Nurofen for children Active Tablets 100 mg 1 x 12 tablets

NUROFEN for children Active is used:

• for the relief of mild to moderate pain such as headache, toothache, spine and postoperative pain. In addition, this medicine is used for pain and fever associated with colds and flu, pain from middle ear infections, sore throat, muscle pain, and pain from soft tissue injuries;
• to reduce fever

The medicine is intended for children from 6 years old.

Mode of use

For the treatment of fever and pain, the daily dose of Nurofen for children Active 20-30 mg/kg body weight is divided into several doses. The following dosage scheme is recommended: Children from 6 to 9 years: initially take 1-2 tablets, maximum three times a day. Do not take more than 6 tablets in 24 hours. Children from 10 to 12 years: Initially, 1-3 tablets are administered, maximum three times a day. No more than 9 tablets should be taken in 24 hours. The tablet dissolves in the mouth and is swallowed, there is no need to drink it with liquid. The medicine is intended for short-term administration. If problems persist or worsen during a short period of use, the patient should consult a doctor. If the pain returns with the same intensity after the effect wears off, or if the maximum single dose is not enough to suppress the pain, you should consult a doctor. Drink enough fluids. Not all drugs (including non-prescription drugs) can be combined, it is necessary to consult them.

APPENDIX NO. 2 ON THE DECISION REGARDING THE EXTENSION OF THE MEDICINE REGISTRATION, EV. Not. 2010/00847 WRITTEN INFORMATION FOR THE USER NUROFEN for children Active (ibuprofen) Read all of this written information carefully because it contains important information for you. This medicine is available without a prescription. However, you should still use Nurofen for children Active carefully to get the best possible results. - Keep this information written down. You may need to read it again. - If you need more information or advice, contact your pharmacist. - If the symptoms of your illness do not improve within 3 days or if they worsen, you should contact a doctor. - If you start to experience any equally serious side effects or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

In this written information for users, you will learn : 1. What Nurofen for children Active is and what it is used for 2. Before you take Nurofen for children Active 3. How to take Nurofen for children Active 4. Possible side effects 5 How to store NUROFEN FOR CHILDREN ACTIV 6. Further information 1. WHAT NUROFEN FOR CHILDREN ACTIV IS AND WHAT IT IS USED FOR

Nurofen for children Active belongs to the group of drugs known as analgesics, antipyretics, nonsteroidal antirheumatic drugs (to reduce inflammation, pain and fever). It contains the drug ibuprofen, which relieves pain, has anti-inflammatory effects and reduces fever. Ibuprofen prevents the formation of certain substances (prostaglandins) that are involved in the body in the development of pain, fever and inflammation.

Nurofen for children Active is used: - for the relief of mild to moderate pain, such as headache, toothache, spine and postoperative pain. In addition, this drug is used for pain and fever associated with colds and flu, pain from middle ear infections, sore throat, muscle pain, and pain from soft tissue injuries. The medicine is intended for children from 6 years old. 2. BEFORE YOU USE NUROFEN FOR CHILDREN ACTIV Do not give Nurofen for children Activ to a child – if he is hypersensitive (allergic) to ibuprofen or any of the other components of Nurofen for children Activ; - if you have or have had a gastric ulcer, perforation or bleeding in the digestive tract; - when he is hypersensitive (allergic) to other analgesics or to acetylsalicylic acid, which can manifest itself in the form of bronchial asthma, nasal secretions or hives; - when your child suffers from serious liver, kidney or heart diseases. The medicine should not be used in the last three months of pregnancy. Be especially careful when using Nurofen for children Active Before administering the medicine, consult the doctor if the child has: - a disease of the immune system (lupus erythematosus, mixed collagenosis); - diseases of the digestive tract or chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease); - heart diseases (high blood pressure, heart failure); - liver dysfunction; - renal function disorders; - allergy (hypersensitivity) such as skin reactions to other medicines, asthma, hay fever, long-term swelling of the mucous membranes or long-term respiratory diseases. In these cases, there is a greater likelihood of hypersensitivity reactions. If your child is affected by any of the points mentioned above, always consult a doctor about the use of the medicine. Do not give the medicine to children under 6 years of age. Administer the drug for the shortest possible time in the lowest possible effective dose, which is necessary to suppress the symptoms of the disease. In elderly patients, adverse reactions may occur more often and their consequences may be more severe. If abdominal pain, black stools, vomiting, diarrhea or other digestive system disturbances, skin rashes or any other signs of hypersensitivity occur, stop taking the medicine and consult a doctor. Caution is required in patients with high blood pressure and/or heart failure, as treatment with Nurofen for children Active may cause fluid retention and swelling. The use of medicines such as Nurofen for children Active may be associated with a small increase in the risk of heart attack or stroke. The risk is more likely with high doses and long-term treatment. Therefore, do not exceed the recommended dose or treatment duration of 3 days. If your child has heart problems, has had a stroke in the past, or has risk factors for a stroke (for example, high blood pressure, diabetes, high cholesterol, or smoking), talk to a doctor or pharmacist about to the appropriateness of its treatment. Headaches can occur during long-term use of high doses of pain relievers (sedatives), which should not be treated with higher doses of the drug. In general, the repeated use of painkillers, especially the combination of different types of painkillers, can lead to permanent kidney disorders with the risk of kidney failure (analgesic nephropathy). Unless recommended by a doctor, the drug should not be given to children under 6 years of age. Use of other medicines If your child is taking or has recently taken other medicines, including medicines obtained without a prescription, please inform the doctor or pharmacist. When you take Nurofen for children Active and some other medicines at the same time, their effects may interact. Such drugs include : - Acetylsalicylic acid, other anti-inflammatory drugs and corticosteroids increase the risk of adverse effects in the digestive tract, including bleeding and the development of gastric ulcers. - Lithium (for the treatment of certain mental illnesses), selective serotonin reuptake inhibitors (SSRIs), i.e. medicines used to treat depression. - Methotrexate (for the treatment of cancer) may worsen the adverse effects. - Medicines that reduce blood clotting (eg warfarin) increase the risk of bleeding. - Concomitant use of medicines for heart conditions (cardiac glycosides) can worsen heart failure and reduce kidney function. - Zidovudine (for the treatment of HIV infection) - prolonged bleeding may occur. Use of Nurofen for children Active with food and drink Tablets can be taken independently of food. They don't have to drink. If indigestion occurs, it is recommended to take the tablets with a meal. Pregnancy and breast-feeding The drug is intended for children. If the drug should be used by a pregnant woman, she should not use it during the last 3 months of pregnancy. During the first 6 months of pregnancy or during breastfeeding, the drug can be taken only on the recommendation of the doctor. Women who want to become pregnant should consult a doctor about the possibility of using the drug. The drug belongs to a group of drugs (non-steroidal anti-rheumatic drugs) that can affect women's fertility. Remedies will appear after discontinuing use. Important information about some components of Nurofen for children Active Each tablet contains 7 mg of aspartame, which is a source of phenylalanine. The drug should not be used by children with phenylketonuria or phenylalanine intolerance. 3. HOW TO USE NUROFEN FOR ACTIVE CHILDREN Always use Nurofen for Active Children exactly as described in this leaflet. If you are not sure, ask your doctor or pharmacist. Nurofen for children Active is intended for short-term use only. Unless otherwise prescribed by the doctor, the following dosage scheme is recommended:

