Orocal d3

Package leaflet: Information for the user

Orocal D, 500 mg + 10 μg (400 I.U.), chewable tablets
Calcium + Cholecalciferol
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the 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 the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Orocal D is and what it is 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. Contents of the package and other information

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

Orocal D is a chewable tablet with a mint flavour, containing calcium and vitamin D, which are essential components in the bone formation process.
Orocal D is used for the prevention and treatment of calcium and vitamin D deficiencies in adults identified as being at risk of calcium and vitamin D deficiency, and as a supplement to specific osteoporosis treatment.

2. Important information before using Orocal D

When not to use 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 treatment with Orocal D, discuss with your doctor or pharmacist:

• if long-term treatment is required, especially if the patient is also taking diuretics (used to treat high blood pressure or oedema) or cardiac glycosides (used to treat heart disorders);
• if the patient has symptoms of kidney dysfunction or a tendency to develop kidney stones;
• if the patient has sarcoidosis (an immune system disorder that may 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 only under strict medical supervision.

Children
Orocal D must not be used in children.
Orocal D and other medicines
Tell your doctor or pharmacist if the patient is currently taking, has recently taken, or plans to take any other medicines.
If the patient is also taking tetracyclines (a type of antibiotic), they should be administered at least 2 hours before or 4–6 hours after calcium administration. Calcium carbonate may interfere with the absorption of tetracycline antibiotics taken simultaneously.
If bisphosphonates are used 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 reduced if administered simultaneously with 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 interact with Orocal D or whose effects may be affected by Orocal D include:

• thiazide diuretics (used to treat high blood pressure or oedema);
• cardiac glycosides (used to treat heart 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 medicines listed above, they should discuss this with their doctor.
Orocal D with food and drink
Orocal D can be taken with or without food and drink.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Orocal D may be used during pregnancy in cases of calcium and vitamin D deficiency.
During pregnancy, do not exceed a daily dose of 2500 mg of calcium and 4000 IU of vitamin D, as overdose may harm the unborn child.
Orocal D may be used during breastfeeding. Calcium and vitamin D pass into breast milk. This should be taken into account if vitamin D is additionally given to the infant.
Driving and operating machinery
Orocal D has no effect on the ability to drive or operate machinery.
Orocal D contains isomalt and sucrose.
Orocal D contains sucrose (0.8 mg), which may be harmful to teeth. It also contains isomalt (E953). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Orocal D contains practically no sodium
Orocal D contains less than 23 mg of sodium per tablet, meaning it is practically sodium-free.
3. How to take Orocal D
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage:
The recommended dose is 1 tablet twice daily. The tablets may be chewed or sucked.
Use in children
Orocal D is not intended for use in children.
Taking more Orocal D than recommended
If more than the recommended dose has been taken, contact your doctor or pharmacist immediately.
If a dose of Orocal D is missed
Do not take a double dose to make up for a missed dose.
If you have any further questions about 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 experiences them.
Hypersensitivity reactions have been reported with unknown frequency (cannot be estimated from the available data).
You should contact a doctor immediately if the patient experiences any of the following symptoms: swelling of the face, tongue, lips (angioedema), or swelling of the throat (laryngeal edema).

Uncommon adverse reactions (may occur in up to 1 in 100 patients)
High levels of calcium in the blood (hypercalcaemia) and in the urine (hypercalciuria) may occur during treatment with high doses.

Rare adverse reactions (may occur in up to 1 in 1000 patients)
Constipation, dyspepsia, flatulence, nausea, abdominal pain, diarrhoea.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients)
Itching, rash, urticaria. Milk-alkali syndrome (also known as Burnett's syndrome, usually observed only after ingestion of large amounts of calcium), the symptoms of which include frequent urge to urinate, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, elevated calcium levels in blood serum, and kidney failure.

If the patient has impaired kidney function, they may be at risk of increased levels of phosphates in the blood, formation of kidney stones, and increased calcium deposition in the kidneys.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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,
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 this medicine.

5. How to store Orocal D

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, following the EXP.
Do not store above 30°C. Store in the original packaging to protect from light. Keep the container tightly closed to protect from moisture.
The shelf life after first opening the container is 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Orocal D contains
The active substances in this medicine are:

• Calcium carbonate 1250 mg (corresponds to 500 mg calcium),
• Cholecalciferol (vitamin D_) 400 IU (10 micrograms).

The other ingredients are:
Xylitol (E967), povidone, isomalt (E953), flavour (spearmint), magnesium stearate, sucralose (E955), mono- and diglycerides of fatty acids, all-rac-α-tocopherol, sucrose, modified food starch, medium-chain triglycerides, sodium ascorbate, colloidal anhydrous silica.

What Orocal D looks like and contents of the pack
Orocal D is a white, round, chewable tablet. It may have minor specks.
Pack sizes:
HDPE plastic bottle with screw cap: 20, 30, 60, 100 and 180 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation 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 authorised in the European Economic Area countries 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