clamminess, increased sweating

alopecia, skin eruption
 
Musculoskeletal, connective tissues and bone disorders

common

uncommon
 
arthralgia, limb pain, myalgia

back pain, muscle cramps
 
Renal and urinary disorders

common

uncommon

urinary infrequency, difficulty in micturation, dysuria, nocturia, oliguria

bladder spasm, haematuria, aggravated urinary frequency, urinary retention
 
Reproductive system and breast disorders

common

uncommon

rare

breast tenderness, testicular atrophy, testicular pain

gynaecomastia, impotence, testicular disorder

breast pain
 
General disorders and administration site reactions

very common

common

uncommon

rare

very rare

fatigue, injection site burning, injection site paraesthesia

Malaise,injection site pain, injection site bruising, injection site stinging, rigors, weakness

injection site pruritus, lethargy, pain, pyrexia

injection site ulceration

injection site necrosis
 
Blood and lymphatic system disorders

Common

hematology changes
 
Investigations

common

uncommon

increased blood creatinine phosphokinase, prolonged coagulation time

increased alanine aminotransferase, increased blood triglycerides, prolonged prothrombin time, increased weight
 

Other adverse events which have been reported in general to occur with leuprorelin acetate treatment include peripheral oedema, pulmonary embolism, palpitations, myalgia, muscle weakness, an alteration in the skin sensation,chills, peripheral vertigo, rash, amnesia and visual disturbances. Infarction of pre-existing pituitary apoplexy has been reported rarely after administration of both short and long acting GnRH agonists. There have been rare reports of thrombocytopenia and leucopenia. Changes in glucose tolerance have been reported.

Local adverse events reported after injection of ELIGARD are similar to the local adverse events associated with similar subcutaneously injected products.

Generally, these localised adverse events following subcutaneous injection are mild and described as being of brief duration.

Changes in Bone Density

Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with GnRH analogues. It can be anticipated that long periods of treatment with leuprorelin may show increasing signs of osteoporosis. Regarding the increased risk for fractures owing to osteoporosis (see section 4.4).

Exacerbation of signs and symptoms of the disease

Treatment with leuprorelin acetate can cause exacerbations of signs and symptoms of the disease during the first few weeks. If conditions such as vertebral metastases and/or urinary obstruction or haematuria are aggravated, neurological problems such as weakness and/or paraesthesia of the lower limbs or worsening of urinary symptoms may occur.

4.9 Overdose

 ELIGARD 22.5mg does not have the potential for abuse, and deliberate overdose is unlikely. There are no reports of abuse or overdose having occurred in clinical practice with leuprorelin acetate, but in the event that excessive exposure becomes a reality, observation and symptomatic supportive treatment are recommended.

5.