Nurofen Sinus & Blocked Nose 200mg/5mg Tablets
Reckitt Benckiser
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INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important information for you. This medicine is available wilhout prescription. However, you still need to use Nurofen Sinus Pain Relief 200mg/5mg Tablets carefully to get the best results from it. Reep 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 10 days.
If any side effects get serious, or if you notice any side effect not isted in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
;i - What is this medicine and what is it used for?
2- Before taking this medicine '3- How to take this medicine A- Possible side-effects j5- How to store 6- Further information
hlurofen Sinus Pain Relief 200mg/5mg Tablets contains jbuprofen and phenylephrine hydrochloride, which are effective jn relieving the symptoms associated with colds and flu, Including relief of aches and pains, sore throats, headache, nasal congestion (blocked nose) and lowering of temperature.
ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) and is effective against aches and pains (including headache), swelling and ban also reduce a fever. Phenylephrine hydrochloride (nasal jdecongestant) reduces swelling in the passages of the nose, relieving nasal congestion and reducing the pressure which may cause a headache.
po not take this medicine If you:
» are allergic to ibuprofen, phenylephrine hydrochloride or any other ingredients of this medicine (see section 6) or to ! aspirin or other painkillers ;• have ever had 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 !• are taking more than 75mg of aspirin a day. If you are on ; low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take this medicine !• have severe liver or kidney problems !• have heart problems, high blood pressure or blood ; coagulation disorder
* have breathing difficulties !• have an overactive thyroid
!• are taking or have taken within the last 14 days a medicine | called monoamine oxidase inhibitor (usually used to treat \ depression)
• 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 an 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 or 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 products (e.g. aspirin, ibuprofen). If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take this medicine.
Nurofen may affect or be affected by some other medicines. For example: Avoid taking this product with corticosteroids tablets, quinnolone antibiotics or medicines that are:
• anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• to stimulate your heart (e.g. glycosides including digoxin)
• 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, cyclosporine, tacrolimus)
• for mania or depression (e.g. lithium, SSRIs or Monoamine Oxidase Inhibitors)
• for pregnancy termination (e.g. mifepristone)
• for HIV treatment (e.g. zidovudine)
• comprised of other sympathomimetic agenls such as decongestanls (e.g. pseudoephedrine).
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
• 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 or 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.
Fertility, pregnancy and breast-feeding
Nurofen Sinus Pain Relief 200mg/5mg Tablets belongs to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine.
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TDD 1022/5
1.3.1 Package Leaflet
Nurofen Sinus Pain Relief 200mg 5mg Tablets 0166405
I It is undkety thafif you only fake Nurofen Sinus Pain Relief | 200mg/5mg Tablets occasionally it will affect your chances of ; becoming pregnant. If you have problems becoming pregnant > talk to your doctor before taking this medicine.
; Tell your doctor if you become pregnant whilst taking Nurofen ; Sinus Pain Relief 200mg/5mg Tablets. Do not take this i medicine in the last 3 months of pregnancy. Avoid the use of ! this medicine in the first 6 months of pregnancy unless the | doctor advises otherwise.
i Speak to your doctor or pharmacist before taking this medicine if ! you are breast-feeding.
Tablets must be taken with water and swallowed whole.
It is important to drink plenty of fluids when suffering from colds and flu.
Adults, the elderly and children over 12 years:
This medicine is for short-term use only. Take the lowest dose for the shortest time necessary. Do not take Nurofen Sinus Pain Relief 200mg/5mg Tablets for longer than 10 days. If you do
not get better, or get worse, talk to your doctor. They will tell you if it is safe to carry on taking the medicine.
Take 2 tablets every 8 hours. Leave at least 4 hours between doses and do not exceed 6 tablets in any 24 hour period.
Do not give to children under 12 years.
If you take more Nurofen Sinus Pain Relief 200mg/5mg Tablets 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 Sinus Pain Relief 200mg/5mg Tablets
Simply refer to the directions above on how to take the medicine and do not take more than is advised.
TELL YOURTJOCTOR If you have any bflfie following side effecls, they become worse or you notice any effects not listed:
Uncommon side effects which affect 1 to 10 users in 1,000:
• allergic reactions, such as skin rashes (urticaria), itching, peeling
• headaches, dizziness, tinnitus (ringing in the ears)
Rare side effects which affect 1 to 10 users in 10,000:
• flatulence (wind), diarrhoea, constipation and vomiting Very rare side effects which affect less than 1 user in 10,000:
• 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 or irregular heart beat
• liver problems
Side effects for which the frequency can not 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
• difficulties in passing urine (in men only).
Medicines such as Nurofen Sinus Pain Relief 200mg/5mg Tablets 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 1o your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effecls 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.
Like all medicines, Nurofen Sinus Pain Relief 200mg/5mg Tablets can cause side effects, although not everybody gets them. Side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms. You may suffer one of the known side effecls of NSAIDs (see below). If any of the side effects gets serious, or if you notice any side effecls not listed in this leaflet, tell your doctor or pharmacist.
If you get any of the following at any time during your treatment 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 consciousness. 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 following uncommon side effecls which affect 1 to 10 users in 1,000:
• indigestion, heartburn or feeling sick
• pains in your stomach (abdomen) or other abnormal stomach problems.
Keep all medicines out of the sight and reach of children.
Do not use after the end of the month of the expiry date (EXP month/year) shown on the pack.
Do not store above 25°C (77°F). Store in a dry place. Store in the original package.
Each tablet contains the active ingredients ibuprofen (200mg) ; and phenylephrine hydrochloride (5mg). The other ingredients ! are cellulose, sodium starch glycoate, hypromellose, !
magnesium stearate, talc, Mastercote yellow (contains \ Hydroxypropylmethyl Cellulose (E464), Titanium Dioxide (El 71), Quinoline Aluminium Lake (El 04) and Sunset Yellow! Aluminium Lake (El 10)) and black printing ink (contains ! shellac, iron oxide black (El 72) and propylene glycol). |
The product is available in cartons of 4, 6, 8,10,12, 14 and I 16 tablets. Not all packs may be marketed. !
Alternative format patient information for the visually impaired ; is available on request from the Marketing Authorisation Holder]
Licence Holder: Reckitt Benckiser Healthcare (UK) Ltd, Hull, ; HU8 7DS.
Manufacturer: Reckitt Benckiser Healthcare International Ltd, ! Nottingham, NG90 2DB. ]
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