Product image of Novofen (Tamoxifen) supplied by GNH India

Novofen

Active Ingredient:
Tamoxifen
Origin:
EU

Novofen (Tamoxifen)

Tamoxifen, the active ingredient in Novofen, is a selective estrogen receptor modulator presented as a 20 mg tablet for oral use. It is employed in hormone‑responsive breast cancer treatment and prevention in adult women and men. GNH India supplies Novofen as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and pharmacies worldwide.

GNH India supplies Novofen as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and pharmacies worldwide.

Manufacturer / TM Owner

Remedica Ltd

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Indications & Clinical Uses

Tamoxifen is a selective estrogen receptor modulator used in conditions that involve estrogen‑driven pathology.

  • Early‑stage hormone‑responsive breast cancer: improves survival by reducing recurrence risk.
  • Metastatic breast cancer: helps control disease progression.
  • Male breast cancer: provides anti‑estrogen effects similar to those in women.
  • Ductal carcinoma in situ (DCIS): lowers the chance of invasive cancer development.
  • High‑risk women (e.g., BRCA‑positive): lowers the incidence of breast cancer.
  • Gynecologic benign conditions such as uterine fibroids (off‑label use, noted in clinical practice).

How It Works

  • Tamoxifen binds competitively to estrogen receptors in breast tissue, acting as an antagonist that blocks estrogen‑driven cellular proliferation. In bone and uterine tissue it can act as a partial agonist, preserving bone density while minimally stimulating the endometrium. This mixed activity modifies gene transcription pathways that regulate cell growth and apoptosis, thereby inhibiting tumor development in estrogen‑sensitive cancers.

Side Effects

Side effects vary with dose and treatment duration, and are monitored throughout therapy.

Common Side Effects

  • Hot‑spots and flush sensation of the skin (hot flashes).
  • Nausea or mild gastrointestinal upset.
  • Fatigue or general tiredness.
  • Vaginal dryness or discharge.
  • Mild weight gain.
  • Mood changes, including mild depression.

Serious or Rare Side Effects

  • Deep‑vein thrombosis or pulmonary embolism.
  • Endometrial hyperplasia or carcinoma.
  • Severe liver enzyme elevation.
  • Visual disturbances or retinal toxicity.
  • Severe allergic reactions (anaphylaxis).
  • Significant neutropenia or pancytopenia.

Precautions & Warnings

Patients should be evaluated for risk factors and monitored regularly while on Tamoxifen.

  • Baseline assessment: obtain medical history, especially thrombotic or uterine conditions.
  • Monitor liver function: periodic liver enzyme tests are recommended.
  • Gynecologic surveillance: regular pelvic exams and ultrasound for endometrial changes.
  • Pregnancy avoidance: use effective contraception during treatment and for several months after cessation.
  • Drug‑interaction review: assess concomitant medications that affect coagulation or CYP2D6 metabolism.
  • Store at below 20°C: keep tablets in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Tamoxifen may interact with several medicines that alter its metabolism or increase clotting risk.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) – reduce tamoxifen activation.
  • Anticoagulants (warfarin) – heightened bleeding risk.
  • Hormonal contraceptives containing estrogen – may increase thrombotic risk.

Moderate Interaction Molecules 

  • SSRIs/SNRIs (other than strong CYP2D6 inhibitors) – monitor for additive side‑effects.
  • Antifungal agents (e.g., ketoconazole) – may raise tamoxifen levels.
  • St. John Wick (???)  ");

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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