IDEOS UNIDIA 1000 mg/880 IU EFFERVESCENT GRANULES

Introduction

Package Leaflet: Information for the User

IDEOS UNIDIA 1000 mg/880 UI Effervescent Granule

Calcium Carbonate/Colecalciferol

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve.

Contents of the Package Leaflet

1. What is Ideos Unidia and what is it used for
2. What you need to know before taking Ideos Unidia
3. How to take Ideos Unidia
4. Possible side effects
5. Storage of Ideos Unidia
6. Package Contents and Additional Information

1. What is Ideos Unidia and what is it used for

Ideos Unidia contains the active ingredients calcium carbonate and colecalciferol (Vitamin D3).

This medication is used in elderly patients for the treatment of calcium and vitamin D deficiency. It is also used in combination with treatments for osteoporosis in patients with, or at high risk of, combined vitamin D and calcium deficiencies.

2. What you need to know before taking Ideos Unidia

Do not take Ideos Unidia:

• if you are allergic to the active ingredients or any of the other components of this medication (listed in section 6),
• if, as a result of a disease, you have a high concentration of calcium in your urine (hypercalciuria) or blood (hypercalcemia),
• if you have kidney stones
• if you have excessive levels of vitamin D in your blood (hypervitaminosis D)

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Ideos Unidia:

• if you have impaired renal function or tend to form kidney stones. Your treatment should be carefully monitored if your kidneys are not functioning properly to ensure that you do not accumulate too much calcium in your blood.
• if you have sarcoidosis (an inflammatory disease of unknown origin characterized by the formation of lumps in different areas).
• if you are an immobilized patient with osteoporosis.

If you are on long-term treatment, your doctor may occasionally want to check your blood calcium levels and take urine samples to monitor kidney function. Depending on the results, your doctor may reduce the dose or decide to interrupt treatment.

Children and Adolescents

Ideos Unidia is not indicated for use in children.

Taking Ideos Unidia with Other Medications

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

Consult your doctor if you are taking any of the following medications:

• heart medications such as digoxin or other cardiac glycosides,
• bisphosphonates or sodium fluoride (medications for treating bone disorders),
• thiazide diuretics,
• phenytoin or barbiturates (medications used in the treatment of epilepsy),
• glucocorticosteroids,
• tetracycline antibiotics,
• other medications that contain vitamin D or calcium.

Calcium salts may decrease the absorption of iron, zinc, and strontium ranelate. Consequently, iron, zinc, or strontium ranelate preparations should be taken at least two hours before or after Ideos Unidia.

Taking Ideos Unidia with Food, Drinks, and Alcohol

This medication may interact with certain foods that contain oxalic acid (e.g., spinach and rhubarb), phosphates (e.g., bran), or phytic acid (e.g., whole grains), as these may reduce the absorption of calcium contained in Ideos Unidia.

Pregnancy, Breastfeeding, and Fertility

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

Due to the high dose of Vitamin D, this medication is not indicated during pregnancy and breastfeeding. In pregnant women, calcium and vitamin D overdoses should be avoided, as permanent hypercalcemia is related to adverse effects on fetal development.

Ideos Unidia may be used during breastfeeding, but your doctor should be informed. This should be considered when administering additional vitamin D to the child.

Driving and Using Machines

Ideos Unidia is not expected to affect your ability to drive or operate machines.

Ideos Unidia Contains Potassium, Sodium, Sorbitol, and Sucrose

• This medication contains 4.2 mmol of potassium (163 mg) per sachet, which should be taken into account in the treatment of patients with renal insufficiency or those on low-potassium diets.
• This medication contains less than 1 mmol of sodium (23 mg) per sachet, making it essentially "sodium-free".
• This medication contains 1.1 mg of sorbitol per sachet.
• If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may produce cavities.

3. How to Take Ideos Unidia

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Adults

Pour the contents of the sachet into a glass, add plenty of water, stir, and drink the resulting solution immediately when the effervescence has stopped. The recommended dose is one sachet per day. Your doctor or pharmacist will indicate how many sachets you need to take per day.

If You Take More Ideos Unidia Than You Should

When taking an excessive dose of this medication, the following symptoms may appear: nausea, vomiting, intense thirst, frequent urination, and constipation. Inform your doctor immediately if any of these effects occur and take the necessary measures.

In the case of prolonged overdose, calcifications may appear in vessels or tissues.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562 04 20.

If You Forget to Take Ideos Unidia

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

You may experience an allergic reaction. If you experience a rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue, stop taking the medication immediately and seek urgent medical attention.

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

• high calcium levels in the blood (hypercalcemia). Symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, extreme thirst, frequent urination, muscle weakness, drowsiness, and confusion
• increased calcium content in the urine (hypercalciuria)

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

• constipation, flatulence, nausea, abdominal pain, diarrhea
• itching, rash, and hives

Not Known (cannot be estimated from available data)

• milk-alkali syndrome associated with high calcium levels in the blood (hypercalcemia), elevated blood pH (alkalosis), and kidney failure.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ideos Unidia

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ideos Unidia

The active ingredients in an 8g sachet are:

Calcium Carbonate 2500 mg

equivalent to calcium element 1000 mg or 25 mmol

Colecalciferol Concentrate (powder) 880 UI

equivalent to colecalciferol (Vitamin D3) 22 µg

The other ingredients are citric acid, malic acid, gluconolactone, maltodextrin, sodium cyclamate, sodium saccharin, lemon flavor (containing sorbitol), rice starch, potassium carbonate, sodium ascorbate, all-rac-alpha-tocopherol, modified starch, sucrose, medium-chain triglycerides, and anhydrous colloidal silica.

Appearance of the Product and Package Contents

Sachets of 8g (paper/aluminum/polyethylene); boxes of 20, 30, 46, 50, or 100 sachets, sample box of 10 sachets, and multi-packs containing 90 (3 boxes of 30) sachets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturer:

Hermes Pharma Ges.m.b.H.

Schwimmschulweg 1a

9400 Wolfsberg, Austria

or

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Local Representative:

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, 2nd floor left.

28027 Madrid

Spain

Date of Last Revision of this Package Leaflet: October 2022

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