NUROFEN FORTE TBL 400MG N12

ATC code: M01AE01 

Active substances: Ibuprofenum

Vendor, principal: Reckitt Benckiser Healthcare. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

NUROFEN FORTE EXPRESS 400MG N12

Package leaflet: Information for the user

Nurofen Forte Express, 400 mg film-coated tablets Ibuprofen
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 10 days.
What is in this leaflet:
1.   What Nurofen Forte Express is and what it is used for
2.   What you need to know before you use Nurofen Forte Express
3.   How to use Nurofen Forte Express
4.   Possible side effects
5.   How to store Nurofen Forte Express
6.   Contents of the pack and other information

1. What Nurofen Forte Express is and what it is used for

Nurofen Forte Express contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs have an analgesic, anti-inflammatory and antipyretic effect.
Nurofen Forte Express is indicated for:
Mild to moderate pain.
Dysmenorrhea (painful menstruation).
Fever.

2. What you need to know before you use Nurofen Forte Express:

Do not use Nurofen Forte Express:

-   if you are allergic to the active substance or any of the other ingredient(s) of this medicine (listed in section 6);
-   if you are allergic to acetylsalicylic acid or other NSAIDs;
-   during the third trimester of pregnancy;
-   if you have had a gastric ulcer, perforation (hole in the gut wall) or gastrointestinal haemorrhage;
-   if you have severe liver, kidney or heart disorders;
-   if you are under the age of 12.

Warnings and precautions

Talk to your doctor or pharmacist before using Nurofen Forte Express.
-   if you have or have had asthma;
-   if you have high blood pressure;
-   if you have systemic lupus erythematosus (a disease that affects the immune system, causing joint pain, skin alteration and symptoms in almost the entire body);
-   if you have been told to limit the amount of sodium in your diet;
-   during the first six months of pregnancy or if you are breast-feeding;
-   Nurofen Forte belongs to a group of medicines that may affect fertility in women. The effect is reversible when you stop using the medicine.
Anti-inflammatory/analgesic medicines, such as ibuprofen, may be associated with a slightly increased risk of infarction or stroke, especially when used in large doses. Do not exceed the recommended dose or duration of treatment.
Talk to your doctor or pharmacist before taking Nurofen Forte Express in the following cases:
-   if you have heart problems, such as heart failure or angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood supply in legs or feet due to narrowed or clogged arteries) or any type of stroke (incl. mini-stroke or transient ischemic attack (TIA));
-   if you have high blood pressure, diabetes or high cholesterol, if heart disease or stroke has occurred in your family history or if you smoke.
In very rare cases, use of NSAIDs has caused severe skin disorders (such as exfoliative (scaling) dermatitis (skin infection), Stevens-Johnson syndrome (lethal form of erythema) and toxic (poisonous) epidermal necrolysis (detachment of the epidermis)). The risk of developing skin reactions is highest in the early stage of treatment: in most cases, the reaction occurs in the first month. Stop using Nurofen Forte Express immediately when you develop a skin rash, mucosal lesions or another hypersensitivity symptom.
Risks of the gastrointestinal tract
Gastrointestinal haemorrhage, ulceration or perforation has been reported in connection with using all NSAIDs at any moment of treatment either with or without warning symptoms, and either with or without medical history of severe gastrointestinal symptoms. The risk of gastrointestinal haemorrhage, ulceration or perforation is higher when the dose of NSAIDs is increased, in patients with a medical history of ulceration, especially if the ulcer is complicated with a bleeding or perforation, and in elderly patients. In these patients, the treatment should be started with the lowest dose, if possible.
In these patients, as well in those that use acetylsalicylic acid or other medicines that increase the risk of gastrointestinal damage in small doses, combination therapy with protective substances (incl. misoprostol and proton pump inhibitors) should be considered.
Patients with a medical history of gastrointestinal toxicity, especially the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage), especially if it occurs at the beginning of treatment.
Special care must be taken in patients that are concomitantly using medicines that increase the risk of a gastrointestinal ulcer and haemorrhage, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors or platelet aggregation inhibitors, such as acetylsalicylic acid.
If gastrointestinal haemorrhage or ulcer occurs during treatment with Nurofen Forte Express, the treatment must be stopped immediately.
Special care must be taken before starting treatment in patients that have a medical history of gastrointestinal diseases (ulcerative colitis (inflammation of the large intestine)), Crohn’s disease (chronic inflammatory bowel disease), as NSAIDs may worsen these diseases.
Elderly patients
In elderly patients, the incidence of NSAID-induced side effects (especially gastrointestinal haemorrhage and perforation that may be lethal) is higher.
Children and adolescents
Dehydrated children and adolescents have a risk of renal impairment.
In order to reduce side effects, use the minimum effective dose for the shortest possible time required to control the symptoms.

