Calcium + Holecalciferol Béres

Patient Information Leaflet: User Information

Calcium + Cholecalciferol Béres, 600 mg + 800 IU, coated tablets

Calcium + Cholecalciferol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• -Keep this leaflet, you may need to read it again.
• -If you have any further questions, ask your doctor or pharmacist.
• -This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• -If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Calcium + Cholecalciferol Béres and what is it used for

This medicine contains calcium (in the form of calcium carbonate) and cholecalciferol (vitamin D), which are important in the process of bone formation.
Calcium + Cholecalciferol Béres can be used to prevent and treat calcium and vitamin D deficiency in patients at risk of vitamin D and calcium deficiency, as well as to supplement the treatment of osteoporosis.

2. Important information before taking Calcium + Cholecalciferol Béres

When not to take Calcium + Cholecalciferol Béres:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you have kidney stones or calcium deposits in the kidney tissue;
• if you have kidney failure or impaired kidney function;
• if you have high levels of vitamin D in the blood;
• if you have chronically elevated calcium levels in the urine or elevated calcium levels in the blood, or a disease that may cause this (e.g., malignant tumor affecting the bones);
• Calcium + Cholecalciferol Béres contains hydrogenated soybean oil. If you are allergic to soy or peanuts, do not take this medicine.

Warnings and precautions

Before starting treatment with Calcium + Cholecalciferol Béres, discuss it with your doctor:

• if you have kidney disease or impaired kidney function;
• if you have sarcoidosis (a inflammatory disease diagnosed by a doctor that causes the formation of granulomas and swelling in various organs);
• if you are prone to kidney stone formation;
• if you are immobilized and have osteoporosis.

Your doctor will decide whether calcium and/or vitamin D can be administered in these cases.
Before starting treatment for osteoporosis with Calcium + Cholecalciferol Béres, your doctor may check your blood calcium levels.
In case of long-term use of Calcium + Cholecalciferol Béres and impaired kidney function, regularly monitor blood calcium levels and kidney function. Depending on the result, your doctor may decide to discontinue treatment.

Children and adolescents

Calcium + Cholecalciferol Béres coated tablets are not intended for use in children and adolescents.

Calcium + Cholecalciferol Béres and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or recently, and about medicines you plan to take.
You must discuss this with your attending physician if you are taking the following medicines:

• other medicines containing calcium or vitamin D, as concomitant use of these products with Calcium + Cholecalciferol Béres may lead to a harmful increase in blood calcium levels. Do not take other products containing calcium or vitamin D without your doctor's recommendation;
• thiazide diuretics;
• corticosteroids used systemically (anti-inflammatory medicines taken orally or intravenously);
• cardiac glycosides (digitalis preparations used to treat heart failure).

Medicines that can be used with special caution

• ion exchange resins, such as cholestyramine, or laxatives, such as paraffin oil, as these medicines reduce the absorption of vitamin D.
• medicines containing tetracyclines and quinolones (antibiotics), as calcium carbonate may affect their absorption. Therefore, tetracycline and quinolone should be taken at least 2 hours before or 4-6 hours after taking Calcium + Cholecalciferol Béres;
• if you are taking Calcium + Cholecalciferol Béres and sodium fluoride or bisphosphonates (used to treat osteoporosis), take these medicines at least 3 hours before taking Calcium + Cholecalciferol Béres;
• rifampicin (a medicine used to treat tuberculosis), actinomycin (an antibiotic used to treat cancer), and imidazole derivatives (antifungal medicines), phenytoin (an antiepileptic medicine), and barbiturates (antiepileptic and sedative medicines), as they may reduce the effect of vitamin D;
• medicines containing estramustine (used in chemotherapy), thyroid hormones, or iron, zinc, or strontium, as their absorption may be reduced. Take these medicines at least 2 hours before or after taking Calcium + Cholecalciferol Béres.

Calcium + Cholecalciferol Béres with food and drink

Oxalic acid (found in spinach, sorrel, and rhubarb) and phytic acid (found in whole grain cereals) may inhibit calcium absorption. Do not take Calcium + Cholecalciferol Béres within 2 hours of consuming foods rich in oxalic acid and phytic acid.

Pregnancy, breastfeeding, and fertility

During pregnancy, the daily intake of calcium should not exceed 2500 mg, and the intake of vitamin D should not exceed 4000 IU (International Units). The use of Calcium + Cholecalciferol Béres is not usually recommended during pregnancy, but your doctor may recommend it in case of calcium or vitamin D deficiency.
Calcium + Cholecalciferol Béres can be taken during breastfeeding, but consult your doctor before starting treatment.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

There is no data on the effect of this medicine on the ability to drive and use machines.

