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Alendronic Acid 10 Mg Tablets

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Package leaflet: Information for the user

Alendronic Acid 10 mg tablets

Alendronic Acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Alendronic Acid is and what it is used for

2.    What you need to know before you take Alendronic Acid

3.    How to take Alendronic Acid

4.    Possible side effects

5.    How to store Alendronic Acid

6.    Contents of the pack and other information

1. What Alendronic Acid is and what it is used for

What is Alendronic Acid?

Alendronic acid belongs to a group of medicines called 'bisphosphonates'. Alendronic acid prevents the loss of bone that occurs in men, post-menopausal women and patients receiving glucocorticoids such as prednisolone and methylprednisolone. Alendronic acid has also been shown to help rebuild bone and makes bone less likely to fracture in post-menopausal women and men with osteoporosis.

What is Alendronic Acid used for?

Your doctor has prescribed Alendronic Acid to treat your osteoporosis.

Alendronic Acid reduces the risk of spine and hip fractures.

Alendronic Acid is used:

-    treat osteoporosis in post-menopausal women

-    treat osteoporosis in men

-    prevent osteoporosis in post-menopausal women who are taking medicines called glucocorticoids but are not taking oestrogen.

What is osteoporosis?

Osteoporosis is thinning and weakening of your bones. It is common in women after the menopause. Osteoporosis can also occur in men. Corticosteroids can also cause bone loss and osteoporosis in both men and women. Early on, osteoporosis usually has no symptoms. If left untreated 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 injuries that would not fracture normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also considerable problems like stooped posture (‘dowager’s hump’).

Osteoporosis in postmenopausal women Osteoporosis often occurs in women several years after, the menopause, which occurs when the ovaries virtually stop producing the female hormone, oestrogen, or are removed (which may occur, for example, at the time of a hysterectomy). The earlier a woman reaches the menopause, the greater the risk of osteoporosis.

Severe Osteoporosis in men

Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone. In all instances, bone is removed faster than it is formed, so bone loss occurs and bones become weaker. Therefore, it is important for a healthy skeleton to maintain bone mass and preventing further bone loss.

By drugs from the group of corticosteroids (eg. prednisone) induced osteoporosis in women who did not receive estrogen Under the influence of corticosteroids bone is removed faster than it is formed so bone loss occurs and bones become weaker Therefore, maintaining bone mass and preventing further bone loss are important to keep your skeleton healthy. If your doctor prescribes corticosteroids, you should use it as directed.

How can osteoporosis be treated or prevented?

It is important to remember that if you already have osteoporosis that it can be treated and that it is never too late to begin.

Alendronic Acid 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. In addition to your treatment with Alendronic Acid, your doctor may recommend that you make some changes to your lifestyle which may help your condition. These are:

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. Talk to 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.

2. What you need to know before you take Alendronic Acid

Do not take Alendronic Acid if you:

•    If you are allergic to alendronate sodium trihydrate or any of the other ingredients of this medicine (listed in section 6).

•    If you have certain disorders of the oesophagus (the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing

•    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 think any of these apply to you, do not take the tablets.

Talkto your doctor or pharmacist first and follow the advice given

Warnings and precautions

It is important to tell your doctor before taking Alendronic Acid Tablets

•    If you suffer from kidney problems

•    if you have any swallowing or digestive problems

•    if you have been told you have low blood calcium.

•    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 poor dental health, gum disease , a planned dental 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 Alendronic Acid.

It is important to maintain good oral hygiene when being treated with Alendronic Acid. 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 Alendronic Acid. These side effects may worsen if patients continue to take Alendronic Acid after developing these symptoms.

Other medicines and Alendronic Acid

Tell your doctor if you are taking, have recently taken or might take any other medicines.It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronic Acid if taken at the same time. Therefore, it is important that you follow the advice given in section 3.How to take Alendronic.

Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. aspirin or ibuprofen) might cause irritation of the digestive tract. Therefore, caution should be used when these medicines are taken at the same time as Alendronic Acid.

Tell your doctor if you are taking have recently taken or might take any other medicines.

Taking Alendronic Acid with food, drink and alcohol

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

3.How to take Alendronic acid.

Children and adolescents

Alendronic Acid should not be given to children and adolescents. Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine

Alendronic Acid is only intended for use in postmenopausal women. You should not take Alendronic Acid 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 Alendronic Acid that may affect your ability to drive or operate machinery. Individual responses to Alendronic Acid may vary (See section 4. Possible side effects).

3. How to take Alendronic Acid

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Follow these instructions carefully to make sure you will benefit from Alendronic Acid

It is very important to follow instructions 1), 2), 3), 4) and 5) to help the Alendronic Acid tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).

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1)    After getting up for the day, and before taking any food, drink or other medicine, swallow your Alendronic Acid tablet whole with a full glass of plain water only (not less than 200ml)

•    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.

2)    After swallowing your alendronic acid tablets 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.

3)    Do not take alendronic acid tablets at bedtime or before getting up for the day.

4)    If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking alendronic acid tablets and contact your doctor.

5)    After swallowing your tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day, including antacids, calcium supplements and vitamins, alendronic acid tablets is effective only if taken when your stomach is empty,

You must take Alendronic Acid exactly as your doctor has told you. It is important that you continue taking Alendronic Acid for as long as your doctor prescribes the medicine.

The recommended dosage is

•    for the treatment of osteoporosis in men and post-menopausal women the usual dose is 10 mg once a day.

•    for the treatment and prevention of steroid induced osteoporosis in post-menopausal women not receiving hormone replacement therapy (HRT) with an oestrogen the usual dose is 10 mg once a day.

Elderly patients

No dose adjustment in elderly patients is necessary.

If you have kidney problems

Alendronic Acid must not be used in patients with severe kidney problems.

If you take more Alendronic Acid 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 Alendronic Acid

Take Alendronic Acid once a day as prescribed. Do not take a double dose to make up for a forgotten dose. Follow the usual schedule with one tablet per day.

If you stop taking Alendronic Acid

It is important that you continue taking Alendronic Acid for as long as your doctor prescribes the medicine. Alendronic Acid can treat your osteoporosis only if you continue to take the tablets.

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

4. Possible side effects

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

Contact your doctor immediately when you experience the

following symptoms. These can be serious and you might

need immediate medical care.

•    severe reactions involving your skin, mucous membranes of your mouth, nose eyes or genitals. Stop taking this medicine and contact your doctor right away if you experience such symptoms,

Very common (may affect more than 1 in 10 people):

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

Common (may affect up to 1 in 10 people):

•    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.

•    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;

•    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 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.

•    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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme.

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

5. How to store Alendronic acid

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Alendronic Acid contains

-    The active substance is alendronic acid.

Each tablet contains 10 mg alendronic acid (equivalent to 13.052 mg sodium alendronate trihydrate).

-    The other ingredients are: Microcrystalline cellulose, maize starch, sodium starch glycolate (Type A), povidone (Kollidon 30) and magnesium stearate

What Alendronic Acid looks like and contents of the pack

Tablet.

White to off-white, round, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘18’ on the other side. The tablets are 5 mm in diameter.

They are supplied in blister packs and HDPE tablet container packs.

Pack size:

PVC/Aclar - Aluminium blister pack: 10, 14, 20, 28, 30, 50, 56, 60,

84, 90, 98, 100, 112, 140 and 250 tablets

HDPE tablet container pack: 30, 50, 100, 250 and 1000 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

This medicinal product is authorised in the Member States of the EEA under the following names:

Alendronat “Aurobindo”

Alendronat Aurobindo 10 mg tabletit Acido Alendronico Aurobindo Alendronic Acid 10 mg tablets Alendroninezuur Aurobindo 10 mg, tabletten Alendronat Aurobindo

Acid Alendronic Aurobindo 10 mg comprimate ACIDO ALENDRONICO AUROBINDO 10 mg comprimidos EFG

Alendronat Aurobindo 10 mg tabletter Alendronic Acid 10 mg tablets

Rare (may affect up to 1 in 1,000 people):    This leaflet was last revised in 09/2014.

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