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  Flurapid С

10 capsules
The recommended dose is 2 capsules 3 times a day. After reducing the symptoms, one capsule may be given 3 times a day.
GENERAL INFORMATION

Leaflet: user information

Флурапид С 200 mg/150 mg/25 mg/2,5 mg твърди капсули
Flurapid C 200 mg / 150 mg / 25 mg / 2.5 mg hard capsules

Paracetamol / Ascorbic acid / Caffeine / Chlorphenamine maleate
Paracetamol/Ascorbic acid/Caffeine/Chlorphenamine maleate

Read all of this leaflet carefully before you start taking this medicine as 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 have to read it again.
  • If you need more information or advice, ask your pharmacist.
  • Ако получите някакви нежелани реакции, уведомете Вашия лекар или фармацевт. Това включва и всички възможни нежелани реакции, неописани в тази листовка. Вижте точка 4.
  • If after 7 days you do not feel better or your condition gets worse, you should seek medical attention.

 

Какво съдържа тази листовка

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

 

  1. Какво представлява Флурапид С и за какво се използва

Flurapid C contains 4 active substances: paracetamol, ascorbic acid, caffeine and chlorphenamine maleate, and is used in adults and children over 12 years of age.

  • Парацетамолът притежава аналгетичен, антипиретичен и много слаб противовъзпалителен ефект.
  • Аскорбиновата киселина (Витамин С) допълва естествените нива от витамин С, които могат да намалеят при вирусна инфекция или настинка.
  • Кофеинът е ксантиново производно и повишава аналгетичните ефекти на парацетомола.
  • Хлорфенаминовият малеат е антихистамин, който освобождава носа и синусите, като Ви помага да дишате по-леко.

Flurapid C is used to relieve symptoms of cold, allergic rhinitis, rhinopharyngitis and flu-like conditions in adults and children over 12 years of age by reducing nasal discharge and soreness, sneezing, increased body temperature, headache, mild to moderate pain of different origins.

If after 7 days you do not feel better or your condition gets worse, you should seek medical attention.

  1. Какво трябва да знаете, преди да приемете Флурапид С

Не приемайте Флурапид С:
–        ако сте алергични към някое от активните вещества или към някоя от останалите съставки на това лекарство (изброени в точка 6);
–         ако имате сериозно чернодробно или бъбречно заболяване;

  • if you suffer from any form of glaucoma (increased intraocular pressure);
  • if you have prostate disease;
  • ако сте дете под 12 години;
  • ако имате високо кръвно налягане или друго сърдечносъдово заболяване;
  • ако приемате други парацетамол-съдържащи продукти, отпушващи носа лекарства

или продукти за лечение на кашлица и настинка;

–        ако приемате лекарства, известни като инхибитори на моноаминооксидазата (МАО инхибитори), които обикновено се използват за лечение на депресия.

Warnings and precautions
Talk to your doctor or pharmacist before taking Flurapid C.

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 C should not be used in children under 12 years of age.

Other medicines and Flurapid C
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 C 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).

Flurapid C contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

  1. Как да приемате Флурапид С

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.

Препоръчителната доза е по 2 капсули 3 пъти дневно. След намаляване на симптомите може да се приема по 1 капсула 3 пъти дневно.

Patients with hepatic and / or renal insufficiency.

The dose should be reduced or dosing intervals extended in patients with impaired hepatic or renal function and Gilbert's syndrome. Flupapid C should not be used in severe hepatic and / or renal failure.

Mode and duration of application
Capsules should be taken whole with a sufficient amount of liquid. Flurapid C should not be used for prolonged periods of time and in high doses without consulting a doctor.

Use in children and adolescents
It is used in adults and children over 12 years of age.

If you take more Flarapid C than you should
If you accidentally or deliberately take a higher dose than the one mentioned in this leaflet, tell your doctor or pharmacist immediately.

If you forget to take Flurapid C
Do not take a double dose to make up for the missed dose.

If you stop taking Flurapid C
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 C can cause side effects, although not everyone gets them.

Stop taking Flurapid C and consult a doctor immediately if any signs of an allergic reaction or any other serious reaction occur.

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;
  • Тежки реакции на свръхчувствителност;
  • 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

Ако получите някакви нежелани лекарствени реакции, уведомете Вашия лекар или фармацевт. Това включва всички възможни, неописани в тази листовка нежелани реакции. Можете също да съобщите за нежелани реакции директно чрез националната система за съобщаване към Изпълнителната агенция по лекарствата, ул. Дамян Груев № 8, 1303 София: тел. +359 2 8903417, уебсайт: www.bda.bg. Като съобщавате за нежелани реакции, можете да дадете своя принос за получаване на повече информация относно безопасността на това лекарство.

  1. Как да съхранявате Флурапид С

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 use this medicine if you notice visible signs of product quality impairment.

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 C contains

  • Активните вещества в една капсула са: парацетамол (200 mg), аскорбинова киселина (150 mg), кофеин (25 mg), хлорфенаминов малеат (2,5 mg).
  • Excipients are: желатин, лактоза монохидрат, колоиден безводен силициев диоксид, магнезиев стеарат, титанов диоксид (E171), жълт железен оксид (E172), червен железен оксид (E172).

Как изглежда Флурапид С и какво съдържа опаковката
Flurapd C - pale yellow, hard gelatin capsules.
Capable of the capsules - white to off-white powder mixture.
Each box contains 1 or 2 blister cards of 10 capsules each.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Fortex Nutraceuticals Ltd.
10 Prohladen kut street,
Sofia 1362, Bulgaria

Date of the last review of the package leaflet
August 2017

LEAFLET: INFORMATION FOR THE USER

Flurapid С 200mg/150mg/25mg/2,5mg capsules, hard
Paracetamol/Ascorbic acid/Caffeine/Chlorphenamine Maleate

Read the leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine is available without prescription. However, to get the best results from the treatment, you should carefully follow the instructions for use of Flurapid C.

