Orocal D3 Lemon

Package Leaflet: Information for the User

Orocal D Lemon, 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 package leaflet or as directed by a doctor or pharmacist.

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

Package Leaflet Contents

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

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

Orocal D Lemon is a chewable tablet medicine with a lemon flavor, containing calcium and vitamin D, which are essential components in the process of bone formation.
Orocal D Lemon 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 Lemon

When not to take Orocal D Lemon

• 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 taking Orocal D Lemon, 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 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 Lemon should not be taken by children.

Orocal D Lemon and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently 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 Orocal D Lemon. Calcium carbonate may interfere with the absorption of antibiotics taken at the same time.
If bisphosphonates are taken at the same time, they should be taken at least 1 hour before taking Orocal D Lemon.
Calcium may reduce the effect of levothyroxine. Therefore, levothyroxine should be taken at least 4 hours before or after taking Orocal D Lemon.
The effect of quinolone antibiotics may be reduced if taken at the same time as calcium. Quinolones should be taken 2 hours before or 6 hours after taking Orocal D Lemon.
Calcium salts may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, medicines containing iron, zinc, or strontium ranelate should be taken at least 2 hours before or after taking Orocal D Lemon.
Other medicines that may affect the effect of Orocal D Lemon or be affected by it include:

• thiazide diuretics (used to treat high blood pressure or edema);
• 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 above medicines, they should discuss it with their doctor.

Orocal D Lemon with food and drink

Orocal D Lemon 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 Lemon may be taken during pregnancy in case of calcium and vitamin D deficiency. During pregnancy, the dose should not exceed 2500 mg of calcium and 4000 IU of vitamin D per day, as overdose may harm the unborn child.
Orocal D Lemon may 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 Lemon has no effect on the ability to drive or use machines.

Orocal D Lemon contains isomaltose and sucrose.

Orocal D Lemon 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 Lemon practically contains no sodium

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

3. How to take Orocal D Lemon

This medicine should always be taken exactly as described in the package leaflet or as directed by a 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 Lemon is not intended for use in children.

Overdose of Orocal D Lemon

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

Missed dose of Orocal D Lemon

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

4. Possible side effects

Like all medicines, Orocal D Lemon 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: facial swelling, tongue swelling, lip swelling (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, and urticaria. 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 increased levels of calcium 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 package leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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 to gather more information on the safety of the medicine.

5. How to store Orocal D Lemon

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 expiration date. The expiry date refers to the last day of the specified month.
The medicine should not be stored above 30°C. The original packaging should be kept to protect from light. The container should be kept tightly closed to protect from moisture.
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 Lemon contains

The active substances of the medicine are:

• calcium carbonate 1250 mg (equivalent to 500 mg of calcium),
• cholecalciferol (vitamin D3) 400 IU (10 micrograms).

Other ingredients are:
xylitol (E 967), povidone, isomaltose (E 953), lemon flavor, magnesium stearate, sucralose (E 955), mono- and diglycerides of fatty acids, all-rac-α-tocopherol, sucrose, modified cornstarch, medium-chain triglycerides, sodium ascorbate, colloidal anhydrous silica.

What Orocal D Lemon looks like and contents of the pack

Orocal D Lemon is a white, round, chewable tablet. The tablets may have small speckles.
Package sizes:
HDPE plastic bottle with a screw cap: 30, 50, 60, 90, 100, 120, and 180 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
To obtain more detailed information on 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
Cheplapharm Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany

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

Austria: Cal-D-Or
Belgium: Steovit D citroen 500 mg/400 IU
Czech Republic: CALCICHEW D3 400 IU chewable tablets
Denmark: Calcichew-D3 Forte
Finland: Calcichew D Forte sitruuna 500 mg/400 IU – chewable tablets
Greece: Calcioral D
Spain: Mastical D sabor limón 500mg/400 UI chewable tablets
Netherlands: Calci-Chew D 500 mg/400 IU, chewable tablets
Luxembourg: Steovit D citron 500 mg/400 IU
Norway: Calcigran Forte
Poland: Orocal D Lemon
Slovakia: Calcichew-D
Sweden: Calcichew-D Citron
Hungary: Calcichew-D 500 mg/400 NE chewable tablets

Date of last revision of the package leaflet: