Package Insert: Information for the Patient

Ideos 500 mg/400 IU Chewable Tablets

Calcium / Vitamin D3

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Ideos is a calcium and vitamin D supplement.

This medication is indicated for:

- Correcting combined calcium and vitamin D deficiency in elderly patients

- Associated with other treatments for osteoporosis, when there is combined deficiency of calcium and vitamin D or high risk of developing it

Do not take Ideos

• if you are allergic to the active ingredients (calcium carbonate or vitamin D) or to any of the other components of this medication (listed in section 6).
• if you are allergic to peanuts or soy.
• if you have a disease that increases calcium levels in the blood or urine, such as bone metastases, hyperthyroidism, or prolonged immobilization.
• if you have calcium stones or calcium deposits in the kidney.
• if you have taken excessive amounts of vitamin D.
• if you have severe kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ideos and especially if:

• you are on long-term treatment,especially if you are an elderly patient taking other heart medications, thiazide diuretics, or if you are prone to kidney stones.
• you have any kidney disease.
• you have a lung inflammatory disease called sarcoidosis.
• you have osteoporosis and are immobile.
• if you are prescribed calcium carbonate, you must control your intake of calcium and alkaline substances from other sources (foods, fortified foods, or other medications). When high doses of calcium are taken with alkaline substances such as carbonate, there is a risk of milk-alkali syndrome. When high doses of calcium carbonate are administered, calcium levels in serum must be monitored.

Children and adolescents

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

Taking Ideos with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• heart medications, including digoxin (a medication for treating heart failure) and other heart medications, as it may increase the risk of arrhythmias
• the absorption of medications for treating osteoporosis, such as bisphosphonates and other medications, such as sodium fluoride, may decrease if taken at the same time as Ideos. Ideos should be taken two hours after these medications.
• the absorption of some antibiotics (tetracyclines) may decrease if taken at the same time as Ideos.Ideos should be taken two hours after these medications.
• medications for treating high blood pressure and reducing the amount of fluid in the body, such as thiazide diuretics, as they may reduce the elimination of calcium by the kidneys.
• corticosteroids may decrease the effect of vitamin D.
• calcium salts may decrease the absorption of iron, zinc, and strontium ranelate. Therefore, iron, zinc, and strontium ranelate preparations should be taken at least two hours before or after calcium/vitamin D.
• if you are being treated with cholestyramine (a medication for reducing cholesterol) or laxatives, leave as much time as possible between taking these medications, as they may affect the absorption of vitamin D.
• phenytoin (epilepsy) or barbiturates (sedatives) may interfere with the absorption of vitamin D.
• calcium and/or vitamin D supplements should only be taken under medical supervision.
• calcium may reduce the effect of levothyroxine (used to treat hypothyroidism), and the doses should be separated by at least 4 hours.
• quinolone antibiotics should not be taken simultaneously with calcium, as their effect may be reduced. The antibiotic should be taken 2 hours before or 6 hours after calcium.

Taking Ideos with food, drinks, or alcohol

You can take the medication at any time, with or without food.

You should be aware that oxalic acid (present in spinach or rhubarb) and phytic acid (present in whole grains) may reduce the amount of calcium absorbed in the intestine. In the 2 hours before or after eating foods high in oxalic acid or phytic acid, patients should not take medications containing calcium.

Pregnancy and breastfeeding

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

You should only take this medication if you have a calcium or vitamin D deficiency and always under medical supervision. High doses of vitamin D and calcium can be harmful to the fetus.

Vitamin D passes into breast milk, so you should be cautious about the possible appearance of elevated calcium in the newborn.

Driving and operating machinery

There is not enough information available about the possible effects on the ability to drive or operate machinery. However, the influence seems unlikely.

Ideos contains sorbitol (E420)

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 an intolerance to certain sugars, 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.

Ideos contains sucrose.If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.This may cause tooth decay.

Ideos contains soy oil. Do not use in case of allergy to peanuts or soy. (see "Do not take Ideos").

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

Your doctor will inform you of the duration of treatment with Ideos. Do not discontinue treatment before.

This medication is for oral administration. The tablets can be dissolved in the mouth without the need for water or can be chewed.

The recommended dose is 1 chewable tablet twice a day.

If you take more Ideos than you should

In cases of overdose or accidental ingestion, inform your doctor or pharmacist immediately. Symptoms that may appear are nausea, vomiting, intense thirst, and constipation.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ideos

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.

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

-Increased calcium in the blood and urine.

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

- Gastrointestinal disorders such as constipation, flatulence, nausea, vomiting, 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 excess calcium in the blood).

In patients with renal insufficiency, there is a potential risk of hyperphosphatemia, nephrolithiasis, and nephrocalcinosis.

Reporting 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 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 about the safety of this medication.

Keep this medication out of the sight and reach of children.

Store below 25°C.

Do not use this medication after the expiration date that appears on the packaging after 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 unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Ideos

The active principles are calcium carbonate and colecalciferol (vitamin D).

Each tablet contains 1250 mg of calcium carbonate (corresponding to 500 mg of elemental calcium) and 400 IU of colecalciferol, equivalent to 4 mg of colecalciferol concentrate in powder form.

The other components (excipients) are: Xylitol, sorbitol (E420), povidone, lemon flavor (containing flavor preparations, natural flavorings, maltodextrin, acacia, sodium citrate, citric acid, butylated hydroxyanisole) and magnesium stearate.

Excipients of colecalciferol concentrate in powder form: all-rac-α-Tocopherol , hydrogenated soybean oil, gelatin, sucrose, anhydrous colloidal silica , cornstarch.

Appearance of the product and contents of the packaging

Each package of Ideos contains 30 or 60 chewable tablets. The tablets are square, white-gray in color.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Theramex Ireland Limited

Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Responsible for manufacturing

Innothera Chouzy

Rue René Chantereau.

Chouzy-sur-Cisse

41150

Valloire-sur-Cisse

France

Local Representative

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.

28027 Madrid

Spain

Last review date of this leaflet: July 2024

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