Calcium hasco (with strawberry flavor)

Package leaflet: Information for the patient

CALCIUM HASCO
115.6 mg calcium ions / 5 ml, syrup
Calcii glubionas anhydricus + Calcii lactobionas dihydricus
Strawberry-flavoured syrup
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 or pharmacist.

• 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 not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If your condition does not improve or worsens, contact your doctor.

Contents of the leaflet

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

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

Calcium Hasco is a medicinal product containing calcium salts. Calcium is a structural component of the body and plays an important role in numerous physiological processes (maintenance of normal blood coagulation, muscle contractility, nerve conduction, cellular membrane function). Calcium also reduces the permeability of blood vessel walls, exerting anti-exudative and anti-edematous effects. Calcium crosses the placenta and is excreted in breast milk.

Indications:

• Prevention and supplementation of calcium deficiency in the body, e.g. during pregnancy or breastfeeding,
• Treatment of osteoporosis,
• Supportive treatment of allergy symptoms.

2. Important information before using Calcium Hasco

When not to use Calcium Hasco

• if the patient is allergic to the active substances (calcium salts) or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has elevated calcium levels in the blood (hypercalcaemia, e.g. in patients with hyperparathyroidism, severe renal insufficiency, or vitamin D overdose);
• if the patient has increased urinary excretion of calcium (hypercalciuria);
• if the patient has severe renal insufficiency or kidney stones;
• if the patient has atrioventricular block.

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Warnings and precautions
Before starting to use Calcium Hasco, consult your doctor or pharmacist.
Exercise particular caution when using Calcium Hasco:

• if the patient has renal insufficiency;
• if the patient is taking high doses of vitamin D.

Calcium Hasco and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
High doses of calcium taken together with certain cardiac drugs (digitalis glycosides or calcium channel blockers) may cause serious disturbances in heart function.
Calcium significantly reduces the absorption of certain antibiotics (tetracyclines and quinolones), levothyroxine, nitrofurantoin, bisphosphonates, chlorpromazine, penicillamine, anticoagulant drugs, and fluoride compounds. Therefore, it is recommended that the interval between taking Calcium Hasco syrup and these medicines be about 3 hours.
Diuretics of the thiazide group reduce calcium excretion, while 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 child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.
Calcium Hasco contains sucrose, sodium benzoate (E 211), propylene glycol (E 1520),
benzyl alcohol, and sodium
Sucrose
The medicine contains 1.5 g of sucrose in each 5 ml of syrup. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Propylene glycol (E 1520)
The medicine contains approximately 3.99 mg of propylene glycol in each 5 ml of syrup. Before administering the medicine to a child under 4 weeks of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Sodium benzoate (E 211)
The medicine contains 10 mg of sodium benzoate in each 5 ml of syrup. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).
Benzyl alcohol
The medicine contains 0.095 mg of benzyl alcohol in each 5 ml of syrup. Benzyl alcohol may cause allergic reactions. Administration of benzyl alcohol to young children is associated with a risk of serious adverse effects, including breathing disorders (so-called "gasping syndrome").
Do not administer to newborns (up to 4 weeks of age) without a doctor's instruction. Do not administer to young children (under 3 years of age) for longer than one week without a doctor's or pharmacist's advice.
Pregnant or breastfeeding women should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
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Sodium
The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of syrup, meaning the medicine is considered "sodium-free".

3. How to use Calcium Hasco

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken orally.
Adults: 15 ml two or three times daily.
Children: up to 6 years: 5 ml two or three times daily,
from 6 to 12 years: 10 ml two or three times daily.
The dose should be measured using the measuring device provided.
If you feel that the effect of Calcium Hasco is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Calcium Hasco
No cases of overdose with Calcium Hasco have been reported. If a higher than recommended dose is taken, seek medical advice immediately.
Missing a dose of Calcium Hasco
Do not take a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rare adverse reactions (in 1 to 10 patients out of 10,000):

• gastrointestinal disorders (constipation, diarrhoea),
• in patients with impaired kidney function, oral administration of high doses of calcium may lead to hypercalcaemia, the symptoms of which include: nausea, abdominal pain, bone pain and muscle weakness.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
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 Hasco

Store below 25°C. Keep in the original packaging.
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Keep the medicine out of the sight and reach of children.
Shelf life after first opening – 6 months.
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. These measures help protect the environment.

6. Contents of the package and other information

What Calcium Hasco contains

• The active substances are organic calcium salts (anhydrous calcium gluconolactobionate and dihydrate calcium lactobionate) in an amount corresponding to 115.6 mg of calcium ions in 5 ml of syrup.
• The other components (excipients) are: sucrose, sodium benzoate (E 211), monohydrate citric acid (E 330), strawberry flavour (containing propylene glycol (E 1520) and benzyl alcohol), purified water.

What Calcium Hasco looks like and contents of the pack
Calcium Hasco is a yellowish syrup.
One pack (a brown glass bottle) contains 150 ml of solution.
The bottle with a measuring device for administering the medicine is placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel.: (22) 742 00 22
e-mail: [email protected]
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