Actival Senior

above 50 years of age

Actival Senior film-coated tablet is a multivitamin preparation with minerals and trace elements for those above 50 years of age.

 

Why do we recommend this preparation?
 
Vitamin supplementation is especially important above 50 years of age, this is what Actival Senior facilitates.

 

In what cases is the preparation recommended?
 

  • Over 50 years of age in the cases of frequently emerging fatigue (e.g. as a result of stress), tiredness, feeling weak, decreasing ability to concentrate, and to prevent vitamin deficiency.

 
Pack sizes:

 

30, 60 and 90 film-coated tablets

 

Dosing:

 

1 film-coated tablet per day for adults.

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

 

Actival Senior film-coated tablet

vitamins, minerals, trace elements and antioxidants

 

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 has told you.

·         Keep this leaflet. You may need to read it again.

·         Ask your pharmacist if you need more information or advice.

·         If any of the side effects get severe talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

·         You must talk to a doctor if you do not feel better of if you feel worse.

 

In this leaflet:

1.           What Actival Senior film-coated tablet is and what it is used for

2.           What you need to know before you take Actival Senior film-coated tablet

3.       How to take Actival Senior film-coated tablet

4.       Possible side effects

5.       How to store Actival Senior film-coated tablet

6.       Contents of the pack and further information

 

 

1.       What Actival Senior film-coated tablet is and what it is used for

 

Actival Senior is a preparation for the older generation (above the age of 50) containing vitamins, minerals and trace elements.

The preparation is recommended:

·         in cases of fatigue (stress), tiredness, feeling weak and decreased ability to concentrate

·         to prevent vitamin deficiencies

 

 

 

2.       What you need to know before you take Actival Senior film-coated tablet

 

Do not take Actival Senior film-coated tablet if

·         you are allergic (hypersensitive) to any of the active substances or other ingredients of the medicine,

·         you have existing vitamin A or vitamin D overdose,

·         you are undergoing retinoid treatment,

·         you have elevated calcium levels in your urine or in your blood,

·         you have renal insufficiency or kidney stones,

·         you have iron overload (haemochromatosis, haemosiderosis),

·         you have hereditary copper metabolism disorder (Wilson disease),

·         you have hyperthyroidism or are undergoing treatment for overactive thyroid, a radioiodine treatment,

·         you have peanuts or soy allergy, because the preparation contains soybean oil.

 

Take special care with Actival Senior film-coated tablets

Talk to your doctor or pharmacist before taking Actival Senior if:

·         you have liver and biliary tract disorders,

·         you have renal insufficiency,

·         you take thyroid hormone or coumarin type anticoagulants,

·         you are sensitive to particular sugars (owing to the sucrose and glucose content of the preparation).

 

Riboflavin (vitamin B2) may colour urine yellow. The tablet’s iron content may colour stools black.

Actival Senior film-coated tablets do not contain a considerable amount of calories, so diabetic patients may also take it.

High doses of vitamin C may modify the results of particular laboratory tests, so inform your doctor prescribing a laboratory test that you take vitamin C.

 

Children

Actival Senior film-coated tablet is not recommended in children.

 

Taking other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or are planning to take any other medicines including non-prescription preparations.

 

Its administration with other multivitamin preparations is not recommended.

 

Its concomitant use with other preparations containing vitamins A, D, E and K, as well as trace elements and retinoid shall be avoided, owing to the possibility of overdose.

 

Its concomitant use with vitamin D or calcium may result in hypercalcaemia (elevated calcium level in the blood).

 

Antacids and tetracyclines (a group of antibiotics) inhibit iron absorption, while medicines containing the active substance penicillamine inhibit the absorption of trace elements. To avoid drug interactions let at least 2 hours pass between taking the film-coated tablet and other medicines.

 

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). 

When taken regularly, a number medicines (e.g. antacids, antibiotics, anti-inflammatory medicines, painkillers, antihypertensives, cholesterol lowering medicines, blood thinners, gastric ulcer medicines, diuretics, laxatives, tranquilizers) inhibit the absorption and bioavailability of particular vitamins, minerals and trace elements.

 

Actival Senior film-coated tablet with food and drinks

Foodstuff containing high quantities of fibre and/or phytic acid (e.g. cereals, bread made from whole-wheat flour, wheat bran) may inhibit the absorption of trace elements. 

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicines if you are pregnant, breast-feeding, if there is a chance you are pregnant or would like to have a baby.

 

This medicine is not specifically recommended for pregnant women but taking Actival Senior film-coated tablets by incident has no risks during pregnancy and breast-feeding.

 

Driving and using machines

It does not affect the ability to drive and operate machinery when taken in the recommended dose.

 

Actival Senior film-coated tablet contains glucose and sucrose

If your doctor has informed you that you are sensitive to particular sugars, consult your doctor before starting to take this medicine.

 

Actival Senior contains colourings (quinoline yellow, orange FCF)

The colouring may cause allergic reactions.

 

 

3.       How to take Actival Senior film-coated tablet

 

Always take the medicine as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

 

The recommended dose in adults is 1 film-coated tablet per day. When possible take the film-coated tablet whole at the end of a meal with a little liquid.

 

The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

 

Take the preparation continuously during the health status or disease justifying its administration.

 

Children

Actival Senior film-coated tablet is not recommended in children.

 

If you take more Actival Senior film-coated tablets than you should

The active substance content of Actival Senior film-coated tablet does not present a risk of overdose. Taking higher doses on the long term may result in overdosing vitamins A, D and E. Unless your doctor recommends otherwise, do not take more than the recommended daily dose.

