CALCIUM POLFARMEX

Patient Information Leaflet

CALCIUM POLFARMEX, 115 mg calcium ions/5 ml, syrup
Calcii glubionas + Calcii lactobionas
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.
This medicine should always be used according to the instructions provided in this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet for future reference.
• Consult your pharmacist if you need advice or additional information.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after a few days, or if the patient feels worse, consult a doctor.

Table of Contents:

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

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

Calcium Polfarmex contains calcium in the form of readily absorbable organic salts:
glubionate and lactobionate, which help correct calcium deficiency in the body.
Calcium is a fundamental mineral component involved in maintaining the body's electrolyte balance and proper functioning of numerous regulatory mechanisms.
Calcium Polfarmex is indicated for the prevention and treatment of conditions caused by calcium deficiency in the body.

2. Important information before using Calcium Polfarmex

When not to use Calcium Polfarmex:

• if the patient is allergic to calcium gluconate or calcium lactobionate, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypercalcaemia;
• if the patient has hypercalciuria;
• if the patient has severe renal insufficiency.

Warnings and precautions
Before starting treatment with Calcium Polfarmex, discuss this with your doctor or pharmacist.
Particular caution is required when administering Calcium Polfarmex to patients:

• with diabetes;
• with glucose-galactose malabsorption syndrome;
• with fructose intolerance;
• with saccharase-isomaltase deficiency;
• with hyperthyroidism;
• with heart diseases;
• with sarcoidosis;
• with impaired kidney function;
• with kidney stones. Consult your doctor, even if the above warnings refer to conditions experienced in the past.

Calcium Polfarmex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Calcium Polfarmex may enhance the effects of sulfonamides and digitalis glycosides, and may interfere with the absorption of tetracyclines and fluoride compounds. Thiazide diuretics reduce calcium excretion. Vitamin D increases calcium absorption.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Calcium Polfarmex may be used during pregnancy and breastfeeding only after consultation with a doctor.

Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.

Calcium Polfarmex contains sucrose, sodium benzoate, ethanol (component of orange flavour), 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 a patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

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

Ethanol (component of orange flavour)
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, meaning the medicine is considered "sodium-free".

3. How to use Calcium Polfarmex

This medicine should always be used according to the instructions in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Orally
Children aged 2 to 11 years – from 2.5 ml to 5 ml twice daily
Children aged 12 to 17 years – from 5 ml to 10 ml two to three times daily
Adults – 15 ml two to three times daily
Use of a higher than recommended dose of Calcium Polfarmex
Overdose may cause gastrointestinal disturbances: nausea, vomiting, abdominal pain, bloating.
In case of overdose, administer magnesium sulfate.
Missed dose of Calcium Polfarmex
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 everybody gets them.
High doses of the medicine may cause gastrointestinal disturbances (constipation). Long-term
use of the medicine may lead to hypercalcaemia or hypercalciuria.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products,
Office for Registration of Medicinal Products, Medical Devices
and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Calcium Polfarmex

Keep the medicine out of the sight and reach of children.
Store below 25 °C.
After first opening the container, the syrup should be used within 6 months.
Do not use this medicine after the expiry date stated on the carton and bottle after:
"EXP". The expiry date refers to the last day of the stated month.
Medicines should 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 Polfarmex contains

• The active substances in Calcium Polfarmex are calcium gluconate and calcium lactobionate. 100 ml of syrup contains 29.4 g of calcium gluconate and 6.4 g of calcium lactobionate.
  The other ingredients are: sucrose, citric acid monohydrate, orange flavouring liquid (containing ethanol), sodium benzoate (E 211), purified water.

What Calcium Polfarmex looks like and contents of the pack
The pack contains 150 ml of syrup.
Marketing authorisation holder and manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: (24) 357 44 44