Manufacturer    23

Recipharm Stockholm AB Lagervagen 7 SE-136 50 Jordbro Sweden

This leaflet was last approved in: 2010-10-29

30 tablets

Kalcipos™-D

500 mg/800 IU chewable tablets

Meda Pharmaceuticals Ltd,, Skyway House, rICDO Parsonage Road, Take ley, Bishop's Stortford

One chewable tablet contains:

Calcium carbonate corresponding to 500 mg calcium, cholecalciferol 20 microgram corresponding to Vitamin D3 800 IU, Glucose 200 mg, sucrose 3.8 mg, soya bean oil 0.8 mg and excipients.

Keep out of the reach and sight of children.

Store in original package, in order 05 to protect from light.    $

Keep the container tightly closed in order to protect from moisture.

Read the package leaflet before use.

Oral use.    _ /-gy

PL 15142/0056    | POM |    (fJJ

30 tablets

Kalcipos™-D

500 mg/800 IU chewable tablets

Calcium / Cholecalciferol (Vitamin D3)

One chewable tablet contains:

Calcium carbonate corresponding to 500 mg calcium, cholecalciferol 20 microgram corresponding to Vitamin D3 800 IU. Glucose 200 mg, sucrose 3.8 mg, soya bean oil 0.8 mg and excipients.

Keep out of the reach and sight of children.

Store in original package, in order to protect from light.

Keep the container tightly closed in order to protect from moisture.

Read the package leaflet before use. Oral use.

PL 15142/0056    EJ

ncDO

Meda Pharmaceuticals Ltd., Skyway House, Parsonage Road, Takeley, Bishop's Stortford

Keep the container tightly closed in order to protect from    19

moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Kalcipos-D contains

- The active substances are calcium carbonate 1300 mg corresponding to calcium 500 mg and cholecalciferol 20 microgram

1. WHAT KALCIPOS-D IS AND WHAT IT IS USED FOR 4

Kalcipos-D is used to prevent and treat calcium and vitamin D₃ deficiency in the elderly, and as an additional treatment in the management of osteoporosis, when a risk of deficiency of calcium and vitamin D₃ is suspected.

Kalcipos-D contains calcium and vitamin D₃ which both are important components for the formation of bone. Vitamin D₃ regulates the uptake and metabolism of calcium as well as the incorporation of calcium in bone tissue.

The amount of calcium in Kalcipos-D is lower than the usually 15 recommended daily intake. Kalcipos-D is therefore meant for patients with need for additional vitamin D, but with a dietary intake of 500-1000 mg of calcium per day. The dietary intake of calcium should be estimated by the prescriber.

Kalcipos-D are not intended for use in children and adolescents.

If you take more Kalcipos-D than you should

If you may have taken more Kalcipos-D than you should, talk to your doctor or pharmacist immediately.

-    heart problems (cardiac glycosides such as digoxin)    8

-    high cholesterol (cholestyramine)

-    constipation (laxatives such as liquid paraffin)

-    epilepsy (phenytoin or barbiturates)

-    inflammatory conditions/suppression of immunity (corticosteroids)

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

Ask your doctor, pharmacist or other health personal if you have :

further questions and always follow their instructions.

2. BEFORE YOU TAKE KALCIPOS-D

Do not take Kalcipos-D

-    if you are allergic (hypersensitive) to the active substances or any of the other ingredients.

-    if you have hypercalcaemia (increased levels of calcium in the blood) or hypercalciuria (increased levels in the urine).

-    if you have hypervitaminosis D (increased levels of vitamin D in the blood).

If any of the side effects gets serious, or if you notice any side 18 effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE KALCIPOS-D

Keep out of the reach and sight of children.

Keep container tightly closed. Do not use Kalcipos-D after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

If you simultaneously use a certain drug for;    9

-    osteoporosis (bisphosphonates)

you should take this at least one hour before you take Kalcipos-D.

If you simultaneously use certain drugs for;

-    infection (quinolones)

you should take these two hours before or six hours after taking Kalcipos-D.

If you simultaneously use certain drugs for;

-    infection (tetracyclines)

intolerance to some sugars, contact your doctor before taking this 14 medicinal product.

Kalcipos-D contains glucose that can be harmful to your teeth and it is therefore important to maintain good oral hygiene.

3. HOW TO TAKE KALCIPOS-D

The dosage is individually decided for you by your doctor.

Usual dose: 1 tablet daily.

The chewable tablet should be chewed or slowly melted in the mouth, never swallowed whole.

•    difficult to swallow    17

•    hives and difficulty breathing

Uncommon (occurs in less than 1 out of 100patients): hypercalcaemia (increased levels of serum calcium) and/or hypercalciuria (increased levels of urine calcium.

Rare (occurs in less than 1 out of1 000 patients) constipation, flatulence, nausea, abdominal pain, diarrhoea, pruritus, rash and urticaria.

Not hiown (cannot be estimated from the available data): Serious allergic reactions .

-    if you have kidney stones    e

-    if you have kidney failure

-    if you are allergic to soya or peanuts. One tablet Kalcipos-D contains 0.8 mg hydrogenated soya bean oil.

Take special care with Kalcipos-D

-    if you suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs, skin and joints).

-    if you are taking other drugs containing vitamin D or calcium.

-    if you have poor kidney function or high tendency of renal stone formation.

Driving and using machines    13

Kalcipos-D has no known effects on ability to drive or use machines.

Important information about some of the ingredients of Kalcipos-D

One tablet of Kalcipos-D chewable tablet contains 0.8 mg hydrogenated soyabean oil. If you are allergic to soya or peanuts you should not take this medicinal product.

One tablet Kalcipos-D chewable tablet contains 200 mg glucose and 3.8 mg sucrose. If you have been told by your doctor that you have

you should take these two hours before or four to six hours after 10 taking Kalcipos-D.

If you simultaneously take certain drugs for;

-    dental caries (sodium fluoride)

-    anaemia (iron)

you should take these drugs at least three hours before taking Kalcipos-D.

If you simultaneously use a certain drug for;

-    hypothyroidism (levothyroxine)

-    if you are immobilized with osteoporosis.    7

Consult your doctor before taking Kalcipos-D if any of the above points apply to you.

Taking other medicines

Tell your doctor or pharmacy staff if you take or recently have taken other drugs, even non prescription drugs.

The effect of the treatment can be affected if this drug is taken simultaneously with certain other drugs against:

-    high blood pressure (thiazide diuretic)

Some symptoms of overdose of Kalcipos-D are loss of appetite,    16

thirst, abnormal increased urine secretion, nausea, vomiting and constipation.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Kalcipos-D can cause side effects, although not everybody gets them.

You should stop taking Kalcipos-D and see your doctor immediately if you experience symptoms of serious allergic reactions, such as • swollen face, lips, tongue or throat

you should separate the intake with Kalcipos-D forte by at    11

least four hours.

Taking Kalcipos-D with food and drink

The calcium absorption may be inhibited by food containing oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals). You should wait at least two hours before you take Kalcipos-D if you have eaten food with high content of oxalic acid or phytic acid.

Pregnancy and breast-feeding    12

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

Kalcipos-D is therefore not recommended during pregnancy. However, Kalcipos-D can be used during pregnancy, in case of a calcium and vitamin D deficiency.

Kalcipos-D can be used during breast-feeding. Calcium and vitamin D₃ pass over into breast milk. This should be considered when giving additional vitamin D to the child.

Ask your doctor or pharmacist for advice before taking any medicine.