Nurofen 400 Mg Capsule Soft
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Nurofen 400 mg Capsule, soft
For use in adults and adolescents weighing from 40 kg (12 years of age and above)
Ibuprofen
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Nurofen carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve
- after 3days in children and adolescents between 12 and 18 years
- after 3 days if you have fever and 4 days for the treatment of pain in adults
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
[For medicinal products available only on prescription:]
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nurofen is and what it is used for
2. Before you take Nurofen
3. How to take Nurofen
4. Possible side effects
5. How to store Nurofen
6. Further information
1. WHAT NUROFEN IS AND WHAT IT IS USED FOR
Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines provide relief by changing how the body responds to pain and fever.
Nurofen is used in adults and children & adolescents weighing from 40 kg (12 years of age and above) for the symptomatic treatment of:
• mild to moderate pain such as headache, period pain, dental pain
• fever and pain associated with the common cold.
2. BEFORE YOU TAKE NUROFEN
Do not take Nurofen if you:
are allergic to ibuprofen, ponceau 4R (E124) or any of the other ingredients of this medicine (listed in section 6).
have ever suffered from shortness of breath, asthma, a runny nose, swelling or hives after using acetylsalicylic acid (known as aspirin) or other similar painkillers (NSAIDs).
have (or have had two or more episodes of) a stomach/duodenal ulcer (peptic ulcer) or bleeding.
have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Nonsteroidal anti-inflammatory drugs)
suffer from unclarified blood-formation disturbances
suffer from a tendency to uncontrolled bleeding (haemorrhage) or clotting (coagulation) disorders
• have severe liver, kidney or heart failure.
• are in the last three months of pregnancy (see section ‘Pregnancy and breast-feeding’).
• suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
• suffer from bleeding on the brain (cerebrovascular bleeding) or other active bleeding.
Do not give to adolescents weighing less than 40 kg or children under 12 years of age.
Take special care with Nurofen if you:
• have systemic lupus erythematosus (SLE) or mixed connective tissue disease (conditions of the immune system causing joint pain, skin rashes and fever).
• have a hereditary blood formation disorder (acute intermittent porphyria) or problems with your blood clotting.
have or have ever had bowel disease (ulcerative colitis or Crohn’s disease).
have ever had high blood pressure and/or heart failure.
have reduced kidney function.
have liver problems.
have recently undergone major surgery.
have or have had asthma or allergic disease as shortness of breath may occur.
suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders as an increased risk of allergic reactions exists. The allergic reactions may present as asthma attacks (so-called analgesic asthma), swelling of skin (Quincke’s oedema) or a skin rash.
are taking other medicines which could increase the risk of ulceration or bleeding such as oral corticosteroids, medicines for thinning the blood (such as warfarin), selective serotonin-reuptake inhibitors (medicines for depression) or anti-platelet agents such as acetylsalicylic acid (aspirin).
Other warnings
• Prolonged use of painkillers for headaches can make them worse. If this situation is experienced or suspected, you should stop taking Nurofen and contact your doctor.
• Medicines such as Nurofen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (which is in children and adolescents 3 days and in adults 3 days for fever and 4 days for pain).
• If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist.
• You should avoid taking Nurofen if you have chicken pox (varicella).
• When Nurofen is taken over a longer period of time, regular liver, kidney and blood checks should be done.
• Taking Nurofen in combination with other NSAIDS including cyclo-oygenase-2 specific inhibitors can increase the risk of side effects and should be avoided. (see section “Taking other medicines” below).
• Using more than one painkilling medicine can increase the risk of severe kidney problems and should be avoided. The risk is increased further by dehydration.
• There is a risk of renal impairment in dehydrated children and adolescents.
Undesirable effects are minimised by using the minimum effective dose for the shortest period of
time. The elderly are at increased risk of side effects.
Consult a doctor before using Nurofen if any above mentioned conditions concerns you.
Taking other medicines:
What should you avoid when you are taking other medicines?
Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid/aspirin, warfarin, ticlopidin), some medicines against high blood pressure (ACE-inhibitors e.g. captopril, betareceptor blocking medicines, angiotensin II antagonists), and even some other medicines may effect or be effected by the treatment of ibuprofen. Seek therefore always advice of a doctor before you use ibuprofen with other medicines.
