Package leaflet: Information for the patient

Alendronat HEXAL 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. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What is Alendronat HEXAL and what is it used for

2. What you need to know before you take Alendronat HEXAL

3. How to take Alendronat HEXAL

4. Possible side effects

6. Contents of the pack and other information

Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents the loss of bone, and helps to rebuild bone. It reduces the risk of spine and hip fractures.

Your doctor has prescribed Alendronat HEXAL to treat your osteoporosis. Alendronat HEXAL has been shown to reduce the risk of spine and hip fractures inwomenand spine fractures inmen.

Osteoporosis is a thinning and weakening of the bones. 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.

As well as your treatment with Alendronat HEXAL, 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.

Do not take Alendronat HEXAL

- 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

Tell your doctor before taking Alendronat Hexal

- if you suffer from kidney problems

- if you have any swallowing or digestive problems

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

- if you have low blood calcium levels

- 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)

- if you are taking corticosteroids (such as prednisone or dexamethasone)

- if you are or have been a smoker (as this may increase the risk of dental problems

It is important to maintain good oral hygiene when being treated with Alendronat Hexal. You may be advised to have a dental check-up before starting treatment with Alendronat Hexal.

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 Alendronat HEXAL. These side effects may worsen if patients continue to take Alendronat HEXAL after developing these symptoms.

Children and adolescents

Alendronat HEXALshould not be given to children and adolescents.

Other medicines and Alendronat HEXAL

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 Alendronat HEXAL if taken at the same time. Therefore, it is important that you follow the advice given in section 3. “How to take Alendronat HEXAL”.

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

Alendronat HEXAL with food and drink

It is likely that food and beverages (including mineral water) will make Alendronat HEXAL less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3. “How to take Alendronat HEXAL”.

Pregnancyand breast-feeding

You should not take Alendronat HEXAL if you are or think you may be pregnant.

You should not take Alendronat HEXAL if you are breast-feeding.

Driving and using machines

Certain side effects (including blurred vision, dizziness and severe bone, muscle and/or joint pain) have been reported during treatment with alendronate which may impair your ability to drive or use machines. The reaction to alendronate may differ from individual to individual (see section 4).

Alendronat HEXALcontains lactose.

If you have been told by your doctor that you have an intolerance to some sugars (for example lactose), contact your doctor before taking this medicine.

Always take Alendronat HEXAL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Take one Alendronat HEXAL 10 mg tablet once daily.

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

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

1) After getting up for the day and before taking any food, drink, or other medicine, swallow your Alendronat HEXAL 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.

2) Do not chewor crush 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 Alendronat HEXAL 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 Alendronat HEXAL and contact your doctor.

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

If you take more Alendronat HEXAL 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 Alendronat HEXAL

If you miss a dose, just take one tablet on the morning after you remember. Do not take two tablets on

the same day.

IfyoustoptakingAlendronat HEXAL

ItisimportantthatyoutakeAlendronat HEXALforaslongasyourdoctorprescribesthemedicine.Sinceitis notknownhowlongyoushouldtakeAlendronat HEXAL,youshoulddiscusstheneedtostayonthis medicinewithyourdoctorperiodicallytodetermineifAlendronat HEXALisstillrightforyou.

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

Like all medicines, Alendronat HEXAL can have side effects, although not everybody gets them.

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

Seeyourdoctorimmediatelyifyounoticeanyofthefollowingsideeffects,whichmaybeserious, andforwhichyoumayneedurgentmedicaltreatment:

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

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

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 extensive skin damage (separation of the epidermis and superficial mucous membranes) - toxic epidermal necrolysis

• an extremely intense allergic reaction with skin rashes, commonly in the form of blisters or sores in the oral cavity and eyes, and other mucous membranes such as, for example, genitalia (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 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. 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.

Other side effects that may occur:

Common(may affect up to 1 in 10people)

• headache

• dizziness

• abdominal pain

• uncomfortable feeling in the stomach or belching after eating

• constipation

• full or bloated feeling in the stomach

• 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

• 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 when the tablets have been chewed or sucked

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

• 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)

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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 blister and the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.Store in the original package in order to protect from moisture.

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

What Alendronat HEXAL contains

The active substance is alendronic acid. Each tablet contains 10 mg alendronic acid (as alendronate sodium trihydrate).

The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate.

What Alendronat HEXALlooks like and contents of the pack

Alendronat HEXAL is a white to off-white, capsule-shaped tablet, embossed with "AN 10" on one side and "Arrow logo" on the other.

The carton boxes with triplex blisters contain 14, 28, 56, 98, 112 and 50 x 1 tablets (unit dose).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

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This leaflet was last revised in 2016-08-19.

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