Nurofen express caps

Package leaflet: Information for the user

Nurofen Express Caps, 200 mg, soft capsules
Ibuprofenum
Medicinal product for use in adults, adolescents and children with body weight from 20 kg (approximately 6 years of age)
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• 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.
• Contact your doctor if your condition does not improve or if you feel worse:
• after 3 days in children and adolescents;
• after 3 days when treating fever or 4 days when treating pain in adults.

Table of contents of the leaflet:

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

1. What Nurofen Express Caps is and what it is used for
Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
These medicines are used to modify the body's response to pain, swelling and high temperature.
Nurofen Express Caps rapidly disintegrates in the body and the active ingredient, released from the capsule, is easily absorbed and quickly reaches the site of pain.
Nurofen Express Caps is indicated for short-term symptomatic treatment of:

• mild or moderate pain such as headache, toothache, painful menstruation,
• pain and fever associated with colds.

Medicinal product for use in adults, adolescents and children with body weight from 20 kg (approximately 6 years of age).
If there is no improvement after 3 days in children and adolescents, 3 days in case of fever and 4 days in case of pain in adults, or if the patient feels worse, consult a doctor.

2. Important information before taking Nurofen Express Caps

When not to take Nurofen Express Caps:

• if the patient is allergic to ibuprofen, cochineal red (E 124), or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has ever experienced breathlessness, asthma, nasal congestion, facial and/or hand swelling or urticaria after taking ibuprofen, acetylsalicylic acid or other similar painkillers (NSAIDs)
• if the patient has gastric ulcer or gastrointestinal bleeding (or has had two or more episodes)
• if the patient has previously experienced gastrointestinal bleeding or perforation related to earlier treatment with NSAIDs
• if the patient has severe liver disease, kidney disease, coronary heart disease or heart failure
• do not administer to children with body weight below 20 kg
• if the patient has cerebral haemorrhage or any other active bleeding
• if the patient has blood clotting disorders
• if the patient has severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
• during the last three months of pregnancy (see below)

Warnings and precautions

• Before starting treatment with Nurofen Express Caps, discuss it with your doctor, pharmacist or nurse. If the patient has an infection – see below “Infections”
• If the patient has certain skin diseases (systemic lupus erythematosus) or mixed connective tissue disease
• If hereditary blood disorders (e.g. acute intermittent porphyria) have been diagnosed
• When there is or has been a disease of the large intestine (ulcerative colitis or Crohn's disease)
• If kidney function disorders have been diagnosed
• If liver function disorders have been diagnosed
• If the patient is trying to become pregnant
• Medical supervision is especially required immediately after major surgical procedures
• If the patient has or has had asthma or allergic disease, as breathlessness may occur
• If the patient has hay fever, nasal polyps or chronic obstructive respiratory disorders, as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema or urticaria
• In case of chickenpox, use of Nurofen Express Caps is not recommended
• If blood clotting disorders are present
• With prolonged use of Nurofen Express Caps, regular monitoring of liver and kidney function parameters and blood morphology is required
• Avoid concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to increased risk of adverse effects (see section "Nurofen Express Caps and other medicines" below)
• Taking the medicine at the lowest effective dose for the shortest necessary duration to relieve symptoms reduces the risk of adverse effects
• Elderly patients are more susceptible to adverse effects
• Chronic use of (various) painkillers may lead to kidney damage with risk of kidney failure. This risk may be increased during physical exertion associated with loss of salts and dehydration. Therefore, this should be avoided
• Headaches may occur as a result of prolonged use of any type of painkiller, which should not be treated with increased doses of this medicine. In such cases, the medicine should be discontinued and medical advice sought. Medication-overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of headache-relieving medicines
• There is a risk of impaired kidney function in dehydrated children and adolescents.

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 Caps, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in 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 is a smoker.

Allergic-type reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during treatment. If the patient experiences any of these symptoms, treatment with Nurofen Express Caps should be stopped immediately and medical help sought from a doctor or emergency services.

Infections
Nurofen Express Caps may mask symptoms of infection such as fever and pain. Therefore, Nurofen Express Caps 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 persist or worsen, immediate consultation with a doctor is required.

Skin reactions
Severe skin reactions have occurred with the use of ibuprofen, such as 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 severe skin reactions described in section 4, Nurofen Express Caps should be discontinued immediately and medical assistance sought.

Before using Nurofen Express Caps, consult a doctor, even if the above warnings refer to conditions that occurred in the past.

Nurofen Express Caps and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken or might take.
In particular, inform if you are taking:

Nurofen Express Caps may affect the action of other medicines or other medicines may affect the action of Nurofen Express Caps. For example:

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

Also, some other medicines may be affected by or have an influence on treatment with Nurofen Express Caps. Therefore, always consult a doctor or pharmacist before using Nurofen Express Caps with other medicines.
Nurofen Express Caps with food and alcohol
Swallow the capsules with water. In patients with gastrointestinal disorders, it is recommended to take Nurofen Express Caps during meals. If taken shortly after a meal, onset of action of Nurofen Express Caps may be delayed. In such a case, do not take more Nurofen Express Caps than recommended in section "How to use Nurofen Express Caps" or before the appropriate interval between doses has elapsed.
The occurrence of some adverse effects, such as those affecting the gastrointestinal system, is more likely when alcohol is consumed simultaneously with Nurofen Express Caps.
Pregnancy, breastfeeding and effect on 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
Do not use this medicine during the last 3 months of pregnancy. Use may cause disturbances in kidney and heart function in the unborn child. It may also affect bleeding tendency in the patient and her child and may delay or prolong labour. Avoid using this medicine during the first 6 months of pregnancy unless otherwise advised by a doctor. Taking Nurofen Express Caps for longer than a few days beyond week 20 of pregnancy may cause disturbances in kidney function in the unborn child and lead to reduced levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If longer-term treatment is necessary, the doctor may recommend additional monitoring tests.
Breastfeeding
The medicine passes into breast milk, but may be used during breastfeeding if administered at the recommended doses and for the shortest possible duration.
Fertility
The medicine belongs to the group of NSAIDs which may adversely affect fertility in women. This effect is transient and reverses upon discontinuation of treatment.
Driving and using machines
The medicine has no effect or has a negligible effect on the ability to drive motor vehicles and operate machinery when used short-term and as directed. If adverse effects such as fatigue or dizziness occur, do not drive or operate machinery.
Consumption of alcohol increases the risk of occurrence of these adverse effects.
Nurofen Express Caps contains 22.26 mg of sorbitol in each capsule. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Nurofen Express Caps contains carmine red 4R (E124). The medicine may cause allergic reactions.
3. How to use Nurofen Express Caps
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Recommended dose:
Adults and adolescents with body weight of approximately 40 kg:
Initial dose: take 1 or 2 capsules (200 mg or 400 mg of ibuprofen) with water. Then, if needed, take an additional 1 or 2 capsules (200 mg to 400 mg of ibuprofen), but do not exceed a total of 6 capsules within 24 hours. After a 200 mg dose, the next dose should not be taken earlier than 4 hours later; after a 400 mg dose, the next dose should not be taken earlier than 6 hours later.
Children with body weight from 20 kg (approximately 6 years) to 39 kg:
Nurofen Express Caps should only be used in children with a body weight of at least 20 kg. The maximum daily dose of ibuprofen is 20–30 mg per kg body weight, divided into 3 to 4 single doses. The interval between consecutive doses should not be less than 6 hours. Do not exceed the maximum recommended daily dose. Do not exceed a total dose of 30 mg ibuprofen/kg body weight within 24 hours. When using Nurofen Express Caps in children, the following dosing is usually applied:
Body weight Dose How often?
Children 20 kg – 29 kg 1 capsule If needed, take the next
(200 mg ibuprofen) capsule after at least 8 hours.
Do not take more than 3
capsules within 24 hours (up
to 600 mg ibuprofen)
Children 30 kg – 39 kg 1 capsule If needed, take the next
(200 mg ibuprofen) capsule after at least 6 to 8
hours.
Do not take more than 4
capsules within 24 hours (up
to 800 mg ibuprofen)
Method of administration
For short-term oral use. Do not chew.
Children and adolescents
In children and adolescents, consult a doctor if treatment is required for more than 3 days or if symptoms worsen. Another formulation(s) of this medicine may be more suitable for children; therefore, consult a doctor or pharmacist.
Adults
If symptoms worsen or do not improve after 3 days of treatment for fever or after 4 days of treatment for pain, consult a doctor.
Use of more than the recommended dose of Nurofen Express Caps
If the patient has taken more than the recommended dose of Nurofen Express Caps or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to obtain advice on possible health risks and what actions should be taken.
Symptoms of overdose may include nausea, stomach pain, vomiting (blood may be present), gastrointestinal bleeding, headache, tinnitus, confusion and nystagmus, or less frequently diarrhoea. Additionally, after ingestion of a large dose, disturbances in balance, visual disturbances, low blood pressure, agitation, confusion, coma, hyperkalaemia, metabolic acidosis, prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, and exacerbation of asthma in asthmatic patients, drowsiness, 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 any medicine, Nurofen Express Caps may cause adverse effects, although they do not occur in everyone.
Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects. Although adverse effects are not common, one of the known adverse effects associated with NSAIDs (see below) may occur. In such a case or if in doubt, treatment should be discontinued and medical advice sought as soon as possible. Elderly individuals using this product are at higher risk of experiencing adverse effects.