Other medicines and Nurofen Forte Express:

Do not use Nurofen Forte Express if you are using another NSAID (incl. COX-2 inhibitors, such as celecoxib or etoricoxib), other analgesics or acetylsalicylic acid (as an analgesic).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Nurofen Forte Express may influence the effect of other medicines and vice versa. These medicines include, for example:
-   acetylsalicylic acid (pain and anti-fever medication, in small doses also prevents blood clotting);
-   diuretics;
-   anticoagulants (i.e. medicines that thin the blood and prevent blood clotting, such as aspirin or acetylsalicylic acid, warfarin and ticlopidine);
-   medicines that lower blood pressure (ACE inhibitors, such as captopril; beta-blockers, such as atenolol; angiotensin II receptor antagonists, such as losartan);
-   corticosteroids (prednisolone or dexamethasone), methodrexate (used to treat cancer), lithium (medicine to treat depression), zidovudine (antiviral medicine), quinolone antibiotics.
Avoid using Nurofen Forte Express concomitantly with cyclooxygenase-2 inhibitors.
Some other medicines may also influence the use of Nurofen Forte Express or vice versa. Therefore, always ask your doctor or pharmacist for advice before taking Nurofen Forte Express with other medicines.

Pregnancy, breast-feeding and fertility

Talk to your doctor or pharmacist before using this medicine. Nurofen Forte Express in contraindicated in the last three months of pregnancy. Ask your doctor for advice before using Nurofen Forte Express during the first six months of pregnancy or if you are breast-feeding.
Nurofen Forte Express is in the group of medicines that may affect fertility in women.
-   The effect is reversible when you stop using the medicine.
-   It is unlikely that Nurofen Forte Express will affect becoming pregnant if it is used from time to time.
-   Ask your doctor for advice before taking Nurofen Forte Express if you have problems with getting pregnant.
Ibuprofen is excreted in breast milk in very small quantities; nevertheless, using the medicine during breast-feeding is not recommended.

Driving and using machines

Precautions are not necessary in the case of recommended doses and duration of treatment.

Nurofen Forte Express contains sodium:

Every tablet contains 48.6 mg of sodium. This should be considered if you need to limit the amount of sodium in your diet.
If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to use Nurofen Forte Express

Always use Nurofen Forte Express exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults and children over the age of 12: the initial dose is 1 tablet, then 1 tablet every 4 hours as required. Do not take more than 3 tablets a day.
Do not give this medicine to children under the age of 12.
Nurofen Forte Express is intended for short-term use. This reduces the risk of potential side effects.
If your condition does not improve or worsens or if you develop new symptoms, ask a doctor or pharmacist for advice.
Nurofen Forte Express may not be used for more than 10 days without a doctor’s prescription.
Children and adolescents
Talk to your doctor if children or adolescents need to take this medicine for more than 3 days or if they feel worse.

If you use more Nurofen Forte than you should:

