Cadelius D 600 mg/2000 IU buccodispersible tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cadelius D 600 mg/2,000 IU orodispersible tablets

calcium / colecalciferol

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these adverse effects are not listed in this leaflet (see section 4).

Package leaflet contents:

1. What Cadelius D 600 mg/2,000 IU is and what it is used for
2. What you need to know before taking Cadelius D 600 mg/2,000 IU
3. How to take Cadelius D 600 mg/2,000 IU
4. Possible side effects
5. How to store Cadelius D 600 mg/2,000 IU
6. Contents of the pack and other 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 components in bone formation. Vitamin D3 regulates the absorption and metabolism of calcium, as well as the deposition of calcium into the bones.

If you have any doubts, consult your doctor or pharmacist 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 starting to 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 renal 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 specific type of connective tissue disease affecting the lungs, skin, and joints).
• If you are taking other medications containing vitamin D or calcium.
• If your kidneys are not functioning properly or you have a tendency to develop kidney stones.
• If you are immobilized due to osteoporosis.

Children and adolescents

Cadelius D 600 mg/2.000 IU is not recommended for use in children or adolescents.

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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 / suppression of immunity (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 adjusted.

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 between 4 and 6 hours after taking Cadelius D 600 mg/2,000 IU.

If you are taking medicines simultaneously 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 (levotiroxine), you should separate the administration of Cadelius D 600 mg/2,000 IU by at least four hours.

Use of Cadelius D 600 mg/2,000 IU with food, beverages, and alcohol:

Calcium absorption may be inhibited by foods containing oxalic acid (found in spinach and rhubarb) or phytic acid (found in most cereals). It is recommended not to take this medication within two hours after consuming foods high in oxalic acid or phytic acid.

Pregnancy, lactation, and fertility:

This medicine is not recommended during pregnancy.

Cadelius D 600 mg/2.000 IU may be taken during breastfeeding. Calcium and vitamin D3 are excreted into breast milk. This should be taken into account when administering additional vitamin D to the infant. 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 become pregnant, consult your doctor before using this medicine.

Driving and use of machines:

No effects on the ability to drive or operate machinery 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 per tablet.

Aspartame is a source of phenylalanine, which may be harmful in patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries.

This medicine contains soybean oil. It must not be used in patients with peanut or soy allergy.

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

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

The dose recommended for you will be individually determined by your doctor.

The usual dose is: 1 tablet per day.

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

The tablets should preferably be taken after meals.

The amount of calcium in Cadelius D 600 mg/2,000 IU is lower than the daily intake usually recommended. Therefore, this medicine is recommended for patients who require additional vitamin D intake but who already have a daily dietary intake of 500–1,000 mg of calcium. Your doctor should estimate your daily calcium intake from your diet.

Use in children and adolescents

Cadelius D 600 mg/2,000 IU is not indicated for use 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. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

Symptoms of a possible overdose of Cadelius D 600 mg/2,000 IU may include loss of appetite, thirst, abnormally large urine output, nausea, vomiting, and constipation.

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

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 adverse effects (may affect up to 1 in 100 patients): hypercalcemia (elevated calcium levels in the blood) and/or hypercalciuria (elevated calcium levels in the urine).

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

Adverse effects with unknown frequency (cannot be estimated from available data): severe allergic reactions.

Other special populations

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 refers to the last day of the month indicated.
• Store in the original packaging to protect from light. Keep the container tightly closed to protect from moisture.
• The product expires 30 days after first opening.
• Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

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

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

The other components are: maltodextrin, anhydrous citric acid (E330), low-substituted hydroxypropylcellulose (E463), lactose monohydrate, stearic acid, aspartame (E951), sucrose, gelatin, orange flavour (natural flavourings, maltodextrin, dextrin), corn starch, partially hydrogenated soybean oil, all-rac-α-tocopherol (E307), silicon dioxide.

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

White or almost white, round, bevelled orodispersible tablets.

Bottle containing 30 tablets.

Multipack containing 60 orodispersible tablets (2 packs of 30).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party:

Marketing Authorization Holder:

ITALFARMACO, S.A.

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

Tel.: 916572323

Manufacturing Responsible Party:

ITALFARMACO, S.p.A.

Viale Fulvio Testi 330

Milan (ITALY)

Tel.: 39 02 6443.1

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario 14

03006 Alicante

Spain

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

Spain: Cadelius 600 mg/2.000 UI buccodispersable tablets

Italy: Riliscal 600 mg/2000 U.I. orodispersible tablets

Portugal: Riliscal 600 mg/2000 IU orodispersible tablets

Greece: CADELIUS 600 mg + 2.000 IU δισκία διασπειρόμενα στο στόμα

Date of the most recent review of this summary: June 2020

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