Undesirable effect Anaemia, splenomegaly Thrombocytopenia Spleen disorder

Undesirable effect

Adverse Reaction

Uncommon

Adverse reaction

System Organ Class

Adverse Event

includes at least one serious adverse reaction

Sitagliptin with Metformin1

Adverse reaction Headache

Subject Incidence

Adverse Drug Reaction Rash Erythema

Adverse Drug Reaction

Undesirable effect Leukocytosis, thrombocytopenia Spleen disorder Elevated alkaline phosphatase, elevated LDH SGOT increased, hyperuricaemia

Undesirable effect Spleen disorder

Depression

Cellulitis, viral upper respiratory tract infection

POSSIBLE SIDE EFFECTS

Adverse Reaction Event

Adverse Drug Reaction Hypertension Rash Erythema

Adverse Drug Reaction Frequency

Undesirable Effect Neutropenia

Adverse Drug Reaction

System Organ Class

4.9 Overdose

After single dose administration of epoetin beta no effects on behaviour or locomotor activity of mice and circulatory or respiratory function of dogs were observed.

Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom

Roche Diagnostics GmbH Sandhofer Strasse 116 D 68305 Mannheim Germany

Adverse reaction event

ADRs with lisinopril

ADRs with amlodipine

System Organ Class

This is a common side effect.

Infections and infestations uncommon

thrombocytopenia, neutropenia, anaemia