PACKAGE LEAFLET : INFORMATION FOR THE USER

Cacit® D3 500 mg/440 IU Effervescent Granules for oral solution

(calcium carbonate/cholecalciferol)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Cacit D3 granules carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    You must contact a doctor if your symptoms worsen or do not improve.

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

In this leaflet:

1.    What Cacit D3 Granules are and what they are used for

2.    Before you take Cacit D3 Granules

3.    How to take Cacit D3 Granules

4.    Possible side effects

5.    How to store Cacit D3 Granules

6.    Further information

1.    WHAT CACIT D3 GRANULES ARE AND WHAT THEY ARE USED FOR

Cacit D3 Granules for oral solution contain calcium carbonate and cholecalciferol as the active ingredients. The granules provide extra calcium and Vitamin D (in addition to a normal diet). They are used in association with some osteoporosis (a condition where bone mass decreases and bone brittleness increases) treatments. They are also taken by elderly people who need extra calcium and vitamin D.

2.    BEFORE YOU TAKE CACIT D3 GRANULES DO NOT take Cacit D3 Granules if you have:

•    an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 on “What Cacit D3 Granules contain”).

• an overactive parathyroid    gland (hyperparathyroidism) or too much vitamin D in your body (hypervitaminosis D).

•    diseases and/or conditions which have resulted in a high concentration of calcium in your urine (hypercalciuria) or blood (hypercalcaemia), for example after a long period of immobility.

•    kidney stones.

Cacit D3 Granules are not intended for use in children.

Take special care with Cacit D3 Granules

The product may be used by patients requiring a salt free diet because it contains a very low amount of salt.

Consult your doctor or pharmacist before taking this medicine if you:

•    have impaired kidney function or have a tendency to form kidney stones - your treatment will need to be monitored carefully if your kidneys are not working properly to ensure you do not build up too much calcium in your blood.

•    have sarcoidosis (formation of nodules especially in the lymph nodes, lungs)

•    are immobilised with osteoporosis.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Seek medical advice before taking Cacit D3 Granules if you are already taking:

•    calcium and/or vitamin D

•    heart medicines such as digoxin or other cardiac glycosides

•    tetracycline antibiotics

•    thiazide diuretics (water tablets)

•    bisphosphonates or sodium fluoride (drugs used to treat bone disorders)

•    phenytoin or barbiturates

•    glucocorticosteroids.

You should also talk to your doctor if you regularly eat food containing oxalic acid, phosphate or phytinic acid.

Pregnancy and breast-feeding

Women who are pregnant or breast-feeding can take Cacit D3 Granules providing their daily intake does not exceed 1500mg calcium and 600 IU vitamin D3.

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

Driving and using machines

Cacit D3 Granules are not expected to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Cacit D3 Granules

Sorbitol and sucrose - if you know you have an intolerance to some sugars, contact your doctor before taking this medicine.

RECTO

Soya oil - if you are allergic to soya or peanut, do not use this medicine. Potassium - this medicine contains 81.57mg / 171.2mg potassium per sachet. This needs to be taken into consideration by patients who have reduced kidney function or are on a controlled potassium diet.

3. HOW TO TAKE CACIT D3 GRANULES

Adults

Pour the contents of the sachet into a glass, fill with water, stir then drink immediately after the fizzing has stopped. The recommended dosage is either 1 or 2 sachets per day. Your doctor or pharmacist will tell you how many sachets you need to take a day.

Cacit Vitamin D3 Granules are NOT intended for use in children.

If you take more Cacit D3 Granules than you should

Do not exceed the recommended dose. If you take too much medicine, tell your doctor immediately or visit your nearest Accident & Emergency Department (take the pack with you if possible). Symptoms of overdose may include nausea (feeling sick), vomiting, polydipsia (excessive thirst), polyuria (frequent passing of urine), constipation.

If you forget to take Cacit D3 Granules

If you miss a dose, take the next dose as soon as you remember and continue taking your medicine as before (do not take a double dose).

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cacit D3 Granules can cause side effects, although not everybody gets them.

You may suffer an allergic reaction. If you experience rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue, stop taking the medicine immediately and seek urgent medical help.

Uncommon side effects: a high concentration of calcium in the blood (hypercalcaemia) or urine (hypercalciuria).

Rare side effects:

•    nausea (feeling sick)

•    abdominal pain

•    diarrhoea

•    constipation

•    wind

•    skin rashes and itching.

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

5.    HOW TO STORE CACIT D3 GRANULES

Keep out of the reach and sight of children.

Do not use Cacit D3 Granules after the expiry which is stated on the carton after “Expiry Date:” The date refers to the last day of that month.

Do not store above 25°C and keep in original packaging.

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 Cacit D3 Granules contain

The active substance in one 4g sachet is calcium carbonate 1250mg (provides 500mg of calcium as calcium citrate when dissolved in water) and 440 IU (International Units) of cholecalciferol (vitamin D).

The other ingredients are citric acid (E330), malic acid (E296), gluconolactone, maltodextrin, sodium cyclamate (E952), sodium saccharin (E954), lemon flavouring {sorbitol (E420), mannitol (E421), D-gluconolactone, dextrin, gum Arabic (E414), lemon oil}, rice starch, potassium carbonate, traces of corn starch, sucrose, gelatin, soya oil and tocopherol (E307) - see also end of Section 2 on ‘Important information about some of the ingredients of Cacit D3 Granules’.

What Cacit D3 Granules look like and contents of the pack

The white granules for oral solution are supplied in 4g sachets (paper/aluminium/ plastic) and packed in boxes of 30 sachets.

Marketing Authorisation Holder

Warner Chilcott UK Limited Old Belfast Road, Millbrook, Larne,

County Antrim, BT40 2SH, United Kingdom

Manufacturer

Hermes Pharma Gmbh

Allgau 36 - A

9400 Wolfsberg - Austria

® WC Group of companies

Marketing Authorisation Number:

PL 10947/0017

This leaflet was last approved in March 2012.