IDEOS 500 mg/2,000 IU CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Ideos 500 mg/2,000 IU Chewable Tablets

Calcium/Cholecalciferol (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 symptoms are the same as yours.
• If you experience 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 Package Leaflet

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

1. What is Ideos and what is it used for

Ideos is a calcium and vitamin D3 supplement.

It is used

• to treat calcium and vitamin D deficiency in adults.

2. What you need to know before you take Ideos

Do not take Ideos

• if you are allergic to calcium, cholecalciferol (vitamin D3) or any of the other ingredients of this medicine (listed in section 6).
• if you have high levels of calcium in your blood (hypercalcaemia).
• if you have high levels of calcium in your urine (hypercalciuria).
• if you have overactive parathyroid glands (hyperparathyroidism).
• if you have bone marrow cancer (myeloma).
• if you have cancer that has spread to your bones (bone metastases).
• if you have prolonged immobilization accompanied by hypercalcaemia 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 taking this medicine:

• if you are on long-term treatment, especially if you are also taking diuretics (used to treat high blood pressure or oedema) 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 medical supervision.

Children and adolescents

This medicine is not intended for use in children and adolescents.

Other medicines and Ideos

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

• Other medicines that may interact or be affected by this medicine are:

• thiazide diuretics (used to treat high blood pressure or oedema)
• 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 2 hours before or 4 to 6 hours after taking this medicine. Calcium carbonate may interfere with the absorption of tetracycline preparations if taken at the same time.
• Medicines containing bisphosphonates (used to treat osteoporosis) should be taken at least 3 hours before taking this medicine.
• Orlistat (used to treat obesity), cholestyramine (a product to reduce high cholesterol levels) or laxatives such as liquid paraffin may alter absorption and thus 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). Therefore, levothyroxine should be taken at least 4 hours before or 4 hours after this medicine.
• The effect of quinolone antibiotics may be reduced if taken at the same time as calcium. Take quinolone antibiotics 2 hours before or 6 hours after taking this medicine.
• Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently, iron, zinc or strontium ranelate preparations should be taken at least 2 hours before or after this medicine.
• 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.

If you are taking any of the above-mentioned medicines, your doctor will give you more instructions.

Taking Ideos with food, drinks and alcohol

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

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.

This medicine is not recommended during pregnancy in patients who do not have a calcium and vitamin D deficiency. When there is a vitamin D deficiency, the recommended 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 may lead to high levels of calcium in the blood and may have a negative effect on the fetus.

This medicine 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, treatment can be switched to other medicines that contain calcium and vitamin D3 with a lower concentration of vitamin D3.

Driving and using machines

This medicine has no influence on your ability to drive and use machines.

This medicine contains

• 0.5 mg of aspartame (E951), a source of phenylalanine. May be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.
• 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 some sugars, consult your doctor before taking this medicine. May cause tooth decay.
• This medicine contains less than 1 mmol of sodium (23 mg) per chewable tablet; this is essentially “sodium-free”.
• This medicine contains traces of benzyl alcohol. Benzyl alcohol may cause allergic reactions.

3. How to take Ideos

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is one chewable tablet per day, corresponding to 500 mg of calcium and 2,000 IU (International Units) of vitamin D3. The dosage is determined individually by your doctor.

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 (i.e. dairy products, vegetables, mineral water).

Use in children and adolescents

This medicine is not intendedfor use in children and adolescents.

If you take more Ideos than you should

Overdose of this medicine 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ideos

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

If you stop taking Ideos

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

If you have any further questions on the use of this medicine, 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 and contact a doctor immediatelyif you experience the following allergic reaction (frequency not known because it cannot be estimated from the available data):

• swelling of the face, lips, tongue or throat with sudden difficulty in breathing and severe skin rash.

Other side effects reported are:

Uncommon:may affect up to 1 in 100 people

• high levels of calcium in the blood (hypercalcaemia) or urine (hypercalciuria).

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

• discomfort (nausea), diarrhoea, abdominal pain, constipation, flatulence, bloating (abdominal distension).
• rash, itching, urticaria.

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 via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ideos

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

Do not use this medicine after the expiry date which is stated on the carton and on the blister strips after “EXP”. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions. Keep the container tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Ideos

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

Appearance of the product and pack contents

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

Available in polypropylene tubes with a polyethylene cap containing a desiccant or in blister packs. Tear off the blister pack to open.

Pack sizes:

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

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturer

HERMES PHARMA GmbH

Hans-Urmiler-Ring 52

82515 Wolfratshausen

Germany

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder

Theramex Healthcare Spain, S.L.

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

28027 Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

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

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

Calcium/Vitamine 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 last revision of this leaflet:23 February 2024

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