CADELIUS D 600 MG/2000 IU ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Cadelius D 600 mg/2,000 IU Oral Dispersible Tablets

calcium / colecalciferol

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, pharmacist, or nurse.
• 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet (see section 4).

Contents of the pack:

1. What Cadelius D 600 mg/2,000 IU is and what it is used for
2. What you need to know before you take Cadelius D 600 mg/2,000 IU
3. How to take Cadelius D 600 mg/2,000 IU
4. Possible side effects
5. Storage of Cadelius D 600 mg/2,000 IU
6. Contents of the pack and further information

1. What Cadelius D 600 mg/2,000 IU is and what it is used for

This medicine is used to treat calcium and vitamin D deficiency in adults.

This medicine contains calcium and vitamin D3, both of which are important for bone formation. Vitamin D3 regulates the absorption and metabolism of calcium, as well as the incorporation of calcium into bones.

Ask your doctor or pharmacist if you have any questions and always follow their instructions.

You should consult a doctor if your condition worsens or does not improve within a few days.

2. What you need to know before you take Cadelius D 600 mg/2,000 IU

Do not take Cadelius D 600 mg/2,000 IU:

• If you are allergic (hypersensitive) to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6).
• If you have hypercalcemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in the urine).
• If you have hypervitaminosis D (high levels of vitamin D in the blood).
• If you have kidney stones.
• If you have kidney failure.
• If you are pregnant.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cadelius D 600 mg/2,000 IU.

• If you have sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints).
• If you are taking other medicines that contain vitamin D or calcium.
• If your kidneys do not function properly or you have a tendency to form kidney stones.
• If you are immobilized due to osteoporosis.

Children and adolescents

The use of Cadelius D 600mg/2,000 IU is not recommended in children or adolescents.

Other medicines and Cadelius D 600 mg/2,000 IU:

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

The effect of treatment may be affected if this medicine is taken at the same time as other medicines used for:

• High blood pressure (thiazide diuretics).
• Heart problems (cardiac glycosides such as digoxin).
• High cholesterol (cholestyramine).
• Constipation (laxatives such as liquid paraffin).
• Epilepsy (phenytoin or barbiturates).
• Inflammatory diseases / immune suppression (corticosteroids).
• Obesity (orlistat).

Please make sure your doctor knows if you are taking any of the medicines listed above. Your dose may need to be changed.

If you are taking medicines for:

• osteoporosis (bisphosphonates). You should take them at least 3 hours before taking Cadelius D 600 mg/2,000 IU.

If you are taking medicines for:

• certain infections (quinolones). You should take them 2 hours before or 6 hours after taking Cadelius D 600 mg/2,000 IU.

If you are taking medicines for:

• certain infections (tetracyclines). You should take them 2 hours before or 4-6 hours after taking Cadelius D 600 mg/2,000 IU.

If you are taking medicines for:

• dental caries (sodium fluoride).
• anemia (iron), you should take them at least 3 hours before taking Cadelius D 600 mg/2,000 IU.

If you are taking medicines for:

• hypothyroidism (levothyroxine), you should space the intake of Cadelius D 600 mg/2,000 UI at least 4 hours apart.

Using Cadelius D 600 mg/2,000 IU with food, drinks, and alcohol:

The absorption of calcium may be inhibited by foods containing oxalic acid (present in spinach and rhubarb) or phytic acid (present in most cereals). It is recommended not to take this medicine during the 2 hours following the intake of foods with high content of oxalic acid or phytic acid.

Pregnancy, breastfeeding, and fertility:

This medicine is not recommended during pregnancy.

Cadelius D 600 mg/2,000 IU can be taken during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when administering additional vitamin D to the baby. Supplementation with Cadelius D 600 mg/2,000 IU does not replace the administration of vitamin D in newborns.

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

Driving and using machines:

No effects on the ability to drive and use machines have been observed.

Cadelius D 600 mg/2,000 IU contains aspartame, lactose, sucrose, and partially hydrogenated soybean oil

This medicine contains 8.67 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it properly.

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

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine. It may cause tooth decay.

This medicine contains soybean oil. It should not be used in case of peanut or soy allergy.

3. How to take Cadelius D 600 mg/2,000 IU

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

The recommended dose is established by your doctor for you individually.

The usual dose is: 1 tablet per day.

The tablets should be dissolved in the mouth. They should not be swallowed whole.

The tablets should be taken preferably after meals.

The amount of calcium in Cadelius D 600 mg/2,000 IU is less than the daily recommended intake. Therefore, this medicine is recommended for patients who need an additional intake of vitamin D but have a daily intake of 500-1,000 mg of calcium per day. Your doctor should estimate the amount of your daily calcium intake through diet.

Use in children and adolescents

Cadelius D 600 mg/2,000 IU is not indicated in children and adolescents.

If you take more Cadelius D 600 mg/2,000 IU than you should:

Call your doctor or pharmacist immediately if you take more of this medicine than prescribed by your doctor. You can also contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

The symptoms of a possible overdose of Cadelius D 600 mg/2,000 IU may include loss of appetite, thirst, abnormal emission of large amounts of urine, nausea, vomiting, and constipation.

If you forget to take Cadelius D 600 mg/2,000 IU:

Do not take a double dose to make up for forgotten doses.

Take it as soon as you remember. Then take the next dose as usual. However, if it is already time for your next dose, skip the missed dose and take only one dose as usual.

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.

You should stop taking this medicine and inform your doctor immediately if you experience symptoms of serious allergic reactions such as:

• Swelling of the face, lips, tongue, or throat.
• Difficulty swallowing.
• Hives and difficulty breathing.

Uncommon side effects (may affect up to 1 in 100 people):hypercalcemia (elevated levels of calcium in the blood) and/or hypercalciuria (elevated levels of calcium in the urine).

Rare side effects (may affect less than 1 in 1,000 people):constipation, flatulence, nausea, abdominal distension (pain), diarrhea, pruritus (itching), rash, and hives.

Unknown frequency side effects (cannot be estimated from the available data):serious allergic reactions.

Other special populations

Patients with renal insufficiency may have a potential risk of hyperphosphatemia, nephrolithiasis, and nephrocalcinosis.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cadelius D 600 mg/2,000 IU

• Keep this medicine out of the sight and reach of children.
• Keep the container tightly closed. Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date is the last day of the month stated.
• Store in the original container to protect from light. Keep the container tightly closed to protect from moisture.
• The shelf life is 30 days after first opening.
• Do not use this medicine if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Place the container and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cadelius D 600 mg/2,000 IU oral dispersible tablets

The active ingredients are calcium carbonate 1,500 mg, corresponding to 600 mg of calcium, and colecalciferol 2,000 IU (vitamin D3) corresponding to 0.050 mg.

The other ingredients are: maltodextrin, anhydrous citric acid (E330), low-substituted hydroxypropylcellulose (E463), lactose monohydrate, stearic acid, aspartame (E951), sucrose, gelatin, orange flavor (natural flavorings, maltodextrin, dextrin), corn starch, partially hydrogenated soybean oil, all-rac-α-tocopherol (E 307), silicon dioxide.

Appearance of Cadelius D 600 mg/2,000 IU and contents of the pack

White or almost white, circular, beveled oral dispersible tablets.

Bottle of 30 tablets.

Multi-pack of 60 (2 bottles of 30) oral dispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

ITALFARMACO, S.A.

San Rafael, 3 – 28108 Alcobendas (Madrid), SPAIN

Tel.: 916572323

Manufacturer:

ITALFARMACO, S.p.A.

Viale Fulvio Testi 330

Milan (ITALY)

Tel.: 39 02 6443.1

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

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario 14

03006 Alicante

Spain

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

Spain: Cadelius 600 mg/2,000 IU oral dispersible tablets

Italy: Riliscal 600 mg/2000 U.I. compresse orodispersibili

Portugal: Riliscal 600 mg/2000 IU comprimidos orodispersíveis

Greece: CADELIUS 600 mg + 2,000 IU δισκ?α διασπειρ?μενα στο στ?μα

Date of last revision of this leaflet: June 2020

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