Calcium Polfarmex

Leaflet attached to the packaging: information for the user

CALCIUM POLFARMEX, 115 mg of calcium ions/5 ml, syrup

Calcii glubionas + Calcii lactobionas

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

This medicine should always be used in accordance with the description in the patient leaflet or as directed by a doctor or pharmacist.
The leaflet should be kept in case it needs to be read again.

• The leaflet should be kept in case it needs to be read again.
• A pharmacist should be consulted if advice or additional information is needed.
• If any side effects occur, including any possible side effects not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after a few days or the patient feels worse, a doctor should be consulted.

Table of contents of the leaflet:

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

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

Calcium Polfarmex, containing calcium in the form of easily absorbable organic salts: glubionate and lactobionate, supplements calcium deficiencies in the body.
Calcium is a basic mineral component that affects the maintenance of electrolyte balance and proper functioning of many regulatory mechanisms.
Calcium Polfarmex is indicated for use in the prevention and treatment of calcium deficiency consequences in the body.

2. Important information before using Calcium Polfarmex

When not to use Calcium Polfarmex:

Warnings and precautions

Before starting to use Calcium Polfarmex, the doctor or pharmacist should be consulted.
Particular caution should be exercised when using Calcium Polfarmex in patients:

• with diabetes;
• with glucose-galactose malabsorption syndrome;
• with fructose intolerance;
• with sucrase-isomaltase deficiency;
• with hyperthyroidism;
• with heart disease;
• with sarcoidosis;
• with impaired renal function;
• with kidney stones. The doctor should be consulted, even if the above warnings refer to past situations.

Calcium Polfarmex and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as medicines planned to be taken.
Calcium Polfarmex may enhance the effect of sulfonamides and digitalis glycosides, and may interfere with the absorption of tetracyclines and fluorine compounds. Thiazide diuretics reduce calcium excretion. Vitamin D increases calcium absorption.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Calcium Polfarmex can be used during pregnancy and breastfeeding only after consulting a doctor.

Driving and using machines

The medicine has no effect on the ability to drive and use machines.

Calcium Polfarmex contains sucrose, sodium benzoate, ethanol (a component of orange flavor) and sodium

Sucrose

The medicine contains 1.5 g of sucrose in 5 ml of syrup. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.

Sodium benzoate (E 211)

The medicine contains 10 mg of sodium benzoate (E 211) in each 5 ml of syrup.

Etanol (a component of orange flavor)

The medicine contains 7.3 mg of alcohol (ethanol) in each 5 ml of syrup. The amount of alcohol in 5 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.

Sodium

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

3. How to use Calcium Polfarmex

This medicine should always be used in accordance with the description in the patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, a doctor or pharmacist should be consulted.
Orally
Children aged 2 to 11 years - from 2.5 ml to 5 ml twice a day
Children aged 12 to 17 years - from 5 ml to 10 ml two to three times a day
Adults - 15 ml two to three times a day

Using a higher dose of Calcium Polfarmex than recommended

Overdose may cause gastrointestinal disorders: nausea, vomiting, abdominal pain, bloating.
In case of overdose, magnesium sulfate should be administered.

Missing a dose of Calcium Polfarmex

A double dose should not be used 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.
High doses of the medicine may cause gastrointestinal disorders (constipation). Long-term use of the medicine may lead to hypercalcemia or hypercalciuria.

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed.
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: 22 49-21-301
Fax: 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 Calcium Polfarmex

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
After the first opening of the package, the syrup should be used within 6 months.
The medicine should not be used after the expiry date stated on the carton and bottle after:
"EXP". The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Calcium Polfarmex contains

• The active substances of the medicine are calcium glubionate and calcium lactobionate. 100 ml of syrup contains 29.4 g of calcium glubionate and 6.4 g of calcium lactobionate. The other ingredients are: sucrose, citric acid monohydrate, orange flavor and aroma (containing ethanol), sodium benzoate (E 211), purified water.

What Calcium Polfarmex looks like and what the package contains

The package contains 150 ml of syrup.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Phone: (24) 357 44 44

Date of last update of the leaflet: