Prospect: information for the user

Ideos Forte 500 mg/1,000 IU chewable tablets

calcium/colecalciferol (vitamin D3)

Read this prospect carefully before starting to take this medication, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is IdeosForteand what is it used for

2.What you need to know before starting to take IdeosForte

3.How to take IdeosForte

4.Adverse effects

5.Storage of IdeosForte

6.Contents of the package and additional information

IdeosForte is a calcium and vitamin D3supplement.

It is used

- to prevent and treat combined calcium and vitamin D deficiency in the elderly.

- to provide vitamin D and calcium as a complementary therapy for osteoporosis (fragile bones), as a complement to specific osteoporosis treatment in adult patients at risk of vitamin D and calcium deficiency.

Treatment is only recommended if sufficient calcium and vitamin D intake cannot be achieved through nutrition and sunlight.

Do not take Ideos Forte

-if you are allergic to calcium, 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 a condition or disease that causes high levels of calcium in your blood (hypercalcemia) and/or high levels of calcium in your urine (hypercalciuria), such as hyperparathyroidism, multiple myeloma, bone metastases

bone cancer

-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 vitamin D (hypervitaminosis D)

-if you have severe kidney problems with consequent severe and progressive hyperparathyroidism, your doctor will consider other forms of vitamin D that may be more suitable for you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ideos Forte

-During prolonged treatment, your calcium levels in blood and urine and renal function should be monitored periodically. This is especially important if you are prone to developing kidney stones. Depending on your blood levels, your doctor may reduce the dose or discontinue treatment.

-if you are receiving concurrent treatment with cardiac glycosides or thiazide diuretics (medications that increase urine excretion) for heart problems, your calcium levels in blood and urine and renal function should be monitored periodically. Depending on your blood levels, your doctor may reduce the dose or discontinue treatment.

-if you have a parathyroid hormone imbalance (pseudohypoparathyroidism)

-if you have kidney problems, you should only take Ideos Forte under medical supervision to reduce the risk of soft tissue calcification. Your calcium levels in blood and urine should be monitored. If you have severe kidney problems with severe and progressive hyperparathyroidism, use other forms of vitamin D that are not colecalciferol, such as calcitriol and vitamin D analogs.

-the taking of additional calcium and vitamin D supplements requires medical supervision and your doctor will require frequent monitoring of calcium levels in blood and urine.

-be especially careful when taking Ideos Forte if you have sarcoidosis (an immunological disorder that can affect the liver, lungs, skin, or lymph nodes). There is a risk that the effect of this medication will become too strong, leading to a calcium overdose in the body. Your calcium levels in blood and urine should be monitored.

-in cases of immobilization and osteoporosis, this medication should be used with special care, as it may increase calcium levels in the blood.

-before taking Ideos Forte, consider the amount of calcium and alkaline, such as carbonates, already ingested from other sources (food, dietary supplements, and other medications). If you take Ideos Forte simultaneously with calcium-rich products containing carbonates, this may lead to milk-alkali syndrome (Burnett syndrome). Milk-alkali syndrome is a metabolic disorder of calcium with an increase in blood calcium levels. Therefore, an additional intake of Ideos Forte requires strict medical supervision with frequent monitoring of calcium levels in blood and urine.

Children and adolescents

Ideos Forte is not indicated for use in children or adolescents.

Taking Ideos Forte with other medications

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

-in case of concurrent treatment with digitalis glycosides (cardiac glycosides derived from the digitalis plant), arrhythmias may occur. Therefore, strict medical monitoring, including an ECG and determination of calcium levels in blood, is necessary.

-in case of simultaneous administration of thiazide diuretics (also known as medications that increase urine excretion), your calcium levels in blood should be monitored periodically, as thiazides reduce calcium excretion in urine.

-in addition, other medications such as sodium fluoride (used to strengthen tooth enamel or treat osteoporosis) and bisphosphonates (used to treat osteoporosis) are affected by interactions. Therefore, these medications should be taken at least 3 hours before Ideos Forte. Check the prospectus of the bisphosphonate you are taking to ensure you leave enough time before taking Ideos Forte.

-ideally, do not take Ideos Forte with products containing phosphate, as they may reduce the amount of phosphate absorbed.

-ideally, leave the widest possible interval between the administration of orlistat (used to treat obesity) or ion exchange resins such as colestiramine (a medication to reduce high cholesterol levels) or laxatives such as liquid paraffin and Ideos Forte, as otherwise, vitamin D will not be absorbed properly.

-the absorption and, therefore, the effectiveness of certain antibiotics (designated tetracyclines) decrease with simultaneous administration of Ideos. These medications should be taken at least 2 hours before or 4-6 hours after Ideos.

-the effect of quinolone antibiotics may be reduced when taken with calcium. In patients with cystic fibrosis, this effect may be intensified. Take quinolone antibiotics 2 hours before or 6 hours after taking Ideos Forte. Check the prospectus of the quinolone antibiotic you are taking to ensure you leave enough time before taking Ideos Forte.

-simultaneous administration of Ideos Forte and rifampicin (used to treat bacterial infections) or phenytoin or carbamazepine (medications for the treatment of epilepsy) or barbiturates (hypnotics) and also actinomycin and imidazole antimycotics may lead to a reduction in the effect of vitamin D.

-simultaneous administration of Ideos Forte and glucocorticoids (e.g. cortisone) may lead to a reduction in the effect of vitamin D and a reduction in calcium levels in the blood.

-

-calcium can reduce the effect of levothyroxine (used to treat hypothyroidism). Therefore, levothyroxine should be taken at least 4 hours before or 4 hours after this medication.

-calcium salts can reduce the absorption of iron, zinc, or strontium ranelate. Take iron, zinc, or strontium ranelate preparations 2 hours after taking this medication.

-calcium salts can reduce the absorption of estramustine (used to treat prostate cancer). Ideally, leave the widest possible interval between the administration of Ideos Forte and estramustine.

-antacids can reduce the absorption of calcium. To minimize this effect, take Ideos Forte at least 4 hours after an antacid.

-taking antacids containing calcium with Ideos Forte may cause an increase in calcium levels in the body. Therefore, your doctor may decide to monitor your calcium levels in blood.

-thiazide diuretics can reduce calcium levels in the body. Therefore, your doctor may monitor your calcium levels in blood.

-amiloride can cause high levels of calcium in the body. You should discuss this with your doctor, who may decide to monitor your calcium levels in blood if you take Ideos Forte with amiloride.

-the absorption and, therefore, the effectiveness of ketoconazole may be reduced by simultaneous administration of Ideos Forte. These medications should be taken at least 2 hours before or 2 hours after Ideos Forte.

-additional supplementation with calcium and vitamin D should only be administered under medical supervision and will require frequent monitoring of calcium levels in blood and urine.

Taking Ideos Forte with food and drinks

You can take Ideos Forte at any time, with or without food. You should be aware that oxalic acid (present in spinach and rhubarb) and phytic acid (present in whole grains) can 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, lactation, and fertility

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

Pregnancy

The recommended daily intake of calcium and vitamin D during pregnancy is approximately 1000 mg of calcium and approximately 600 IU of vitamin D (15 µg of colecalciferol). Therefore, Ideos Forte is not recommended during pregnancy and lactation, unless your doctor has diagnosed a combined deficiency of calcium and vitamin D.

During pregnancy, the total daily intake of calcium should not exceed 2500 mg and the total daily intake of vitamin D3 should not exceed 4000 IU (100 µg of colecalciferol).

High levels of vitamin D during pregnancy should be avoided, as prolonged high levels of calcium in the blood can cause physical and mental retardation, as well as cardiac and ocular disorders in the child.

Lactation

Ideos Forte can be used during lactation if your doctor has diagnosed a combined deficiency of calcium and vitamin D. Calcium and vitamin D and their metabolites pass into breast milk, which should also be taken into account if your child receives additional vitamin D.

Driving and operating machinery

Ideos Forte does not affect your ability to drive and operate machinery.

Ideos Forte

• 0.5 mg of aspartame (E951), a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.
• 58.3 mg of

sorbitol, 185 mg of isomaltase (E-953), and 1.9 mg of sucrose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause tooth decay.

This medication contains less than 1 mmol of sodium (23 mg) per chewable tablet, which is essentially "sodium-free".

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

Dose

Unless your doctor tells you otherwise, the recommended dose is:
Adults and elderly people: 1 chewable tablet per day (corresponding to 500 mg of calcium and 1000 IU [International Units] of vitamin D3).

Administration Form

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

Pay attention to a daily sufficient intake of calcium through nutrition (for example, dairy products, vegetables, mineral water).

Treatment Duration

Ideos Forte should be taken as a prolonged treatment. Talk to your doctor about the duration of treatment with this medication (see also section 2, Warnings and Precautions).

If you take more Ideos Forte than you should

A overdose of Ideos Forte may produce symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine output, decreased body fluids or constipation.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Ideos Forte

If you forget to take Ideos Forte, take it as soon as you remember. However, do not take a double dose to compensate for the missed doses.

If you interrupt the Ideos Forte treatment

If you want to interrupt or prematurely suspend treatment, consult your doctor.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Stop taking Ideos Forte and contact a doctor immediatelyif you experience the following allergic reactions(unknown frequency - cannot be estimated from available data):

• Allergic reactions such as facial swelling, lip, tongue, or throat swelling with sudden difficulty breathing and severe skin rash.

Other reported adverse effects are:

Rare:

• Nausea, diarrhea, abdominal pain, constipation, gas, bloating (abdominal distension).

Skin rash, itching, urticaria.

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

Uncommon:

• High levels of calcium in the blood (hypercalcemia) or urine (hypercalciuria).
• (Uncommon adverse effects may affect up to 1 in 100 people)

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on 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. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30?°C.

If your doctor interrupts treatment, do not store any remaining capsules unless the doctor instructs you otherwise. Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at theSIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ideos Forte

-The active principles are calcium and colecalciferol. Each chewable tablet contains 500 mg of calcium (as calcium carbonate) and 25 micrograms of colecalciferol (vitamin D3, equivalent to 1000 UI), in the form of a concentrated colecalciferol powder (in the form of a powder).

-The other components are: isomaltose (E953), xylitol, sorbitol (E420), anhydrous citric acid, sodium citrate dihydrate, magnesium stearate, sodium carmellose, orange aroma “CPB”, orange aroma “CVT”, hydrated colloidal silica, aspartame (E951), potassium acesulfame, sodium ascorbate, all-rac-alpha-tocopherol, modified cornstarch, sucrose, medium-chain triglycerides, and colloidal silicon dioxide.

Appearance of the product and contents of the packaging

IdeosForteare round and white tablets.

The chewable tablets are presented in laminated aluminum strips in the following packaging sizes:

30 or 90 chewable tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Responsible manufacturer

HERMESPHARMAGmbH

Georg-Kalb-Straße 5

82049 Pullach i. Isartal

Germany

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

Theramex Heathcare Spain, S.L.

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

28027 Madrid

Spain

Last review date of this leaflet: October 2023

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/)