Do not take this medicine if you are taking acetylsalicylic acid (aspirin) at doses above 75mg daily. If you are on low-dose acetylsalicylic acid (aspirin) (up to 75mg daily) speak to your doctor or pharmacist before taking Nurofen.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell them if you are taking:
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other NSAIDs (anti-inflammatories and analgesics) |
may increase the risk of gastrointestinal ulcers or bleeding |
|
digoxin (for heart insufficiency) |
effect of digoxin may be enhanced |
|
glucocorticoids (medicinal products containing cortisone or cortisone-like substances) |
may increase the risk of gastrointestinal ulcers or bleeding |
|
Anti-platelet agents |
may increase the risk of gastrointestinal ulcers or bleeding |
|
medicines for thinning the blood (such as warfarin, acetylsalicylic acid and ticlopidin) |
ibuprofen may enhance the effects of these medicines |
|
phenytoin (for epilepsy) |
effect of phenytoin may be enhanced |
|
selective serotonin reuptake inhibitors (medicines used for depression) |
may increase the risk of bleeding |
|
lithium (a medicine for manic depressive illness and depression) |
effect of lithium may be enhanced |
|
probenecid and sulfinpyrazones (medicines for gout) |
it may take longer for ibuprofen to be broken down by the body |
|
medicines for high blood pressure (ACE-inhibitors e.g. captopril, betareceptor blocking medicines, angiotensin II antagonists) and water tablets |
ibuprofen may reduce the effects of these medicines and there could be a possible increased risk for the kidney |
|
potassium sparing diuretics |
may lead to high blood potassium levels (hyperkalaemia) |
|
methotrexate (a medicine for cancer or rheumatism) |
effect of methotrexate may be enhanced |
|
tacrolimus and cyclosporine (immunosuppressive medicines) |
kidney damage may occur |
|
zidovudine (a medicine for treating Aids) |
use of Nurofen may result in an increased risk of bleeding into a joint or a bleeding that leads to swelling in HIV (+) haemophiliacs |
|
sulfonylureas (antidiabetic medicines) |
interactions may be possible |
|
quinolone antibiotics |
risk of convulsions (fits) may be increased |
|
mifepristone (used to terminate pregnancies) |
effect of mifepristone can be reduced. |
Taking Nurofen with food and drink
Swallow the capsules with water. It is recommended that patients with sensitive stomachs take Nurofen with food. Some side effects, such as those affecting the gastrointestinal system can be more likely when alcohol is taken at the same time as Nurofen.
Pregnancy and breast-feeding
Pregnancy
Tell your doctor if you become pregnant whilst taking Nurofen.
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.
Breast-feeding
Only small amounts of ibuprofen and its metabolites pass into breast-milk. This may be taken during breast-feeding if it is used at the recommended dose and for the shortest possible time.
Female Fertility
Nurofen belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine. Avoid taking this medicine if you are trying to become pregnant.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
For short-term use and at normal dosage this medicine has no or negligible influence on the ability to drive and use machines.
Patients who experience dizziness, drowsiness, vertigo or visual disturbances while they are taking Nurofen, should avoid driving or using machinery. These effects may be worse when taken in combination with alcohol.
Important information about some of the ingredients of Nurofen
This medicinal product contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains the colour ponceau 4R (E124). It may cause allergic reactions.
3. HOW TO TAKE NUROFEN
Always take Nurofen exactly as stated in this package leaflet. You should check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the standard dose is:
Dosage:
Adults and children & adolescents weighing from 40 kg (12 years old and above):
Initial dose: Take 1 capsule (400 mg ibuprofen) with water, then if necessary 1 capsule (400 mg ibuprofen) every six hours. Do not exceed 3 capsules (1200 mg ibuprofen) in 24 hours.
Do not give Nurofen to adolescents weighing under 40 kg or children under 12 years of age.
Method of administration:
For oral use. Do not chew.
It is recommended that patients with a sensitive stomach take Nurofen with food. If taken shortly after eating, the onset of action of Nurofen may be delayed. If this happens, do not take more Nurofen than recommended within this section or until the correct re-dosing interval has passed.
Duration of treatment
This product is intended for short term use only. You should only take the lowest dose for the shortest time necessary to relieve your symptoms.
In children and adolescents
If in children and adolescents between 12 and 18 years Nurofen is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
In adults
If Nurofen is required for longer than 3 days for the treatment of fever and 4 days for treatment of pain or if the symptoms worsen, consult your doctor.
Please speak to the doctor or pharmacist if you feel that the effect of this medicine is greater or less than you expected.
If you take more Nurofen than you should
Consult a doctor immediately. The following signs may occur: feeling sick, being sick, stomach pain, diarrhoea, ringing in the ear, headache, blood in stools or vomit (gastrointestinal bleeding), dizziness, drowsiness, confusion, disorientation. Rarely: loss of consciousness.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nurofen 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 you do, or if you have concerns, stop taking this medicine and talk to your doctor as soon as possible. Elderly people using this product are at increased risk of developing problems associated with side effects.
The following frequencies are taken as a basis when evaluating side effects:_
very common: affects more than 1 user in 10_
common: affects 1 to 10 users in 100_
uncommon: affects 1 to 10 users in 1,000_
rare: affects 1 to 10 users in 10,000_
very rare: affects less than 1 user in 10,000_
not known: frequency cannot be estimated from the available data_
STOP TAKING this medicine and seek immediate medical help if you develop:
• signs of intestinal bleeding such as: severe pain in the abdomen, black tarry stools, vomiting blood or dark particles that look like coffee grounds.
• signs of very rare but serious allergic reaction such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, racing heart, drop in blood pressure leading to shock. These can happen even on first use of this medicine.
• severe skin reactions such as rashes covering the whole body, peeling, blistering or flaking skin.
Tell your doctor if you have any of the following side effects, they become worse or you notice any effects not listed.
Common
• gastrointestinal complaints, such as heart burn, abdominal pain, feeling sick and indigestion, vomiting, wind (flatulence), diarrhoea, constipation, and slight blood losses in stomach and/or bowel that may cause anaemia in exceptional cases.
Uncommon
• stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), worsening of colitis and Crohn's disease
• central nervous disturbances such as headache, dizziness, sleeplessness, agitation, irritability or tiredness
• visual disturbances
• allergic reactions , such as skin rashes, itching and asthma attacks. You must stop taking Nurofen and inform your doctor at once.
Rare
• tinnitus (ringing in the ears)
• kidney damage (papillary necrosis) and elevated uric acid concentrations in the blood
Very rare
• swelling (oedema), high blood pressure (hypertension) and cardiac failure have been reported in association with NSAID treatment.
• inflammation of the oesophagus or pancreas, formation of membrane-like narrowing in the small and large intestines (intestinal, diaphragm-like strictures)
• serious infections of the skin and soft-tissue complications have occurred during chicken pox (varicella) infection.
• passing less urine than normal and swelling (especially in patients with high blood pressure or reduced kidney function); swelling (oedema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) that my lead to acute kidney failure. If one of the above mentioned symptoms occur or if you have a general miserable feeling, stop taking Nurofen and consult your doctor immediately as these could be first signs of a kidney damage or kidney failure.
• problems in the blood cell production - first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding. In these cases you must stop the therapy immediately and consult a doctor. You must not treat these symptoms with pain killers or medicinal products that reduce fever (antipyretic products).
• psychotic reactions and depression
• worsening of infection-related inflammations (e.g. necrotising fasciitis) associated with use of certain painkillers (NSAIDs) has been described. If signs of an infection occur or get worse during use of Nurofen, you must go to a doctor without delay to investigate whether there is a need for an anti-infective/antibiotic therapy.
• high blood pressure, palpitations, heart failure, heart attack.
• liver dysfunction, liver damage, especially during long-term treatment, liver failure, acute inflammation of the liver (hepatitis)
• symptoms of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or consciousness clouding have been observed when using ibuprofen. Patients with autoimmune disorders (SLE, mixed connective-tissue disease) may be more likely to be affected. Contact a doctor at once, if these occur.
• severe forms of skin reactions such as skin rash with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia).
• severe general hypersensitivity reactions
• worsening of asthma and bronchospasm
This medicinal product contains Ponceau 4 R (E124) which may cause allergic reactions.
Medicines such as Nurofen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please stop taking the product immediately and tell your doctor or pharmacist.
5. HOW TO STORE NUROFEN
Keep out of the sight and reach of children. Do not use Nurofen after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FU RTHER INFORMATION What Nurofen contains:
Each capsule contains 400mg ibuprofen. The other ingredients are:
- Fill:
- Macrogol 600
- Potassium hydroxide
- Purified water
- Capsule shell:
- Sorbitol liquid (E420)
- Gelatin
- Ponceau 4R (E124)
- Ink:
- Titanium Dioxide (E171)
- Propylene Glycol,
- Hypromellose (E464)
- Processing Aids:
- Triglycerides (medium chain)
- Lecithin (E322)
What Nurofen looks like and contents of the pack
The capsules are red, oval-shaped and transparent with a nurofen logo printed in white. The capsules are available in packs of 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 40 or 50 soft capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
To be completed nationally
Manufacturer
To be completed nationally
This medicinal product is authorised in the Member States of the EEA under the following names:
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Austria Bulgaria Cyprus France Germany Hungary Italy Netherlands Poland Portugal Romania UK |
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