Summary of Product Characteristics

1.  Name of the medicinal product:
   
   
   1. Lenalidomide Grindeks 2.5 mg hard capsules
   2. Lenalidomide Grindeks 5 mg hard capsules
   3. Lenalidomide Grindeks 7.5 mg hard capsules
   4. Lenalidomide Grindeks 10 mg hard capsules
   5. Lenalidomide Grindeks 15 mg hard capsules
   6. Lenalidomide Grindeks 20 mg hard capsules
   7. Lenalidomide Grindeks 25 mg hard capsules
      
      
2. Qualitative and Quantitative Composition:
   
   
   1. Lenalidomide Grindeks 2.5 mg hard capsules:
      Each hard capsule contains Lenalidomide ammonium chloride equivalent to 2.5 mg of Lenalidomide. Other ingredient with known effect: Each hard capsule contains 20 mg of lactose (as anhydrous lactose).
      
      
   2. Lenalidomide Grindeks 5 mg hard capsules:
      Each hard capsule contains Lenalidomide ammonium chloride equivalent to 5 mg of Lenalidomide. Other ingredient with known effect: Each hard capsule contains 39 mg of lactose (as anhydrous lactose).
      
      
   3. Lenalidomide Grindeks 7.5 mg hard capsules:
      Each hard capsule contains Lenalidomide ammonium chloride equivalent to 7.5 mg of Lenalidomide. Other ingredient with known effect: Each hard capsule contains 59 mg of lactose (as anhydrous lactose).
      
      
   4. Lenalidomide Grindeks 10 mg hard capsules:
      Each hard capsule contains Lenalidomide ammonium chloride equivalent to 10 mg of Lenalidomide. Other ingredient with known effect: Each hard capsule contains 79 mg of lactose (as anhydrous lactose).
      
      
   5. Lenalidomide Grindeks 15 mg hard capsules:
      Each hard capsule contains Lenalidomide ammonium chloride equivalent to 15 mg of Lenalidomide. Other ingredient with known effect: Each hard capsule contains 118 mg of lactose (as anhydrous lactose).
      
      
   6. Lenalidomide Grindeks 20 mg hard capsules:
      Each hard capsule contains Lenalidomide ammonium chloride equivalent to 20 mg of Lenalidomide. Other ingredient with known effect: Each hard capsule contains 157 mg of lactose (as anhydrous lactose).
      
      
   7. Lenalidomide Grindeks 25 mg hard capsules:
      Each hard capsule contains Lenalidomide ammonium chloride equivalent to 25 mg of Lenalidomide. Other ingredient with known effect: Each hard capsule contains 197 mg of lactose (as anhydrous lactose). For a complete list of other ingredients, see section 6.1 (List of excipients).
      
      
3. Indications
   
   
   1. Multiple Myeloma:
      Lenalidomide Grindeks as monotherapy is indicated for maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) following autologous stem cell transplantation.
      
      Lenalidomide Grindeks as combination therapy with dexamethasone or bortezomib and dexamethasone or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with untreated multiple myeloma who are not eligible for transplantation.
      
      Lenalidomide Grindeks in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
      
      
   2. Follicular Lymphoma:
      Lenalidomide Grindeks in combination with rituximab (anti-CD20 antibodies) is indicated for the treatment of adult patients with pretreated follicular lymphoma (Grade 1-3a).

       

      Contraindications:

      • Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
      • Pregnant women.
      • Women of childbearing potential unless all conditions of the Pregnancy Prevention Program are complied with (see sections 4.4 and 4.6).
        
        
4. Pharmacotherapeutic group:
   
   Other immunosuppressants. ATC code: L04AX04.

1. List of excipients:
   Capsule content: Lactose, Microcrystalline cellulose (E 460), Croscarmellose sodium (E 468), Magnesium stearate (E 470b).
   
   
   • Lenalidomide Grindeks 2.5 mg hard capsules: Titanium dioxide (E 171), Gelatin, Brilliant Blue FCF – FD&C Blue 1 (E 133), Yellow iron oxide (E 172).
   • Lenalidomide Grindeks 5 mg hard capsules: Titanium dioxide (E 171), Gelatin.
   • Lenalidomide Grindeks 7.5 mg hard capsules: Titanium dioxide (E 171), Gelatin, Iron oxide yellow Yellow iron oxide (E 172).
   • Lenalidomide Grindeks 10 mg hard capsules: Titanium dioxide (E 171), Gelatin, Iron oxide yellow Yellow iron oxide (E 172), Brilliant Blue FCF – FD&C Blue 1 (E 133).
   • Lenalidomide Grindeks 15 mg hard capsules: Titanium dioxide (E 171), Gelatin, Brilliant Blue FCF – FD&C Blue 1 (E 133).
   • Lenalidomide Grindeks 20 mg hard capsules: Titanium dioxide (E 171), Gelatin, Brilliant Blue FCF – FD&C Blue 1 (E 133), Yellow iron oxide (E 172).
   • Lenalidomide Grindeks 25 mg hard capsules: Titanium dioxide (E 171), Gelatin, Printing ink: Shellac (E 904), Propylene glycol (E 1520), Black iron oxide (E 172), Potassium hydroxide (E 525), Concentrated ammonia solution (E 527).
     
     
2. Marketing Authorization Holder:
   AS Grindeks. Krustpils iela 53, Riga, LV1057, Latvia.
   Tel.: +371 67083205,
   Fax: +371 67083505,
   E-Mail: grindeks@grindeks.lv
   
   
3. Distributed in Austria by:
   Stelopharm GmbH, Herrengasse 6-8/3/5, 1010 Vienna
   
   
4. Prescription/Pharmacy Dispensing:
   Requires a prescription and dispending pharmacy, repeated dispensing prohibited.

For additional information on special warnings and precautions for use, drug-interactions and other interactions, fertility, pregnancy and breastfeeding, and side effects, please refer to the published product information.

Date of information: April 2022

Stelopharm GmbH
1010 Vienna; Herrengasse 6-8/3