Nurofen Meltlets Lemon
0003 382 article 31 ibup
INFORMATION FOR THE USER
Read all of this leaflet carefully because It contains important information Ifor you. this medicine is available without prescription. However, you still peed to use Nurofen Meltlels Lemon carefully to get the best results from It.
J(eep 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 lifter 3 days for children and adolescents between 12 and 18 years and after 10 days Ibr adults.
It any side effects get serious, or It you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
|1. What Nurofen Meltlels Lemon are and what they are used tor
2. Before you take Nurofen Meltlels Lemon
3. How to lake Nurofen Meltlels Lemon
4. Possible side effects
3. How to store Nurofen Meltlels Lemon 3. Further Information
1. What Nurofen Meltlels Lemon are end what they ore used tor
[The active ingredient (which makes this medicine work) is Ibuprofen.
|t belongs to a group of medicines known as non-sleroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the Jody's response to pain, swelling, and high temperature.
Nurofen Meltlels Lemon are used tor the relief of:
» Headaches and migraine pain !• Dental pain and neuralgia ;• Period pain
<• Rheumatic, muscular and back pain [• Feverishness and symptoms of cold and flu
2. Before taking Nurofen Meltlels Lemon
Do not take Nurofen Meltlels Lemon It you:
[• are allergic to ibuprofen or any of the other ingredients (see section 6) or to aspirin or other painkillers !• have ever had a stomach ulcer, perforation or bleeding j» have had a worsening of asthma, skin rash, itehy runny nose or facial 1 swelling when previously taking ibuprofen, aspirin or similar | medicines
• have had gastrointestinal bleeding or perforation when previously I taking NSAIDs (Non-sleroidal anti-inflammatory drugs)
» are taking other NSAIDs (Non-Steroidal Anti-inflammatory Drugs)
!• 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
1 you take this medicine
I* have severe liver or kidney problems
» have heart problems, high blood pressure or blood coagulation
! disorder
;• have breathing difficulties
i» 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 a history of gastrointestinal disease (such as ulcerative colitis, !
Crohn's disease) |
• have Systemic Lupus Erythematosus (a condition of the immune 1 system causing joint pain skin changes and other organ disorders) |
• are a smoker
• are in the first 6 months of pregnancy.
• have phenylketonuria or are intolerant to phenylalanine. j
(see 'Important information about some of the ingredients at Nurofen 1 Meltlels Lemon1). !
To reduce the risk of side effects, do not take this product with other NSAID j 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 meltlels may affect or be affected by some 1 other medicines. For example: [
Avoid taking this product with corticosteroid tablets, quinolone antibiotics 1 or drugs that are prescribed:
• medicines that are anti-coagulanls (i.e. thin blood/prevent clotting e.g.; aspirin/acelylsalicylic acid, warfarin, ticlopidine)
• to stimulate your heart (e.g. glycosides) [
• medicines that reduce high blood pressure (ACE-inhibitors such as ' captopril, beta-blockers such as atenolol medicines, angiotensin-ll I receptor antagonists such as losartan)
• to help you passing water (diuretics),
• for the temporary suppression at your immune system |
(e.g. methotrexate, ciclosporine, tacrolimus)
• for mania or depression (e.g. Lithium or SSRIs) j
• for pregancy termination (e.g. mifepristone)
• for HIV treatment (e.g. zidovudine). I
Some other medicines may also affect or be affected by the treatment; of Nurofen Meltlels. You should therefore always seek the advice of 1 your doctor or pharmacist before you use Nurofen Meltlels with other | medicines.
Other warnings
• Nurofen Meltlels Lemon belongs to a group of medicines which may ! Impair fertility In women. This is reversible on stopping the medicine.; It is unlikely that Nurofen Meltlels Lemon, used occasionally will affect 1
your chances of becoming pregnant. ______1
However, tell your doctor before taking this medicine if
you have problems becoming pregnant.
