Alendronic Acid 70 Mg Tablets
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Alendronie acid (as alendronate sodium trihydrate)
Read all of this leaflet carefully before you start taking this rrvedicine.
• Keep this leaflet You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist
• This merSrine has been presented for you. Do not pass it on to others. It may ham them, even if their symptoms are toe same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Alendronic Acid 70 mg Tablets are and what they are used for
2. Before you talcs Alendronic Acid 70 mg Tab fete
3. Howto take AJerafi-onk: Arid 70 mg Tablets
4. Possible side effects
5. Howto store Alendronic Arid 70 mg Tablets
6. Further inrformartlon
1. What Alendronic Acid 70 mg Tablets are and what they are used for
Alendronic acid belongs to a group of non-bormonal medicines called bisphosphonates.
Atendronic Arid 70 mg Tablets are used to:
• prevent the loss of bone (osteoporosis) that occurs in women after they have been through the menopause
* reduce the risk of spine and hip fractures.
About osteoporosis
At the menopause the female body stops making oestrogen, which can result in bone loss and weakening (osteoporosis). Initially, osteoporosis may have no obvious symptoms. However, if left untreated it can result in fractures (broken bones) occurring as a result of normal, everyday activities and instances which might not normally cause a fracture. Common fractures include: hip, spine, or wrist and can lead not only to pain but also to considerable deformity and disability {such as he&^it loss, stooped posture, or ‘dowager’s hump', and less of mobility).
Alendronic Arid 70 mg Tablets not only prevent the loss of bone that occurs in women after the menopause but actually helps to reMd bone and reduces the risk of spine and hip fractures.
In addition to your treatment with Alendronic Add 70 mg Tablets, your doctor may recommend that you make some lifestyle changes to help your condition. These are:
* Stop smoking: Smoking may increase the rate at which you lose hone and, therefore, may increase your risk of fracture.
* Take exercise: Bones need exercise to stay strong and healthy. Consult your doctor before you begin any exercise programme.
* Eat a balanced diet: Your doctor can advise you about your diet or whether you should take any dietary supplements.
2. Before you take Alendronic Acid 70 mg Tablets
Do not take Alendronic Acid 70 mg Tablets ft:
* you are allergic (hypersensitive) to aferateonic acid or any of the ingredients of Alendronic Acid 70 mg Tablets (see Section 6: Further Information)
* you have certain disorders of the oesophagus (the feeding tube that connects your mouth with your stomach)
* you are uiabfe to stand or sit upright for at toast 30 minutes
* your doctor has told you that you have low blood calcium.
If arty of these apply to you, do not take Alendronic Arid
70 mg Tablets. Talk to your doctor first and follow the advice
given.
Take special care with Alendronic Arid 70 mg Tablets
Talk to y out doctor before taking Alendronic Arid 70 mg
Tablets ft:
* you suffer from kidney problems
* you have any swallowing or digestive problems
* you have gum disease
* you have a [toned dental extraction.
A dental examination should be S' = S g
considered before you start treatment gT=-g g
with Alendronic Ackf 70 mg Tablets if _ f§
you have any of the following conditions: mmmmm °
• you have cancer 2ETZ
• you are undergoing chemotherapy or radiotherapy
• you are taking corflcosierokfe
• you do not receive rortone dental care
• you have gum disease.
Appropriate preventative dental care, as recommended by the dentist, should be followed during treatment
Taking otter mec&cines
Please trif your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If taken at the same time, other medicines which are taken by mouth (including antacids and calcium supplements) can have an effect on afendrunic arid. Therefore, you must wait at least 30 minutes alter taking alendronic acid before taking any other medicines which are taken by mouth (see Section 3: Howto take Alendronic Acid 70 mg Tablets).
Taking Atendranic Acid 70 mg Tablets with food and drink If token at the same time, food and drink (Including mineral water) can have an effect on alendronic arid. AJendrunic acid is effective only if token when your stomach to empty. Therefore, you must wait at least 30 minutes after taking Alendronic Acid 70 mg Tablets before taking food or drink:
Pregnancy and breast-feeding
You shoidd not take alendronic arid if you:
• are pregnant planning to become pregnant or if you think you may be pregnant
* are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving aid using machines
Alendronic Acid 70 mg Tablets should not affect your ability to drive or operate machinery.
Children
Afendronic Acid 70 mg Tablets should not be given to children.
3. How to take Alendronic Acid 70 mg Tablets
Alendronic Arid 70 mg Tablets are for oral use.
Always lake Alendronic Acid 70 mg Tablets exactly as your doctor has told you. You shoidd check with your doctor or pharmacist if you are not sure.
You may have previously been prescribed a 10 mg tablet of alendronic acid which is taken once a day, however, the usual dose of Alendronic Arid 70 mg Tablets is one 70 mg tablet once weekly.
It to very important that you follow the steps listed below to help the Afendronfc Arid 70 mg Tablet reach your stomach quickly, help reduce potential for irritation of your oesophagus and to help make sure you benefl from Alendronic Arid 70 mg Tablets.
1. Choose the day of the week that best fits your schedule. Every week, take one Alendronic Acid 70 mg Tablet on your chosen day.
2. After getting up for the day and at least 30 minutes before taking your first food, drink, or other medicines (including antacids and calcium supplements), swallow your Alendronic Arid 70 mg Tablet with a fun glass of plain tap water only (not less than 200 ml or 7 fl. oz.). Alendronic
Acid 70 mg Tablets are effective only ff taken v/tien your stomach is empty.
