COLDREX MAXGRIP for flu and cold with lemon flavor x 10 sach
Leaflet
Leaflet: information for the user
Coldrex ® MaxGrip Lemon 1000 mg/10 mg/70 mg powder for oral solution
paracetamol/phenylephrine hydrochloride/ascorbic acid
Coldrex ® MaxGrip Lemon 1000 mg/10 mg/70 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.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse 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, pharmacist or nurse. 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 :
1. What Coldrex MaxGrip Lemon is and what it is used for
2. What you need to know before you take Coldrex MaxGrip Lemon
3. How to take Coldrex MaxGrip Lemon
4. Possible side effects
- How to store Coldrex MaxGrip Lemon
6. Contents of the pack and other information
1. What Coldrex MaxGrip Lemon is and what it is used for
Coldrex MaxGrip Lemon contains paracetamol, phenylephrine and ascorbic acid (vitamin C):
- Paracetamol is a painkiller that also helps reduce high fever;
- Phenylephrine hydrochloride is a decongestant sympathomimetic that unclogs the nose and sinuses, helping you breathe more easily.
- Vitamin C supplements natural vitamin C levels, which can decrease with a viral infection like a cold.
Coldrex MaxGrip Lemon provides short-term relief of cold and flu symptoms, including headache, fever, sore throat, muscle and joint pain, stuffy nose, sinusitis and related pain.
2. What you need to know before you take Coldrex MaxGrip Lemon
Do not exceed the recommended dose.
Administer the lowest dose that has a therapeutic effect.
Do not take Coldrex MaxGrip Lemon :
- if you are allergic (hypersensitive) to paracetamol, phenylephrine, ascorbic acid or any of the other ingredients;
- 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;
- if you are currently taking or have taken in the last two weeks medicines known as monoamine oxidase inhibitors (MAOIs), which are usually used to treat depression.
Take special care when using Coldrex MaxGrip Lemon
Consult your doctor before use :
- if you have liver or kidney problems;
- if you have high blood pressure, heart disease or a blood vessel disease such as Raynaud's syndrome (which may manifest as pain in the fingers or toes in response to cold or stress), diabetes or an overactive thyroid gland;
- if you have glaucoma (excessively high pressure inside the eyes);
- if you have pheochromocytoma (tumor near the kidney);
- if you have prostate problems or difficulty urinating;
- if you are pregnant, trying to get pregnant or 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.
Not recommended for children under 12 years of age, unless prescribed by a doctor.
Other medicines and Coldrex MaxGrip Lemon
Consult your doctor before using this medicine if you are taking any of the following medicines :
- warfarin or similar blood thinners;
- blood pressure control medications such as beta-blockers;
- digoxin or other similar medicines to treat heart disease;
- appetite suppressants or stimulants;
- medicines to treat depression, such as tricyclic antidepressants, e.g. amitriptyline.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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.
This product should not be used during pregnancy or breastfeeding without medical advice.
Driving and using machines
This product may cause dizziness. If this happens to you, do not drive or operate machinery.
Important information about some of the ingredients of Coldrex MaxGrip Lemon
- Each dose contains 5 g of sucrose. You should take this into account if you suffer from diabetes. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product;
- Contains a source of phenylalanine. May be harmful for people with phenylketonuria;
- Contains sunset yellow (E110) and carmoisine (E122). May cause allergic reactions;
- Contains 117mg sodium per dose. This should be taken into consideration by patients on a controlled sodium diet.
3. How to take Coldrex MaxGrip Lemon
Adults (including the elderly) and children aged 12 years and over:
One sachet dissolved in a glass of water every four to six hours.
Pour the contents of the sachet into an empty container and fill halfway with very hot water. Stir well. Add cold water if necessary.
Do not take more than once every 4 hours. Do not take more than 4 sachets daily.
Do not exceed the indicated dose.
Do not take for more than 7 days. Consult a doctor if symptoms persist.
Do not take with other paracetamol-containing products or other medicines to relieve cough and cold or stuffy nose.
Use in children
Children aged 12 and over: see above.
Children under 12 years of age:
Not recommended unless prescribed by a doctor.
If you take more Coldrex MaxGrip Lemon than you should
You should seek medical advice immediately, even if you feel well, due to the risk of severe liver failure.
If you forget to take Coldrex MaxGrip Lemon
Do not take a double dose to make up for a missed dose. Do not take more often than once every 4 hours.
4. Possible side effects
Like all medicines, Coldrex MaxGrip Lemon can cause side effects, although not everybody gets them.
When using this product, you may experience:
Headache, dizziness, nervousness, difficulty sleeping, increased blood pressure, nausea and vomiting.
Stop taking the medicine and tell your doctor in case of:
- allergic reactions, such as rashes or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat or face;
- skin rash or peeling skin, or mouth ulcers;
- previous respiratory problems caused by acetylsalicylic acid or non-steroidal anti-inflammatory drugs and the presence of a similar reaction when using this product;
- unexplained bruising or bleeding;
- unusually fast heartbeat or a feeling of an unusually fast or irregular heartbeat;
- Vision loss, which can be due to abnormally high blood pressure in the eye. The latter is more likely in people suffering from glaucoma;
- difficulty urinating. More likely in men with an enlarged prostate;
- Very rare cases of serious skin reactions have been reported.
These reactions are rare.
If any of the side effects gets serious or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
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.
5. How to store Coldrex MaxGrip Lemon
Store below 30 ° C.
Keep out of the reach of children.
Do not use after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month.
Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.
6. Contents of the pack and other information
What does Coldrex MaxGrip Lemon contain?
- The active substances are paracetamol 1000 mg, phenylephrine hydrochloride 10 mg, ascorbic acid (vitamin C) 40 mg
- Each sachet also contains citric acid, silicon dioxide, corn starch, sodium citrate, sugar, sodium cyclamate, sodium saccharin, natural curcumin, (E100), lemon essence
What Coldrex MaxGrip Lemon looks like and what the pack contains
Each pack contains 5, 8, 10 or 14 sachets with 7.6 g of powder each.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Adriatic BST doo, Verovškova ulica 55, 1000 Ljubljana, Slovenia
Manufacturer:
SmithKline Beecham, SA, Carretera de Ajalvir, km.2.500, 28806 Alcalá de Henares
Madrid, Spain
Wrafton Laboratories Limited,
Exeter Road, Wrafton, Braunton,
EX33 2DL,
United Kingdom
Omega Pharma International NV,
Venecoweg 26, Nazareth 9810,
Belgium
For any information about this medicinal product, 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 : January 2019
