Actival Extra Magnesium

Multivitamin with 250 mg magnesium

  • Active ingredients contained in one film-coated tablet:

0.5 mg (1666 NE) all-(E) retinol (in the form of retinol-acetate) (vitamin A); 1.8 mg (1000 NE) beta carotene, 1.4 mg thiamine (in the form of thiamine-nitrate) (vitamin B1); 1.6 mg riboflavin (B2-vitamin); 18 mg nicotinamide (vitamin B3); 6 mg pantothenic acid (in the form of calcium pantothenate) (vitamin B5); 2 mg pyridoxine (in the form of pyridoxine hydrochloride) (B6-vitamin); 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 NE) cholecalciferol (vitamin D3-vitamin); 20.1 mg (30 NE) α–tocopherol (in the form of α-tocopherol-acetate) (vitamin E); 5 mg rutoside, 200 mg calcium (in the form of calcium-carbonate); 250 mg magnesium (in the form of heavy magnesium-oxide); 15 mg zinc (in the form of zinc-sulphate-monohydrate), 4 mg iron (in the form of ferrous(II)-gluconate); 1 mg bore (in the form of boric acid); 1.4 mg copper (in the form of copper-gluconate); 0.04 mg selenium (in the form of sodium-selenite).

 

Other ingredients:

Core: butyl-hydroxyl-toluol (E321), gelatine, saccharose, maize starch, silica, dl-α-tocopherol, glucose syrup, sodium-ascorbinate, modified starch for food, tri-sodium-citrate, citric acid, maltodextrin, partially hydrolysed soy bean oil, poly-sorbate 80, mannitol. microcrystalline cellulose, hydroxyl-propyl-cellulose; crospovidone, magnesium stearate, talcum.

 

Coating: Partially hydrolysed poly-vinyl alcohol), talcum, titanium dioxide (E171), macrogol 3350, soy lecithin, indigo carmine (E132), yellow ferrous oxide (E172), quinolone yellow (E104).

 

 

Package leaflet: Product information for users

Actival Extra Magnesium film-coated tablets

vitamins, minerals and trace elements

 

 

Read this package leaflet completely and carefully before using the 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 Extra Magnesium film-coated tablets are and what they are used for
  2. Before you use Actival Extra Magnesium film-coated tablets

3       How to use Actival Extra Magnesium film-coated tablets

4       Possible side effects

5       How to store Actival Extra Magnesium film-coated tablets

6       Content of the pack and further information

 

 

1       What Actival Extra Magnesium film-coated tablets are and what they are used for

 

Actival Extra Magnesium film-coated tablets are a multivitamin product containing minerals and trace elements.

 

It is used for preventing or improving general vitamin, mineral and trace element deficiencies caused by increased demand or insufficient intake in adults and adolescents.

 

Multivitamin supplementation is especially recommended in the following cases:

- nutritional imbalances (e.g. slimming diet)

- exposure to significant physical stress (e.g. in sports).

Due to increased magnesium levels, to satisfy the body’s increased magnesium demand, prevent magnesium deficiency, and mitigate symptoms of magnesium deficiency (like fatigue, weakness, nervousness, irritability, slight anxiety, minor sleep disorders, reduced concentration, muscle tremors, muscle spasms, e.g. leg cramps at night).

 

 

2       Before you start using Actival Extra Magnesium film-coated tablets

 

Do NOT use Actival Extra Magnesium film-coated tablets

  • If you are allergic (hypersensitive) to any of the ingredients in Actival Senior Plus (see list of ingredients in Section 6);
  • If you have renal failure or kidney stones;
  • 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 a history of iron build-up 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

Before you starting the use of Actival Extra Magnesium film-coated tablets, consult your doctor or pharmacist.

  • If you have a liver or bile duct disease;
  • If you have 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 vitamin products.

 

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

Riboflavin (vitamin B2I) may turn your urine yellow.

The iron in the film-coated tablet may turn your stool black.

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

 

Children

This product is not recommended for children.

 

Other medicines and Actival Extra Magnesium

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.

 

In order to avoid interactions, leave at least 2 hours between the intake of Actival Senior Plus film-coated tablet and other medicines (gastric acid reducers and medicines containing fluoroquinolone, tetracycline, phenytoin, penicillamine and bi-phosphonate).

 

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

 

Taking Actival Extra Magnesium film-coated tablets with meal 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.

Although Actival Extra Magnesium film-coated tablets have not been compiled according to the needs of pregnant and breast-feeding mothers, you can use the recommended daily dose (1 film-coated tablet per day) during pregnancy and breast-feeding.

