PATIENT INFORMATION LEAFLET ALENDRONIC ACID 70MG TABLETS

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 further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you personally and you should 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this Leaflet

1.    What Alendronic acid 70mg Tablets are and what they are used for

2.    Before you take Alendronic acid 70mg Tablets

3.    How to take Alendronic acid 70mg Tablets

4.    Possible side effects

5.    How to store Alendronic acid 70mg Tablets

6.    Further Information

WHAT ALENDRONIC ACID 70MG . TABLETS ARE AND WHAT THEY ARE USED FOR

The active ingredient, alendronate monosodium trihydrate, belongs to a group of medicines called "bisphosphonates". It works by preventing the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone.

Alendronic acid 70mg Tablets are used to treat the following condition:

- Postmenopausal osteoporosis.

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BEFORE YOU TAKE ALENDRONIC ACID 70MG TABLETS

If any of the following applies to you, speak to your doctor or pharmacist before you start taking Alendronic acid 70mg Tablets as they may not be suitable for you.

Do not take Alendronic acid 70mg Tablets:

-    If you are allergic (hypersensitive) to alendronate monosodium trihydrate or any of the other ingredients of Alendronic acid 70mg Tablets.

-    If you have certain disorders of the oesophagus (the tube that connects your mouth with your stomach).

-    If you are unable to stand or sit upright for at least 30 minutes.

-    If your doctor has told you that you have low blood calcium.

-    If you are or think you may be pregnant.

-    If you are breast-feeding.

-    you    have a planned dental extraction

-    you    suffer from kidney problems

-    you    have any allergies

-    you have trouble swallowing or digestive problems.

A dental examination should be considered before you start the treatment with alendronic acid if you have any of the conditions below.

-    you    have cancer

-    you    are undergoing chemotherapy or

radiotherapy

-    you are taking steroids

-    you don't receive routine dental care.

-    you have gum disease.

Appropriate preventive dental care, as recommended by the dentist, should be followed during treatment.

Taking other medicines:

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

-    After swallowing your tablet, wait at least 30 minutes before taking any other medication for the day. Alendronic acid 70mg Tablets are only effective if taken when your stomach is empty.

Taking Alendronic acid 70mg Tablets with food and drink:

Patients must wait at least 30 minutes after taking alendronate before taking any food or drink.

Pregnancy and breast-feeding:

Alendronic acid 70mg Tablets can not be used during pregnancy and if you are breastfeeding.

Driving and using machines:

Your medicine does not usually affect your ability to drive or operate machinery.

Other precautions you should take:

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

HOW TO TAKE ALENDRONIC ACID . 70MG TABLETS

Your doctor has decided on the dose that is suited to you. The length of your course of treatment will depend on what condition you are suffering from. Always take Alendronic acid 70mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Children and adolescents:

Alendronate should not be given to children and adolescents.

1.    Choose the day of the week that best fits your schedule. Every week, take your Alendronic acid 70mg Tablets on your chosen day.

2.    After getting up for the day and before taking your first food, drink or other medication, swallow your Alendronic acid 70mg Tablet with a full glass of plain water only (not less than 200 ml or 7 fl. oz.).

Do not chew or allow the tablet to dissolve in your mouth.

3.    After swallowing your Alendronic acid 70mg Tablet do not lie down. Stay fully upright (or sat upright) for at least 30 minutes and do not lie down until after your first food of the day.

4.    Do not take Alendronic acid 70mg Tablets at bedtime or before getting up for the day.

5.    If you develop difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic acid 70mg Tablets and contact your doctor.

6.    After swallowing your Alendronic acid 70mg Tablet, wait at least 30 minutes before taking your first food, drink or other medication of the day, including antacids, calcium supplements and vitamins. Alendronic acid 70mg Tablets are only effective if taken when your stomach is empty.

If you take more Alendronic acid 70mg Tablets than you should:

If you (or someone else) accidentally take too many Alendronic acid 70mg Tablets, drink a full glass of milk and contact your doctor or pharmacist immediately.

If you forget to take Alendronic acid 70mg Tablets:

If you forget to take a dose, take one Alendronic acid 70mg Tablet on the morning after you remember. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Alendronic acid 70mg Tablets:

Always contact your doctor or pharmacist before you stop taking Alendronic acid 70mg Tablets. Alendronic acid 70mg Tablets can treat your osteoporosis only if you continue to take the tablets.

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

difficulties, digestive problems, bone, muscle or joint pain, headache.

Uncommon more than one in a thousand people but less than one in a hundred: rash, reddening of the skin, itching. feeling sick, being sick, swelling of the stomach wall, black or bloody stools, inflammation of the food passage, wearing away of the food passage.

Rare more than one in ten thousand people but less than one in a thousand: allergic reaction including hives and swelling of the lips, tongue and throat, fever, discomfort, muscle pains, rash (occasionally made worse by sunlight), reduced blood calcium levels.

Symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth.

difficulty in swallowing, ulcers of the mouth, stomach and other peptic ulcers (some with bleeding).

eye pain, diminished or hazy vision and/or seeing black floating spots. jaw problems associated with delayed healing and infection, often following tooth extraction

During post-marketing experience the following side effects have been reported (frequency unknown):

• dizziness, vertigo, alopecia, joint swelling, tiredness, swelling in the hands or legs.

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

Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions.

Do not use Alendronic acid 70mg Tablets after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of the 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.

HOW TO STORE ALENDRONIC ACID . 70MG TABLETS

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FURTHER INFORMATION

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POSSIBLE SIDE EFFECTS

Take special care with Alendronic acid 70mg Tablets:

It is important to tell your doctor before taking Alendronic acid if you have any of the following conditions:

-    if your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus).

-    you have low blood calcium levels

-    you have gum disease

You may have previously been prescribed a 10 mg tablet of alendronate which is taken once a day. One Alendronic acid 70mg Tablet is taken once a week.

It is very important that you follow actions 2, 3,4 and 5 described below. This will help the Alendronic acid 70mg Tablet reach your stomach quickly and help reduce the risk of irritating your oesophagus.

CP.ALD.70T.4.RC.V2P1

Like all medicines, Alendronic acid 70mg Tablets can cause side effects, although not everybody gets them. These are usually mild but some patients may experience digestive disturbances which may be severe.

If the following happens, stop taking the tablets and tell your doctor immediately or go to the accident and emergency department at your nearest hospital:

- An allergic reaction (angioedema): swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Side effects sometimes seen are: Common more than one in a hundred people but less than one in ten: stomach pain, constipation, diarrhoea, flatulence, oesophageal ulcer, acid regurgitation, swollen abdomen, swallowing

What Alendronic acid 70mg Tablets contain

-    The active substance is alendronate monosodium trihydrate and each tablet contains 70 mg of alendronate monosodium trihydrate.

-    The other ingredients are microcrystalline cellulose, crospovidone and magnesium stearate.

What Alendronic acid 70mg Tablets look like and contents of the pack Each tablet is white, oval, flat and marked with a "70" on one side.

Alendronic acid 70mg Tablets are available in blisters of 4 tablets.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited,

Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, U.K.

Distributor

Kent Pharmaceuticals Limited,

Repton Road, Measham, DE12 7DT, U.K. PL: 20395/0070

This Leaflet was revised in October 2012.

CPALD.70T.4.RC.V2P1

Dimensions: 140mm x 320mm

Pantone Blue 280 C