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S360 Leaflet Fosamax 20130622 2. BEFORE YOU TAKE FOSAMAX

PATIENT INFORMATION LEAFLET FOSAMAX ONCE WEEKLY 70mg TABLETS

(alendronate sodium)

Your medicine is known by Fosamax Once Weekly 70mg Tablets

but will be referred to as Fosamax throughout the following leaflet..

Read all of this leaflet carefully before you start taking this

medicine, even if this is a repeat prescription.

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

-    It is particularly important to understand the information in section 3. HOW TO TAKE FOSAMAX, before taking this medicine.

In this leaflet:

1.    What Fosamax is and what it is used for

2.    Before you take Fosamax

3.    How to take Fosamax

4.    Possible side effects

5.    How to store Fosamax

6.    Further information

1. WHAT FOSAMAX IS AND WHAT IT IS USED FOR

What is Fosamax?

Fosamax belongs to a group of non-hormonal medicines called bisphosphonates. Fosamax prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.

What is Fosamax used for?

Your doctor has prescribed Fosamax to treat your osteoporosis. Fosamax reduces the risk of spine and hip fractures.

Fosamax is a once weekly treatment.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman's skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis.

Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager's hump') and loss of mobility.

How can osteoporosis be treated?

Osteoporosis can be treated and it is never too late to begin treatment. Fosamax not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.

As well as your treatment with Fosamax, your doctor may suggest you make changes to your lifestyle to help your condition, such as:

Stopping smoking    Smoking appears to increase the

rate at which you lose bone and, therefore, may increase your risk of broken bones.

Exercise    Like muscles, bones need exercise

to stay strong and healthy. Consult your doctor before you begin any exercise programme.

Eating a balanced diet    Your doctor can advise you about

your diet or whether you should take any dietary supplements (especially calcium and Vitamin D).

Do not take Fosamax

(1)    if you are allergic (hypersensitive) to alendronate sodium trihydrate or any of the other ingredients

(2)    if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing

(3)    if you cannot stand or sit upright for at least 30 minutes

(4)    if your doctor has told you that you have low blood calcium

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.

Take special care with Fosamax

It is important to tell your doctor before taking Fosamax if:

•    you suffer from kidney problems

•    you have any swallowing or digestive problems

•    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 been told you have low blood calcium

•    you have poor dental health, gum disease, a planned extraction or you don't receive routine dental care

•    you have cancer

•    you are undergoing chemotherapy or radiotherapy

•    you are taking corticosteroids (such as prednisone or dexamethasone)

•    you are or have been a smoker (as this may increase the risk of dental problems).

You may be advised to have a dental check-up before starting treatment with Fosamax.

It is important to maintain good oral hygiene when being treated with Fosamax. You should have routine dental check-ups throughout your treatment and you should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.

Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Fosamax. These side effects may worsen if patients continue to take Fosamax after developing these symptoms.

Taking other medicines

It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Fosamax if taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW TO TAKE FOSAMAX.

Certain drugs for rheumatism or long-term pain called NSAIDs (e.g. aspirin or ibuprofen) might cause digestive problems. Therefore, caution should be used when these drugs are taken at the same time as Fosamax.

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

Taking Fosamax with food and drink

It is likely that food and beverages (including mineral water) will make Fosamax less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW TO TAKE FOSAMAX.

Children and adolescents

Fosamax should not be given to children and adolescents. Pregnancy and breast-feeding

Fosamax is only intended for use in postmenopausal women. You should not take Fosamax if you are or think you may be pregnant, or if you are breast-feeding.

Driving and using machines

There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with Fosamax that may affect your ability to drive or operate machinery. Individual responses to Fosamax may vary (See POSSIBLE SIDE EFFECTS.)

Important information about some of the ingredients of Fosamax

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

3. HOW TO TAKE FOSAMAX

Rare:


Take one Fosamax tablet once a week.

Follow these instructions carefully to make sure you will benefit from Fosamax.

1)    Choose the day of the week that best fits your schedule. Every week, take one Fosamax on your chosen day.

It is very important to follow instructions 2), 3), 4) and 5) to help the Fosamax reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).

