IDEOS 500 mg/400 IU CHEWABLE TABLETS

2. What you need to know before you take Ideos

Do not take Ideos

• if you are allergic to the active substances (calcium carbonate or vitamin D) or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to peanuts or soy.
• if you have any 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 too much vitamin D.
• if you have severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ideos, especially if:

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

Children and adolescents

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

Taking Ideos with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• Heart medications, including digoxin (a medication for heart failure) and other heart medications, as it may increase the risk of arrhythmias
• The absorption of osteoporosis medications such as bisphosphonates and other medications like 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 high blood pressure and to reduce fluid in the body, such as thiazide diuretics, as they may reduce calcium elimination in the urine.
• 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/colecalciferol.
• If you are being treated with colestyramine (a medication to reduce cholesterol) or laxatives, you should leave as much time as possible between taking these medications, as it may affect the absorption of vitamin D
• Phenytoin (for epilepsy) or barbiturates (sedatives) may interfere with vitamin D absorption.
• 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 doses should be separated by at least 4 hours.
• Quinolone antibiotics should not be taken at the same time as calcium, as it may reduce their effect. Take the antibiotic 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 (found in spinach or rhubarb) and phytic acid (found 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should only take this medicine 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 caution is advised due to the possible appearance of high calcium levels in the newborn.

Driving and Using Machines

There is not enough information available on the possible effects on the ability to drive or use machines. However, the influence appears to be unlikely.

Ideos contains Sorbitol (E420)

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 some sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Ideos contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine. It may cause tooth decay.

Ideos contains soybean oil. Do not use if you are allergic to peanuts or soy. (See "Do not take Ideos").

3. How to take Ideos

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Your doctor will tell you how long to take Ideos. Do not stop treatment before.

This medicine is for oral use. The tablets can be dissolved in the mouth without water or can be chewed.

The recommended dose is 1 chewable tablet twice a day.

If you take more Ideos than you should

In case of overdose or accidental ingestion, inform your doctor or pharmacist immediately. The 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ideos

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

If you have any further questions on 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 blood and urine.

Rare side 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.

Frequency not known (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).

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

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 side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ideos

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

Store below 25°C.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Ideos

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

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

The other ingredients (excipients) are: Xylitol, sorbitol (E420), povidone, lemon flavor (containing flavoring preparations, natural flavoring substances, 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, corn starch.

Appearance of the product and contents of the pack

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Theramex Ireland Limited

Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturer

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

Date of last revision of this package leaflet: July 2024

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