IDEOS FORTE 500 mg/1000 IU CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Ideos Forte 500 mg/1,000 IU Chewable Tablets

Calcium/colecalciferol (Vitamin D3)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Ideos Forte is a calcium and vitamin D3 supplement.

It is used

• to prevent and treat combined calcium and vitamin D deficiency in the elderly.
• for the intake of vitamin D and calcium as complementary therapy for osteoporosis (fragile bones), as a complement to specific osteoporosis treatment in adult patients at risk of vitamin D and calcium deficiency.

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

2. What you need to know before you take Ideos Forte

Do not take Ideos Forte

• if you are allergic to calcium, vitamin D3, or any of the other ingredients of this medicine (listed in section 6)
• if you have high levels of calcium in the blood (hypercalcemia)
• if you have high levels of calcium in the urine (hypercalciuria)
• if you have a disease and/or condition that causes high levels of calcium in the blood (hypercalcemia) and/or high levels of calcium in the urine (hypercalciuria), such as overactivity of the parathyroid glands (hyperparathyroidism), bone marrow cancer (myeloma),

a cancer that has affected the bones (bone metastases)

• if you have limited mobility of the limbs (prolonged immobilization) accompanied by hypercalcemia and/or hypercalciuria
• if you have kidney stones (nephrolithiasis)
• if you have calcium deposits in the kidneys (nephrocalcinosis)
• if you have an excess of vitamin D (hypervitaminosis D)
• if you have severe kidney problems with consequent severe and progressive overactivity of the parathyroid glands (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, calcium levels in the blood and urine and kidney function should be monitored periodically. This is especially important if you have a tendency to develop kidney stones. Depending on blood levels, your doctor may reduce the dose or stop treatment.
• if you are receiving simultaneous treatment with cardiac glycosides or thiazide diuretics (medicines that increase urine excretion) for heart problems, calcium levels in the blood and urine and kidney function should be monitored periodically. Depending on blood levels, your doctor may reduce the dose or stop treatment.
• if you have a 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 the blood and urine should be monitored. If you have severe kidney problems with severely overactive parathyroid glands, use other forms of vitamin D that are not colecalciferol, such as 1,25-dihydroxycolecalciferol (calcitriol) and vitamin D analogs.
• the intake of additional calcium and vitamin D supplements requires medical supervision and your doctor will require frequent monitoring of calcium levels in the blood and urine.
• be careful when taking Ideos Forte if you have sarcoidosis (an immune disorder that can affect the liver, lungs, skin, or lymph nodes). There is a risk that the effect of this medicine may become too strong, which can lead to an overdose of calcium in the body. Calcium levels in the blood and urine should be monitored.
• in cases of immobilization and osteoporosis, this medicine 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 substances, such as carbonates, already ingested from other sources (food, dietary supplements, and other medicines). If products rich in calcium with carbonates are taken simultaneously, this can lead to the milk-alkali syndrome (Burnett syndrome). The milk-alkali syndrome is a metabolic disorder of calcium with an increase in calcium levels in the blood. Therefore, additional intake of Ideos Forte requires strict medical supervision with frequent monitoring of calcium levels in the blood and urine.

Children and adolescents

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

Taking Ideos Forte with other medicines

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

• In case of simultaneous treatment with digitalis glycosides (cardiac glycosides derived from the digitalis plant), cardiac arrhythmias may occur. Therefore, strict medical monitoring, including an ECG and determination of calcium levels in the blood, is necessary.
• In case of simultaneous administration of thiazide diuretics (also known as medicines to increase urine excretion), calcium levels in the blood should be monitored periodically, as thiazides reduce calcium excretion in the urine.
• Additionally, other medicines such as sodium fluoride (used to strengthen tooth enamel or treat osteoporosis) and bisphosphonates (used to treat osteoporosis) are affected by interactions. Therefore, these medicines should be taken at least 3 hours before Ideos Forte. You should review the package leaflet of the bisphosphonate you are taking to ensure you leave enough time before taking Ideos Forte.
• It is recommended to avoid taking Ideos Forte with products containing phosphate, as they may reduce the amount of phosphate absorbed.
• It is recommended to leave the widest possible interval between the administration of orlistat (used to treat obesity) or ion exchange resins such as cholestyramine (a medicine to reduce high cholesterol levels) or laxatives such as liquid paraffin and Ideos Forte, as otherwise, vitamin D may not be absorbed properly.
• The absorption and, therefore, the efficacy of certain antibiotics (called tetracyclines) decrease with simultaneous administration of Ideos. These medicines 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. You should review the package leaflet 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 (medicines 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.

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• Calcium may reduce the effect of levothyroxine (used to treat thyroid deficiency). For this reason, levothyroxine should be taken at least 4 hours before or 4 hours after this medicine.
• Calcium salts may reduce the absorption of iron, zinc, or strontium ranelate. Take iron, zinc, or strontium ranelate preparations with an interval of 2 hours after taking this medicine.
• Calcium salts may reduce the absorption of estramustine (used to treat prostate cancer). It is recommended to leave the widest possible interval between the administration of Ideos Forte and estramustine.
• Antacids may reduce calcium absorption. To minimize this effect, you should 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 the blood.
• Loop diuretics may reduce calcium levels in the blood. Therefore, your doctor may monitor your calcium levels in the blood.
• Amiloride may cause high calcium levels in the body. You should talk to your doctor, who may decide to monitor your calcium levels in the blood if you take Ideos Forte with amiloride.
• The absorption and, therefore, the efficacy of ketoconazole may be decreased by simultaneous administration of Ideos Forte. These medicines 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 the 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) may 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 medicines containing calcium.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 breastfeeding, unless your doctor has diagnosed a combined calcium and vitamin D deficiency.

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

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

Breastfeeding

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

Driving and using machines

Ideos Forte does not affect the ability to drive and use machines.

Ideos Forte

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

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

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

It may produce caries.

This medicine contains less than 1 mmol of sodium (23 mg) per chewable tablet, i.e., it is essentially "sodium-free".

3. How to take Ideos Forte

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose

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

Method of administration

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

You should pay attention to a sufficient daily intake of calcium through nutrition (e.g., dairy products, vegetables, mineral water).

Duration of treatment

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

If you take more Ideos Forte than you should

Overdose of Ideos Forte may cause symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine production, dehydration, 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 medicine 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 make up for forgotten doses.

If you stop taking Ideos Forte

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Allergic reactions such as swelling of the face, lips, tongue, or throat with sudden difficulty breathing and severe skin rash.

Other side effects reported are:

Rare:

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

skin rash, itching, urticaria.

(rare side effects may affect up to 1 in 1,000 people)

Uncommon:

• high levels of calcium in the blood (hypercalcemia) or urine (hypercalciuria).
• (uncommon side effects may affect up to 1 in 100 people)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ideos Forte

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

Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date is the last day of the month stated.

Do not store above 30°C.

If your doctor stops treatment, do not keep leftover tablets unless the doctor tells you to. Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Container Content and Additional Information

Ideos Forte Composition

• The active ingredients 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 IU), as concentrated colecalciferol (in powder form).
• The other components are: isomaltose (E953), xylitol, sorbitol (E420), anhydrous citric acid, sodium dihydrogen citrate, magnesium stearate, sodium carmellose, orange flavor "CPB", orange flavor "CVT", hydrated colloidal silica, aspartame (E951), acesulfame potassium, sodium ascorbate, all-rac-alpha-tocopherol, modified corn starch, sucrose, medium-chain triglycerides, and colloidal silicon dioxide.

Product Appearance and Container Content

Ideos Forte are round and white tablets.

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

30 or 90 chewable tablets.

Only some package 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

Manufacturer

HERMES PHARMA GmbH

Georg-Kalb-Straße 5

82049 Pullach i. Isartal

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Theramex Heathcare Spain, S.L.

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

28027 Madrid

Spain

Date of the last revision of this leaflet: October 2023

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