Do not take toe tablet wfth:
• rraneraf water
• coffee or tea
• juice.
Do not chew or allow your Aleudronic Arid Tablet to dissolve in your mouth.
3. After swaiowing your AJendronte Acid 70 mg Toilet do not lie down. Stay tolly upright (sitting, standing or walking) for at least 30 minutes and do not be down unto aler your first food of toe
4. Do not take Alendronte Acid 70 mg Tablets at bedttore or before getting ijp for the day.
If patients do not drink a toll glass of water wito their Atendronic Arid 70 mg Tablet and/or rf they lie down witom 30 minutes after taking toeir tablet or before their first food of toe day, toe following reactions may occur: Irritation or ulceration of toe oesophagus (toe feeding lube that connects your mouth with your stomach) which can cause chest pain, heartburn, difficulty or pato upon swallowing and/or scarring leading to narrowing of the oesophagus.
If you develop difficulty or pain upon swallowing, chest pain, or new or worsering heartburn, stop taking Atendronic Acid 70 mg Tablets and contact your doctor
If you take more Atendronic Acid 70 mg Tablets than you should
If you tete too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make y ourself vomit, aid do not tie down.
If you forget to Me Atendronic Acid 70 mg Tablets If you miss a dose, take one Atendronic Acid 70 mg Tabtet the morning after you remember. Do not take two tablets on toe same day. Return to taking one tablrt once a week, as originaly scheduled on your chosen day. Do not trice a double dose to make up for a forgotten tablet
If you stop taking Atendronic Acid 70 mg Tablets It is important that you continue taking Atendronic Acid 70 mg Tablets for as long as your doctor prescribes toe medicine. Atendronic Arid /0 mg Tablets can treat your osteoporosis only if you continue to take toe tablets.
If you have any fu rther questions on the use of this product ask yoir doctor or pharmacist
4. Possible side effects
Most patients do not experience any side effects from tricing Atendronic Acid 70 mg Tablets. However, like all medicines, Atendronic Arid 70 mg Tabtets can cause side effects, although not everybody gets them.
Common (affecting more than 1 person in 100, but less than 1 into)
* headache
* abdominal pain, indigestion, constipation, diantioea, flatulence, full or bloated feeling in the stomach, arid reflux
* difficulty swallowing, ulceration of toe oesophagus which can cause chest pain, heartburn or difficulty or pain when swallowing
* bore, muscle or joint pain.
Uncommon (affecting more than 1 person in 1,000, but less thanl In 100)
* nausea, vomiting, Mack or Mood/ stools
* irritation or Inflammation of tire stomach or oesophagus
* rash, itching (pruritus), reddening of toe start (erythema).
Rare (affecting more than 1 person in 10.000, bid less than 1 in 1,000)
* eye pain, reduced or hazy vision and/or black floating spots
* narrowing of toe oesophagus
* mouth ulcers (when the tablets have been chewed or sucked)
* stomach or peptic ulcers (sometimes severe or with bteedmg) although it is not known whether or not these were caused by treatment with Atendronic Acid 70 mg Tablets
* jaw problems associated with delayed healing and infection,
often following tooth extraction (see “Trice special care with Atendronic Arid 70 mg Tablets77 in Section 2)
* allergic reactions such, as hives or rarely, swelling of toe face, tips, tongue and/or throat possibly causing difficulty in breathing or swallowing (angioedema)
• transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever, usually at toe start of treatment
* 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 toe mouth.
Very rare (affecting less than 1 person in 10,000, including
isolated reports)
• severe skin reactions deluding Stevercs-Johnson syndrome (severe allergic reaction that can result in skin blistering, fever and eye damage) and toxic epidermal necrolysis (skin becomes intensely red and peels of in toe manner of a second degree bum, often accompanied by bisters).
if any of the side effects gels serious, or rf you notice any
side effects not listed to this leaflet, please tell your doctor or
pharmacist
5. How to store Alendronic Acid 70 nng Tablets
• Keep out of tire reach and sight of children.
• This medicinal product does not require any special storage comftkms.
Use-by date
Do not use Alendronic Arid 70 mg Tablets after the expiry date 'which is stated on toe carton and Mister after “EXP”. The expiry date refers to the last day of tori 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.
6. Further information
Whri Atendronic Arid 70 mg Tabtets contains
♦ The active substance is atendronic acid (as alendronate sodium trihydrate). Each tablet contains 70 mg atendronic arid
* The other ingredients are: magnesium stearate, mannitol powder and microcrystalline ceflutese (PH 102).
What Atendronic Acid 70 mg Tablets looks lice arid contents of the pack
Atendronic Arid 70 mg Tablets are white, oval biconvex tabtets, marked with "APCT on one side and “ALE 70” on the other side.
Afendronic Arid 70 mg Tablets are supplied in Mister packs containing 2 or 4 tebtets packed to a carton together with a patient leaflet Pack sizes consists of 2r 4? 8,12. or 40 tabtets. Mot afl pack sizes may be available.
Marketing Authorisation HoWer and Manufacturer
Marketing Arihorfsation Hofder:
Zanza Labaratorias (Holdings) Ltdr Unit 2A, Olympic Way,
Seflofl Business Park, Liverpool. L301RD UK
Manufacturer:
Kriwijk Farma BV, ArchEmedesweg 2r 2333 CtJ Leiden,
The Netherlands
This leaflet ms last revised July 2013.