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  Flurapid

8 sachets
The recommended dose for adults and children over 15 years is: 1 sachet, 2 or 3 times every four to six hours. The interval between two intakes should be at least 4 hours.
GENERAL INFORMATION

Package Leaflet: Patient Information

 

Флурапид 500 mg/25 mg/200 mg прах за перорален разтвор в саше

Paracetamol / Pheniramine Maleate / Ascorbic Acid

 

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

Paracetamol/Pheniramine maleate/ Ascorbic acid

 

Read all of this leaflet carefully before you start taking this medicine as it contains important information for you.

However, to get the best results from treatment, you should carefully follow the instructions for using Flurapid.

  • Keep this leaflet. You may have to read it again.
  • If you need more information or advice, ask your pharmacist.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
  • You should seek medical advice should your symptoms worsen or not improve after 7 days.

 

What this leaflet contains:

  1. Какво представлява Флурапид и за какво се използва
  2. Какво трябва да знаете, преди да приемете Флурапид
  3. Как да приемате Флурапид
  4. Possible side effects
  5. Как да съхранявате Флурапид
  6. Packaging content and additional information

 

  1. Какво представлява Флурапид и за какво се използва

 

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

  • Парацетамол е болкоуспокояващо лекарство, което подпомага също така и понижаването на високата температура.
  • Фенираминов малеат е антихистамин, който освобождава носа и синусите, като Ви помага да дишате по-леко.
  • Аскорбинова киселина (Витамин С) допълва естествените нива от витамин С, които могат да намалеят при вирусна инфекция или настинка.

 

Flurapid is used for short-term relief of colds, allergic rhinitis, rhinopharyngitis and influenza-like conditions in adults and children over 15 years of age: it reduces nasal discharge and soreness, sneezing, increased body temperature, headache, mild to moderate pain of different origins.

 

  1. Какво трябва да знаете, преди да приемете Флурапид

 

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 severe liver or kidney disease;
  • if you suffer from any form of glaucoma (increased intraocular pressure);
  • if you have prostate disease;
  • if you are a child under 15;
  • if you are a child under 15 years of age you have high blood pressure or other cardiovascular disease;
  • if you take other paracetamol-containing products, nose-disposing medicines or cough and cold medicine products;
  • if you are taking medicines known as monoamine oxidase inhibitors (MAOIs) that are commonly used to treat depression.

 

Warnings and precautions:

Talk to your doctor or pharmacist before taking Flurapid.

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

  • if you accidentally take a higher dose than necessary;
  • if you have severe kidney or liver disease;
  • if you are taking other medicines containing paracetamol;
  • if you have any allergies;
  • if you are pregnant or breast-feeding;
  • if you have raised 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 the age of 15 years.

 

Other medicines and Flurapid

Tell 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 drugs for the treatment of cardiac diseases;
  • medicines for the treatment of depression, such as tricyclic antidepressants, e.g. Amitriptyline;
  • if you are taking other medicines containing antihistamines or paracetamol.

 

Flurapid with food, beverages and alcohol

Alcohol should not be taken during treatment.

 

Pregnancy, breastfeeding and fertility

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

This medicine is not recommended during pregnancy and breastfeeding 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 experience 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).

 

  1. Как да приемате Флурапид

 

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 for adults and children over 15 years is:

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

 

Application method

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

For flu-like 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 Flupapid 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 make up for the missed dose.

 

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

 

  1. Possible side effects

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

Stop taking Flurapid and talk to your doctor straight away if you get any signs of an allergic reaction or any other serious reaction.

 

The following side effects are possible:

Много чести (могат да засегнат повече от 1 на 10 души)

  • Reducing the number of white blood cells and platelets;
  • Severe hypersensitivity reaction;
  • Asphyxiation, difficulty in breathing.

 

Редки (могат да засегнат повече от 1 на 1 000 души)

  • Skin rash, itching, redness;
  • Enhancement of liver enzymes;
  • Swelling, palpitations;
  • Hallucinations, nervousness;
  • Dry mouth, constipation, diarrhea, vomiting or abdominal pain.

 

Много редки (могат да засегнат повече от 1 на 10 000 души)

  • Impaired renal function;
  • Allergic skin reaction;
  • Hepatic function impairment.

 

Reporting of side effects

If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet.

Вие можете също да съобщите нежелани реакции директно чрез националната система за съобщаване директно към Изпълнителната Агенция по Лекарствата, ул. Дамян Груев, No 8, 1303 София: тел. +359 2 8903417, уебсайт www.bda.bg.

As you report side effects, you can contribute to getting more information on the safety of this medicine.

 

  1. Как да съхранявате Флурапид

 

Keep out of the reach and sight of children.

 

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

 

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

Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

 

  1. Packaging content and additional information

What Flurapid contains

-Активните вещества в едно саше са: парацетамол (500 mg), фенираминов малеат (25 mg) и

ascorbic acid (200 mg),

Други съставки (помощни вещества) са: манитол, натриев цикламат, аромат лимон, лимонена киселина.

 

What Flurapid looks like and contents of the pack

Flurapid contains powder for oral solution in a sachet.

