Orocal d3 lemon

Package leaflet: Information for the user

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

Contents of the leaflet

1. What Orocal D Lemon is and what it is used for
2. What you need to know before taking Orocal D Lemon
3. How to take Orocal D Lemon
4. Possible side effects
5. How to store Orocal D Lemon
6. Contents of the pack and other information

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

Orocal D Lemon is a chewable tablet with a lemon flavour, containing calcium and vitamin D, which are essential components in the process of bone formation.
Orocal D Lemon is used for the prevention and treatment of calcium and vitamin D deficiency in adults diagnosed with a risk of calcium and vitamin D deficiency, and as an adjunct to specific osteoporosis treatment.

2. Important information before using Orocal D Lemon

When not to use 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 excess vitamin D in the blood.

Warnings and precautions
Before starting to take Orocal D Lemon, discuss this 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 impaired kidney function or a tendency to develop kidney stones;
• if the patient has sarcoidosis (an immune system disorder which may increase vitamin D levels in the body);
• if the patient has osteoporosis and is also immobilised;
• if the patient is taking other products containing vitamin D. Additional doses of calcium and vitamin D should be taken under strict medical supervision.

Children
Orocal D Lemon should not be used in children.
Orocal D Lemon and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans 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 tetracycline antibiotics taken at the same time.
If bisphosphonates are used concurrently, 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 simultaneously with 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 action of Orocal D Lemon or whose action may be affected by Orocal D Lemon 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 above-mentioned medicines, they should discuss this with their doctor.
Orocal D Lemon with food and drink
Orocal D Lemon may 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 Lemon may be used during pregnancy in cases 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 Lemon may be used during breastfeeding. Calcium and vitamin D pass into breast milk. This should be taken into account if vitamin D is also being given to the infant.
Driving and operating machinery
Orocal D Lemon has no effect on the ability to drive or operate machinery.
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 certain sugars, the patient should contact their doctor before taking this medicine.
Orocal D Lemon is practically sodium-free
Orocal D Lemon contains less than 23 mg of sodium per tablet, meaning it is practically sodium-free.
3. How to take Orocal D Lemon
This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage:
The recommended dose is 1 tablet twice daily. Tablets may be chewed or sucked.
Use in children
Orocal D Lemon is not intended for use in children.
Taking more than the recommended dose of Orocal D Lemon
If more than the recommended dose is taken, contact your doctor or pharmacist immediately.
Missing a dose of Orocal D Lemon
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 will experience them.
Hypersensitivity reactions have been reported with unknown frequency (cannot be estimated from available data). You should contact a doctor immediately if the patient experiences 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, indigestion, bloating, 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, with symptoms including frequent urge to urinate, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, increased calcium levels in blood serum, and kidney failure.

If the patient has impaired kidney function, they may be at risk of increased phosphate levels in the blood, kidney stone formation, and increased calcium concentration 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 Drug Reactions, 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 provide more information on the safety of this medicine.

5. How to store Orocal D Lemon

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. The expiry date refers to the last day of the specified month.
Do not store above 30°C. Store in the original packaging to protect from light. Keep the container tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the package and other information

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

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

The other ingredients are:
Xylitol (E 967), povidone, isomaltose (E 953), flavour (lemon), magnesium stearate, sucralose (E 955), 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 Lemon looks like and contents of the pack
Orocal D Lemon is a white, round chewable tablet. The tablets may have small specks.

Pack sizes:
HDPE plastic bottle with screw cap: 30, 50, 60, 90, 100, 120 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 medicine, 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

Cheplapharm Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany

This medicinal product is authorised for marketing in the European Economic Area (EEA) under the following names:
Austria: Cal-D-Or
Belgium: Steovit D citroen 500 mg/400 I.E.
Czech Republic: CALCICHEW D3 400 IU žvýkací tablety
Denmark: Calcichew-D3 Forte
Finland: Calcichew D Forte sitruuna 500 mg/400 IU – purutabletti
Greece: Calcioral D
Spain: Mastical D sabor limón 500mg/400 UI comprimidos masticables
Netherlands: Calci-Chew D 500 mg/400 I.E., kauwtabletten
Luxembourg: Steovit D citron 500 mg/400 I.E
Norway: Calcigran Forte
Poland: Orocal D Lemon
Slovakia: Calcichew-D
Sweden: Calcichew-D Citron
Hungary: Calcichew-D 500 mg/400 NE rágótabletta