FOSAVANCE 70 mg. / 5600 UI. 4 tablets
The active compounds are alendronate sodium trihydrate and cholecalciferol (vitamin D3). Each tablet contains 70 mg alendronic acid as alendronate sodium trihydrate and 70 micrograms (2800IU) cholecalciferol (vitamin D3).
Microcrystalline cellulose (E460), lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate (E572), butylated hydroxytoluene (E321), modified starch (maize), and sodium aluminum silicate (E554).
1. WHAT FOSAVANCE IS AND WHAT IT IS USED?
What is FOSAVANCE?
FOSAVANCE is a tablet containing the two active substances alendronate sodium trihydrate and vitamin D3.
What is alendronate?
Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents the loss of bone that occurs in women who have passed menopause, and helps to rebuild bone. It reduces the risk of fractures in the spine and hip.
What is vitamin D?
Vitamin D is an essential nutrient, required for calcium absorption and healthy bones. The body can only absorb calcium properly from our food if it has enough vitamin D. Very few foods contain vitamin D. The main source is through exposure to summer sunlight, which makes vitamin D in our skin. In the process of aging skin produces less vitamin D. Too little vitamin D can lead to a loss of bone mass and osteoporosis. Severe vitamin D may cause muscle weakness which can lead to falls and increased risk of fractures.
What FOSAVANCE looks like and how it is offered?
FOSAVANCE tablets are capsule-shaped, white to off-white in color, depicted outline of a bone on one side and 710 'on the other side.
The tablets are available in sealed aluminum blisters in cartons:
• 2 tablets (1 carton containing 2 tablets in aluminum blisters).
• 4 tablets (1 carton containing 4 tablets in aluminum blisters).
• 6 tablets (3 cartons, each containing 2 tablets in aluminum blisters)
• 12 tablets (3 cartons, each containing 4 tablets in aluminum blisters)
40 tablets (10 cartons, each containing 4 tablets in aluminum blisters)
It is possible that the market does not offer all types of packaging.
What is FOSAVANCE?
Your doctor has prescribed FOSAVANCE to treat your osteoporosis and because you are at risk of deficiency of vitamin D. FOSAVANCE reduces the risk of fractures in the spine and hip fractures in postmenopausal women.
FOSAVANCE is a once a week.
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which keeps bones healthy women. As a result, develop bone loss 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 this process is usually painful fractures of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activities such as lifting, or from minor injury that would not generally break normal bone. Broken most of the hip, spine or wrist bones and can lead not only to pain but also to considerable problems like stooped posture ('dowager's garbitsa1) and loss of mobility.
How can you treat osteoporosis?
Osteoporosis can be treated and it is never too late to begin treatment. FOSAVANCE not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of fractures in the spine and hip.
In addition, treatment with FOSAVANCE, your doctor may suggest a change in lifestyle, which could be useful for your condition, such as:
Stopping smoking is known that smoking increases the rate of bone loss and may therefore increase the risk of broken bones.
Exercise Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise program.
Balanced diet Your doctor can advise you about your diet or whether you should take supplements.
2. BEFORE YOU TAKE FOSAVANCE
Do not take FOSAVANCE:
(1) if you are allergic (hypersensitive) to alendronate sodium trihydrate, colecalciferol or any of the other ingredients
(2) if you have certain problems with your gullet (esophagus - the tube that connects your mouth to your stomach) such as narrowing or difficulty swallowing
(3) if you can not stand or sit upright for at least 30 minutes
(4) if your doctor has told you that you have low blood calcium. If you believe that any of these circumstances apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.
Pay special attention to FOSAVANCE:
It is important to tell your doctor before taking FOSAVANCE:
* If you have kidney problems
• if you have any allergies
* If you have trouble swallowing or digestive system
• if you have low levels of serum calcium
Irritation, inflammation or ulceration of the gullet (esophagus - the tube that connects your mouth to your stomach) often with symptoms of chest pain, burning pain behind the breastbone, or carcass or painful swallowing may occur, especially if patients do not drink a full glass of water and / or if you lie (they lie IRI seated) at least 30 minutes after take FOSAVANSE. These side effects may worsen if patients continue to take.
Taking FOSAVANCE with food and drink:
It is likely that food and beverages (including mineral water) will make FOSAVANCE less effective if taken simultaneously. It is therefore important to follow the advice given in section
3. HOW TO TAKE FOSAVANCE
Take one FOSAVANCE tablet once a week.
Follow these instructions carefully to make sure you will benefit from treatment with FOSAVANCE.
1) Choose the day of the week that best fits your schedule. Every week, take one FOSAVANCE tablet on your chosen day.
2) After getting up for the day and before taking any food, drink or other medicine, swallow your FOSAVANCE tablet with a full glass of water (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 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 FOSAVANCE at bedtime or before getting up in the morning.
5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAVANCE and contact your doctor.
6) After swallowing the tablet FOSAVANCE, wait at least 30 minutes before taking your first day food, drink or drugs, including antacids, calcium supplements and vitamins. FOSAVANCE is effective only if taken on an empty stomach.
7) It is important to continue taking FOSAVANCE for as long as instructed by your doctor. FOSAVANCE can be used to treat your osteoporosis only if you continue to take the tablets.
If you take more FOSAVANCE than you should:
If you accidentally take too many tablets, 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 FOSAVANCE:
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, FOSAVANCE can have side effects. The following terminology is used to describe the frequency with which adverse reactions have been reported.
Common (occurring in at least 1 in 100 and less than 1 in 10 patients treated)
Uncommon (occurring in at least 1 in 1000 and less than 1 in 100 patients treated)
Rare (occurring in at least not less than 1 in 10,000 and less than 1 in 1000 patients treated)
Very rare (occurring in less than 1 in 10,000 patients treated)
Immune system disorders:
Rare: allergic reactions such as hives; swelling of face, lips, tongue and / or throat, possibly causing difficulty breathing or swallowing
Disruption of the exchange Mr. nutrition
Rare: symptoms indicative of low levels of calcium in the blood, including muscle cramps or spasms and / or tingling sensation in the fingers and around the mouth
Rare: blurred vision, pain or redness in the eye
abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; feeling of fullness or bloating; diarrhea; flatulence (intestinal gas); heartburn; difficulty swallowing; pain when swallowing; ulceration of the gullet (esophagus - the tube that connects your mouth to your stomach) which can cause chest pain, heartburn or pain when swallowing nausea; vomiting; irritation or inflammation of the gullet (esophagus - the tube that connects your mouth to your stomach) or stomach; black or tar-like stools
narrowing of the gullet (esophagus - the tube that connects your mouth to your stomach); mouth ulcers when the tablets have been chewed or sucked; stomach or peptic ulcers (sometimes severe or with bleeding), but without being sure that they were caused by FOSAVANCE. Problems with the jaws associated with delayed healing and infection, often following tooth extraction.
rash; itching; red skin rash, which is aggravated by exposure to sunlight
Very rare: severe skin reactions
Common: bone, muscle or joint pain
Rare: severe bone, muscle or joint pain
Rare: transient flu-like symptoms such as muscle aches, malaise and sometimes fever, usually at the beginning of treatment
Inform your doctor promptly about these or other unusual symptoms. It will help if you pay attention to what you experienced, when it started and how long it lasted.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. STORING FOSAVANCE
Keep out of reach of children.
Store in the original blister in order to protect from moisture and light.
Do not take tablets after the expiration date stated on the blister and carton.