This website has been developed by Besins Healthcare (UK) Ltd.

This website has separate sections for healthcare professionals (containing promotional information), and patients who have been prescribed Testogel® (testosterone) within the UK.

Please confirm that:

This website is provided for HCPs in the UK by Besins Healthcare (UK) Ltd.

Why Testogel®?

Safety — Testogel® 16.2 mg/g gel

CONTRAINDICATIONS1,2

Testogel® is contraindicated in:

  • Cases of known or suspected prostatic cancer or breast carcinoma
  • Hypersensitivity to testosterone or any of the excipients

Please also see special warnings and precautions.

ADVERSE REACTIONS2

Adverse reactions with testosterone products include: Increased haematocrit, increased red blood cell count and increased haemoglobin (common ≥ 1/100 to < 1/10).

Preferred Terms
MedDRA System Organ ClassCommon Adverse Reactions (≥ 1/100 to < 1/10)Uncommon Adverse Reactions (≥ 1/1000 to < 1/100)
Psychiatric disordersEmotional symptoms (mood swings, affective disorder, anger, aggression, impatience, insomnia, abnormal dreams, increased libido)
Vascular disordersMalignant hypertension, flushing, phlebitis
Gastrointestinal disordersDiarrhoea, abdominal distension, oral pain
Skin and subcutaneous tissue disordersSkin reactions (acne, alopecia, dry skin, skin lesions, contact dermatitis, hair colour changes, rash, application site hypersensitivity, application site pruritus)
Reproductive system and
breast disorders		Gynaecomastia, nipple disorder, testicular pain, increased erection
General disorders and administration site conditionsPitting oedema
InvestigationsPSA increased, increased haematocrit or haemoglobin

SPECIAL WARNINGS AND PRECAUTIONS:2

  • In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such case treatment must be stopped immediately. In addition, diuretic therapy may be required
  • Testogel® should be used with caution in patients with thrombophilia or risk factors for venous thromboembolism (VTE), as there have been post-marketing reports of thrombotic events (e.g. deep-vein thrombosis, pulmonary embolism, ocular thrombosis) in these patients during testosterone therapy
  • In thrombophilic patients, VTE cases have been reported even under anticoagulation treatment, therefore continuing testosterone treatment after first thrombotic event should be carefully evaluated. In case of treatment continuation, further measures should be taken to minimise the individual VTE risk
  • Testosterone may cause a rise in blood pressure and Testogel® should be used with caution in men with hypertension

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION:2

  • Changes in insulin sensitivity, glucose tolerance, glycaemic control, blood glucose and glycosylated haemoglobin levels have been reported with androgens. In diabetic patients, antidiabetics’ medication might need reduction

Please consult the Summary of Product Characteristics to view the contraindications, full set of warnings, precautions and the full list of adverse events associated with Testogel® 16.2 mg/g gel.2

Testogel® 16.2 mg/g SmPC

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Besins Healthcare (UK) Ltd Drug Safety on 0203 862 0920 or Email: pharmacovigilance@besins-healthcare.com

References

  1. Hackett G, Kirby M, Edwards D, et al. British Society for Sexual Medicine Guidelines on Adult Testosterone Deficiency, With Statements for UK Practice. J Sex Med. 2017;14(12):1504–1523.
  2. Testogel® 16.2mg/g gel – Summary of Product Characteristics (SmPC) – https://www.medicines.org.uk/emc/product/8919/smpc. Accessed February 2022.

TES/2022/046. February 2023.

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