Béres Drops Extra 4x30 ml + Béres Vitamin C 50 mg combined package

In what cases is the preparation recommended?

 

It is recommended for supplementing trace elements:

  • To support the functioning of the immune system and the organism’s resistance, e.g. colds, times of influenza;
  • In the case of deficient diets (e.g. special diets, slimming diets, vegetarian diets), intense physical activity,
  • In the case of fatigability, loss of appetite, poor health, weakness, insomnia, and to prevent these symptoms; as well as to support recovery after diseases and operations,
  • As a supplementary therapy to improve the general condition and well-being of cancer patients.

 

Béres Vitamin C 50 mg tablets are recommended for supplementing Béres Drops Extra oral solution drops to enhance the absorption of iron.

 

Pack sizes:

  • 4 x 30 ml bottles in a box + Béres Vitamin C 50 mg 120 tablets 

 

Dosing:
To prevent trace element deficiency:
 

  • For body weight of 20-40 kg 1 x 20 drops with 1 tablet per day,
  • For body weights over 40 kg 2 x 20 drops with 2 x 1 tablets per day.

 

To treat complaints listed below and as a complementary therapy:

  • For body weights ranging between 10-20 kg 2 x 10 drops with 1 tablet per day,
  • For body weights ranging between 20-40 kg 2 x 20 drops with 2 x 1 tablets per day,
  • For body weights over 40 kg 3 x 20 drops with 3 x 1 tablets per day.

 

Children and adolescents:

 

  • It can be administered from 3 years of age (over 15 kg) at the recommended dose.


Additional important information:

Always take the drops and the tablet together during meals. It is recommended to take the drops with ample liquid, at least half a decilitre (e.g. water, fruit juice, syrup or tea), and the tablet in one, without chewing it or breaking it up.   

Active substances of Béres Drops Extra (in 1 ml (18 drops) aqueous solution)

 

Iron (in the form of iron(II) sulphate heptahydrate)

2,00 mg

Zink (in the form of zinc sulphate heptahydrate)

2,23 mg

Magnesium (in the form of magnesium sulphate heptahydrate)

0,40 mg

Manganese (in the form of manganese(II) sulphate monohydrate)

0,31 mg

Copper (in the form of copper sulphate monohydrate)

0,25 mg

Molybdenum (in the form of ammonium molybdate tetrahydrate)

0,19 mg

Vanadium (in the form of ammonium monovanadate)

0,12 mg

Boron (in the form of boric acid)

0,10 mg

Fluorine (in the form of sodium fluoride)

0,090 mg

Cobalt (in the form of cobalt chloride hexahydrate)

0,025 mg

Chromium (in the form of chromium(III) chloride hexahydrate)

0.018 mg

Selenium (in the form of anhydrous sodium selenite)

0.012 mg


 

Active substances of C-vitamin Béres 50 mg tablet:

50 mg ascorbic acid per tablet

 

Auxiliary materials of Béres Drops Extra:

succinic acid, tartaric acid, potassium sodium tartrate, amino acetic acid (glycine), glycerine, sulphuric acid, purified water.

 

Béres Vitamin C 50 mg tablets contain: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, glyceryl dibehenate.

Béres Drops Extra oral solution drops + Béres Vitamin C 50 mg tablets

 

 Read this patient information leaflet carefully, it contains important information.

  • Always take this medicine exactly as described in the information leaflet or as your doctor or pharmacist advises.
  • Please keep the patient information leaflet, because you might need the information in it later on as well.
  • For further information or advice, consult your pharmacist
  • If you notice any side effects tell your doctor or pharmacist.
  • This also refers to any possible side effects not listed in this leaflet. See point 4.
  • You must contact your doctor if your symptoms do not improve or worsen.

 

Contents of the patient information leaflet:

1. What type of medicine is Béres Drops Extra oral solution drops + Béres Vitamin C 50 mg tablets (hereinafter: Béres Drops Extra + Béres Vitamin C 50 mg and what diseases can it be utilised for?

2. Important notes before taking Béres Drops Extra + Béres Vitamin C 50 mg

3. How to take Béres Drops Extra + Béres Vitamin C 50 mg?

4. Possible side effects

5. Storage of Béres Drops Extra + Béres Vitamin C 50 mg

6. Contents of packaging and other information

  

1. What type of medicine is Béres Drops Extra + Béres Vitamin C 50 mg, and what diseases can it be applied for?


Béres Drops Extra + Béres Vitamin C 50 mg is a roborant preparation containing trace elements and Vitamin C.

 

It is recommended for trace element supply:
 

  • To support the functioning of the immune system and the organism’s resistance, e.g. colds, times of influenza;
  • In the case of deficient diets (e.g. special diets, slimming diets, vegetarian diets), intense physical activity,
  • In the case of fatigability, loss of appetite, poor health, weakness, insomnia, and to prevent these symptoms; as well as to support recovery after diseases and operations,
  • As a supplementary therapy to improve the general condition and well-being of cancer patients.

 

Béres Vitamin C 50 mg tablets are recommended for supplementing Béres Drops Extra oral solution drops to enhance the absorption of iron.

 

2. Before you take Béres Drops Extra + Béres Vitamin C 50 mg

 

 Do not take Béres Drops Extra + Béres Vitamin C 50 mg if

  • you are allergic (hypersensitive) to any of the active substances or auxiliary materials of Béres Drops Extra drops;
  • you have metal allergy;
  • you have severe kidney disorders, and diseases based on iron and copper metabolism disorders (haemochromatosis, haemosiderosis, Wilson disease).

 

Warnings and precautions

Take it with enhanced precaution if you are suffering from liver and kidney tract diseases as a part of trace elements are eliminated with the bile and excretion may be affected.

Consult your doctor if you have any kidney disease in your medical history.

Vitamin C may change the result of certain laboratory tests, so tell the doctor ordering any laboratory test if you take medicines with vitamin C content.

 

Children and adolescents

It can be administered from 3 years of age (over 15 kg) at the recommended dose.

 

Other medicines and Béres Drops Extra + Béres Vitamin C 50 mg

Inform your doctor or pharmacist by all means about the medicines you are taking or have recently taken, including over-the-counter preparations.
Co-administration with other preparations containing trace elements shall be avoided. At least 1 hour should pass between taking Béres Drops Extra + Béres Vitamin C 50 mg and other medicinal products.
The regular administration of particular pain relief preparations (acetylsalicylic acid, indometacin) might hinder iron absorption.
Particular diuretics (furosemide, thiazides) hinder the absorption of zinc, others (etacrynic acid, thiazides) hinder magnesium absorption, preparations reducing gastric acid levels hinder iron absorption, and so-called tetracycline type of antibiotics may hinder the absorption of particular trace elements.

 

Taking Béres Drops Extra + Béres Vitamin C 50 mg simultaneously with particular dishes or drinks

 

Do not take the medicine in milk or coffee, as these drinks impair the absorption of active substances. In the cases of particular tea types, the solution may get darker during use. This is an innocuous phenomenon, caused by the tannin content of tea. Adding a few drops of lemon juice or lemon substitutes or possibly ascorbic acid to the tea will prevent this black discoloration.
Foodstuffs containing a high quantity of fibres and/or phytic acid (e.g. cereals, bread made from whole-grain cereals, wheat bran) may inhibit the absorption of trace elements contained by the preparation.

 

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding or you may be pregnant or would like a child, talk to your doctor or pharmacist before you take this preparation.

Béres Drops Extra oral solution drops + Béres Vitamin C 50 mg can be taken during pregnancy and breast-feeding if the dosing recommendations are followed.

 

The effects of the preparation on driving capabilities and capabilities of the operation of machines

 

Béres Drops Extra + Béres Vitamin C 50 mg drops do not have any effect on driving capabilities and the operation of machines when taken as recommended.

 

 

3. How to take Béres Drops Extra + Béres Vitamin C 50 mg?

 

Always take this medicine exactly as described in the information leaflet or as your doctor or pharmacist advises. If you are unsure about dosage, consult your doctor or pharmacist.

 

Recommended dose of this preparation.

To prevent trace element deficiency:

  • For body weight of 20-40 kg 1 x 20 drops or 1 x 8 pump-presses with 1 tablet per day,
  • For body weights over 40 kg 2 x 20 drops or 2 x 8 pump-presses with 2 x 1 tablets per day.

 

To treat complaints listed below and as a complementary therapy:

  • For body weight of 15-20 kg 1 x 20 drops or 1 x 8 pump-presses with 1 tablet per day,
  • For body weights ranging between 20-40 kg 2 x 20 drops or 2 x 8 pump-presses with 2 x 1 tablets per day,
  • For body weights over 40 kg 3 x 20 drops with 3 x 8 pump-presses 3 x 1 tablets per day.

 

As a complementary therapy for patients with tumour diseases to improve their condition and well-being over 40 kg body weight - with medical advice - higher daily dose can be used, which must not exceed 120 drops (equivalent to 48 pump-presses). In this case it is recommended to take the daily dose in 4 equal portions with 1 tablet each time.

 

Please note that the active ingredient content of the amount obtained with 1 press of the dosing pump is not equal to the active ingredient content of 1 drop of the dropper package. See details of using bottles with dosing pump at the end of this leaflet.

 

Application for children

It can be administered from 3 years of age (over 15 kg) at the recommended dose. To prevent taking more than the recommended dose keep the preparation out of reach of children – in the interest of their safety.

 

Always take the drops and the tablet together during your meals. It is recommended to take the drops with ample liquid, at least half a decilitre (e.g. water, fruit juice, syrup or tea), and the tablet in one, without chewing or breaking it up.

 

For disease prevention, applied in the specified doses, the optimal effect (as experience has shown) is expectable after about 6 weeks of continuous administration, which effect can be maintained throughout the intended period (e.g. until the end of the winter catarrhal and influenza season) by continuing the administration of the dose recommended for disease prevention.
Take the recommended dose continuously during the treatment until the complaints and symptoms persist. You can repeat the treatment when the complaints reemerge.
If applied as a supplementary therapy (e.g. during a tumour disease), the administration of Béres Drops Extra + Béres Vitamin C 50 mg is specified individually by the doctor taking the patient’s condition and the actual treatment(s) into consideration. 

 

 

If you took more Béres Drops Extra + Béres vitamin C 50 mg than prescribed

If you take a higher dose of Béres Drops Extra oral solution than recommended, transitory stomach pains, or rarely hypersensitivity reactions may occur. In such cases consult your doctor.

 

If you take a higher dose of Béres Vitamin C 50 mg tablets than recommended it might produce a vitamin C overdose. Symptoms of vitamin C overdose: stomach burning, uneasiness of the stomach, nausea or diarrhoea. 

Ascorbic acid is a water-soluble vitamin, therefore the excess amount is eliminated by the organism with urine and faeces. So if you took too many tablets it is recommended to drink ample liquids.

Too high doses of ascorbic acid may cause hemolytic anemia in patients having certain inborn enzyme deficient diseases (glucose-6-phosphate dehyrogenase).

Ascorbic acid helps the absorption of iron, therefore ascorbic acid - when taken in higher doses - may increase the risk of developing iron storage disorder (hemochromatosis) and hemolytic anemia of various origins (siderblastic anemia, thalassemia).

Taking high doses of ascorbic acid for a long time will increase the risk of developing kidney stones, and when abruptly stopping the long-term administration of ascorbic acid, more intense symptoms of deficiency may appear than initially.

  

If the prescribed dose of Béres Drops Extra drops was missed

 

Do not take a double dose the next time to make up for the omitted dose. Continue the treatment as prescribed.
If you have further questions about the administration of the preparation consult your doctor or pharmacist.

 

 

4. Possible side effects

 

Like all medicines, Béres Drops Extra drops can cause side effects, although not everybody gets them.
 

Rare side effects (fewer than 1 case in 1000 patients but more than 1 case in 10,000 patients):

Mainly when taken on an empty stomach or with less liquid than necessary, mild temporary stomach complaints may arise.

 

Very rare side effects (fewer than 1 case in 10,000 patients):

Hypersensitivity reactions (rash, urticaria, itching) may emerge.
If any of the side effects gets serious, or if you notice a side effects not listed in this leaflet, please inform your doctor or pharmacist.

 

When vitamin C is used in high doses for a long time - primarily if the daily vitamin C intake is higher than 1000 mg - stomach burn, nausea, diarrhoea may occur and the risk of kidney stone production may increase.

 

Reporting side effects

 

If you notice any side effects tell your doctor or pharmacist. This also refers to any possible side effects that are not listed in this patient information leaflet. You can report side effects directly to the authorities via the contact details included in Appendix V.

By reporting the side effects you can also contribute to making as much information as possible available regarding the safe use of this medicine.

 

5. How to store Béres Drops Extra + Béres vitamin C 50 mg?

 

Béres Drops Extra oral solution drops

Store it below 25°C. Keep it in its original packaging to protect it from light.

Packaging with dropper inlet:

The product is to be used within 3 months after opening.

 

Packaging with dosing pump:

The bottle can be used after its opening and after the insertion of the dosing pump within 6 months.

 

Béres vitamin C 50 mg tablets

Store at max. 25°C. Keep the container properly closed to protect it from moisture.

 

Keep the product out of reach of children!

Do not take this medicine after the expiry date (Felhasználható:/Felh.) indicated on the box and on the bottle and the tablet container. The expiry date refers to the last day of that month.

 

Do not throw any medicines into waste water or household waste. Ask your pharmacist what to do with your medicines no longer required. These measures help protect the environment.

 

6. Content of packaging and other information

 

What do Béres Drops Extra + Béres Vitamin C 50 mg contain?

 

Iron (in the form of iron(II) sulphate heptahydrate)

2,00 mg

Zink (in the form of zinc sulphate heptahydrate)

2,23 mg

Magnesium (in the form of magnesium sulphate heptahydrate)

0,40 mg

Manganese (in the form of manganese(II) sulphate monohydrate)

0,31 mg

Copper (in the form of copper sulphate monohydrate)

0,25 mg

Molybdenum (in the form of ammonium molybdate tetrahydrate)

0,19 mg

Vanadium (in the form of ammonium monovanadate)

0,12 mg

Boron (in the form of boric acid)

0,10 mg

Fluorine (in the form of sodium fluoride)

0,090 mg

Cobalt (in the form of cobalt chloride hexahydrate)

0,025 mg

Chromium (in the form of chromium(III) chloride hexahydrate)

0.018 mg

Selenium (in the form of anhydrous sodium selenite)

0.012 mg

 

Béres Vitamin C 50 mg tablets

50 mg ascorbic acid per tablet

 

Other ingredients:

Béres Drops Extra oral solution drops : succinic acid, tartaric acid, potassium sodium tartrate, aminoacetic acid (glycine), glycerine, sulphuric acid, purified water.

Béres Vitamin C 50 mg tablets contain: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, glyceryl dibehenate.

 

What do Béres Drops Extra + Béres Vitamin C 50 mg look like and what does the packaging contain?

Béres Drops Extra oral solution drops: 30 ml, 100 ml light green or yellowish green, clear aqueous solution intended for oral administration, filled in a brown bottle sealed with a white polyethylene tamper-evident screw-cap and colourless polyethylene dropper inlet or in a brown bottle sealed with a white polyethylene tamper-evident screw cap.

 

Béres Vitamin C 50 mg tablets

30, 60, 100, 120, 200 white or off-white, flat, round tablets with cut edge, with a “C” on one side in a white HDPE container, sealed with a white PP cap and a tamper-evident heat-shrink band.  

 

1 bottle of Béres Drops Extra sealed with a dropper inlet and a screw cap (30 ml solution) and 1 tablet container (30 tablets) in one box or

1 bottle of Béres Drops Extra sealed with a screw cap (30 ml solution) and 1 tablet container (30 tablets) and 1 plastic dosing pump in one box.

 

2 bottles of Béres Drops Extra sealed with a dropper inlet and a screw cap (2x30 ml solution) and 1 tablet container (60 tablets) in one box or

2 bottles of Béres Drops Extra sealed with a screw cap (2x30 ml solution) and 1 tablet container (60 tablets) and 1 or 2 plastic dosing pumps in one box.

 

4 bottles of Béres Drops Extra sealed with a dropper inlet and a screw cap (4x30 ml solution) and 1 tablet container (120 tablets) in one box or

4 bottles of Béres Drops Extra sealed with a screw cap (4x30 ml solution) and 1 tablet container (120 tablets) and 1 or 4 plastic dosing pumps in one box.

 

1 bottle of Béres Drops Extra sealed with a dropper inlet and a screw cap (100 ml solution) and 1 tablet container (100 tablets) in one box or

1 bottle of Béres Drops Extra sealed with a screw cap (100 ml solution) and 1 tablet container (100 tablets) and 1 plastic dosing pump in one box.

