Nurofen Day & Night Cold & Flu 200mg/5mg Tablets
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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 without prescription. However, you still need to use Nurofen Day & Night Cold & Flu 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 It your symptoms worsen or do not Improve after 10 days.
;lf 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 is this medicine and what is it used for?
2- Before taking this medicine
3- How to take this medicine A- Possible side-effects
|5- How to store 6- Further information
Nurofen Day & Night Cold & Flu contains ibuprofen and phenylephrine hydrochloride, which are effective in 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.
;lbuprofen 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 pan also reduce a fever. Phenylephrine hydrochloride (nasal pecongestant) reduces swelling in the passages of the nose, relieving nasal congestion and reducing the pressure which may cause a headache.
|Do 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
Warnings and precautions
Talk to your doctor or pharmacist before taking Nurofen 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 olher organ disorders)
• are a smoker
• are in the first 6 months of pregnancy.
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 "TlA').
- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Other medicines and Nurofen Day & Night Cold & Flu
To reduce the risk of side effecls, 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:
• medicines that are anti-coagulanls (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• to stimulate your heart (e.g. glycosides including digoxin)
• medicines that 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)
• containing other sympathomimetic agents such as decongestants (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.
Fertility, pregnancy and breast-feeding
Nurofen Day & Night Cold & Flu 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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1.3.1 Package Leaflet
Lemsip Max All Night Cold & Flu Tablets Initial Application 200mg 5mg 01664
It is uniikety tfiatlf you only fake NuroTen Day & MgTit Cord & Flu 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 Day & Night Cold & Flu. Do not take this 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.
Speak to your doctor or pharmacist before taking this medicine if you are breast-feeding.
Tablels 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 Day & Night Cold & Flu 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 ot 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 Day & Night Cold & Flu 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 Day & Night Cold & Flu
Simply refer to the directions above on how to take the medicine and do not take more than is advised.
STOP TARINCTthe medicine and felTyour doctor If you experience the following uncommon side effects which affect 1 to 10 users in 1,000:
• 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 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:
• drop in blood pressure or irregular heart beat
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 Day & Night Cold & Flu 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 safety of this medicine.
Like all medicines, Nurofen Day & Night Cold & Flu 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 effects of NSAIDs (see below). If any of the side effects gels serious, or if you notice any side effects 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.
• signs of blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and severe exhaustion
• signs of liver problems such as stomach pain, jaundice (yellowing of skin and whites of the eyes) or passing dark brown urine.
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 Hydroxypropy I methyl 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 (El72) and propylene glycol).
The product is available in cartons of 4, 6, 8,10,12,14 and 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.
Product licence number: PL 00063/0556
Leaflet was last revised in November 2015.
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