• Anti-inflammatoiy/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. ! I
• You should discuss your treatment with your doctor or pharmacist before taking Nurofen Meltlels it you:
- have heart problems including heart failure, angina 1------i
(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. >
• There is a risk of renal impairment in dehydrated children and ;
_ ^adolescents._____________________RBI 94463!
;PTegnancy and~breasffeeding ~
Tell your doctor it you become pregnant whilst taking Nuiafen. Do not take [this medicine in the last 3 months at pregnancy. Avoid the use of this medicine in the first 6 months of pregnancy, unless the doctor advises btherwise. Speak to your doctor or pharmacist before taking this medicine ;if you are breastfeeding.
Important Information about some of the ingredients of Nurofen Meltlels Lemon
[Each tablet contains aspartame (E951) which is a source of phenylalanine which may be harmful to people with phenylketonuria or who are intolerant to phenylalanine. Each orodispersible tablet contains a Source equivalent to 14 mg of phenylalanine.
3. How to take Nurofen Meltlels Lemon
This product is tor short term use only. You should take the lowest dose tor )he shortest time necessary to relieve your symptoms.
Adults, the elderly and children & adolescents between 12 and 18 lyeais:
[Take 1 or 2 tablets up to three times a day as required.
Place a tablet on the tongue, allow it to dissolve and then swallow; no [water is required. Leave at least four hours belween doses.
Do not take more than 6 tablets in 24 hours.
[Do not give to children under 12 years.
;ln children and adolescents belween 12 and 18 years:
If in children and adolescents this medicinal product is required tor more [than 3 days, or if symptoms worsen a doctor should be consulted.
In adulls:
[Do not take tor longer than 10 days unless your doctor tells you to. If symptoms persist or the pain or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.
[If you take more Nurofen Meltlels Lemon 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 Meltlels Lemon.
[Simply refer to the directions above on how to lake the medicine and do [nottake morettian is advised.
4. Possible side effects
STOP TAKING The medfcFne and fell your dotior II 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 effecls, they become worse or you notice any effecls not listed:
Uncommon side effecls which affect 1 to 10 users in 1,000:
• allergic reactions, such as skin rashes (urticaria), itching, peeling
• headaches
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
• stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation at the lining of the mouth with ulceration (ulcerative stomatitis), inflammation at the stomach (gastritis)
• liver problems
Side effects tor 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
Medicines such as Nurofen Meltlels Lemon 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 effecls 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 effecls, you can help provide more information on the safely at this medicine.
Like all medicines, Nurofen can cause side effects, although not everybody pels them. Side effects may be minimised by taking the lowest dose tor 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 effecls gels serious, or it you notice any side effects not listed in this leaflet, fell your [doctor or pharmacist.
[STOP TAKING the medicine and seek immediate medical help if you
5. How to store Nurofen Meltlels Lemon
Keep all medicines out of the sight and reach of children.
Do not use alter the expiry date slated on the carton alter 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 Informution
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signs of intestinal bleeding such as: bright red faeces (stools/moflons), black tony stools, vomiting blood or dark particles that look like coffee grounds, signs at 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.: Sleven-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
Each orodispersible tablet contains the active ingredient Ibuprofen 200mg. they also contain: Ethylcellulose (E462), Silicon Dioxide (E551), Hypromellose (E464), Mannitol (E420), Aspartame (E951), Croscarmellose Sodium (E468), Magnesium Stearate (E572), Flavour (lemon flavours, maltodexlrin).
Nurofen Meltlels Lemon are available in packs of 4,6,10,12,14,16,
18,20,22,24,30,36,40 or 48 orodispersible tablets.
Not all packs will be marketed.
Manufoclurer: Reckitt Benckiser Healthcare International Ltd, Nottingham, NG90 2DB, UK.
Marketing Authorisation Holder: Reckitt Benckiser Healthcare (UK) Ltd, Slough, SL14AQ.
Product licence number: PL 00063/0382 Dale at revision: August 2015
RB1944631
1.3.1 Package Leaflet
Nurofen Orodispersible Tablets Lemon PL00063/0382
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