Actival Senior Plus

For people over 50

Vitamin supplementation is especially important over 50. The new Actival Senior Plus multivitamin film-coated tablets, with minerals and trace elements, are here to help you. 

 

Actival Senior Plus film-coated multivitamin tablets, also containing minerals and trace elements, have been compiled especially for the elderly (people over 50).

 

Why is the use of this product recommended?
 

Vitamin supplementation is especially important over 50. The new Actival senior may be a great help. As it does not contain iodine, patients with hyperthyreosis can also use it.


When is the use of Actival Senior Plus recommended?

 

If you are exhausted (e.g. by stress) or tired, feel weak and  have poor concentration. When you need increased amounts of vitamins and minerals, especially vitamin A, B5 and D, or if your vitamin intake is insufficient, to prevent vitamin and folate deficiency.

 


Content of the pack:

30, 60 or 90+30 film-coated tablets



Dosage:

One (1) film-coated tablet daily for adults.

 

 

PACKAGE LEAFLET: PRODUCT INFORMATION FOR USERS

 

Read this entire package leaflet carefully before you start taking this product, as it contains information important for you.

Always use the product exactly as described in this leaflet or as your doctor or pharmacist has told you.

- Keep this leaflet. You may need to read this information again.

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

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

- You must talk to a doctor if you do not feel better, or if you feel worse.

 

In this leaflet:

1 What Actival Senior Plus film-coated tablets are and what they are used for

2 Before you use Actival Senior Plus

3 How to use Actival Senior Plus

4 Possible side effects

5 How to store Actival Senior Plus

6 Content of the pack and further information

 

1 What Actival Senior Plus film-coated tablets are and what they are used for

Actival Senior Plus film-coated multivitamin tablets, also containing minerals and trace elements, have been compiled especially for the elderly (people over 50).

Use of the product is recommended in the following cases:

- In the case of exhaustion (e.g. by stress), tiredness, weakness, poor concentration.

- When you need increased amounts of vitamins and minerals, especially vitamin A, B5 and D, or if your vitamin intake is insufficient, to prevent vitamin and folate deficiency.

 

2 Before you use Actival Senior Plus:

Do NOT use Actival Senior Plus:

- If you are allergic (hypersensitive) to any of the ingredients in Actival Senior Plus (see list of ingredients in Section 6);

- In the case of an overdose of A or D;

- During retinoid treatment;

- If the calcium levels in your blood or urine is above the upper limit of normal;

- If you have renal failure or kidney stones;

- If you have a history of iron overload disorder (hemochromatosis or hemosiderosis);

- If you have a genetic disorder of copper metabolism (Wilson’s disease);

- If you are allergic to peanuts or soy.

 

Warnings and precautions

Talk to your doctor or pharmacist before using Actival Senior Plus:

- If you have a liver or bile duct disease;

- If you have a history of renal failure;

- If you are sensitive to certain sugars (as the product contains saccharose);

- Talk to your doctor about the simultaneous use of this supplement with other vitamins.

Riboflavin (vitamin B2I) may turn your urine yellow. The iron in the tablet may turn your stool black.

Actival Senior Plus does not contain a high amount of calories, and can also be used by diabetes patients.

The vitamin C content of Actival Senior Plus film-coated tablets may change the findings of laboratory tests. Tell the doctor who requires laboratory tests that you use Actival Senior Plus tablets containing vitamin C.

 

Children and adolescents

The use of Actival Senior Plus film-coated tablets is not recommended for children and adolescents.

 

Other medicines and Actival Senior Plus

It is imperative to talk to your pharmacist about any other medicines you currently use, have recently used or plan to you. Talk to your doctor about the simultaneous use of Actival Senior Plus and other multivitamin products.

Avoid using the product simultaneously with other products containing vitamin A, D or E, trace elements or retinoid products to prevent excessive intake.

Using it simultaneously with vitamin D or calcium may increase calcium levels in your blood.

The use with antacid products and tetracycline (a group of antibiotics) prevent the absorption of iron, while products containing penicillin-amine as an API prevent the absorption of trace elements.

In the case of simultaneous use, the absorption of medicines containing fluoroquinolone, tetracycline, phenytoin, penicillin amine, bi-phosphonate may change. In order to avoid interactions, leave at least 2 hours between the intake of Actival Senior Plus film-coated tablet and other medicines.

On preliminary medical advice, it may be used simultaneously with folic acid antagonist and medicines containing levodopa.