The interval between individual doses is 6-8 hours. The tablets are taken as needed up to three times a day. The tablet is placed on the tongue, allowed to dissolve freely and then swallowed; the medicine should not be taken with water. Do not bite the tablets. For patients with increased stomach sensitivity, it is recommended to take Nurofen for children Activ during meals. If you have the impression that the effect of Nurofen for children Active is too strong or too weak, tell your doctor or pharmacist. Do not give the medicine to the child for more than 3 days without consulting your doctor. If the child takes more Nurofen for children Active than it should If you suspect an overdose of the drug Nurofen for children Active or it is an accidental use of the drug by a child, inform the doctor immediately. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE ADVERSE REACTIONS Like all medicines, Nurofen for children Active can cause side effects, although not everybody gets them. The following side effects have been reported: Uncommon side effects (affects 1 to 10 users in 1,000) · hypersensitivity reactions (symptoms may include swelling of the face, tongue and larynx, difficulty breathing, short-term cessation of breathing, heart rhythm quickly, low blood pressure (anaphylaxis). Angioedema or severe shock (may be characterized by abdominal pain, fever, chills, nausea and vomiting) · worsening of asthma and narrowing of the airways (bronchospasm) · abdominal pain, nausea, indigestion · headache various skin rashes Rare side effects (affects 1 to 10 users in 10,000) diarrhoea, flatulence, constipation and vomiting aseptic meningitis (inflammation of the meninges) peeling skin, hair loss and other skin conditions (exfoliative dermatitis, photosensitivity dermatitis , dermatitis maculopa) skin rashes) · strokes, low blood pressure, palpitations · dry eyes and mouth, gum ulcers, runny nose, hearing disorders . of the stomach and other disorders of the digestive tract (melena, hematemesis, ulcerative stomatitis), dizziness, nervousness, ringing in the ears, depression, drowsiness, insomnia, irritability, difficulty concentrating, emotional instability, convulsions, renal failure, changes in the amount of urine produced, nephritis, blood in the urine and other kidney diseases (papillary necrosis, cystitis, tubular necrosis), liver disorders (hepatitis, jaundice), liver necrosis, insufficient liver function, inflammation of the pancreas, duodenum, esophagus, hematopoiesis disorders . The first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding, unexplained bleeding and bruising, · severe forms of skin reactions (including Stevens-Johnson syndrome, erythema multiforme and epidermal toxic). necrolysis), · blurred vision, changes in visual perception of colors and other eye disorders, · in patients with immune system disorders: aseptic meningitis, which may manifest as neck stiffness, headache, nausea, vomiting, fever or disorientation. If you start to experience any serious side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE NUROFEN FOR CHILDREN ACTIV Store at a temperature of up to 25 °C. Keep out of reach and sight of children. Do not use after the expiry date written on the box. Medicines should not be thrown away with waste water or household waste. Return unused medication to the pharmacy. These measures will help protect the environment. 6. ADDITIONAL INFORMATION

What does Nurofen for children Active contain

- The medicine is 100 mg of ibuprofen in a tablet to dissolve in the mouth - Other ingredients are ethyl cellulose, precipitated silicon dioxide, hypromellose, mannitol, aspartame, croscarmellose sodium, strawberry flavor, magnesium stearate. What Nurofen for children Active looks like and contents of the pack White to off-white round tablets . The medicine is available in boxes of 4, 6, 10, 12, 18, 20, 24, 30 tablets. Not all pack sizes must be marketed.

The holder of the registration decision

Reckitt Benckiser Healthcare International Ltd, Slough, United Kingdom Manufacturer Ethypharm Industries, Chateauneuf-en-Thymerais, France Reckitt Benckiser Healthcare International Ltd., Nottingham, United Kingdom If you require any information about this medicine, please contact your local Marketing Authorization Representative placing on the market Holder: Reckitt Benckiser (Slovak Republic) sro Drieňová 3, 821 08 Bratislava, Tel. +421-248213000 This written user information was last approved in 11/2010.

Try other products from the Nurofen brand, which are in the categories Respiratory system, Joint, muscle and tendon pain and Medicines. 12 customers rated the product and 100% of them would recommend it. Nurofen for children Active tablets 100 mg 1 x 12 tablets is registered in the ŠUKL database under the code 92755. If you are not sure which product to choose, take inspiration from the Children's fever category.