  • Keep this leaflet. You may need to read it again.
  • If you need further information or advice, ask your pharmacist.
  • You must contact a doctor if your symptoms worsen or do not improve after 7 days.
  • If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

 In this leaflet:

  1. What Flurapid C is and what it is used for
  2. What do you need to know before taking Flurapid C
  3. How to take Flurapid C
  4. Possible side effects
  5. How to store Flurapid C
  6. Contents of the package and further information

 

  1. What Flurapid C is and what it is used for

Flurapid C contents 4 active ingredients: paracetamol, ascorbic acid, caffeine, chlorphenamine maleate and is to be used by adults and children above 12 years old.

  • Paracetamol has analgesic, antipyretic and very weak anti-inflammatory effect.
  • Ascorbic acid (Vitamin С) supplements the natural levels of vitamin C, which may be reduced in a viral infection or cold.
  • Caffeine is a xanthine derivative and increases the analgesic effects of paracetomol.
  • Chlorphenamine maleate is an antihistamine that releases the nose and sinuses, helping you breathe more easily.

Flurapid C is used for short-term relief of the symptoms of colds, allergic rhinitis, nasopharyngitis and influenza-like illness in adults and children above 12 years: it decreases nose secretion and lacrimation, sneezing, fever, headache, mild to moderate pain of various origin.

  1. What do you need to know before taking Flurapid C

 Do not take Flurapid C:

  • if you are allergic to any of the active substances or to any of the other ingredients (listed in section 6)
  • if you have serious liver or kidney disease
  • if you suffer from any form of glaucoma (increased eye pressure)
  • if you have prostate disease
  • if you are a child under 12 years
  • if you have high blood pressure or other cardiovascular disease
  • if you are taking other acetaminophen-containing products or decongestant nasal drug products for the treatment of cough and cold
  • if you are taking medicines known as monoamine oxidase inhibitors (MAO inhibitors) that are typically used to treat depression

Warnings and precautions:
Talk to your doctor or pharmacist before taking Flurapid C.
This is important because some states are more likely to get side effects (see also section 4):

  • if you accidentally have taken a higher dose than necessary
  • if you have severe kidney or liver disease
  • if you are taking other medicines containing paracetamol
  • if you have an allergy
  • if you are pregnant or breast-feeding
  • if you have elevated intraocular pressure
  • if you have prostate problems
  • if your symptoms last more than 7 days
  • if you have high blood pressure or heart disease

Children
Flurapid C should not be taken by children below 12 years of old.

Other medicines and Flurapid C
You should inform your doctor or pharmacist if you are taking, have been taking, or you are going to take other medicines. This applies in particular to:

  • warfarin or similar medicines for blood thinning
  • medicines to control blood pressure, such as beta blockers
  • digoxin or other similar medicines to treat heart disease
  • medicines to treat depression such as tricyclic antidepressants, e. amitriptyline
  • if you are taking other medicines containing antihistamines or acetaminophen

Flurapid C with food, drinks and alcohol
You should not drink alcohol during the treatment.

Pregnancy, lactation and fertility
If you are pregnant or breastfeeding, or if you think you are pregnant, or if you are planning pregnancy, consult your doctor or pharmacist before taking this medicine.

This medicine is not recommended during pregnancy and breastfeeding, except only if your doctor considers it absolutely necessary.

Driving and using machines
People who are driving or operating machinery, should be aware that the use of this medicine has a risk of sleepiness.

If you get side effects such as blurred vision, dizziness or sleepiness should refrain from activities that require caution (ie. driving, operating machinery or dangerous tools).

  1. How to take Flurapid C

Always take this medicine exactly as described in this leaflet or as you have been told by your doctor or pharmacist. If you’re not sure, ask your doctor or pharmacist.

Method of administration
It is to be used by adults and children above 12 years of old. It is to be taken 2 capsules 3 times per day. You can take 1 capsule 3 times per day after reducing of the symptoms.

Patients with hepatic and / or renal failure.

The dose should be reduced or the dosing intervals should be extended by patients with impaired hepatic or renal function and Gilbert’s syndrome. Flurapid C should not be used in cases of severe hepatic and / or renal failure.

Method and duration of treatment
The capsules should be taken whole with sufficient liquid. Flurapid C should not be taken for a long period of time and in high dosage without consulting a doctor.

If you take more dose of Flurapid C
If you have taken intentionally or accidentally a higher dose of that in this leaflet, tell your doctor or pharmacist.

If you have forgotten to take Flurapid C
You should not take a double dose to make up.

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 C can cause side effects, although not everybody gets them.

Stop taking Flurapid C and consult a doctor immediately if you experience signs of an allergic reaction or any other serious reaction.

Possible side effects are the following:

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

Adverse event reporting

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 C

Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Keep at temperatures below 25°C.
Do not dispose of this medicine in wastewater or household waste.
Ask your pharmacist how to dispose of medicines of no longer use. These measures will help to protect the environment.

Contents of the package and further information

What are the contents of  Flurapid C
The active substances in one capsule are: paracetamol (200 mg), ascorbic acid (150 mg), caffeine (25 mg), chlorphenamine maleate (2,5 mg)
Other ingredients (excipients) include: gelatin, lactose monohydrate, silicon dioxide, magnesium stearate, titanium dioxide (E171), ferrous oxide (Е1720)

What Flurapid C looks like and contents of the pack
Flurapid C contains hard capsules in a blister.
The content of the capsules ис white crystal powder with dry agglomerates.
Each box contains 10 capsules and the package leaflet.

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

Date of last revision of the leaflet
November 2015

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