Leaflet: information for the user

Ostine 500 mg/ 400 IU chewable tablets

calcium carbonate/vitamin D3

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Ostine is and what it is used for

2.What you need to know before you start taking Ostine

3.How to take Ostine

4.Possible side effects

5Storage of Ostine

6.Contents of the pack and additional information

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.isuseful as

Ostineis indicated for:

• Correction of vitamin D and calcium deficiency, especially in the elderly.
• Calcium and vitamin D supplement associated with certain osteoporosis treatments.

Do not take Ostine

• if you are allergicto the active ingredients or to any of the othercomponents of this medication(listed in section 6).
• if you haveabnormally high levels of calcium in your blood (hypercalcemia).
• if you havea high excretion of calcium in your urine (hypercalciuria).
• if you haveany disease that increases the levels of calcium in your blood or urine, such as hyperthyroidism, multiple myeloma, or bone metastases.
• if you havekidney stones (calcium stones) or calcium deposits in your kidneys (nephrocalcinosis).
• if you havesevere kidney problems (renal insufficiency).
• if you have taken too much vitamin D (vitamin D hypervitaminosis)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ostine:

• if you havesarcoidosis, a disease whose most common symptoms are fatigue, enlargement of lymph nodes, and inflammation of the lungs and other organs,
• if you havekidney disease (renal insufficiency).
• if you are already taking additional doses of calcium (for example, nutritional supplements or calcium-enriched foods) and are using medications that contain carbonate (for example, antacids) at the same time, the calcium content in your serum and urine should be monitored.
• if you have a long period of immobilization and if you have high levels of calcium in your blood and/or urine. Your doctor will allow you to take this medication when you start walking again.
• if you are on long-term treatment, periodic blood and urine tests are necessary to monitor calcium levels. This monitoring is particularly important in older people and when the treatment is taken at the same time as cardiac glycosides (e.g., digoxin) or diuretics. Depending on the results, your doctor may decide to reduce or even discontinue your treatment.
• if you are taking other medications or other products that contain calcium and/or vitamin D. High levels of calcium and vitamin D can be harmful to your health.

Consult your doctor or pharmacist if you are unsure.

Children and adolescents

Ostine is not indicated for use in children or adolescents under 18 years of age.

Other medications and Ostine

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

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

• digoxin (a medication used to treat heart problems), as it may cause more side effects,
• bisphosphonates or medications containing strontium (used in osteoporosis),
• antibiotics (medications used to treat bacterial infections): oral tetracycline, rifampicin, and some fluoroquinolones (ciprofloxacin and norfloxacin),
• dolutegravir (a medication used to treat HIV infection).
• medications or supplements containing iron or zinc,
• estramustine (a medication used to treat certain types of prostate cancer),
• thyroid hormones, used in cases of thyroid disease,
• carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone: medications used to treat epilepsy.
• orlistat (a medication used to treat obesity), as it may reduce the amount of vitamin D3 absorbed.
• thiazide diuretics (medications 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 medications: medications 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, 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

Ostine is not recommended for use during pregnancy and breastfeeding.

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

Driving and operating machinery

Ostine does not affectyour abilityto drive or operate machinery.

Ostine contains sorbitol

This medication contains 475 mg of sorbitol in each chewable tablet. Sorbitol is a source of fructose. If your doctor has told you that you have a certain sugar intolerance, or if 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 medication.

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

Only for adults.

Take one tablet twice a day.

Tablets can be dissolved in the mouth or chewed.

If you take more Ostine than you should

You may experience the following clinical signs: loss of appetite, intense thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, 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 medications containing calcium and carbonate (so-called antacids) are taken at the same time (see “Warnings and precautions”).

Stop taking Ostine and consult your doctor immediately to take measures (who will perform the necessary procedures).

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

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

If you forgot to take Ostine

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects that are infrequent (may affect up to 1 in 100 people):

• Increased calcium in the blood and urine.

Adverse effects that are rare (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.

Adverse effects of unknown frequency (cannot be estimated from 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 excessive calcium in the blood). May be accompanied by elevated blood pH (alkalosis) and renal insufficiency with high doses (see “Warnings and precautions” and “If you take more Ostine than you should”).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Store below 25°C.

Keep out of sight and reach of children.

Do not use Ostineafter the expiration datethat appearson the packagingafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Ostine Composition

• The active principles are calcium and colecalciferol (vitamin D3). Each tablet contains 1,250 mg of calcium carbonate (equivalent to 500 mg of calcium)and 400 IU of colecalciferol (equivalent to 0.01 mg of vitamin D3).
• The other components are xylitol, sorbitol, polyvinylpyrrolidone, lemon flavoring* and magnesium stearate. (* lemon flavoring composition: lemon essential oils, orange, litsea cubeba, maltodextrin, gum arabic and sodium citrate).

Product appearance and packaging contents

Carton box with 2 or 4 polypropylene tubes and polyethylene stopper. Each tube contains 15 tablets.

It is marketed in formats of 30 and 60 chewable tablets.

Marketing authorization holder and manufacturer responsible

Marketing authorization 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)

Last review date of this leaflet: April 2022

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)