COLDREX PLUS COUGH cough for flu and cold x 10 sach
Leaflet
Leaflet: patient information
Coldrex Plus Cough
500 mg/200 mg/10 mg powder for oral solution
Coldrex Plus Cough
500 mg/200 mg/10 mg powder for oral solution
Paracetamol, Guaifenesin, Phenylephrine hydrochloride
Paracetamol, Guaifenesin, Phenylephrine 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.
- 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.
What this leaflet contains:
1. What Coldrex Plus Cough is and what it is used for
2. What you should know before taking Coldrex Plus Cough
3. How to take Coldrex Plus Cough
4. Possible side effects
5. How to store Coldrex Plus Cough
6. Contents of the package and additional information
1. What Coldrex Plus Cough is and what it is used for
Coldrex Plus Cough contains the following active substances:
- Paracetamol, which has a pain-relieving (analgesic) effect and is effective against pain, including headaches and sore throats, and also helps to reduce the temperature when you have a fever (antipyretic).
- Guaifenesin, which is an expectorant that helps loosen mucus (phlegm) when you have a cough.
- Phenylephrine hydrochloride, which is a decongestant used to reduce swelling in the nasal passages to help you breathe easier.
Coldrex Plus Cough is used for short-term relief of cold and flu symptoms, including pain, such as headache and sore throat, nasal congestion, chills and high fever. Removes stubborn mucus (sputum) and relieves cough, in adults and children over 12 years old.
This medicine should only be used if you have all of the following symptoms - pain and/or high fever, stuffy nose and cough.
If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
You should see a doctor if you do not feel better or if you feel worse after 3 days.
2. What you should know before taking Coldrex Plus Cough
Do not take Coldrex Plus Cough if:
- you are allergic to paracetamol, guaifenesin, phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
- you have liver or severe kidney disease;
- you have heart or cardiovascular disease or blood problems, such as anemia (low red blood cell count);
- you have high blood pressure (hypertension);
- you have an overactive thyroid gland (hyperthyroidism);
- you have diabetes;
- you have a pheochromocytoma (a rare tumor of the tissues of the adrenal gland);
- you are taking tricyclic antidepressants such as imipramine or amitriptyline;
- you are taking beta-blockers (eg atenolol) or vasodilators (eg hydralazine) used to treat high blood pressure (hypertension);
- you are taking other medicines containing paracetamol;
- you are taking antidepressants called monoamine oxidase (MAO) inhibitors, or have taken them in the last 14 days - these are medicines such as moclobemide, phenelzine, isocarboxazid and tranylcypromine;
- you have angle-closure glaucoma (high pressure in the eyes);
- you have difficulty urinating, an enlarged prostate or other prostate problems;
- you are taking other decongestant medications (eg, ephedrine and xylometazoline) or stimulants (eg, dexamphetamine);
Warnings and precautions
Talk to your doctor or pharmacist before taking Coldrex Plus Cough if:
- you have a very bad cough or asthma or it is accompanied by a fever, rash or persistent headache. Consult your doctor if your cough lasts more than 5 days or reoccurs;
- you have circulatory disorders, such as a condition called Raynaud's phenomenon, which is due to poor circulation in the fingers and toes;
- you have angina or other cardiovascular diseases;
- you have an autoimmune disease called myasthenia gravis, in which the muscles tire easily and become weak;
- you have an enlarged prostate gland, as this can cause more difficulty urinating;
- you have severe stomach or intestinal problems;
- you have liver or kidney disease;
- you are taking a cough suppressant;
- you have difficulty sleeping (insomnia), nervousness, increased body temperature, tremors and/or convulsions;
- you have an intolerance to some sugars;
- you suffer from phenylketonuria, a rare inherited metabolic disease.
You should see your doctor if:
- develop a high fever;
- develop signs of other inflammations, such as general malaise, night sweats, fatigue, pain or swelling;
- your symptoms do not improve after 3 days.
Children and adolescents
Do not give this medicine to children under 12 years of age.
Other medicines and Coldrex Plus Cough
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking any of the following medicines, please talk to your doctor before taking Coldrex Plus Cough:
- If you are taking probenecid, talk to your doctor as it may be necessary to reduce the dose of Coldrex Plus Cough.
- Medicines to treat high cholesterol levels that reduce the amount of fat in the blood, such as cholestyramine.
- Medicines to control nausea or vomiting, such as metoclopramide or domperidone.
- Medicines called anticoagulants, which are used to thin the blood, such as warfarin or other coumarins - you can take individual doses of paracetamol, but you should consult your doctor if you need to take it regularly.
- Barbiturates (for epilepsy or to help sleep), such as phenobarbitones.
- Tricyclic antidepressants, such as imipramine, amitriptyline.
- Monoamine oxidase (MAO) inhibitors, such as moclobemide, phenelzine, isocarboxazid, and tranylcypromine, used to treat depression.
- Medicines to treat heart or circulatory problems or to lower blood pressure (eg digoxin, guanethidine, reserpine, methyldopa).
- Aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs).
- Medicines to treat migraines (eg ergotamine and methylsergide).
- Zidovudine, as this can cause blood problems (low white blood cell count).
- Phenothiazines used as sedatives (eg, chlorpromazine, perikanisin, and fluphenazine).
- Other flu or cold medicines or decongestant medicines containing sympathomimetic amines.
- If you are going to have blood or urine tests, as taking this medicine may affect the results.
- If you are going to have a general anaesthetic, as this can cause changes in your heart rhythm.
Coldrex Plus Cough and alcohol
Do not drink alcohol when taking this medicine.
Pregnancy and breastfeeding
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.
This medicine should not be used during pregnancy and breastfeeding without medical advice.
Driving and using machines
This medicine may cause dizziness. If affected, do not drive or operate machinery.
Coldrex Plus Cough contains sucrose
Contains 2.1 g of sucrose (sugar) per sachet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This should be considered in patients with diabetes.
Coldrex Plus Cough contains aspartame (E951)
Contains a source of phenylalanine. May be harmful to people with phenylketonuria.
Coldrex Plus Cough contains sodium
Each sachet contains 129 mg sodium. This should be considered in patients on a controlled sodium diet.
3. How to take Coldrex Plus Cough
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, the elderly and children aged 12 and over
The recommended dose is 1 sachet every 4 to 6 hours, as needed. Do not take more than 4 sachets (4 doses) in a 24 hour period.
Use in children and adolescents
Do not give the medicine to children under 12 years of age.
Pour the contents of 1 sachet into a standard glass. Fill the beaker to the brim with approximately 250ml of hot, but not boiling, water. Stir until dissolved and allow to cool to drinking temperature. Drink the entire yellow solution within an hour and a half.
Do not exceed the indicated dose. If your symptoms last more than 3 days or get worse, you should see a doctor or pharmacist.
If you have taken more than the required dose of Coldrex Plus Cough
Immediate medical attention should be sought in case of overdose due to the risk of irreversible liver damage. Talk to a doctor right away if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
Go to the nearest hospital. Take your medicine and this leaflet with you.
If you forget to take Coldrex Plus Cough
Do not take a double dose to make up for a missed dose.
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.
Most people have no side effects while taking this medication. However, if you experience any of the following side effects or anything else unusual, stop taking the medicine immediately and contact your doctor or pharmacist.
The following side effects may represent the most common side effects, although there are no exact frequencies:
- Difficulty falling asleep (insomnia),
- Diarrhea, nausea,
- Nervousness, tremors, irritability, restlessness or agitation,
- Increase in blood pressure with headache, dizziness, vomiting and irregular heart rhythm (palpitations).
The frequency of the events below is not known but is likely to be rare:
- Allergic reactions, which may be severe, such as skin rash, peeling skin, itching, swollen red areas of the skin, sometimes with shortness of breath or swelling of the mouth, lips, tongue, throat or face.
- Breathing problems, which are more likely if you have experienced them before when taking other pain relievers such as aspirin or ibuprofen.
- Stomach upset (pain or discomfort), nausea, vomiting, diarrhoea,
- Numbness or cooling of the skin,
- liver problems,
- A faster or irregular heartbeat,
- Acute increase in eye pressure, enlargement of the pupil of the eye,
- Trouble or pain with passing fluids.
The frequency of the events below is not known but is thought to be very rare:
- You may be more prone to bleeding, bruising, fever and inflammation such as sore throat and ulcers due to blood changes.
Very rare cases of serious skin reactions have been reported.
If you have ever had an allergic reaction (hypersensitivity) to decongestants, medicines that suppress or stimulate appetite, you may be at increased risk of developing an allergic reaction when taking this product.
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 to the Executive Medicines Agency, Damyan Gruev Street No. 8, 1303 Sofia, phone: +35928903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton and sachet. The expiration date corresponds to the last day of the specified month.
To be stored below 25°C.
After reconstitution with hot water, the solution is stable for an hour and a half.
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.
6. Contents of the package and additional information
What Coldrex Plus Cough contains
Each sachet contains the active substances: paracetamol (500 mg), guaifenesin (200 mg) and phenylephrine hydrochloride (10 mg)
The other ingredients are: sucrose, citric acid E330, tartaric acid E334, sodium cyclamate E952, sodium citrate E331, acesulfame potassium E950, aspartame E951, menthol flavoring powder [contains natural menthol, corn maltodextrin and gum arabic (E414)], lemon flavoring [contains flavoring agent, natural flavoring agent, maize maltodextrin, gum arabic E414, sodium citrate E331, citric acid E330 and butylated hydroxyanisole E320 (0.01%)], flavoring agent lemon juice [contains flavoring agent, natural flavoring agent(s), maltodextrin, modified starch E1450 and butylated hydroxyanisole E320 (0.03%)], quinoline yellow E104.
What Coldrex Plus Cough looks like and what the package contains
Coldrex Plus Cough is a powder for oral solution, whitish in color and with a characteristic citrus/mint aroma, in a sachet.
The prepared solution is multi-hued yellow with a characteristic citrus/mint aroma.
Coldrex Plus Cough is available in packs of 5, 6, 10, 14, 15 and 20 sachets, although not all pack types may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Adriatic BST doo
Verovškova ulica 55
1000 Ljubljana
Slovenia
Manufacturer :
Wrafton Laboratories Limited
Braunton, Devon, EX33 2DL
United Kingdom
Omega Pharma International NV,
Venecoweg 26, B-9810
Nazareth,
Belgium
This medicine is authorized for use in the EEA member states under the following names:
Bulgaria | Coldrex Plus Cough | |
Ireland |
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România |
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United Kingdom |
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Date of last revision of leaflet: March 2019.
