Generic Actonel Risedronate

For the use of a prescription of an Endrocnnologist Rheumatologist/ Orthopaedician/ Gynaecologist Surgeon only

Risedronate Sodium Tablets 35 mg RISOFOS (RISEDRONATE)

Composition

Each film-coated tablet contains

Risedronate Sodium............35 mg

(As Risedronate Sodium Hemi-Pentahydrate)

 

Colours:

Sunset Yellow FCF and Titanium Dioxide

 

Description

RISOFOS (RISEDRONATE) (risedronate sodium tablets) is a pyndinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism.

RISOFOS (RISEDRONATE) has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, RISOFOS (RISEDRONATE) inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (e.g. lack of ruffled border). Animal studies showed that RISOFOS (RISEDRONATE) treatment reduces bone turnover (activation frequency i.e. the rate at which bone remodelling sites are activated) and bone resorption at remodeling

 

Indication

RISOFOS (RISEDRONATE) is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

 

Dosage and Administration

Treatment of postmenopausal osteoporosis The recommended dosage is 35 mg once a week.

Prevention of postmenopausal osteoporosis The recommended dosage is 35 mg once a week.

RISOFOS (RISEDRONATE) should be taken at least 30 minutes before the first food or drink of the day other than water.

To facilitate delivery to the stomach, RISOFOS (RISEDRONATE) should be swallowed while the patient is in an upright position and with a full glass of plain water (200 ml). Patients should not lie down tor 30 minutes after taking the medication.

 

Contraindications

• Hypocalcaemia

• Known hypersensitivity to any component of this product

• Inability to stand or sit upright for at least 30 minutes.

Warnings and Precautions

Patients should be informed to pay particular ! attention to the dosing instructions as clinical benefits may be compromised by failure to take the drug according to instructions.

Patients should not chew or suck on the tablet because of a potential for oropharyngeal irritation.

If patients develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or severe persistent or worsening heartburn) they should consult their physician before continuing RISOFOS (RISEDRONATE) .

 

General

Hypocalcaemia and other disturbances ot bone and mineral metabolism should be effectively treated before starting RISOFOS (RISEDRONATE) therapy. Adequate intake of calcium and vitamin D is important in all patients.

Biphosphonates have been associated with gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcers. This association has been reported for biphosphonates in post-marketing experience, but has not been found in most pre-approval clinical trials, including those conducted with risedronate.

 

Drug interactions

No specific drug-drug interaction studies were performed.

Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (cytochrome P450).

 

HRT

Concomitant use of estrogen replacement therapy and risedronate in the treatment of osteoporosis in postmenopausal women showed significant change in bone mass density.

Calcium supplements/Antacids Co-administration ot risedronate and calcium, antacids or oral medications containing divalent cations will interfere with the absorption of nsedronate.

 

Aspirin/NSAIDs

The risk of upper gastrointestinal adverse events associated with NSAIDs does not appearto be greater with concomitant treatment with risedronate sodium.

K-Blocker s and Pro ton Pum p Inhibitors No significant incidence of upper-gastrointestinal adverse experience was observed with (blockers and/or PPIs when risedronate sodium was co-administered.

 

Renal Impairment

RISOFOS (RISEDRONATE) is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 ml/min).

 

Hepatic Impairment

No dosage adjustment is necessary.

 

Pregnancy

There are not adequate and well-controlled studies of risedronate in pregnant women. RISOFOS (RISEDRONATE) should be used during pregnancy only

if the potential benefit justifies the potential risk to the mother and fetus.

 

Lactation

It is not known whether risedronate is excreted in human milk. Because many drugs are excreted in human breast milk, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

 

Paediatric Use

Safety and effectiveness in paediatric patients have not been established.

 

Use in elderly

No overall differences in efficacy or safety were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out

 

Side effects

For patients with osteoporosis, the overall occurrence ot side effects with risedronate was similar to placebo and most were either mild or moderate. The most common side effects include back pain, joint pain, upset stomach, abdominal pain, constipation, diarmoea, abdominal distension and headache.

 

Overdosage

Increase in serum calcium and phosphorous following substantial overdose may be expected in some patients. Signs and symptoms of hypocalcaemia may also occur in some of these patients. Milk or antacids containing calcium should be given to bind RISOFOS (RISEDRONATE) and reduce absorption of the drug.

In case of substantial overdose, gastric lavage may be considered to remove unabsorbed drug. Standard procedures including administration of calcium intravenously, would be expected to restore physiologic amounts of ionized calcium and to relieve signs and symptoms of hypocalcaemia.

 

Storage:

Store in a cool dry place Presentation:

Rlsofos: Blister pack of 4 tablets

Cipla

 

 

What Is RiSOFOS (Risedronate) ?

RISOFOS (RISEDRONATE) is a prescription medicine used to prevent and treat osteoporosis in postmenopausal women.

 

What Is osteoporosis?

Osteoporosis is a disease that causes bone to become spongy and thin leading to fractures.

 

How should I take RISOFOS (RISEDRONATE) ?

If your doctor has prescribed RISOFOS (RISEDRONATE) :

• Choose one day of the week that you will remember and that best fits your schedule Every week take RISOFOS (RISEDRONATE) on your chosen day in the morning before you eat or drink anything except plain water.

• Take RISOFOS (RISEDRONATE) while you are in upright position.

• Take RISOFOS (RISEDRONATE) with a glass full of plain water (200 ml). Do not take with any other drink besides plain water. Do not take it with coffee, tea, juice, milk or other dairy drinks.

• Swallow RISOFOS (RISEDRONATE) whole. Do not chew the tablet or keep it in your mouth to melt or dissolve

• After taking RISOFOS (RISEDRONATE) you must wait at least 30 minutes BEFORE:

* Lying down. You may sit, stand or do normal activities like reading the newspaper or taking a walk

* Eating or drinking anything except plain water

* You take vitamins, calcium, or antacids. Take vitamins, calcium, and antacids at a different time of the day from when you take RISOFOS (RISEDRONATE) .

• Keep taking RISOFOS (RISEDRONATE) as long as your doctor tells you.

• For RISOFOS (RISEDRONATE) to treat your osteoporosis or keep you from getting osteoporosis, you have to take it as often and in the way It is prescribed.

 

Why do I have to take RISOFOS (RISEDRONATE) 30 minutes before breakfast?

It is very important to take RISOFOS (RISEDRONATE) on an empty stomach. Food and drink (other than plain water) and other medicines can reduce the amount ol RISOFOS (RISEDRONATE) absorbed by your body, making the treatment ineffective.

 

Why must I remain upright for 30 minutes after taking RISOFOS (RISEDRONATE) ?

The upright position allows your RISOFOS (RISEDRONATE) to move down your oesophagus (food pipe) as quickly as possible, so as to avoid any irritation on the way. Staying upright for 30 minutes is realty quite easy You can sit or move around The only thing that you can't do is lie down flat.

 

How do I come to know It's working?

RISOFOS (RISEDRONATE) builds bone mass and stops further loss of bone, but this difference won't be seen or felt -so it is Important to continue taking it for as long as your doctor recommends. This benefit will not be maintained if you stop taking RISOFOS (RISEDRONATE) tablets To measure the strength of your bones - bone density -your doctor may check the progress every 1-2 years This is called a bone density test and is measured with a special X-ray machine. This type of bone density measurement (often referred to as , DEXA) measures the amount of mineral in the bone Of your spine and hip.