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Alendronic Acid 10mg Tablets

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RAGE 1: FRONT FACE (INSIDE OF REEL)

RAGE 1: FRONT FACE (INSIDE OF REEL)

Driving and using machines

In some cases Alendronic Acid 10 mg Tablets may cause adverse reactions that may affect your ability to drive or operate machinery (like problems with sight). Do NOT drive or operate machinery if you are affected.

HOW TO TAKE ALENDRONIC ACID

Always take Alendronic Acid 10 mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor may also prescribe calcium and vitamin D supplements if you are not getting enough from your diet.

You should follow the instructions below carefully to make sure your medicine is effective and to reduce the risk of your medicine irritating your gullet.

♦    Alendronic Acid 10 mgTablets should be taken first thing when you get up in the morning. It should be taken with a full glass of plain water (not tea, coffee, mineral water or juice) half an hour before any food, drink or other medication

♦    The tablets should be swallowed whole, not chewed, sucked or allowed to dissolve in the mouth

♦    Do NOT lie down after taking your tablet. You must stay upright (sitting, standing or walking) until you have taken your first meal of the day which must be at least half an hour after your dose of Alendronic Acid

♦    Do NOT take yourtablets at bedtime or before getting out of bed

♦    Ifyou develop pain ordifficulty on swallowing, chest pain or new or worsening heartburn, stop taking Alendronic Acid 10 mg Tablets and contact your doctor.


ALENDRONIC ACID 10 mg TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 furtherquestions, 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 ofthe side effects get 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 is and what it is used for

2.    Before you take Alendronic Acid

3.    How to take Alendronic Acid

4.    Possible side effects

5.    How to store Alendronic Acid

6.    Further information

OWHAT ALENDRONIC ACID IS AND WHAT IT IS USED FOR

♦ Alendronic Acid belongs to a group of drugs called bisphosphonates, which prevent bone loss from the body.

♦ Alendronic Acid is used to treat

osteoporosis (thinning of the bones) in men and post-menopausal women. It is also used to reduce the risk of back and hip fractures.

©BEFORE YOU TAKE ALENDRONIC ACID

Do NOT take Alendronic Acid if you:

♦    are allergic (hypersensitive) to alendronic acid or any of the other ingredients of this medicine

♦    have previously had a reaction to other bisphosphonate drugs, e.g. risedronate sodium

♦    sufferfrom certain disorders ofthe oesophagus (also called the gullet, the tube that connects your mouth with your stomach)

♦    are unable to stand orsit upright forat least 30 minutes

♦    have been told by your doctor that you have low blood calcium levels, disturbed calcium and mineral metabolism, vitamin D deficiency or parathyroid gland problems.

Take special care with Alendronic Acid It is important to talk to your doctor before you start to take this medicine if you have

♦    difficulty swallowing

♦    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)

♦    kidney problems

♦    inflammation of the stomach lining or the duodenum (first section of the small intestine)

♦    a stomach ulcer or other digestive problems

♦    recently had stomach surgery (not including pyloroplasty, where the outlet of the stomach is widened).

If any of these conditions applies to you, you must consult your doctor before starting treatment with Alendronic Acid.

A dental examination should be considered before you start 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

You smoke.

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

If you do develop difficulty or pain when swallowing, pain behind the breastbone (centre of the chest), or new or worsening heartburn, stop taking your tablets and contact your doctor.

Taking other medicines

Do NOT take any other oral medication at exactly the same time as taking Alendronic Acid Tablets. If you are taking any other medicines, you should take your dose of Alendronic Acid at least 30 minutes before you take your other medication.

Talk to your doctor defore you take non-steroidal anti-inflammatory drugs (NSAID's) while taking Alendronic Acid. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Alendronic Acid with food and drink

These tablets should be taken on an empty stomach, as food and drink can greatly reduce the effectiveness of the medicine. Take the tablets at least 30 minutes before your first meal of the day.

Pregnancy and breast-feeding

Do NOT take Alendronic Acid 10 mg Tablets

if you are pregnant or are breast-feeding.

The usual dosage instructions are given below:

♦    Adults (including the elderly):

One 10 mg tablet once a day.

♦    Children and adolescents:

Alendronate should not be given to children and adolescents.

If you take more Alendronic Acid than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Drink a full glass of milk and do not lie down.

An overdose is likely to cause an upset stomach or heartburn.

Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Alendronic Acid

If you forget to take a tablet when you first get up in the morning, do NOT take a tablet later in the day, take one when you first get up the next morning. Never take two doses together or on the same day. Take the remaining doses at the correct time.

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

POSSIBLE SIDE EFFECTS

Like all medicines, Alendronic Acid can cause side effects, although not everybody gets them.

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

♦    an allergic reaction (swelling ofthe lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

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

If the following happens, stop taking your tablets and contact your doctor:

♦    you develop difficulty or pain when swallowing, pain behind the breastbone (centre of the chest), or new or worsening heartburn.

♦    blisters/bleeding of the lips, eyes, nose, mouth and genitals, or a severe blistering rash where large areas of the skin may peel.

The following side effects have been reported at the approximate frequencies shown:

Very common (affecting more than 1 user in 10)

♦    pain in the bones, muscles or joints, sometimes severe

♦    pain in the bones, muscles or joints, sometimes severe.

Common (affect 1 to 10 users in 100)

♦    stomach pain, indigestion or heartburn, constipation, diarrhoea, wind

♦    ulceration of the oesophagus (gullet), difficulty swallowing, full or bloated feeling in the stomach, a backflow of acid from the stomach into the gullet and the mouth

♦    joint swelling, swelling in the hands or legs (oedema)

♦    headache, dizziness, vertigo

♦    itching, hair loss

♦    tiredness.

Uncommon (affect 1 to 10 users in 1,000)

♦    rashes and reddening of the skin

♦    allergic reaction, including hives and rapid swelling of the skin and mucous membranes (angioedema)

♦    feeling sick, being sick, inflammation and/or erosion of the gullet, inflammation of the stomach lining, black tarry stools

♦    changes in the sense of taste

♦    eye inflammation (usually painful)

♦    transient symptoms (pain in the muscles, malaise and rarely fever) at the initiation of the treatment.

Rare (affect 1 to 10 users in 10,000)

♦    rash on exposure to sunlight and other allergic reactions (for example, the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)

♦    low blood calcium levels

♦    stomach and other peptic ulcers, stomach tears and bleeding

♦    mouth, throat ulcers when the tablets have been chewed or sucked

♦    narrowing of the oesophagus (gullet)

♦    jaw problems (generally following tooth extraction and/or local infection)

♦    unusual fracture of the thigh bone.

Blood calcium and phosphate levels may be affected by Alendronic Acid 10 mg Tablets. Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone. Osteonecrosis (arthritis) of the jaw has been reported mainly in cancer patients, but some cases have also been reported in patients treated for osteoporosis.

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.

^ HOW TO STORE ALENDRONIC ACID

Keep out of the reach and sight of children.

Do not use Alendronic Acid after the expiry date that is stated on the outer packaging. 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.

^ FURTHER INFORMATION

What Alendronic Acid tablets contains:

♦    The active ingredient is alendronic acid (as sodium monohydrate)

♦    The other ingredients are low-substituted hyprolose, hyprolose, colloidal hydrated silica, and sodium stearyl fumarate.

What Alendronic Acid tablets look like and contents of the pack:

♦    AlendronicAcid tablets are white to off-white, round biconvex tablets. They are debossed with "T" on one side and "10" on the other side.

♦    The product is available in pack sizes of 14, 28, 30, 50, 56, 84, 90, 98, 112, and 140 tablets.

Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and company responsible for manufacture:

TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: September 2012

PL 00289/0703

TFTTTI    85087-ZB

EEVA IIK LIMITED    160 x 323