When taking multiple doses you might experience stomach complaints and hypersensitivity reactions in rare cases.

Excessive vitamin A intake may cause fatigue, irritability, loss of appetite, gastrointenstinal symptoms, skin and hair changes (redness, itching).

Very high doses of vitamin D intake may lead to elevated calcium levels in the blood (symptoms: nausea, vomiting, excessive thirst, excessive urination and constipation).

Taking higher doses of vitamin E for a long time may cause gastrointestinal symptoms, fatigue and weakness.

 

If you forget to take Actival Senior film-coated tablet

Do not take a double dose the next time. Continue as recommended.

 

If you stop taking Actival Senior film-coated tablet

In general, no harmful effects develop when stopping the treatment.

 

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

 

 

4.       Possible side effects

 

Like all medicines, Actival Senior can cause side effects, although not everybody gets them.

 

Very rarely – in fewer than 1 in 10,000 users – hypersensitivity reactions (rash, urticaria, itching) may occur.

 

If any of the side effects get severe talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

 

5.       How to store Actival Senior film-coated tablet

 

Store at or below 25  C.

Keep it in the original packaging to protect from moisture.

 

Keep this medicine out of the sight and reach of children. 

Do not take the medicine after the expiry date printed on the packaging  (Felhasználható:). 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 will help to protect the environment.

 

 

6.       Contents of the pack and further information

 

What Actival Senior film-coated tablets contain

·         Active substances in each film-coated tablet:

0.06 mg (200 IU) all-E retinol (in the form of retinol acetate) (vitamin A), 1.4 mg thiamine (in the form of thiamine nitrate) (vitamin B1), 1.6 mg riboflavin (vitamin B2), 15 mg nicotinamide (vitamin B3), 4 mg pantothenic acid (in the form of calcium panthotenate) (vitamin B5), 5 mg pyridoxine (in the form of pyridoxine hydrochloride) (vitamin B6), 0.003 mg cyanocobalamin (vitamin B12), 0.1 mg folic acid, 0.1 mg biotin (vitamin H), 100 mg ascorbic acid (vitamin C), 0.005 mg (200 IU) colecalciferol (vitamin D3), 13.4 mg (20 IU) α–tocopherol (in the form of α‑tocopherol acetate) (vitamin E), 0.08 mg phytomenadione (vitamin K1), 194 mg calcium (in the form of calcium carbonate and anhydrous calcium hydrogen phosphate), 112 mg phosporus (in the form of anhydrous calcium hydrogen phosphate), 100 mg magnesium (in the form of heavy magnesium oxide), 10 mg zinc (in the form of zinc sulphate monohydrate), 4 mg iron (in the form of iron(II) gluconate), 4 mg manganese (in the form of manganese sulfate monohydrate), 1.5 mg boron (in the form of boric acid), 0.2 mg copper (in the form of cupric gluconate), 0.1 mg iodine (in the form of potassium iodate), 0.05 mg chromium (in the form of chromium picolinate), 0.02 mg selenium (in the form of selenous acid), 50 mg succininc acid, 30 mg glycine.

 

·         Other ingredients:

Tablet core: mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, butylated hydroxytoulene (E321), sucrose, spray dried glucose syrup, gelatin, maize starch, sodium citrate, citric acid,  maltodextrin, dl-α-tocopherol, partially hydrogenated soybean oil,  modified starch, silicon dioxide, gum arabic (E414), tricalcium phosphate, polysorbate 80.

 

Tablet coating: partially hydrogenated polivinyl alcohol, talc, titanium dioxide (E171), quinoline yellow (E104), macrogol 3350, soy lecithin, yellow iron oxide (E172), orange FCF (E110),

 

What Actival Senior looks like and the contents of the pack

Orange, oblong film-coated tablets scored on both sides having a mild, characteristic scent.

30, 60, 90, 90+30 film-coated tablets in a white HDPE tablet container sealed with an aluminum foil closed with a white polypropylene screw cap with a paper/wax/Al/polyethylene insert. 1 or 2 containers in a box.

Not all pack sizes may be 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.

Registration category:over-the-counter medicinal preparation

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

 
 

 

 

Name of active substance Quantity active substances per film-coated tablet
A-vitamin (retinol) 0,06 mg (200 IU)
B1-vitamin (thiamine) 1,4 mg
B2-vitamin (riboflavin) 1,6 mg
B3-vitamin (nicotinamide) 15 mg
B5-vitamin (pantothenic acid) 4 mg
B6-vitamin (pyridoxine) 5 mg
B12-vitamin (cyanocobalamin) 0,003 mg
Folsav 0,1 mg
H-vitamin (biotin) 0,1 mg
C-vitamin (ascorbic acid) 100 mg
D3-vitamin (cholecalciferol) 0,005 mg (200 IU)
E-vitamin (alpha-tocopherol) 13,4 mg (20 IU)
K1-vitamin (phytomenadione) 0,08 mg
Calcium 194 mg
Phosporus 112 mg
Magnesium 100 mg
Zinc 10 mg
Iron 4 mg
Manganese 4 mg
Boron 1,5 mg
Copper 0,2 mg
Iodine 0,1 mg
Chromium 0,05 mg
Selenium 0,02 mg
Succinic acid 50 mg
Glycine 30 mg

 

Registration category:over-the-counter medicinal preparation

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



© Copyright 2012 Béres Pharmaceuticals Ltd.

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