TYLOL HOT for adults x 6 sach
Tylool hot
TYLOL HOT FOR ADULTS Sachets * 6
LEAFLET: INFORMATION FOR THE USER
TYLOL HOT 500 mg / 4 mg / 60 mg powder for oral suspension
TYLOL HOT 500 mg / 4 mg / 60 mg powder for oral suspension
paracetamol / chlorpheniramine maleate / pseudoephedrine hydrochloride
(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. You should seek medical attention if your symptoms worsen or do not improve.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after 3 days you do not feel better or your condition worsens, you should seek medical attention
In this leaflet:
1. What TYLOL HOT is and what it is used for
2. What you need to know before you take TYLOL HOT
3. How to take TYLOL HOT
4. Possible side effects
5. How to store TAYLOL HOT
6. Contents of the package and additional information
1. What TYLOL XOT is and what it is used for
TYLOL HOT has an analgesic (pain-relieving), antipyretic (temperature-reducing), antihistaminic (anti-allergic) and reducing swelling of the mucous membrane of the upper respiratory tract effect, 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 mucosa of the upper respiratory tract.
TYLOL HOT is indicated for the relief of the following cold and flu symptoms:
nasal congestion (blocked nose)
runny nose
sneezing
increased body temperature
mild to moderate pain of various origins
If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
2. What you need to know before you take TYLOL HOT
Do not take TYLOL HOT
if you are allergic to paracetamol, chlorpheniramine maleate and/or pseudoephedrine hydrochloride or to any of the other ingredients of TYLOL HOT (listed in section 6). An allergic reaction can be recognized 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 you are taking MAQ inhibitors (to treat depression and other mental illnesses). To start treatment with TYLOL HOT, you must not have taken such drugs for at least 2 weeks.
Warnings and precautions
Talk to your doctor or pharmacist before taking TYLOL HOT if you suffer from:
liver, kidney or lung damage
previous anemia
severe heart disease
bronchial asthma
glaucoma (increased intraocular pressure)
hyperthyroidism (increased thyroid function)
hypertension (high blood pressure)
diabetes
Avoid simultaneous use of TYLOL HOT with other paracetamol-containing products, as this may lead to an overdose of paracetamol.
If you use antihypertensive drugs (to lower high blood pressure) and/or antidepressants, you should consult the relevant specialist.
Children and adolescents
The use of TYLOL HOT in children under 12 years of age should only be done under medical supervision or they should use TYLOL HOT FOR CHILDREN.
Consultation with a doctor is imperative if the high temperature lasts more than 3 days, and the other symptoms - more than 5 days.
Do not exceed the recommended maximum daily dose or that prescribed by the doctor.
Other medicines and TYLOL HOT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
At doses exceeding the recommended, the effect of long-term administered anticoagulants (blood-clotting drugs) is potentiated. The simultaneous intake of certain drugs for the treatment of depression, sedatives, drugs for epilepsy, 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 when pseudoephedrine hydrochloride is used concurrently with decongestants, tricyclic antidepressants, appetite suppressants, amphetamines such 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.
Tylool hot
TAILOL HOT with food, drinks and alcohol
During treatment with TYLOL HOT, the use of alcohol should be avoided because alertness may decrease.
Pregnancy, lactation and fertility
Ask your doctor or pharmacist before using any medicine.
Medical supervision is recommended for pregnant and lactating women.
Driving and using machines
Fatigue, drowsiness or dizziness may occur during treatment with TYLOL HOT, therefore driving a car and operating potentially dangerous machinery should be done carefully.
TAYLOL HOT contains
One sachet contains 17.5 g of sucrose. This should be considered in patients with diabetes mellitus. If your doctor has told you that you have an intolerance to some sugars, consult him before taking this product.
This medicinal product contains 6.3 mmol (144.3 mg) sodium per sachet. This should be considered in patients on a controlled sodium diet.
3. How to take TYLOL HOT
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
TYLOL HOT is taken orally,
The recommended maximum daily dose is 4 sachets.
The contents of each sachet are dissolved in 160 ml of warm water (a standard glass) and drunk immediately, without waiting. If necessary, the next dose should be taken after an interval of 6 hours.
If you have taken more TYLOL HOT than you should
If you think you have taken more than the recommended dose, seek medical attention immediately, regardless of the fact that you may feel fine, as taking too much paracetamol can cause liver damage. The most common symptoms of overdose are nausea, vomiting, abdominal pain, dizziness, the appearance of allergic reactions on the part of the skin (most often redness and itching), hallucinations, sweating and general malaise, etc.
If you forget to take TYLOL HOT
Do not take a double dose to make up for a missed dose.
If you have stopped taking TYLOL HOT
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
TYLOL HOT 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 long-term intake of higher doses, various changes in the blood picture can be observed.
Adverse reactions from pseudoephedrine hydrochloride are very rare. Sleep disturbance, hallucinations, allergic reactions and urinary retention have been reported.
Chlorpheniramine maleate may cause drowsiness, allergic reactions, blurred vision, urinary retention, dry mouth, headache, dizziness, loss of appetite, vomiting, diarrhea, palpitations, arrhythmia, decreased blood pressure, hepatitis, hemolytic anemia (reduction in of red blood cells, which may cause pale or yellowing of the skin, weakness or shortness of breath).
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly to:
Medicines Executive Agency (EMA):
BULGARIA, Sofia 1303, 8 Damyan Gruev St
Tel. +359 2 8903555
e-mail: bda@bda.bg
website: www.bda.bg
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store TAYLOL HOT
Keep out of the reach of children.
To be stored in the original packaging.
To be stored below 25°C.
Keep away from light and moisture.
Do not use TYLOL HOT after the expiry date marked on the sachet and carton. The expiration date corresponds to the last day of the specified month,
6. Contents of the package and additional information What TYLOL HOT contains
The active substances are: paracetamol, chlorpheniramine maleate, pseudoephedrine hydrochloride. Each TYLOL HOT sachet contains 500 mg paracetamol, 4 mg chlorpheniramine maleate, 60 mg pseudoephedrine hydrochloride
The other ingredients are: citric acid, anhydrous, tartaric acid, sodium bicarbonate, sodium carbonate, anhydrous, povidone, sucrose, sodium benzoate (E 211), quinoline yellow (E 104), lemon flavor
What TYLOL HOT looks like and contents of the pack
Off-white to yellow, lemon-flavored, free-flowing granular powder for oral suspension in sachets. 6 or 12 sachets in a cardboard box.
Marketing authorization holder and manufacturer responsible for batch release within the EU
NOBEL PHARMA EOOD, Bulgaria
Date of the last revision of the leaflet: 01/2017
