PATIENT INFORMATION LEAFLET INFORMATION FOR USERS
Actival Junior Chewable Tablets
With 3 different - raspberry, cherry, strawberry - flavours
Read this information leaflet carefully, it contains important information for you.
This medicine is available without a prescription. However, it is indispensable to use this medicine carefully in order to achieve an optimal effect.
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Please keep the patient information leaflet, because you might need the information in it later on as well.
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For further information or advice, consult your pharmacist.
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You must contact a doctor urgently if your symptoms do not improve or worsen.
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If any side effects become severe, or if you notice any symptoms not listed in the information leaflet, please contact your doctor or pharmacist.
Contents of the patient information leaflet:
1. What type of medicine is Actival Junior Chewable Tablets and what diseases is it recommended for?
2. Before taking Actival Junior Chewable Tablets
3. How to take Actival Junior Chewable Tablets?
4. Possible side effects
5. How to store Actival Junior Chewable Tablets?
6. Additional information
1. WHAT TYPE OF MEDICINE IS ACTIVAL JUNIOR CHEWABLE TABLETS AND WHAT DISEASES IS IT RECOMMENDED FOR?
To prevent general vitamin, mineral and trace element deficiencies resulting from increased need or decreased intake.
Multivitamin supply is recommended mainly in the cases below:
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Imbalanced nutrition (e.g. during slimming diets, vegetarian diets)
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Increased physical strain (e.g. doing sports).
2. BEFORE TAKING ACTIVAL JUNIOR CHEWABLE TABLETS
Do not give Actival Junior Chewable Tablets to your child if
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your child is allergic (hypersensitive) to any of the active ingredients or other components of the Actival Junior Chewable Tablets,
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your child has a higher than normal calcium, vitamin A or vitamin D level,
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your child suffers from phenylketonuria, kidney insufficiency, inborn disorder of copper metabolism (Wilson disease), overactive thyroid,
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if your child has other retinoid treatments.
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The product contains soybean oil. Do not use the product if your child has peanut or soybean allergy.
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It contains a phenylalanine source. On the degradation of the product phenylalanine is produced, therefore it may be harmful when used by patients suffering from phenylketonuria.
Actival Junior Chewable Tablets may be used with precaution
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talk to your pediatrician if you want to use it together with other vitamins
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consult your doctor before treatment with Actival Junior Chewable Tablets if your child has liver and biliary tract disease or secretion disorder.
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if your child is sensitive to certain sugars, as the product contains sacharose and glucose. In such cases consult your doctor before you give the product to your child.
Other medicines taken during the treatment
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It is not recommended to take it together with other multivitamin type preparations.
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Avoid using it at the same time with other vitamins A, D, E K, trace elements and preparations with retinoid content due to the risk of excessive intake.
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If your child takes it together with vitamin D or calcium, a higher calcium level may develop. To avoid interferences, leave at least 2 hours between taking Actival Junior Chewable Tablets and other medicines.
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Seek medical advice before taking the product together with certain coagulants, folic acid antagonists (certain cytostatic drugs) and drugs with L-thyroxin content (affecting thyroid).
Pregnancy and breast-feeding
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Before taking any drugs talk to your doctor or pharmacist.
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Although Actival Junior Chewable Tablets are not formulated according to the needs of pregnant women or nursing mothers, the daily maximum dose (3 tablets per day) may be taken during pregnancy and breast-feeding.
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In the case of pregnancy be aware that it is not recommended to take more than 5500 IU (international units) vitamin A and more than 600 IU vitamin D3. It is not recommended to take a high-dose of vitamin A during breast-feeding.
The effects of the preparation on driving capabilities and capabilities of the operation of machines
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Actival Junior Chewable Tablets does not have any effect on driving capabilities and the operation of machines.
Important information on certain ingredients of Actival Junior Chewable Tablets
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It contains a phenylalanine source. On the degradation of the product phenylalanine is produced, therefore it may be harmful when used by patients suffering from phenylketonuria.
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The preparation contains glucose and saccharose. If your doctor has previously warned you that your child is sensitive to certain sugars, contact your doctor before you start using the drug.
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The product contains soybean oil. Do not use the product if your child has peanut or soybean allergy.
3. HOW TO TAKE ACTIVAL JUNIOR CHEWABLE TABLETS?
Usual dose of the product: 1 tablet per day at the age of 2-3, 2 tablets per day at the age of 4-10, 3 tablets per day from 11 years of age.
The preparation is to be taken after a meal chewed. The preparation is recommended to be taken uninterrupted during the health status or disease justifying its administration.
