Nurofen Express Forte 400mg

Nurofen Express Forte contains the active ingredient Ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These drugs work by changing the body’s response to pain and high temperature.

• The tablet contains 400 mg of Ibuprofen.
• A quickly absorbed drug with a targeted analgesic effect.
• It can be used during breastfeeding.
• The active substance (ibuprofen) is in liquid form – ready to be absorbed directly into the bloodstream.
• Nurofen Express Forte is intended for use in adults and adolescents weighing more than 40 kg (aged 12 years and over).

Symptoms

Nurofen Express Forte is intended for use in adults and children and adolescents weighing more than 40 kg (aged 12 years and over) for the short-term symptomatic treatment of mild to moderate pain such as headache, menstrual pain, toothache and fever and pain associated with a cold.

Active substance: Ibuprofen

Composition

Each capsule contains 400 mg of ibuprofen.

In addition, the drug contains: macrogol 600, potassium hydroxide, purified water. Capsule composition: gelatin, liquid sorbitol, partially dehydrated, purified water, cochineal red (E 124); Ink: Opacode WB White NS-78-18011 with the following composition: titanium dioxide (E 171), propylene glycol, hypromellose 3 cP; Processing aids: medium-chain saturated fatty acid triglycerides, lecithin.

Dosage

Before use, read the leaflet, which contains indications, contraindications, data on side effects and dosage, as well as information on the use of the medicinal product, or consult a doctor or pharmacist, as each drug used improperly may threaten your life or health.

• Adults and adolescents weighing more than 40 kg (aged 12 years and over): Initial dose: 1 capsule (400 mg ibuprofen) with water; take 1 capsule (400 mg ibuprofen) every 6 hours as needed. Do not take more than 3 capsules (1200 mg ibuprofen) in any 24 hour period.
• The drug should not be given to adolescents weighing less than 40 kg under the age of 12 years.
• Use orally. Do not chew the capsules.
• Patients with a sensitive stomach should take Nurofen Express Forte with a meal. When taken immediately after eating, the onset of action may be delayed. In this situation, you should not take a larger dose of Nurofen Express Forte and in a shorter time interval than recommended.
• The product is intended for short-term use only. The lowest effective dose should be used for the shortest duration necessary to control symptoms.
• In adolescents, medical advice should be sought if treatment is required for more than 3 days or if symptoms worsen.
• If you do not feel better or if you feel worse after 3 days when treating fever or 4 days when treating pain, you should contact your doctor.
• If you have the impression that the effect of the medicine is stronger or weaker than expected, talk to your doctor or pharmacist.

Always use Nurofen Express Forte according to this leaflet. Check with your doctor or pharmacist if you are not sure.

Contraindications

• in case of hypersensitivity to ibuprofen, cochineal red (E124) or any of the ingredients of the drug,
• if you have experienced shortness of breath, asthma, rhinitis, swelling or hives while previously using acetylsalicylic acid (aspirin) or other similar painkillers (NSAIDs),
• if you have (or have had two or more distinct episodes of) ulceration of the stomach and/or duodenum (peptic ulcer) or bleeding,
• if you have had bleeding or perforation in the digestive tract during previous use of NSAIDs (non-steroidal anti-inflammatory drugs),
• if you have unexplained disorders of the hematopoietic system,
• if you have severe liver, kidney or heart failure,
• if you are in the last trimester of pregnancy (see Pregnancy and breast-feeding section),
• if you are severely dehydrated (due to vomiting, diarrhea or insufficient fluid intake)
• if you have cerebrovascular or other active bleeding.

Do not give the drug to children under 12 years of age and adolescents weighing less than 40 kg.

When to take special care with Nurofen Express Forte:

• if you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system causing joint pain, skin lesions and fever)
• if you have severe skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome or toxic epidermal necrolysis. The use of Nurofen Express Forte should be stopped immediately at the first appearance of skin rash, changes in the mucous membranes or any other signs of allergic reactions,
• if you have certain inherited disorders of blood formation (e.g. acute transient porphyria) or bleeding disorders,
• if you have or have had a bowel disease (ulcerative colitis or Crohn’s disease)
• in case of impaired kidney function,
• in case of impaired liver function,
• if you have recently had surgery,
• if you have or have had asthma or an allergic disease, as shortness of breath may occur,
• if you suffer from hay fever, nasal polyps or chronic obstructive respiratory disorders as there is an increased risk of an allergic reaction. An allergic reaction may take the form of an asthma attack (so-called analgesic asthma), severe angioedema (Quincke’s edema) or skin rash,
• if you are taking medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) or antiplatelet medicines such as acetylsalicylic acid (aspirin).