The regular use of numerous medicines (e.g. antacids, antibiotics, anti-inflammatory drugs, pain killers, antihypertensive agents, medicines against epilepsy, cholesterol lowering medicines, blood thinners, agents against gastric ulcer, products used to treat tuberculosis, diuretics, laxatives, tranquilisers, anti-tumour agents) reduce the absorption of certain vitamins, minerals and trace elements.

 

Using Actival Senior Plus film-coated tablets with food and beverages

Foods containing a large amount of fibre and/or phytic acid (e.g. cereals, whole-wheat bread, wheat bran) reduce the absorption of trace elements contained in the product.

 

Pregnancy, breast-feeding and fertility

During pregnancy or breast-feeding, or the likelihood of pregnancy is not excluded or you would like to have children, consult your doctor or pharmacist before using the product. Pregnant and breast-feeding patients are not recommended to use Actival Senior Plus film-coated tablets, but if accidentally taken, it does not represent any risk.

 

Effects of the product on safe driving and other motor skills

This product is not expected to affect skills required for safe driving or the safe operation of machines.

 

Actival Senior Plus tablets contain saccharose and soy oil

If your doctor has warned you that you are sensitive to certain sugars, seek your doctor’s advice before starting to use this product.

Do NOT use the product if you are allergic to peanuts or soy.

 

3 How to use Actival Senior Plus?

Always use the product exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure of the dosage, ask your doctor of pharmacist.

Adults are recommended to take 1 film-coated tablet daily. Swallow the tablet at the end of a meal with a glass of water or fruit juice. Do not chew.

The score line on the tablet only serves breaking if you are unable to swallow the whole tablet.

It is recommended to take the product on a regular basis during vitamin or mineral deficiency. Use for longer than the prescribed period is not recommended. Do not exceed the recommended daily dose.

 

 

Use by children and adolescents

Use by children and adolescents is not recommended.

 

If you take more Actival Senior Plus film-coated tablets than prescribed

The active ingredients contained in Actival Senior Plus film-coated tablets do not pose the risk of overdose if taken in the recommended dose for the recommended period. Using more of the product than recommended for a longer period may result in vitamin A, D and E overdose. Unless your doctor otherwise advises, do not exceed the recommended daily dose and duration of treatment.

If multiple of the recommended dose (1 film-coated tablet daily) is taken, you may have stomach troubles and rarely hypersensitivity reactions.

Excessive vitamin A intake may cause fatigue, irritability, loss of appetite, gastrointestinal troubles, or changes in the skin and hair (erythema, itching).

Excessive vitamin D intake may lead to elevated calcium levels in the blood, with the following symptoms: nausea, vomiting, unquenchable thirst, abundant urination and constipation.

Excessive vitamin E intake may cause gastrointestinal symptoms, fatigue and weakness.

 

If your forget to take Actival Senior Plus film-coated tablet

Do NOT take an extra dose to make up for the missed tablet. Just resume your regular schedule.

 

If you stop taking Actival Senior Plus film-coated tablets early

You can stop taking the product without any adverse effects.

 

If you have any further question on the use of the product, ask your doctor or pharmacist.

 

4 Possible side effects

As with all medications, this product may also cause side effects, although not everybody gets them.

Very rare (happens to less than 1 patient in 10,000): hypersensitivity reactions (erythema, hives, itching skin).

 

Reporting side-effects

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

You can report the side effects directly to the authority at the following addresses:

National Institute of Pharmacy and Nutrition

P.O.Box 450

H-1372 Budapest

Website: www.ogyei.gov.hu

By reporting side effects, you contribute to the information available about the safe use of this product.

 

5 How to store Actival Senior Plus

Do not store the product in a hot place (the maximum allowed temperature is 25° C).

In order to protect the product against humidity, keep it tightly closed.

Keep out of the reach of children.

Do not use the product after the expiry date specified on the box (“Best before”). The expiry date means the last day of the given month.

Do not throw any medicines down the sink or sewer or in household trash. Seek your pharmacist’s advice on discarding any medication no longer used. These actions will help protect and improve our environment.

 

6 Content of the pack and further information

Content of Actival Senior Plus film-coated tablet

-Active ingredients contained in one film-coated tablet: 0.80 mg (2666 NE) 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 (B2-vitamin); 15 mg nicotinamide (vitamin B3); 7.5 mg pantothenic acid (in the form of calcium pantothenate) (vitamin B5); 5 mg pyridoxine (in the form of pyridoxine hydrochloride) (B6-vitamin); 0.003 mg cyanocobalamin

(vitamin B12); 0.3 mg folic acid; 0.1 mg biotin (vitamin H); 100 mg ascorbic acid (vitamin C); 0.01 mg (400 NE) cholecalciferol (vitamin D3-vitamin); 13.4 mg (20 NE) α–tocopherol (in the form of α-tocopherol-acetate) (vitamin E), 200 mg calcium (in the form of calcium-carbonate and anhydrous calcium-hydrogen-phosphate)é 100 mg magnesium (in the form of heavy magnesium-oxide)é 10 mg zinc (in the form of zinc-sulphate-monohydrate), 4 mg iron (in the form of ferrous(II)-gluconate); 1.5 mg bore (in the form of boric acid); 0.2 mg copper (in the form of copper-gluconate); 0.02 mg selenium (in the form of sodium-selenite).

-Other ingredients: Core: mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, butyl-hydroxyl-toluol (E321), saccharose, gelatine, maize starch, trisodium-citrate, citric acid, maltodextrin, dl-α-tocopherol, partially hydrolysed soy bean oil, modified starch, silica, polysorbate 80. Coating: partially hydrolysed poly(vinyl alcohol), talcum, titanium dioxide (E171), macrogol 3350, soy lecithin, black and yellow ferrous oxide (E172).

 

What an Actival Senior Plus tablet looks like and the contents of the pack

It is a longish, yellow, film-coated tablet with a score line on both sides.

The score line is only to help breaking for ease of swallowing and not to divide into equal doses.

30, 60, 36, 72, 108, 90, 90+30, 60+60, 30+30 film-coated tablets in white HPDE tablet containers with polypropylene screw-tops, sealed by multi-layer tamper-evident, heat adhesive films.

 

A box contains 1 or 2 containers.

Not all kinds of packaging are necessarily marketed.

 

Marketing authorisation holder:

Béres Gyógyszergyár Zrt.

H-1037 Budapest, Mikoviny u. 2–4

Tel: +36-1-430-5500

Fax: +36-1-250-7251

Email: [email protected]

Manufacturer:

Béres Gyógyszergyár Zrt.

H-5005 Szolnok, Nagysándor József út 39.

 

OGYI-T-23232/01 30x HDPE container

OGYI-T-23232/02 36x HDPE container

OGYI-T-23232/03 60x HDPE container

OGYI-T-23232/04 72x HDPE container

OGYI-T-23232/05 90x HDPE container

OGYI-T-23232/06 108x HDPE container

OGYI-T-23232/07 90x+30x HDPE container

OGYI-T-23232/08 60x+60x HDPE container

OGYI-T-23232/09 30x+30x HDPE container

 

Date of the last review of the package leaflet: July 2017

 

 

Active ingredients contained in one film-coated tablet:0.80 mg (2666 NE) 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 (B2-vitamin); 15 mg nicotinamide (vitamin B3); 7.5 mg pantothenic acid (in the form of calcium pantothenate) (vitamin B5); 5 mg pyridoxine (in the form of pyridoxine hydrochloride) (B6-vitamin); 0.003 mg cyanocobalamin

(vitamin B12); 0.3 mg folic acid; 0.1 mg biotin (vitamin H); 100 mg ascorbic acid (vitamin C); 0.01 mg (400 NE) cholecalcipherol (vitamin D3-vitamin); 13.4 mg (20 NE) α–tocopherol (in the form of α-tocopherol-acetate) (vitamin E), 200 mg calcium (in the form of calcium-carbonate and 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 ferrous(II)-gluconate); 1.5 mg bore (in the form of boric acid); 0.2 mg copper (in the form of copper-gluconate); 0.02 mg selenium (in the form of sodium-selenite).

-Other ingredients: Core: mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, butyl-hydroxyl-toluol (E321), saccharose, gelatine, maize starch, tri-sodium-citrate, citric acid, maltodextrin, dl-α-tocopherol, partially hydrolysed soy bean oil, modified starch, silica, polysorbate 80. Coating: Partially hydrolysed poly(vinyl alcohol), talcum, titanium dioxide (E171), macrogol 3350, soy lecithin, black and yellow ferrous oxide (E172).

 

Registration category:over-the-counter medicinal preparation

For risk and side effects, please read the patient information leaflet or consult your doctor,pharmacist



© Copyright 2012 Béres Pharmaceuticals Ltd.

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