Label: information for the user

Carbocal D 600 mg/400 IU chewable tablets, orange flavor

Calcium/vitamin D3

Read this label carefully before starting to take the medication.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

This medication contains two active principles: calcium and vitamin D3. Calcium is an important constituent of bones and vitamin D3 helps with the absorption of calcium in the intestine and its deposition in bones.

It is indicated for:

• Correction of vitamin D and calcium deficiencies in the elderly.
• In combination with osteoporosis treatments, if calcium and vitamin D levels are too low, or there is a high risk of them being too low.

Do not take Carbocal D

• If you are allergic (hypersensitive) to calcium, vitamin D, or any of the other components of Carbocal D (particularly soybean oil or peanut oil) (see section 6).
• If you have abnormally high levels of calcium in your blood (hypercalcemia) and/or excessive loss of calcium in your urine (hypercalciuria)
• If you have any condition that may lead to hypercalcemia and/or hypercalciuria (e.g. overactive parathyroid glands, bone marrow disease (myeloma), malignant bone tumor (bone metastases))
• If you have kidney failure.
• If you have kidney stones (calcium stones) or have calcium deposits in your kidneys (nephrocalcinosis)
• If you have excessive intake of vitamin D (hypervitaminosis D)

Be especially careful with Carbocal D

In the case of long-term treatment with Carbocal D, the amount of calcium in your blood should be regularly monitored (calcemia). This control is particularly important in the elderly and when the treatment is being administered at the same time as cardiac glycosides (e.g. digoxin) or diuretics. Depending on the result, your doctor will decide whether to reduce or discontinue treatment.

Before taking Carbocal D consult your doctor or pharmacist:

• If you have had kidney stones.
• If you are suffering from any immunological disorder (sarcoidosis), for which the levels of calcium in your blood and urine should be controlled.
• If you are immobile and have reduced bone mass (osteoporosis). This can increase calcium levels in your blood too much, which can cause adverse effects.
• If you are taking other medications that contain vitamin D3 or calcium. This can increase calcium levels in your blood too much, which can cause adverse effects.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

In particular:

• Thiazide diuretics (medications used to treat high blood pressure), as they can increase the amount of calcium in your blood,
• Oral steroids, as they can reduce the amount of calcium in your blood,
• Orlistat (a medication used to treat obesity), cholestyramine, or laxatives such as paraffin oil, as they can reduce the absorption of vitamin D3,
• Phenytoin (a medication for epilepsy) and barbiturates (some medications that help you sleep), as they can make vitamin D3 less effective,
• Cardiac glycosides (medications used to treat heart problems), as taking too much calcium can cause more adverse effects.
• Tetracycline antibiotics, as they can reduce the amount absorbed. In that case, it is recommended that the dose be taken at least 2 hours before, or 4-6 hours after taking Carbocal D,
• Estramustine (a medication used in chemotherapy), thyroid hormones, or medications that contain iron, zinc, or strontium, as they can reduce the amount absorbed. They should be administered at least 2 hours before or after Carbocal D
• Bisphosphonates (a treatment for certain bone conditions), fluorine or fluoroquinolones (a type of antibiotic), as the amount absorbed can be reduced. These medications should be taken at least 3 hours before or after Carbocal D
• Other medications that contain calcium or vitamin D while taking Carbocal D. This can increase calcium levels in your blood too much

Taking Carbocal D with food and drinks

In the two hours before taking Carbocal D, you should avoid eating foods that contain oxalates (e.g. spinach and rhubarb) or citric acid (e.g. whole grains), which can reduce calcium absorption.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

This medication can be used during pregnancy, however the daily intake of calcium should not exceed 1500mg and the daily intake of vitamin D should not exceed 600 UI. Therefore, in the case of pregnancy, the daily dose of Carbocal D should not exceed one tablet per day. Higher amounts can have negative effects on the baby.

During breastfeeding you can take Carbocal D. Since calcium and vitamin D3 pass through breast milk, you should consult your doctor first if your child is receiving any other product that contains vitamin D3.

Driving and operating machinery

No adverse effects on the ability to drive and operate machinery are known.

Important information about some of the components of Carbocal D

This medication contains sorbitol. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking/using this medication.

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

This medication contains sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking the medication

Carbocal D also contains partially hydrogenated soybean oil. It should not be used in case of allergy to peanuts or soybeans.

Follow exactly the administration instructions for Carbocal D as indicated by your doctor. Consult your doctor if you have any doubts.

The normal dose is 1 tablet twice a day for adults and the elderly (e.g. one tablet in the morning and another tablet at night). Pregnant women should take only one tablet a day.

Chew the Carbocal D tablets and drink a little water afterwards, if desired.

If you take more Carbocal D than you should

If you take more Carbocal D than you should and experience any of the overdose symptoms, stop taking Carbocal D and contact your doctor immediately.

Overdose symptoms may include: loss of appetite, excessive thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental health problems, increased urine production, bone pain, kidney stones.

In the case of prolonged overdose, calcium deposits may appear in blood vessels or other body tissues.

In the case of severe overdose, a heart attack may occur.

In case of overdose or accidental ingestion, call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Carbocal D

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Carbocal D may cause adverse effects, although not all people will experience them.

Rare adverse effects (affecting 1 to 10 patients per 1000): elevated levels of calcium in the blood or urine.

Very rare adverse effects (affecting 1 to 10 patients per 10,000): constipation, flatulence, nausea, abdominal pain, diarrhea, itching, hives, and urticaria.

If you consider any of the adverse effects you are experiencing to be severe or if any adverse effect not mentioned in this leaflet appears, inform your doctor or pharmacist.

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

Do not store at a temperature above 86°F (30°C).

Keep the bottle perfectly closed to protect it from humidity.

Do not use this medication after the expiration date that appears on the packaging and on the bottle after CAD. The expiration date is the last day of the month indicated.

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

Composition of Carbocal D

• The active principles are calcium carbonate and colecalciferol (vitamin D3).

Each tablet contains 1500 mg of calcium carbonate (equivalent to 600 mg of calcium) and 400 UI of colecalciferol (equivalent to 10 micrograms of vitamin D3).

• The other components (excipients) are: Dl-alfa-tocoferol, partially hydrogenated soybean oil, gelatin, sucrose, cornstarch, pregelatinized cornstarch, polisorbate 80, sorbitol, orange flavor (natural flavorings, flavorings, maltodextrin, and E-307), sodium croscarmellose, aspartame, magnesium stearate, and xylitol.

Appearance of the product and contents of the package

Carbocal D is presented in the form of white, orange-flavored chewable tablets.

Each package contains 60 chewable tablets.

Holder of the marketing authorization and responsible manufacturer

The holder is:Farmasierra Laboratorios S.L.

Ctra. de Irún 26,200

San Sebastián de los Reyes 28709

Madrid Spain

The responsible manufacturer is:

Farmasierra Manufacturing S.L.

Carretera de Irún km 26,200

San Sebastián de los Reyes

28709 – Madrid - Spain

This prospectus was approved in May 2011.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.es/