Nurofen express forte mini

Package leaflet: Information for the user

Nurofen Express Forte Mini, 400 mg, soft capsules
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
You should always take this medicine exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult 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.
• Adolescents aged 12 years and older and adults: If there is no improvement after 3 days or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What Nurofen Express Forte Mini 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 fever.
Nurofen Express Forte Mini is intended for use in adults and adolescents with a body weight of at least 40 kg (aged 12 years and older).
Nurofen Express Forte Mini is used for the short-term symptomatic treatment of mild to moderate pain, such as headache, toothache, menstrual pain, fever and pain associated with colds.
In adolescents aged 12 years and older and adults: If there is no improvement after 3 days or if you feel worse, consult your doctor.

2. Information before using Nurofen Express Forte Mini

Do not use Nurofen Express Forte Mini together with other Nurofen products or medicines containing
ibuprofen.
When not to use Nurofen Express Forte Mini

• if the patient is allergic to ibuprofen, cochineal red A (E 124), peanuts or soya, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has ever experienced breathlessness, asthma, rhinitis, facial and (or) hand swelling, or urticaria after taking ibuprofen, acetylsalicylic acid, or other similar painkillers (NSAIDs)
• if the patient currently has (or has had two or more separate episodes in the past) peptic ulceration or bleeding in the stomach or duodenum
• if the patient has previously experienced gastrointestinal bleeding or perforation during prior treatment with NSAIDs (non-steroidal anti-inflammatory drugs)
• if the patient has severe liver, kidney, or heart failure
• if the patient has unexplained disorders of the blood system
• if the patient is in the last three months of pregnancy (see section "Pregnancy, breastfeeding and fertility")
• if the patient has severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake)
• if the patient has bleeding in the brain (cerebral haemorrhage) or any other active bleeding.

Warnings and precautions:
Before starting to take Nurofen Express Forte Mini, consult a doctor or
pharmacist:

• if the patient has an infection - see section "Infections" below
• if the patient has certain skin diseases (systemic lupus erythematosus, SLE) or mixed connective tissue disease (an immune system disorder causing joint pain, skin rash, and fever)
• if the patient has certain inherited blood disorders (e.g. acute intermittent porphyria) or problems with blood clotting
• if the patient currently has or has previously had bowel disease (ulcerative colitis or Crohn's disease)
• if the patient has impaired kidney function
• if the patient has impaired liver function. During prolonged use of this medicine, regular monitoring of liver and kidney function tests and blood counts is necessary
• if the patient has recently undergone major surgery
• if the patient is trying to become pregnant
• if the patient has asthma or allergic conditions, as breathlessness may occur
• if the patient has hay fever, nasal polyps, or chronic obstructive pulmonary disease, the risk of allergic reactions is increased. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), sudden swelling (Quincke's oedema), or skin rash (urticaria)
• if the patient is taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (medicines used for depression), or antiplatelet agents (e.g. acetylsalicylic acid)
• if the patient is taking other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, as they may increase the risk of adverse effects and should therefore be avoided (see section "Other medicines" below)
• if the patient has chickenpox, use of this medicine is not recommended.

Adverse effects are minimized by using the lowest effective dose for the
shortest possible duration.
Prolonged use of any painkiller to relieve headache may worsen it. If this occurs or is suspected, treatment with this medicine should be stopped and medical advice sought. Medication-overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of painkillers.
In general, habitual use (of several types) of painkillers may lead to permanent, serious kidney problems and should therefore be avoided. This risk may be further increased by salt loss and dehydration associated with physical exertion.
There is a risk of impaired kidney function in dehydrated adolescents.
Anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using this medicine, discuss treatment with a doctor or pharmacist:

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

Infections
This medicine may mask signs of infection such as fever and pain. Therefore, this medicine 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 takes this medicine during an existing infection and symptoms of infection persist or worsen, immediate medical advice should be sought.
Severe skin reactions
Severe 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 generalized exanthematous pustulosis (AGEP). If the patient experiences any of the symptoms related to these severe skin reactions described in section 4, Nurofen Express Forte Mini should be stopped immediately and medical help sought.
Allergic reactions to ibuprofen have included symptoms such as difficulty breathing, swelling of the face and neck (angioedema), and chest pain. If any of these symptoms occur, Nurofen Express Forte Mini should be stopped immediately and urgent medical attention sought.
Elderly patients
Elderly patients are more likely to experience adverse effects.
Nurofen Express Forte Mini and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. In particular, if you are taking any of the following medicines:

This medicine may affect the action of certain other medicines or be affected by other medicines, such as:

• anticoagulants, which thin the blood and prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine,
• medicines used to treat high blood pressure (ACE inhibitors, e.g. captopril, beta-blockers, e.g. atenolol, angiotensin II receptor antagonists, e.g. losartan).

Some other medicines may also interact with this medicine or be affected by it. Therefore, always consult a doctor or pharmacist before using this medicine together with other medicines.

Use of Nurofen Express Forte Mini with alcohol
Alcohol should not be consumed while taking this medicine. Certain adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when alcohol is consumed simultaneously with this medicine.

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

Pregnancy
Inform the doctor if pregnancy occurs while taking Nurofen Express Forte Mini. This medicine should not be used during the last three months of pregnancy. Use of this medicine may cause kidney and heart problems in the unborn child. The medicine may also affect bleeding tendency in both the mother and child and may delay or prolong labour. This medicine should not be taken during the first six months of pregnancy unless otherwise advised by a doctor. Use of this medicine for longer than a few days beyond the 20th week of pregnancy may cause kidney problems in the unborn child and lead to reduced levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.

If prolonged treatment beyond a few days is necessary, the doctor may recommend additional monitoring tests.

Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. This medicine may be used during breastfeeding, provided it is taken at the recommended dose and for the shortest possible duration.

Fertility
This medicine belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible upon discontinuation of the medicine.

Driving and operating machinery
When used short-term at the recommended doses, this medicine has no effect or only a negligible effect on the ability to drive or operate machinery.
However, if adverse effects such as fatigue, dizziness, drowsiness or visual disturbances occur while taking this medicine, driving and operating machinery should be avoided. These effects may be intensified when the medicine is taken together with alcohol.

Nurofen Express Forte Mini contains sorbitol
This medicine contains 72.59 mg of sorbitol in each capsule.
Sorbitol is a source of fructose. If the patient (or child) has a doctor-confirmed intolerance to certain sugars or has been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the body cannot break down fructose, speak with a doctor before the patient (or child) uses or receives this medicine.

Nurofen Express Forte Mini contains carmine (E 124)
This medicine may cause allergic reactions.

Nurofen Express Forte Mini contains soya lecithin.
If the patient is allergic to peanuts or soya, this medicine should not be used.

3. How to use Nurofen Express Forte Mini

This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage
Adults and adolescents with body weight over 40 kg (aged 12 years and older):
Initial dose: Take 1 capsule (400 mg ibuprofen) with water. If needed, an additional capsule (400 mg ibuprofen) may be taken, but the total dose should not exceed 3 capsules
(1200 mg ibuprofen) within a 24-hour period. The interval between doses should not be less than 6 hours.
Do not administer this medicine to adolescents with body weight below 40 kg or to children under 12 years of age.
Method of administration
For oral use. Swallow the capsules whole with water. Do not chew.
Patients with sensitive stomachs are advised to take this medicine with food. If taken shortly after a meal, onset of action may be delayed. In such cases, do not take a higher dose than recommended or before the appropriate interval between doses has passed.
Duration of treatment
This medicine is intended for short-term use only. Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If an infection is suspected, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Adolescents: consult a doctor if treatment is required for more than 3 days or if symptoms worsen.
Taking more Nurofen Express Forte Mini than recommended
If you take more than the recommended dose or if the medicine is accidentally ingested by a child, contact your doctor or the nearest hospital immediately for advice on potential risks and necessary actions. Symptoms of overdose may include: nausea, abdominal pain, vomiting (possibly with blood), blood in stool (gastrointestinal bleeding), headache, tinnitus (ringing in the ears), diarrhoea, confusion, and nystagmus (involuntary eye movement). After large doses, reported symptoms include weakness, dizziness, blurred vision, low blood pressure, restlessness, disorientation, coma, hyperkalaemia (elevated potassium levels in blood), prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, worsening of asthma in asthmatics, drowsiness, loss of consciousness, feeling cold, chest pain, palpitations, convulsions (mainly in children), blood in urine, low potassium levels in blood, and breathing difficulties.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects can be minimised by taking the lowest possible dose for the shortest time necessary to relieve symptoms.
The patient may experience known adverse effects typical of NSAIDs (see below). If in doubt, discontinue use and consult a doctor as soon as possible.
Patients of advanced age using this medicine have an increased risk of disorders associated with adverse effects.

DISCONTINUE taking this medicine and contact a doctor immediately if any of the following 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 severe allergic reaction, such as worsening asthma symptoms, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, 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 rashes on the trunk, often with blisters in the centre, peeling skin, and mucosal ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) [very rare – may occur in 1 in 10,000 people].
• Widespread rash, high fever, swollen lymph nodes and increased eosinophil count (a type of white blood cell) (DRESS syndrome) [frequency unknown – cannot be estimated based on available data].
• Red, scaly, widespread rash with papules 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 generalised exanthematous pustulosis) [frequency unknown – cannot be estimated based on available data].

Inform the doctor if any of the following adverse effects occur, worsen, or if the patient experiences any unlisted symptoms.

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

• Gastrointestinal discomfort such as heartburn, abdominal pain, nausea, indigestion, diarrhoea, vomiting, gas (bloating), diarrhoea and constipation, and minor bleeding from the stomach and/or intestines, which in exceptional cases may lead to anaemia.

Uncommon (may affect up to 1 in 100 people):

• Gastric and intestinal ulcers, sometimes with bleeding and perforation, inflammation of the oral mucosa with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis, inflammation of the gastric mucosa), exacerbation of colitis and Crohn's disease;
• Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability or fatigue;
• Visual disturbances;
• Allergic reactions such as skin rash, itching and asthma attacks. Discontinue use of this medicine immediately and inform the doctor;
• Various skin rashes.

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

• Ringing in the ears (tinnitus);
• Increased blood urea levels, flank or abdominal pain, blood in urine and fever may be symptoms of kidney damage (renal papillary necrosis);
• Increased blood uric acid levels;
• Hearing impairment;
• Decreased haemoglobin concentration.

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

• Inflammation of the oesophagus or pancreas, and development of diaphragm-like strictures in the small and large intestine;
• During chickenpox infection, severe skin infections and soft tissue complications have occurred;
• High blood pressure, palpitations, heart failure, myocardial infarction, vasculitis and oedema;
• Reduced urine output compared to usual, and oedema (especially in patients with high blood pressure or impaired kidney function), oedema and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of these symptoms occur, or if the patient feels unwell, discontinue use of this medicine and consult a doctor immediately, as these may be early signs of kidney damage or kidney failure;
• Liver function disorders, liver damage (early signs may include skin discolouration), particularly during long-term treatment, liver failure, acute hepatitis;
• Blood cell production disorders. Initial symptoms include: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained bruising. In such cases, discontinue treatment immediately and contact a doctor. Do not self-medicate with painkillers or antipyretics;
• Psychotic reactions and depression;
• Exacerbation of infection-related inflammatory conditions (e.g. necrotising fasciitis) has been reported with the use of certain painkillers (NSAIDs). If signs of infection occur or worsen during treatment with this medicine, seek immediate medical evaluation to determine whether anti-infective or antibiotic treatment is required;
• During ibuprofen use, symptoms of aseptic meningitis have been observed, including neck stiffness, headache, malaise, nausea, vomiting, fever and disturbances in consciousness. Patients with autoimmune disorders (lupus, mixed connective tissue disease) have a higher risk of such symptoms. If these symptoms occur, contact a doctor immediately;
• Hair loss (alopecia);
• Severe hypersensitivity reactions;
• Worsening of asthma and bronchospasm.

Frequency not known (frequency cannot be estimated from available data):

• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome;
• Respiratory tract reactivity including asthma, bronchospasm or shortness of breath;
• Skin becomes sensitive to light.

This medicine contains cochineal red (E 124), which may cause allergic reactions.
Use of medicines such as this one may be associated with a small increased risk of myocardial infarction or stroke.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform a doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Nurofen Express Forte Mini

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister after:
"EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Nurofen Express Forte Mini contains
The active substance is ibuprofen.

• Each soft capsule contains 400 mg of ibuprofen

Other ingredients are:
Capsule contents:

• Macrogol 600
• Potassium hydroxide (purity at least 85%) (E 525)
• Purified water

Soft capsule shell:

• Sorbitol liquid, partially dehydrated
• Gelatine (E 441)
• Carmoisine (E 124)

Printing ink:

• Opacode WB white NSP-78-180002 with the following composition: titanium dioxide (E 171), propylene glycol (E 1520), SDA 35A alcohol (ethanol and ethyl acetate), isopropyl alcohol, poly(vinyl alcohol) phthalate, purified water, macrogol/PEG MW400 (E 1521) and ammonium hydroxide 28% (E 527)

Auxiliary substances used in the manufacturing process:

• Soya lecithin (E 322)

What Nurofen Express Forte Mini looks like and contents of the pack
The soft capsules are red and oval-shaped, with a white imprint "NURO400". Each capsule is approximately 10.0 mm wide and approximately 15.5 mm long. The capsules are available in packs of 10, 20, 24, 30 or 40 capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Manufacturer/Importer:
RB NL Brands B.V.
Schiphol Boulevard 207
1118 BH Schiphol
The Netherlands

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
email: [email protected]

This medicine is authorised for sale in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names: