FLURAPID MAX cold and cough

• Short description
• How to use

• • elevated temperature body
  • headache and muscle aches
  • sinus headaches
  • stuffy nose
  • sore throat
  • cough

• CONTENT
  What FLURAPID MAX cold and cough looks like and contents of the pack FLURAPID MAX cold and cough contains powder for oral solution in sachet. Each box contains 8 sachets and a package leaflet for the patient.

  Method of use
  The recommended dose is: Adults and children over 15 years of age: 1 sachet every 4 or 6 hours if necessary. Do not take more than once every 4 hours. Do not take more than 4 sachets over a period of 24 hours. Do not exceed the indicated dose.

• General information
• Ingredients

• Package leaflet: Information for the patient

  FLURAPID MAX cold and cough 1000 mg/200mg/12,2 mg powder for oral solution in sachet

  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 have told you.  

  - Keep this leaflet. You may need to read it again.  

  - Ask your pharmacist if you need more information or advice.

  - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

  - You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

  What is in this leaflet

   1. What FLURAPID MAX cold and cough is 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 pack and other information

   1. What FLURAPID MAX cold and cough is and what it is used for

   FLURAPID MAX cold and cough is used to quickly relieve symptoms of colds and flu, fever, headache and body aches, sinus pain, congested nose, sore throat, and cough.

  FLURAPID MAX cold and cough contains three active ingredients:

  • Paracetamol – a well-known analgesic: product used for lowering the temperature (antipyretic);

  • Guaifenesin – expectorant. Facilitates expectoration. Dilutes secretions, which helps relieve chest cough;

  • Phenylephrine hydrochloride – decongestant. It reduces the swelling of the mucous membranes of the nose and sinuses, unclogs the nose and helps you breathe easier.

  FLURAPID MAX cold and cough is recommended only if all symptoms (pain and/or fever, nasal congestion and chest cough) are present.

  You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

  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 section 6);

  - if you are taking or have taken in the last 2 weeks drugs known as monoamine oxidase inhibitors (MAOI’s) which are commonly used to treat depression;

  - if you are taking drugs with or without a prescription that contain paracetamol to treat pain, fever, colds 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 kidney or liver diseases;

  - you have high blood pressure, heart disease, or vascular 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;

  - you have pheochromocytoma (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, difficulty breathing; urges to vomit, vomiting; loss of appetite.

  Tell your doctor immediately if you have combination of these symptoms.

   It is especially important to know that:

  - If the effect of treatment is insufficient or absent (e.g. symptoms of the disease last longer that 3 days), it is necessary to consult your doctor or pharmacist;

  - Do not take doses higher than recommended, as the risk of paracetamol overdose cannot be ruled out. To prevent this, it is necessary to check that other concomitant medications also do not contain paracetamol;

  - This medicine should be used with caution and always after consulting a doctor if you are taking or have recently taken any other medicines (see section 2);

  - The risk of liver damage is increased when taking a large doses over a long period of time, more often in people who regularly use medicines that damage the liver or consume alcohol regularly;

  - Patients with heart diseases, high blood pressure, severe stomach and intestinal problems, 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 colds 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, so there should be an interval of at least 1 hour between taking doses of both medicines;

  - phenobarbital, phenytoin, carbamazepine, rifampicin – liver damage may occur;

  - coumarin anticoagulants (agents that reduce the ability of the blood to clot) – may increase their action and the occurrence of bleeding;

  - MAO inhibitors or tricyclic antidepressants (products for treatment of depression) – a life-threatening increase in blood pressure is possible;

  - medicines for heart diseases and high blood pressure – it is possible to reduce their effect or the appearance of heart rhythm disorders;

  - analgesics and antipyretics, incl. aspirin – increases the risk of kidney damage;

  - appetite suppressants or stimulants;

  - sympathomimetics (common in eye or nose drops) – increases the risk of side effects from the heart.

  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, therefore alcohol should not be consumed while taking this medicine.

  Pregnancy, breast-feeding and fertility

  If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

  This medicine should not be taken by pregnant or breast-feeding 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 use machines.

   FLURAPID MAX cold and cough contains:

  - sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine;

  - sodium. This medicinal product contains 83 mg of sodium (the main ingredient in table salt) in each sachet. This amount is equivalent to 4.15% of the recommended maximum daily sodium intake 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 have told you. Check with your doctor or pharmacist if you are not sure.  

  The recommended dose is:

  Adults and children over 15 years of age: 1 sachet every 4 or 6 hours if necessary. Do not take more than once every 4 hours. Do not take more than 4 sachets over a period of 24 hours. Do not exceed the indicated dose.

  Method of administration:

  Pour the contents of one sachet into a glass, add warm water at a temperature not exceeding 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 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 take more FLURAPID MAX cold and cough than you should

  Paracetamol poisonings have been observed in adults and especially in children, which can sometimes be very serious. They may be due to an overdose as a result of taking a higher dose or to inadvertent accidents. Overdose is manifested by nausea, vomiting, paleness, abdominal pain, swating and drowsiness, most often 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 increase blood pressure.

  If you have taken more than the recommended dose or if you experience symptoms of overdose, contact a doctor or visit the nearest medical institution immediately.

  If you forget to take FLURAPID MAX cold and cough

  Do not take a double dose to make up for a forgotten dose. Take the dose of FLURAPID MAX cold and cough when you remember. Do not take more than one dose every 4 hours.

  If you stop taking FLURAPID MAX cold and cough

  Do not stop treatment prematurely, as this may not achieve the expected effect.

   If you have any further questions on 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 according to 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 1/1000), very rare (≤1/10 000), with unknown 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 (diarrhea, nausea, vomiting), headache or dizziness, palpitations, high blood pressure, difficulty falling asleep (insomnia), nervousness, tremor, irritability, disturbance, confusion or anxiety;

  • Very rare – serious skin reactions, 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 of side effects

  If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

  Bulgarian Drug Agency

  8, Damyan Gruev str.,

  1303 Sofia, Bulgaria

  +359 2 8903417

  www.bda.bg

  By reporting side effects, you can help provide more information on the safety of this medicine.

  5. How to store FLURAPID MAX cold and cough

  Keep this medicine out of the sight and reach of children.

  Do not use this medicine after the expiry date which is stated on the sachet or carton after EXP. The expiry date refers to the last day of that month.

  Do not use this medicine if you notice any visible signs of deterioration in the quality of the product.

  Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

   6. Contents of the pack and other information

   What FLURAPID MAX cold and cough contains  

  - The active substances in one sachet are 1000 mg paracetamol, 200 mg guaifenesin and 12,2 mg phenylephrine hydrochloride.

  - The excipients are sucrose, citric acid, ascorbic acid (Vitamin C), sodium citrate, saccharin sodium, sodium cyclamate, povidone, colloidal anhydrous silica, lemon flavour.

   What FLURAPID MAX cold and cough looks like and contents of the pack

  FLURAPID MAX cold and cough contains powder for oral solution in sachet.

  Each box contains 8 sachets and a package leaflet for the patient.

   Marketing Authorisation Holder and Manufacturer

  Fortex Nutraceuticals Ltd.

  10, Prohladen kat str.,

  1362, Sofia, Bulgaria

  This leaflet was last revised in February 2020.

   

•  What FLURAPID MAX cold and cough contains  

  - The active substances in one sachet are 1000 mg paracetamol, 200 mg guaifenesin and 12,2 mg phenylephrine hydrochloride.

  - The excipients are sucrose, citric acid, ascorbic acid (Vitamin C), sodium citrate, saccharin sodium, sodium cyclamate, povidone, colloidal anhydrous silica, lemon flavour.

   

Related products