Nurofen 400mg Capsule, soft – patient leaflet, side effects, dosage

1. WHAT NUROFEN 400MG SOFT CAPSULES 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 400mg Soft Capsules is used in adults and adolescents weighing from 40 kg (12 years of age and above) for the short-term symptomatic treatment of:

• mild to moderate pain such as headache, period pain, dental pain
• fever and pain associated with the common cold.

You must contact a doctor if your symptoms worsen or do not improve after 3 days in adolescents or in adults, after 3 days if you have fever or 4 days for pain.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NUROFEN 400MG SOFT CAPSULES

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema) and chest pain have been reported with ibuprofen. Stop taking Nurofen 400mg Soft Capsules immediate and contact your doctor or medicinal emergencies if you notice any of these signs.

Do not take Nurofen 400mg Soft Capsules 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 distinct episodes of) a stomach/duodenal ulcer (peptic ulcer) or bleeding.
• have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non- steroidal anti-inflammatory drugs)
• suffer from unclarified blood-formation disturbances
• 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.

Warnings and precautions:

Talk to your doctor or pharmacist before using this product if you:

• have an infection - please see heading “Infections” below
• have systemic lupus erythematosus (SLE) or mixed connective tissue disease (conditions of the immune system causing joint pain, skin rashes and fever).
• have certain hereditary blood formation disorder (e.g. acute intermittent porphyria) or problems with your blood clotting.
• have or have ever had bowel disease (ulcerative colitis or Crohn’s disease).
• 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), acute swellings (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

• Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema) and chest pain have been reported with ibuprofen. Stop taking Nurofen 400mg Soft Capsules immediately and contact your doctor or medicinal emergencies if you notice any of these signs.
• Prolonged use of painkillers for headaches can make them worse. If this situation is experienced or suspected, you should stop taking Nurofen 400mg Soft Capsules and contact your doctor.
• You should avoid taking Nurofen 400mg Soft Capsules if you have chicken pox (varicella).
• When Nurofen 400mg Soft Capsules is taken over a longer period of time, regular liver, kidney and blood checks should be done.
• Taking Nurofen 400mg Soft Capsules 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).
• In general the habitual use of (several sorts of) analgesics can lead to lasting severe kidney problems and should be avoided. The risk is increased further by loss of salt and dehydration.
• There is a risk of renal impairment in dehydrated adolescents.

Infections

Nurofen 400 mg Soft Capsules may hide signs of infections such as fever and pain. It is therefore possible that Nurofen 400 mg Soft Capsules may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Serious skin reactions

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) and acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen Nurofen 400 mg Soft Capsules treatment. You should stop takingStop using Nurofen 400 mg Soft Capsules and seek medical attention immediately, if you notice any of the symptoms related to these serious skin reactions described in Section 4. develop any skin rash, lesion of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

Anti-inflammatory/pain-killer medicines like 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 400mg Soft Capsules 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.

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 400mg Soft Capsules if any above mentioned conditions concerns you.

Other medicines and Nurofen 400 mg Soft Capsules:

Nurofen 400mg Soft Capsules® 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, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

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:

Taking Nurofen 400mg Soft Capsules with alcohol

You should not drink alcohol while using Nurofen 400mg Soft Capsules. Some side effects, such as those affecting the gastrointestinal tract or the central nervous system can be more likely when alcohol is taken at the same time as Nurofen 400mg Soft Capsules.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Tell your doctor if you become pregnant whilst taking Nurofen 400mg Soft Capsules.

Do not take this medicine if you are in the last 3 months of pregnancy. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. Avoid the use of this medicine in the first 6 months of pregnancy unless the doctor advises otherwise. If taken for more than a few days from 20 weeks of pregnancy onward, ibuprofen can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

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 400mg Soft Capsules belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine.

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 400mg Soft Capsules, 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 400mg Soft Capsules

This medicine contains 36.6 mg of sorbitol in each capsule. 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 400MG SOFT CAPSULES

Always take Nurofen 400mg Soft Capsules 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):

As 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 400mg Soft Capsules 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 400mg Soft Capsules with food. If taken shortly after eating, the onset of action of Nurofen 400mg Soft Capsules may be delayed. If this happens, do not take more Nurofen 400mg Soft Capsules 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 The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

In adolescents

If in adolescents Nurofen 400mg Soft Capsules is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

In adults

If Nurofen 400mg Soft Capsules 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 400mg Soft Capsules than you should

If you have taken more Nurofen 400mg Soft Capsules 400 mg Soft Capsules than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken. The symptoms of overdose can include: Nausea (feeling sick), vomiting (being sick – may be blood streaked), blood in stools (gastrointestinal bleeding), ringing in the ears, headache, stomach pain, diarrhoea and shaky eye movements. At high doses, weakness and dizziness, drowsiness, confusion, disorientation, loss of consciousness, cold body feeling, chest pain, palpitations, convulsions (mainly in children), blood in urine, low levels of potassium in your blood and breathing problems have been reported.

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 400mg Soft Capsules 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.

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 skinreddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis]
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome)
• A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis)

Tell your doctor if you have any of the following side effects, they become worse or you notice any effects not listed.

Common (may affect up to 1 in 10 people)

• 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 (may affect up to 1 in 100 people)

• 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 400mg Soft Capsules and inform your doctor at once.
• various skin rashes

Rare (may affect up to 1 in 1,000 people)

• tinnitus (ringing in the ears)
• kidney damage (papillary necrosis) and elevated uric acid concentrations in the blood
• hearing impaired
• increased urea concentrations in the blood
• decrease haemoglobin levels

Very rare (may affect up to 1 in 10,000 people)

• 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)
• severe 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 400mg Soft Capsules 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 400mg Soft Capsules, 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
• inflammation of the blood vessels (vasculitis)

Not known (cannot be estimated from the available data)

• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome
• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
• A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using this medicine if you develop these symptoms and seek medical attention immediately. See also section 2.
• Skin becomes sensitive to light.

This medicinal product contains Ponceau 4 R (E124) which may cause allergic reactions.

Medicines such as Nurofen 400mg Soft Capsules may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE NUROFEN 400MG SOFT CAPSULES

Keep out of the sight and reach of children. Do not use Nurofen 400mg Soft Capsules 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.

Do not throw away medicines 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. CONTENTS OF THE PACK AND FURTHER INFORMATION

What Nurofen 400mg Soft Capsules 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 400mg Soft Capsules 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

Reckitt Benckiser Healthcare (UK) Limited, SL1 4AQ, UK

Manufacturer

Patheon Softgels BV, De Posthoornstraat 7, Tilburg, NL-5048 AS, Netherlands.

This leaflet was last approved in November 2020October 2022 upon approval

PL 00063/0615