Dolomit Vis

Package Leaflet: Information for the Patient

DOLOMIT VIS

32 mg of Mg²+ ions and 54 mg of Ca²+ ions tablets
(Magnesii carbonas + Calcii carbonas)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

The medicine should always be taken exactly as described in this package leaflet for the patient or as advised by a doctor, pharmacist, or nurse.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is D VIS and what is it used for
• 2. Important information before taking D VIS
• 3. How to take D VIS
• 4. Possible side effects
• 5. How to store D VIS
• 6. Package contents and other information

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

Dolomite is a natural mineral that mainly contains calcium carbonate and magnesium carbonate, as well as small amounts of iron, aluminum, silicon, manganese, zinc, and copper ions. It is used therapeutically to balance the body's calcium and magnesium metabolism in cases of hypocalcemia and hypomagnesemia, as well as prophylactically to prevent calcium and magnesium deficiencies.
The daily human requirement for calcium is 700-800 mg and for magnesium is 270-350 mg. Both of these elements are supplied to the body through food.
Prophylactically, magnesium and calcium-containing medications are used in cases of physical and mental fatigue, increased irritability, stressful situations, sleep disorders, muscle pain, during prolonged physical exertion, during periods of rapid growth in children and adolescents, during pregnancy and lactation. Additionally, during the recovery period after illnesses and bone fractures. In women during menopause, to prevent bone demineralization and as a supportive treatment in the comprehensive treatment of osteoporosis.

2. Important information before taking D VIS

When not to take D VIS

D VIS should not be taken if there is hypersensitivity to the active substance or any of the excipients, hypercalcemia (elevated calcium levels in the blood), hypermagnesemia (excess magnesium), atrioventricular block, myasthenia (an autoimmune neuromuscular disease), anuria, kidney disease with impaired filtration, and significantly decreased systolic and diastolic blood pressure. It should not be taken in combination with oral anticoagulants or digitalis glycosides.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.
A contraindication to the administration of the medicinal product is the development of malignant tumors, as magnesium may stimulate their growth.

When to exercise special caution when taking D VIS

• -if the patient has kidney failure, mild hypercalciuria (calcium metabolism disorders) or kidney stones, as calcium excretion in the urine needs to be monitored. Patients with kidney stones should drink plenty of fluids during treatment. During treatment, blood calcium levels should be monitored.

Patients with kidney stones should drink plenty of fluids during treatment. During treatment, blood calcium levels should be monitored.

Other medications and D VIS

The doctor or pharmacist should be informed about all medications currently being taken or recently taken, as well as any medications the patient plans to take.
Due to reduced absorption of both calcium and magnesium, as well as the following medications, D VIS should not be taken simultaneously with phosphates, iron compounds, fluoroquinolones, tetracyclines, and oral anticoagulants (a 3-hour interval between administration of both medications is recommended).
Diuretics (furosemide, ethacrynic acid) increase magnesium excretion in the urine.
Calcium salts administered intravenously weaken the effect of magnesium.
Thiazide diuretics (e.g., hydrochlorothiazide) increase calcium reabsorption and pose a risk of hypercalcemia. High doses of calcium in combination with vitamin D may weaken the effect of verapamil and other calcium antagonists.
High doses of calcium administered simultaneously with cardiac glycosides enhance their effect and may lead to heart rhythm disorders.

Taking D VIS with food and drink

Alcohol and glucose in larger quantities increase magnesium excretion in the urine.

Pregnancy and breastfeeding

Before taking the medicine, the patient should consult their doctor.

Driving and operating machinery

D VIS does not affect the ability to drive vehicles or operate machinery.

Important information about some ingredients

The medicine contains sugars, lactose, and sucrose. See section 2.

3. How to take D VIS

Adults and children over 12 years:

• prophylactically 1 to 2 tablets per day;
• therapeutically in cases of calcium and magnesium deficiency 2 to 6 tablets per day, depending on the severity of the deficiency. The medicine should be taken after a meal, with water. If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking more than the recommended dose of D VIS

In case of diarrhea, the daily dose should be reduced or the medicine temporarily discontinued.
Symptoms of drowsiness may indicate that a high magnesium level has been reached in the serum.
In case of taking more than the recommended dose, the patient should immediately consult their doctor or pharmacist.

Missing a dose of D VIS

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, D VIS can cause side effects, although not everybody gets them.
Side effects are listed below, by system organ class and frequency, from most frequent to least frequent:

• 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 1000 patients;
• rare: occurs in 1 to 10 in 10,000 patients;
• very rare: occurs in less than 1 in 10,000 patients;
• frequency not known: cannot be estimated from the available data. Gastrointestinal disorders Nausea, vomiting, loose stools - frequency not known (cannot be estimated from the available data). General disorders and administration site conditions In case of prolonged use, symptoms of drowsiness may occur - frequency not known (cannot be estimated from the available data).

Reporting suspected side effects

If any side effects occur, including any side effects not listed in the package leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49-21-301, Fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store D VIS

• The medicine should be stored in a place inaccessible and invisible to children.
• Store in a temperature below 25°C. Do not use D VIS after the expiration date stated on the packaging after "Expiration Date". The expiration date refers to the last day of the specified month. Medicines should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What D VIS contains

1 tablet (250 mg of dolomite) contains: magnesium carbonate and calcium carbonate (equivalent to 32 mg of magnesium ions and 54 mg of calcium ions) and excipients: sucrose, lactose monohydrate, potato starch, magnesium stearate, peppermint oil.

What D VIS looks like and what the package contains

Packaging: PE or PP container with a PE cap with a tamper-evident seal or a brown glass bottle with a PE cap, in a cardboard box.
30 pieces - 1 container of 30 pieces.
60 pieces - 1 container of 60 pieces.
72 pieces - 1 container of 72 pieces.
Not all packaging types may be marketed.

Marketing authorization holder and manufacturer:

Zakłady Chemiczno-Farmaceutyczne "VIS" Sp. z o.o.
ul. Św. Elżbiety 6a
41-905 Bytom
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder.

Date of the last update of the package leaflet: