Label: information for the user

Cadelius D 600 mg/2.000 UI buccal dispersible tablets

calcium / colecalciferol

Read this label carefully before starting to take this medicine because it contains important information for you.

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

Label contents:

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

This medication contains calcium and vitamin D3, both essential components in bone formation. Vitamin D3 regulates calcium absorption and metabolism, as well as calcium incorporation into bones.

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

You should consult a doctor if you worsen or do not improve in a few days.

Do not take Cadelius D 600 mg/2.000 UI:

• If you are allergic (hypersensitive) to calcium, vitamin D, or any of the other components of this medication (listed in section 6).
• If you have hypercalcemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in 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 UI.

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

Children and adolescents:

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

Other medications and Cadelius D 600 mg/2.000 UI:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The treatment effect may be affected if this medication is taken simultaneously with other medications 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 / immunosuppression (corticosteroids).
• Obesity (orlistat).

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

If you are taking simultaneously medications for:

• Osteoporosis (bisphosphonates). You should take them at least 3 hours before taking Cadelius D 600 mg/2.000 UI.

If you are taking simultaneously medications for:

• Some infections (quinolones). You should take them 2 hours before or 6 hours after taking Cadelius D 600 mg/2.000 UI.

If you are taking simultaneously medications for:

• Some infections (tetracyclines). You should take them 2 hours before or between 4 and 6 hours after taking Cadelius D 600 mg/2.000 UI.

If you are taking simultaneously medications for:

• Dental caries (sodium fluoride).
• Anemia (iron), you should take it at least 3 hours before taking Cadelius D 600 mg/2.000 UI.

If you are taking simultaneously medications for:

• Hypothyroidism (levotiroxine), you should space the intake of Cadelius D 600 mg/ 2.000 UI, at least, 4 hours.

Use of Cadelius D 600 mg/2.000 UI 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 medication during the 2 hours following the intake of foods with high content of oxalic acid or phytic acid.

Pregnancy, breastfeeding, and fertility:

This medication is not recommended during pregnancy.

Cadelius D 600 mg/2.000 UI 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 UI does not replace the administration of vitamin D in newborns.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery:

No effects have been observed on the ability to drive and operate machinery.

Cadelius D 600 mg/2.000 UI contains aspartame, lactose, sucrose, and partially hydrogenated soybean oil

This medication 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 disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

This medication contains sucrose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication. It may cause tooth decay.

This medication contains soybean oil. Do not use in case of allergy to peanuts or soy.

Follow exactly the administration instructions for this medication as indicated 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 must 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 usual daily recommended intake. Therefore, this medication is recommended for patients who need an additional supply of vitamin D but have a daily intake of 500-1,000 mg of calcium. Your doctor should estimate your daily intake of calcium through your diet.

Use in children and adolescents

Cadelius D 600 mg/2,000 IU is not indicated for 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 medication than prescribed by your doctor. You can also contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 forgot to take Cadelius D 600 mg/2,000 IU:

Do not take a double dose to compensate for the missed 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 other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medicationmay cause adverse effects, although not everyone will experience them.

You should stop taking this medication and immediately inform your doctor if you experience severe allergic reaction symptoms such as:

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

Less common 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 fewer than 1 in 1,000 patients):constipation, flatulence, nausea, abdominal pain, diarrhea, pruritus (itching), rash, and urticaria.

Unknown adverse effects (cannot be estimated with available data):severe allergic reactions.

Other special populations

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Keep the container perfectly closed. Do not use this medication after the expiration date that appears on the container, after CAD. The expiration date is the last day of the month indicated.
• Store in the original container to protect it from light. Keep the container perfectly closed to protect it from moisture.
• The expiration date is 30 days after its first opening.
• Do not use this medication if you observe any visible sign of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Cadelius D 600 mg/2.000 UI chewable tablets composition

The active principles are calcium carbonate 1.500 mg, corresponding to 600 mg of calcium, and colecalciferol 2.000 UI (vitamin D3) corresponding to 0.050 mg.

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

Appearance of Cadelius D 600 mg/2.000 UI and packaging content

White or almost white, circular, bisected chewable tablets.

30 tablets bottle.

Multi-pack of 60 (2 packs of 30) chewable tablets.

Only some packaging sizes may be commercially available.

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

For more information about this medicine, please contact 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 European Economic Area with the following names:

Spain:Cadelius 600 mg/2.000 UI chewable tablets

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

Portugal:Riliscal 600 mg/2000 IU orodispersible tablets

Greece:CADELIUS600 mg + 2.000 IUdisintegrating tablets

Last review date of this leaflet: June 2020

For detailed and updated information about this medicine, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).