WWW.DISSERTATION.XLIBX.INFO
FREE ELECTRONIC LIBRARY - Dissertations, online materials
 
<< HOME
CONTACTS



«1 Package leaflet: Information for the user /./ 70 mg tablets Alendronic acid Read all of this leaflet carefully before you start taking this ...»

PACKAGE LEAFLET

1

Package leaflet: Information for the user

/…/ 70 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 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. See section 4.

What is in this leaflet

1. What /.../ is and what it is used for

2. What you need to know before you take /.../

3. How to take /.../

4. Possible side effects

5. How to store /.../

6. Contents of the pack and other information

1. What /.../ is and what it is used for What is /.../?

/.../ belongs to a group of non-hormonal medicines called bisphosphonates. /.../ prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.

What is /.../ used for?

Your doctor has prescribed /.../ to treat your osteoporosis. /.../ reduces the risk of spine and hip fractures.

/.../ is a once weekly treatment.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause.

At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis.

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 ussualy 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.

How can osteoporosis be treated?

Osteoporosis can be treated and it is never too late to begin treatment. /.../ not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.

As well as your treatment with /.../, your doctor may suggest you make changes to your lifestyle to

help your condition, such as:

2 Stopping smoking Smoking appears to increase the rate at which you lose bone and,

–  –  –

2. What you need to know before you take /.../

Do not take /.../:

- if you are allergic to alendronate sodium trihydrate 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 of 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking /…/ if:

- you suffer from kidney problems.

- you have any swallowing or digestive problems

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

- you have been told you have low blood calcium levels you have poor dental health, gum disease, a planned dental extraction or you don’t receive routine dental care,

- you have cancer,

- you are undergoing chemotherapy or radiotherapy,

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

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

You may be advised to have a dental check-up before starting treatment with /.../.

It is important to maintain good oral hygiene when being treated with /.../. 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 /.../. These side effects may worsen if patients continue to take /.../ after developing these symptoms.

Rare skin conditions with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals has been reported with use of Alendronic Acid.

Children and adolescents /…/ should not be given to children and adolescents.





Other medicines and /…/

–  –  –

Certain drugs for rheumatism or long-term pain (e.g. aspirin or ibuprofen) might cause gastrointestinal irritation. Therefore, caution should be used when these drugs are used concomittantly with /…/.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

/.../ with food and drink It is likely that food and beverages (including mineral water) will make /…/ less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3 ‘How to take /.../’.

Pregnancy and breast-feeding /…/ is only intended for use in postmenopausal women.

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.

Driving and using machines There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with alendronic acid that may affect your ability to drive or operate machines.

Individual responses from /…/ may vary (see section 4, ‘Possible side effects’).

/.../ contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

–  –  –

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take one /.../ tablet once a week.

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

1. Choose the day of the week that best fits your schedule. Every week, take one tablet /.../ on your chosen day.

It is very important to follow instructions 2, 3, 4 and 5 to help the tablet /.../ reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).

2. After getting up for the day and before taking any food, drink, or other medicine, swallow your tablet /.../ 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.

Only swallow /…/ whole. Do not chew or crush the tablet, nor allow it to dissolve in your mouth because of the risk for ulceration in your mouth or gullet.

–  –  –

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

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

If you take more /.../ 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.

Symptoms of overdose may include upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer.

If you forget to take /.../ If you miss a dose, just take one tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.

If you stop taking /.../ It is important that you continue taking /.../ for as long as your doctor prescribes the medicine. /.../ can treat your osteoporosis only if you continue to take the tablets.

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

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

- bone, muscle and/or joint pain which is sometimes severe.

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

- heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing,

- joint swelling,

- abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,

- hair loss; itching,

- headache; dizziness,

- 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,

- blurred vision; pain or redness in the eye,

- 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.

5

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.

- symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,

- stomach or peptic ulcers (sometimes severe or with bleeding), narrowing of the gullet (oesophagus – the tube that connects your mouth with your stomach), rash made worse by sunlight; severe skin reactions,

- 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 (osteonecrosis) 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 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.

- mouth ulcers when the tablets have been chewed or sucked;

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.

Tell your doctor or pharmacist promptly about these or any other unusual symptoms.

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.

5. How to store /.../ Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not take this medicine after the expiry date which is stated on the carton and blister after “EXP”.

The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information What /.../ contains

- The active ingredient is alendronic acid. Each tablet contains 91.36 mg alendronate sodium trihydrate equivalent to 70 mg alendronic acid.

- Other ingredients (excipients) are: cellactose 80 (lactose monohydrate and cellulose, powdered), collodial anhydrous silica (E551), croscarmellose sodium (E468) and magnesium stearate (E470b).

–  –  –

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Actavis Group PTC ehf Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland Manufacturer Actavis UK Ltd Whiddon Valley Barnstaple North Devon EX32 8NS United Kingdom Actavis Nordic A/S Ørnegårdsvej 16 2820 Gentofte Denmark Balkanpharma Dupnitsa AD 3, Samokovsko Shosse Str.

2600 Dupnitsa Bulgaria

–  –  –

This leaflet was last revised in {MM/YYYY} {month YYYY}.

[To be completed nationally]

7



Similar works:

«002-ID-0216-Guide_to_ID_for_Child_Care_and_Preschools A Guide to the Control of Infectious Diseases In Child Care Centers & Preschools This booklet is a guide to infectious diseases which affect children and staff in child care centers and preschools. The guide provides information on incubation period and symptoms, method of spread and minimum control measures for selected diseases and conditions which are of public health importance. The staff at the Infectious Diseases Program of the...»

«T H E SUMMARY O F P R O F E S S I O N A L A C C O M P L I S H M E N T S 1. Name and surname: Danuta Anna Nowakowska 2. Held diplomas, scientific / artistic degrees with the name, place and year of obtaining and the title of thesis: 1973 dentistry diploma with honors Department of Dentistry, Faculty of Medicine, Wroclaw Medical University; 1976I degree of specialization in general dentistry; 1978 II degree of specialization in dental prosthetics; 1980 medical doctor degree awarded by the...»

«EVIDENCE REVIEW: Cataract Surgery Amended 16th May 2014 Mr. John P Hampson Public Health Specialist Cheshire West & Chester Council Mr. Michael Briggs Consultant Ophthalmic Surgeon Royal Liverpool Hospital March 1st 2014 INTRODUCTION Cataracts are associated with old age and around one third of 65-74 year olds will develop an opacity in their lenses. According to a Cochrane review1 cataract is a major cause of blindness (up to 80% of cases) and is responsible for other symptoms including glare...»

«Doctoral Dissertation FRAILTY AND ITS ASSOCIATION WITH COGNITIVE FUNCTION AMONG NON-DEMENTED JAPANESE COMMUNITY-DWELLING OLDER ADULTS By Sanmei Chen A Dissertation Submitted to Graduate School of Human-Environment Studies Kyushu University in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy Department of Behavior and Health Sciences Graduate School of Human-Environment Studies Kyushu University 2016 Abstract Frailty is a very important clinical syndrome and common...»

«1 GRADUATE PROGRAMS IN KINESIOLOGY HANDBOOK OF INFORMATION TEMPLE UNIVERSITY PHILADELPHIA, PA 19122 2 TABLE OF CONTENTS Revised September, 2009 Introduction... 3 Temple University... 3 Tuition... 3 Housing... 4 The College of Health Professions.. 4 The Department of Kinesiology.. 4 The Biokinetics Research Laboratory.. 4 The Health-Fitness and Wellness Center.. 5 Graduate Program Admission Requirements.. 5 Academic Achievement.. 5 Analytical Skills.. 5 Communication Skills.. 6 Related Life...»

«PUBLISHED BY World's largest Science, Technology & Medicine Open Access book publisher 96,000+ 2750+ 89+ MILLION INTERNATIONAL AUTHORS AND EDITORS OPEN ACCESS BOOKS DOWNLOADS AUTHORS AMONG 12.2% BOOKS TOP 1% AUTHORS AND EDITORS DELIVERED TO MOST CITED SCIENTIST FROM TOP 500 UNIVERSITIES 151 COUNTRIES Selection of our books indexed in the Book Citation Index in Web of Science™ Core Collection (BKCI) Chapter from the book Cataract Surgery Downloaded from:...»

