Leaflet: information for the user

IDEOS UNIDIA 1000 mg/880 UI effervescent granule

Calcium carbonate/vitamin D3

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• For advice on any matter relating to this medicine or for information about any aspect of its use, consult your pharmacist.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. See section 4.
• You must see a doctor if you get worse or do not improve.

1. What isIdeos Unidiaand what it is used for

2. What you need to know before you start takingIdeos Unidia

3. How to takeIdeos Unidia

4. Possible side effects

5. Storage ofIdeos Unidia

6. Contents of the pack and additional information

Ideos Unidia contains the active principles 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 deficiencies of vitamin D and calcium.

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 you have a high concentration of calcium in your urine (hypercalciuria) or blood (hypercalcemia) due to any disease,
• 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 kidney impairment or a tendency to form kidney stones. Your treatment should be carefully controlled if your kidneys do not function 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 nodules in different locations).
• if you are a bedridden patient with osteoporosis.

If you are on long-term treatment, your doctor may, from time to time, want to control the level of calcium in your blood and take urine samples to control kidney function. Depending on the results, your doctor may reduce the dose or decide to discontinue 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 taken recently, or may need to take any other medication.

Consult your doctor if you take any of the following medications:

• heart medications such as digoxin or other cardiac glycosides,
• bisphosphonates or sodium fluoride (medications used to treat bone disorders),
• thiazide diuretics,
• phenytoin or barbiturates (medications used in the treatment of epilepsy),
• glucocorticosteroids,
• tetracycline antibiotics,
• other medications containing 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 containing 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, excessive calcium and vitamin D intake should be avoided as permanent hypercalcemia is associated with 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 operating machinery

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

Ideos Unidia contains potassium, sodium, sorbitol, and saccharose

• This medication contains 4.2 mmol of potassium (163 mg) per tablet, which should be taken into account in the treatment of patients with renal insufficiency or low-potassium diets.
• This medication contains less than 1 mmol of sodium (23 mg) per tablet, making it essentially "sodium-free".
• This medication contains 1.1 mg of sorbitol per tablet.
• If your doctor has indicated that you are intolerant to certain sugars, consult with them before taking this medication. It may cause tooth decay.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

Adults

Pour the contents of the sachet into a glass, add a large amount 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 tell you 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 need to urinate, and constipation. Inform your doctor immediately if any of these effects occur and take necessary measures.

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

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

If you forgot to take Ideos Unidia

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, pharmacist, or nurse.

Like all medications,this medicationmay cause adverse effects, although not everyone will experience them.

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

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

• High blood calcium levels (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 urine (hypercalciuria)

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

• Constipation, flatulence, nausea, abdominal pain, diarrhea
• Itching, rash, and urticaria

Unknown (cannot be estimated from available data)

• Milk-alkali syndrome associated with high blood calcium levels (hypercalcemia), elevated blood pH (alkalosis), and kidney insufficiency.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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.

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.

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ideos Unidia

The active principles in an 8 g sachet are:

Calcium carbonate2500 mg

Equivalent to elemental calcium1000 mg or 25 mmol

Colecalciferol concentrate (in powder)880 UI

Equivalent to colecalciferol (vitamin D3)22 µg

The other components are citric acid, malic acid, gluconolactone, maltodextrin, sodium cyclamate, sodium saccharin, lemon aroma (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 contents of the packaging

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Responsible for manufacturing:

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, planta 2ª izquierda.

28027 Madrid

Spain

Last review date of this leaflet: October 2022

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