Leaflet: information for the user

Ideos 500 mg/2,000 IU chewable tablets

calcium/colecalciferol (vitamin D3)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Ideos is a calcium and vitamin D supplement3.

It is used

• to treat calcium and vitamin D deficiency in adults.

Do not take Ideos

• if you are allergic to calcium, colecalciferol (vitamin D3) or any of the other components of this medication (listed in section 6).
• if you have high levels of calcium in your blood (hypercalcemia).
• if you have high levels of calcium in your urine (hypercalciuria).
• if you have overactive parathyroid glands (hyperparathyroidism).
• if you have bone cancer (myeloma).
• if you have cancer that has affected your bones (bone metastases).
• if you have prolonged immobility of your limbs (prolonged immobilization) accompanied by hypercalcemia and/or hypercalciuria.
• if you have kidney stones (nephrolithiasis).
• if you have calcium deposits in your kidneys (nephrocalcinosis).
• if you have excessive intake of vitamin D (hypervitaminosis D).
• if you have severe kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you are on long-term treatment,especiallyif you are also taking diuretics (used in the treatment of high blood pressure or edema) or cardiac glycosides (used to treat heart disorders).
• if you have kidney disease.
• if you have sarcoidosis (a disorder of the immune system that can increase vitamin D levels in the body).
• if you have osteoporosis and are unable to move.
• if you are taking other products that contain vitamin D. Additional doses of calcium and vitamin D.
• should be taken under close medical supervision.

Children and adolescents

This medication is not indicated for use in children and adolescents.

Other medications and Ideos

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

• Other medications that may influence or be influenced by this medication are:

• thiazide diuretics (used in the treatment of high blood pressure or edema)
• cardiac glycosides (used to treat heart disorders)
• HIV inhibitors (e.g., raltegravir, dolutegravir, elvitegravir).

• If you are also taking tetracyclines (a type of antibiotic), take them at least two hours before or four to six hours after taking this medication. Calcium carbonate can interfere with the absorption of tetracycline preparations if taken at the same time.
• Medications containing bisphosphonates (used to treat osteoporosis) should be taken at least three hours before taking this medication.
• Orlistat (used to treat obesity), cholestyramine (a product to reduce high cholesterol levels) or laxatives such as liquid paraffin may alter absorption and, therefore, reduce the effect of fat-soluble vitamins, e.g., vitamin D3.
• Phenytoin (a product for the treatment of epilepsy) or barbiturates (hypnotics) may cause a reduction in the effect of vitamin D.
• Glucocorticoids (e.g., cortisone) may cause a reduction in the effect of vitamin D and a decrease in calcium levels in the blood.
• Calcium may reduce the effect of levothyroxine (used to treat thyroid deficiency). For this reason, levothyroxine should be taken at least four hours before or four hours after this medication.
• The effect of quinolone antibiotics may be reduced if taken at the same time as calcium. Take quinolone antibiotics two hours before or six hours after taking this medication.
• 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 this medication.
• Additional supplementation of calcium and vitamin D should be administered only under medical supervision and will require frequent monitoring of calcium levels in blood and urine.

If you are taking any of the medications mentioned above, your doctor will give you further instructions.

Taking Ideos with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

This medication is not recommended for use during pregnancy in patients who do not have calcium and vitamin D deficiency. When there is a vitamin D deficiency, the recommended daily dose depends on national guidelines; however, the maximum daily dose should not exceed 2,500 mg of calcium and 4,000 IU of vitamin D per day.

Prolonged overdose of calcium and vitamin D during pregnancy should be avoided, as this can lead to high levels of calcium in the blood and may have a negative effect on the fetus.

This medication can be used during breastfeeding. Since calcium and vitamin D pass into breast milk, consult your doctor first if your child is receiving other products that contain vitamin D. This should be taken into account when administering additional vitamin D to the child.

Alternatively, the treatment can be changed to other medications that contain calcium and vitamin D3with lower concentrations of vitamin D3.

Driving and operating machinery

This medication has no effect on your ability to drive and use machines.

This medication contains

• 0.5 mg ofaspartame (E951), a source of phenylalanine. It may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.
• 38.5 mg of sorbitol (E420), 185 mg of isomaltose (E953) and 3.85 mg of sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication. It may harm your teeth.
• This medication contains less than 1 mmol of sodium (23 mg) perchewable tablet; this is, essentially “sodium-free”.
• This medication contains traces of benzyl alcohol. Benzyl alcohol may cause allergic reactions.

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

The recommended dose is 1 chewable tablet per day, corresponding to 500 mg of calcium and 2,000 IU (International Units) of vitamin D3. Your doctor will decide on the dosage individually.3

The tablet should be chewed before swallowing. It can be taken at any time, with or without food.

Be sure to pay attention to a daily sufficient intake of calcium through nutrition (i.e., dairy products, vegetables, mineral water).

Use in children and adolescents

This medicationis not intendedfor use in children and adolescents.

If you take more Ideos than you should

Overdosing on this medication may cause symptoms such as discomfort (nausea), vomiting, thirst or excessive thirst, increased urine production, dehydration, or constipation. If you suspect an overdose, contact your doctor or pharmacist immediately.

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 forget to take Ideos

If you forget to take this medication, take it as soon as you remember. However, do not take a double dose to compensate for the missed tablets.

If you interrupt treatment with Ideos

If you wish to interrupt or prematurely discontinue treatment, consult your doctor.

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 may experience them.

Stop taking Ideos and contact a doctor immediatelyif you experience the following allergic reaction (of unknown frequency because it cannot be estimated from the available data):

- Swelling of the face, lips, tongue, or throat with sudden difficulty breathing and skin rashserious.

The other reported adverse effects are:

Rarely:may affect up to 1 in 100 people

• elevated levels of calcium in the blood (hypercalcemia) or urine (hypercalciuria).

Very Rare:may affect up to 1 in 1,000 people

• uncomfort (nausea), diarrhea, abdominal pain, constipation, flatulence, swelling (abdominal distension).
• eruption, itching, urticaria.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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 box and on the laminated aluminum foil strips after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Keep the container perfectly closed to protect it from moisture.

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

Composition of Ideos

• The active principles are calcium and colecalciferol. Each chewable tablet contains 500 mg of calcium (as calcium carbonate) and 50 micrograms of colecalciferol (vitamin D3, equivalent to 2,000 UI) as colecalciferol concentrate (in the form of powder).
• The other components (excipients) are: isomaltose (E953), xylitol, sorbitol (E420), citric acid, sodium citrate monobasic, sodium saccharin, magnesium stearate, Orange “CPB” flavor, Orange “CVT” flavor, hydrated colloidal silica,aspartame, potassium acesulfame, sodium ascorbate, all-rac-alpha-tocopherol, modified cornstarch, sucrose, and medium-chain triglycerides, anhydrous colloidal silica, mannitol, benzyl alcohol, and propylene glycol.

Appearance of the product and contents of the package

The chewable tablets are round, white, 18 mm in diameter.

It is available in polypropylene tubes with a polyethylene cap that contains a desiccant or in laminated aluminum paper strips. Break the strip to open it.

Package sizes:

Tubes: 30, 60 (2x30) and 90 (3x30) chewable tablets.

Strips: 30 (5x6), 60 (10x6), 90 (15x6) chewable tablets.

Only some package sizes 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

HERMESPHARMAGmbH

Hans-Urmiler-Ring 52

82515Wolfratshausen

Germany

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization

Theramex Healthcare Spain, S.L.

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

28027 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Belgium:Calcium/Vitamin D3 Theramex 500 mg/2000 UI chewable tablets

Calcium/Vitamin D3 Theramex 500 mg/2000 IE chewable tablets

Calcium/Vitamin D3 Theramex 500 mg/2000 IE chewable tablets

Spain:Ideos 500 mg/2,000 UI chewable tablets

Portugal:Cacit 500 mg / 2000 UI chewable tablets

Sweden:Calcium/Cholecalciferol Theramex

Date of the last review of this prospectus:23 February 2024

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