«PUBLISHED BY World's largest Science, Technology & Medicine Open Access book publisher 96,000+ 2750+ 89+ MILLION INTERNATIONAL AUTHORS AND EDITORS OPEN ACCESS BOOKS DOWNLOADS AUTHORS AMONG 12.2% BOOKS TOP 1% AUTHORS AND EDITORS DELIVERED TO MOST CITED SCIENTIST FROM TOP 500 UNIVERSITIES 151 COUNTRIES Selection of our books indexed in the Book Citation Index in Web of Science™ Core Collection (BKCI) Chapter from the book Oxidative Stress and Chronic Degenerative Diseases A Role for...»

«ANATOMY A brief outline for non-medical staff involved in clinical audit, injury scaling or trauma audit The TRAUMA Audit & Research NETWORK DEVELOPING EFFECTIVE CARE FOR INJURED PATIENTS THROUGH PROCESS AND OUTCOME ANALYSIS AND DISSEMINATION ANATOMY Acknowledgements • The Sourcebook of Medical Illustration. Edited by P. Cull. Contributors • P Nee, Consultant in Emergency Medicine, Whiston Hospital • M Woodford, National Coordinator, The Trauma Audit and Research Network • N Zoltie,...»

«Thalidomide Celgene® (thalidomide) Pregnancy Prevention Programme Information for Healthcare Professionals Prescribing or Dispensing Thalidomide Celgene® UK Celgene contact details: Phone: 0808 156 3059 Fax: 0808 156 3058 Email: rmp.uk.ire@celgene.com This booklet is intended for healthcare professionals involved in prescribing or dispensing Thalidomide Celgene®, and contains information about: • Preventing harm to unborn babies: If Thalidomide Celgene® is taken during pregnancy it can...»

«The University of Texas at San Antonio Phone (210) 458-5465 Department of Chemistry Fax (210) 458-7428 One UTSA Circle zachary.tonzetich@utsa.edu San Antonio, TX 78249 http://utsa.edu/chem/tonzetich.html CURRICULUM VITAE Zachary J. Tonzetich Educational Background 2007 – 2010 Massachusetts Institute of Technology, Cambridge, MA National Institutes of Health Postdoctoral Fellow. Supervisor: Professor Stephen J. Lippard. 2002 – 2007 Massachusetts Institute of Technology, Cambridge, MA Ph.D....»

«Public Health Foundation of India CCEBDM & CCGDM Convocation – Thane (Maharashtra) Welcome Address delivered by Dr. Benny Negalur. Dignitaries on dais from L to R (Dr. Sandeep Bhalla, Dr. Ajay Thakkar, Dr. Sanjay Oak, Dr. H. B. Chandalia, Dr. Vijay Negalur and Dr. Pradeep Vaidya) Venue: Jupiter Hospital, Thane (Maharashtra) Date: 27th April, 2014 Agenda CCEBDM & CCGDM Convocation at Thane Overview A joint Convocation programme of PHFI’s ‘Certificate Course in Evidence Based Diabetes...»

«Herpes Zoster: [Print] eMedicine Dermatology http://emedicine.medscape.com/article/1132465-print emedicine.medscape.com eMedicine Specialties Dermatology Viral Infections Herpes Zoster Joseph S Eastern, MD, Clinical Assistant Professor, Department of Internal Medicine, Section of Dermatology, University of Medicine and Dentistry of New Jersey Updated: Oct 25, 2010 Introduction Background Zoster is a common, predominantly dermal, and neurologic disorder caused by the varicella-zoster virus...»





 
<<  HOME   |    CONTACTS
2016 www.dissertation.xlibx.info - Dissertations, online materials

Materials of this site are available for review, all rights belong to their respective owners.
If you do not agree with the fact that your material is placed on this site, please, email us, we will within 1-2 business days delete him.