Package leaflet: Information for the patient

OROTRE 500 mg + 400 IU tablets

calcium carbonate and colecalciferol
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What OROTRE is and what it is used for
What you need to know before taking OROTRE
How to take OROTRE
Possible side effects
How to store OROTRE
Contents of the pack and other information

1. What OROTRE is and what it is used for

OROTRE contains colecalciferol, better known as vitamin D, and calcium carbonate, substances important for bone formation.
OROTRE is indicated:

in elderly patients for the treatment of calcium and vitamin D deficiency.
in patients of all ages who are at risk of calcium and vitamin D deficiency, as an adjunctive treatment for bone fragility (osteopor游戏副本

2. What you need to know before taking OROTRE

Do not take OROTRE

If you are allergic to calcium carbonate, colecalciferol, or any of the other ingredients of this medicine (listed in section 6).
If you have increased levels of calcium in your blood or urine, especially if you have been immobilized for a prolonged period.
If you suffer from kidney stones (nephrolithiasis).
If you have a severe kidney disease (severe renal insufficiency).
If you have a condition characterized by excess vitamin D (hypervitaminosis D) in the body.

Warnings and precautions
Talk to your doctor or pharmacist before taking OROTRE.
In particular, inform your doctor, who may perform blood tests and/or monitor kidney function and may reduce the dose or discontinue treatment:

If you are elderly and are already being treated with medicines for heart conditions or high blood pressure (cardiac glycosides or diuretics), especially if you have a tendency to develop kidney stones (see section “Other medicines and OROTRE”);
If you have high levels of calcium in your blood;
If you have a kidney disease;
If you have sarcoidosis, an inflammatory disease that may affect the entire body and increases vitamin D levels in the body;
If you are a patient who is immobilized and suffer from osteoporosis. Also inform your doctor:
If you are taking medicines to treat heart disorders (digitalis and thiazide diuretics), bone disorders (bisphosphonates), antibiotics (tetracyclines), or a medicine used to prevent dental caries (sodium fluoride) (see section “Other medicines and OROTRE”);
If you are taking other products already containing vitamin D or calcium (see sections “Other medicines and OROTRE” and “OROTRE with food and drink”).

Other medicines and OROTRE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

Digitalis, a medicine used to treat heart rhythm disorders. Your doctor will monitor you closely and carry out appropriate tests;
Antibiotics such as tetracyclines and quinolones (medicines used to treat infections). If you are taking tetracyclines, take the antibiotic at least 2 hours before or 4–6 hours after OROTRE; if you are taking quinolones, take the antibiotic at least 2 hours before or 6 hours after OROTRE;
Bisphosphonates and strontium ranelate, medicines used to treat bone diseases, or sodium fluoride, a medicine used to prevent dental caries. Take the medicine at least 2 hours before OROTRE;
Corticosteroids, medicines used to treat inflammation, as they may reduce the effect of vitamin D;
Thiazide diuretics, medicines used to treat high blood pressure;
Medicines, supplements, foods, or drinks containing vitamin D (see section “OROTRE with food and drink”);
Iron and zinc. Take the medicine at least 2 hours before or after OROTRE;
Anticonvulsants (phenytoin) or barbiturates, medicines used to treat uncontrolled body movements or depression;
Levothyroxine, a medicine used to treat thyroid disorders. Administration of OROTRE and levothyroxine should be spaced by at least 4 hours.
Orlistat, a medicine used for weight reduction. This medicine may reduce the absorption of fat-soluble vitamins, such as vitamin D.

OROTRE with food and drink
Consider the total intake of calcium and/or vitamin D when consuming other products or foods fortified with calcium and/or vitamin D.
Use caution with foods containing oxalic acid (e.g., rhubarb, spinach, tea leaves, kiwi, beetroot), phosphates (e.g., milk, fish, meat, and eggs), or phytic acid (whole grains), due to possible interactions with OROTRE.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Take OROTRE during pregnancy only if prescribed by your doctor.

Breastfeeding
Take OROTRE during breastfeeding only if prescribed by your doctor.
Calcium, vitamin D, and its metabolites are excreted in breast milk.

Driving and using machines
OROTRE has no effect on the ability to drive vehicles or operate machinery.

OROTRE contains sucrose, isomalt, and sodium
This medicine contains sucrose, which may be harmful to teeth.
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially “sodium-free”.

3. How to take OROTRE

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet to be dissolved in the mouth, morning and evening. The tablets may
also be dissolved in a glass of water.
If you take more OROTRE than you should
If you accidentally ingest/overdose on OROTRE, contact your doctor immediately or go to the nearest hospital.
You may experience increased levels of calcium in the blood and urine, with symptoms including: intense thirst, nausea, vomiting, frequent need to urinate, constipation and dehydration.
Prolonged vitamin D overdose may lead to calcium deposits in blood vessels and tissues, as a consequence of increased calcium concentration in the blood.
If you are also taking milk-containing foods or antacid medicines, you may experience frequent and urgent need to urinate, chronic headache, chronic loss of appetite, nausea or vomiting, unusual tiredness or weakness, high calcium levels in the blood, low levels of acid in the blood, and kidney disease.
These are symptoms of “milk-alkali syndrome” (see section 4 “Possible side effects”):
Treatment
Stop treatment with OROTRE and drink plenty of fluids. Depending on your clinical condition and the medicines you are taking, your doctor may decide to modify or discontinue your current therapies and to perform clinical and laboratory checks.
If you forget to take OROTRE
Do not take a double dose to make up for the forgotten tablet.
If you stop treatment with OROTRE
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
The side effects reported with the use of OROTRE are listed below:
Uncommon (may affect up to 1 in 100 people):

high levels of calcium in the blood and urine (hypercalcemia and hypercalciuria).
Rare (may affect up to 1 in 1,000 people):
constipation, difficulty digesting (dyspepsia), passing gas from the intestine (flatulence), nausea, abdominal pain and diarrhoea.
Very rare (may affect up to 1 in 10,000 people):
milk-alkali syndrome (urgent and frequent need to urinate, chronic headache, chronic loss of appetite, nausea or vomiting, unusual tiredness or weakness, high levels of calcium in the blood, low levels of acid in the blood and kidney problems), generally observed only in cases of overdose (see section “If you take more OROTRE than you should”);
itching, skin rash and urticaria.
Not known (frequency cannot be estimated from the available data):
allergic reactions such as swelling of the face, lips and hands (angioedema) or swelling of the larynx (laryngeal edema).

Special populations
In patients with kidney problems, there may also be a potential risk of increased phosphate concentration in the blood, kidney stones and kidney calcification. See section “Warnings and Precautions”.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OROTRE

Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What OROTRE contains

The active substances are calcium carbonate 1250 mg (equivalent to 500 mg of calcium) and colecalciferol (vitamin D) 4 µg (equivalent to vitamin D 400 IU).
The other components are xylitol, povidone, isomaltose (see section “OROTRE contains isomaltose and sucrose”), lemon flavour, mono- and diglycerides of fatty acids, sucralose, magnesium stearate.
The components of the concentrated colecalciferol are: all-rac-alpha-tocopherol, sucrose (see section “OROTRE contains isomaltose and sucrose”), modified maize starch, sodium ascorbate, medium-chain triglycerides, anhydrous colloidal silica.

Description of the appearance of OROTRE and contents of the pack
OROTRE is presented as tablets contained in a bottle.
It is available in packs containing 1 bottle with 20 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH - Ziegelhof 24 - 17489 Greifswald, Germany
Manufacturer
Asker Contract Manufacturing AS, Drammensveien 852, NO-1383 Asker, Norway