Alendronic Acid 70mg Tablets
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LABORATORIES LIMITED PKG. DEV. PAONTA
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDRONIC ACID 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.
- Ifyou have any further questions, askyourdoctororpharmacist.
- 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, talkto your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
In this leaflet:
1. What Alendronic Acid 70 mg Tablet is and what it is used for
2. What you need to know before you take Alendronic Acid 70 mg Tablets
3. How to take Alendronic Acid 70 mg Tablets
4. Possible side effects
5. How to store Alendronic Acid 70 mg Tablets
6. Contents of the pack and other information
1. WHAT ALENDRONIC ACID 70 mg TABLET IS AND WHAT IT IS USED FOR What is Alendronic Acid 70 mg Tablet?
Alendronic Acid 70 mg belongs to a group of non-hormonal medicines called bisphosphonates. Alendronic Acid 70 mg 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 Alendronic Acid 70 mg Tablet used for?
Your doctor has prescribed Alendronic Acid 70 mg Tablet to treat your osteoporosis. Alendronic Acid 70 mg Tablet reduces the risk of spine and hip fractures.
Alendronic Acid 70 mg Tablet 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 usually 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. Alendronic Acid 70 mg Tablet 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 Alendronic Acid 70 mg Tablets, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Stopping smoking Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.
Exercise Like muscles, bones need exercise to stay strong and healthy. Consult
your doctor before you begin any exercise programme.
Eating a balanced diet Your doctor can advise you about your diet or whether you should take any dietary supplements (especially calcium and Vitamin D).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALENDRONIC ACID 70 mg TABLETS Do not take Alendronic Acid 70 mg 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 problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing
• ifyou cannotstand or sit upright for at least 30 minutes
• if your doctor has told you that you have low blood calcium
If you thinkany of these apply to you, do nottake the tablets. Talkto yourdoctorfirst and follow the advice given.
Warnings and precautions
Talkto your doctor or pharmacist before taking Alendronic Acid 70 mg Tablets if:
• you sufferfrom 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,
• 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 ordexamethasone),
• 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 Alendronic Acid 70 mg Tablets.
It is important to maintain good oral hygiene when being treated with Alendronic Acid 70 mg 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.
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 Alendronic Acid 70 mg Tablet. These side effects may worsen if patients continue to take Alendronic Acid 70 mg Tablets after developing these symptoms.
Rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals has been reported with use of Alendronic Acid.
Other medicines and Alendronic Acid 70 mg Tablets
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronic Acid 70 mg if taken at the same time. Therefore, it is important that you follow the advice given in section 3 HOW TO TAKE ALENDRONIC ACID 70 mg Tablets.
Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. aspirin or ibuprofen) might cause digestive problems. Therefore, caution should be used when these medicines are taken at the same time as Alendronic Acid 70 mg.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Alendronic Acid 70 mg Tablet with food and drink
It is likely that food and beverages (including mineral water) will make alendronate less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3 HOW TO TAKE ALENDRONIC ACID 70 mg Tablets.
Children and adolescents
Alendronic Acid 70 mg Tablet should not be given to children and adolescents.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, askyour doctor or pharmacist for advice before taking this medicine.
Alendronic Acid 70 mg Tablet is only intended for use in postmenopausal women. You should not take Alendronic Acid 70 mg Tablet if you are or think you may be pregnant, or if you are breastfeeding.
Driving and using machines
There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with Alendronic Acid 70 mg Tablets that may affect your ability to drive or operate machinery. Individual responses to Alendronic Acid 70 mg Tablets may vary. (See section 4 POSSIBLE SIDE EFFECTS).
3. HOWTO TAKE ALENDRONIC ACID 70 mg TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
These tablets are for oral use.
Take one tablet once a week.
Follow these instructions carefully to make sure you will benefit from Alendronic Acid 70 mg Tablets.
1) Choose the day of the weekthat best fits your schedule. Every week, take one Alendronic Acid 70 mg tablet on your chosen day.
It is very importantto follow instructions 2), 3), 4) and 5) to help the Alendronic Acid 70 mg 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 Alendronic Acid 70 mg tablet whole with a full glass of water only (not mineral water) (not less than 200 ml or7fl.oz.).
• Do nottake with mineral water (still or sparkling).
• Do nottake with coffee ortea.
• Do nottake with juice or milk.
Do not crush or chew the tablet or allow it to dissolve in your mouth.
3) Do not lie down — stay fully upright (sitting, standing or walking) — for at least 30 minutes after swallowing the tablet. Do not lie down until afteryourfirstfood of the day.
4) Do nottake Alendronic Acid 70 mg Tablet at bedtime or before getting up forthe day.
5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking and contact yourdoctor.
6) After swallowing your Alendronic Acid 70 mg tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. Alendronic Acid 70 mg Tablet is effective only if taken when your stomach is empty.
If you take more Alendronic Acid 70 mg Tablet 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.
If you forget to take Alendronic Acid 70 mg Tablet
Ifyou miss adose, just take one tablet on the morning afteryou remember. Do nottake 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 Alendronic Acid 70 mg Tablet
It is important that you continue taking Alendronic Acid 70 mg Tablet for as long as your doctor prescribes the medicine. Alendronic Acid 70 mg Tablet can treat your osteoporosis only if you continue to take the tablets.
If you have any further questions on the use of this medicine, askyour doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (occurring in at least 1 of 10 patients treated):
• bone, muscle and/or joint pain which is sometimes severe.
Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated:
• 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 (occurring in at least 1 of 1,000 and less than 1 of 100 patients treated):
• nausea; vomiting,
• irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach,
• black ortar-like stools,
• blurred vision; pain or redness in the eye,
• rash; redness of the skin,
• transientflu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment,
• taste disturbance.
Rare (occurring in at least 1 of 10,000 and less than 1 of 1,000 patients treated):
• 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;
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.
If you get any side effects, talkto your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5. HOW TO STORE ALENDRONIC ACID 70 mg TABLETS
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date printed on the packaging. 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 protect the environment.
6. CONTENTS OFTHE PACKAND OTHER INFORMATION What Alendronic Acid 70 mg Tablet contains
The active substance is alendronic acid. Each film-coated tablet contains 70 mg alendronic acid (equivalentto 76.188 mg sodium alendronate).
The other ingredients are mannitol, croscarmellose sodium, magnesium stearate, talc and silica, colloidal anhydrous.
What Alendronic Acid 70 mg Tablet looks like and contents of the pack
White to off-white circulartablets, marked with “A” on one side and “4” on other side.
They are supplied in blister packs of 2,4,8,12,24 or 40 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is Ranbaxy (UK) Limited Building 4, Chiswick Park 566 Chiswick High Road,
London W45YE,
United Kingdom
The Manufacturer is Ranbaxy Ireland Ltd.
Spafield, Cork Road Cashel, Co. Tipperary Ireland
This leaflet was last revised in September 2012.
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