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PATIENT INFORMATION LEAFLET

Calcium Sandoz® Syrup

calcium glubionate and calcium lactobionate

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.

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

Calcium Sandoz Syrup belongs to a group of medicines called calcium supplements.

It is used to:

•    treat low levels of calcium in your body

•    help to slow down or stop loss of calcium from bones in osteoporosis (thinning of the bone)

•    treat people who do not get enough calcium in their diet

•    treat babies with low levels of calcium.

Do not take Calcium Sandoz Syrup if:

•    you are allergic (hypersensitive) to calcium glubionate or calcium lactobionate or any of the ingredients of Calcium Sandoz Syrup (see section 6 Further information)

• you have high levels of calcium in your blood

• you have very high levels of calcium in your urine

•    you have ever suffered from kidney stones, or have severe kidney problems

•    you have galactosaemia (a rare genetic disorder which means you cannot metabolise the sugar galactose).

If any of the above applies to you, or you are not sure, speak to your doctor or pharmacist before you take Calcium Sandoz Syrup.

Take special care with Calcium Sandoz Syrup

Before you take Calcium Sandoz Syrup tell your doctor if:

•    you are diabetic because Calcium Sandoz Syrup contains sugar

•    you have high levels of calcium in your urine.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines as they may interfere with Calcium Sandoz Syrup:

• vitamin D    - used for replacement therapy

• cardiac glycosides for example digoxin    - to treat an irregular heartbeat

•    tetracyclines (a type of antibiotic) for example, doxycycline, oxytetracycline -used to treat bacterial infections

•    fluoride preparations    - used to prevent tooth decay.

•    thiazide diuretics (water tablets) for example bendroflumethiazide, chlortalidone

- used to treat water retention or high blood pressure

If you are taking tetracycline antibiotics or fluoride preparations you should leave a gap of at least three hours between taking these medicines and taking Calcium Sandoz Syrup.

Pregnancy and breast-feeding

Calcium Sandoz Syrup may be taken by patients who are pregnant or breastfeeding.

Important information about some of the ingredients of Calcium Sandoz Syrup

•    Calcium Sandoz Syrup contains benzoic acid which may cause mild irritation to the skin, eyes and mucous membranes. It may also increase the risk of jaundice in newborn babies.

•    Calcium Sandoz Syrup contains 1.5g of sucrose per 5ml. This means you could be taking up to 22.5g of sucrose each day. Calcium Sandoz Syrup may not be suitable for you if you suffer from hereditary fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency or diabetes.

Always take Calcium Sandoz Syrup exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. Never change the dose yourself however well you feel.

Your doctor will tell you how many 5ml spoonfuls you should take and how often you should take them. If you are unsure about how many spoonfuls to take or when you should take them, ask your doctor or pharmacist.

Calcium Sandoz Syrup should be taken by mouth either as provided or after it is diluted with syrup Bp. If diluted it should be used within 14 days.

Adults

The usual dose for each condition is given below.

•    Osteoporosis: The usual dose is eleven to fifteen, 5ml spoonfuls of Calcium Sandoz Syrup per day.

•    Low calcium levels: The usual dose is three to fifteen, 5ml spoonfuls of Calcium Sandoz Syrup per day.

Elderly

Your doctor may give you a lower dose.

Make sure that you follow the instructions given to you by your doctor

Children

The usual dose for each condition is given below.

•    Low calcium levels: The usual dose is six to nine 5ml spoonfuls of Calcium Sandoz Syrup per day.

•    Low calcium diet: The usual dose is two to six 5ml spoonfuls of Calcium Sandoz Syrup per day.

Newborn

For newborn infants, the syrup may be mixed with the first (small) part of the milk feed.

•    Low calcium levels: 1.85ml of syrup per kg of body weight a day

What to do if you take more Calcium Sandoz Syrup than you should

If you accidentally take too much Calcium Sandoz Syrup or someone else takes any of your medicine, you should tell your doctor at once or go to your nearest accident and emergency department. Show any left-over medicines or

the empty packet to the doctor.

What to do if you forget to take Calcium Sandoz Syrup

If you miss a dose, take it as soon as possible, unless it is almost time to take your next dose. Do not take a double dose. Then go on as before.

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

Do not worry. Like all medicines, Calcium Sandoz Syrup can sometimes cause side effects, although not everyone gets them.

The following side effects have been reported:

Rare side effects (that affect less than 1 person in 1000):

•    constipation

•    diarrhoea

Other side effects:

•    increased calcium levels in your blood, symptoms of which include:

•    feeling or being sick

•    feeling thirsty

•    passing water more frequently

•    loss of appetite

•    stomach pain

•    bone pain

•    muscle weakness

•    drowsiness

•    confusion.

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 internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the reach and sight of children.

Do not take Calcium Sandoz Syrup after the expiry date which is printed on the bottle label. The expiry date refers to the last day of that month after EXP.

You should store your medicine in the original bottle with the lid kept firmly on.

After the bottle has been opened the contents should be used within 1 year.

If your doctor decides to stop your treatment, you should return any unused medicine to the pharmacist unless your doctor tells you to keep it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required.

These measures will help protect the environment.

What Calcium Sandoz Syrup contains

The active ingredients in this medicine are calcium glubionate and calcium lactobionate.

Each 5ml spoonful of Calcium Sandoz Syrup contains 1.09g calcium glubionate and 0.73g calcium lactobionate. The other ingredients are:

Orange natural flavour, tamaris flavour, benzoic acid, formic acid, sugar and water.

What Calcium Sandoz Syrup looks like and contents of the pack

Calcium Sandoz Syrup comes in bottles of 300ml.

Marketing Authorisation Holder and Manufacturer

The product licence holder is: Alliance Pharmaceuticals Ltd, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, UK.

Calcium Sandoz Syrup is manufactured by: FAMAR France, Site Industriel D’Orleans, Avenue du Champ de Mars, 45072, Orleans, Cedex 2 France

The information in this leaflet applies only to Calcium Sandoz Syrup. If you have any questions or you are not sure about anything, ask your doctor or pharmacist.

This leaflet was last approved: 14th January 2015

Calcium Sandoz is a registered Trademark of Novartis AG and is used under licence by Alliance Pharmaceuticals Limited.

Alliance, Alliance Pharmaceuticals Limited and associated devices are registered trademarks.

© Alliance Pharmaceuticals Limited 2015.

Calcium Sandoz PIL UK 006