CALCIUM VERLA 600 mg film-coated tablets

Important Information (Mandatory Information)

Calcium Verla 600 mg film-coated tablets. Active substance: Calcium carbonate. Areas of application: for the prevention of calcium deficiency in cases of increased requirement (e.g. growth period, pregnancy, lactation) and for the supportive treatment of osteoporosis.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Calcium Verla 600 mg film-coated tablets, mineral preparation, for use in adults, adolescents, and children aged 6 years and older
Active substance: Calcium carbonate

Read all of this leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. WHAT CALCIUM VERLA 600 MG IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCIUM VERLA 600 MG
3. HOW TO TAKE CALCIUM VERLA 600 MG
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CALCIUM VERLA 600 MG
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT CALCIUM VERLA 600 MG IS AND WHAT IT IS USED FOR

Calcium Verla 600 mg is a mineral preparation.

It is used:

• for the prevention of calcium deficiency when calcium requirements cannot be met by diet.
• for the treatment of calcium deficiency
• for the supportive treatment of osteoporosis.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCIUM VERLA 600 MG

Do not take Calcium Verla 600 mg:

• if you are allergic to calcium or any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium in your blood (hypercalcaemia) or in your urine (hypercalciuria)
• if you have calcium-containing kidney stones or calcium deposits in the kidneys (nephrocalcinosis).

Warnings and precautions

Talk to your doctor or pharmacist before taking Calcium Verla 600 mg.

Special care is required when taking Calcium Verla 600 mg in case of:

• impaired kidney function (use should only take place under ongoing medical monitoring of calcium and phosphate concentrations in the blood and urine as well as kidney function).
• diseases or conditions that favor the occurrence of hypercalcaemia (e.g. primary hyperparathyroidism, certain tumor diseases, sarcoidosis, immobilisation). In such cases, calcium levels should be monitored during the use of Calcium Verla 600 mg.
• low phosphate concentration in the blood (in case of hypophosphataemia, the phosphate concentration in the blood must be monitored by the treating doctor).

Ask your doctor for advice if calcium-containing kidney stones have occurred in your family.

Taking Calcium Verla 600 mg increases the excretion of calcium in the urine. In the first few months after starting treatment, this also increases the tendency for calcium salts to precipitate and, under certain circumstances, for stones to form in the kidney and urinary bladder. This can be avoided by drinking plenty of fluids.

A magnesium deficiency can lead to reduced secretion and effect of parathyroid hormone and thus cause a secondary calcium deficiency. Therefore, magnesium status should be checked before starting calcium therapy and magnesium should be administered if necessary.

When using Calcium Verla 600 mg preventively, all dietary sources of calcium must be taken into account to avoid overdosing. This should be checked regularly.

Please note that taking Calcium Verla 600 mg together with high doses of calcium and alkaline substances (such as carbonates commonly used in antacids) from other sources (e.g. food, food supplements or other medicines) can lead to milk-alkali syndrome (Burnett's syndrome) with high calcium levels in the blood, under-acidification of the blood (metabolic alkalosis), kidney failure and soft tissue calcification. If high doses are taken, calcium levels in serum and urine should be monitored.

High doses of Calcium Verla 600 mg, especially if vitamin D is also taken, can lead to high calcium levels in the blood and consequently to kidney dysfunction. In such cases, calcium and phosphate levels in serum and urine as well as kidney function should be monitored.

If stomach acid production is too low (achlorhydria), the solubility of calcium carbonate may be impaired and the bioavailability of calcium reduced. To ensure adequate absorption of calcium, Calcium Verla 600 mg should be taken with a meal in these cases.

Children and adolescents

Calcium Verla 600 mg should not be used in children under 6 years of age, as there is a general risk of choking when taking film-coated tablets.

Taking Calcium Verla 600 mg with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following medicines affect the action of Calcium Verla 600 mg

Calcium Verla 600 mg affects the action of other medicines as follows:

• If taking Calcium Verla 600 mg increases blood calcium levels, sensitivity to certain medicines that increase heart strength (cardiac glycosides such as digoxin, digitoxin) is increased and the risk of cardiac arrhythmias is elevated. Strict medical monitoring, including ECG examination and monitoring of blood calcium concentration, is therefore required.
• The absorption and thus also the efficacy of various other medicines (e.g. levothyroxine, tetracyclines, quinolones, some cephalosporins, ketoconazole, iron, zinc, sodium fluoride, estramustine and bisphosphonate preparations) can be reduced by taking Calcium Verla 600 mg at the same time. As a rule, an interval of at least 2 hours should therefore be kept between taking Calcium Verla 600 mg and taking other preparations.
• Calcium can reduce the absorption of phosphate by forming poorly soluble salts.

Taking Calcium Verla 600 mg with food and drink

Please note that dairy products have a high calcium content. One liter of milk can contain up to 1200 mg of calcium.

Foods with a high content of phosphate (e.g. processed and hard cheese), phytic acid (e.g. whole grain products) or oxalic acid (e.g. spinach, rhubarb) can inhibit calcium absorption. After consuming such foods, an interval of 2 hours should be kept before taking Calcium Verla 600 mg if possible.

Pregnancy and breast-feeding

Calcium Verla 600 mg can be taken during pregnancy and breast-feeding in the usual dosage recommended for adults.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Calcium Verla 600 mg
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, i.e. it is essentially "sodium-free".

3. HOW TO TAKE CALCIUM VERLA 600 MG

Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Adults:
1 film-coated tablet 1 to 2 times daily (equivalent to 600-1200 mg calcium).

Use in children and adolescents

Adolescents aged 12 and over:
1 film-coated tablet 1 to 2 times daily (equivalent to 600-1200 mg calcium).

Children aged 6 and over:
1 film-coated tablet once daily (equivalent to 600 mg calcium).

Children under 6 years:
The use of Calcium Verla 600 mg in this age group is not recommended (see also section 2).

Impaired kidney function

In case of impaired kidney function, the warnings and precautions listed in section 2 must be observed.

Impaired liver function

There are insufficient data for specific dosage recommendations in case of impaired liver function.

Method of administration

Please swallow the film-coated tablets whole with sufficient liquid (preferably a glass of water); the score line is not intended for breaking the tablet. You can take Calcium Verla 600 mg with food or between meals. Please note the information in section 2 regarding taking Calcium Verla 600 mg with food and drink.

Duration of use

Calcium Verla 600 mg can also be taken long-term if necessary. In particular, use for the treatment of calcium deficiency and osteoporosis should be long-term. Talk to your doctor about how long you should take Calcium Verla 600 mg.

If you take more Calcium Verla 600 mg

than you should

this is usually without consequences. If symptoms occur, please contact your doctor.

If you forget to take Calcium Verla 600 mg

Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rarely (may affect up to 1 in 1,000 people), gastrointestinal complaints such as constipation, flatulence, nausea, abdominal pain, and diarrhea may occur.

Hypersensitivity reactions of the skin such as itching, hives, or rash are possible. The frequency cannot be estimated from the available data.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CALCIUM VERLA 600 MG

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "expiry date:" and on the blister after "EXP". The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Never throw away any medicines via wastewater (e.g. not down the toilet or sink). Ask your pharmacy how to throw away medicines you no longer use. These measures will help protect the environment. More information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Calcium Verla 600 mg contains

The active substance is:
Calcium

1 film-coated tablet contains:
600 mg calcium (as calcium carbonate).

The other ingredients are

Sodium starch glycolate (type A) (Ph. Eur.), povidone (K 25), microcrystalline cellulose, sodium dodecyl sulfate, magnesium stearate (Ph. Eur.), stearic acid (Ph. Eur.), hypromellose, light liquid paraffin, titanium dioxide.

What Calcium Verla 600 mg looks like and contents of the pack

White, oval film-coated tablets with "Verla" embossing and a decorative score line on the back.

Calcium Verla 600 mg is available in packs of 20, 40, and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Verla-Pharm Arzneimittel GmbH & Co. KG
82324 Tutzing
Hauptstraße 98
www.verla.de

This leaflet was last revised in September 2021.

Source: www.verla.de and information from the package leaflet
Status: 04/2026
Active substance: Calcium carbonate. Areas of application: for the prevention of calcium deficiency in cases of increased requirement (e.g. growth period, pregnancy, lactation) and for the supportive treatment of osteoporosis.