Alendronic Acid 10 Mg Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER Alendronic Acid 10 mg tablets
Alendronic Acid
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.
- 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 is and what it is used for
2. Before you take Alendronic Acid
3. How to take Alendronic Acid
4. Possible side effects
5. How to store Alendronic Acid
6. Further information
1. WHAT ALENDRONIC ACID IS AND WHAT IT IS USED FOR
What is Alendronic Acid?
Alendronic acid belongs to a group of medicines called 'bisphosphonates'. Alendronic acid prevents the loss of bone that occurs in men, postmenopausal women and patients receiving glucocorticoids such as prednisolone and methylprednisolone. Alendronic acid has also been shown to help rebuild bone and makes bone less likely to fracture in postmenopausal women and men with osteoporosis.
What is Alendronic Acid used for?
Your doctor has prescribed Alendronic Acid to treat your osteoporosis. Alendronic Acid reduces the risk of spine and hip fractures.
Alendronic Acid is used:
- treat osteoporosis in post-menopausal women
- treat osteoporosis in men
- prevent osteoporosis in post-menopausal women who are taking medicines called glucocorticoids but are not taking oestrogen.
What is osteoporosis?
Osteoporosis is thinning and weakening of your bones. It is common in women after the menopause. Osteoporosis can also occur in men. Corticosteroids can also cause bone loss and osteoporosis in both men and women. Early on, osteoporosis usually has no symptoms. If left untreated 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 injuries that would not fracture normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also considerable problems like stooped posture ('dowager's hump').
Osteoporosis in postmenopausal women
Osteoporosis often occurs in women several years after, the menopause, which occurs when the ovaries virtually stop producing the female hormone, oestrogen, or are removed (which may occur, for example, at the time of a hysterectomy). The earlier a woman reaches the menopause, the greater the risk of osteoporosis.
Severe Osteoporosis in men
Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone. In all instances, bone is removed faster than it is formed, so bone loss occurs and bones become weaker. Therefore, it is important for a healthy skeleton to maintain bone mass and preventing further bone loss.
By drugs from the group of corticosteroids (eg. prednisone) induced osteoporosis in women who did not receive estrogen
Under the influence of corticosteroids bone is removed faster than it is formed so bone loss occurs and bones become weaker Therefore, maintaining bone mass and preventing further bone loss are important to keep your skeleton healthy. If your doctor prescribes corticosteroids, you should use it as directed.
How can osteoporosis be treated or prevented?
It is important to remember that if you already have osteoporosis that it can be treated and that it is never too late to begin. Alendronic Acid 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. In addition to your treatment with Alendronic Acid, your doctor may recommend that you make some changes to your lifestyle which may help your condition. These are:
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. Talk to 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.
2. BEFORE YOU TAKE ALENDRONIC ACID
Do not take Alendronic Acid if you:
• Ifyouare allergic (hypersensitive) to alendronate sodium trihydrate or any of the other ingredients.
• Ifyouhave certain disorders of the oesophagus (the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing
• Ifyouare unable to stand or sit upright for at least 30 minutes
• Ifyourdoctor has told you that you have low blood calcium
• Seealso “Take special care with Alendronic Acid”.
Take special care with Alendronic Acid
It is important to tell your doctor before taking Alendronic Acid Tablets
• Ifyousuffer from kidney problems
• ifyouhave any swallowing or digestive problems
• ifyouhave been told you have low blood calcium.
• Ifyourdoctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus),
• youhave poor dental health, gum disease , a planned dental extraction or you don't receive routine dental care
• youhave cancer
• youareundergoing chemotherapy or radiotherapy
• youaretaking corticosteroids (such as prednisone or dexamethasone)
• youareor have been a smoker
You may be advised to have a dental check-up before starting treatment with Alendronic Acid.
It is important to maintain good oral hygiene when being treated with Alendronic Acid. 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. These side effects may worsen if patients continue to take Alendronic Acid after developing these symptoms.
Taking other medicines
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronic Acid if taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW TO TAKE ALENDRONIC ACID.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Alendronic Acid with food and drink It is likely that food and beverages (including mineral water) will make Alendronic Acid 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.
Children and adolescents
Alendronic Acid should not be given to children and adolescents.
Pregnancy and breast-feeding
Alendronic Acid is only intended for use in postmenopausal women. You should not take Alendronic Acid if you are or think you may be pregnant, or if you are breast-feeding.
