Fasonat 10

Fasonat 10
7 Jun

Fasonat 10

Orthopedic Drugs

- Alendronate sodium belongs to a group of non-hormonal medicines called 
  bisphosphonates. 
  It prevents the loss of bone that occurs in women after they have been through the 
  menopause, and helps to rebuild bone. 
- The absorption and bioavailability of Alendronate Sodium are  reduced by food and 
   beverage other than plain water, in thus for treatment and prevention of osteoporosis, 
  Alendronate Sodium is effective when administered at least 30 minutes before breakfast .
- Protein binding in human plasma is approximately 78% Alendronate Sodium transiently 
  distributes to soft tissue then rapidly  redistributed to bone.
- About 50% of the Alendronate is excreted in urine within 72h and the reminder being 
  chemically adsorbed on bone. 

Indecation

- Fasonat® can be used in postmenopausal osteoporosis, a thinning and weakening of 
  bones as a result from menopause.
- Fasonat® is used for the prevention of osteoporosis in women who are at risk of 
  developing osteoporosis.
- Fasonat® is used in glucocorticoids induced osteoporosis in men and women 
  receiving glucocorticoids in a daily dosage equivalent to 7.5mg or greater of prednisone 
  and who have low bone mineral density. 
- Fasonat® is used in the treatment of Paget’s disease of bone.

Dosage & Administration

- Fasonat® 10 dose: once daily. 
- Fasonat® 70 dose: once weekly. 
- Osteoporosis in postmenopausal women: one Fasonat® 10 tablet once a day.
- Prevention of osteoporosis in postmenopausal women: Fasonat® 10 ½  tablet once aday.
- Treatment of glucocorticoid –induced osteoporosis in men and women : The 
   recommended dosage is Fasonat® 10  ½ tablet once a day except for postmenopausal 
   women not receiving estrogen the recommended dosage is one tablet Fasonat® 10 once 
   a day.  
- For the use of Fasonat® you may have previously been prescribed a tablet of Fasonat®
  10 which is taken once a day. Then one Fasonat® 70 mg tablet is taken once a week.
- You must follow the following actions to help Fasonat® tablet to reach the stomach 
   quickly and help reduce potential for irritation of the esophagus:- 
1. For Fasonat® 70 choose the day of the week that best fits your schedule. Every week,  
    take one Fasonat® 70 on your chosen day.

2. After getting up for the day and before taking your first food, beverage, or other   
    medication, swallow your Fasonat® tablet with a full glass of  plain water only (not less 
    than 200 ml).
-  Not mineral water 
-  Not coffee, milk or tea        
-  Not juice. 
   Do not chew or allow the tablet of Fasonat® to dissolve in your mouth, and do not break 
   the tablet.
3. After swallowing your Fasonat® tablet do not lie down, stay fully upright for at least 
    30 minutes and do not lie down until after your first food of the day.
4. Do not take Fasonat® 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 Fasonat® and contact your doctor.  
6. After swallowing your Fasonat® tablet, wait at least 30 minutes before taking your first 
    food, beverage, or other medication of the day. Fasonat® is effective only if taken when 
    your stomach is empty.
7. If you miss a dose, just take one Fasonat® tablet on the morning after you remember. Do 
    not take two tablets of Fasonat® on the  same day.
8. It is important that you continue taking Fasonat® for as long as your doctor prescribes the
    medicine, unless you develop gastrointestinal irritation.
-  Fasonat® can treat your osteoporosis only if you continue to take the tablets.
-  Use in children: Fasonat® should not be given to children.
-  No dose adjustment is necessary for elderly or for patients with mild to moderate renal 
   insufficiency.
-  No dose adjustment is necessary in hepatic impairment.

- Each tablet  of Fasonat®  70 contains :       
   Alendronic acid 70 mg (as  Alendronate sodium).
- Each tablet of Fasonat® 10 contains:
   Alendronic acid 10 mg (as  Alendronate sodium).

  Do not take Fasonat® if:
• You have certain disorders of the oesophagus because they may cause the tablet not to 
   reach your stomach,
• You are unable to stand or sit upright for at least 30 minutes, 
• You are allergic to sodium Alendronate, 
• You have hypocalcemia.

  Fasonat® can interact with other medication which you take by mouth, including antacids, 
  calcium supplements and vitamins. Therefore,  after taking  Fasonat® wait at least 30 
  minutes before taking other medication.
- Concomitant  administration of  Fasonat® with coffee or orange Juice reduces 
   bioavailability of Alendronate sodium  by approximately60%.

- Fasonat® should not be taken during pregnancy or lactation. 
 

* Common side effects :-
- Gastro-intestinal: digestive disturbances which may be severe. These include irritation or 
   ulceration of oesophagus , chest pain,  heartburn, difficulty or pain upon swallowing.
- Other gastro-intestinal side-effects: including abdominal pain ,dyspepsia, constipation, 
   diarrhea, flatulence, full or bloated feeling in the stomach and black and/or bloody stools.
-  Musculoskeletal: bone, Muscle or joint pain.
-  Neurological: headache. 
* Uncommon side effects:
-  Allergic reactions : Rash, erythema. 
- Gastro-intestinal : Nausea, vomiting, gastritis, oesophagitis.
* Rare side effects:
- Body allergic reactions : Hives, swelling of the (face, lips, tongue, and/or throat), possibly 
  causing difficulty in breathing or swallowing. 
- Gastro- intestinal:Ulcers (Mouth ulcers have occurred when the tablet have been chewed or 
  sucked), and narrowing of oesophagus. 
- other side effects: Eye pain, diminished or hazy vision, inflammation of sclera.

Over dose:-
- If you take more than the prescribed dosage, drink a full glass of milk and contact your 
  doctor immediately.
- Do not make yourself vomit, and do not lie down.

• Fasonat® can be used with care if  you:- 
- suffer from kidney problems,   
- have any swelling , oesophagal or intestinal problems,  
- develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn. 
• Fasonat® can interact with food, drinks and other medications. After swallowing 
  Fasonat® tablet, food, beverage or other medications must not be taken for at least 30 
  minutes after taking Fasonat®. 
• There are no data that suggest that Fasonat® affects the ability to drive or operate 
   machinery.

* Fasonat®   70 :- Blister of 4 tablets, pack of one blister.
* Fasonat®   10 :- Blister of 10 tablets, pack of one blister.

- Store in a dry place, at a temperature below 25 °C.