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NUROFEN COLD AND FLU

Active substance(s): IBUPROFEN / PSEUDOEPHEDRINE HYDROCHLORIDE

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Transcript
Reckitt Benckiser

0025 375 article 31 ibup

Nurofen Sinus Relief
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE
YOUR MEDICINE
It gives you important information about Nurofen Sinus Relief.
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.
1. What is this medicine and what is it used for?
Nurofen Sinus Relief tablets contain two active ingredients (which make the medicine
work). These are lbuprofen and Pseudoephedrine Hydrochloride.
lbuprofen belongs to a group of medicines known as non-steroidal antiinflammatory
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 Relief
• 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 Relief 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 Relief 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.

1.3.1 Package Leaflet
Ibuprofen Pseudoephedrine HCl 200mg 30mg Tablets

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Reckitt Benckiser

0025 375 article 31 ibup

Can you take Nurofen Sinus Relief with other medicines?
Nurofen Sinus Relief 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, betablockers such as atenolol medicines, angiotensin-II 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 Relief. You should therefore always seek the advice of your doctor or
pharmacist before you use Nurofen Sinus Relief with other medicines.
Other warnings
• Nurofen Sinus Relief 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
Relief, 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 Sinus Relief 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 Relief:
If symptoms persist or pain or fever worsen, or if any new symptoms occur, consult
your doctor or pharmacist.

1.3.1 Package Leaflet
Ibuprofen Pseudoephedrine HCl 200mg 30mg Tablets

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0025 375 article 31 ibup

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 Relief 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 E110), black printing ink (contains shellac, Iron
Oxide Black (E172) and propylene glycol).
Nurofen Sinus Relief is available in packs of 12 and 24 tablets.
Licence Holder: Reckitt Benckiser Healthcare (UK) Ltd, Slough, SL1 4AQ.

1.3.1 Package Leaflet
Ibuprofen Pseudoephedrine HCl 200mg 30mg Tablets

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0025 375 article 31 ibup

Manufacturer: Reckitt Benckiser Healthcare International Ltd, NG90 2DB.
Product Licence No. PL 00063/0375
Date of revision August 2015.

1.3.1 Package Leaflet
Ibuprofen Pseudoephedrine HCl 200mg 30mg Tablets

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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