Contents
20 soft capsules
Storage method
15°C-25°C
Manufacturer
RECKITT BENCKISER

Warnings

This is medicine. For safety, use it according to the leaflet attached to the package. Do not exceed the maximum dose of the drug. If in doubt, consult your doctor or pharmacist.

• Long-term use of painkillers to treat headaches can make the symptoms worse. If this happens or is suspected, stop taking Nurofen Express Forte and contact your doctor.
• Nurofen Express Forte should be avoided during chickenpox.
• During long-term use of Nurofen Express Forte, regular liver and kidney function tests and blood counts should be performed.
• Taking Nurofen Express Forte concomitantly with other NSAIDs, including specific cyclooxygenase-2 inhibitors, may increase the risk of side effects and should therefore be avoided.
• Habitual use of (more than one) painkillers can lead to serious kidney problems and should be avoided. This risk is greater with salt loss and dehydration.
• NSAIDs may mask the symptoms of infection and fever.
• There is a risk of renal impairment in dehydrated adolescents.
• Taking anti-inflammatory/painkillers such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, particularly when taken in high doses. Do not exceed the recommended dose and duration of treatment.

Talk to your doctor or pharmacist before taking Nurofen Express Forte if:

• you have heart problems such as heart failure, angina pectoris (chest pain), you have had a heart attack, bypass surgery, you have peripheral arterial disease (poor blood circulation in the legs due to narrow or blocked arteries) or if you have had any kind of stroke (including mini-stroke or transient ischemic attack – TIA).
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Side effects may be minimized by using the lowest effective dose for the shortest possible time. The elderly are more likely to experience side effects.

If you suffer from any of the disorders or conditions listed above, consult your doctor before taking Nurofen Express Forte.

Nurofen Express Forte contains sorbitol. People with known intolerance to some sugars should consult their doctor before taking this medicine.

The medicine contains the coloring agent cochineal red (E124) which may cause allergic reactions.

Pregnancy and breastfeeding

• 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.
• Tell your doctor if you think you may be pregnant while taking Nurofen Express Forte.
• The drug must not be used in the last trimester of pregnancy. Unless your doctor tells you otherwise, Nurofen Express Forte should be avoided during the first and second trimester of pregnancy.
• Ibuprofen and its metabolites may pass into breast milk in small doses. The drug can be used during breastfeeding if it is taken at the recommended dose and for the shortest possible time.

Driving
If you experience dizziness, drowsiness, balance disorders or visual disturbances while taking Nurofen Express Forte, you should avoid driving or operating machinery. These effects may be potentiated by concomitant consumption of alcohol.

Interactions with other drugs
Some other medicines may influence or affect the treatment of Nurofen Express Forte. Therefore, always consult your doctor or pharmacist before taking Nurofen Express Forte with other medicines.

Nurofen Express Forte may affect how other medicines work, or other medicines may affect how Nurofen Express Forte works. For example:

• anticoagulants (i.e. blood thinning/preventing blood clots such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking the following medicines:

• Other NSAIDs (anti-inflammatory and painkillers) including selective cyclo-oxygenase-2 inhibitors, as this may increase the risk of gastrointestinal ulceration or bleeding;
• digoxin (medicine for heart failure) possible intensification of the effect of digoxin;
• glucocorticoids (medicines containing cortisone or cortisone-like substances) possible increased risk of gastrointestinal ulceration or bleeding;
• antiplatelet drugs possible increased risk of gastrointestinal ulceration or bleeding;
• phenytoin (a medicine used to treat epilepsy) the effect of phenytoin may be enhanced;
• selective serotonin reuptake inhibitors (medicines used to treat depression) possible increased risk of bleeding;
• lithium (a medicine used to treat manic-depressive disorders and depression) the effect of lithium may be enhanced;
• probenecid and sulfinpyrazone (medicines used to treat gout) may increase the time it takes for ibuprofen to break down in the body;
• potassium-sparing diuretics possible increase in potassium levels in the blood (hyperkalaemia);
• methotrexate (a medicine used to treat cancer and rheumatic disease) the effect of methotrexate may be enhanced;
• tacrolimus and cyclosporine (immunosuppressants) possible kidney damage;
• zidovudine (a medicine used to treat AIDS) the use of Nurofen Express Forte may increase the risk of intra-articular bleeding or bleeding leading to swelling in HIV (+) haemophilia patients;
• sulfonylureas (medicines for diabetes) possible interactions;
• quinolone antibiotics may increase the risk of seizures;
• mifepristone (medicine used to terminate pregnancy) the effect of mifepristone may be reduced;
• acetylsalicylic acid (low doses) blood thinning effect may be reduced;
• blood thinners (such as warfarin) ibuprofen may increase the effect of these medicines;
• voriconazole and fluconazole (CYP2C9 inhibitors), used in fungal infections, the effect of ibuprofen may be enhanced. Reduction of the ibuprofen dose should be considered, particularly when high doses of ibuprofen are co-administered with voriconazole or fluconazole.

