User Information: Package Insert

Calcio/Vitamina D3 Kern Pharma 600 mg/400 IU Chewable Tablets EFG

Read this entire package insert carefully before starting to take this medication as it contains important information for you

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given 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 package insert.

1.What is Calcio/Vitamina D3 Kern Pharma and how is it used

2.What you need to know before starting to take Calcio/Vitamina D3 Kern Pharma

3.How to take Calcio/Vitamina D3 Kern Pharma

4.Possible adverse effects

5.Storage of Calcio/Vitamina D3 Kern Pharma

6.Contents of the package and additional information

This medication is an association of Calcium and Vitamin D.

This medication is indicated for the treatment of calcium and vitamin D deficiency states.3.

This medication may also be used as a vitamin D and calcium supplement in the treatment of osteoporosis in patients with manifest calcium and vitamin D deficiency or with a high risk of developing it.

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

Do not take Calcio/Vitamina D3 Kern Pharma 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 the urine).
• If you have kidney stones.
• If you have kidney failure.
• If you are allergic to soy or peanuts.
• If you have hypervitaminosis D (high levels of vitamin D in the blood).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Calcio/Vitamina D3 Kern Pharma.

• 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 immobile due to osteoporosis.

Use of Calcio/Vitamina D3 Kern Pharma with other medications

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

The effect of treatment may be affected if this medication is taken simultaneously with other medications:

• Cardiac problems (cardiac glycosides such as digoxin). High blood pressure (thiazide diuretics).
• High cholesterol (cholestyramine).
• Constipation (laxatives such as liquid paraffin).
• Epilepsy (phenytoins or barbiturates).
• Inflammatory conditions / immunosuppression (corticosteroids).
• Obesity (orlistat).

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

If you are taking medications for osteoporosis (bisphosphonates) simultaneously, you should take it at least one hour before taking Calcio/Vitamina D3 Kern Pharma.

If you are taking medications for infection (fluoroquinolones) simultaneously, you should take it two hours before or six hours after taking Calcio/Vitamina D3 Kern Pharma.

If you are taking medications for infection (tetracyclines) simultaneously, you should take it two hours before or six hours after taking Calcio/Vitamina D3 Kern Pharma.

If you are taking medications for dental caries (sodium fluoride) or anemia (iron) simultaneously, you should take it at least three hours before taking Calcio/Vitamina D3 Kern Pharma.

If you are taking medications for hypothyroidism (levothyroxine) simultaneously, you should separate the intake of Calcio/Vitamina D3 Kern Pharma by at least four hours.

Use of Calcio/Vitamina D3 Kern Pharma with foods, beverages, 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 Calcio/Vitamina D3 Kern Pharma during the two hours following the consumption of foods with high oxalic acid or phytic acid content.

During treatment with Calcio/Vitamina D3 Kern Pharma, do not take foods that may be "fortified" with vitamin D.

Pregnancy, breastfeeding, and fertility

During pregnancy, the daily intake should not exceed 1500 mg of calcium and 600 IU of vitamin D.

The use of Calcio/Vitamina D3 Kern Pharma is not recommended during pregnancy.

Calcio/Vitamina D3 Kern Pharma can be taken during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when additional vitamin D is provided to the infant.

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

Driving and operating machinery

This medication contains aspartame

Aspartame is a source of phenylalanine. Phenylalanine may be harmful to people with phenylketonuria.

This medication contains sorbitol, lactose, and saccharose

If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medication.

This medication contains soy oil

If you are allergic to peanuts or soy, do not take this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. 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 to 2 tablets per day.

The tablets should be chewed and then, if desired, a small amount of water can be consumed.

The tablets can also be placed in a half glass of water and once dissolved in it, the contents can be consumed.

Calcio/Vitamina D3 Kern Pharma is not indicated for children.

If you take more Calcio/Vitamina D3 Kern Pharma 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 Calcio/Vitamina D3 Kern Pharma may include loss of appetite, abnormal emission of large amounts of urine, nausea, vomiting, and constipation.

If you forgot to take Calcio/Vitamina D3 Kern Pharma

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

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

Like all medications, Calcio/Vitamina D3 Kern Pharma may produce adverse effects, although not all people will experience them.

You should stop taking Calcio/Vitamina D3 Kern Pharma 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 serum) and/or hypercalciuria (elevated calcium levels in urine).

Rare adverse effects (may affect up to 1 in 1,000 patients):constipation, flatulence, nausea, abdominal pain, and diarrhea.

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

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

• No special storage conditions are required.
• 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.
• The period of validity is 60 days after its first opening.
• Do not use this medication if you observe any visible sign of deterioration.
• Medications should not be disposed ofthrough drains or in the trash.Deposit the 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 the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Contents of the packaging and additional information / Additional information

The active principles are calcium carbonate 1500 mg corresponding to 600 mg of calcium and colecalciferol 0.01 mg corresponding to 400 UI of vitamin D.

The other components are: sodium croscarmellose, maltodextrin, cornstarch, aspartame (E-951), sorbitol (E-420), sodium saccharin, lactose monohydrate, anise essence, peppermint essence, molasses essence, magnesium stearate, all-rac-α-tocopherol, silicon dioxide, partially hydrogenated soybean oil, gelatin, and sucrose.

Appearance of Contents of the packaging and additional information / Additional information and contents of the packaging

Contents of the packaging and additional information / Additional information are presented in the form of chewable tablets for oral administration.

Container of 60 tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

KERN PHARMA, S.L.

Venus, 72. Poligono Industrial Colon II.

08228– Tarrasa, Barcelona

Spain

Responsible for manufacturing:

ITALFARMACO, S.p.A.

Viale Fulvio Testi 330

Milan (ITALY)

Tel.: 39 02 6443.1

Date of the last review of this prospectus:July 2013

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