COLDREX flu and cold x 24 tabl
Leaflet: user information
Coldrex tablets
Coldrex tablets
Ascorbic acid/Caffeine/Paracetamol/Phenylephrine hydrochloride/Terpine hydrate
Ascorbic acid/Caffeine/Paracetamol/Phenylephrine hydrochloride/Terpin hydrate
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, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If after 7 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
- What are Coldrex tablets and what are they used for?
- What you need to know before taking Coldrex tablets
- How to take Coldrex tablets
- Possible side effects
- How to store Coldrex tablets
- Package contents and additional information
- What are Coldrex tablets and what are they used for?
If after 7 days you do not feel better or your condition worsens, you should seek medical attention.
Coldrex tablets are used to relieve cold and flu symptoms: fever, headache, sore throat, runny nose and stuffy nose, sinus pain and muscle pain.
Contains paracetamol - an analgesic (pain reliever) and antipyretic (reduces temperature), phenylephrine hydrochloride - a decongestant, which causes swelling of the lining of the nose and sinuses, helping you to breathe more easily, caffeine, which acts as a mild stimulant, terpine hydrate - an expectorant (expectorant) and ascorbic acid (vitamin C), which is usually used for flu and inflammatory diseases of the upper respiratory tract (colds and flu), due to the increased needs of the body, especially in the initial stage of the disease.
- What you need to know before taking Coldrex tablets
Do not exceed the recommended dose.
Use the lowest dose that has a therapeutic effect.
Do not take Coldrex tablets
- if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
Do not take Coldrex tablets if you are allergic to paracetamol, caffeine, phenylephrine hydrochloride, terpine hydrate, ascorbic acid or any of the other ingredients.
Coldrex tablets are not recommended during pregnancy.
Consult your doctor or pharmacist before taking Coldrex tablets if:
- you have kidney or liver disease;
- you have hypertension, heart disease, peripheral blood vessel disease (Raynaud's disease);
- you are taking digoxin or other medicines to treat heart disease;
- you have diabetes or an overactive thyroid gland;
- you suffer from glaucoma;
- you have pheochromocytoma or prostate problems;
- you are taking anticoagulants - medicines used to thin the blood;
- you are taking medicines to treat Parkinson's disease;
- you are taking beta-blockers or other medicines to control blood pressure;
- you take appetite suppressants or stimulants;
- you are breastfeeding;
- the infection is prolonged, as this may increase the risk of metabolic acidosis.
Signs of metabolic acidosis include:
- deep, rapid, labored breathing;
- urges to vomit, vomiting;
- loss of appetite;
Tell your doctor right away if you have any combination of these symptoms.
Remember: Coldrex tablets contain paracetamol
Do not take with other medicines containing paracetamol such as pain relievers, medicines to reduce fever, fever, flu or sleeping pills.
Warnings and precautions
Talk to your doctor or pharmacist before taking Coldrex tablets.
Children and adolescents
Do not apply to children under 12 years of age.
Other medicines and Coldrex tablets
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use other medicines.
Do not take Coldrex tablets if you are taking tricyclic antidepressants or other medicines to treat depression and are taking, or have taken in the last two weeks, monoamine oxidase inhibitors.
Coldrex tablets with food, drink and alcohol
This medicine contains caffeine. Avoid drinking large amounts of tea, coffee or caffeinated beverages while taking Coldrex tablets. Increased caffeine intake can make you irritable and tense, have trouble sleeping, or feel an unpleasant feeling of tightness and heaviness in your chest.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
The medicinal product is not recommended during pregnancy due to a possible increase in the risk of miscarriage associated with the use of caffeine.
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 must be used during breastfeeding according to a doctor's prescription.
Caffeine is excreted in breast milk and may have a stimulating effect on the infant, but toxic concentrations have not been observed.
Driving and using machines
Do not drive or operate machinery if you feel dizzy.
- How to take Coldrex tablets
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
For oral use.
Adults, including those over 65 , and children 12 and over:
The recommended dose is 1 (one) – 2 (two) tablets every 4-6 hours as needed.
Do not take at intervals shorter than 4 hours.
Do not take more than 8 tablets in a 24-hour period.
Do not take longer than 7 (seven) days without consulting a doctor.
Do not exceed the recommended dose.
Use in children and adolescents
Do not apply to children under 12 years of age.
If you have taken more than the required dose of Coldrex tablets
Taking too much can damage the liver. If you take more than the recommended dose, seek medical attention immediately, even if you feel well.
Taking high doses of terpine hydrate and ascorbic acid can cause stomach problems, and caffeine and phenylephrine can make you irritable and tense.
If you forget to take use Coldrex tablets
Do not take a double dose to make up for a missed dose.
Take the dose when you remember.
- Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
With paracetamol, side effects are very rare (affecting less than 1 in 10,000 patients). Allergic reactions may occur, e.g. skin rash. Stop taking the medicine and consult your doctor if:
- you experience an allergic reaction such as itching, rash, breathing problems, swelling of the lips, tongue, throat or face;
- mouth ulcers occur;
- you have had breathing problems when using acetylsalicylic acid or non-steroidal anti-inflammatory drugs;
- you have unexpected bleeding or bruising;
- experience loss or blurring of vision, which may occur more often if you suffer from glaucoma;
- you feel an unusual fast pulse or heart skips a beat;
- you experience fluid retention, which is more likely in men with an enlarged prostate.
- very rare cases of serious skin reactions have been reported.
The dye sunset yellow (E110) can cause an allergic reaction in some patients.
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, phone: +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 tablets
Keep out of the reach of children.
To be stored at a temperature below 25 °C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. 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 dispose of medicines you no longer use. These measures will help protect the environment.
- Package contents and additional information
What do Coldrex tablets contain?
- The active substances are:
paracetamol 500 mg
caffeine 25 mg
phenylephrine hydrochloride 5 mg
terpine hydrate 20 mg
ascorbic acid 30 mg
- The other ingredients (excipients) are: corn starch, starch, talc, stearic acid, povidone, potassium sorbate, sodium lauryl sulfate, sunset yellow (E110).
What Coldrex tablets look like and what the package contains
Coldrex tablets are white-pink capsule-shaped tablets with rounded ends.
The package may contain 12 or 24 tablets.
Marketing Authorization Holder:
Adriatic BST doo, Verovškova ulica 55, 1000 Ljubljana, Slovenia
Manufacturer:
Wrafton Laboratories Limited,
Exeter Road, Wrafton, Braunton,
EX33 2DL,
United Kingdom
Omega Pharma International NV, Venecoweg 26,
B-9810 Nazareth, Belgium
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Bulgaria
Pharma Support Services Ltd
1 Danail Krapchev St., Apt. 9
Sofia 1700,
Bulgaria
phone: +359 2805 7108
e-mail: office@phsupport.net
Date of last revision of leaflet :
October 2019
