Read this patient information leaflet carefully. It contains information important to you.
This is an over-the-counter medicine. For the optimal effect however, it is essential to administer the preparation with caution.
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.
Urgently contact your doctor if your symptoms do not ease or get more severe.
If any of the side effects get severe or if you perceive side effects not listed in the patient information leaflet, please inform your doctor or pharmacist.
Contents of the patient information leaflet:
1. What type of medicine is Actival Extra film-coated tablet and what diseases is it recommended for?
2. Before taking Actival Extra film-coated tablet
3. How to take Actival Extra film-coated tablet?
4. Possible side effects
5. How to store Actival Extra film-coated tablet?
6. Additional information
1. WHAT TYPE OF MEDICINE IS ACTIVAL EXTRA FILM-COATED TABLET AND WHAT DISEASES IS IT RECOMMENDED FOR?
Actival Extra film-coated tablet is a multivitamin preparation containing minerals, trace elements, beta-carotene, lutein and lycopene.
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:
Imbalanced nutrition (e.g. during slimming diets, vegetarian diets)
Increased physical strain (e.g. doing sports).
2. BEFORE TAKING ACTIVAL EXTRA FILM-COATED TABLET
Do not take Actival Extra film-coated tablet in the cases of
allergy (hypersensitivity) to the active substances and auxiliary materials of Actival Extra film-coated tablet,
kidney disorders or having kidney stones,
hyperthyroidism, undergoing treatment for hyperthyroidism, undergoing radioiodine therapy,
vitamin A or D overdose,
undergoing retinoid treatment,
higher than normal calcium level in the blood or urine,
iron overload (haemochromatosis, haemosiderosis),
the hereditary copper metabolism disorder (Wilson disease).
The preparation contains soybean oil. Do not take the preparation if you have soy or peanut allergy.
Az Actival Extra film-coated tablet can be taken with caution in the cases of
liver or biliary tract diseases,
sensitivity to sugars (the preparation contains sucrose and glucose).
Consult your doctor prior to administration in the cases mentioned above!
Taking other medicines during the therapy
Inform your doctor or pharmacist by all means about the medicines you are taking or have recently taken, including over-the-counter preparations.
It is not recommended to take it with other multivitamin preparations.
Avoid taking it with other preparations containing vitamins A, D, E and K, trace elements and retinoid owing to the chance of excess intake! Elevated calcium level in the blood may result from co-administering it with vitamin D or calcium.
To avoid drug interactions leave at least 2 hours between taking the film-coated tablet and other medicines (antacids and medicines containing fluoroquinolone, tetracycline, phenytoin, penicillamine and bisphosphonate).
Based on prior medical consultation it may be co-administered with coumarin-type anticoagulants, folic acid antagonist, as well as medicines containing L-DOPA and levothyroxine (thyroid hormone).
Taking Actival Extra film-coated tablet simultaneously with particular dishes or drinks
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 and lactation
Consult your doctor or pharmacist before taking any medicine. Although Actival Extra film-coated tablet is a vitamin preparation not designed for pregnant women and nursing mothers you can take the recommended daily dose (1 film-coated tablet) during pregnancy and lactation.
If you are pregnant make sure that you do not take more than 5500 IU (International Unit) of vitamin A and 600 IU of vitamin D3.
Retinol is secreted in breast milk therefore taking high doses of vitamin A is not recommended during breastfeeding. The recommneded daily dose during breasfeeding is 4000 IU.
The effects of the preparation on driving capabilities and capabilities of the operation of machines
Actival Extra film-coated tablet does not have any effect on driving capabilities and the operation of machines.
Important information about particular substances of Actival Extra film-coated tablets
The preparation contains glucose and sucrose. If your doctor has already informed you about your sensitivity to particular sugars, please consult your doctor prior to taking this medicine.
The preparation contains soybean oil. Do not take the preparation if you have soy or peanut allergy.
Actival Extra film-coated tablet does not mean a considerable calorie intake, therefore it can be taken by people with diabetes.
Riboflavin (vitamin B2) may colour urine yellow. The iron content of the film-coated tablet may colour faeces black.
Vitamin C in high doses may modify the result of particular laboratory tests, so inform the doctor ordering the laboratory test about your taking a preparation containing vitamin C.
The preparation contains colourants (quinoline yellow, orange S, indigo carmine) that may cause allergic reactions.
3. HOW TO TAKE ACTIVAL EXTRA FILM-COATED TABLET?
Always take Actival Extra film-coated tablet exactly as your doctor has told you. If you are unsure about dosage, consult your doctor or pharmacist. The usual dose of the preparation is 1 film-coated tablet per day for adults. It is expedient to swallow the film-coated tablet whole without chewing at the end of a meal with some liquid. The preparation is recommended to be taken uninterrupted during the health status or disease justifying its administration.
The preparation is not recommended for children.
