Terbinafine 1 % Cream – Summary of Product Characteristics (SmPC) – (emc)

Terbinafine 1% Cream is a well-known antifungal medication that is commonly used to treat various skin infections. This cream has gained popularity due to its effectiveness against conditions like athlete’s foot, jock itch, and ringworm. In this article, we will delve into the summary of product characteristics, including its uses, side effects, application instructions, precautions, and recommended dosages.

What is Terbinafine 1% Cream?

Terbinafine 1% Cream contains 1% terbinafine hydrochloride, which is the active ingredient responsible for its antifungal properties. It is specifically designed to combat fungal infections by disrupting the cell membrane of fungi, leading to their death. This cream is typically applied externally and is effective for treating a variety of skin infections.

As an antifungal medication, Terbinafine is often preferred due to its quick action and minimal systemic absorption. This means that it acts directly on the affected area, reducing the risk of side effects associated with oral antifungals. The cream is suitable for adults and is not recommended for use in children under 16 years of age.

One of the primary benefits of using Terbinafine 1% Cream is its effectiveness against common fungal infections, providing relief from symptoms such as itching and irritation. Its formulation is easy to apply and absorbs well into the skin.

What are the uses of Terbinafine 1% Cream?

Terbinafine 1% Cream is primarily used for the treatment of fungal infections affecting the skin, including:

  • Athlete’s foot: A common condition caused by fungal growth between the toes.
  • Jock itch: Fungal infection affecting the groin area.
  • Ringworm: A highly contagious fungal infection that can appear on various parts of the body.

These conditions often present with symptoms such as itching, redness, and peeling skin. By applying Terbinafine 1% Cream as directed, patients can experience significant relief from these uncomfortable symptoms.

In addition to skin infections, Terbinafine is effective against certain fungal nail infections, although it may not be the primary treatment for nail fungus. Its action can also extend to other dermatophyte infections, making it a versatile option in antifungal therapy.

What are the side effects of Terbinafine 1% Cream?

While Terbinafine 1% Cream is generally well-tolerated, some individuals may experience side effects. Common side effects include:

  • Skin irritation: Redness or burning sensation at the application site.
  • Itching: Increased itching may occur as the skin reacts to the product.
  • Allergic reactions: In rare cases, some users may develop an allergic reaction, which can manifest as rash or swelling.

It’s essential for users to monitor their skin for any adverse reactions, particularly during the first few applications. If any severe reactions occur, such as difficulty breathing or swelling of the face, immediate medical attention is required.

Consultation with a healthcare provider is advisable for anyone experiencing persistent side effects or for those with sensitive skin, as they may need an alternative treatment.

How to apply Terbinafine 1% Cream?

Applying Terbinafine 1% Cream correctly is crucial for achieving optimal results. Follow these guidelines:

  1. Clean the affected area: Wash the skin with soap and water, then pat dry.
  2. Apply the cream: Use a thin layer of the cream and gently massage it into the affected area.
  3. Frequency: Typically, the cream should be applied once daily for one to two weeks, depending on the severity of the infection.

It’s important to ensure that the cream is applied to the entire affected area, not just the visible parts. This helps to prevent the spread of the infection and ensures complete healing.

Users should avoid contact with the eyes and mucous membranes, as the cream is not intended for those areas. After applying the cream, wash your hands thoroughly to remove any residue.

What are the precautions for using Terbinafine 1% Cream?

Before using Terbinafine 1% Cream, consider the following precautions:

  • Do not use on the face: This cream is intended for use on the skin and should not be applied to facial areas.
  • Avoid in children under 16: The safety and effectiveness in younger populations have not been adequately studied.
  • Consult your doctor: If you have sensitive skin or are prone to allergic reactions, discuss the use of this cream with a healthcare professional.

Additionally, if you are pregnant or breastfeeding, it is crucial to consult a physician before using this medication. They can evaluate the risks and benefits based on your specific situation.

What should you know about Terbinafine 1% Cream during pregnancy?

During pregnancy, the safety of using Terbinafine 1% Cream is not fully established. Although topical medications generally have a lower risk of systemic absorption, it is still recommended to exercise caution. Pregnant women should consult their healthcare provider before using this cream to weigh the potential risks and benefits.

In many cases, doctors may recommend alternative treatments that have been studied more extensively in pregnant populations. If Terbinafine is deemed necessary, it should be used only under medical supervision.

What is the recommended dosage for Terbinafine 1% Cream?

The recommended dosage for Terbinafine 1% Cream generally involves applying a thin layer of the cream to the affected area once daily. Treatment duration can vary based on the type and severity of the infection:

  • Athlete’s foot: Usually treated for 1 week.
  • Jock itch: Typically requires 1 week of treatment.
  • Ringworm: May take 1 to 2 weeks for complete resolution.

Adhering to the recommended dosage and duration is essential for the effectiveness of the treatment. Users should not exceed the suggested application frequency, as this will not enhance effectiveness and may lead to increased side effects.

Questions related to Terbinafine 1% Cream

Why was Lamisil discontinued?

Lamisil, the brand name for Terbinafine, is still available; however, certain formulations may be discontinued based on market demands or regulatory changes. It’s important to consult a healthcare provider regarding available options.

What is the composition of terbinafine cream?

Terbinafine cream typically contains 1% terbinafine hydrochloride as the active ingredient, along with other inactive ingredients that help with consistency and stability of the formulation. These may include emulsifiers, preservatives, and stabilizers to enhance the cream’s effectiveness.

What are the ingredients in Lamisil 1%?

The ingredients in Lamisil 1% include 1% terbinafine hydrochloride, but also consist of a variety of excipients that help deliver the active ingredient efficiently. These ingredients are designed to optimize the absorption and effectiveness of the antifungal treatment.

Is terbinafine cream better than clotrimazole?

Both terbinafine and clotrimazole are effective antifungal treatments, but their efficacy can vary based on the specific type of fungal infection. Some studies suggest that terbinafine may be more effective for certain dermatophyte infections, while clotrimazole may be preferred for others. Consulting with a healthcare provider can help determine the best option based on individual circumstances.

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