Flurapid

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• Package leaflet: Information for the patient

   Flurapid 500 mg/25 mg/200 mg powder for oral solution in sachet

  Paracetamol/Pheniramine maleate/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 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 7 days.

  What is in this leaflet

  1. What Flurapid  is and what it is used for  

  2. What you need to know before you take Flurapid

  3. How to take Flurapid  

  4. Possible side effects  

  5. How to store Flurapid

  6. Contents of the pack and other information

   1. What Flurapid is and what it is used for  

  Flurapid contains 3 active substances:  paracetamol, pheniramine maleate and ascorbic acid and is used in adults and children over 15 years of age.

  • Paracetamol is a painkiller that also helps to reduce fever.

  • Pheniramine maleate is an antihistamine that relieves the nose and sinuses by helping you to breathe more easily.

  • Ascorbic acid (Vitamin C) complements the natural levels from vitamin C, which can be reduced by a viral infection or flu.

  Flurapid is used for short-term relief of cold symptoms, allergic rhinitis, rhinopharyngitis and flu conditions in adults and children over 15 years of age: reduced nasal and tear secretion, sneezing, fever, headache, mild to moderate pain.

   2. What you need to know before you take Flurapid  

  Do not take Flurapid:  

  - if you are allergic to any of the active substances or any of the other ingredients (listed in section 6);

  - if you have liver disease or kidney desease;

  - if you suffer from some kind of glaucoma (increased intraocular pressure);

  - if you have prostate disease;

  - if you are a child under 15 years of age;

  - if you have high blood pressure or other cardiovascular disease;

  - if you are taking other medicines, containing paracetamol, nasal or for cough and cold medicines;

  - if you are taking medicines known as monoamine oxidase inhibitors (MAOIs)  are commonly used to treat conditions such as depression.

   Warnings and precautions

  Talk to your doctor  or pharmacist before taking Flurapid.

  This is important because in some conditions you are more likely to get side effects (see also section 4):

  - if you accidentally take a higher dose than you needed;

  - if you have severe kidney or liver disease;

  - if you are taking other medicines containing paracetamol;

  - if you have some allergie;

  - if you are pregnant or breast-feeding;

  - if you have elevated intraocular pressure;

  - if you have problems with the prostate;

  - if your symptoms last longer than 7 days;

  - if you have high blood pressure or heart disease.

   Children  

  Flurapid should not be used in children under 15 years of age.  

   Other medicines and Flurapid

  Tell to your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This applies especially to:

  - warfarin or other similar blood thinners;

  - blood pressure control medicines such as beta-blockers;

  - digoxin or other similar medicines for treatment of cardiac diseases;

  - medicines for the treatment of depression, such as tricyclic antidepressants, for example amitriptyline;

  - if you are taking other medicines containing antihistamines or paracetamol.

   Flurapid with food, drink and alcohol

  Alcohol should not be taken during the treatment.

   Pregnancy, breast-feeding and fertility

  If you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Flurapid is not recommended during pregnancy or breast-feeding, unless your doctor thinks it is absolutely necessary.

   Driving and using machines

  People who drive or operate machinery should be aware that there is a risk of somnolence when using this medicine. If you get any side effects such as blurred vision, dizziness or drowsiness, you should refrain from activities that require increased attention (eg driving, using machines or dangerous tools).

   3. How to take Flurapid

  Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. If you are not sure in something, ask your doctor or pharmacist.

   The recommended dose for adults and children over 15 years is:

  1 sachet, 2 or 3 times every four to six hours. Тhe interval between two intakes should be at least 4 hours.

  Method of administration

  The contents of a sachet dissolve in a cup of hot or cold water and drunk.  

  For flu conditions, it is recommended that Flurapid be taken with hot water in the evening as soon as the first symptoms develop.

  In the case of acute renal failure the interval between two intakes should be at least 8 hours.  

   Duration of treatment  

  The duration of treatment should not exceed 7 days.  

  Do not use this medicine for long-term treatment without consulting a doctor, especially if the symptoms last longer than 7 days.

  If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

   If you take more Flurapid than you should

  If you accidentally or deliberately take a higher dose than indicated in this leaflet tell your doctor or pharmacist immediately.  

   If you forget to take Flurapid

  Do not take a double dose to compensate the forgotten one.

   Ask your doctor or pharmacist if you have any further questions for the use of this medicine.  

   4. Possible side effects  

   Like all medicines, Flurapid can cause side effects, although not everybody gets them.  

  Talk to your doctor and stop taking Flurapid if you get an allergic reaction or any possible side effects.

   The following side effects are possible:

  Very common (may affect more than 1 in 10 people):

  - Reduction of the number of white blood cells and platelets;

  - Severe hypersensitivity reactions;

  - Choking, shortness of breath.

   Rare (may affect more than 1 in 1 000 people):

  - Skin rash, itching, redness;

  - Increased liver enzymes;

  - Еdema, heart palpitation;

  - Hallucinations, nervousness;

  - Dry mouth, constipation, diarrhea, vomiting or abdominal pain.

   Very rare (may affect more than 1 in 10 000):

  - Impaired kidney function;

  - An allergic skin reaction;

  - Impairment of liver function.

   Reporting of side effects

  If you get any side effects, contact your doctor or pharmacist. This includes any possible side effects, not listed in this leaflet.  

  5. How to store Flurapid

  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 carton box after EXP. The expiry date refers to the last day of month.  

  Do not dispose of medicines in the sewer or in the household waste container.

  Ask your doctor or pharmacist how to dispose of medicines you no longer use.

  These measures will help to protect the environment.  

   6. Contents of the pack and other information  

   What Flurapid contains

  - The active substances in one sachet are: 500 mg paracetamol, 25 mg pheniramine maleate and 200 mg ascorbic acid.

  - The excipients are: mannitol, sodium cyclamate, lemon flavour, citric acid.

   What Flurapid looks like and contents of the pack

  Flurapid is a powder for oral solution in sachet.

  The sachet's contents are an almost white mixture of dust and dry agglomerates.

  Each box contains 8 or 12 sachets and а patient leaflet.

  Not all pack sizes may be marketed.

   

  Marketing Authorisation Holder and Manufacturer

  Fortex Nutraceuticals Ltd.,

  10, Prohladen kat Street,  

  Sofia 1362, Bulgaria

   Date of the last review of the package leaflet

  May 2021

   

• What Flurapid contains

  - The active substances in one sachet are: 500 mg paracetamol, 25 mg pheniramine maleate and 200 mg ascorbic acid. - The excipients are: mannitol, sodium cyclamate, lemon flavour, citric acid.

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