Ideos 500 mg/400 IU chewable tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ideos 500 mg/400 IU chewable tablets

Calcium / Vitamin D3

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ideos is and what it is used for
2. What you need to know before taking Ideos
3. How to take Ideos
4. Possible side effects
5. How to store Ideos
6. Contents of the pack and other information

1. What Ideos is and what it is used for

Ideos is a calcium and vitamin D supplement.

This medicine is indicated for:

• Correcting combined calcium and vitamin D deficiency in elderly patients
• Use in combination with other osteoporosis treatments, when there is combined deficiency of calcium and vitamin D or a high risk of developing osteoporosis

2. What you need to know before taking 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 soya.
• if you have a medical condition that increases calcium levels in blood or urine, such as bone metastases, hyperthyroidism, or prolonged immobilization.
• if you have calcium kidney stones or calcium deposits in the kidneys.
• 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, especially if:

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

Children and adolescents

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

Taking Ideos with other medicines

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

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

• Medicines for the heart, including digoxin (a medicine used to treat heart failure) and other heart medications, as it may increase the risk of arrhythmias.
• The absorption of medicines used to treat osteoporosis such as bisphosphonates and other medicines such as fluoride (sodium fluoride) may be reduced if taken at the same time as Ideos. Ideos should be taken two hours after these medicines.
• The absorption of certain antibiotics (tetracyclines) may be reduced if taken at the same time as Ideos. Ideos should be taken two hours after these medicines.
• Medicines used to treat high blood pressure and to reduce fluid retention, such as thiazide diuretics, as they may reduce the urinary excretion of calcium.
• Corticosteroids may reduce the effect of vitamin D.
• Calcium salts may reduce 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 cholestyramine (a medicine to lower cholesterol) or laxatives, the longest possible interval should be maintained between taking these medicines, as they may affect the absorption of vitamin D.
• Phenytoin (for 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); doses should be separated by at least 4 hours.
• Quinolone antibiotics should not be taken simultaneously with calcium, as their effect may be reduced. Take the antibiotic 2 hours before or 6 hours after calcium.

Taking Ideos with food, drinks or alcohol

You may take this medicine at any time, with or without food.

Please note 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. Patients should not take calcium-containing medicines within 2 hours before or after consuming foods high in oxalic acid or phytic acid.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using 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 may be harmful to the fetus.

Vitamin D is excreted in breast milk, so caution should be exercised due to the potential risk of elevated calcium levels in the newborn.

Driving and use of machines

There is insufficient information regarding possible effects on the ability to drive or operate machinery. However, any influence is considered 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 certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients 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 certain sugars, consult them before taking this medicine. It may cause dental caries.

Ideos contains soybean oil. It must not be used if you are allergic to peanuts or soy (see section "Do not take Ideos").

3. How to take Ideos

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine the duration of treatment with Ideos. Do not stop the treatment early.

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

The recommended dose is 1 chewable tablet twice daily.

If you take more Ideos than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ideos

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 may produce adverse effects, although not everyone will experience them.

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

• Increased calcium levels in 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 the available data):

• Hypersensitivity reactions such as angioedema and laryngeal edema (swelling of the face, tongue, lips, throat with difficulty breathing).
• Milk-alkali syndrome (kidney 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 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 Medicines: https://www.notificaram.es. By reporting adverse 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 25ºC.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly discard containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ideos

The active substances are calcium carbonate and colecalciferol (vitamina 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 flavour (containing flavouring preparations, natural flavouring substances, maltodextrin, acacia, sodium citrate, citric acid, butylated hydroxyanisole) and magnesium stearate.

Excipients of the colecalciferol concentrate in powder form: all-rac-α-tocoferol, 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-shaped, white to grey in colour.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Theramex Ireland Limited
Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland

Manufacturing Responsible Party

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 the most recent review of this leaflet: July 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/