If you have taken more Nurofen Forte than you should, or if children have accidentally taken this medicine, contact your doctor or nearest hospital immediately to get information on possible dangers and necessary treatment options.
Symptoms of overdose include nausea, abdominal pain, vomiting (may be blood-mixed), headache, ringing in the ears, confusion and flickering eye movements. Drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, chills in the body and respiratory problems may occur at particularly high doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Nurofen Forte Express is generally well tolerated; however, the following side effects may occur:
Very common (> 1/10)
Common (> 1/100 to < 1/10)
Uncommon (> 1/1,000 to < 1/100)
Rare (> 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Unknown: incidence cannot be estimated from available data
The following list of side effects is based on the practice of short-term use of over-the-counter doses of Nurofen Forte Express. More side effects may occur in the case of long-term treatment of chronic conditions.
Gastrointestinal disorders:
Uncommon: stomach pain, dyspepsia (indigestion) and nausea.
Rare: diarrhoea, flatulence, constipation and vomiting.
Very rare: peptic (stomach or duodenal) ulcer, perforation or haemorrhage that may be lethal in some cases, especially in the elderly patients (see section 4.4).
Meleana, haematemesis, ulcerative stomatitis (oral inflammation), worsening of ulcerative colitis and Crohn’s disease (see section 4.4).
Nervous system disorders:
Uncommon: headache.
Very rare: aseptic meningitis.
Renal and urinary disorders:
Very rare: urinary retention and swelling. Also, acute renal impairment. Papillary necrosis, especially in long-term use, and increased urea (urine residue) concentration in serum.
Abnormal hepatic function:
Very rare: abnormal hepatic function, especially in long-term use.
Blood and lymphatic system disorders:
Very rare: haematopoietic disorders (anaemia (low red blood cell count), leukopenia (low white blood cell count), thrombocytopenia (low platelet count in the blood), pancytopenia (lack of all blood cell types), agranulocytosis (low count of certain white blood cells in the blood)). Initial symptoms: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, bleeding nose and skin.
Skin and subcutaneous tissue disorders:
Uncommon: various skin rashes.
Very rare: severe skin reactions, such as multiform erythema (redness of the skin), epidermal necrolysis and Stevens-Johnson syndrome.
Unknown: a severe skin reaction called DRESS may occur. The symptoms of DRESS are skin rash, fever, swelling of the lymph nodes and an increase in the number of eosinophils (a type of white blood cells).
Immune system disorders:
Uncommon: urticaria and pruritus.
Very rare: patients with immune system disorders (systemic lupus erythematosus (certain collagen disease), mixed-type connective tissue disease)), have developed single symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever and disorientation (see section 4.4). Unknown: respiratory reactions: asthma or dyspnea.
General disorders:
Uncommon: allergic reactions with urticaria (hives) and tingling.
Very rare: severe allergic reactions. The symptoms may include: swelling of the face, tongue and throat; dyspnea (breathlessness); tachycardia (rapid heart rate); hypotension (low blood pressure); anaphylaxis (severe allergic reaction with rapid progression); angioedema (topical skin swelling) or severe shock.
Worsening of asthma and bronchospasm (constriction of bronchial muscles).
Cardiovascular disorders:
Very rare: swelling, hypertension (heightened blood pressure) and cardiac impairment have been reported in connection with NSAID treatment.

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 www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nurofen Forte Express

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 30 °C.
Store in the original package in order to protect from moisture.
Do not use Nurofen Forte Express after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nurofen Forte Express contains

The active substance is ibuprofen sodium dihydrate.
One tablet contains 512 mg of ibuprofen sodium dihydrate, which equals to 400 mg of ibuprofen.
The other ingredients are croscarmellose sodium, xylitol, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, carmellose sodium, talc, gum arabic, sucrose, titanium dioxide, macrogol 6000, Opacode S-1-15094 red ink (shellac, red iron oxide, propylene glycol, ammonium hydroxide and simethicone).

What Nurofen Forte Express looks like and contents of the pack

White to greyish-white, biconvex, round, sugar-coated tablet with a diameter of 12.5 mm and a red marking “N>>” on one side.
PVC/PVdC/Al blister.
Blisters are packaged in a cardboard carton.
The pack contains 10, 12 or 24 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Reckitt Benckiser (Poland) S.A.
Ul. Okunin 1
05-100 Nowy Dwor Mazowiecki Poland

Manufacturers

Reckitt Benckiser Healthcare International Ltd.
Nottingham site Thane Road Nottingham NG90 2DB United Kingdom
SIA Elvim
Kurzemes prospekts 3-513
Riga, LV-1067
Latvia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Katrinko OÜ Kärberi 34-30 13919 Tallinn.
Telephone: 5151555

This leaflet was last revised in April 2018