Orocal D3

Package Leaflet: Information for the User

Orocal D, 500 mg + 10 μg (400 IU), chewable tablets
Calcium + Cholecalciferol

Read the package leaflet carefully 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 doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Orocal D and what is it used for
• 2. Important information before taking Orocal D
• 3. How to take Orocal D
• 4. Possible side effects
• 5. How to store Orocal D
• 6. Package contents and other information

1. What is Orocal D and what is it used for

Orocal D is a medicine in the form of chewable tablets with a mint flavor, containing calcium and vitamin
D, which are essential components in the process of bone formation.
Orocal D is used to prevent and treat calcium and vitamin D deficiencies in adults with a diagnosed risk of calcium and vitamin D deficiency and as a supplement to specific osteoporosis treatment.

2. Important information before taking Orocal D

When not to take Orocal D

• If the patient is allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe kidney failure.
• If the patient has high levels of calcium in the blood or urine.
• If the patient has kidney stones.
• If the patient has an excess of vitamin D in the blood.

Warnings and precautions

Before starting to take Orocal D, the patient should discuss it with their doctor or pharmacist:

• if long-term treatment is required, especially if the patient is also taking diuretics (used to treat high blood pressure or edema) or cardiac glycosides (used to treat heart rhythm disorders);
• if the patient has symptoms of kidney function disorders or a tendency to form kidney stones;
• if the patient has sarcoidosis (an immune system disorder that can increase vitamin D levels in the body);
• if the patient has osteoporosis and is also immobilized;
• if the patient is taking other products containing vitamin D. Additional doses of calcium and vitamin D should be taken under close medical supervision.

Children

Orocal D should not be taken by children.

Orocal D with other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
If the patient is also taking tetracyclines (a type of antibiotic), they should be taken at least 2 hours before or 4-6 hours after taking calcium. Calcium carbonate may interfere with the absorption of antibiotics from the tetracycline group.
If bisphosphonates are taken at the same time, they should be taken at least 1 hour before taking Orocal D.
Calcium may reduce the effect of levothyroxine. Therefore, levothyroxine should be taken at least 4 hours before or after taking Orocal D.
The effect of quinolone antibiotics may be weakened if taken at the same time as calcium. Quinolones should be taken 2 hours before or 6 hours after taking Orocal D.
Calcium salts may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, products containing iron, zinc, or strontium ranelate should be taken at least 2 hours before or after taking Orocal D.
Other medicines that may affect the action of Orocal D or be affected by Orocal D include:

• thiazide diuretics (used to treat high blood pressure or edema);
• cardiac glycosides (used to treat heart rhythm disorders).

Orlistat (used to treat obesity) may interfere with the absorption of fat-soluble vitamins, such as vitamin D.
If the patient is taking any of the above medicines, they should discuss it with their doctor.

Orocal D with food and drink

Orocal D can be taken with food and drink.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Orocal D may be taken during pregnancy in case of calcium and vitamin D deficiency.
During pregnancy, the daily dose should not exceed 2500 mg of calcium and 4000 IU of vitamin D, as overdose may harm the unborn child.
Orocal D can be taken during breastfeeding. Calcium and vitamin D pass into breast milk. This should be taken into account if the baby is also given vitamin D.

Driving and using machines

Orocal D has no effect on the ability to drive and use machines.

Orocal D contains isomaltose and sucrose

Orocal D contains sucrose (0.8 mg), which may be harmful to teeth. It also contains isomaltose (E953). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Orocal D practically contains no sodium

Orocal D contains less than 23 mg of sodium per tablet, which means it practically contains no sodium.

3. How to take Orocal D

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Dosage:
The recommended dose is 1 tablet twice a day. The tablets can be chewed or sucked.

Use in children

Orocal D is not intended for use in children.

Overdose of Orocal D

In case of overdose, the patient should immediately consult their doctor or pharmacist.

Missed dose of Orocal D

A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Orocal D can cause side effects, although not everybody gets them.
Hypersensitivity reactions have occurred with an unknown frequency (cannot be estimated from the available data). The patient should immediately consult their doctor if they experience any of the following symptoms: swelling of the face, tongue, lips (angioedema) or throat swelling (laryngeal edema).
Uncommon side effects(may affect up to 1 in 100 people)
High levels of calcium in the blood (hypercalcemia) and urine (hypercalciuria) may occur during treatment with high doses.
Rare side effects(may affect up to 1 in 1,000 people)
Constipation, indigestion, bloating, nausea, abdominal pain, diarrhea.
Very rare side effects(may affect up to 1 in 10,000 people)
Itching, rash, hives. Milk-alkali syndrome (also known as Burnett's syndrome, usually observed only in cases of high calcium intake), whose symptoms are: frequent urination, headache, loss of appetite, nausea or vomiting, unusual feeling of fatigue or weakness, and elevated calcium levels in the blood serum and kidney failure.
If the patient has kidney function disorders, they may be at risk of increased phosphate levels in the blood, kidney stone formation, and increased calcium levels in the kidneys.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Orocal D

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the label, after the EXP date.
The medicine should not be stored at temperatures above 30°C. The original packaging should be kept to protect from light. The container should be kept tightly closed to protect from moisture.
The shelf life after first opening the container is 6 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Orocal D contains

The active substances of the medicine are:

• calcium carbonate 1250 mg (equivalent to 500 mg of calcium),
• cholecalciferol (vitamin D) 400 IU (10 micrograms).

Other ingredients are:
xylitol (E967), povidone, isomaltose (E953), mint flavor, magnesium stearate, sucralose (E955), mono- and diglycerides of fatty acids, all-rac-α-tocopherol, sucrose, modified cornstarch, saturated medium-chain triglycerides, sodium ascorbate, colloidal silica anhydrous.

What Orocal D looks like and what the package contains

Orocal D is a white, round, chewable tablet. It may have small speckles.
Package size:
HDPE plastic bottle with a screw cap: 20, 30, 60, 100, and 180 tablets.
Not all package sizes may be available.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orifarm Healthcare Sp. z o.o.
ul. Przyokopowa 31
01-208 Warsaw
Poland
[email protected]
Manufacturer:
Asker Contract Manufacturing AS
Drammensveien 852
NO-1383 Asker
Norway

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Finland: Calcichew D Forte Minttu
Netherlands: Tacal D 500 mg/400 I.E. munt
Norway: Nycoplus Calcigran Forte 500 mg/400 IE tyggetabletter med spearmintsmak
Poland: Orocal D
Sweden: Calcichew-D Spearmint

Date of last revision of the leaflet: