Calcium gluconicum Farmapol

Package Leaflet: Information for the User

CALCIUM GLUCONICUM FARMAPOL

45 mg of calcium ions, tablets

Calcii gluconas

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

This medicine should always be used exactly as described in the package leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 30 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet:

• 1. What is Calcium Gluconicum Farmapol and what is it used for
• 2. Important information before using Calcium Gluconicum Farmapol
• 3. How to use Calcium Gluconicum Farmapol
• 4. Possible side effects
• 5. How to store Calcium Gluconicum Farmapol
• 6. Package contents and other information

1. What is Calcium Gluconicum Farmapol and what is it used for

Calcium Gluconicum Farmapol is a medicine containing calcium.
Calciumis an essential mineral component of the body. It is an important component of bone tissue,
participates in the functioning of the nervous system and muscles. It is necessary for blood coagulation.
It reduces the permeability of blood vessel walls, thereby acting as an anti-edema, anti-allergic, and anti-inflammatory agent.
It stimulates the body's defense mechanisms.
A calcium deficiency leads to neuromuscular disorders and bone demineralization (bone softening due to decalcification).

Indications for use:

• states of increased demand for calcium (e.g., during intense growth in children and adolescents, during pregnancy, breastfeeding, and during recovery from illness);
• states of calcium deficiency in the body (e.g., due to absorption disorders, increased calcium deposition in bone tissue);
• treatment of osteoporosis of various origins (also preventive);
• tetany (a disease caused by a decrease in calcium and magnesium levels in the blood; symptoms include: painful muscle spasms, tingling, and numbness of fingers and toes);
• supportive treatment for allergic diseases (e.g., urticaria, bronchial asthma, angioedema);
• supportive treatment for inflammatory conditions (e.g., respiratory tract diseases, throat diseases);
• supportive treatment for bone fractures and bone demineralization.

2. Important information before using Calcium Gluconicum Farmapol

When not to use Calcium Gluconicum Farmapol

• if the patient is hypersensitive (allergic) to calcium salts or any other component of the medicine (listed in section 6);
• if the patient has elevated calcium levels in the blood (hypercalcemia), e.g., due to hyperparathyroidism, excessive vitamin D in the body (hypervitaminosis D), multiple myeloma, or bone metastases;
• if the patient has severe hypercalciuria (excessive calcium in the urine);
• if the patient has renal insufficiency, as there is a risk of excessive increase in calcium levels in the blood (hypercalcemia);
• if the patient is currently taking high doses of vitamin D.

Warnings and precautions

Before starting treatment with the medicine, discuss it with your doctor or pharmacist:

• if the patient is taking cardiac glycosides;
• if the patient has kidney function disorders;
• if the patient has heart disease;
• if the patient has sarcoidosis (a systemic disease affecting the whole body, usually characterized by: lymph node enlargement, high fever, weakness, pain, and joint swelling),
• if the patient has kidney stones.

Calcium Gluconicum Farmapol and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not use Calcium Gluconicum Farmapol:

• with antibiotics from the tetracycline group (e.g., doxycycline) and fluorine compounds, as calcium reduces their absorption; these medicines should be taken 3 hours before or after taking Calcium Gluconicum Farmapol;
• with vitamin D and parathyroid hormone, as these medicines increase calcium absorption;
• with glucocorticosteroids (medicines used to treat, among other things, rheumatic disease and asthma, e.g., hydrocortisone), as they reduce calcium absorption;
• with cardiac glycosides (medicines used to treat heart rhythm disorders, e.g., digoxin and strophanthin); as they enhance their effect when taken with high doses of calcium and may lead to heart rhythm disorders;
• with thiazide diuretics (medicines that increase urine production, e.g., hydrochlorothiazide), as there is a risk of excessive increase in calcium levels in the blood;
• with calcium channel blockers (medicines used, among other things, to treat hypertension and heart failure, e.g., verapamil), as they may weaken their effect when taken with high doses of calcium.

Using Calcium Gluconicum Farmapol with food and drink

Take the medicine after a meal, with a glass of water.
Do not take Calcium Gluconicum Farmapol with the following food products, as they reduce calcium absorption:

• products containing oxalates (e.g., spinach, rhubarb);
• milk and its products (yogurt, cheese, kefir, etc.);
• grain products (bread, pasta, etc.);
• large amounts of fat;
• products with an alkaline reaction (e.g., potatoes, cabbage, celery, tomatoes, carrots). Do not take Calcium Gluconicum Farmapol with products with an acidic reaction (e.g., oatmeal, white and rye bread, eggs, fish, coffee, black tea), as they increase calcium absorption.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Calcium Gluconicum Farmapol may be used during pregnancy and breastfeeding only with a doctor's prescription. The doctor will determine the dose and duration of treatment.

Driving and using machines

The medicine does not affect the ability to drive vehicles or operate machinery.

3. How to use Calcium Gluconicum Farmapol

This medicine should always be used exactly as described in the package leaflet or as directed by a doctor or pharmacist. If you have any doubts, consult a doctor or pharmacist.

Use in adults

Orally, 1 to 2 tablets 4 times a day.
Take the medicine after a meal, with a glass of water.

Using a higher dose of Calcium Gluconicum Farmapol than recommended

If you have taken a higher dose of the medicine than recommended, consult a doctor or pharmacist.
Overdose symptoms may occur (listed in section 4).

Missing a dose of Calcium Gluconicum Farmapol

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur: bloating, constipation, or diarrhea, increased calcium levels in the blood, especially in patients with kidney insufficiency, manifested by: loss of appetite,
gastrointestinal disorders (bloating, nausea, constipation, or diarrhea), muscle weakness, excessive urine production, deposition of calcium compounds (e.g., kidney stones).

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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 Calcium Gluconicum Farmapol

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Calcium Gluconicum Farmapol contains

The active substance of the medicine is calcium gluconate. One tablet contains 45 mg of calcium ions in the form of 500 mg of calcium gluconate.

• Other ingredients are: potato starch, talc, sodium carboxymethylcellulose (type C), magnesium stearate.

What Calcium Gluconicum Farmapol looks like and what the package contains

The medicine is in the form of white, oval tablets. The package contains 50 tablets.

Marketing authorization holder and manufacturer

Przedsiębiorstwo Farmaceutyczne Farmapol Sp. z o.o.
ul. Święty Wojciech 29
61-749 Poznań
tel.: + 48 61 852 63 53
e-mail: info@farmapol.pl
To obtain more detailed information, contact the marketing authorization holder's representative.
Information for the blind and visually impaired:the leaflet content is available at the free phone number: 0800 706 848.
Date of last revision of the leaflet:06/2021