CALCIUM/VITAMIN D3 KERN PHARMA 600 mg/400 IU CHEWABLE TABLETS

Introduction

Prospectus: Information for the user

Calcium/Vitamin D3 Kern Pharma 600 mg/400 UI Chewable Tablets EFG

Read the entire prospectus carefully before starting to take this medication because it contains important information for you

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.

Contents of the prospectus:

1. What is Calcium/Vitamin D3 Kern Pharma and what is it used for
2. What you need to know before starting to take Calcium/Vitamin D3 Kern Pharma
3. How to take Calcium/Vitamin D3 Kern Pharma
4. Possible adverse effects
5. Storage of Calcium/Vitamin D3 Kern Pharma
6. Package contents and additional information

1. What is Calcium/Vitamin D3 Kern Pharma and what is it used for

This medication is an association of Calcium and Vitamin D.

This medication is indicated for the treatment of calcium and vitamin D3 deficiency states.

This medication can 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 at high risk of its occurrence.

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

2. What you need to know before starting to take Calcium/Vitamin D3 Kern Pharma/Before taking Calcium/Vitamin D3 Kern Pharma

Do not take Calcium/Vitamin 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 Calcium/Vitamin 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 immobilized due to osteoporosis.

Use of Calcium/Vitamin D3 Kern Pharma with other medications

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

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

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

Please ensure that your doctor is aware 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 them at least one hour before taking Calcium/Vitamin D3 Kern Pharma.

If you are taking medications for infection (quinolones) simultaneously, you should take them two hours before or six hours after taking Calcium/Vitamin D3 Kern Pharma.

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

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

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

Use of Calcium/Vitamin D3 Kern Pharma with food, beverages, and alcohol

Calcium absorption 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 Calcium/Vitamin D3 Kern Pharma during the two hours following the intake of foods with high oxalic acid or phytic acid content.

During treatment with Calcium/Vitamin D3 Kern Pharma, you should not take foods that may be "fortified" with vitamin D.

Pregnancy, breastfeeding, and fertility

Daily intake during pregnancy should not exceed 1500 mg of calcium and 600 UI of vitamin D.

The use of Calcium/Vitamin D3 Kern Pharma is not recommended during pregnancy.

Calcium/Vitamin D3 Kern Pharma can be taken during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when vitamin D is additionally administered to the infant.

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

Driving and using machines

This medication contains aspartame

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

This medication contains sorbitol, lactose, and sucrose

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

This medication contains soybean oil

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

3. How to take Calcium/Vitamin D3 Kern Pharma

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

The usual dose is: 1 to 2 tablets per day.

The tablets should be chewed and, if desired, you can drink a little water afterwards.

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

Calcium/Vitamin D3 Kern Pharma is not indicated for children.

If you take more Calcium/Vitamin 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

The symptoms of a possible overdose of Calcium/Vitamin D3 Kern Pharma may include loss of appetite, abnormal emission of large amounts of urine, nausea, vomiting, and constipation.

If you forget to take Calcium/Vitamin D3 Kern Pharma

Take it as soon as you remember. Subsequently, 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 make up for missed doses.

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

4. Possible adverse effects

Like all medications, Calcium/Vitamin D3 Kern Pharma can cause adverse effects, although not everyone experiences them.

You should stop taking Calcium/Vitamin D3 Kern Pharma 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 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 frequency adverse effects (cannot be estimated from available data):serious allergic reactions.

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

5. Storage of Calcium/Vitamin D3 Kern Pharma

• No special storage conditions are required.
• Keep this medication out of sight and reach of children.
• Keep the package tightly closed. Do not use this medication after the expiration date shown on the package, after EXP. The expiration date is the last day of the month indicated.
• The validity period is 60 days after first opening.
• Do not use this medication if you observe any visible signs of deterioration.
• Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information / Additional information

Composition of Package contents and additional information / Additional information

The active ingredients 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 ingredients 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 Package contents and additional information / Additional information and package contents

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

Bottle of 60 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

KERN PHARMA, S.L.

Venus, 72. Poligono Industrial Colon II.

08228– Tarrasa, Barcelona

Spain

Manufacturer:

ITALFARMACO, S.p.A.

Viale Fulvio Testi 330

Milan (ITALY)

Tel.: 39 02 6443.1

Date of the last revision of this prospectus:July 2013

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