Calcium + Cholecalciferol Béres contains hydrogenated soybean oil and sucrose

Calcium + Cholecalciferol Béres contains hydrogenated soybean oil. Do not take this medicine if you are allergic to peanuts or soy.
Calcium + Cholecalciferol Béres contains small amounts of sucrose. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Calcium + Cholecalciferol Béres

Always take this medicine exactly as described in the patient information leaflet or as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Adults and the elderly
Recommended dose: one coated tablet per day.

Use in children and adolescents

Calcium + Cholecalciferol Béres is not intended for use in children and adolescents.
It is recommended to take the coated tablet within 1.5 hours after a meal, without chewing, with a glass of water or juice. The dividing line on the tablet facilitates only its breaking, if it is not possible to swallow the tablet whole. If necessary, the tablet can be broken in half.
If the medicine is used to supplement the treatment of osteoporosis, discuss the duration of treatment with your doctor.
Since dietary habits have a significant impact on the need and scope of calcium supplementation, in case of significant changes in dietary habits, inform your doctor.

Taking a higher dose of Calcium + Cholecalciferol Béres than recommended

In case of taking too many tablets, contact your doctor immediately. Taking a higher dose than recommended may cause unwanted and harmful side effects. Symptoms of overdose may include: loss of appetite, increased thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, disorientation, increased urination, bone pain, and in severe cases, cardiac arrhythmias. In extreme cases, calcium overdose can lead to coma and even be fatal. Prolonged high levels of calcium in the blood can lead to irreversible kidney damage and calcium deposition in the body.

Missing a dose of Calcium + Cholecalciferol Béres

Do not take a double dose to make up for a missed tablet, as there is a risk of overdose.
Continue taking the medicine as before.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Uncommon (may affect up to 1 in 100 people):

significant increase in blood calcium levels (hypercalcemia).
Symptoms include: nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, increased thirst, frequent urination, muscle weakness, drowsiness, disorientation.
Excessive increase in urine calcium levels (hypercalciuria). If you are taking this medicine for a long time, your doctor may periodically check your blood and urine calcium levels and kidney function.

Rare (may affect up to 1 in 1000 people):

Constipation, bloating, nausea, abdominal pain, diarrhea, itching, rash, urticaria.

Very rare (may affect up to 1 in 10,000 people):

Milk-alkali syndrome (may occur after consuming large amounts of calcium with easily absorbable alkaline compounds, e.g., calcium carbonate, with symptoms such as frequent urination, persistent headaches, loss of appetite, nausea or vomiting, unusual fatigue or weakness, significantly elevated blood calcium levels, alkalosis, and kidney failure).
Patients with kidney failure may be at increased risk of developing high phosphate levels in the blood, kidney stone formation, and calcium deposition in the kidneys.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Calcium + Cholecalciferol Béres

Do not store above 25°C.
Store in the original package to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Calcium + Cholecalciferol Béres contains

Active substances:
600 mg calcium (in the form of 1500 mg calcium carbonate) and
20 micrograms of cholecalciferol (equivalent to 800 IU of vitamin D).
Additionally, the medicine contains:
tablet core:
magnesium stearate, crospovidone (type A), copovidone, microcrystalline cellulose (type 102),
sucrose, gelatin, all-rac-α-tocopherol (E 307), hydrogenated soybean oil, corn starch,
colloidal silica.
coating:
iron oxide yellow (E 172), iron oxide red (E 172), hypromellose 15 cps, titanium dioxide (E 171), macrogol 3350, talc.

What Calcium + Cholecalciferol Béres looks like and contents of the pack

Light orange, oval, coated tablet with a dividing line on one side.
The surface of the break is white.
The dividing line on the tablet facilitates only its breaking, for easier swallowing, and not for dividing into equal doses.
30, 60, 90, 120 coated tablets in colorless blisters of PVC/Aluminum in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Béres Pharmaceuticals Ltd.
H-1037 Budapest, Mikoviny utca 2-4, Hungary
Phone: +36-1-430-5500
Fax: +36-1-250-7251
Email: [email protected]

Manufacturer:

Béres Pharmaceuticals Ltd.
5000 Szolnok, Nagysándor József út 39
Hungary

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:
Hungary:
Calcium/Cholecalciferol Béres 600 mg/800 NE
Czech Republic:
Videmel Forte
Estonia:
Calcium/Colecalciferol Béres
Latvia:
Calcium/Colecalciferol Beres 600 mg/800 SV apvalkotās tablets
Poland:
Calcium + Cholecalciferol Béres
Romania:
CalciviD 600 mg/800 UI
Slovakia:
Kalcizen Forte

Date of last revision of the leaflet: