Reckitt Benckiser

NUROF€N*A

Sinus Pressure & Headache Relief 200mg/30m"

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE

It gives you important information about Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets.

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

If you have any questions after you have read it, ask your doctor or pharmacist.

Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets

1.    What is this medicine and what is it used for?

Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets contain two active ingredients (which make the medicine work). These are Ibuprofen and Pseudoephedrine Hydrochloride.

Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by reducing pain, swelling and high temperature. Pseudoephedrine belongs to a group of drugs called vasoconstrictors which act on the blood vessels in the nose to relieve nasal congestion.

Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets

•    clears a blocked nose and sinuses

•    relieves aches, pains, headache and high temperature (fever)

•    eases the discomfort of a sore throat.

2.    Before taking this medicine

Do not take Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets if you:

•    have (or have had two 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 (non-steroidal anti-inflammatory drugs) (NSAIDs).

•    are taking other NSAID painkillers or more than 75mg aspirin a day

•    are taking Monoamine Oxidase Inhibitors (for depression and known as MAOIs) or have taken these in the last 14 days.

•    have severe liver or kidney problems

•    have heart problems, high blood pressure, prostate problems or an overactive thyroid

•    have diabetes or glaucoma.

•    are under 12 years of age

•    are pregnant or breast feeding.

Check with your pharmacist or doctor

before taking Nurofen Sinus Pressure

and Headache Relief 200mg/30mg

Tablets if you:

•    have asthma

•    have kidney or liver problems

•    have high cholesterol or have previously had a heart attack or a stroke

•    have a history of gastrointestinal disease (such as ulcerative colitis, Crohn's disease)

•    have Systemic Lupus Erythematosus (SLE)-an illness affecting the immune system causing joint pain, skin changes and other problems

•    are a smoker.

Other medicines and Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets

Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets may affect or be    \

affected by some other medicines. For example:    !

•    medicines that are anti-coagulants (i.e. thin

blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)    \

•    medicines that reduce    high    blood pressure    !

(ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan)    \

•    medicines for depression    (lithium, selective    !

serotonin uptake inhibitors and monoamine oxidase inhibitors (known as MAOIs)) may affect or be affected by treatment with pseudoephedrine.    \

Some other medicines may also affect or be affected by the treatment of Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets with other medicines.

Continued overleaf \

_____________________________________RB2JJ5Q.9!

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Reckitt Benckiser

NUROF€N*A

Sinus Pressure & Headache Relief 200mg/30m"

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE

It gives you important information about Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets.

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

If you have any questions after you have read it, ask your doctor or pharmacist.

Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets

1.    What is this medicine and what is it used for?

Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets contain two active ingredients (which make the medicine work). These are Ibuprofen and Pseudoephedrine Hydrochloride.

Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by reducing pain, swelling and high temperature. Pseudoephedrine belongs to a group of drugs called vasoconstrictors which act on the blood vessels in the nose to relieve nasal congestion.

Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets

•    clears a blocked nose and sinuses

•    relieves aches, pains, headache and high temperature (fever)

•    eases the discomfort of a sore throat.

2.    Before taking this medicine

Do not take Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets if you:

•    have (or have had two 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 (non-steroidal anti-inflammatory drugs) (NSAIDs).

•    are taking other NSAID painkillers or more than 75mg aspirin a day

•    are taking Monoamine Oxidase Inhibitors (for depression and known as MAOIs) or have taken these in the last 14 days.

•    have severe liver or kidney problems

•    have heart problems, high blood pressure, prostate problems or an overactive thyroid

•    have diabetes or glaucoma.

•    are under 12 years of age

•    are pregnant or breast feeding.

Check with your pharmacist or doctor

before taking Nurofen Sinus Pressure

and Headache Relief 200mg/30mg

Tablets if you:

•    have asthma

•    have kidney or liver problems

•    have high cholesterol or have previously had a heart attack or a stroke

•    have a history of gastrointestinal disease (such as ulcerative colitis, Crohn's disease)

•    have Systemic Lupus Erythematosus (SLE)-an illness affecting the immune system causing joint pain, skin changes and other problems

•    are a smoker.

Other medicines and Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets

Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets may affect or be    \

affected by some other medicines. For example:    !

•    medicines that are anti-coagulants (i.e. thin

blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)    \

•    medicines that reduce    high    blood    pressure    !

(ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan)    \

•    medicines for depression    (lithium,    selective    !

serotonin uptake inhibitors and monoamine oxidase inhibitors (known as MAOIs)) may affect or be affected by treatment with pseudoephedrine.    \

Some other medicines may also affect or be affected by the treatment of Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets with other medicines.

Continued overleaf \

_____________________________________RB2JJ5Q.9!

Pharmacode Reads This Way

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Other warnings

•    Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets belong to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets, 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 Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets 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 take longer than necessary to control your symptoms (10 days).

You should discuss your treatment with your doctor or pharmacist before taking this medicine 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.

3.    How to take this medicine

This product is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. Do not take it for longer than 10 days unless your doctor tells you to.

Adults, the elderly and children of 12 years and older:

Take 1 or 2 tablets with water, up to three times a day as required.

Leave at least 4 hours between doses.

Do not take more than 6 tablets in 24 hours.

Not suitable for children under 12 years.

Whilst taking Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets:

If symptoms persist or pain or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.

If you take too many tablets by mistake, contact your doctor or pharmacist straight away or telephone your local casualty department for advice.

4.    Possible side effects

Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets is generally well tolerated by most people. However side effects may occur.

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 a serious allergic reaction such as severe skin rashes, peeling, flaking or blistering skin, facial swelling, unexplained wheeziness, shortness of breath, easy bruising.

Tell your doctor if you experience:

-    indigestion or heartburn

-    stomach pain or other abnormal stomach symptoms

-    rashes, itching

-    worsening of asthma,

-    sweating, thirst, muscle weakness or tremors, sleeplessness, chest pain or fast, irregular heart beat

-    liver and kidney problems

-    headache, dizziness and hearing disturbance, difficulty in urinating, mood changes e.g. restlessness.

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.

5.    How to store

Keep all medicines out of the sight and reach of children. Do not use after the expiry date shown on the pack.

Store in a dry place.

6.    Further information

Each tablet contains the active ingredients ibuprofen 200mg and Pseudoephedrine Hydrochloride 30mg.

Also contains: Calcium Phosphate,

Microcrystalline Cellulose, Polyvinyl Pyrrolidone, Sodium Carboxymethyl Cellulose, Magnesium Stearate, Hydroxypropylmethyl Cellulose, Talc, Titanium Dioxide, Quinoline Yellow and Sunset Yellow (contains Aluminium and El 10), black printing ink (contains shellac, Iron Oxide Black (El 72) and propylene glycol).

Nurofen Sinus Pressure and Headache Relief 200mg/30mg Tablets is available in packs of 12 and 24 tablets.

Licence Holder: Reckitt Benckiser Healthcare (UK) Ltd, Slough, SL1 4AQ. Manufacturer: Reckitt Benckiser Healthcare International Ltd,

NG90 2DB.

Product Licence No. PL 00063/0718 Date of revision - December 2015.

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RB2JJ5Q9