Penciclovir Topical

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For penciclovir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to penciclovir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing the use of topical penciclovir in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. There is no specific information comparing use of penciclovir in the elderly with use in other age groups. However, penciclovir has been used in some older patients and has not been found to cause different side effects or other problems than it does in younger adults.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of penciclovir. Make sure you tell your doctor if you have any other medical problems, especially:

• Immune system problems—It is not known if penciclovir will work properly in patients with these problems

penciclovir should only be used on the lips or face.

Penciclovir is best used as soon as possible after the symptoms of herpes infection (for example, pain, burning, or blisters) begin to appear.

Do not use penciclovir in or near the eyes.

Do not use penciclovir inside the mouth or nose or on other internal parts of the body.

Dosing

The dose of penciclovir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of penciclovir. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):
  • For herpes simplex infection (cold sores):
    • Adults—Apply to the affected area(s) of the skin every two hours, while awake, for four days.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of penciclovir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

• Mild pain, burning, or stinging

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache

• Change in sense of taste
• decreased sensitivity of skin, particularly to touch
• redness of the skin
• skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

Rinse with water if this medicine gets in your eyes.

Redness, burning, stinging, or numbness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using penciclovir, tell your doctor or pharmacist if you are allergic to it; or to famciclovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Tell your doctor if you are pregnant before using this medication. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others. Doing so may spread the infection.

Cold sore outbreaks can be triggered by many factors such as stress, hormonal changes (such as pregnancy, menstrual period), injury/surgery on the mouth (such as dental work), tiredness, sunlight, cold weather, or fever/cold/flu.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

Storage

Store this medication at room temperature between 68-77 degrees F (20-25 degrees C). Firmly screw the cap back on the tube of medication after each use. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.