Alendronic Acid 70 Mg Tablets
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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 non-hormonal medicines called bisphosphonates. Alendronic Acid 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 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 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 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, 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.
• Eatingabalanced diet:Your doctor can advise you about your diet or
whether you should take any dietary supplements (especially calcium and Vitamin D).
2. BEFORE YOU TAKE ALENDRONIC ACID
Do not take Alendronic Acid
• ifyouare allergic (hypersensitive) to alendronate sodium trihydrate or any of the other ingredients
• ifyouhave certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing
• ifyoucannot stand or sit upright for at least 30 minutes
• ifyourdoctor has told you that you have low blood calcium
If you think any of these apply to you, do not take the tablets. Talk to your
doctor first and follow the advice given.
Take special care with Alendronic Acid
It is important to tell your doctor before taking Alendronic Acid if:
• yousuffer from kidney problems
• youhave any swallowing or digestive problems
• yourdoctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus)
• youhave been told you have low blood calcium
• 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, followed.
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
Take one Alendronic Acid tablet once a week.
Follow these instructions carefully to make sure you will benefit from Alendronic Acid
1) Choose the day of the week that best fits your schedule. Every week, take one Alendronic Acid tablet on your chosen day.
It is very important to follow instructions 2), 3), 4), 5) and 6) 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).
2) 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 water only (not mineral water) (not less than 200 ml or 7 fl. oz.).
• 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.
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 after your first food of the day.
4) Do not take Alendronic Acid at bedtime or before getting up for the day.
5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid and contact your doctor.
6) After swallowing your Alendronic Acid 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 is effective only if taken when your stomach is empty.
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
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 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.
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,
• tastedisturbance.
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,
• 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
What Alendronic Acid contains
- The active substance is alendronic acid.
Each tablet contains 70 mg alendronic acid (equivalent to 91.363 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, oval, biconvex, uncoated tablets debossed with 'F' on one side and '21' on the other side.
The tablets are supplied in blister packs comprising of PVC/Aclar -Aluminium.
Pack size: 2, 4, 8, 12, 20, 30, 40, 50 or 60 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 70 mg compresse
Netherlands: Alendroninezuur Aurobindo 70 mg, tabletten
Poland: Alendronat Aurobindo
Romania: Acid Alendronic Aurobindo 70 mg comprimate
Spain: ACIDO ALENDRONICO SEMANAL AUROBINDO 70 mg
comprimidos EFG
United Kingdom: Alendronic Acid 70 mg tablets This leaflet was last approved in 07/2013.