If you have taken more Actival Extra film-coated tablets than recommended
The active substance content of Actival Extra film-coated tablet does not carry a risk of overdose. However, vitamin A, D and E overdose may occur when taken on the long term at increased doses. Do not exceed the recommended daily dose until otherwise directed by your doctor.
Stomach complaints and hypersensitivity reactions may be caused in rare cases by taking multiple doses.
Excess vitamin A intake may cause fatigue, irritability, loss of appetite, gastrointenstinal symptoms, skin and hair changes (redness, itching).
A very large dose of vitamin D intake may lead to higher than normal calcium level in the blood (the symptoms of which are: nausea, vomiting, excessive thirst, excessive urination and constipation).
Taking larger doses of vitamin E for a longer time may cause gastrointestinal symptoms, fatigue and weakness.
If you have forgotten to take Actival Extra film-coated tablet
Do not take a double dose to make up for the forgotten tablet, take the next dose as prescribed.
If you stop taking Actival Extra film-coated tablet
In general, discontinuation of the treatment is not followed by any harmful effects.
In case you have further questions about administering the preparation, please consult your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all mendicines, Actival Extra film-coated tablet can cause side effects, although not everybody gets them.
Very rarely (in fewer than one case out of 10,000) hypersensitivity reactions (rash, urticaria, itching) may be experienced when taking the preparation.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
5. HOW TO STORE ACTIVAL EXTRA FILM-COATED TABLET?
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 Extra film-coated tablet after the expiry date (Felhasználható:) printed on the container. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.
6. ADDITIONAL INFORMATION
What does Actival Extra film-coated tablet contain?
Active substances in 1 film-coated tablet:
0.5 mg (1666 IU) all-(E)-retinol (as retinol acetate) (vitamin A), 1.8 mg (1000 IU) beta carotene, 1.4 mg thiamine (as thiamine nitrate) (vitamin B1), 1.6 mg riboflavin (vitamin B2), 18 mg nicotinamid (vitamin B3), 6 mg pantothenic acid (as calcium-pantothenate) (vitamin B5), 2 mg pyridoxine (as pyridoxine hydrochloride) (vitamin B6), 0.001 mg cyanocobalamin (vitamin B12), 0.2 mg folic acid, 0.03 mg biotin (vitamin H), 125 mg ascorbic acid (vitamin C), 0.005 mg (200 IU) cholecalciferol (vitamin D3), 20.1 mg (30 IU) α tocopherol (as α tocopherol-acetate) (vitamin E), 0.04 mg phytomenadione (vitamin K1), 10 mg para-aminobenzoic acid, 5 mg rutin, 200 mg calcium (as calcium hydrogen phosphate - anhydrous), 155 mg phosphorus (as calcium hydrogen phosphate - anhydrous), 100 mg magnesium (as heavy magnesium oxide), 15 mg zinc (as zinc sulfate monohydrate), 4 mg iron (as ferrous(II) gluconate), 1 mg boron (as boric acid), 1 mg manganese (as manganese(II) sulphate monohydrate), 1.4 mg copper (as cupric gluconate), 0.1 mg iodine (as potassium iodate), 0.075 mg molybdenum (as ammonium molybdate tetrahydrate), 0.024 mg chromium (as chromium picolinate), 0.04 mg selenium (as selenious acid), 0.01 mg vanadium (as ammónium-metavanadate), 0.3 mg lutein and 0.3 mg lycopene.
Tablet core: butylated hydroxytoluene (E321), trisodium-citrate, citric acid, maltodextrine, dl-α-tocopherol, gelatin (fish; hydrolised, calf and young pig skin), calcium silicate, silicon dioxide, partially hydrogenated soybean oil, sugar, maize starch, glucose syrup, sodium ascorbate, modified food starch, tricalcium phosphate, gum arabic (E414), magnesium stearate, mannitol, crospovidone, microcrystalline cellulose, hydroxypropyl cellulose
Coating: Opadry II. Green 85G21832
partially hydrolised pilyvinyl alcohol, talc, titanium dioxide (E171), macrogol (PEG 3350), soya lecithin, indigo carmine (FD&C Blue 2), iron oxide yellow (E172), quinoline yellow (E104).
What does Actival Extra preparation look like and the contents of the pack
Green, oblong film-coated tablet with a breakline on both sides. 30, 36, 60, 72, 90, 108, 90+30 and 60+60 film-coated tablets in a white HDPE tablet container with an aluminum foil and white polypropylene screw cap. 1 container in a box.
Not all pack sizes may be marketed.
Marketing authorisation holder:
Béres Gyógyszergyár Zrt.
Mikoviny u. 2-4.
Email: [email protected]
BBéres Gyógyszergyár Zrt.
5005 Szolnok, Nagysándor József út 39.
OGYI-T-9416/04 36 db
OGYI-T-9416/05 72 db
OGYI-T-9416/06 108 db
OGYI-T-9416/07 90 db+30 db
OGYI-T-9416/08 60 db+60 db
Patient information leaflet approval date: 22 April, 2011.