Nurofen express forte

Package leaflet: Information for the user

Nurofen Express Forte, 400 mg, soft capsules
Ibuprofenum
For use in adults and adolescents with body weight above 40 kg (aged 12 years and older)
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms do not improve or if you feel worse, consult your doctor:
• after 3 days in adolescents,
• after 3 days when treating fever or 4 days when treating pain in adults.

Leaflet contents:

1. What Nurofen Express Forte is and what it is used for
2. Important information before taking Nurofen Express Forte
3. How to take Nurofen Express Forte
4. Possible side effects
5. How to store Nurofen Express Forte
6. Contents of the pack and other information

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

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
These medicines work by altering the body's response to pain and high temperature.
Nurofen Express Forte is intended for use in adults and adolescents with body weight above 40 kg (aged 12 years and older), for short-term symptomatic treatment of:

• mild to moderate pain, e.g. headache, menstrual pain, toothache
• fever and pain associated with colds

If after 3 days in children and adolescents, or 3 days for fever and 4 days for pain in adults, there is no improvement in symptoms or if the patient feels worse, medical advice should be sought.

2. Important information before taking Nurofen Express Forte

When not to use Nurofen Express Forte:

• in case of hypersensitivity to ibuprofen, cochineal red (E124), or any of the excipients of the medicine (listed in section 6),
• if the patient has experienced asthma, difficulty breathing, rhinitis, angioedema, or urticaria during previous treatment with acetylsalicylic acid or other similar pain-relieving drugs (NSAIDs),
• if the patient has (or has had two or more distinct episodes of) gastric or duodenal ulcer (peptic ulcer) or gastrointestinal bleeding,
• if the patient has experienced gastrointestinal bleeding or perforation during previous treatment with NSAIDs (non-steroidal anti-inflammatory drugs),
• if the patient has unexplained disorders of the blood-forming system,
• if the patient has severe liver, kidney, or heart failure,
• if the patient is in the last three months of pregnancy (see section Pregnancy and breastfeeding),
• if the patient is severely dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake),
• if the patient has a haemorrhagic stroke or any other active bleeding.

Do not administer the medicine to children under 12 years of age or to adolescents weighing less than 40 kg.
Warnings and precautions:
Before starting treatment with Nurofen Express Forte, discuss it with your doctor,
pharmacist, or nurse.

• if the patient has an infection – see below "Infections"

• if the patient has systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases causing joint pain, skin changes, and fever),

• if the patient has experienced serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis. Treatment with Nurofen Express Forte must be discontinued immediately at the first signs of skin rash, mucosal lesions, or any other symptoms of allergic reaction,

• if the patient has certain inherited blood disorders (e.g. acute intermittent porphyria) or coagulation disorders,

• if the patient has or has had inflammatory bowel disease (ulcerative colitis or Crohn's disease),

• in case of impaired kidney function,

• in case of impaired liver function,

• if the patient has recently undergone surgery,

• if the patient suffers or has suffered from asthma or allergic disease, as difficulty in breathing may occur,

• if the patient has hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there is an increased risk of allergic reaction. The allergic
  reaction may present as an asthma attack (so-called analgesic-induced asthma), acute angioedema (Quincke's oedema), or skin rash,

• if the patient is 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 agents such as acetylsalicylic acid.

Other warnings

• Prolonged use of painkillers for headache treatment may worsen the condition. If this occurs or is suspected, treatment with Nurofen Express Forte should be discontinued and medical advice sought.
• Nurofen Express Forte should be avoided during chickenpox.
• During long-term treatment with Nurofen Express Forte, regular monitoring of liver and kidney function and blood morphology is recommended.
• Concomitant use of Nurofen Express Forte with other NSAIDs, including selective cyclooxygenase-2 inhibitors, may increase the risk of adverse effects; therefore, such combination should be avoided (see section below "Use with other medicines").
• Habitual use (more than one) of painkillers may lead to serious kidney dysfunction and should be avoided. This risk is greater in cases of salt loss and dehydration.
• In dehydrated adolescents, there is a risk of impaired kidney function.

Infections
Nurofen Express Forte may mask symptoms of infection such as fever and pain. Therefore,
Nurofen Express Forte may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If the patient is taking this medicine during an existing infection and symptoms persist or worsen, immediate medical consultation is required.
Skin reactions
Serious skin reactions have occurred with the use of ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP). If the patient experiences any of the symptoms associated with these serious skin reactions described in section 4, Nurofen Express Forte must be discontinued immediately and medical help should be sought.
The use of anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Nurofen Express Forte, the patient should discuss treatment with a doctor or
pharmacist if:

• the patient has heart conditions such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischaemic attack - TIA).
• the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Allergic-type reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), or chest pain, have been reported. If any of these symptoms occur, Nurofen Express Forte should be discontinued immediately and the patient should contact a doctor or emergency medical services without delay.
The risk of adverse effects can be minimised by using the lowest effective dose for the shortest possible duration. In elderly patients, the risk of adverse effects is higher.
If the patient has any of the above-mentioned disorders or conditions, medical advice should be sought before starting treatment with Nurofen Express Forte.
Nurofen Express Forte and other medicines
Always consult a doctor or pharmacist before taking Nurofen Express Forte with other medicines. Nurofen Express Forte may affect the action of other medicines, or other medicines may affect the action of Nurofen Express Forte. For example:

