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The product code for this leaflet is: PL 30306/0032

 

Alendronic Acid 70 mg Tablets

Company Details

Actavis UK Ltd


Whiddon ValleyBarnstapleDevonEX32 8NS
Telephone:
Fax:
Medical Information Direct Line:
Medical Information e-mail:medinfo@actavis.co.uk
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PATIENT INFORMATION LEAFLET

Alendronic Acid 70mg tablets

Read all of this leaflet carefully before you start taking this medicine.

  • 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.

Index

1 What Alendronic Acid tablets are and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

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1 What Alendronic Acid tablets are and what they are used for

They are part of a group of drugs known as bisphosphonates. Alendronic acid prevents the loss of bone (osteoporosis) in women that occurs after the menopause, and helps to rebuild bone.

Osteoporosis if untreated can result in fractures (broken bones) of the spine and hips, and alendronic acid can reduce the risk of the fractures occurring.

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2 Before you take

Do not take Alendronic Acid tablets and tell your doctor if you:

  • are allergic (hypersensitive) to alendronic acid or any of the other ingredients (see section 6).
  • have certain disorders of the oesophagus (sometimes called the gullet, it is the tube that connects your mouth with your stomach)
  • are unable to stand or sit upright for at least 30 minutes
  • doctor has told you that you have low blood calcium

Alendronic acid should not be given to children and adolescents.

Check with your doctor or pharmacist before taking Alendronic Acid tablets if you:

  • suffer from kidney problems
  • have any allergies
  • have thyroid problems or vitamin D deficiency
  • have any swallowing or digestive problems including a history of stomach ulcers or bleeding or are due to have surgery
  • are having treatment for cancer or taking steroids
  • have a history of dental disease such as poor dental hygiene or are having dental treatment
  • have been told that you have Barrett’s oesophagus (a condition with changes in the cells that line the lower oesophagus)

Taking other medicines

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

Pregnancy and breast-feeding

Alendronic Acid tablets must not be taken during pregnancy or while breast-feeding.

If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Alendronic acid tablets may cause dizziness. Make sure you are not affected before driving or operating machinery.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.

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3 How to take

Always take Alendronic Acid tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

One Alendronic Acid tablet is to be taken once a week.

Choose a day of the week to take your tablet that best fits with your normal schedule. After getting up for the day and at least 30 minutes before taking your first food, beverage or other medicine, swallow your Alendronic Acid tablet with a full glass of plain water (not less than 200ml or 7 fl. oz).

Side effects involving the oesophagus and stomach increase if Alendronic Acid tablets are not taken correctly.

Do not take your tablet with mineral water, coffee, tea or fruit juice.

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

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

Do not take Alendronic acid at bedtime or before getting up for the day.

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

After swallowing your Alendronic Acid 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 is effective only if taken when your stomach is empty.

Maintain good oral hygiene, receive routine dental check ups, and report any symptoms such as dental pain or swelling.

If you take more than you should

If you have taken too many tablets drink a full glass of milk and contact your doctor or hospital Accident and Emergency department immediately.

Symptoms such as heartburn, stomach upset, inflammation of the food pipe or stomach, or ulcers may occur.

Do not make yourself vomit, and do not lie down.

If you forget to take the tablets

If you forget to take a dose of Alendronic acid take the missed tablet the morning after you remember. You should then continue with your weekly schedule using your chosen day. Do not take a double dose to make up for a forgotten dose.

If you stop taking the tablets

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

Talk to your doctor before you stop taking the tablets and follow their advice.

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4 Possible side effects

Like all medicines, Alendronic Acid tablets can cause side effects, although not everybody gets them.

Stop taking this medicine and contact your doctor at once if you experience any of the following:

  • a severe allergic reaction: swelling of the face, lips, tongue and/or throat, possibly causing difficulty in breathing or swallowing. You should go to your local Accident and Emergency department immediately as this can be life threatening.
  • severe skin reactions: Stevens-Johnson syndrome (severe form of skin rash with flushing, fever, blisters or ulcers) and toxic epidermal necrolysis (severe rash involving reddening, peeling and swelling of the skin that resembles severe burns).

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

  • Very common (occurs in more than 1 in 10 users):
    • bone, muscle or joint pain.
  • Common (occurs in less than 1 in 10 users):
    • headache, dizziness, weakness, swelling, feeling of dizziness or spinning (vertigo), hair loss, itching of the skin, difficulty swallowing, tightening of the stomach muscles, joint swelling
    • stomach pain, heartburn, constipation, diarrhoea, indigestion, flatulence, feeling full or bloated, ulceration of the oesophagus (the tube that connects your mouth with your stomach), acid regurgitation
  • Uncommon (occurs in less than 1 in 100 users):
    • feeling or being sick, taste disturbance, inflammation or pain in the eye or iris, a feeling of general discomfort and illness, inflammation of the oesophagus, ulceration of the throat, black and/or bloody stools
    • rash, and redness of the skin
  • Rare (occurs in less than 1 in 1,000 users):
    • sensitivity to sunlight, low blood calcium levels
    • transient flu-like symptoms (muscle weakness, a general feeling of illness and in rare cases fever) normally at the beginning of treatment,
    • symptoms such as stomach ulcer, some severe, with bleeding have been seen but it is unclear if this is related to Alendronic Acid tablets
    • tightening of the muscle surrounding the oesophagus
    • mouth ulcers have occurred when the tablets have been chewed or sucked.
    • 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.
    • fracture of the thigh bone in patients on long-term treatment with alendronic acid. Thigh pain, weakness or discomfort may be an early indication of a possible fracture of the thigh bone
    • damage to the jaw bone and teeth may occur in patients taking alendronic acid

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

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5 How to store

Keep out of the reach and sight of children.

There are no special precautions for storage.

Do not use Alendronic Acid tablets after the expiry date stated on the pack. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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6 Further information

What Alendronic Acid tablets contain

  • The active substance (the ingredient that makes the tablet work) is alendronic acid 70mg (as sodium trihydrate)
  • The other ingredients are Cellactose 80, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate

What Alendronic Acid tablets look like and contents of the pack

Alendronic Acid tablets are white, round, biconvex tablets

Pack sizes of 2, 4 and 12 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf
Reykjavikurvegi
76-78, 220 Hafnarfjordur
Iceland

Manufacturer

Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
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Date of revision: July 2012

Actavis
Barnstaple
EX32 8NS
UK

AAAE0498


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