Patient leaflet - Alendronic Acid 70 mg film-coated tablets

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

What is Alendronic Acid?

Alendronic Acid is a film-coated tablet containing the active substance alendronate sodium.

What is alendronate?

Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate 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 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 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. 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.

As well as your treatment with Alendronic Acid, 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).

2 What you need to know before you

take Alendronic Acid

Do not take Alendronic Acid

if you are allergic to alendronic acid or any of
the other ingredients of this medicine (listed in section 6).
if you have certain problems with your gullet
(oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing
if you cannot 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. Talk to your doctor first and follow the advice given.

Warnings and precautions

Talk to your doctor before taking Alendronic Acid

if you suffer from kidney problems
if you have any swallowing or digestive
problems
if you have low blood calcium levels
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)
if you are aware that the absorption of
minerals from the digestive tract is impaired (malabsorption syndrome)
if you have gum disease, planned dental
extraction, poor dental health or you don’t receive routine dental care
if you have cancer
if you are undergoing chemotherapy or
radiotherapy
if you are taking angiogenesis inhibitors (such
as bevacizumab, or thalidomide), which are used in the treatment of cancer
if you are taking corticosteroids (such as
prednisone or dexamethasone), which are used to treat conditions such as asthma, rheumatoid arthritis and severe allergies
if 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 within less than 30 minutes after taking Alendronic Acid. These side effects may worsen if patients continue to take Alendronic Acid after developing these symptoms.

Children and adolescents

Alendronic Acid should not be given to children and adolescents under the age of 18.

Other medicines and Alendronic Acid Tell your doctor or pharmacist 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 Acid.

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

Alendronic Acid with food and drink

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.

Pregnancy and breast-feeding

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.

You should not take Alendronic Acid if you are breast-feeding.

Driving and using machines

Alendronic Acid can impair your ability to react or drive. Patients taking Alendronic Acid can suffer from side effects including blurred vision, dizziness, severe muscle joint and bone pain, which may affect your ability to drive or use machines. If you are affected in this way, you should contact your doctor before driving or using machinery. Individual responses to Alendronic Acid may vary (See section 4).

Alendronic Acid contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film‑coated tablet, that is to say essentially ‘sodium‑free’.

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.

Take one 70 mg film-coated tablet once a week.

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

1) Choose the day of the week that best fits your schedule. Every week, take one alendronate 70 mg film-coated tablet on your chosen day.

It is very important to follow instructions 2), 3), 4) and 5) to help the Alendronic Acid 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 Alendronic Acid 70 mg Film-coated Tablet whole with a full glass of tap water only (not mineral water) (not less than 200 ml or 7 fl. oz.) so that alendronate is sufficiently absorbed by the body
-
Do not take with mineral water (still or
sparkling).
- Do not take with coffee or tea.
- Do not take with juice or milk.
3) Do not chew or crush the tablet or allow it to dissolve in your mouth, in order to avoid mouth ulcers.
4) 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 meal of the day.
5) Do not take Alendronic Acid at bedtime or before getting up for the day.
6) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid and contact your doctor.
7) After swallowing your Alendronic Acid, wait at least 30 minutes before taking your first meal, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. Alendronic Acid is effective only if taken when your stomach is empty.

If you take more Alendronic Acid than you should

If you take more than one tablet at a time, 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

If you miss a dose, just take one tablet the next morning after you you realise you have missed it. 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 Alendronic Acid

It is important that you continue taking Alendronic Acid for as long as your doctor prescribes the medicine. Since it is not known how long you should take Alendronic Acid, you should discuss the need to stay on this medicine with your doctor periodically to determine if Alendronic Acid is still right for you.

Continued on the next page >> If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects

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

See your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:

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.

Rare (may affect up to 1 in 1,000 people):

allergic reactions such as hives; swelling of
the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing
severe skin reactions such as ring-shaped, red
and often blistering rashes - common on hands and feet (toxic epidermal necrolysis), mucosal and skin inflammation in combination with high fever (Stevens‑Johnson syndrome)
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 wound healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such symptoms, ‑ unusual (atypical) fracture of the thigh bone
(femur) particularly in patients on long‑term treatment for osteoporosis. 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.
severe bone, muscle and/or joint pain

Not known (cannot be estimated from the available data)

unusual fractures in bones other than the femur

Other side effects that may occur:

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)

headache
dizziness
vertigo
abdominal pain
uncomfortable feeling in the stomach or
belching after eating
constipation
bloating or distended abdomen
diarrhoea
flatulence
joint swelling
hair loss
itching
tiredness
swelling in the hands or legs

Uncommon (may affect up to 1 in 100 people)

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
skin 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
blurred vision; pain or redness in the eye

Rare (may affect up to 1 in 1,000 people)

narrowing of the gullet (oesophagus - the tube
that connects your mouth with your stomach)
mouth ulcers
stomach or intestinal ulcers (sometimes severe
or with bleeding)
skin rash made worse by sunlight
symptoms of low blood calcium levels including
muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth.

Very rare (may affect up to 1 in 10,000 people):

Talk to your doctor if you have ear pain,
discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.

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 Yellow Card Scheme: 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 and the blister 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 film-coated tablet contains 70 mg alendronic acid (as sodium trihydrate).

The other ingredients are:microcrystalline cellulose, colloidal anhydrous silica,

croscarmellose sodium, magnesium stearate, carrageenan, macrogol .

What Alendronic Acid looks like and contents of the pack

White, round, biconvex film coated tablet, debossed with “ALN 70” on one side with a diameter of approximately 10 mm.

The film-coated tablets are packed in OPA-Aluminium-PVC/Aluminium blister which are inserted in a carton

Pack sizes:

Blister: 2, 4, 6, 8, 12, 14 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Manufacturer:

Lek Pharmaceuticals d.d.

Verovśkova 57,

1526 Ljubljana, Slovenia or

Lek S.A.

ul. Domaniewska 50 C,

02-672 Warszawa,

Poland or

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

Or