Ideos Forte 500 mg/1000 IU chewable tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ideos Forte 500 mg/1.000 IU chewable tablets

calcium/colecalciferol (vitamin D3)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ideos Forte is and what it is 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 elderly people.
• to provide vitamin D and calcium as an adjunctive 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 when adequate intake of calcium and vitamin D cannot be achieved through nutrition and sunlight exposure.

2. What you need to know before taking 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 causing elevated calcium levels in the blood (hypercalcemia) and/or elevated calcium levels in the urine (hypercalciuria), for example, overactivity of the parathyroid glands (hyperparathyroidism), bone marrow cancer (myeloma), cancer that has spread to the bones (bone metastases)
• if you have limited limb movement (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 leading to 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

Talk to your doctor or pharmacist before taking Ideos Forte

• during long-term treatment, calcium levels in blood and urine and kidney function should be monitored periodically. This is especially important if you are prone to developing kidney stones. Depending on blood levels, your doctor may reduce the dose or stop treatment.
• if you are receiving concomitant treatment with cardiac glycosides or thiazide diuretics (medicines that increase urine excretion) for heart problems, calcium levels in 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 disorder of parathyroid hormone (pseudohypoparathyroidism).
• if you have kidney problems, you should take Ideos Forte only under medical supervision to reduce the risk of soft tissue calcification. Your blood and urine calcium levels should be monitored. If you have severe kidney problems with accompanying severe and progressive overactivity of the parathyroid glands, use forms of vitamin D other than cholecalciferol, such as 1,25-dihydroxycholecalciferol (calcitriol) and vitamin D analogs.
• taking additional supplements of calcium and vitamin D requires medical supervision, and your doctor will require frequent monitoring of calcium levels in blood and urine.
• take special care when taking Ideos Forte if you have sarcoidosis (an immune disorder that may affect the liver, lungs, skin, or lymph nodes). There is a risk that the effect of this medicine may become too strong, potentially leading to calcium overdose in the body. Calcium levels in blood and urine should be monitored.
• in cases of immobilization and osteoporosis, this medicine should be used with particular caution, as it could increase blood calcium levels.
• before taking Ideos Forte, consider the amount of calcium and alkali, such as carbonates, already ingested from other sources (food, dietary supplements, and other medicines). If calcium-rich products containing carbonates are taken simultaneously, this may lead to the milk-alkali syndrome (Burnett's syndrome). The milk-alkali syndrome is a metabolic disorder of calcium with increased blood calcium levels. Therefore, additional intake of Ideos Forte requires strict medical supervision with frequent monitoring of blood and urine calcium levels.

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 need to take any other medicines.

• When taken together with digitalis glycosides (cardiac glycosides derived from the foxglove plant), cardiac arrhythmias may occur. Therefore, strict medical monitoring, including ECG and blood calcium level determination, is necessary.

• When taken together with diuretics of the thiazide class (also known as medicines that increase urine excretion), blood calcium levels should be monitored periodically, as thiazides reduce calcium excretion in urine.

• In addition, 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. Check the package leaflet of the bisphosphonate you are taking to ensure sufficient time is left before taking Ideos Forte.

• Ideos Forte should be avoided with phosphate-containing products, as they may reduce the amount of phosphate absorbed.

• A maximum interval should be maintained between taking orlistat (used to treat obesity), or ion-exchange resins such as colestyramine (a medicine to reduce high cholesterol levels), or laxatives such as liquid paraffin, and Ideos Forte, as otherwise vitamin D may not be adequately absorbed.

• The absorption, and therefore the effectiveness, of certain antibiotics (called tetracyclines) decreases when taken at the same time as 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 at least 2 hours before or 6 hours after taking Ideos Forte. Check the package leaflet of the quinolone antibiotic you are taking to ensure sufficient time is left before taking Ideos Forte.

• Concurrent administration of Ideos Forte with rifampicin (used to treat bacterial infections), or phenytoin or carbamazepine (medicines for the treatment of epilepsy), or barbiturates (hypnotics), as well as actinomycin and imidazole antifungals, may reduce the effect of vitamin D.