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 machinery. Individual responses to Alendronic Acid may vary (See section 4.POSSIBLE SIDE EFFECTS).
3. HOW TO TAKE ALENDRONIC ACID
Always take Alendronic Acid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Follow these instructions carefully to make sure you will benefit from Alendronic Acid
It is very important to follow instructions 1), 2), 3), 4) and 5) to help the Alendronic Acid tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
1) After getting up for the day, and before taking any food, drink or other medicine, swallow your Alendronic Acid tablet whole with a full glass of plain water only (not less than 200ml)
• Donottake with mineral water (still or sparkling)
• Donottake with coffee or tea
• Donottake with juice or milk.
Do not crush or chew the tablet or allow it to dissolve in your mouth.
2) After swallowing your alendronic acid tablets 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 after your first food of the day.
3) Do not take alendronic acid tablets at bedtime or before getting up for the day.
4) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking alendronic acid tablets and contact your doctor.
5) After swallowing your 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 tablets is effective only if taken when your stomach is empty,
Treatment of osteoporosis in men and post-menopausal women The usual dose is 10 mg once a day.
Prevention of steroid induced osteoporosis in post-menopausal women not receiving oestrogens
The usual dose is 10 mg once a day.
Elderly patients
No dose adjustment in elderly patients is necessary.
If you have kidney problems
Alendronic Acid must not be used in patients with severe kidney problems.
If you take more Alendronic Acid 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
Take Alendronic Acid once a day as prescribed. Do not take a double dose to make up for a forgotten dose. Follow the usual schedule with one tablet per day.
If you stop taking Alendronic Acid
It is important that you continue taking Alendronic Acid for as long as your doctor prescribes the medicine. Alendronic Acid 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.
• stomachor peptic ulcers (sometimes severe or with bleeding),
• narrowing of the gullet (oesophagus - the tube that connects your mouth with your stomach),
• rashmade worse by sunlight; severe skin reactions,
• paininthe 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,
• fractureof 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.
• mouthulcers when the tablets have been chewed or sucked;
During post-marketing experience the following reactions have been reported (frequency rare):
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.
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 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.
5. HOW TO STORE ALENDRONIC ACID
Keep out of the reach and sight of children.
Do not use Alendronic Acid after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions. 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
4. POSSIBLE SIDE EFFECTS
Like all medicines, Alendronic Acid can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects have been reported.
Very common (occurring in at least 1 of 10 patients treated)
Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated) Uncommon (occurring in at least 1 of 1000 and less than 1 of 100 patients treated)
Rare (occurring in at least 1 of 10,000 and less than 1 of 1000 patients treated)
Very rare (occurring in less than 1 of 10,000 patients treated)
Very common:
• bone,muscle and/or joint pain which is sometimes severe.
Common:
• 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,
• jointswelling,
• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,
• hairloss; itching,
• headache; dizziness,
• tiredness; swelling in the hands or legs.
Uncommon:
• nausea;vomiting,
• irritationor inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach,
• blackortar-like stools,
• blurredvision; 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:
• allergicreactions 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,
What Alendronic Acid contains
- The active substance is alendronic acid.
Each tablet contains 10 mg alendronic acid (equivalent to 13.052 mg sodium alendronate trihydrate).
- The other ingredients are: Microcrystalline cellulose, maize starch, sodium starch glycolate (Type A), povidone (Kollidon 30) and magnesium stearate
What Alendronic Acid looks like and contents of the pack
Tablet.
White to off-white, round, biconvex, uncoated tablets debossed with 'F' on one side and '18' on the other side.
They are supplied in blister packs and HDPE tablet container packs.
Pack size:
PVC/Aclar - Aluminium blister pack: 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 140 and 250 tablets
HDPE tablet container pack: 30, 50, 100, 250 and 1000 tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
This medicinal product is authorised in the Member States of the EEA under the following names:
Italy Acido Alendronico Aurobindo 10 mg compresse
Netherlands Alendroninezuur Aurobindo 10 mg, tabletten
Poland Alendronat Aurobindo
Romania Acid Alendronic Aurobindo 10 mg comprimate
Spain ACIDO ALENDRONICO AUROBINDO 10 mg comprimidos
EFG
United Kingdom Alendronic Acid 10 mg tablets
This leaflet was last approved in 07/2013.