4.7 Effects on ability to drive and use machines
 Puregon has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects
 Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection (3% of all patients treated). The majority of these local reactions are mild and transient in nature. Generalised hypersensitivity reactions have been observed uncommonly (approximately 0.2% of all patients treated with follitropin beta).

Treatment of females:

In approximately 4% of the women treated with follitropin beta in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4). Adverse reactions related to this syndrome include pelvic pain and/or congestion, abdominal pain and/or distension, breast complaints and ovarian enlargement.

The table below lists the adverse reactions with follitropin beta reported in clinical trials in females, according to system organ class and frequency; common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).

SOC
 Frequency
 Adverse reaction
 
Nervous system disorders
 Common
 Headache
 
Gastrointestinal disorders
 Common
 Abdominal distension

Abdominal pain
 
Uncommon
 Abdominal discomfort

Constipation

Diarrhoea

Nausea
 
Reproductive system and breast disorders
 Common
 OHSS

Pelvic pain
 
Uncommon
 Breast complaints1

Metrorrhagia

Ovarian cyst

Ovarian enlargement

Ovarian torsion

Uterine enlargement

Vaginal haemorrhage
 
General disorders and administration site conditions
 Common
 Injection site reaction2
 
Uncommon
 Generalised hypersensitivity reaction3

1. Breast complaints include tenderness, pain and/or engorgement and nipple pain

2. Local reactions at the site of injection include: bruising, pain, redness, swelling and itching

3. Generalised hypersensitivity reaction include erythema, urticaria, rash and pruritus

In addition, ectopic pregnancy, miscarriage and multiple gestations have been reported. These are considered to be related to ART or subsequent pregnancy.

In rare instances, thromboembolism has been associated with follitropin beta/hCG therapy as with other gonadotrophins.

Treatment of males:

The table below lists the adverse reactions with follitropin beta reported in a clinical trial in males (30 patients dosed), according to system organ class and frequency; common (≥ 1/100 to < 1/10).

SOC
 Frequency1
 Adverse reaction
 
Nervous system disorders
 Common
 Headache
 
Skin and subcutaneous tissue disorders
 Common
 Acne

Rash
 
Reproductive system and breast disorders
 Common
 Epididymal cyst

Gynaecomastia
 
General disorders and administration site conditions
 Common
 Injection site reaction2

1. Adverse reactions that are reported on