If your child has taken more of Actival Junior chewable tablets than prescribed
The active ingredient content of Actival Junior Chewable Tablets does not pose an overdose risk. In the long term, taken in increased doses, overdosage of vitamin A, D and E may occur. Do not take more than the recommended dose unless otherwise directed by the paediatrician.
If your child has forgotten to take Actival Junior Chewable Tablets
Do not give double dose to your child to make up for a missed tablet. Just let him/her continue taking the daily dose.
Should you have any questions on how to use the product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Actival Junior Chewable Tablets can cause side effects, although not everybody gets them.
Rarely - 1-10 in 10 000 users – (mainly when the prescribed dose is exceeded) – mild, transitory stomach pains, diarrhoea, and very rarely - less than 1 in 10 000 users - oversensitivity reactions (skin rash and itching) may occur.
If any side effects become severe, or if you notice any symptoms not listed in the information leaflet, please contact your doctor or pharmacist.
5. HOW TO STORE ACTIVAL JUNIOR CHEWABLE TABLETS?
Store it below 25°C.
Keep the tablet container tightly closed to protect the tablets from moisture.
The medicine is to be kept out of reach of children!
Do not take Actival Junior Chewable Tablets after the expiry date (Felhasználható:) printed on the container. The expiry date refers to the last day of that month.
6. ADDITIONAL INFORMATION
What does Actival Junior Chewable Tablets contain?
417 IU vitamin A (as retinol acetate), 0.45 mg thiamine (as thiamine nitrate) (vitamin B1), 0.5 mg riboflavin (vitamin B2), 5.5 mg nicotinamid (vitamin B3), 2 mg pantothenic acid (as calcium-pantothenate) (vitamin B5), 0.65 mg pyridoxine (as pyridoxine hydrochloride) (vitamin B6), 0.5 µg cyanocobalamin (vitamin B12), 30 mg ascorbic acid (vitamin C), 100 IU cholecalciferol (vitamin D3), 3 IU α tocopherol (as α tocopherol-acetate) (vitamin E), 37.5 mg folic acid, 12.5 mg biotin (vitamin H), 5 µg phytomenadione (vitamin K1), 2 mg rutin, 10 mg succinic acid, 7.5 mg glycin, 50 mg calcium (as calcium carbonate and calcium hydrogen phosphate – anhydrous), 19.4 mg phosphorus (as calcium hydrogen phosphate - anhydrous), 25 mg magnesium (as magnesium oxide), 2.5 mg iron (as elemental iron), 1.5 mg zinc (as zinc oxide), 0.425 mg manganese (as manganese(II) sulphate monohydrate), 0.3 mg boron (as sodium tetraborate), 0.175 mg copper (as cupric gluconate), 22.5 µg iodine (as potassium iodate), 20 µg molybdenum (as ammonium molybdate), 5 µg selenium (as selenious acid)
Other compounds:
Butylhydroxytoluene, gelatin, sucrose, maize starch, trisodium-citrate, citric acid, maltodextrine, dl-α-tocopherol, partially hydrogenated soybean oil, modified starch, silicon dioxide, gum arabic, glucose , calcium phosphate, polysorbate 80, mannitol, xylitol, sorbitol, copovidone, magnesium stearate, aspartame (containing phenylalanine), acesulfame-K, raspberry, cherry, apple, strawberry, berry flavor, carminic acid (E120), red iron oxide (E172), blackberry extract, chlorophylline copper complex (E141), berry extract.
What does Actival Junior Chewable Tablets preparation look like and the contents of the pack?
Redish pink coloured, cherry flavoured; purple pink, raspberry flavoured; green coloured, apple flavoured; pink coloured strawberry flavoured, lilac coloured forest fruit flavoured, with characteristic odour, of special triangular shaped (♣) chewable tablets with slightly dotted surface.
30, 60, 120, 60+60 chewable tablets in white polyethylene container sealed with aluminium sealing foil and white, polypropylene screw-cap in 1 or 2 container boxes. Not all pack sizes are marketed.
Marketing authorisation holder:
Béres Gyógyszergyár Zrt.
1037 Budapest
Mikoviny u. 2-4.
Tel: 430-5500
Fax: 250-7251
Email: [email protected]
Manufacturer:
Béres Gyógyszergyár Zrt.
5005 Szolnok, Nagysándor József út 39.
OGYI-T-9623/01 30x
OGYI-T-9623/02 60x
OGYI-T-9623/03 90x
OGYI-T-9623/04 60x+60x
Patient information leaflet approval date: may, 2013