• Concurrent administration of Ideos Forte and glucocorticoids (e.g., cortisone) may reduce the effect of vitamin D and reduce blood calcium levels.

• Calcium may reduce the effect of levothyroxine (used to treat thyroid insufficiency). Therefore, levothyroxine should be taken at least four hours before or four hours after this medicine.

• Calcium salts may reduce the absorption of iron, zinc, or strontium ranelate. Take iron, zinc, or strontium ranelate preparations with a two-hour interval after taking this medicine.

• Calcium salts may reduce the absorption of estramustine (used to treat prostate cancer). A maximum interval should be maintained between administration of Ideos Forte and estramustine.

• Antacids may reduce calcium absorption. To minimize this effect, take Ideos Forte at least 4 hours after an antacid.

• Taking antacids containing calcium together with Ideos Forte may cause increased calcium levels in the body. Therefore, your doctor may decide to monitor your blood calcium levels.

• Loop diuretics may reduce calcium levels in your blood. Therefore, your doctor may monitor your blood calcium levels.

• Amiloride may cause elevated calcium levels in the body. You should talk to your doctor, who may decide to monitor your blood calcium levels if you are taking Ideos Forte with amiloride.

• The absorption, and therefore also the effectiveness, of ketoconazole may be reduced by concurrent 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 blood and urine.

Taking Ideos Forte with food and drinks

You may take Ideos Forte at any time, with or without food. Note that oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains) may reduce the amount of calcium absorbed in the intestine. Patients should not take calcium-containing medicines within 2 hours before or after consuming foods high in oxalic acid or phytic acid.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using 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 cholecalciferol). Therefore, Ideos Forte is not recommended during pregnancy and breastfeeding unless your doctor has diagnosed you with a combined deficiency of calcium and vitamin D.

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

Vitamin D overdosage during pregnancy should be avoided, as prolonged high calcium levels in the blood may cause delayed physical and mental development, as well as cardiac and ocular disorders in the child.

Breastfeeding

Ideos Forte may be used during breastfeeding if your doctor has diagnosed you with a combined deficiency of calcium and vitamin D. Calcium, vitamin D, and their metabolites pass into breast milk, which should also be considered 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 which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
• 58.3 mg of sorbitol, 185 mg of isomalt (E-953), and 1.9 mg of sucrose.

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

May cause dental caries.

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

3. How to take Ideos Forte

Follow exactly the instructions for use of this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

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

Administration method

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

You should ensure an adequate daily intake of calcium through your diet (for example, dairy products, vegetables, mineral water).

Duration of treatment

Ideos Forte should be taken as a long-term treatment. Discuss with your doctor the appropriate duration of treatment with this medicine (see also section 2, Warnings and precautions).

If you take more Ideos Forte than you should

An overdose of Ideos Forte may cause symptoms such as nausea, vomiting, excessive thirst, excessive drowsiness, increased urine output, dehydration, or constipation.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ideos Forte

If you forget to take a dose, take it as soon as you remember. However, do not take a double dose to make up for a missed dose.

If you stop taking Ideos Forte

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

Other reported adverse effects are:

Rare:

• nausea, diarrhoea, abdominal pain, constipation, flatulence, 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 of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse 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 refers to the last day of the month indicated.

Do not store above 30°C.

If your doctor discontinues treatment, do not keep any leftover capsules unless otherwise instructed by your doctor. Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ideos Forte

• The active substances 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 flavour “CPB”, orange flavour “CVT”, colloidal hydrated silica, aspartame (E951), potassium acesulfame, sodium ascorbate, all-rac-alpha-tocopherol, modified maize starch, sucrose, medium-chain triglycerides and colloidal silicon dioxide.

Appearance of the product and contents of the pack

Ideos Forte are round, white tablets.

The chewable tablets are available in laminated aluminium strips in the following pack sizes:

30 or 90 chewable tablets.

Only some 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

Manufacturer

HERMES PHARMA GmbH

Georg-Kalb-Straße 5

82049 Pullach i. Isartal

Germany

Further information about this medicinal product is available from the local representative of the Marketing Authorization Holder:

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.

28027 Madrid

Spain

Date of the most recent 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/)