Side effects

Like all medicines, Nurofen Express Forte can cause side effects, although not everybody gets them. Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. You may experience the known side effects of NSAIDs. If in doubt, stop taking the medicine and talk to your doctor as soon as possible. Elderly patients using this medicine have an increased risk of developing disorders associated with side effects.

STOP TAKING the medicine and contact your doctor immediately if you experience any of the following symptoms:

• signs of gastrointestinal bleeding such as: severe abdominal pain, tarry stools, vomiting blood or dark particles that look like coffee grounds;
• signs of a very rare but serious allergic reaction such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, fast heart rate, drop in blood pressure leading to shock. This reaction can occur even when you first take the medicine;
• serious skin reactions such as a rash that covers the whole body, peeling or blistering of the skin;
• serious skin reaction known as DRESS syndrome (frequency not known). Symptoms of DRESS include skin rash, fever, swollen glands and an increase in the number of eosinophils (a type of white blood cell).

Other possible side effects:

If any of the side effects develops or gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Common (may affect up to 1 in 10 people):

• digestive tract disorders, e.g. heartburn, abdominal pain, nausea, indigestion, vomiting, flatulence, diarrhoea, constipation, slight bleeding from the stomach and / or duodenum which may cause anemia in exceptional cases.

Uncommon (may affect up to 10 in 100 people):

• ulceration of the stomach or intestines, sometimes with bleeding and perforation, inflammation of the oral mucosa with ulceration (ulcerative stomatitis), gastritis (gastritis), worsening of colitis and Crohn’s disease;
• central nervous system disorders such as headaches, dizziness, insomnia, agitation, irritability or fatigue;
• blurred vision;
• allergic reactions such as rash, itchy skin and asthma attacks. In this case, you must stop taking Nurofen Express Forte and contact your doctor immediately.

Rare (may affect up to 100 in 1,000 people):

• tinnitus (ringing in the ears);
• kidney damage (papillary necrosis) and increased levels of uric acid in the blood.

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

• cases of edema, hypertension and heart failure have been reported with the use of NSAIDs;
• inflammation of the esophagus or pancreas, formation of diaphragm-like strictures in the intestine;
• severe infections of the skin and soft tissues have been observed during chickenpox;
• decreased urine output and swelling (especially in patients with high blood pressure or kidney problems); swelling and cloudy urine (nephrotic syndrome); inflammation of the kidneys (interstitial inflammation) which may lead to acute kidney failure. If you experience one of these symptoms or if you feel generally unwell, stop taking Nurofen Express Forte and contact your doctor immediately, as these may be the first signs of kidney damage or failure;
• disorders in the production of blood cells: the first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe weakness, nosebleeds and skin bleeding. In this case, stop treatment immediately and contact your doctor. These symptoms must not be treated with painkillers or antipyretics;
• psychotic reactions and depression;
• exacerbation of infection-related inflammation (e.g. necrotizing fasciitis) has been reported with the use of certain painkillers (NSAIDs). If symptoms of an infection develop or worsen while taking Nurofen Express Forte, you should contact your doctor immediately to determine whether you need to use anti-infectives/antibiotics;
• high blood pressure, palpitations, heart failure, heart attack;
• liver function disorders, liver damage, especially during long-term treatment, liver failure, acute hepatitis;
• Symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever and altered consciousness have been observed with ibuprofen. Patients with autoimmune diseases (systemic lupus, mixed connective tissue disease) are at higher risk of these disorders. If you experience such symptoms, contact your doctor immediately;
• severe skin reactions such as rash with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia);
• severe generalized hypersensitivity reactions;
• exacerbation of asthma or bronchospasm;
• inflammation of the blood vessels.

The medicine contains cochineal red (E124) which may cause allergic reactions.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, stop taking the medicine immediately and tell your doctor or pharmacist.