2 bottles of Béres Drops Extra sealed with a dropper inlet and a screw cap (2x100 ml solution) and 1 tablet container (200 tablets) in one box or

2 bottles of Béres Drops Extra sealed with a screw cap (2x100 ml solution) and 1 tablet container (200 tablets) and 1 or 2 plastic dosing pumps in one box.

 

Not all package sizes are marketed.

 

Marketing authorisation holder

 

Béres Gyógyszergyár Zrt.
1037 Budapest, Mikoviny u. 2-4.
Hungary
Tel.: +36-1-430-5500
Fax: +36-1-250-7251
E-mail: [email protected]

 

Manufacturer

 

Béres Gyógyszergyár Zrt.
5005 Szolnok, Nagysándor József út 39.
Hungary

 

OGYI-T-22924/01   1x30 ml + 30x      in a bottle with a dropper, and tablets in an HDPE container

OGYI-T-22924/02   1x30 ml + 30x      in a bottle with 1 dosing pump, and tablets in an HDPE container

OGYI-T-22924/03   2x30 ml + 60x      in a bottle with a dropper, and tablets in an HDPE container

OGYI-T-22924/04   2x30 ml + 60x      in a bottle with 1 dosing pump, and tablets in an HDPE container

OGYI-T-22924/05   2x30 ml + 60x      in a bottle with 2 dosing pump, and tablets in an HDPE container

OGYI-T-22924/06   4x30 ml + 120x    in a bottle with a dropper, and tablets in an HDPE container

OGYI-T-22924/07   4x30 ml + 120x    in a bottle with 1 dosing pump, and tablets in an HDPE container

OGYI-T-22924/08   4x30 ml + 120x    in a bottle with 4 dosing pump, and tablets in an HDPE container

OGYI-T-22924/09   1x100 ml + 100x  in a bottle with a dropper, and tablets in an HDPE container

OGYI-T-22924/10   1x100 ml + 100x  in a bottle with 1 dosing pump, and tablets in an HDPE container

OGYI-T-22924/11   2x100 ml + 200x  in a bottle with a dropper, and tablets in an HDPE container

OGYI-T-22924/12   2x100 ml + 200x  in a bottle with 1 dosing pump, and tablets in an HDPE container

OGYI-T-22924/13   2x100 ml + 200x  in a bottle with 2 dosing pump, and tablets in an HDPE container

 

Date of the latest review of the Patient Information Leaflet: October 2015 

 

Instructions for Use

 

http://www.beres.hu/userfiles/uploaded_images/beres_csepp/Adagolo.jpg

 

1. Remove the tamper-evident cap by twisting it anticlockwise.

 

2. Take the dosing pump out of the protecting bag and screw it onto the bottle.

 

3. Before the first use, to let the air out of the dosing pump, hold the bottle vertically and press the pump (appr. 2-4 times) until the liquid appears, and then press it 3 times before obtaining the exact amount of dose.

 

4. Pump the proper dose into a half decilitre of liquid as recommended above.

 

5. If you do not use the preparation for more than a week, you will have to repeat the operation described in point 3. If you use it frequently this repetition is not necessary.

 

6. If your packaging includes several bottles (2 or 4) and a dosing pump, then if the liquid has been used up in one bottle, screw off the pump from the empty bottle and screw it on a full bottle. Repeat the operation described in point 3.

 

Béres Drops Extra oral solution drops have a marketing authorization for packaging with pump of 1 x 30 ml, 2 x 30 ml, 4 x 30 ml, 1 x 100 ml, 2 x 100 ml and also packaging with dropper of 1 x 30 ml, 2 x 30 ml, 4 x 30 ml, 1 x 100 ml, 2 x 100 ml. Please note that the active ingredient content of the amount obtained with 1 press of the dosing pump is not equal to the active ingredient content of 1 drop of the dropper packaging.

 

Number of pump presses

Number of drops equal to the given amount

2 presses

5 drops

4 presses

10 drops

8 presses

20 drops

48 presses

120 drops

 

Registration category:Over-the-counter roborant medicinal product

FOR RISKS AND SIDE EFFECTS, PLEASE READ THE PATIENT INFORMATION LEAFLET OR CONSULT YOUR DOCTOR, PHARMACIST!



© Copyright 2012 Béres Pharmaceuticals Ltd.

Increst Communication