COLDREX JUNIOR For colds and flu for children with lemon flavor x 10 sach
Coldrex Junior x10 for colds and flu for children from 6 to 12 years
Fast and effective medicine against the symptoms of cold and flu in children from 6 to 12 years old. Provides short-term relief of cold and flu symptoms, including headache, high fever, sore throat, muscle and joint pain, nasal congestion, sinusitis and associated pain.
Leaflet: user information
Coldrex Junior Hot Drink 300 mg/5 mg/20 mg powder for oral solution
Coldrex Junior Hot Drink 300 mg/5 mg/20 mg powder for oral solution
paracetamol/phenylephrine hydrochloride/ascorbic acid
Read all of this leaflet carefully before you start taking this medicine because it contains important information for 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, tell your pharmacist. This also includes any possible side effects not described in this leaflet.
- If after 7 days you do not feel better or your condition worsens, you should seek medical attention.
This medicine is available without a prescription. However, in order to get the best results from the treatment, you must carefully follow the instructions for use of the medicinal product.
What this leaflet contains
1. What Coldrex Junior Hot Drink is and what it is used for
2. What you need to know before you take Coldrex Junior Hot Drink
3. How to take Coldrex Junior Hot Drink
4. Possible side effects
5. How to store Coldrex Junior Hot Drink
6. Contents of the package and additional information
- What Coldrex Junior Hot Drink is and what it is used for
Coldrex Junior Hot Drink is a medicinal product in the form of a lemon-flavored hot drink for the relief of cold and flu symptoms in children from 6 to 12 years of age and contains three active ingredients:
- paracetamol , which relieves pain and lowers high temperature;
- phenylephrine hydrochloride , a decongestant that unblocks the nose and sinuses and helps your child breathe easier;
- vitamin C (ascorbic acid), which is used for flu and colds due to the increased needs of the body, especially in the initial stage of the disease.
- What you need to know before taking Coldrex Junior Hot Drink
Do not exceed the recommended dose.
Use the lowest dose that has a therapeutic effect.
Do not take Coldrex Junior Hot Drink
- if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in point 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Coldrex Junior Hot Drink .
Consult your doctor or pharmacist before giving Coldrex Junior Hot Drink if the child is taking:
- other medicinal products containing paracetamol;
- other decongestant or cold medicines;
- warfarin or medicines used to thin the blood;
- beta-blockers , used for heart disease and high blood pressure;
- digoxin;
- appetite suppressants or stimulants;
- medicines to treat depression, such as tricyclic antidepressants (eg amitriptyline);
- the child is malnourished or underweight, as the dose may need to be adjusted in such cases.
- the infection is prolonged, as this may increase the risk of metabolic acidosis.
Signs of metabolic acidosis include:
- deep, rapid, labored breathing;
- urge to vomit, vomiting;
- loss of appetite;
Tell your doctor right away if you have any combination of these symptoms.
Other medicines and Coldrex Junior Hot Drink
Do not use this medicinal product if you are taking prescription or over-the-counter medicines that contain paracetamol for pain, fever, cold and flu symptoms, or sleeping pills.
Do not give Coldrex Junior Hot Drink if the child is:
- allergic (hypersensitive) to paracetamol, phenylephrine hydrochloride, vitamin C or any of the excipients;
- on treatment with tricyclic antidepressants or other medicines for the treatment of depression and if monoamine oxidase inhibitors have been taken in the last two weeks;
Tell your doctor or pharmacist if your child is taking these or any other medicines, including herbal or over-the-counter medicines.
Remember: Coldrex Junior Hot Drink contains paracetamol and a decongestant .
Consult your doctor if any of the above apply to your child or:
- has a liver or kidney disease ;
- have hypertension, heart disease, vascular disease (Raynaud's disease), which appears as pain in the fingers;
- he is diabetic. Each sachet contains 1.863g of sugar;
- suffers from increased thyroid function;
- take other medicines (see below);
- suffers from congenital fructose intolerance, glucose/galactose malabsorption syndrome or sucrase/isomaltose deficiency;
- is on a low-salt diet. Each sachet contains 0.055g of sodium.
Pregnancy, lactation and fertility
The medicinal product is intended for use in pediatrics, for the treatment of children from 6 to 12 years of age.
The medicinal product should not be used during pregnancy, unless prescribed by a doctor.
Paracetamol: no data on risk during pregnancy. Paracetamol is excreted in breast milk, but there is no evidence that it increases the risk to the infant.
Due to the content of phenylephrine, the medicinal product should be used during breastfeeding only according to a doctor's prescription.
Driving and using machines
This medicinal product is intended for use in pediatrics, for the treatment of children aged 6 to 12 years, however, patients should be advised not to operate machinery if they feel dizzy.
- How to take Coldrex Junior Hot Drink
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Use in children and adolescents
For oral use.
The recommended dose for children 6 to 12 years of age is one sachet every 4 to 6 hours as needed.
Do not take more than 4 (four) sachets in a 24-hour period.
Do not take for more than 3 (three) days without consulting a doctor.
Not to be taken by children under 6 years of age, unless prescribed by a doctor.
Do not exceed the indicated dose.
Coldrex Junior Hot Drink is taken as a hot drink.
- Pour the contents of one sachet into a glass, add warm water (about 125 ml) and mix well.
- If necessary, add cold water.
- If you prefer, add sugar or honey.
If you have taken more than the required dose of Coldrex Junior Hot Drink
If the child has taken more than the recommended dose , seek medical help immediately and tell the exact amount, even if the child feels fine. An overdose of paracetamol can cause liver damage.
If you forget to take Coldrex Junior Hot Drink
Do not take a double dose to make up for a missed dose.
Take the dose when you remember.
Do not give more than one dose every 4 hours.
- Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When using paracetamol and phenylephrine side effects are very rare (may affect up to 1 in 10,000 people).
Stop taking Coldrex Junior Hot Drink and consult your doctor if you observe:
- allergic reactions, e.g. itching, rash, trouble breathing, swelling of the lips, tongue, throat, or face, mouth ulcers;
- unexpected bleeding or bruising;
- heart rhythm problems (unexpected heartbeats);
- loss or impairment of vision.
Very rare cases of serious skin reactions have been reported.
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 adverse reactions directly through the national reporting system, Executive Medicines Agency 8 Damyan Gruev Street, 1303 Sofia, Tel.: +35 928903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
- How to store Coldrex Junior Hot Drink
Keep out of the reach of children.
To be stored at a temperature below 25 o C.
Do not use this medicine after the expiry date which is stated on the carton.
The expiration date corresponds to the last day of the specified month.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
- Package contents and additional information
What Coldrex Junior Hot Drink contains
- The active substances are:
paracetamol 300 mg
phenylephrine hydrochloride 5 mg
ascorbic acid (vitamin C) 20 mg
- The other ingredients (excipients) are: citric acid, sodium citrate, sodium cyclamate, corn starch, sugar, sodium saccharin, natural curcumin (E100), colloidal anhydrous silicon dioxide, lemon essence.
What Coldrex Junior Hot Drink looks like and contents of the pack
Coldrex Junior Hot Drink
The package contains 5 or 10 sachets
Each sachet contains 3 g of pale yellow powder.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Adriatic BST doo, Verovškova ulica 55, 1000 Ljubljana, Slovenia
Manufacturer is:
SmithKlineBeecham SA, Ctra. De Ajalvir, Km 2.5
Alcala de Henares, 28806 Madrid, Spain
Omega Pharma International NV
Venecoweg 26, Nazareth 9810,
Belgium
Wrafton Laboratories Limited
Exeter Road, Wrafton, Braunton
EX33 2DL
United Kingdom
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Pharma Support Services Ltd
1 Danail Krapchev St., Apt. 9
Sofia 1700,
Bulgaria
phone: +359 2805 7108
e-mail: office@phsupport.net
Shelf life - 3 years
Without a doctor's prescription.
Last updated - September 2019
