OSTINE Chewable Tablets

Introduction

Package Leaflet: Information for the User

Ostine 500 mg/ 400 UI Chewable Tablets

Calcium Carbonate/Cholecalciferol

Read the entire package leaflet carefully before starting to take the medicine.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ostine and what is it used for
2. What you need to know before taking Ostine
3. How to take Ostine
4. Possible side effects

5 Storage of Ostine

1. Contents of the pack and further information

1. What is Ostine and what is it used for

Ostine is a fixed combination of calcium and vitamin D. The high concentration of calcium and vitamin D in each dose unit facilitates the absorption of a sufficient amount of calcium with a limited number of doses. This is why the product is useful as a vitamin and calcium supplement, associated with other treatments, for osteoporosis and as a correction of vitamin D and calcium deficiency in the elderly.

Ostine is indicated for:

• Correction of vitamin D and calcium deficiency, especially in elderly individuals.
• Vitamin D and calcium supplement associated with certain treatments for osteoporosis.

2. What you need to know before taking Ostine

Do not take Ostine

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• if you have abnormally high levels of calcium in the blood (hypercalcemia).
• if you have high levels of calcium in the urine (hypercalciuria).
• if you have any disease that increases calcium levels in the blood or urine, such as hyperthyroidism, myeloma, or bone metastases.
• if you have kidney stones (kidney lithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• if you have severe kidney problems (renal insufficiency).
• if you have taken too much vitamin D (hypervitaminosis D)

Warnings and precautions

Talk to your doctor or pharmacist before taking Ostine:

• if you have sarcoidosis, a disease whose most common symptoms are fatigue, increased size of the nodes, and inflammation of the lungs and other organs,
• if you have kidney disease (renal insufficiency).
• if you are already taking additional calcium doses (e.g., nutritional supplements or calcium-enriched foods) and are using carbonate-containing medications (e.g., anti-acids) at the same time, you should monitor your serum and urine calcium levels.
• if you have a long period of immobilization and if you have high calcium levels in the blood and/or urine. Your doctor will allow you to take this medicine when you start walking again.
• if you are undergoing long-term treatment, it is necessary to perform periodic blood and urine tests to monitor calcium levels. This monitoring is particularly important in elderly people and when treatment is being taken at the same time as cardiac glycosides (e.g., digoxin) or diuretics. Depending on the result, your doctor may decide to reduce or even interrupt your treatment.
• if you take other medicines or products that contain calcium and/or vitamin D. High levels of calcium and vitamin D can be harmful to your health.

In case of doubts, consult your doctor or pharmacist.

Children and adolescents

This medicine is not intended for use in children or adolescents under 18 years of age.

Other medicines and Ostine

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Ostine may interact (i.e., its effects may be altered) with the following medicines:

• Digoxin (a medicine used to treat heart problems), as it may cause more side effects,
• Bisphosphonates or medicines containing strontium (used in osteoporosis),
• Antibiotics (medicines used to treat bacterial infections): oral tetracycline, rifampicin, and some fluoroquinolones (ciprofloxacin and norfloxacin),
• Dolutegravir (a medicine used to treat HIV infection).
• Medicines or supplements that contain iron or zinc,
• Estramustine (a medicine used to treat certain types of prostate cancer),
• Thyroid hormones, used in cases of thyroid disease,
• Carbamazepine, phenytoin, phenobarbital, primidone: medicines used to treat epileptic seizures.
• Orlistat (a medicine used to treat obesity), as it may reduce the amount of vitamin D3 absorbed.
• Thiazide diuretics (medicines used to treat high blood pressure or edema), as they may increase the amount of calcium in the blood

You should wait 30 minutes or more between taking Ostine and bisphosphonates, and more than two hours between taking Ostine and the following medicines: medicines containing strontium, iron, or zinc, estramustine, thyroid hormones, some fluoroquinolones (ciprofloxacin, norfloxacin), and tetracyclines. It is also recommended to take Ostine at least 2 hours after or 6 hours before taking dolutegravir.

Taking Ostine with food, drinks, or alcohol

There may be interactions with food. You should take Ostine 2 hours before or after the following foods:

• oxalic acid (present in spinach or rhubarb, coconut, tea...),
• phosphates (pork, ham, sausages, processed cheese, dessert cream, cola drinks),
• phytic acid (present in whole grains, dried vegetables, oilseeds, chocolate...).

Pregnancy, breastfeeding, and fertility

The use of Ostine is not recommended during pregnancy and breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Ostine does not affect the ability to drive or use machines.

Ostine contains sorbitol

This medicine contains 475 mg of sorbitol in each chewable tablet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

3. How to take Ostine

Follow the administration instructions of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Only for adults.

Take one tablet twice a day.

The tablets can be dissolved in the mouth or chewed.

If you take more Ostine than you should

The following clinical signs may occur: loss of appetite, intense thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disorders, increased urine production, bone pain, kidney stones, and high blood pressure.

These symptoms may be part of the milk-alkali syndrome that can occur when, for example, large amounts of calcium and carbonate-containing medications (so-called anti-acids) are taken at the same time (see "Warnings and precautions" and "If you take more Ostine than you should").

In these cases, stop taking Ostine and consult your doctor immediately to take measures (who will perform the necessary procedures).

If you take too much Ostine for a long time, calcium deposits may appear in the blood vessels or body tissues.

In case of overdose or accidental ingestion, call the Toxicology Information Service. Phone 91 562 04 20.

If you forget to take Ostine

Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people):

• Increased calcium in the blood and urine.

Rare side effects (may affect up to 1 in 1,000 people):

• Gastrointestinal disorders such as constipation, flatulence, nausea, abdominal pain, diarrhea
• Skin disorders such as itching, rash, or irritation.

Side effects of unknown frequency (cannot be estimated from the available data):

• Hypersensitivity reactions such as angioedema and laryngeal edema (swelling of the face, tongue, lips, throat with difficulty breathing).
• Milk-alkali syndrome (renal failure due to excess calcium in the blood). There may be high blood pH (alkalosis) and renal insufficiency with high doses (see "Warnings and precautions" and "If you take more Ostine than you should").

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ostine

Store below 25°C.

Keep out of sight and reach of children.

Do not use Ostine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ostine

• The active substances are calcium and cholecalciferol (vitamin D3). Each tablet contains 1,250 mg of calcium carbonate (equivalent to 500 mg of calcium) and 400 UI of cholecalciferol (equivalent to 0.01 mg of vitamin D3).
• The other components are xylitol, sorbitol, povidone, lemon flavor, and magnesium stearate. (*lemon flavor composition: lemon essential oils, orange, litsea cubeba, maltodextrin, acacia gum, and sodium citrate).

Appearance of the product and pack contents

Cardboard box with 2 or 4 polypropylene tubes and a polyethylene cap. Each tube contains 15 chewable tablets.

30 and 60 chewable tablet formats are available.

Marketing authorization holder and manufacturer

Holder:

QUALIX PHARMA, S.L.

c/ Botánica 137-139

08908 L'Hospitalet de Llobregat

(Barcelona) Spain

Manufacturer:

Innothera Chouzy

Rue René Chantereau, Chouzy-Sur-Cisse.

41150 Valloire-Sur-Cisse (France)

Date of last revision of this package leaflet: April 2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)