Calcium gluconate farmapol

Package leaflet: Information for the user

CALCIUM GLUCONICUM FARMAPOL
45 mg of calcium ions, tablets
Calcii gluconas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 30 days, you should contact your doctor.

Contents of the leaflet:

1. What Calcium Gluconicum Farmapol is and what it is used for
2. Important information before taking Calcium Gluconicum Farmapol
3. How to take Calcium Gluconicum Farmapol
4. Possible side effects
5. How to store Calcium Gluconicum Farmapol
6. Contents of the pack and other information

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

Calcium Gluconicum Farmapol is a medicine containing calcium.
Calcium is an essential mineral component of the body. It is an important constituent of bone tissue and participates in the function of the nervous and muscular systems. It is essential for blood coagulation.
It reduces the permeability of blood vessel walls, thereby exerting anti-edematous, anti-swelling, and antiallergic effects. It stimulates the body's defense mechanisms.
Calcium deficiency leads to neuromuscular disturbances and bone demineralization (bone decalcification leading to softening of the bones).
Indications for use:

• Conditions with increased calcium demand (e.g., during periods of rapid growth in children and adolescents, during pregnancy, breastfeeding, and during convalescence after illness);
• Conditions of calcium deficiency in the body (e.g., due to impaired absorption or increased deposition of calcium in bone tissue);
• Treatment of osteoporosis of various origins (including preventive use);
• Tetany (a condition caused by decreased levels of calcium and magnesium in the blood; symptoms include, among others, painful muscle cramps, tingling, and numbness in fingers or toes);
• As adjunctive therapy in the treatment of allergic diseases (e.g., urticaria, bronchial asthma, angioedema);
• As adjunctive therapy in inflammatory conditions (e.g., respiratory tract and throat diseases);
• As adjunctive therapy in bone fractures and bone demineralization.

2. Important information before using Calcium Gluconicum Farmapol

When not to use Calcium Gluconicum Farmapol

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

Warnings and precautions
Before starting treatment with this medicine, discuss the following with your doctor or pharmacist:

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

Calcium Gluconicum Farmapol and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to use.
Do not use Calcium Gluconicum Farmapol:

• with tetracycline antibiotics (e.g. doxycycline) and fluoride compounds, as calcium reduces their absorption; these medicines should be taken 3 hours before or after Calcium Gluconicum Farmapol;
• with vitamin D and parathormone (parathyroid hormone), as these drugs increase calcium absorption;
• with glucocorticosteroids (medicines used, among others, in the treatment of rheumatic diseases and asthma, e.g. hydrocortisone), as they reduce calcium absorption;
• with cardiac glycosides (medicines used in the treatment of heart disorders, e.g. digoxin and strophanthin), as their concurrent use with high doses of calcium intensifies their effect and may lead to cardiac disturbances;
• with thiazide diuretics (medicines increasing urine production, e.g. hydrochlorothiazide), as there is a risk of excessive increase in blood calcium levels;
• with calcium channel blockers (medicines used, among others, in the treatment of hypertension and heart failure, e.g. verapamil), as their effect may be reduced when used simultaneously with high doses of calcium.

Taking Calcium Gluconicum Farmapol with food and drink
The medicine should be taken after a meal, with water.
Do not take Calcium Gluconicum Farmapol simultaneously with the following food products, as they reduce calcium absorption:

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

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Calcium Gluconicum Farmapol may be used during pregnancy and breastfeeding only on a doctor's prescription. The doctor will determine the dosage and duration of treatment.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

3. How to use Calcium gluconicum Farmapol

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Use in adults
Orally, 1 to 2 tablets 4 times daily.
The medicine should be taken after a meal, with water.
Taking more Calcium gluconicum Farmapol than recommended
If you have taken more than the recommended dose, consult your doctor or pharmacist.
Symptoms of overdose (listed in section 4) may occur.
Missed dose of Calcium gluconicum Farmapol
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse symptoms may occur: bloating, constipation or diarrhoea, increased calcium levels in the blood—particularly in patients with renal insufficiency—manifesting as loss of appetite, gastrointestinal disturbances (bloating, nausea, constipation or diarrhoea), muscle weakness, excessive urination, and deposition of calcium compounds (e.g. kidney stones).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Calcium gluconicum Farmapol

Keep this medicine out of 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 stated month.
Medicines must 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 packaging and other information

What Calcium Gluconicum Farmapol contains
The active substance is calcium gluconate. One tablet contains 45 mg of calcium ions
in the form of 500 mg of calcium gluconate.

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

What Calcium Gluconicum Farmapol looks like and contents of the pack
The medicine is in the form of white, oval tablets. The pack contains 50 tablets.
Marketing Authorisation Holder and Manufacturer
Farmaceutyczne Farmapol Sp. z o.o.
Święty Wojciech 29
61-749 Poznań
tel.: + 48 61 852 63 53 e-mail: [email protected]
For more detailed information, please contact the representative of the Marketing Authorisation Holder.
Information for blind and partially sighted people: the leaflet content is available free of charge by calling: 0800 706 848.