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

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

 

Marketing Authorization Holder

 

Fortex Nutraceuticals Ltd.

10 Prohladen kаt street,

Sofia 1362, Bulgaria

 

Manufacturer

Fortex Nutraceuticals Ltd.

10 Prohladen kаt street,

Sofia 1362, Bulgaria

 

Date of the last review of the package leaflet

February 2017

 

Package leaflet: Information for the patient

Flurapid 500mg/25mg/200mg 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, ascorbic acid and pheniramine maleate and is used in adults and adolescent older than 15 years.

Flurapid is indicated for treatment of symptoms associated with the common cold, influenza and upper respiratory tract infections such as runny nose, watery eyes, sneezing, headache and/or fever.

You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

  1. What you need to know before you take Flurapid?

Do not take Flurapid:

– if you are allergic to paracetamol, ascorbic acid, pheniramine maleate or any of the other ingredients of this medicine (listed in section 6).
– if you have liver disease or kidney desease
– if you have narrow-angle glaucoma
– if you are taking or have taken within the last two weeks monoamine oxidase inhibitors (for depression)
– if you take other medicines containing paracetamol and/or pheniramine maleate
– if you have high blood pressure or ceardiovascular  desease
– if you are a man with prostate problems
– do not give Flurapid to children under 15 years

Warnings and precautions
Talk to your doctor or pharmacist before taking Flurapid:
– if you take higher dose than necessary
– if you have kidney or liver problems
– if you are pregnant or breast-feeding
– if you take other paracetamol- containing drugs
– if you have high eye pressure (ocular hypertension)
– if you have a deficiency of a certain enzyme called glucose-6-phosphata dehydrogenase
– if you have haemolytic anaemia (abnormal breakdown of red blood cells)
– if you have predisposition to constipation, vertigo and urinary problems
– if you have asthma, chronic obstructive pulmonary disease, cardiovascular disease, hypertension, hyperthyroidism and pyloroduodenal obstruction

Do not use any other products containing paracetamol if you are taking this product as you could exceed the recommended daily dose (see the section 5.”How to take Flurapid”).

Do not drink alcohol or use medicinal products containing alcohol while you are taking this product. This product may cause drowsiness increased by alcohol.

In cases of high fever, signs of a secondary infection, or persistence of your symptoms for more than 7 days, consult your doctor or pharmacist.

Other medicines and Flurapid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not use Flurapid in combination with other paracetamol- or antihistamine-containing medicines.

Please talk to your doctor before you take Flurapid in case you use one of the following medicines:
– metoclopramide or domperidone (medicines used to treat nausea and vomiting)
– cholestyramine (used to lower your cholesterol);
– warfarin and other coumarin derivatives (medicines to thin the blood)
– sedatives, especially barbiturates (medicines that cause relaxation and sleepiness)
– sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine)
– hypnotics

Flurapid with food, drink and alcohol
Do not drink alcohol or use medicinal products containing alcohol while you are taking this product. This product may cause drowsiness increased by alcohol.

Pregnancy and breast-feeding
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. Flurapid is not recommended during pregnancy or breast-feeding.

Driving and using machines
Flurapid could cause drowsiness and/or dizziness. If you experience drowsiness and/or dizziness you should not drive or use machine.

  1. How to take Flurapid

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacistif you are not sure.

Flurapid is indicated for adults and children older than 15 years.

The recommended dose is one sachet 2 or 3 times per day. The interval has to be at least 4 hours between 2 doses.

Do not take more than 3 sachets per day.

The content of the sachet must be dissolved in cold or warm water.

In case of flu it is best to take Flurapid dissolved in warm water in the evening.

If you have kidney problems the interval between 2 doses will be determined by your doctor and should be minimum 8 hours.

The maximum period of treatment is 7 days without seeking the medical advice.

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 have taken more Flurapid/or it was accidently taken by a child, seek medical advice immediately because of the risk of delayed, serious liver damage. Symptoms of paracetamol overdose are nausea, vomiting and reduced appetite.

If you forget to take
Do not take a double dose to make up for a forgotten dose.

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

  1. Possible side effects

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

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 1000 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 renal function
  • Allergic skin reaction
  • Liver function impairment

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.

You can also report adverse events directly through the national system for reporting directly to the Bulgarian Drug Agency, Damyan Gruev Str., No 8, 1303 Sofia, tel. +359 2 8903417, website www.bda.bg.

Reporting adverse reactions, you can do your bit to obtain more information on the safety of this medicine.

  1. 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 label and carton after EXP. The expiry date refers to the last day of that month.

Store below 25 °C.

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.

  1. Contents of the pack and other information

What Flurapid contains:

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

What Flurapid looks like and contents of the pack
Flutrapid is a powder for oral solution in sachet.
Each sachet contains almost white mixture of dry powder and agglomerates.
Pack sizes: 8 sachets and patient leaflet.

Marketing Authorisation Holder and Manufacturer
Fortex Nutraceutical Ltd.
Prohladen kat str., 10
Sofia 1362, Bulgaria

This leaflet was last revised in
February 2017

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