STOP taking the 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 serious allergic reaction, such as worsening asthma symptoms, 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, 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 (skin exfoliation, 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 eosinophils (a type of white blood cell) (DRESS syndrome) [Frequency unknown – cannot be estimated from available data]. A red, peeling, widespread rash with subcutaneous nodules and blisters, mainly located in skin folds, on the 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].

Inform your doctor if any other possible adverse effects occur

Common: (may occur in 1 in 10 people)

• Gastrointestinal discomfort such as heartburn, abdominal pain, nausea, indigestion, diarrhoea, vomiting, bloating (gas), constipation, minor gastrointestinal bleeding which in rare cases may lead to anaemia.

Uncommon: (may occur in 1 in 100 people)

• Gastrointestinal ulcers, perforation or bleeding, inflammation of the oral mucosa with ulceration, exacerbation of existing bowel disease (ulcerative colitis or Crohn’s disease), gastric mucosal inflammation.
• Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability or fatigue.
• Visual disturbances.
• Various skin rashes.
• Hypersensitivity reactions with urticaria and itching.

Rare: (may occur in 1 in 1,000 people)

• Tinnitus (ringing in the ears).
• Increased blood urea levels, lower back pain and/or abdominal pain, blood in urine, and fever may indicate kidney damage (papillary necrosis).
• Decreased haemoglobin concentration.

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

• Oesophagitis, pancreatitis, development of diaphragm-like intestinal strictures.
• Heart failure, myocardial infarction, and facial or hand swelling.
• Reduced urine output compared to normal 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 the above symptoms occur or if the patient feels generally unwell, treatment with Nurofen Express Caps should be stopped immediately and medical advice sought urgently, as these may be early signs of kidney damage or kidney failure.
• Psychotic reactions and depression.
• High blood pressure, vasculitis.
• Palpitations.
• Liver function disorders, liver damage (early signs may include skin discoloration), particularly during long-term treatment, liver failure, acute hepatitis.
• Blood cell production disorders – early symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained bruising. In such cases, treatment should be stopped immediately and medical advice sought. The patient should not self-medicate with painkillers or antipyretics.
• Severe skin infections and soft tissue complications during chickenpox infection.
• Worsening of inflammatory conditions associated with infection (e.g. necrotizing fasciitis) has been reported with the use of certain painkillers (NSAIDs). If signs of infection appear or worsen, the patient should seek immediate medical advice. The doctor will assess whether anti-infective treatment (antibiotic therapy) is indicated.
• Aseptic meningitis symptoms such as neck stiffness, headache, nausea, vomiting, fever and altered consciousness have been observed during ibuprofen use. Patients with autoimmune disorders (lupus, mixed connective tissue disease) are at higher risk of such symptoms. If any of these symptoms occur, immediate medical attention is required.
• Hair loss (alopecia).

Frequency unknown: frequency cannot be estimated from available data

• Chest pain, which may indicate a potentially serious allergic reaction called Kounis syndrome.
• Respiratory tract reactivity, including asthma, bronchospasm, shortness of breath.
• Photosensitivity reactions.

Taking medicines such as Nurofen Express Caps may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If any adverse effect worsens or if any adverse effects not listed in this leaflet occur, 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 Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 Caps

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging of the carton and blister. The expiry date (EXP) refers to the last day of the stated month. Do not store above 25°C. Keep in the original packaging.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nurofen Express Caps contains
The active substance is ibuprofen.
Each capsule contains 200 mg of ibuprofen.
The other ingredients are:
Macrogol 600
Potassium hydroxide (min. 85% of the sum of bases, calculated as KOH)
Purified water
Capsule shell composition:
Liquid sorbitol, partially dehydrated
Gelatin
Cochineal red (E 124)
Printing ink:
Opacode WB white NS-78-18011 (containing titanium dioxide (E 171), propylene glycol, hypromellose 3 cP)

What Nurofen Express Caps looks like and contents of the pack
Red, oval, transparent soft capsules with identification printing. The capsules are available in packs containing 2, 4, 6, 8, 10, 12, 20, and 24 soft capsules.
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
Poland

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

For further information, please contact the local representative of the Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Poland
Tel: (22) 211 26 92

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Nurofen Rapid 200 mg Weichkapseln
Bulgaria Nurofen Express 200mg Soft Capsules
Cyprus Nurofen 200mg Liquid Capsules
Czech Republic Nurofen Rapid 200mg capsules
France NUROFLASH 200 mg capsule molle
Germany Nurofen Immedia 200mg Weichkapseln
Greece Nurofen 200mg Μαλακες κάψουλες
Hungary Nurofen Rapid 200 mg lágy kapszula
Malta Nurofen Express 200mg capsules
The Netherlands Nurofen Fastine Liquid Caps 200 mg, capsule, zacht
Poland Nurofen Express Caps
Romania NUROFEN EXPRESS 200 mg capsule moi
Slovakia Nurofen Rapid 200 mg Capsules, mäkké kapsuly
Slovenia Nurofen Immedia 200mg mehke kapsule