Aciclovir Cream

ACICLOVIR 5% PATIENT INFORMATION LEAFLET

ANTIVIRAL FOR COLD SORE

Aciclovir 50 mg/g

Cold sores are highly contagious and usually appear as small, fluid-filled blisters around the lips or mouth.

Aciclovir 5% Cream is a topical antiviral medication that treats cold sores (herpes labialis) caused by the herpes simplex virus (HSV-1).

 It works by inhibiting viral replication. Applied at the first sign of tingling or burning, it can reduce symptom severity and help the sore heal more quickly.

Available pack sizes: 10 g

Although licensed for cold sores, 2g and 10g strengths may sometimes be used off-label for genital herpes. The patient information leaflet will still state cold sores as the licensed indication.

Who can use

• Adults with Recurrent Cold Sores
• The studies included adults with a history of recurrent herpes simplex labialis (HSV-1) affecting the lips. Treatment was started at the first sign of symptoms (tingling, burning, itching).

It is appropriate for:

• Otherwise healthy adults
• People with recurrent cold sores
• Those able to recognise early symptoms (prodromal stage)

Who Should Not Use

Do not use it if you are allergic to aciclovir, valaciclovir, propylene glycol, or any of the other ingredients in this cream.

• For external use only. Do not apply inside the mouth, nose, or eyes. (can irritate)
• For genital herpes, unless advised by a doctor

The referenced adult trials focused on adults. For children, check the product licence and patient information leaflet for age guidance. [sources]

• Do not use this product to treat mouth ulcers.
• Do not use it for herpes infections in or near the eyes or in the genital area.
• Only use this cream to treat cold sores on the lips and the surrounding facial area.
• If your cold sore is severe, seek medical advice before using this product.

If you have HIV or another condition that weakens your immune system, consult your doctor before using this product.

If the cream is accidentally swallowed, seek medical advice immediately. See the patient leaflet for more information.

For external use only.

• Wash your hands before and after applying the cream.
• Apply a thin layer to the affected area.
• Use 5 times a day (approximately every 4 hours).
• Start treatment as soon as possible at the first sign of tingling or burning.
• Continue for 5 days.
• If not healed after 5 days, treatment may continue for up to 10 days.
• If still not healed after 10 days, seek medical advice.

Do not exceed the recommended dose.

Do not apply inside the mouth, nose, eyes, or genital area. [sources]

Pregnancy and Breastfeeding

If you are pregnant, planning to become pregnant, or breastfeeding, speak to your doctor before using this cream. A small amount of the medicine can pass into breast milk.

Taking Other Medicines

Inform your doctor or pharmacist if you are taking any other medicines. This includes medicines bought without a prescription.

Active Ingredients: Contains 5% Aciclovir w/w (50 mg per gram)

Like all medicines, this cream can cause side effects, although not everyone will experience them.

Signs of an Allergic Reaction (Rare)

Stop using the cream and seek medical help immediately if you notice:

• Rash
• Itchy skin
• Raised, red bumps (hives)
• Swelling of the lips, face, or eyelids

These may be signs of an allergic reaction.

Uncommon (up to 1 in 100 people):

• Mild burning or stinging after applying the cream
• Itching
• Dry or flaky skin

Rare (up to 1 in 1,000 people):

• Redness
• Skin rash

If any side effects become severe or do not improve, speak to your doctor or pharmacist.

• Keep this medicine out of the sight and reach of children.
• Store below 25°C.
• Keep the tube in its original packaging to protect it.
• Do not refrigerate.
• Do not use after the expiry date printed on the tube or carton.

If you no longer need this medicine, do not throw it away with household waste. Return it to your pharmacist for safe disposal. This helps protect the environment.