Sanosvit Calcium

Leaflet attached to the packaging: patient information

Sanosvit Calcium

114 mg of calcium ions (Ca)/5 ml, syrup

Calcii glubionas + Calcii lactobionas

Read the 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 or pharmacist.

• The 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 this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What Sanosvit Calcium is and what it is used for
• 2. Important information before using Sanosvit Calcium
• 3. How to use Sanosvit Calcium
• 4. Possible side effects
• 5. How to store Sanosvit Calcium
• 6. Contents of the packaging and other information

1. What Sanosvit Calcium is and what it is used for

Sanosvit Calcium is a medicine in the form of a banana-flavored syrup containing calcium glubionate and calcium lactobionate as active substances.
Calcium is an essential mineral component necessary for maintaining water and electrolyte balance in the body and proper functioning of many regulatory mechanisms.
It is an essential component of bone tissue, conditions proper nerve conduction and muscle contractility.
It is necessary in the blood coagulation process. By reducing the permeability of blood vessel walls, calcium acts as an anti-edema, anti-inflammatory, and anti-allergic agent.
The organic calcium compounds contained in the medicine are easily absorbed by the body. The administration of the medicine supplements calcium deficiencies in the body and leads to a reduction in edema and allergic reactions.
Sanosvit Calcium is used for the prevention and supplementation of calcium deficiency in the body, e.g., during pregnancy or lactation, in the treatment of osteoporosis, and as a supportive treatment for allergy symptoms.

2. Important information before using Sanosvit Calcium

When not to use Sanosvit Calcium:

• if the patient is allergic to calcium glubionate or calcium lactobionate, or any other component of this medicine (listed in section 6);
• if the patient has diseases or conditions leading to hypercalcemia (elevated calcium levels in the blood) and/or hypercalciuria (elevated calcium excretion in the urine); kidney stones; galactosemia or diabetes.

Warnings and precautions

Before starting to use Sanosvit Calcium, the patient should discuss it with their doctor or pharmacist.
The patient should consult their doctor if they:

• are taking digitalis glycosides, epinephrine, tetracyclines, or thiazide diuretics;
• have kidney failure, heart disease, sarcoidosis, kidney stones, or gout.

During long-term treatment with calcium-containing medicines, high doses of the medicine, especially when taken with vitamin D and/or calcium-containing medicines or foods (e.g., milk), the patient's calcium levels in the blood and kidney function should be monitored.

Sanosvit Calcium and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Thiazide diuretics reduce calcium excretion in the urine. Due to the risk of hypercalcemia when using thiazide diuretics, the patient's calcium levels in the blood should be regularly monitored.
The medicine may interfere with the absorption of tetracyclines. Therefore, tetracyclines should be taken at least 2 hours before or 4-6 hours after taking calcium compounds.
High doses of the medicine and vitamin D may weaken the effect of verapamil and other calcium channel blockers.
High doses of calcium salts taken with digitalis glycosides (digoxin and strophanthin derivatives) may enhance their effect and lead to heart rhythm disorders.
The medicine enhances the effect of sulfonamides.
Vitamin D, glucocorticosteroids, parathyroid hormone, thiazide diuretics, and citric acid increase calcium absorption, while calcitonin, excess lipids, and phosphates reduce calcium absorption.
When bisphosphonates are used concomitantly, they should be taken at least 1 hour before taking calcium compounds, as bisphosphate absorption may be reduced.
The medicine may reduce the effectiveness of levothyroxine by reducing its absorption.
A 4-hour interval should be maintained between taking calcium compounds and levothyroxine.
The absorption of quinolone antibiotics may be reduced when taken with calcium. Quinolone antibiotics should be taken 2 hours before or 6 hours after taking calcium compounds.
Calcium salts may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, a 2-hour interval is required between taking these medicines and calcium salts.
If it is necessary to use any other medicines concomitantly, the patient should consult their doctor to determine any possible changes in taking the medicine.

Using Sanosvit Calcium with food and drink

The alkaline reaction of food, phytin (e.g., grain products), oxalates (e.g., spinach, rhubarb), and phosphates (e.g., milk and its products) reduce calcium absorption.
The acidic reaction of food increases calcium absorption.

Kidney function disorders

Patients with kidney stones should drink plenty of fluids during treatment. In patients with mild hypercalciuria, kidney failure, or kidney stones, calcium levels in the blood and urine should be monitored.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnant women should avoid overdosing on calcium.