If you are pregnant, remember that the intake of more than 5500 NE (international unit) of vitamin A and 600 NE of vitamin D3 is not recommended.

As retinol passes through to mother’s milk, the application of high doses of vitamin A is not recommended. During beast-feeding the recommended daily dose is 4000 NE.

 

Effects of the product on safe driving and other motor skills

Actival Extra Magnesium film-coated tablets are not expected to affect safe driving and other motor skills.

 

Actival Extra Magnesium film-coated tablets contain glucose, 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.

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

 

 

3       How to use Actival Extra Magnesium film-coated tablets

 

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 and adolescents 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 the condition that requires its use or 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

This product is not recommended for children.

 

If you take more Actival Extra Magnesium film-coated tablets than prescribed

The active ingredients contained in Actival Extra Magnesium 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 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.

The permanent intake of increased doses of magnesium may result in overdose, which generally does not trigger toxic reactions in the case of normal renal function.

In the event of renal failure, however, magnesium toxaemia may develop with the following symptoms: low blood pressure, nausea, vomiting, depression of the central nervous system, reduced reflexes, differences in the ECG reports, reduced respiration, in extremely rare cases: coma, respiratory arrest, cardiac arrest, cessation of urination (anuria)

 

If you forget to take Actival Extra Magnesium film-coated tablets

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

 

If you stop taking Actival Extra Magnesium 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).

 

Rare (happens to 1-10 patients in 10,000):

diarrhoea, abdominal pain.

 

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 addresses specified in Appendix V.

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

 

 

5       How to store Actival Extra Magnesium film-coated tablets

 

Do not store the product in a hot place (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

 

In the Actival Extra Magnesium film-coated tablets

  • Active ingredients contained in one film-coated tablet:

0.5 mg (1666 NE) all-(E) retinol (in the form of retinol-acetate) (vitamin A); 1.8 mg (1000 NE) beta carotene, 1.4 mg thiamine (in the form of thiamine-nitrate) (vitamin B1); 1.6 mg riboflavin (B2-vitamin); 18 mg nicotinamide (vitamin B3); 6 mg pantothenic acid (in the form of calcium pantothenate) (vitamin B5); 2 mg pyridoxine (in the form of pyridoxine hydrochloride) (B6-vitamin); 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 NE) cholecalciferol (vitamin D3-vitamin); 20.1 mg (30 NE) α–tocopherol (in the form of α-tocopherol-acetate) (vitamin E); 5 mg rutoside, 200 mg calcium (in the form of calcium-carbonate); 250 mg magnesium (in the form of heavy magnesium-oxide); 15 mg zinc (in the form of zinc-sulphate-monohydrate), 4 mg iron (in the form of ferrous(II)-gluconate); 1 mg bore (in the form of boric acid); 1.4 mg copper (in the form of copper-gluconate); 0.04 mg selenium (in the form of sodium-selenite).

 

Other ingredients:

Core: butyl-hydroxyl-toluol (E321), gelatine, saccharose, maize starch, silica, dl-α-tocopherol, glucose syrup, sodium-ascorbinate, modified starch for food, tri-sodium-citrate, citric acid, maltodextrin, partially hydrolysed soy bean oil, poly-sorbate 80, mannitol. microcrystalline cellulose, hydroxyl-propyl-cellulose; crospovidone, magnesium stearate, talcum.

 

Coating: Partially hydrolysed poly-vinyl alcohol), talcum, titanium dioxide (E171), macrogol 3350, soy lecithin, indigo carmine (E132), yellow ferrous oxide (E172), quinolone yellow (E104).

 

What Actival Extra Magnesium tablet looks like and the contents of the pack

Actival Extra Magnesium is supplied as a light green, oval, film-coated tablet scored on one side. The score line is only to help breaking for ease of swallowing and not to divide into equal doses.

 

30, 36, 60, 72, 90, 108, 90+30, 60+60, 30+30 film-coated tablets in white HPDE 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-23230/01                  30x                                     HDPE container

OGYI-T-23230/02                  36x                                     HDPE container

OGYI-T-23230/03                  60x                                     HDPE container

OGYI-T-23230/04                  72x                                     HDPE container

OGYI-T-23230/05                  90x                                     HDPE container

OGYI-T-23230/06                  108x                                     HDPE container

OGYI-T-23230/07                  90x+30x                              HDPE container

OGYI-T-23230/08                  60x+60x                              HDPE container

OGYI-T-23230/09                  30x+30x                              HDPE container

 

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

 

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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