Calcium aflofarm (banana flavor)

Package leaflet: information for the patient

Calcium Aflofarm (banana flavoured)
(Calcii glubionas, Calcii lactobionas)
116 mg calcium ions / 5 ml, syrup
Please read carefully the entire leaflet before taking the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by the physician or pharmacist.
Keep this leaflet, as you may need to read it again.

• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days in adults or after 3 days in children, or if the patient feels worse, consult a doctor.

Table of contents of the leaflet

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

1. What Calcium Aflofarm (banana flavoured) is and what it is used for

Calcium Aflofarm (banana flavoured) is a syrup containing 116 mg of calcium ions per 5 ml of syrup.
Calcium Aflofarm (banana flavoured) syrup is indicated:

• for supplementation of calcium deficiency, especially in conditions of increased demand (pregnancy, breastfeeding, periods of rapid growth in children, convalescence, bone fractures, rickets);
• as supportive treatment in allergic diseases, upper respiratory tract infections, and osteoporosis.

2. Important information before taking Calcium Aflofarm (banana flavoured)

When not to take Calcium Aflofarm (banana flavoured):

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypercalcaemia (excess calcium in the blood), hypercalciuria (excess calcium in the urine), or galactosaemia.

Warnings and precautions
This medicine contains calcium. Due to the risk of overdose, check whether other medicines being taken also contain calcium before use.
Before starting to take Calcium Aflofarm (banana flavoured), discuss this with a doctor or pharmacist.

• if the patient is predisposed to developing kidney stones;
• if the patient has kidney or heart disease. Concurrent use of cardiac glycosides and calcium compounds increases the risk of cardiac rhythm disturbances. Do not administer together with high doses of vitamin D or during treatment with tetracycline antibiotics or thiazide diuretics (e.g. chlorothiazide).

Calcium Aflofarm (banana flavoured) and other medicines
Tell your doctor or pharmacist if the patient is taking, has recently taken, or might take any other medicines.
The patient should inform the doctor if they are taking any of the following medicines or food products.

• Calcium compounds reduce, among others, the absorption of tetracyclines, fluoroquinolones, fluoride compounds, and sulfasalazine.
• A three-hour interval should be maintained between administration of calcium preparations and other medicines.
• Concurrent use of calcium salts and thiazide diuretics may lead to symptoms of milk-alkali syndrome (hypercalcaemia, metabolic alkalosis, renal failure).
• Vitamin D, glucocorticosteroids, parathormone, citric acid, and acidic gastric content enhance the absorption of calcium salts.
• Excess lipids, alkaline gastric content, phytates (cereals), oxalates (spinach, rhubarb), and phosphates reduce the absorption of calcium salts.
• Concurrent use of cardiac glycosides and calcium compounds increases the risk of cardiac rhythm disturbances.
• High doses of calcium, especially in combination with vitamin D, may reduce the effectiveness of verapamil and other calcium channel blockers (medicines used for hypertension and heart diseases).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
No effect.
Calcium Aflofarm (banana flavoured) contains sucrose
The syrup contains 1.53 g of sucrose in 5 ml of product. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

3. How to take Calcium Aflofarm (banana flavour)

Oral administration. A measuring cup is attached to the package.

Recommended dose:

• children aged 2 to 11 years - 2.5 to 5 ml of syrup twice daily;
• children aged 12 to 17 years - 5 to 10 ml of syrup 2 to 3 times daily;
• adults - 15 ml of syrup 2 to 3 times daily.

Taking more than the recommended dose of Calcium Aflofarm (banana flavour)
Seek immediate advice from a doctor or pharmacist, even if the patient feels well.

Missed dose of Calcium Aflofarm (banana flavour)
Do not take a double dose to make up for a missed dose.
If a dose is missed and symptoms persist, take the next dose at the scheduled time.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Gastrointestinal disturbances may occur in rare cases.
In patients with renal insufficiency, hypercalcaemia may occur, the symptoms of which include loss of appetite, gastrointestinal disturbances, muscle weakness, and polyuria.
Other adverse effects may occur in some individuals during treatment with this medicine.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Calcium Aflofarm (banana flavour)

Keep this medicine out of sight and reach of children.
Store in the original packaging, at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the label.
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 pack and other information

What Calcium Aflofarm (banana flavour) contains

• The active substance is calcium gluconolactobionate and calcium lactobionate.
• 5 ml of syrup contains 116 mg of calcium ions in the form of calcium gluconolactobionate and calcium lactobionate.
• Other ingredients are: sucrose, propionic acid, sodium benzoate (E 211), banana flavour AR 0476 G, hydrochloric acid 10%, purified water.

What Calcium Aflofarm (banana flavour) looks like and contents of the pack
Calcium Aflofarm (banana flavour) is a yellowish-brown syrup with a banana odour and sweet, banana taste.
The pack consists of a glass bottle containing 150 ml of syrup, with an aluminium cap and a measuring cup.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Krzywa 2
95-030 Rzgów