25°C. Store in the original pack.

6. Further Information

Each caplet contains the active ingredient Ibuprofen 200mg (as Jbuprofen Lysine 342mg).

Also contains: Povidone, Sodium Starch Glycollate Type A, iMagnesium Stearate, Hypromellose, Talc, Opaspray White |M-1 -7111B (contains Hypromellose and Titanium Dioxide (El 71) and Black Ink (contains shellac, Iron oxide black !(E172) and propylene Glycol).

jNurofen 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, &L1 4AQ.

jManufacturer: Reckitt Benckiser Healthcare International Ltd, ;NG90 2DB.

IProduct licence number: PL 00063/0380 jDate of revision: July 2014

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NUROFCN

TENSION HEADACHE

4. Possible side effects

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 skin reaction (rashes, itchiness, peeling, flaking or blistering)

-    swelling of your face or throat

Tell your doctor if you experience:

•    fever, flu-like symptoms, sore throat, mouth ulcers, headache, a stiff neck, vomiting, unexplained bleeding and bruising, severe exhaustion.

•    indigestion, stomach or abdominal pain, constipation, diarrhoea, flatulence or if you feel sick, chest pain or fast, irregular heart beat.

•    liver and kidney problems associated with swelling in your arms and legs.

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'.)

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 safely of this medicine.

5. How to store Nurofen Tension Headache

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: July 2014

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TR785291