5. HOW TO STORE CALCIUM CARBONATE/ COLECALCIFEROL 1500MG/400IU CHEWABLE TABLETS

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 25°C. Store in the original package in order to protect from moisture.

•    Do not use this medicine after the expiry date which is stated on the carton and blister strip has passed. The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Calcium Carbonate / Colecalciferol 1500mg / 400IU chewable tablets contains

•    Each chewable tablet contains

Calcium Carbonate 1500mg (equivalent to Calcium 600mg).

Colecalciferol as Colecalciferol Concentrate (Powder Form) 400 IU (equivalent to Vitamin D₃ 10micrograms).

•    The other ingredients are Starch Pregelatinized, Povidone K30, Aspartame E951, Xylitol, Mannitol E421, Sorbitol E420, Magnesium Stearate,

Tutti Frutti flavour as Powdarome Tutti Frutti Premium (contains Maize Maltodextrin, Propylene Glycol, Alpha Tocopherol).

•    Vitamin D, concentrate contains DL-a-tocopherol, Modified Food Starch, Triglycerides of medium chain fatty acids, Sodium Ascorbate Crystalline, Sucrose, Colloidal anhydrous silica.

What Calcium Carbonate / Colecalciferol 1500mg / 400IU chewable tablets looks like and contents of the pack

•    The tablets are White to off white coloured flat circular beveled edge chewable tablets debossed with 'BP' on one side and '5' on the other side.

•    Calcium Carbonate and Colecalciferol chewable tablets are provided in packs of 56 and 112 tablets.

Marketing Authorisation Holder and Manufacturer responsible for batch release Marketing Authorization Holder:

Blue Bio Pharmaceuticals Limited, 5th Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland Manufacturer

Central Pharma (contract packing) Ltd,

Caxton Road, Elm Farm Industrial Estate,

Bedford MK 41 OXZ UK.

This leaflet was last revised in February 2016

PACKAGE LEAFLET: INFORMATION FOR THE USER Calcium Carbonate/ Colecalciferol 1500mg/400IU Chewable Tablets

Read all of this leaflet carefully before you start

taking this medicine because it contains important

information for you.

Always take this medicine exactly as described in this

leaflet or as your pharmacist has told you

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

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

•    You must talk to a doctor if you do not feel better or your symptoms worsen.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Calcium Carbonate / Colecalciferol 1500mg / 400IU Chewable Tablets are and what they are used for

2.    What you need to know before you take Calcium Carbonate / Colecalciferol 1500mg / 400IU Chewable Tablets

3.    How to take Calcium Carbonate / Colecalciferol 1500mg / 400IU Chewable Tablets

4.    Possible side effects

5.    How to store Calcium Carbonate / Colecalciferol 1500mg / 400IU Chewable Tablets

6.    Contents of the pack and other information.

1. WHAT CALCIUM CARBONATE/ COLECALCIFEROL 1500MG/400IU CHEWABLE TABLETS ARE AND WHAT THEY ARE USED FOR

Calcium Carbonate and Colecalciferol chewable tablets contain Calcium and Vitamin D₃ which are both essential for healthy bones and teeth.

Calcium Carbonate and Colecalciferol chewable tablets provide extra calcium and vitamin D, to your diet. It is therefore used in conditions where your body's calcium and vitamin D levels need to be increased.

Calcium Carbonate and Colecalciferol chewable tablets can be recommended by pharmacist for certain bone conditions, for example, osteoporosis.

Studies show that taking calcium and vitamin D₃ over a long time can prevent hip and other non vertebral bone fractures in later life.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCIUM CARBONATE/COLECALCIFEROL 1500MG/400IU CHEWABLE TABLETS

Warnings and precautions:

Talk to your doctor or pharmacist before taking Calcium Carbonate and Colecalciferol chewable tablets.

Tell your pharmacist if you:

•    Have high levels of calcium in your blood (hypercalcaemia) or high levels of calcium in your urine (hypercalciuria). If you are unsure your doctor will advise you.

•    Have problems with your kidneys, for example kidney stones.

•    Have sarcoidosis (inflammation that produces lumps of cells in various organs in the body), your doctor will be able to tell you if you do.

•    Have previously been told by your doctor that you have an intolerance to some sugars.

•    Are taking any other medication, even those you may have bought for yourself without prescription.

Other medicines and Calcium Carbonate / Colecalciferol 1500mg / 400IU chewable tablets

•    Tell your pharmacist if you are taking calcium supplements or antacids for indigestion, digitalis drugs (eg. Lanoxin), diuretics or corticosteroids.

•    If you are taking thyroxine, bisphosphonates, iron or fluoride medicines, tetracycline or quinolone antibiotics make sure your pharmacist knows this. When taking these medicines leave a period of about 4 hours before taking your Calcium Carbonate and Colecalciferol chewable tablets. Do not take them at the same time.

•    Tell your pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility In pregnancy or when breast feeding, Calcium Carbonate and Colecalciferol chewable tablets should only be used under medical supervision. Ask your pharmacist for advice before taking any medicine.

Calcium Carbonate / Colecalciferol 1500mg / 400IU chewable tablets with food This medicine should not be taken within 2 hours of eating foods rich in oxalic acid (e.g. spinach and rhubarb), phosphate (e.g. bananas), or phytic acid (e.g. whole cereals).

Calcium Carbonate / Colecalciferol 1500mg / 400IU chewable tablets contains Aspartame, Sorbitol and Sucrose

•    This medicinal product contains Aspartame which is a source of phenylalanine. May be harmful for people with phenylketonuria.

•    This medicinal product also contains Sorbitol and Sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE CALCIUM CARBONATE/ COLECALCIFEROL 1500MG/400IU CHEWABLE TABLETS

Always take Calcium Carbonate and Colecalciferol chewable tablets exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your pharmacist if you are not sure.

Adults, elderly and children over 12 years of age:

2 tablets daily, ideally one taken in the morning and one tablet in the evening. The tablets should be chewed. Do not swallow whole.

Children under 12:

Calcium Carbonate and Colecalciferol chewable tablets must not be given to children under 12 years old.

If you take more Calcium Carbonate / Colecalciferol 1500mg / 400IU chewable tablets than you should

You should only take what your pharmacist recommends. If you take too many Calcium Carbonate and Colecalciferol chewable tablets contact your pharmacist if you can do so. If not, go to the nearest hospital casualty department immediately, taking the Calcium Carbonate and Colecalciferol chewable tablets pack and remaining tablets with you.

If you forget to take Calcium Carbonate / Colecalciferol 1500mg / 400IU chewable tablets

If you forget to take your tablet, take it as soon as possible and continue to take the tablets as normal. Do not take a double dose to make up for a forgotten tablet. If you stop taking Calcium Carbonate / Colecalciferol 1500mg / 400IU chewable tablets Always talk to your pharmacist before stopping using Calcium Carbonate and Colecalciferol chewable tablets.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Calcium Carbonate and Colecalciferol chewable tablets can cause side effects, although not everybody gets them.

Rare side effects (affecting fewer than 1 in 1,000 people)

•    Constipation, wind, feeling sick, stomach ache, diarrhoea

•    Skin rash

•    Hypercalcaemia (too much calcium in your blood) and hypercalciuria (too much calcium in your urine).

If you are on long term treatment your doctor may, from time to time wish to check the level of calcium in your blood and take urine samples to monitor kidney function.

Reporting of side effects

If you get any side effects, talk to your doctor or, pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.