Activir 5% Cream 2g tube Herpes labialis (cold sore)

Description:

Activir 5% Crème is a topical antiviral medication designed to treat cold sores (herpes labialis) on the lips and face. It contains the active ingredient acyclovir, which works by stopping the growth of the virus causing the infection. Activir 5% Crème helps reduce the duration of cold sores and relieves the symptoms associated with outbreaks.

Usage Instructions:

1. Preparation:

   • Wash your hands before and after applying the cream.
   • Clean and dry the affected area thoroughly.

2. Application:

   • Apply a thin layer of Activir 5% Crème to the affected area 5 times a day (approximately every 4 hours) for 4 days.
   • Start using the cream at the first sign of a cold sore (tingling, itching, or redness).

3. Precautions:

   • Avoid touching or scratching the affected area to prevent spreading the infection.
   • Do not use the cream inside your mouth, eyes, or genital area.
   • If you experience any severe reactions or if symptoms persist beyond 4 days, consult a healthcare professional.

Ingredients:

Active Ingredient:

• Acyclovir 5%

Inactive Ingredients:

• Propylene Glycol
• Liquid Paraffin
• White Soft Paraffin
• Cetostearyl Alcohol
• Poloxamer 407
• Arlacel 165
• Dimethicone 20
• Glycerol Monostearate
• Macrogol Stearate
• Sodium Lauryl Sulfate
• Purified Water

Storage:

• Store at a temperature below 25°C.
• Keep the tube tightly closed when not in use.
• Keep out of reach of children.

• Please read the following full disclosure before purchasing or using these tablets.

• SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)

  1. NAME OF THE MEDICINAL PRODUCT

  Activir 5% Crème

  2. QUALITATIVE AND QUANTITATIVE COMPOSITION

  Each gram of cream contains 50 mg of acyclovir (5% w/w).

  3. PHARMACEUTICAL FORM

  Cream for topical application.

  4. CLINICAL PARTICULARS

  4.1 Therapeutic indications

  Activir 5% Crème is indicated for the treatment of herpes labialis (cold sores) in adults and children over 12 years of age.

  4.2 Posology and method of administration

  • Adults and children over 12 years of age:

    • Apply to the affected area 5 times a day at intervals of approximately 4 hours, omitting the night-time application.
    • Treatment should be started as soon as possible after the first signs of an infection (e.g., tingling, redness).
    • Continue treatment for 4 days. If healing does not occur, treatment may be continued for up to 10 days. If lesions are still present after 10 days, consult a doctor.

  • Children under 12 years of age:

    • The safety and efficacy of Activir 5% Crème have not been established in children below 12 years of age.

  4.3 Contraindications

  • Hypersensitivity to acyclovir, valacyclovir, or any of the excipients listed in section 6.1.

  4.4 Special warnings and precautions for use

  • Activir 5% Crème is for cutaneous use only.
  • Avoid contact with the eyes and mucous membranes (e.g., inside the mouth or nose).
  • Use with caution in patients with severe renal impairment.
  • Prolonged or repeated use of this product may result in allergic contact dermatitis.
  • If a severe hypersensitivity reaction or skin irritation occurs, discontinue use immediately and seek medical advice.

  4.5 Interaction with other medicinal products and other forms of interaction

  • No clinically significant interactions have been identified.

  4.6 Fertility, pregnancy, and lactation

  • Pregnancy: There are no adequate data from the use of acyclovir in pregnant women. Use only when the potential benefits outweigh the potential risks to the fetus.
  • Breastfeeding: Acyclovir is excreted in human milk. Use with caution in breastfeeding women.

  4.7 Effects on ability to drive and use machines

  • Activir 5% Crème has no influence on the ability to drive and use machines.

  4.8 Undesirable effects

  • Common (≥1/100 to <1/10): Mild drying or flaking of the skin, transient burning or stinging sensation.
  • Uncommon (≥1/1,000 to <1/100): Itching.
  • Rare (≥1/10,000 to <1/1,000): Erythema, contact dermatitis following application. Where sensitivity tests have been conducted, the reactive substances have been shown to be components of the cream base rather than acyclovir.

  4.9 Overdose

  • Overdose is unlikely to occur due to low systemic absorption of topical acyclovir. In case of accidental ingestion of a large quantity of the cream, gastric lavage may be considered if deemed necessary.

  5. PHARMACOLOGICAL PROPERTIES

  5.1 Pharmacodynamic properties

  • Acyclovir is an antiviral agent which is highly active against herpes simplex virus (HSV) types I and II and varicella-zoster virus (VZV).

  5.2 Pharmacokinetic properties

  • Absorption: Acyclovir is minimally absorbed through the skin.
  • Distribution: Following topical application, detectable levels are found in urine only at very low concentrations.
  • Elimination: Acyclovir is primarily excreted unchanged in the urine.

  6. PHARMACEUTICAL PARTICULARS

  6.1 List of excipients

  • Propylene Glycol
  • Liquid Paraffin
  • White Soft Paraffin
  • Cetostearyl Alcohol
  • Poloxamer 407
  • Arlacel 165
  • Dimethicone 20
  • Glycerol Monostearate
  • Macrogol Stearate
  • Sodium Lauryl Sulfate
  • Purified Water

  6.2 Incompatibilities

  • Not applicable.

  6.3 Shelf life

  • 3 years.

  6.4 Special precautions for storage

  • Store below 25°C. Keep the tube tightly closed when not in use.

  6.5 Nature and contents of container

  • 2g aluminium tube with a screw cap.

  6.6 Special precautions for disposal and other handling

  • No special requirements.

  7. MARKETING AUTHORISATION HOLDER

  • [Manufacturer Name]
  • [Manufacturer Address]
  • [Manufacturer Contact Information]

  8. MARKETING AUTHORISATION NUMBER(S)

  • [Marketing Authorisation Number]

  9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

  • [Date of First Authorisation/Renewal]

  10. DATE OF REVISION OF THE TEXT

  • [Date of Revision]

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  Note: This summary provides important information about the product. For further details, consult the full prescribing information or your healthcare provide