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.

What is in this leaflet:

1. What Alendronic Acid 70mg Tablets are and what they are used for
2. What you need to know before you take Alendronic Acid 70mg Tablets
3. How to take Alendronic Acid 70mg Tablets
4. Possible side effects
5. How to store Alendronic Acid 70mg Tablets
6. Contents of the pack and other information

Do not take Alendronic Acid 70mg Tablets:

• If you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6)
• If you have certain disorders of the oesophagus (this is also called the gullet and is the tube that connects your mouth with your stomach) such as narrowing of the gullet or difficulty swallowing
• If your doctor has told you that you have low calcium levels in your blood
• If you are unable to stand or sit upright for at least 30 minutes at a time.

Warnings and precautions

Talk to your doctor before taking these tablets:

• If you have difficulty or pain when swallowing
• If you have inflammation of the stomach lining or the duodenum (first section of the small intestine)
• If you have a stomach ulcer or other digestive problems including bleeding in the stomach
• If you have had surgery on your stomach or gullet in the last year (not including pyloroplasty which is where the outlet from the stomach is widened)
• 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 have or have ever had any kidney problems
• If you have or have ever had low vitamin D levels. If so your doctor may wish to monitor your vitamin D levels during treatment with alendronic acid
• If you have or have had a condition called hypoparathyroidism (a condition where your parathyroid gland does not work properly)
• If you have or have had pain, swelling or numbness of the jaw, loosening of a tooth or a ‘heavy jaw feeling’
• If you are undergoing dental treatment or you are to undergo dental surgery
• If you have cancer, are undergoing chemotherapy or radiotherapy, are taking steroids, do not receive regular dental care, have a mouth infection or smoke. If so your doctor may want you to have a dental examination before starting treatment.

It is important to maintain good oral hygiene when being treated with Alendronic Acid 70mg Tablets. 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.

Other medicines and Alendronic Acid 70mg Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take any other medicines orally (by mouth) at the same time as taking Alendronic Acid 70mg Tablets. You should leave at least 30 minutes between your dose of Alendronic Acid 70mg Tablets and any other oral medicines. It is important that you follow all of the advice given in section 3 - ‘How to take Alendronic Acid 70mg Tablets.

You should speak to your Doctor before you take Alendronic Acid 70mg Tablets if you are currently taking a non-steroidal anti-inflammatory drug (NSAID).

Alendronic Acid 70mg Tablets with food and drink

These tablets must be taken on an empty stomach as food and drink can greatly reduce the effectiveness of the medicine. You must take the tablets with a full glass of plain water at least 30 minutes before any other food or drink. It is important that you follow all of the advice given in section 3 - ‘How to take Alendronic Acid 70mg Tablets.’

Pregnancy and breast-feeding

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 this medicine. Do not take Alendronic Acid 70mg Tablets if you are pregnant, think you may be pregnant or are breast-feeding.

Driving and using machines

Alendronic Acid 70mg Tablets are not expected to have any effects on your ability to drive and use machines. However in rare cases patients taking Alendronic Acid 70mg Tablets can suffer from side effects including dizziness, severe muscle joint and bone pain and eye pain or inflammation. If you are affected in this way, you should contact your doctor before driving or using machinery.

Alendronic Acid 70mg Tablets contain lactose

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

Use in children and adolescents

Alendronate should not be given to children and adolescents.

If you take more Alendronic Acid 70mg Tablets than you should

You may suffer from a stomach upset, heartburn, inflammation of the gullet or stomach, muscle and stomach cramps, spasms, weakness and fits. You should drink a full glass of milk and contact your nearest doctor or hospital casualty department immediately. Do not try and make yourself sick (vomit) and do not lie down.

If you forget to take Alendronic Acid 70mg Tablets

Take one tablet on getting up the next morning after you remember.

Do not take two tablets on the same day. Return to taking one tablet once a week on the day that you originally decided upon. Do not take a double dose to make up for a forgotten dose.

All medicines can cause allergic reactions, although serious allergic reactions are very rare. You should stop taking Alendronic Acid 70mg Tablets and tell your doctor immediately if you get any of the following symptoms:

• sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). This is known as ‘angioedema’.
• a rash, blistering or other effects on the skin, eyes, mouth or genitals, itching or high temperature (symptoms of severe skin reactions called Stevens-Johnson syndrome or toxic epidermal necrolysis).

If you have difficulty and/or pain when swallowing, you feel pain behind the breast-bone or new or worsened heartburn, stop taking Alendronic Acid 70mg Tablets and contact your doctor. If you ignore these symptoms and continue to take your tablets it is likely that these gullet reactions may get worse.

The following side effects have been reported:

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

• Muscle, joint or bone pain, which is sometimes severe.

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

• Stomach pain
• Wind
• Vertigo
• Indigestion
• Full or bloated feeling in the stomach
• Ulceration of the oesophagus (gullet)
• Constipation
• Regurgitation of acid from the stomach (reflux)
• Pain or difficulty when swallowing
• Diarrhoea
• Headache
• Dizziness
• Hair loss
• Itching (pruritus)
• Joint swelling
• Weakness or lack of energy
• Excess fluid (swelling), usually in the legs (peripheral oedema).

Uncommon side effects (may affect up to 1 in 100 people):

• Feeling and being sick (nausea and vomiting)
• Inflammation of the stomach
• Inflammation and/or thinning (erosion) of the gullet
• Rash
• Black tarry stools
• Reddening of the skin
• Changes in your sense of taste
• Inflammation of the eye
• Temporary flu-like symptoms (muscle pain, general feeling of illness and, in rare cases, fever) usually at the start of treatment.

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

• Narrowing of the gullet
• Allergic (hypersensitivity) reactions including swelling and skin eruptions
• Severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• Stomach or other peptic ulcers (although it is not clear whether these ulcers are caused by alendronic acid)
• Mouth and/or throat ulcers
• Skin rash with sensitivity to light
• Low calcium levels which may cause muscle cramps or spasms and tingling sensation in the fingers or around the mouth.
• Pain and/or inflammation of the jaw (this is more common in people who have had a tooth taken out and/or a mouth infection).
• 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.

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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

What Alendronic Acid 70mg Tablets contain:

• The active substance is alendronic acid. Each tablet contains 70mg of alendronic acid as sodium alendronate trihydrate.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate.

What Alendronic Acid 70mg Tablets look like and contents of the pack

Alendronic Acid 70mg Tablets are white to off-white oval tablets stamped ’AN 70‘ on one side and ‘>’ on the other.

The tablets are available in blister packs of 2, 4, 8, 12 and 40 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer: