COLDREX / Coldrex for flu and cold x 24 tablets
Leaflet: information for the user
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, 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 7 days 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 you do not feel better after 7 days or your condition worsens, you should seek medical attention.
Coldrex tablets are used to relieve the symptoms of colds and flu: fever, headache, sore throat, runny nose and stuffy nose, sinus pain and muscle aches.
It contains paracetamol - an analgesic (pain reliever) and antipyretic (reduces fever), phenylephrine hydrochloride - a decongestant that causes swelling of the mucous membrane of the nose and sinuses, helping you breathe easier, 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.
Administer the lowest dose that has a therapeutic effect.
Do not take Coldrex tablets
- if you are allergic to the active substances or 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 vascular 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 medication to treat Parkinson's disease;
- you are taking beta-blockers or other medicines to control blood pressure;
- you are taking 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;
- nausea, vomiting;
- loss of appetite;
Tell your doctor immediately if you have a combination of these symptoms.
Remember: Coldrex tablets contain paracetamol.
Do not take with other medicines containing paracetamol such as painkillers, 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 use in 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 any other medicines.
Do not take Coldrex tablets if you are taking tricyclic antidepressants or other medications to treat depression and are taking or have taken monoamine oxidase inhibitors in the last two weeks.
Coldrex tablets with food, drinks and alcohol
This medicine contains caffeine. Avoid drinking large amounts of tea, coffee or caffeinated drinks while taking Coldrex tablets. Excessive caffeine intake may make you irritable and tense, have trouble sleeping or experience an unpleasant feeling of tightness and heaviness in your chest.
Pregnancy, breastfeeding 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 increased risk of miscarriage associated with caffeine use.
Paracetamol is excreted in breast milk, but there is no evidence that it increases the risk to the nursing infant. Due to the content of phenylephrine, the medicinal product should be used during breastfeeding only under medical supervision.
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 years of age , and children 12 years of age and older:
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 for longer than 7 (seven) days without consulting a doctor.
Do not exceed the recommended dose.
Use in children and adolescents
Do not use in children under 12 years of age.
If you take more Coldrex tablets than you should
Taking too much can damage your 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 Coldrex tablets, use
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.
Side effects with paracetamol are very rare (affecting less than 1 in 10,000 patients). Allergic reactions, e.g. skin rash, may occur. 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 appear;
- 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 frequently if you suffer from glaucoma;
- you feel an unusual increase in your pulse or a skipping heartbeat;
- 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) may cause an allergic reaction in some patients.
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 tablets
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 after “EXP”. 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 dispose of medicines you no longer use. This will help to 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 pack contains
Coldrex tablets are white-pink capsule-shaped tablets with rounded ends.
The package may contain 12 or 24 tablets.
Marketing Authorisation 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Bulgaria
Pharma Support Services Ltd.
1 Danail Krapchev St., apt. 9
Sofia 1700,
Bulgaria
tel.: +359 2805 7108
email: office@phsupport.net
Date of last revision of the leaflet :
October 2019
