Thursday, 21 June 2012

Alendronic Acid 70mg (Actavis UK Ltd)





Alendronic Acid 70mg Tablets



Alendronic acid (as sodium trihydrate)




Please read this leaflet carefully before you start to take your tablets.



  • It contains important information.


  • It is particularly important to read the section “How to take your tablets”.


  • If you are not sure about anything, or want to know more, ask your doctor or a pharmacist.


  • Keep this leaflet safe, as you may want to read it again.





About Your Tablets



Your tablets are called Alendronic Acid 70mg Tablets.



They are part of a group of drugs known as bisphosphonates.





What Is In Your Tablets



Each tablet contains:



  • Alendronic acid 70mg (as sodium trihydrate) (active ingredient); and


  • Cellactose 80, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate (inactive ingredients).

Alendronic Acid 70mg Tablets are white, round, biconvex tablets, marked with ‘70’ on one side and plain on the other side.



Alendronic Acid 70mg Tablets are supplied in blister packs of 2, 4 and 12 tablets. Not all pack sizes may be marketed.





Who makes your tablets



The marketing authorisation holder is




Actavis Group PTC ehf

Reykjavikurvegi

76-78, 220 Hafnarfjordur

Iceland



The manufacturer and distributor is




Actavis

Barnstaple

EX32 8NS

UK





What your tablets do



Alendronic acid belongs to a group of medicines called 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.





Before You Take Your Tablets




Do not take Alendronic Acid 70mg Tablets and tell your doctor if;



  • you have certain disorders of the oesophagus (sometimes called the gullet and is the tube that connects your mouth with your stomach)


  • you are unable to stand or sit upright for at least 30 minutes


  • you are allergic to any of the ingredients


  • your doctor has told you that you have low blood calcium


  • you are or think you may be pregnant


  • you are breast-feeding.

Alendronic acid should not be given to children.





Please tell your doctor or pharmacist before you start to take Alendronic Acid 70mg Tablets if you;



  • suffer from kidney problems


  • have any allergies


  • have any swallowing or digestive problems


  • have an intolerance to some sugars e.g. lactose


  • are taking any other medicines including ones you have bought yourself without prescription.




Can you take Alendronic acid with other medicines?



Alendronic acid can interact with food, drinks and other medicines which you take by mouth, and it is important to follow the advice given under the heading “How to take your tablets”. You should always tell your doctor about all medicines you are taking or plan to take,
including any obtained without prescription.






How To Take Your Tablets



Alendronic Acid 70mg Tablets are to be taken by mouth once a week.



It is important that you carefully follow the instructions on how to take your tablets.



Choose a day of the week to take your tablet that best fits with your normal schedule. Every week, take one Alendronic Acid 70mg Tablet on your chosen day.



After getting up for the day and before taking your first food, beverage or other medicine, swallow your Alendronic Acid 70mg Tablet with a full glass of plain water (not less than 200ml or 7 fl. oz).



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 70mg 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.



If you miss a dose, just take one Alendronic Acid 70mg Tablet on the morning after your remember. Do not take two tablets on the same day.



The following week return to taking one tablet once a week, as originally scheduled on your chosen day.



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




What to do if you take too many tablets



It is important not to take too many tablets. If you have taken too many tablets drink a full glass of milk and contact your doctor or hospital Accident and Emergency department immediately. Do not make yourself vomit, and do not lie down.






What unwanted effects could Alendronic Acid 70mg Tablets have?



While taking Alendronic Acid 70mg Tablets you may have some side effects. Tell your doctor if you suffer from any of the following:



  • irritation or ulceration of the oesophagus (the tube that connects your mouth with your stomach), which can cause chest pain, heartburn, difficulty or pain upon swallowing and/or scarring leading to narrowing of the oesophagus.These reactions may occur if patients do not drink a full glass of water with alendronic acid and/or if they lie down less than 30 minutes after taking alendronic acid or before their first food of the day. Oesophageal reactions may worsen if patients continue to take alendronic acid after developing symptoms suggesting irritation of the oesophagus.


  • stomach/abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, feeling full or bloated, nausea and vomiting and black and/or bloody stools.


  • some patients may experience bone, muscle or joint pain, (rarely, with flu-like symptoms or fever), headache or rarely a rash (occasionally made worse by sunlight), itching, eye pain, diminished or hazy vision and/or see black floating spots.


  • rarely stomach or other peptic ulcers have occurred. It is not known whether or not these were caused by treatment with Alendronic acid.


  • very rarely severe skin reactions have occurred. Allergic reactions such as hives or, rarely, more severe allergic reactions have occurred. If you experience 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 may be due to a severe allergic reaction which can be life threatening.


  • mouth ulcers have occurred when the tablets have been chewed or sucked.

If you feel unwell in any other way, tell your doctor as soon as you can.



Alendronic acid should not affect your ability to drive or operate machinery.





Looking After Your Tablets



Keep all tablets out of the sight and reach of children.



No special storage conditions are required for this medicine.



Do not take the tablets after the expiry date.You should take any tablets that are out of date or which you no longer need back to your pharmacist.



These tablets are only for you. Only a doctor can prescribe them for you. Never give them to anyone else as it may harm them, even if their symptoms are the same as yours.




PL number 30306/0032



This leaflet was written in November 2007.






Actavis

Barnstaple

EX32 8NS

UK






No comments:

Post a Comment