▲

^actavis

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

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

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Index

^ What Calcium and

Ergocalciferol tablets are and what they are used for Before you take How to take ^ Possible side effects Tj How to store

Further information

j What calcium and Ergocalciferol tablets are and what they are used for

Calcium and Ergocalciferol (vitamin D₂) tablets may be used to treat vitamin D deficiency including rickets (weak bones and teeth).

2j Before you take

Do not take Calcium and Ergocalciferol tablets and tell your doctor if you:

•    are allergic (hypersensitive) to calcium lactate, calcium phosphate, ergocalciferol (vitamin D) or any of the other ingredients in Calcium and Ergocalciferol tablets (see secion 6)

•    have high levels of calcium in the blood (hypercalcaemia) or urine (hypercalciuria)

•    have an overactive thyroid gland (hyperthyroidism)

•    have severe kidney failure

•    have osteoporosis (brittle bones) caused by immobility or tumours

•    have recently had a large intake of vitamin D.

Continued top of next column 50130495

Check with your doctor or pharmacist

before taking Calcium and Ergocalciferol tablets if you:

•    have kidney or heart disease

•    have kidney stones or gallstones

•    have sarcoidosis (enlarged lymph nodes)

•    are elderly and taking cardiac glycosides

(heart medicine such as digitalis, digoxin) or diuretics (water tablets) as calcium increases the effects of these medicines on the heart

•    are taking any medicines or vitamin supplements containing calcium or vitamin D.

Taking other medicines

Please tell your doctor or pharmacist if you

are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

•    diuretics (water tablets), particularly thiazide diuretics (e.g. hydrochlorothiazide)

•    cardiac glycosides (e.g. digitalis and digoxin)

•    medicines to treat epilepsy (e.g. phenytoin or phenobarbital)

•    corticosteroids (e.g. prednisolone and dexamethasone)

•    tetracycline antibiotics, a gap of at least two to three hours should be left between taking these medicines and Calcium and Ergocalciferol tablets

•    bisphosphonate or sodium fluoride, a gap of at least three hours should be left between taking these medicines and Calcium and Ergocalciferol tablets.

Pregnancy and breast-feeding:

If you are pregnant, planning to become pregnant or are breast-feeding tell your doctor or pharmacist before taking this medicine.

Sugar intolerance

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose and sucrose.

Tests

Your doctor may want to carry out blood or urine tests, especially if you are on long-term treatment or are elderly and being treated with cardiac glycosides or diuretics.

Continued over page

I 15mm

^actav/s creating value in pharmaceuticals 0044 1271 311400 0044 1271 311449 artworkstudlo@actavls.co.u 0044 1271 327411	colours/plates: Calcium and Ergocalciferol tablets i. Black User Test Pil 2
	ifa-M-v-a CH1 QA/iriC . dimnnriAnr. 1 /IOvT1A Dnni Crtd 1		3.
	ItCI 1 1 1 IW. JU 1	umiciDium. i ‘toA/. i u i tcc i icu	4.
	k print proof no: 06	pharmacode:	5.
	origination date: 23/08/07	design repeat (single):	6.
MOCKUP	originated by: R.Wrey	web:	Non Printing Colours
			1.
ONLY	revision date: 19/12/08
			2.
	revised by: R.Wrey	Supplier: MYH	3.

Driving and using machinery

Calcium and Ergocalciferol tablets may cause drowsiness or confusion. Make sure you are not affected before you drive or operate machinery.

Taking Calcium and Ergocalciferol tablets with food and drink

Spinach, rhubarb and whole cereals contain acids (oxalic and phytic) which can affect how the calcium is absorbed. Do not eat foods containing high amounts of these acids within two hours of taking Calcium and Ergocalciferol tablets. Calcium and Ergocalciferol tablets should be taken after meals.

How to take

Always take Calcium and Ergocalciferol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Crush tablets before taking, after meals.

Doses:

Adults and children over 6 years

One tablet a day. Elderly should not use regularly for more than 1 to 2 months unless otherwise advised by your doctor.

Children under 6 years Not recommended

If you take more than you should

If you (or someone else) swallow a lot of the tablets at the same time or if you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include stomach pain, loss of appetite, bone pain, constipation, headache, unusual tiredness or weakness, confusion or mood changes, feeling or being sick, depositing of calcium in tissues such as kidneys and arteries, excessive thirst, increase in amount and frequency of urination, kidney stones, feeling of dizziness or spinning, increased urea in the blood, irregular heart beat, coma and an increased plasma cholesterol level. Individuals with symptoms of overdose should avoid exposure to direct sunlight.

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

Possible side effects

Like all medicines, Calcium and Ergocalciferol tablets can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects, they get worse or you notice any effects not listed.

Continued top of next column 50130495

Uncommon (occurs in less than 1 in 100 users):

•    high levels of calcium in the blood (hypercalcaemia) the symptoms include, feeling and being sick, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, a need to pass more water than usual, muscle weakness, drowsiness and confusion.

•    high levels of calcium in urine (hypercalciuria).

Rare (occurs in less than 1 in 1,000 users):

•    constipation, wind (flatulence), feeling sick, stomach pain, diarrhoea, itchy skin rash caused by allergic reaction - pale or red irregular raised patches with severe itching (hives), rash, itching.

How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place. Protect from light.

Do not use Calcium and Ergocalciferol tablets after the expiry date stated on the label/carton/bottle. The expiry 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 Calcium and Ergocalciferol tablets contain

•    Each tablet contains the following active substances (the ingredients that makes the tablets work)

300mg calcium lactate, 150mg calcium phosphate equivalent to 2.415mmol of calcium (Ca²⁺) and 10micrograms ergocalciferol (vitamin D₂) equivalent to 400iu. Calcium and Ergocalciferol tablets are available in one strength.

•    The other ingredients are lactose, maize starch, sucrose, stearic acid and magnesium stearate.

What Calcium and Ergocalciferol tablets look like and contents of the pack

Calcium and Ergocalciferol tablets are white, circular, biconvex, uncoated tablets.

Pack size is 28.

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in December 2008.

actavis

Actavis, Barnstaple, EX32 8NS, UK

Actavis creating value in pharmaceuticals 0044 1271 311400 0044 1271 311449 artworkstudlo@actavls.co.u 0044 1271 327411	colours/plates: Calcium and Ergocalciferol tablets 1 Black User Test Pil 2
	itcsrv, r»/"\* cm QrVIOC , ^1 i™ i . 1 A Q\/"~) 1 A DrvrJ Crvc-i 1		3.
	'	UMMCI DIUI D. 1 nOA/. 1 U 1 \CCI 1 CU	4.
	k print proof no: 06	pharmacode:	5.
	origination date: 23/08/07	design repeat (single):	6.
MOCKUP	originated by: R.Wrey	web:	Non Printing Colours
			1.
ONLY	revision date: 19/12/08
			2.
	revised by: R.Wrey	Supplier: MYH	3.