Product image of Himale (Sildenafil) supplied by GNH India

Himale

Active Ingredient:
Sildenafil
Origin:
EU

Himale (Sildenafil)

Himale is a prescription oral medication containing sildenafil, a phosphodiesterase type 5 (PDE5) inhibitor. Although the specific dosage strength and tablet form are not disclosed, the product is manufactured for the EU market and is intended for use under medical supervision. It belongs to the therapeutic class for erectile dysfunction and pulmonary arterial hypertension, and it works by enhancing blood flow in targeted vascular tissues.

Manufacturer / TM Owner

Axone, Lda.

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Indications & Clinical Uses

Himale is prescribed for conditions that benefit from increased nitric oxide‑mediated vasodilation.

  • Treatment of erectile dysfunction in adult males.
  • Management of pulmonary arterial hypertension (PAH) to improve exercise capacity.
  • Adjunct therapy in patients with heart failure where PAH is present.
  • Use in combination with lifestyle modifications for erectile dysfunction, such as smoking cessation and weight loss.
  • May be part of a comprehensive PAH regimen that includes endothelin receptor antagonists or prostacyclin analogues.
  • Off‑label use may be considered for high‑altitude pulmonary edema under specialist guidance.

How It Works

  • Sildenafil selectively inhibits the enzyme phosphodiesterase type 5, which normally degrades cyclic guanosine monophosphate (cGMP). By blocking PDE5, intracellular cGMP levels rise, leading to relaxation of smooth muscle in the corpus cavernosum and pulmonary vasculature, thereby enhancing blood flow to these tissues.

Side Effects

Adverse reactions reported with sildenafil‑containing products vary in frequency and severity.

Common

  • Headache, often described as mild to moderate and transient.
  • Flushing, typically affecting the face and neck.
  • Dyspepsia or indigestion, which may improve with food intake.

Serious

  • Priapism, a prolonged erection lasting more than four hours that requires urgent medical attention.
  • Sudden loss of vision, such as non‑arteritic anterior ischemic optic neuropathy.
  • Severe hypotension, especially when combined with nitrates or other vasodilators.

Precautions & Warnings

Before initiating Himale, certain safety considerations should be reviewed.

  • Patients with known cardiovascular disease should be evaluated for suitability.
  • Use is contraindicated in individuals taking nitrates for chest pain.
  • Caution is advised in patients with severe hepatic or renal impairment.
  • Those with a history of non‑arteritic anterior ischemic optic neuropathy should discuss risks with a clinician.
  • Inform the prescriber of any recent eye surgery or retinal disorders.
  • Avoid use in patients with uncontrolled hypertension or hypotension.

Avoid Interactions

Sildenafil can interact with several medication classes; awareness helps prevent adverse events.

Avoid

  • Nitrate medications (e.g., nitroglycerin, isosorbide dinitrate) due to risk of profound hypotension.
  • Guanylate cyclase stimulators used for PAH (e.g., riociguat) because combined vasodilation may be excessive.
  • Certain potent CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) that can raise sildenafil plasma levels.

Use with caution

  • Alpha‑blockers for hypertension or benign prostatic hyperplasia, as additive blood pressure effects may occur.
  • Antihypertensive agents, especially when dose timing overlaps.
  • Other PDE5 inhibitors or recreational drugs such as poppers (amyl nitrite).
  • Medications that prolong the QT interval, though the interaction is less common.

Frequently Asked Questions

The active ingredient in Himale is sildenafil, a phosphodiesterase type 5 (PDE5) inhibitor.

No, Himale is a prescription‑only medication in the EU and must be prescribed by a qualified healthcare professional.

Yes, sildenafil is approved for both erectile dysfunction and pulmonary arterial hypertension, and Himale may be prescribed for either indication.

Sildenafil increases cyclic GMP levels in the corpus cavernosum, leading to smooth‑muscle relaxation and enhanced blood flow that facilitates erection.

Avoid taking nitrates, potent CYP3A4 inhibitors, and other PDE5 inhibitors, as these combinations can cause dangerous drops in blood pressure.

There are no specific dietary restrictions, but taking the medication with a high‑fat meal may delay its onset of action.

Common side effects include headache, facial flushing, and dyspepsia (indigestion).

Seek immediate care if you experience a prolonged erection lasting more than four hours, sudden vision loss, or severe dizziness.

Patients with severe hepatic impairment should use Himale only under close medical supervision, as drug clearance may be reduced.

Combining Himale with antihypertensives may lower blood pressure further; dosage timing and monitoring should be discussed with a clinician.

Regular assessment of exercise capacity, blood pressure, and potential visual changes is recommended for patients using sildenafil for pulmonary hypertension.

Sildenafil does not directly affect sperm production or fertility, but patients should discuss any concerns with their healthcare provider.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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