Package leaflet: information for the patient

DOLOMIT VIS
64 mg Mg²⁺ ions + 108 mg Ca²⁺ ions tablets
(Magnesii carbonas + Calcii carbonas)
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor, pharmacist, or nurse.

Keep this leaflet for future reference.
If advice or further information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents:

What DOLOMIT VIS is and what it is used for
Important information before taking DOLOMIT VIS
How to take DOLOMIT VIS
Possible side effects
How to store DOLOMIT VIS
Contents of the pack and other information

1. What DOLOMIT VIS is and what it is used for

Dolomite is a natural mineral primarily containing calcium carbonate and magnesium carbonate, as well as small amounts of ions of iron, aluminium, silicon, manganese, zinc, and copper. It is therapeutically used to correct calcium-magnesium metabolism imbalances in states of hypocalcemia and hypomagnesemia, and preventively to prevent the development of calcium and magnesium deficiencies.
The daily human requirement for calcium is 700–800 mg and for magnesium 270–350 mg. Both elements are supplied to the body through food.

Calcium- and magnesium-containing medicines are used preventively in cases of physical and mental fatigue, increased irritability, stressful situations, sleep disturbances, muscle pain, prolonged physical exertion, periods of rapid growth in children and adolescents, pregnancy, and lactation. Additionally, they are indicated during convalescence after illness or bone fractures. In women during menopause, they help prevent bone demineralization and are used as supportive treatment in comprehensive osteoporosis management.

2. Important information before using D VIS

When not to use D VIS
Do not take D VIS if there is hypersensitivity to the active substance or any of the excipients, hypercalcemia (elevated calcium levels in blood), hypermagnesemia (excess magnesium), atrioventricular block, myasthenia gravis (autoimmune neuromuscular disorder), anuria, kidney diseases with impaired filtration, or significant reduction in systolic and diastolic blood pressure. Do not use concomitantly with oral anticoagulants or cardiac glycosides.

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a physician before taking this medicine.

An existing malignant tumor is a contraindication for the administration of this medicinal product, as magnesium may stimulate tumor growth.

When to exercise special caution with D VIS

If the patient has renal insufficiency, mild hypercalciuria (calcium metabolism disorders), or kidney stones, calcium excretion in urine should be monitored. Patients with kidney stones should drink plenty of fluids during treatment. Serum calcium levels should be monitored during therapy.

Other medicines and D VIS
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to use.

Due to reduced absorption of both calcium and magnesium, as well as the following medicines, D VIS should not be administered simultaneously with phosphates, iron compounds, fluoroquinolones, tetracyclines, or oral anticoagulants derived from warfarin (a 3-hour interval between administration of both drugs is recommended).

Diuretics (furosemide, ethacrynic acid) increase magnesium excretion in urine.

Calcium salts administered intravenously reduce the effect of magnesium.

Thiazide diuretics (e.g. hydrochlorothiazide) enhance calcium reabsorption and may pose a risk of hypercalcemia. High doses of calcium in combination with vitamin D may reduce the effect of verapamil and other calcium antagonists.

High doses of calcium administered concomitantly with cardiac glycosides intensify their effect and may lead to cardiac rhythm disturbances.

Use of D VIS with food and drink
Alcohol and high amounts of glucose increase magnesium excretion in urine.

Pregnancy and breastfeeding
Consult a physician before taking this medicine.

Driving and operating machinery
D VIS does not affect the ability to drive or operate machinery.

Important information about certain excipients
The medicine contains lactose. See section 2.

3. How to use D VIS medicine

Adults and children over 12 years of age:

Prophylactically: 1 tablet per day;
Therapeutically in cases of calcium and magnesium deficiency: 1 to 3 tablets per day, depending on the extent of the deficiency. The medicine should be taken after a meal, with water. If you feel that the effect of the medicine is too strong or too weak, consult your doctor. Taking a higher than recommended dose of D VIS If diarrhea occurs, reduce the daily dose or temporarily discontinue the medicine. Symptoms of drowsiness may indicate that a high serum magnesium level has already been reached. In case of ingestion of a higher than recommended dose, seek immediate medical advice from a doctor or pharmacist. Missed dose of D VIS Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions listed below are categorized by MedDRA system organ class, and within each group, listed by frequency, from most common to least common:

Very common: occurs in more than 1 in 10 patients;
Common: occurs in 1 to 10 in 100 patients;
Uncommon: occurs in 1 to 10 in 1,000 patients;
Rare: occurs in 1 to 10 in 10,000 patients;
Very rare: occurs in fewer than 1 in 10,000 patients;
Frequency not known: cannot be estimated based on available data.

Gastrointestinal disorders
Nausea, vomiting, loose stools – frequency not known (cannot be estimated based on available data).

General disorders and administration site conditions
With prolonged use, symptoms of drowsiness and loose stools may occur – frequency not known (cannot be estimated based on available data).

Reporting of suspected adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49-21-301, Fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicinal product.

5. How to store Dolomit VIS

Keep this medicine out of the sight and reach of children.
Store below 25°C. Do not use Dolomit VIS after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the stated month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dolomit VIS contains
One tablet (500 mg of dolomite) contains: magnesium carbonate and calcium carbonate (corresponding to 64 mg of magnesium ions and 108 mg of calcium ions), and excipients: talc, monohydrate lactose, potato starch, magnesium stearate, gelatin.

What Dolomit VIS looks like and contents of the pack
Packaging: container made of PE or PP with a PE cap and tamper-evident seal, in a cardboard box.
30 tablets – 1 container of 30 tablets
60 tablets – 1 container of 60 tablets
100 tablets – 1 container of 100 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Zakłady Chemiczno-Farmaceutyczne „VIS” Sp. z o.o.
ul. Św. Elżbiety 6a
41-905 Bytom, Poland
For further information, please contact the local representative of the Marketing Authorisation Holder.