• anticoagulant medicines (i.e. blood thinners/preventing blood clots, such as acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan)

Also, some other medicines may be affected by or may influence treatment with Nurofen Express Forte. Therefore, always consult a doctor or pharmacist before taking Nurofen Express Forte with other medicines.
In particular, inform the doctor if the patient is taking any of the following medicines:

Nurofen Express Forte and alcohol
Alcohol should not be consumed while taking Nurofen Express Forte. The risk of certain adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be increased when alcohol is consumed simultaneously with Nurofen Express Forte.

Pregnancy, breastfeeding and fertility

If a patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Inform your doctor if you suspect you are pregnant while using Nurofen Express Forte.

Do not use this medicine during the last three months of pregnancy. Use during this period may cause kidney and heart problems in the unborn child. It may also affect bleeding tendency in both the mother and the child, and may delay or prolong labour. Avoid using this medicine during the first six months of pregnancy unless otherwise advised by a doctor. Taking ibuprofen for longer than a few days beyond the 20th week of pregnancy may cause kidney dysfunction in the unborn child, leading to reduced amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment beyond a few days is necessary, the doctor may recommend additional monitoring tests.

Breastfeeding
Ibuprofen and its metabolites may pass into breast milk in small amounts. The medicine may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration.

Fertility
Nurofen Express Forte belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect reverses upon discontinuation of the medicine.

Driving and operating machinery
When used for short periods at therapeutic doses, Nurofen Express Forte has no or negligible influence on the ability to drive or operate machinery.

However, if the patient experiences dizziness, drowsiness, balance disturbances, or visual disturbances while taking Nurofen Express Forte, driving and operating machinery should be avoided. These effects may be intensified by concomitant alcohol consumption.

Nurofen Express Forte contains 36.6 mg of sorbitol in each capsule. Patients with known sensitivities to certain sugars should consult their doctor before starting treatment with this medicine.

Nurofen Express Forte contains the colouring agent cochineal red (E124), which may cause allergic reactions.

3. How to take Nurofen Express Forte

Always use this medicine exactly as described in this leaflet. If in doubt, consult your doctor or pharmacist. Unless otherwise advised by a doctor, the usual dose is:

Dosage:
Adults and adolescents with body weight above 40 kg (aged 12 years and above):
Initial dose: 1 capsule (400 mg ibuprofen), taken with water. If needed, take 1 capsule (400 mg ibuprofen) every 6 hours. Do not take more than 3 capsules (1200 mg ibuprofen) within 24 hours.
This medicine should not be given to adolescents with body weight below 40 kg or under 12 years of age.

Method of administration
For oral use. Do not chew the capsules.
Patients with sensitive stomachs should take Nurofen Express Forte during meals. Taking the medicine immediately after food may delay the onset of action. In such a case, do not take a higher dose of Nurofen Express Forte or take it more frequently than recommended.

Duration of treatment
This product is intended for short-term use only. Use the lowest effective dose for the shortest duration necessary to relieve symptoms. In case of infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adolescents
In adolescents, consult a doctor if Nurofen Express Forte is required for more than 3 days or if symptoms worsen.

Adults
If there is no improvement after 3 days of treatment for fever or after 4 days of treatment for pain, or if the patient feels worse, consult a doctor.
If the patient feels that the effect of the medicine is stronger or weaker than expected, speak to a doctor or pharmacist.

Overdose of Nurofen Express Forte
If the patient has taken more than the recommended dose of Nurofen Express Forte, or if a child has accidentally taken the medicine, always contact a doctor or go to the nearest hospital for advice on possible health risks and what actions should be taken.
Symptoms of overdose may include nausea, vomiting (blood may be present), blood in stool (gastrointestinal bleeding), headache, tinnitus, stomach pain, diarrhoea, disorientation and nystagmus. After ingestion of a large dose, drowsiness, dizziness, confusion, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing difficulties may occur.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Nurofen Express Forte may cause adverse effects, although not everyone will experience them.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms. The patient may experience known adverse effects typical of NSAIDs. If in doubt, treatment should be discontinued and a doctor should be consulted as soon as possible. Elderly patients taking this medicine are at increased risk of adverse effects.

STOP TAKING THE MEDICINE and contact a doctor immediately if any of the following symptoms occur:

• Symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds.
• Symptoms 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, rapid heartbeat, or a drop in blood pressure leading to shock. Such a reaction may occur even after the first dose of the medicine.
• Red, flat, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genital organs, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) [Very rare – frequency: may occur in 1 out of 10,000 people].
• Widespread rash, high fever, swollen lymph nodes, and increased eosinophils (a type of white blood cells) (DRESS syndrome) [Frequency unknown – cannot be estimated from available data].
• Red, peeling widespread rash with nodules under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) [Frequency unknown – cannot be estimated from available data].

Other possible adverse effects
If any of the adverse effects listed below worsen or if any adverse effects not listed in this leaflet occur, inform your doctor.

Common (may occur in 1 out of 10 people)

• Gastrointestinal disturbances, e.g. heartburn, abdominal pain, nausea, indigestion, vomiting, bloating, diarrhoea, constipation, minor bleeding from the stomach and/or duodenum, which may exceptionally lead to anaemia.

Uncommon (may occur in 1 out of 100 people)

• Gastric or intestinal ulcers, sometimes with accompanying bleeding and perforation, inflammation of the oral mucosa with ulceration (oral ulcerative stomatitis), inflammation of the gastric mucosa (gastritis), exacerbation of colitis and Crohn's disease.
• Central nervous system disturbances such as headache, dizziness, insomnia, restlessness, irritability, or fatigue.
• Visual disturbances.
• Allergic reactions such as rash, itching of the skin, and asthma attacks. In such cases, treatment with Nurofen Express Forte must be discontinued immediately and a doctor should be contacted without delay.

Rare (may occur in 1 out of 1,000 people)

• Tinnitus (ringing in the ears).
• Kidney damage (papillary necrosis) and increased blood uric acid levels.

Very rare (may occur in 1 out of 10,000 people)

• During NSAID use, cases of oedema, hypertension, and heart failure have been reported.
• Oesophagitis or pancreatitis, development of diaphragm-like intestinal strictures.
• During chickenpox, severe skin and soft tissue infections have been observed.
• Decreased urine output and oedema (especially in patients with high blood pressure or impaired kidney function); oedema and cloudy urine (nephrotic syndrome); kidney inflammation (interstitial nephritis) potentially leading to acute kidney failure. If any of these symptoms or general malaise occur, treatment with Nurofen Express Forte should be stopped immediately and a doctor contacted without delay, as these may be early signs of kidney damage or kidney failure.
• Blood cell production disorders: initial symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe weakness, nosebleeds, and skin bleeding. In such cases, treatment must be stopped immediately and a doctor contacted. These symptoms must not be treated with painkillers or antipyretics.
• Psychotic reactions and depression.
• Exacerbation of infection-related inflammatory conditions (e.g. necrotizing fasciitis) has been reported with some painkillers (NSAIDs). If signs of infection appear or worsen during treatment with Nurofen Express Forte, immediate medical consultation is required to determine whether antimicrobial/antibiotic treatment is necessary.
• High blood pressure, palpitations, heart failure, heart attack.
• Liver function disorders, liver damage (especially during long-term treatment), liver failure, acute hepatitis.
• During ibuprofen use, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, and disturbances of consciousness have been observed. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are at higher risk of such disorders. If these symptoms occur, contact a doctor immediately.
• Hair loss (alopecia).
• Severe, generalized hypersensitivity reactions.
• Worsening of asthma or bronchospasm.
• Vasculitis.

Frequency unknown

• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.
• Photosensitivity reactions.

The medicine contains cochineal red (E124), which may cause allergic reactions.
If any adverse effect worsens or if any adverse effects not listed in this leaflet occur, stop taking the medicine immediately and inform your doctor or pharmacist.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nurofen Express Forte

Keep this medicine out of sight and reach of children. Do not use Nurofen Express Forte after the expiry date stated on the cardboard box and blister pack. The expiry date refers to the last day of the specified month. Do not store above 25°C. Store in the original packaging to protect from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Nurofen Express Forte contains
Each capsule contains 400 mg of ibuprofen. The other ingredients are:
Macrogol 600
Potassium hydroxide
Purified water

Capsule shell composition:
Gelatin
Liquid sorbitol, partially dehydrated
Purified water
Carmoisine (E 124)

Printing ink:
Opacode WB White NS-78-18011
Composed of: Titanium dioxide (E 171)
Propylene glycol
Hypromellose 3 cP

Processing aids:
Medium-chain triglycerides
Lecithin

What Nurofen Express Forte looks like and contents of the pack
Red, oval, transparent soft capsules with a white Nurofen logo. Each capsule is approximately 10.3 mm wide and approximately 16.9 mm long.
Available in packs containing 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 40 or 50 soft capsules.
PVC/PVDC/Aluminium blister pack in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer

Marketing Authorisation Holder
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Customer service hotline: (22) 211 26 92

Importer
RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
The Netherlands

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Austria Nurofen Rapid 400 mg Weichkapseln
Bulgaria Nurofen Express Forte
Cyprus Nurofen Express 400mg Capsule, soft
France NurofenCaps 400mg, capsule molle
Germany Nurofen Intensive 400 mg Weichkapseln
Hungary Nurofen Rapid Forte 400 mg lágy kapszula
Italy Nurofencaps 400 mg capsule molli
Netherlands Nurofen Fastine Liquid Capsules 400 mg, capsule, zacht
Poland Nurofen Express Forte
Portugal Nurofen Zavance 400 mg cápsulas moles
Romania Nurofen Express Forte 400 mg capsules moi
United Kingdom Nurofen 400mg Capsules, soft