Calcium/vitamin D3 Kern Pharma 600 mg/400 IU chewable tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

Read the entire leaflet carefully before starting to take this medicine because 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 must not be given 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.

Leaflet contents:

1. What Calcio/Vitamina D3 Kern Pharma is and what it is used for
2. What you need to know before taking 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 pack and additional information

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

This medicine is a combination of Calcium and Vitamin D.

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

This medicine may also be used as a vitamin D and calcium supplement in the treatment of osteoporosis in patients with evident deficiency of calcium and vitamin D, or who are at high risk of such deficiency.

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

2. What you need to know before taking Calcio/Vitamina D3 Kern Pharma / Before taking Calcio/Vitamina D3 Kern Pharma

Do not take Calcio/Vitamina D3 Kern Pharma 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 kidney stones.
• If you have renal 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 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.

Use of Calcium/Vitamin D3 Kern Pharma with other medicines

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:

• Heart 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 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 one hour before taking Calcium/Vitamin D3 Kern Pharma.

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

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

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

If you are taking medicines for hypothyroidism (levotiroxine), you should separate the administration of Calcium/Vitamin D3 Kern Pharma by at least four hours.

Use of Calcio/Vitamina D3 Kern Pharma 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 Calcio/Vitamina D3 Kern Pharma within two hours after consuming foods high in oxalic acid or phytic acid.

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

Pregnancy, lactation and fertility

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

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

Calcium/Vitamin D3 Kern Pharma may be taken during lactation. Calcium and vitamin D3 are excreted in breast milk. This should be taken into account when additional vitamin D is administered to the infant.

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 machinery

This medicine contains aspartame

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

This medicine contains sorbitol, lactose, and sucrose

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

This medicine contains soya oil

If you are allergic to peanuts or soya, do not take this medicine.

3. How to take Calcio/Vitamina D3 Kern Pharma

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

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

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

The tablets should be chewed and then, if desired, you may drink a small amount of water.

Alternatively, the tablets may be placed in half a glass of water and, once dissolved, the solution may be drunk.

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

If you take more Calcium/Vitamin D3 Kern Pharma than you should

Contact 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 Calcium/Vitamin D3 Kern Pharma may include loss of appetite, abnormally large amounts of urine, nausea, vomiting, and constipation.

If you forget to take Calcio/Vitamina D3 Kern Pharma

Take it as soon as you remember. Afterwards, take your 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. Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, Calcio/Vitamina D3 Kern Pharma can cause adverse effects, although not everyone experiences them.

You should stop taking Calcio/Vitamina 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 diarrhoea.

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

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

5. Storage of Calcio/Vitamina D3 Kern Pharma

• No special storage conditions are required.
• 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.
• The shelf life is 60 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 properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information / Other information

Composition of Contents of the pack and other information / Other information

The active substances are calcium carbonate 1500 mg, equivalent to 600 mg of calcium, and colecalciferol 0.01 mg, equivalent to 400 IU of vitamin D.

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

Appearance of Contents of the pack and other information / Other information and contents of the pack

Contents of the pack and other information / Other information is presented in the form of chewable tablets for oral administration.

Bottle containing 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this package leaflet: July 2013

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