«Package leaflet: Information for the patient FOSAMAX® 10 mg Tablets (Alendronic acid) Read all of this leaflet carefully before you start taking ...»
Package leaflet: Information for the patient
FOSAMAX® 10 mg Tablets
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. See section 4.
• It is particularly important to understand the information in section 3. How to take Fosamax, before taking this medicine.
What is in this leaflet:
1. What Fosamax is and what it is used for
2. What you need to know before you take Fosamax
3. How to take Fosamax
4. Possible side effects 5 How to store Fosamax
6. Contents of the pack and other information
1. What Fosamax is and what it is used for What is Fosamax?
Fosamax is a tablet containing the active substance alendronic acid (commonly called alendronate) and belongs to a group of medicines called ‘bisphosphonates’. Fosamax prevents the loss of bone that occurs in women after they have been through the menopause. It can also prevent loss of bone in men or people taking steroids, such as prednisolone and methylprednisolone.
It has also been shown to help rebuild bone and reduce the risk of spine and hip fractures (broken bones) in women (after their menopause) and in men who have thinning of their bones (osteoporosis).
What is Fosamax used for?
Your doctor has prescribed Fosamax because you either have osteoporosis or you are at risk of developing this disease.
What is osteoporosis?
Osteoporosis is thinning and weakening of your 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.
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.
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’) and loss of mobility.
How can osteoporosis be treated or prevented?
As well as your treatment with Fosamax, your doctor may recommend that you make some changes to
your lifestyle which may help your condition. These are:
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 Fosamax
Do not take Fosamax if you:
• are allergic to alendronic acid, the active ingredient, or any of the other ingredients of this medicine (listed in section 6)
• have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing
• cannot stand or sit upright for at least 30 minutes
• 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 or pharmacist first and follow the advice given.
Warnings and precautions Talk to your doctor or pharmacist before taking Fosamax.
It is important to tell your doctor before taking Fosamax if you:
• suffer from kidney problems
• 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)
• have been told you have low blood calcium
• have poor dental health, gum disease, a planned extraction or you don't receive routine dental care
• have cancer
• are undergoing chemotherapy or radiotherapy
• you are taking angiogenesis inhibitors (such as bevacizumab, or thalidomide)
• are taking corticosteroids (such as prednisone or dexamethasone)
• 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 Fosamax.
It is important to maintain good oral hygiene when being treated with Fosamax. 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 Fosamax. These side effects may worsen if patients continue to take Fosamax after developing these symptoms.
Children and adolescents Fosamax should not be given to children and adolescents less than 18 years of age.
Other medicines and Fosamax 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 Fosamax if taken at the same time. Therefore, it is important that you follow the advice given in section 3 How to take Fosamax.
Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid (aspirin) or ibuprofen) might cause digestive problems. Therefore, caution should be used when these medicines are taken at the same time as Fosamax.
Fosamax with food and drink It is likely that food and drinks (including mineral water) will make Fosamax less effective if taken at the same time. Therefore it is important that you follow the advice given in Section 3 How to take Fosamax.
Pregnancy and breast-feeding Fosamax is only intended for use in postmenopausal women. Do not take Fosamax 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 Fosamax that may affect your ability to drive or operate machinery. Individual responses to Fosamax may vary. (See section 4.) Fosamax contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Fosamax Always take Fosamax exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
Taking your medicine It is very important that you follow actions 1 to 5 to help the tablet reach your stomach quickly and help reduce possible irritation of your 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 Fosamax Tablet whole with a full glass of plain water only (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.
2. 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 Fosamax 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 Fosamax and talk to your doctor immediately.
5. After swallowing your tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. Fosamax will only work if your stomach is empty.
The usual dosage is
• for the treatment of osteoporosis in men and post-menopausal women the usual dose is 10 mg once a day.
• for the treatment and prevention of steroid induced osteoporosis in post-menopausal women not receiving hormone replacement therapy (HRT) with an oestrogen the usual dose is 10 mg once a day.
If you take more Fosamax 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 Fosamax
• If you forget to take your dose, skip the missed dose.
• Take the next dose as normal.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Fosamax It is important that you take Fosamax for as long as your doctor prescribes the medicine.
Since it is not known how long you should take Fosamax, you should discuss the need to stay on this medicine with your doctor periodically to determine if Fosamax is still right for you.
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.
See your doctor immediately if you notice any of the following side effects, which may be serious,
and for which you may need urgent medical treatment:
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.
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; severe reactions involving your skin, mucous membranes of your mouth, nose, eyes or genitals. Stop taking this medicine and contact your doctor right away if you experience such symptoms;
• 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;
• bone, muscle and/or joint pain which is severe.
Other side effects include:
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):
• 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.
Rare (may affect up to 1 in 1000 people):
• 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;
• 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.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Fosamax Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after ‘EXP’.
The expiry date refers to the last day of that month.
Do not store above 30°C.