Alendronic Acid 70 Mg Film-Coated Tablets
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Alendronic Acid 70 mg film-coated 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 symptoms 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.
What is in this leaflet:
1. What Alendronic Acid is and what it is used for
2. What you need to know before you take Alendronic Acid
3. How to take Alendronic Acid
4. Possible side effects
5. How to store Alendronic Acid
6. Contents of the pack and other information
1. What Alendronic Acid is and what it is used for What is Alendronic Acid?
Alendronic Acid contains the active substance 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.
How Alendronic Acid works?
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.
The optimal duration of this treatment has not been established. Your doctor periodically re-evaluates the need for continued treatment, particularly after 5 or more years of use.
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.
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).
You must talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before you take Alendronic Acid Do not take Alendronic Acid
• 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.
• if you cannot stand or sit upright for at least 30 minutes.
• if your doctor 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.
Warnings and precautions
Talk to your doctor before taking Alendronic Acid 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
• you have poor dental health, gum disease, a planned 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 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.
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.
Alendronic acid has not been investigated in the treatment of glucocorticoid induced osteoporosis. Children and adolescents
Alendronic Acid should not be given to children and adolescents.
Other medicines and Alendronic Acid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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.
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.
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).
3. How to take Alendronic Acid
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The recommended dose is 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) 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).
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).
Do not take with mineral water (still or sparkling). Do not take with coffee or tea.
• Do not take 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and tell your doctor immediately if you experience any of the following
symptoms:
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 (angioedema).
• rare cases of potentially life-threatening skin rashes have been reported with the use of alendronate, appearing as a skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome) or severe skin reactions which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell (toxic epidermal necrolysis).
• 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.
• 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.
• stomach or peptic ulcers (sometimes severe or with bleeding).
Contact your doctor if you experience such symptoms.
Other possible side effects:
Very common (may affect more than 1 in 10 people):
• musculoskeletal (bone, muscle 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
• headache
• alopecia
• asthenia
• dizziness
• peripheral oedema
• pruritus
• vertigo
Uncommon (may affect up to 1 in 100 people):
• nausea, vomiting
• irritation or inflammation of the gullet (oesophagus) or stomach
• black or tar-like stools
• rash; redness of the skin
• taste disturbance
• eye inflammation
• transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment
Rare (may affect up to 1 in 1,000 people):
• symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
• narrowing of the gullet (oesophagus)
• rash made worse by sunlight
• mouth ulcers when the tablets have been chewed or sucked
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
5. How to store Alendronic Acid
Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date which stated on the carton 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 Alendronic Acid contains
The active substance is 70 mg alendronic acid in each film-coated tablet.
The other ingredients are:
- tablet core: cellulose microcrystalline (E460), colloidal anhydrous silica, croscarmellose sodium (E468), magnesium stearate (E572)
- film-coating: cellulose microcrystalline (E460), carrageenan (E407), macrogol 8000.
What Alendronic Acid looks like and contents of the pack
Alendronic Acid film-coated tablets are white, round and biconvex, with an engraved mark “M14” on one side.
Each pack contains blisters of 2, 4 or 12 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
1103 Budapest, Gyomroi ut 19-21.
Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
Hungary: Matekit 70 mg filmtabletta
United Kingdom: Alendronic Acid 70 mg film-coated tablets
This leaflet was last revised in August 2013.
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