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 old
Fast and effective medicine for cold and flu symptoms in children aged 6 to 12. Provides short-term relief of cold and flu symptoms, including headache, fever, sore throat, muscle and joint pain, nasal congestion, sinusitis and related pain.
Leaflet: information for the user
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, please tell your pharmacist. This includes any possible side effects not listed in this leaflet.
- If you do not feel better after 7 days or your condition worsens, you should seek medical attention.
This medicine is available without a prescription. However, to get the best results from the treatment, you should 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 pack and other information
- What is Coldrex Junior Hot Drink and what is it used for?
Coldrex Junior Hot Drink is a medicinal product in the form of a hot lemon-flavored drink for relieving cold and flu symptoms in children aged 6 to 12 years and contains three active ingredients:
- paracetamol , which relieves pain and lowers high fever;
- phenylephrine hydrochloride , a decongestant that unclogs the nose and sinuses and helps your child breathe more easily;
- vitamin C (ascorbic acid), which is used for flu and colds due to the body's increased needs, 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.
Administer the lowest dose that has a therapeutic effect.
Do not take Coldrex Junior Hot Drink
- if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 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 medicines containing a decongestant or for colds;
- 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 (e.g. amitriptyline);
- the child is malnourished or underweight, as dose adjustment may be necessary 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;
- nausea, vomiting;
- loss of appetite;
Tell your doctor immediately if you have a combination of these symptoms.
Other medicines and Coldrex Junior Hot Drink
Do not use this medicine if you are taking prescription or non-prescription medicines that contain paracetamol to treat 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 to treat 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 medicines or medicines obtained without a prescription.
Remember: Coldrex Junior Hot Drink contains paracetamol and a decongestant .
Consult your doctor if any of the above applies to your child or:
- has liver or kidney disease ;
- has hypertension, heart disease, vascular disease (Raynaud's disease), which appears as pain in the fingers;
- e diabetic. Each sachet contains 1.863g of sugar;
- suffers from increased thyroid function;
- is taking other medications (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 sodium..
Pregnancy, breastfeeding 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 evidence of risk during pregnancy. Paracetamol is excreted in breast milk, but there is no evidence of increased risk to the infant.
Due to the content of phenylephrine, the medicinal product should be used during breastfeeding only on medical prescription.
Driving and using machines
This medicinal product is intended for use in pediatrics, for the treatment of children from 6 to 12 years of age, 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 in the form of 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 take more Coldrex Junior Hot Drink than you should
If your child has taken more than the recommended dose, seek medical attention immediately and tell them the exact amount, even if they feel well. Overdose with 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 experience:
- allergic reactions, e.g. itching, rash, breathing problems, swelling of the lips, tongue, throat or face, mouth ulcers;
- unexpected bleeding or bruising;
- heart rhythm problems (unexpected palpitations);
- loss or impairment of vision.
Very rare cases of serious skin reactions have been reported.
Reporting side effects
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system, Bulgarian Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, Tel.: +35 928903417, website: www.bda.bg. By reporting side effects, you can help to provide more information on the safety of this medicine.
- How to store Coldrex Junior Hot Drink
Keep out of the reach of children.
Store below 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. 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 does Coldrex Junior Hot Drink contain?
- 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, saccharin sodium, natural curcumin (E100), colloidal anhydrous silica, lemon essence.
What does Coldrex Junior Hot Drink look like and what does the package contain?
Coldrex Junior Hot Drink
The package contains 5 or 10 sachets.
Each sachet contains 3 g of pale yellow powder.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Pharma Support Services Ltd.
1 Danail Krapchev St., apt. 9
Sofia 1700,
Bulgaria
tel.: +359 2805 7108
email: office@phsupport.net
Shelf life – 3 years
Without a doctor's prescription.
Last update – September 2019