2)    After getting up for the day and before taking any food, drink, or other medicine, swallow your Fosamax whole with a full glass of water only (not mineral water) (not less than 200 ml or 7 fl. oz.).

•    Do not take with mineral water (still or sparkling).

•    Do not take with coffee or tea.

•    Do not take with juice or milk.

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

3)    Do not lie down — stay fully upright (sitting, standing or walking) — for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day.

4)    Do not take Fosamax at bedtime or before getting up for the day.

5)    If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Fosamax and contact your doctor.

6)    After swallowing your Fosamax , wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. Fosamax is effective only if taken when your stomach is empty.

If you take more Fosamax than you should

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.

If you forget to take Fosamax

If you miss a dose, just take one tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.

If you stop taking Fosamax

It is important that you continue taking Fosamax for as long as your doctor prescribes the medicine. Fosamax 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.

4. POSSIBLE SIDE EFFECTS

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

The following terms are used to describe how often side effects have been reported.

Very common (occurring in at least 1 of 10 patients treated)

Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated)

Uncommon (occurring in at least 1 of 1000 and less than 1 of 100 patients treated)

Rare (occurring in at least 1 of 10000 and less than 1 of 1000 patients treated)

Very rare (occurring in less than 1 of 10,000 patients treated)

Very Common:

•    bone, muscle and/or joint pain which is sometimes severe, Common:

•    heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing,

•    joint swelling,

•    abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,

•    hair loss; itching,

•    headache; dizziness,

•    tiredness; swelling in the hands or legs.

Uncommon:

•    nausea; vomiting,

•    irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach,

•    black or tar-like stools,

•    blurred vision; pain or redness in the eye,

•    rash; redness of the skin,

•    transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment,

•    taste disturbance.

•    allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing,

•    symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,

•    stomach or peptic ulcers (sometimes severe or with bleeding),

•    narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach),

•    rash made worse by sunlight, severe skin reactions,

•    pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis) generally associated with delayed healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such symptoms,

•    unusual fracture of the thigh bone particularly in patients on long-term treatment for osteroporosis 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,

•    mouth ulcers when the tablets have been chewed or sucked.

Tell your doctor or pharmacist promptly about these or any other unusual symptoms.

It will help if you make a note of what you experienced, when it started and how long it lasted.

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.

5. HOW TO STORE FOSAMAX

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    There are no special storage instructions for this medicine. However, do not put the tablets into another container; they might get mixed up. Do not remove the tablets from the blister pack until you are ready to take the medicine.

•    Do not use after the expiry date printed on the carton label or blister strip.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. FURTHER INFORMATION

What Fosamax contains

•    Each Fosamax contains 91.37mg of the active ingredient, alendronate sodium trihydrate equivalent to 70mg of alendronic acid.

•    Fosamax also contain the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium and magnesium stearate.

What Fosamax looks like and contents of the pack Fosamax are oval, white tablets marked with an outline of a bone image on one side and ‘31' on the other.

Fosamax are available as blister packs of 4 tablets.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Merck, Sharp & Dohme (Italia) S.p.A, Via Emilia 21,27100 Pavia, Italy.

|POMl PL No: 19488/0360

Leaflet revision date: 22 June 2013

Fosamax is a registered trade mark of Merck & Co. Inc., USA.

HOW CAN YOU OBTAIN MORE INFORMATION ABOUT ‘FOSAMAX’?

For more information about osteoporosis, contact (in UK)_The National Osteoporosis Society, Camerton, Bath BA2 0PJ.

Telephone (01761) 471771; Fax (01761) 471104; Helpline 0845 4500230 or (in RoI) The Irish Osteoporosis Society, 33 Pearse Street, Dublin 2, Telephone (01) 6774267.

The National Osteoporosis Society and the Irish Osteoporosis Society are independent charities not connected with Merck Sharp & Dohme Limited.

