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Cacit 500mg Effervescent Tablets

Document: leaflet MAH BRAND_PL 10947-0016 change

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Cacit® 500mg Effervescent Tablets

(calcium carbonate)

Read all of this leaflet carefully before you start taking this medicine.

This medicine is available without prescription. However, you still need to use Cacit Effervescent Tablets 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 Effervescent Tablets are and what they are used for

2.    Before you take Cacit Effervescent Tablets

3.    How to take Cacit Effervescent Tablets

4.    Possible side effects

5.    How to store Cacit Effervescent Tablets

6.    Further information

1.    WHAT CACIT EFFERVESCENT TABLETS ARE AND WHAT THEY ARE USED FOR

Cacit Effervescent Tablets contain calcium carbonate as the active ingredient (which when dispersed in water provide 500mg of elemental calcium as calcium citrate). The tablets provide extra calcium, in addition to a normal diet, and are used to treat conditions in which the body’s calcium levels need to be increased. Calcium is essential for healthy growth of bones and teeth.

2.    BEFORE YOU TAKE CACIT EFFERVESCENT TABLETS

Do not take Cacit Effervescent Tablets if you have:

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

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

•    a high concentration of calcium in your urine (hypercalciuria) or blood (hypercalcaemia). A high concentration of calcium in the blood may be caused by impaired kidney function, an overactive parathyroid gland, too much Vitamin D in your body or certain bone tumours.

•    been immobilised for long periods and had a high concentration of calcium in your blood or urine.

•    kidney stones.

Take special care with Cacit Effervescent Tablets

Consult your doctor before taking this medicine if you have:

•    a tendency to form kidney stones or impaired kaidney function - 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.

•    sarcoidosis (formation of nodules especially in the lymph nodes, lungs, bones and skin).

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 Effervescent Tablets if you are already taking:

•    vitamin D

•    heart medicines such as digoxin and cardiac glycosides

•    tetracycline antibiotics

•    thiazide diuretics (water tablets)

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

Pregnancy and breast-feeding

Women who are pregnant or breast-feeding can take Cacit Effervescent Tablets.

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

Driving and using machines

Cacit Effervescent Tablets are not expected to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Cacit Effervescent Tablets

Sunset yellow FCF (E110) colouring - this may cause allergic reactions including asthma. Allergy is more common in those people who are allergic to aspirin. Sodium - This medicine contains up to 100mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

3. HOW TO TAKE CACIT EFFERVESCENT TABLETS

The tablets must be dissolved completely in a glass of water and the solution consumed immediately.

Cacit (Calcium Carbonate) 500mg PIL - (Warner Chilcott) UK

colours/plates:

1. Black

item no: AAAG9368

dimensions: 148 x 210

2.

print proof no: 3

pharmacode:

3.

4.

origination date: 04.06.14

min pt size: 9pt

5.

6.

approved for print/date

revision date: 12.12.14

Technical Approval

Non Printing Colours

1.

date sent: 04.06.14

2.

technically app. date:

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Your doctor will normally prescribe a suitable dose for you:

Adults and Elderly:

•    To treat conditions caused by lack of calcium, the dose is usually between 2 and 5 tablets per day.

•    To prevent bone damage caused by osteoporosis, a dose of 1 to 3 tablets is required per day.

•    To supplement calcium in your diet, the dose is up to 3 tablets a day.

Children:

To treat conditions caused by lack of calcium and to supplement calcium in your diet:

•    6 to 10 years: 1 tablet daily (500 mg per day),

•    over the age of 10 years: 2 tablets daily (1 g per day).

If you take more Cacit Effervescent Tablets 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), polydipsia (excessive thirst), polyuria (frequent passing of urine), constipation.

If you forget to take Cacit Effervescent Tablets

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 pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cacit Effervescent Tablets 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 tablets immediately and seek urgent medical help.

The following rare side effects have been reported:

•    nausea

•    abdominal pain

•    diarrhoea

•    constipation

•    wind

•    skin rashes and itching

•    high concentration of calcium in the blood (hyper-calcaemia) or urine (hypercalciuria).

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

©Warner Chilcott

Reporting of side effects

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

You can also report side effects directly via the national reporting system:

Yellow Card Scheme Website:

www.mhra.gov.uk/vellowcard

• By reporting side effects you can help provide more information on the safety of this medicine

5.    HOW TO STORE CACIT EFFERVESCENT TABLETS

Keep out of the reach and sight of children. Keep the tube tightly closed in order to protect from moisture. Do not use Cacit Effervescent Tablets after the expiry which is stated on the carton after ‘Exp’.

The date refers to the last day of that month. 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 Effervescent Tablets contain The active substance is calcium carbonate, 1.25g per tablet (500mg elemental calcium when dissolved in water as calcium citrate).

The other ingredients are citric acid (E330), sodium saccharin (E421), sodium cyclamate, sunset yellow FCF (E110) and flavour - see also end of Section 2 on ‘Important information about some of the ingredients of Cacit Effervescent Tablets’.

What Cacit Effervescent Tablets look like and contents of the pack

The tablets are supplied in boxes of 76 tablets (4 plastic tubes each containing 19 tablets).

Marketing Authorisation Holder

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

County Antrim, BT40 2SH, United Kingdom

Manufacturer

Hermes Pharma Ges.m.b.H.

Allgau 36 9400 Wolfsberg Austria

® WC Group of companies

Marketing Authorisation Number: PL 10947/0016

This leaflet was last approved in December 2014

AAAG9368

Cacit (Calcium Carbonate) 500mg PIL - (Warner Chilcott) UK

colours/plates:

1. Black

item no: AAAG9368

dimensions: 148 x 210

2.

print proof no: 3

pharmacode:

3.

4.

origination date: 04.06.14

min pt size: 9pt

5.

6.

approved for print/date

revision date: 12.12.14

Technical Approval

Non Printing Colours

1.

date sent: 04.06.14

2.

technically app. date:

3.