Leaflet ACTONEL 35mg gastro-resistant tablets


Indicated for: osteoporosis

Route of administration: oral

Substance: risedronic acid (bisphosphonate)

ATC: M05BA07 (Musculo-skeletal system | Drugs affecting bone structure and mineralization | Bisphosphonates)

Risedronic acid is a bisphosphonate used for the prevention and treatment of osteoporosis, particularly in postmenopausal women. It is also used to treat Paget's disease of the bone.

It works by inhibiting the activity of osteoclasts, the cells responsible for bone resorption, leading to increased bone density and reduced risk of fractures. It is taken orally, usually once a week or once a month, depending on the indication.

Common side effects include gastrointestinal disturbances such as nausea, abdominal pain, and heartburn. In rare cases, it may cause osteonecrosis of the jaw or atypical femur fractures.

Patients taking risedronic acid should follow administration instructions, such as taking the medication on an empty stomach and avoiding lying down for 30 minutes after taking it, to reduce the risk of esophageal irritation.

General data about ACTONEL 35mg

  • Substance: risedronic acid
  • Date of last drug list: 01-05-2026
  • Commercial code: W66935003
  • Concentration: 35mg
  • Pharmaceutical form: gastro-resistant tablets
  • Quantity: 4
  • Product type: original
  • Price: 86.38 RON
  • Prescription restrictions: P-6L - Medicines prescription that isn't retained in the pharmacy (can be renewed); the prescription can be used for 6 months from the moment of release.

Marketing authorisation

  • Manufacturer: BALKANPHARMA DUPNITSA AD - BULGARIA
  • Holder: THERAMEX IRELAND LIMITED - IRLANDA
  • Number: 13897/2021/01
  • Shelf life: 5 years

Pharmaceutical forms available for risedronic acid

Concentrations available for risedronic acid

  • 30mg
  • 35mg
  • 5mg
  • 75mg

Compensation lists for ACTONEL 35mg Theramex

B - Sublist B with 50% discount from the reference price

Price

Copayment

Patient

86.38 RON

12.25 RON

74.13 RON

NHP 7 (C2) - Endocrine diseases

Price

Copayment

Patient

86.38 RON

22.81 RON

63.57 RON