Driving and using machines

Sanosvit Calcium does not affect the ability to drive or use machines.
The medicine contains sucrose, sodium benzoate (E 211), flavoring ingredients, including propylene glycol (E 1520), and sodium

Sucrose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Propylene glycol (E 1520)

The medicine contains 10.88 mg of propylene glycol in 5 ml of syrup.

Sodium benzoate

The medicine contains 6 mg of sodium benzoate in every 5 ml of syrup.

Sulfites (from flavoring)

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of syrup, which means the medicine is considered "sodium-free".

3. How to use Sanosvit Calcium

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Recommended dose
Children from 1 to 6 years old: 5 ml of syrup 2-3 times a day.
Children from 6 to 12 years old: 10 ml of syrup 2-3 times a day.
Adolescents and adults: 15 ml of syrup 2-3 times a day.
5 ml of syrup contains 114 mg of calcium ions.
The syrup should be taken orally undiluted.
After use, the packaging should be tightly closed.
The medicine can be used in both children and adults, but due to its syrup form and pleasant taste, it is mainly used in children.

Using a higher dose of Sanosvit Calcium than recommended

In case of taking a higher dose of the medicine than recommended, the patient should consult their doctor or pharmacist.
Overdosing on the medicine may lead to hypercalcemia. Symptoms of overdosing on the medicine include: loss of appetite, increased thirst, nausea, vomiting, stomach and intestinal disorders, polyuria, muscle weakness.

Missing a dose of Sanosvit Calcium

If the medicine is taken regularly and it has not been long since the missed dose, it should be taken as soon as possible.
If it is almost time for the next scheduled dose, it should be taken at the appropriate time.
A double dose should not be taken to make up for the missed dose.

4. Possible side effects

Like all medicines, Sanosvit Calcium can cause side effects, although not everybody gets them.
Uncommon side effects(occurring in less than 1 in 100 patients):

• hypercalcemia (elevated calcium levels in the blood) and hypercalciuria (elevated calcium excretion in the urine).

Rare side effects(occurring in less than 1 in 1,000 patients):

• constipation, indigestion, bloating, nausea, abdominal pain, and diarrhea.

Very rare side effects(occurring in less than 1 in 10,000 patients):

• milk-alkali syndrome (usually observed only in case of overdosing; symptoms include frequent urination, headache, loss of appetite, nausea or vomiting, unusual fatigue or weakness, elevated calcium levels in the blood, and kidney failure);
• itching, rash, and urticaria.

Side effects may occur when calcium intake exceeds 2000-2500 mg/day, during long-term use, or in patients with kidney failure.
In patients with kidney failure, taking high doses of calcium orally may lead to hypercalcemia, whose symptoms include: loss of appetite, gastrointestinal disorders, muscle weakness, polyuria, and kidney damage.

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, the patient should inform their doctor or 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 181 C, 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 gather more information on the safety of the medicine.

5. How to store Sanosvit Calcium

Store in the original, tightly closed packaging.
Store at a temperature below 25°C. Do not freeze.
After opening the bottle, the medicine should not be stored for more than 3 months.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sanosvit Calcium contains

• The active substances of the medicine are calcium glubionate and calcium lactobionate. 5 ml of syrup contains 1442.5 mg of calcium glubionate and 313.6 mg of calcium lactobionate.
• The other ingredients are: sucrose, propionic acid, sodium benzoate (E 211), concentrated hydrochloric acid (for pH adjustment), banana flavor (contains, among others: propylene glycol - E 1520, methylheptinocarbonate, eugenol, citral, isoeugenol, sulfites), purified water.

What Sanosvit Calcium looks like and what the packaging contains

The medicine is a banana-flavored syrup.
A brown glass bottle in a cardboard box, containing 150 ml of syrup, closed with a white HDPE cap with a white ring and a transparent LDPE or LDPE and HDPE seal (drip limiter).

Marketing authorization holder:

Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orifarm Healthcare Sp. z o.o.
Ul. Koszykowa 65,
00-667 Warsaw
Poland
[email protected]

Manufacturer:

Orifarm Manufacturing Poland Sp. z o.o.
Ul. Księstwa Łowickiego 12
99-420 Łyszkowice
Poland

Date of the last update of the leaflet: