Tylol Hot for children x12 sachets Nobel Pharma

TAYLOL HOT FOR CHILDREN sachet * 12 NOBEL
 
PACKAGE LEAFLET: INFORMATION FOR THE USER
TYLOL HOT PEDIATRIC 250 mg/2 mg/30 mg powder for oral suspension TYLOL XOT FOR CHILDREN 250 mg/2 mg/30 mg powder for oral suspension paracetamol/chlorpheniramine maleate/pseudoephedrine hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.

If you need further information or advice, ask your pharmacist.
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you do not feel better after 3 days or your condition worsens, you should seek medical attention.

What this leaflet contains: 1. What TAYLOL HOT FOR CHILDREN is and what it is used for 2. What you need to know before you take TAYLOL HOT FOR CHILDREN 3. How to take TAYLOL HOT FOR CHILDREN 4. Possible side effects 5. How to store TAYLOL HOT FOR CHILDREN 6. Contents of the pack and other information
1. What TAYLOL HOT FOR CHILDREN is and what it is used for
TAYLOL HOT FOR CHILDREN from 6 to 12 years old has analgesic (pain-relieving), antipyretic (temperature-lowering), antihistamine (antiallergic) and swelling-reducing effects on the mucous membrane of the upper respiratory tract, which is due to its active ingredients:

paracetamol, chlorpheniramine maleate and pseudoephedrine hydrochloride.

Paracetamol relieves pain and lowers body temperature. Chlorpheniramine maleate relieves the following symptoms: runny nose, swelling of the nasal mucosa, redness and/or hypersensitivity of the eyes. Pseudoephedrine hydrochloride reduces swelling of the mucous membrane of the upper respiratory tract.
TAYLOL HOT FOR CHILDREN is indicated for the relief of the following cold and flu symptoms:

 nasal congestion (blocked nose)
 runny nose
 sneezing
 elevated body temperature
 mild to moderate pain of various origins

If you do not feel better after 3 days or your condition worsens, you should seek medical attention.
2. What you need to know before you take TAYLOL HOT FOR CHILDREN Do not give TAYLOL HOT FOR CHILDREN

 if your child is allergic (hypersensitive) to paracetamol, chlorpheniramine maleate and/or pseudoephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised by the presence of: rash, itching, reddening of the skin or difficulty breathing.
if you suffer from diabetes mellitus, severe liver or kidney disease.
 if taking MAO inhibitors (for the treatment of depression and other mental illnesses). To start treatment with TAYLOL HOT FOR CHILDREN, the child must not have taken such medicines for at least 2 weeks.

Warnings and precautions
Talk to your doctor before your child starts taking TAYLOL HOT FOR CHILDREN if they suffer from:

liver, kidney, or lung damage
 pre-existing anemia
 severe heart disease
 bronchial asthma
 glaucoma (increased intraocular pressure)
 hyperthyroidism (increased thyroid function)
 hypertension (high blood pressure)
 diabetes mellitus

Do not give your child other medicines containing paracetamol while he is taking TAYLOL HOT FOR CHILDREN due to the risk of paracetamol overdose.
Patients who use antihypertensive medications (to lower high blood pressure) and/or antidepressants should consult with the appropriate specialist.
Children The use of TAYLOL HOT FOR CHILDREN in children under 6 years of age should only be done under medical supervision.
A doctor's consultation is necessary if the high fever lasts more than 3 days and the other symptoms last more than 5 days.
Do not exceed the recommended maximum daily dose or that prescribed by the doctor.
Other medicines and TAYLOL HOT FOR CHILDREN Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
At doses exceeding the recommended ones, the effect of long-term anticoagulants (anticoagulants) is potentiated. The simultaneous use of some drugs for the treatment of depression, sedatives, epilepsy drugs, as well as large amounts of alcohol, increases the likelihood of adverse drug reactions caused by paracetamol. Rarely, an increase in blood pressure may occur with the simultaneous use of pseudoephedrine hydrochloride with decongestants, tricyclic antidepressants, appetite suppressants, amphetamines as psychostimulants and MAO inhibitors. The antihypertensive effectiveness of methyldopa (for high blood pressure), alpha and beta adrenergic blockers, guanethidine decreases with simultaneous use with pseudoephedrine hydrochloride.
If you are not sure whether you can use TAYLOL HOT FOR CHILDREN together with another medicine, be sure to seek the advice of a doctor.
TAYLOL HOT FOR CHILDREN with food, drinks and alcohol When treating with TAYLOL HOT FOR CHILDREN, alcohol consumption should be avoided because alertness may be reduced.
Pregnancy, breast-feeding and fertility Ask your doctor or pharmacist before using any medicine. TAYLOL HOT FOR CHILDREN is intended for children from 6 to 12 years of age. However, keep in mind that medical supervision is recommended for pregnant and breastfeeding women.
Driving and using machines TAYLOL HOT FOR CHILDREN is intended for children from 6 to 12 years of age.
TAYLOL HOT FOR CHILDREN contains One sachet contains 8.75 g of sucrose. This should be taken into account in patients with diabetes mellitus. If your doctor has told you that you have an intolerance to some sugars, contact him before taking this product.
This medicinal product contains 3.1 mmol (72.2 mg) sodium per sachet. This should be taken into consideration by patients on a controlled sodium diet.
TAYLOL HOT FOR CHILDREN contains sunset yellow dye, which may cause allergic reactions.
3. How to take TAYLOL HOT FOR CHILDREN
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Follow the recommended dosage carefully. If you are not sure about anything, ask your doctor or pharmacist.
TAYLOL HOT FOR CHILDREN is intended for children over 6 years of age. It is taken orally. The recommended dosage of TAYLOL HOT FOR CHILDREN is listed below:
The contents of each sachet should be dissolved in 80 ml of warm water (half a standard glass) and drunk immediately, without waiting. If necessary, the next dose should be taken after an interval of 6 hours. The recommended maximum daily dose is 4 sachets.
The use of TAYLOL HOT FOR CHILDREN in children under 6 years of age should only be done under medical supervision.
If you take more TAYLOL HOT FOR CHILDREN than you should If you think your child has taken more than the recommended dose, seek medical attention immediately, even if they feel well, as taking too much paracetamol can cause liver damage. The most common symptoms of overdose are nausea, vomiting, abdominal pain, dizziness, allergic skin reactions (most often redness and itching), hallucinations, sweating and general malaise, mild anxiety, tachycardia (rapid heartbeat) and/or a slight increase in blood pressure, etc.
If you forget to take TAYLOL HOT FOR CHILDREN Do not take a double dose to make up for a missed dose.
If you stop taking TAYLOL HOT FOR CHILDREN If you have any further questions on the use of this product, please ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, TAYLOL HOT FOR CHILDREN can cause side effects, although not everybody gets them.
TAYLOL HOT FOR CHILDREN is well tolerated.
In therapeutic doses, paracetamol is usually well tolerated. In rare cases, it can cause allergic reactions such as rash and itching. Very rarely, with prolonged use of higher doses, various changes in the blood count may be observed. Adverse reactions from pseudoephedrine hydrochloride are very rare. As a result of overexcitation of the central nervous system, sleep disorders may occur. In very rare cases, hallucinations, allergic reactions and urinary retention associated with pseudoephedrine hydrochloride have been reported.
Chlorpheniramine and the new maleate may cause drowsiness and allergic reactions.
If any of the side effects gets serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to:
Bulgarian Medicines Agency (BDA): BULGARIA, Sofia 1303, 8 Damyan Gruev Str. Tel. +359 2 8903555 e-mail: [email protected] website: www.bda.be
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store TAYLOL HOT FOR CHILDREN
Keep out of the reach of children. Store in the original packaging. Store below 25°C. Protect from light and moisture.
Do not use TAYLOL HOT FOR CHILDREN after the expiry date which is stated on the sachet and carton. The expiry date refers to the last day of that month.
6. Contents of the pack and other information What TAYOL HOT FOR CHILDREN contains

The active substances are: paracetamol, chlorpheniramine maleate, pseudoephedrine hydrochloride. Each sachet of TAYLOL HOT FOR CHILDREN contains 250 mg paracetamol, 2 mg chlorpheniramine maleate, 30 mg pseudoephedrine hydrochloride.
The other ingredients are: citric acid, anhydrous, tartaric acid, sodium hydrogen carbonate, sodium carbonate, anhydrous, povidone, sucrose, sodium benzoate (E 211), quinoline yellow (E 104), orange flavor, sunset yellow (E 110)

What TAYLOL HOT FOR CHILDREN looks like and what the package contains: Yellowish-orange granular powder for oral suspension with orange flavor in sachets 6 or 12 sachets in a carton
Marketing Authorisation Holder and Manufacturer Responsible for Batch Release within the EU
NOBEL PHARMA EOOD, Bulgaria
Date of last revision of the leaflet: 01/2017