S360 Leaflet Fosamax 20130622

2. BEFORE YOU TAKE ALENDRONATE SODIUM

PATIENT INFORMATION LEAFLET ALENDRONIC ACID ONCE WEEKLY 70mg TABLETS

(alendronate sodium)

Your medicine is known by Alendronic Acid Once Weekly 70mg

Tablets but will be referred to as Alendronate Sodium throughout

the following leaflet..

Read all of this leaflet carefully before you start taking this

medicine, even if this is a repeat prescription.

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

-    It is particularly important to understand the information in section 3. HOW TO TAKE ALENDRONATE SODIUM, before taking this medicine.

In this leaflet:

1.    What Alendronate Sodium is and what it is used for

2.    Before you take Alendronate Sodium

3.    How to take Alendronate Sodium

4.    Possible side effects

5.    How to store Alendronate Sodium

6.    Further information

1. WHAT ALENDRONATE SODIUM IS AND WHAT IT IS USED FOR

What is Alendronate Sodium?

Alendronate Sodium belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate Sodium prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.

What is Alendronate Sodium used for?

Your doctor has prescribed Alendronate Sodium to treat your osteoporosis. Alendronate Sodium reduces the risk of spine and hip fractures.

Alendronate Sodium is a once weekly treatment.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman's skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis.

Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager's hump') and loss of mobility.

How can osteoporosis be treated?

Osteoporosis can be treated and it is never too late to begin treatment. Alendronate Sodium not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.

As well as your treatment with Alendronate Sodium, your doctor may suggest you make changes to your lifestyle to help your condition, such as:

Do not take Alendronate Sodium

(1)    if you are allergic (hypersensitive) to alendronate sodium trihydrate or any of the other ingredients

(2)    if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing

(3)    if you cannot stand or sit upright for at least 30 minutes

(4)    if your doctor has told you that you have low blood calcium

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.

Take special care with Alendronate Sodium

It is important to tell your doctor before taking Alendronate Sodium if:

•    you suffer from kidney problems

•    you have any swallowing or digestive problems

•    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 been told you have low blood calcium

•    you have poor dental health, gum disease, a planned extraction or you don't receive routine dental care

•    you have cancer

•    you are undergoing chemotherapy or radiotherapy

•    you are taking corticosteroids (such as prednisone or dexamethasone)

•    you are or have been a smoker (as this may increase the risk of dental problems).

You may be advised to have a dental check-up before starting treatment with Alendronate Sodium.

It is important to maintain good oral hygiene when being treated with Alendronate Sodium. You should have routine dental checkups throughout your treatment and you should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.

Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronate Sodium. These side effects may worsen if patients continue to take Alendronate Sodium after developing these symptoms.

Taking other medicines

It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronate Sodium if taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW TO TAKE ALENDRONATE SODIUM.

Certain drugs for rheumatism or long-term pain called NSAIDs (e.g. aspirin or ibuprofen) might cause digestive problems . Therefore, caution should be used when these drugs are taken at the same time as Alendronate Sodium.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained

without a prescription.

Taking Alendronate Sodium with food and drink

It is likely that food and beverages (including mineral water) will make Alendronate Sodium less effective if taken at the same time. Therefore, it is important that you follow the advice given in section

3. HOW TO TAKE ALENDRONATE SODIUM.

Children and adolescents

Alendronate Sodium should not be given to children and adolescents.

Pregnancy and breast-feeding

Alendronate Sodium is only intended for use in postmenopausal women. You should not take Alendronate Sodium if you are or think you may be pregnant, or if you are breast-feeding.

Stopping smoking


Exercise


Eating a balanced diet


Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.

Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before you begin any exercise programme.

Your doctor can advise you about your diet or whether you should take any dietary supplements (especially calcium and Vitamin D).


Driving and using machines

There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with Alendronate Sodium that may affect your ability to drive or operate machinery. Individual responses to Alendronate Sodium may vary (See POSSIBLE SIDE EFFECTS.)

Important information about some of the ingredients of Alendronate Sodium

Alendronate Sodium contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.


Take one Alendronate Sodium tablet once a week.

Follow these instructions carefully to make sure you will benefit from Alendronate Sodium.

1)    Choose the day of the week that best fits your schedule. Every week, take one Alendronate Sodium on your chosen day.

It is very important to follow instructions 2), 3), 4) and 5) to help the Alendronate Sodium reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).

2)    After getting up for the day and before taking any food, drink, or other medicine, swallow your Alendronate Sodium whole with a full glass of water only (not mineral water) (not less than 200 ml or 7 fl. oz.).

•    Do not take with mineral water (still or sparkling).

•    Do not take with coffee or tea.

•    Do not take with juice or milk.

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

3)    Do not lie down — stay fully upright (sitting, standing or walking) — for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day.

4)    Do not take Alendronate Sodium at bedtime or before getting up for the day.

5)    If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronate Sodium and contact your doctor.

6)    After swallowing your Alendronate Sodium, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. Alendronate Sodium is effective only if taken when your stomach is empty.

If you take more Alendronate Sodium than you should

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.

If you forget to take Alendronate Sodium

If you miss a dose, just take one tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.

If you stop taking Alendronate Sodium

It is important that you continue taking Alendronate Sodium for as long as your doctor prescribes the medicine. Alendronate Sodium 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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Alendronate Sodium can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported.

Very common (occurring in at least 1 of 10 patients treated)

Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated)

Uncommon (occurring in at least 1 of 1000 and less than 1 of 100 patients treated)

Rare (occurring in at least 1 of 10000 and less than 1 of 1000 patients treated)

Very rare (occurring in less than 1 of 10,000 patients treated)

Very Common:

•    bone, muscle and/or joint pain which is sometimes severe, Common:

•    heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing,

•    joint swelling,

•    abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,

•    hair loss; itching,

•    headache; dizziness,

•    tiredness; swelling in the hands or legs.

Uncommon:

•    nausea; vomiting,

•    irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach,

•    black or tar-like stools,

•    blurred vision; pain or redness in the eye,

•    rash; redness of the skin,

•    transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment,

•    taste disturbance.

•    allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing,

•    symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,

•    stomach or peptic ulcers (sometimes severe or with bleeding),

•    narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach),

•    rash made worse by sunlight, severe skin reactions,

•    pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis) generally associated with delayed healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such symptoms,

•    unusual fracture of the thigh bone particularly in patients on long-term treatment for osteroporosis 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,

•    mouth ulcers when the tablets have been chewed or sucked.

Tell your doctor or pharmacist promptly about these or any other unusual symptoms.

It will help if you make a note of what you experienced, when it started and how long it lasted.

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.

5. HOW TO STORE ALENDRONATE SODIUM

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    There are no special storage instructions for this medicine. However, do not put the tablets into another container; they might get mixed up. Do not remove the tablets from the blister pack until you are ready to take the medicine.

•    Do not use after the expiry date printed on the carton label or blister strip.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. FURTHER INFORMATION

What Alendronate Sodium contains

•    Each Alendronate Sodium contains 91.37mg of the active ingredient, alendronate sodium trihydrate equivalent to 70mg of alendronic acid.

•    Alendronate Sodium also contain the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium and magnesium stearate.

What Alendronate Sodium looks like and contents of the pack

Alendronate Sodium are oval, white tablets marked with an outline of a bone image on one side and ‘31' on the other.

Alendronate Sodium are available as blister packs of 4 tablets. Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Merck, Sharp & Dohme (Italia) S.p.A, Via Emilia 21,27100 Pavia, Italy.

|POM | PL No: 19488/0360

Leaflet revision date: 22 June 2013

HOW CAN YOU OBTAIN MORE INFORMATION ABOUT ‘ALENDRONATE SODIUM’?

For more information about osteoporosis, contact (in UK)_The National Osteoporosis Society, Camerton, Bath BA2 0PJ. Telephone (01761) 471771; Fax (01761) 471104; Helpline 0845 4500230 or (in RoI) The Irish Osteoporosis Society, 33 Pearse Street, Dublin 2, Telephone (01) 6774267.

The National Osteoporosis Society and the Irish Osteoporosis Society are independent charities not connected with Merck Sharp & Dohme Limited.

S360 LEAFLET Alendronic acid 20130622