Dolomit Vis

Leaflet attached to the packaging: patient information

DOLOMIT VIS

64 mg of Mg²+ ions and 108 mg of Ca²+ ions tablets
(Magnesii carbonas + Calcii carbonas)

Please read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, please contact a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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 states of hypocalcemia and hypomagnesemia, as well as prophylactically to prevent calcium and magnesium deficiencies.
The daily requirement of the human body for calcium is 700-800 mg, and for magnesium, it is 270-350 mg. Both of these elements are supplied to the body through food.
Prophylactically, magnesium and calcium-containing medications are used in states 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

Do not take D VIS if you are hypersensitive to the active substance or any of the excipients, have hypercalcemia (elevated blood calcium levels), hypermagnesemia (excessive magnesium levels), atrioventricular block, myasthenia (an autoimmune neuromuscular disease), anuria, kidney disease with impaired filtration, or significantly decreased systolic and diastolic blood pressure. Do not take D VIS in combination with oral anticoagulant medications or digitalis glycosides.
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking the medication.
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 you have kidney failure, mild hypercalciuria (calcium metabolism disorders), or kidney stones, as calcium excretion control is required. 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

Please inform your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Due to the 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 anticoagulant medications (a 3-hour interval between administration of both medications is recommended).
Diuretic medications (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 taken 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 medication, please consult your doctor.

Driving and operating machinery

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

Important information about some ingredients

The medication contains sugar lactose. See section 2.

3. How to take D VIS

Adults and children over 12 years old:

• prophylactically, 1 tablet per day;
• therapeutically, in cases of calcium and magnesium deficiency, 1 to 3 tablets per day, depending on the severity of the deficiency. The medication should be taken after a meal, with water. If you feel that the medication's effect is too strong or too weak, please consult your doctor.

Taking a higher dose of D VIS than recommended

In case of diarrhea, the daily dose should be reduced or the medication temporarily discontinued.
Symptoms of drowsiness may indicate that a high magnesium level has been reached in the blood.
In case of taking a higher dose of D VIS than recommended, please consult your doctor or pharmacist immediately.

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 medications, D VIS can cause side effects, although not everyone will experience them.
Side effects are listed below, according to the MedDra system organ classification, and in each group - according to frequency of occurrence, from most common to rarest:

• very common: occur in more than 1 in 10 patients;
• common: occur in 1 to 10 in 100 patients;
• uncommon: occur in 1 to 10 in 1000 patients;
• rare: occur in 1 to 10 in 10,000 patients;
• very rare: occur in less than 1 in 10,000 patients;
• frequency not known: cannot be determined based on available data. Gastrointestinal disorders Nausea, vomiting, loose stools - frequency not known (cannot be determined based on available data). General disorders and administration site conditions Prolonged use may cause symptoms of drowsiness - frequency not known (cannot be determined based on available data).

Reporting suspected side effects

If you experience any side effects, including any side effects not listed in the leaflet, please inform your 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,
phone: +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 gather more information on the safety of the medication.

5. How to store D VIS

• The medication should be stored in a place inaccessible and invisible to children.
• Store at 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. Medications should not be disposed of in the sewage system or household waste containers. Please ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What D VIS contains

1 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, lactose monohydrate, potato starch, magnesium stearate, gelatin.

What D VIS looks like and what the packaging contains

Packaging: PE or PP container with a PE cap with a tamper-evident seal in a cardboard box.
30 pieces - 1 container of 30 pieces.
60 pieces - 1 container of 60 pieces.
100 pieces - 1 container of 100 pieces.
Not all packaging types may be available on the market.

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, please contact the local representative of the marketing authorization holder.

Date of the last update of the leaflet: