Ostine chewable tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ostine 500 mg/400 IU chewable tablets

calcium carbonate/colecalciferol

Read all of this leaflet carefully before you start taking this medicine.

• 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 and must not be given to other people, even if they have the same symptoms as yours, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Ostine is and what it is used for

2. What you need to know before taking Ostine

3. How to take Ostine

4. Possible side effects

5. How to store Ostine

6. Contents of the pack and other information

1. What Ostine is and what it is used for

Ostine is a fixed combination of calcium and vitamin D. The high concentration of calcium and vitamin D in each dosage unit facilitates the absorption of a sufficient amount of calcium with a limited number of doses. Therefore, the product is useful as a vitamin and calcium supplement, in combination with other treatments, for osteoporosis, and as 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 supplementation associated with certain osteoporosis treatments.

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 calcium levels in your blood (hypercalcemia).
• if you have high excretion of calcium in the urine (hypercalciuria).
• if you have a disease that increases calcium levels in blood or urine, such as hyperthyroidism, myeloma, or bone metastases.
• if you have kidney stones (calcific lithiasis) or calcium deposits in the kidney (nephrocalcinosis).
• if you have severe kidney problems (renal failure).
• if you have taken excessive vitamin D (hypervitaminosis D).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ostine:

• if you have sarcoidosis, a disease whose most common symptoms are fatigue, enlarged lymph nodes, and inflammation of the lungs and other organs,
• if you have kidney disease (renal failure).
• if you are already taking additional calcium (e.g., nutritional supplements or calcium-fortified foods) and are using medications containing carbonate (e.g., so-called antacids) at the same time, serum and urinary calcium levels should be monitored.
• if you are undergoing prolonged immobilization and have high calcium concentration in blood and/or urine. Your doctor will allow you to take this medicine once you resume walking.
• if you are on long-term treatment, periodic blood and urine tests are necessary to monitor calcium levels. This monitoring is particularly important in elderly patients and when treatment is taken concomitantly with 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 medicines or products containing calcium and/or vitamin D. Elevated levels of calcium and vitamin D may be harmful to health.

If in doubt, consult your doctor or pharmacist.

Children and adolescents

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

Other medicines and Ostine

Inform your doctor or pharmacist if you are using or have recently used any 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 adverse 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 containing iron or zinc,
• Estramustine (a medicine used to treat certain types of prostate cancer),
• Thyroid hormones, used in thyroid disease,
• Carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone: medicines used to treat epileptic seizures,
• Orlistat (a medicine used to treat obesity), as it may reduce the amount of vitamin D3 you absorb,
• Thiazide diuretics (medicines used to treat high blood pressure or edema), as they may increase blood calcium levels.

You should wait 30 minutes or more between taking Ostine and bisphosphonates, and more than two hours between taking Ostine and the following medicines: those containing strontium, iron, or zinc, estramustine, thyroid hormones, certain 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

Interactions with food may occur. You should take Ostine 2 hours before or after consuming the following foods:

• oxalic acid (found in spinach or rhubarb, coconut, tea, etc.),
• phosphates (pork meat, ham, sausages, processed cheese, dessert creams, cola drinks),
• phytic acid (found in whole grains, dried legumes, oilseeds, chocolate, etc.).

Pregnancy, breastfeeding, and fertility

The use of Ostine is not recommended during pregnancy or 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 operate machinery.

Ostine contains sorbitol

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

This medicine contains sucrose (sucrose is present in small amounts in the colecalciferol concentrate). If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.

This medicine contains hydrogenated soya oil. It must not be used if you are allergic to peanuts or soya.

3. How to take Ostine

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist.

For adults only.

Take one tablet twice daily.

The tablets may be dissolved in the mouth or may be 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 disturbances, increased urine production, bone pain, kidney stones, and high blood pressure.

These symptoms may be part of the milk-alkali syndrome, which may occur, for example, when large amounts of calcium- and carbonate-containing medicines (so-called antacids) are taken simultaneously (see "Warnings and precautions").

In such cases, stop taking Ostine and contact your doctor immediately so that appropriate measures can be taken (the doctor will carry out the necessary procedures).

If you take too much Ostine for a prolonged period, calcium deposits may develop in blood vessels or body tissues.

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

If you forget to take Ostine

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• Increased calcium in blood and urine.

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

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

Adverse effects with unknown frequency (cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ostine

Store below 25°C.

Keep out of the sight and reach of children.

Do not use Ostine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ostine

• The active substances are calcium and colecalciferol (vitamin D3). Each tablet contains 1,250 mg of calcium carbonate (equivalent to 500 mg of calcium) and 4 mg of colecalciferol concentrate (equivalent to 400 IU of colecalciferol (equivalent to 0.01 mg of vitamin D3).
• The other components are xylitol, sorbitol, povidone, lemon flavour* and magnesium stearate. (* Composition of the lemon flavouring: essential oils, maltodextrin, acacia gum, sodium citrate, citric acid and butylhydroxyanisole). Excipients of the powdered colecalciferol concentrate: alpha-tocopherol, hydrogenated soybean oil, gelatin, sucrose, silicon dioxide and corn starch.

Appearance of the product and pack contents

Cardboard box containing 2 or 4 polypropylene tubes with polyethylene caps. Each tube contains 15 tablets.

Chewable tablet presentations of 30 and 60 tablets are marketed.

Marketing Authorization Holder and Manufacturer

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)

Date of the most recent revision of this leaflet: April 2022

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