COLDREX MAXGRIP for flu and cold with a berry flavor x 10 sach
Leaflet: user information
Coldrex ® MaxGrip Berries 1000 mg/10 mg/70 mg powder for oral solution
paracetamol/phenylephrine hydrochloride/ascorbic acid
Coldrex ® MaxGrip Berry fruit 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 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 :
1. What Coldrex MaxGrip Berries is and what it is used for
2. What you need to know before you take Coldrex MaxGrip Berries
3. How to take Coldrex MaxGrip Berries
4. Possible side effects
- How to store Coldrex MaxGrip Berries
6. Contents of the package and additional information
1. What Coldrex MaxGrip Berries is and what it is used for
Coldrex MaxGrip Berries contains paracetamol, phenylephrine and ascorbic acid (vitamin C):
- Paracetamol is a pain-relieving drug that also helps reduce high fever;
- Phenylephrine hydrochloride is a sympathomimetic nasal decongestant that unclogs the nose and sinuses, helping you breathe easier,
- Vitamin C supplements natural levels of vitamin C, which can decrease with a viral infection such as the common cold.
Coldrex MaxFlu Berries provides short-term relief of cold and flu symptoms, including headache, high fever, sore throat, muscle and joint pain, nasal congestion, sinusitis and associated pain.
2. What you need to know before you take Coldrex MaxGrip Berries
Do not exceed the recommended dose.
Use the lowest dose that has a therapeutic effect.
Do not take Coldrex MaxGrip Berries :
- if you are allergic (hypersensitive) to paracetamol, phenylephrine, ascorbic acid or any of the other ingredients;
- do not use this medicinal product if you are taking prescription or over-the-counter medicines that contain paracetamol for 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 commonly used to treat depression.
Pay special attention when using Coldrex MaxGrip Berries
Consult your doctor before use :
- if you have liver or kidney problems;
- if you have high blood pressure, heart disease or 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 (a 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;
- urges to vomit, vomiting;
- loss of appetite;
Tell your doctor right away if you have any combination of these symptoms.
Not recommended for children under 12 years of age, unless prescribed by a doctor.
Other medicines and Coldrex MaxGrip Berries
Ask your doctor before using this medicine if you are taking any of the following medicines :
- warfarin or similar blood thinners;
- medicines to control blood pressure 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 those obtained without a prescription.
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.
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 Berries
- Each dose contains 5 g of sucrose. You should keep this in mind if you suffer from diabetes. If your doctor has informed you that you suffer from an intolerance to some sugars, seek advice before taking this medicinal product;
- Contains a source of phenylalanine. May be harmful to people with phenylketonuria;
- Contains sunset yellow (E110) and carmoisine (E122). May cause allergic reactions;
- Contains 117mg of sodium per serving. This should be kept in mind by patients on a controlled sodium diet.
3. How to take Coldrex MaxGrip Berries
Adults (including the elderly) and children aged 12 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. If necessary, add cold water.
Not to be taken more often 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 have taken more than the required dose of Coldrex MaxGrip Berries
You should seek medical advice immediately, even if you feel well, because of the risk of severe liver failure.
If you forget to take Coldrex MaxGrip Berries
Do not take a double dose to make up for a missed dose. Not to be taken more often than once every 4 hours.
4. Possible side effects
Like all medicines, Coldrex MaxGrip Berries can cause side effects, although not everybody gets them.
When using this product, you may experience:
Headache, dizziness, nervousness, difficulty falling asleep, increased blood pressure, nausea and vomiting.
Stop taking the medicine and inform 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 skin bruising or bleeding;
- an unusually fast pulse or a feeling of an unusually fast or irregular heartbeat;
- loss of vision, which may be due to pathologically increased blood pressure in the eye. The latter is more likely in people suffering from glaucoma;
- difficulty urinating. It is 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 become serious or you notice other side effects not described in this leaflet, please tell your doctor or pharmacist.
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, Tel.: +35 928903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Coldrex MaxGrip Berries
Store below 30 ° C.
Keep out of the reach of children.
Do not use after the expiry date stated on the box and sachet. The expiration date corresponds to the last day of the specified month.
Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of your unwanted medicines. These measures will help protect the environment.
6. Contents of the package and additional information
What Coldrex MaxGrip Berries contains
- The active substances are paracetamol 1000 mg, phenylephrine hydrochloride 10 mg, ascorbic acid (vitamin C) 70 mg
- The other ingredients are sucrose, sodium citrate anhydrous, tartaric acid, aspartame, artificial berry flavor, Euroblend black currant color (contains sunset yellow E110, carmoisine E122 and green S E142).
What Coldrex MaxGrip Berries looks like and contents of the pack
Pale pink powder with a characteristic fruity menthol smell.
Each pack contains 5, 8, 10 or 14 sachets of 7.6 g of powder each.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 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 the leaflet : January 2019.
