A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Fine Foods N.T.M. SpA Via dell’Artigianato 8/10 24041 Brembate (BG)
Menarini - Von Heyden GmbH
Glienicker Weg 125
Fine Foods N.T.M. SpA
Via R. Follereau 25
24027 Nembro (BG)
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
•Periodic Safety Update Reports
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
An updated RMP shall be submitted every three years.
When the submission of a PSUR and the update of a RMP coincide, they should be submitted at the same time.
In addition, an updated RMP should be submitted:
•At the request of the European Medicines Agency;
- Adenuric - Menarini International Operations Luxembourg S.A. (MIOL)
Prescription drugs listed. Manufacturer: "Menarini International Operations Luxembourg S.A. (MIOL)"
•Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
•Additional risk minimisation measures
The PAC – which is inserted inside the carton box - must include the following key messages (see also annex IIIA):
Health Care Professional information
The PAC should include the following information for the healthcare professional information regarding Ranexa:
•To refer to the Ranexa SPC prior to prescribing any medications to the patient, as there are potential drug interactions which should be taken into consideration.
•Ranexa is contraindicated in patients taking:
•Potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone)
•Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone
•A dose reduction of Ranexa may be needed in combination with:
•Moderate CYP3A4 inhibitors (e.g. diltiazem, erythromycin, fluconazole)
•Caution should be exercised when prescribing Ranexa to patients:
•Taking certain other drugs mentioned in the product information
•With certain other risk factors listed in the product information
•Inform the patient about the potential for an interaction with other prescribed medicinal products and to contact his/her doctor in case of dizziness, nausea or vomiting.
The PAC should include the following information for the patient:
•That the card should be shown to any doctor involved in their treatment
•That prior to Ranexa treatment the patient should tell their doctor if they have any of the following:
•Have ever had an abnormal electrocardiogram (ECG)
•Is taking medications to treat epilepsy, bacterial or fungal infections, HIV infection, depression or heart rhythm disorders
•Is taking the herbal remedy St John’s Wort
•Is taking allergy medicines
•Is taking medications to reduce cholesterol
•Is taking medication to reduce the risk of transplanted organ rejection
•That during treatment with Ranexa the patient should:
•Not drink Grapefruit Juice
•Call their doctor if they feel dizzy or sick, become sick or experience any unexpected symptoms after starting Ranexa.
•To refer to the Ranexa package leaflet for more information.
•To ensure to take a list of all their other medicines with them at any visit to the health care professional.