FORTEX FLURAPID MAX cold and cough x 8 sach
FLURAPID MAX cold and cough 1000 mg/200 mg/12.2 mg powder for oral solution in sachet
FLURAPID MAX cold and cough 1000 mg/200 mg/12.2 mg powder for oral solution in sachet
Paracetamol/Guaiphenesin/Phenylephrine hydrochloride
Paracetamol/Guaiphenesin/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 is FLURAPID MAX cold and cough and what it is used for
2. What you need to know before you take FLURAPID MAX cold and cough
3. How to take FLURAPID MAX cold and cough
4. Possible side effects
5. How to store FLURAPID MAX cold and cough
6. Contents of the package and additional information
1. What is FLURAPID MAX cold and cough and what it is used for
FLURAPID MAX cold and cough is used for rapid relief of cold and flu symptoms, fever, headache and body aches, sinus pain, stuffy nose, sore throat, cough.
FLURAPID MAX cold and cough contains three active ingredients:
- Paracetamol - a well-known pain reliever analgesic: a product that reduces temperature (antipyretic);
- Guaifenesin – expectorant. Facilitates expectoration. Dilutes secretions, which helps relieve a chesty cough.;
- Phenylephrine hydrochloride – decongestant. It causes swelling of the mucous membrane of the nose and sinuses, unclogs the nose and helps you breathe more easily.
FLURAPID MAX cold and cough is recommended only if all symptoms (pain and/or fever, nasal congestion and chesty cough) are present.
If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
2. What you need to know before you take FLURAPID MAX cold and cough
Do not take FLURAPID MAX cold and cough if:
- you are allergic to paracetamol, guaifenesin, phenylephrine or any of the other ingredients of this medicine (listed in point 6);
- 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;
- you are taking prescription or over-the-counter medicines that contain paracetamol for pain, fever, cold and flu symptoms, or sleeping pills.
Warnings and precautions
Talk to your doctor or pharmacist before taking FLURAPID MAX cold and cough if:
- you suffer from liver or kidney diseases;
- 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);
- you have increased thyroid function or diabetes mellitus;
- you have a pheochromocytoma (a tumor near the kidney);
- you suffer from glaucoma (increased intraocular pressure);
- you have prostate problems or difficulty urinating;
- the infection is prolonged, as this may increase the risk of metabolic acidosis. Signs of metabolic acidosis include: deep, rapid, labored breathing; urge to vomit, vomiting; loss of appetite.
Tell your doctor right away if you have any combination of these symptoms.
It is especially important to know that:
- If the effect of the treatment is insufficient or absent (e.g. the symptoms of the disease last longer than 3 days), it is necessary to consult your doctor or pharmacist;
- You should not take doses higher than recommended, as the risk of paracetamol overdose cannot be excluded. To prevent this, it is necessary to check whether other simultaneously taken drugs also do not contain paracetamol;
- This medicine should be used with particular care and absolutely after consulting a doctor if you are taking or have recently taken certain medicines (see point 2);
- When taking large doses for a long period of time, more often in people who regularly use drugs that damage the liver or regularly consume alcohol, the risk of liver damage increases;
- Patients with heart diseases, with high blood pressure values, severe diseases of the stomach and intestines, some lung diseases and especially asthma, should take the medicine only after consulting a doctor.
Children and adolescents
FLURAPID MAX cold and cough should not be used in children under 15 years of age.
Other medicines and FLURAPID MAX cold and cough
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This applies in particular to the following medicines:
- medicines containing paracetamol, decongestants for cold and flu or cough products. If you are taking such medicines, do not take FLURAPID MAX cold and cough;
- metoclopramide, domperidone, cholestyramine - change the absorption of paracetamol, therefore there should be an interval of at least 1 hour between doses;
- phenobarbital, phenytoin, carbamazepine, rifampicin - liver damage may occur;
- coumarin anticoagulants (agents that reduce the ability of blood to clot) - it is possible to increase their action and the appearance of hemorrhages;
- MAO-inhibitors or tricyclic antidepressants (products for the treatment of depression) - a life-threatening increase in blood pressure is possible;
- medicines for diseases of the heart and high blood pressure - it is possible to reduce their effect or the appearance of heart rhythm disorders;
- painkillers and antipyretic drugs, incl. aspirin - the risk of kidney damage increases;
- means to suppress or stimulate the appetite;
- sympathomimetics (common in eye or nose drops) - the risk of side effects from the heart increases.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
FLURAPID MAX cold and cough with food, drink and alcohol
There are no restrictions on taking FLURAPID MAX cold and cough with food and drink.
