This combination product contains two medications: acyclovir and hydrocortisone. Together, these medications are used to treat the tingling, pain, and swelling that occurs with cold sores. When used early, this medication helps to reduce the severity and duration of a cold sore.

Cold sores are caused by the herpes virus. Acyclovir belongs to the class of medications called antivirals and works by preventing the virus from reproducing, allowing the body's natural defenses to fight the infection. Hydrocortisone belongs to the class of medications called corticosteroids and works to decrease the swelling and redness that cold sores cause.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Acyclovir - hydrocortisone should be started immediately after you notice the first signs or symptoms of a cold sore. It should be applied to all the lesions 5 times a day for 5 days. To reduce the risk of transferring the infection or irritating the area, avoid vigorously rubbing the cream into the skin.

Acyclovir - hydrocortisone topical cream should be applied only to the lips and around the mouth where a cold sore is developing. Avoid using this medication around the eyes, inside the mouth, nose or eyes, on the genitals or the rectal area. Do not cover the cold sore or area around it with a bandage. Do not use any other skin care products or medications on the cold sore or the area around it.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Clean and dry the affected area before applying the cream. To avoid rinsing it off before it is absorbed into the skin, avoid showering, bathing, or swimming for at least 30 minutes after applying the cream.

Wash your hands thoroughly with soap and water before and after applying the cream. This will help you to prevent infecting the cold sore with bacteria and prevent spreading the cold sore virus to other areas and other people.

If you have not noticed any improvement after 2 weeks, contact your doctor for further advice.

It is important that this medication be applied exactly as prescribed by your doctor.

If you miss a dose, apply it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Each gram of cream contains 5 mg of acyclovir and 1 mg of hydrocortisone. Nonmedicinal ingredients: cetostearyl alcohol, citric acid, isopropyl myristate, mineral oil, poloxamer 188, propylene glycol, sodium hydroxide, sodium lauryl sulfate, water, and white petrolatum.

Do not use acyclovir - hydrocortisone if you:

• are allergic to acyclovir, hydrocortisone, or any ingredients of the medication
• are allergic to valacyclovir
• have an untreated bacterial, fungal, tuberculous, or viral infection

Do not give this medication to children under 12 years of age.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bitter taste after applying
• changes in skin colour
• drying or flaking skin where applied
• skin redness
• tingling or burning sensation

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• red, inflamed, irritated skin
• signs of absorbing too much hydrocortisone (e.g., round, red, full face; weight gain; backache; acne; thirst)
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of allergic reaction (e.g., swelling of mouth, throat, lips, hands)
• skin infection

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Circulation problems: If you have problems with blood circulation, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Immune system: If you have a weak immune system, or you are taking medications that weaken your immune system, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Medications that may affect your immune system include medications taken to prevent rejection after an organ or stem cell transplant, cancer medications, and high doses of corticosteroids that are taken by mouth.

Infection: Topical corticosteroids increase the possibility of developing skin infections where the medication is applied. If your condition does not improve within 14 days, or if the cold sore appears to get worse, contact your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this medication, contact your doctor immediately.

Breast-feeding: It is not known if acyclovir passes into breast milk. Hydrocortisone passes into breast milk. If you are breast-feeding and using this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under the age of 12 years.

There may be an interaction between acyclovir - hydrocortisone and any of the following:

• aldesleukin
• calcipotriene

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.