Concomitant use with alcohol increases the risk of liver damage, so alcohol should not be consumed while taking this medicine.
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 medicine should not be taken by pregnant and lactating women, due to a lack of data on its safe use.
Driving and using machines
FLURAPID MAX cold and cough may cause dizziness. If this happens to you, do not drive or operate machinery.
FLURAPID MAX cold and cough contains:
- sucrose. If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicinal product;
- sodium. This medicinal product contains 83 mg of sodium (the main ingredient of table salt) in each sachet. This amount is equivalent to 4.15% of the recommended maximum daily dietary intake of sodium for adults.
3. How to take FLURAPID MAX cold and cough
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Adults and children over 15 years of age: 1 sachet every 4 or 6 hours as needed. Do not take more often than once every 4 hours. Do not take more than 4 sachets in a 24 hour period. Do not exceed the indicated dose.
Application method:
Pour the contents of one sachet into a glass, add warm water with a temperature not higher than 45°C, then stir and drink immediately.
Use in children and adolescents
This medicine should not be used in children under 15 years of age.
If high fever and other symptoms persist for more than 3 days, consult your doctor and stop taking FLURAPID MAX cold and cough. Do not exceed the indicated daily dose.
If you have taken more than the required dose of FLURAPID MAX cold and cough
Paracetamol poisoning has been observed in adults and especially in children, which can sometimes be very serious. They may be due to overdose as a result of taking a higher than indicated dose or to inadvertent accidents. Overdose is manifested by nausea, vomiting, pallor, abdominal pain, sweating and drowsiness, most often occurring in the first 24 hours. Paracetamol overdose can cause severe liver damage and loss of consciousness. Taking high doses of phenylephrine can lead to a significant increase in heart rate and blood pressure.
If you have taken more than the recommended dose or if symptoms of overdose appear, immediately consult a doctor or visit the nearest medical facility.
If you forget to take FLURAPID MAX cold and cough
Do not take a double dose to make up for a missed dose. Take the FLURAPID MAX cold and cough dose when you remember. Do not take more than one dose every 4 hours.
If you have stopped taking FLURAPID MAX cold and cough
Do not stop the treatment prematurely, because then you may not achieve the expected effect of it.
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.
Adverse reactions are classified by system organ class and frequency as follows: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) ), rare (≥1/10,000 to <1/1,000), very rare (≤ 1/10,000), not known (frequency cannot be estimated from the available data).
The following side effects are possible:
• Common - loss of appetite, nausea or vomiting;
• Rare - severe allergic reactions (anaphylaxis), difficulty breathing, stomach pain or discomfort (diarrhoea, nausea, vomiting), headache or dizziness, heart palpitations (palpitations), high blood pressure, difficulty sleeping (insomnia), nervousness, shaking (tremor). , irritability, restlessness, confusion or anxiety;
• Very rare – serious skin reactions, the appearance of certain blood cell disorders, pancreatitis (inflammation of the pancreas) with paracetamol.
If signs of an adverse reaction or any other serious reaction occur, stop taking FLURAPID MAX cold and cough and consult your doctor.
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, 8 Damyan Gruev Street, 1303 Sofia: phone +359 2 8903417, website: www.bda.bg. By reporting side effects, you can help get more information about the safety of this medicine.
5. How to store FLURAPID MAX cold and cough
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the sachet or carton after EXP. The expiration date corresponds to the last day of the specified month.
Do not use this medicine if you notice visible signs of product deterioration.
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 does FLURAPID MAX cold and cough contain
- The active substances in one sachet are: 1000 mg of paracetamol, 200 mg of guaifenesin and 12.2 mg of phenylephrine hydrochloride.
- Excipients are: sucrose, citric acid, ascorbic acid (Vitamin C), sodium citrate, sodium saccharin, sodium cyclamate, povidone, colloidal anhydrous silicon dioxide, lemon flavor.
What FLURAPID MAX cold and cough looks like and what the package contains
FLURAPID MAX cold and cough contains powder for oral solution in a sachet.
Each box contains 8 sachets and a patient leaflet.
Marketing Authorization Holder and Manufacturer
Fortex Nutraceuticals Ltd
10 Prohladen kat St.,
Sofia 1362, Bulgaria
