Sitavig: Uses, Side Effects and Dosage

What is SITAVIG™ used for?

• SITAVIG™ is a medication that is applied once to treat outbreaks of cold sores (herpes labialis) in adults.

How does SITAVIG™ work?

SITAVIG™ works by:

• Sticking to the gum, when placed on the upper gum by the incisor tooth (the tooth just to the right or left of your two front teeth).
• Over about 14 hours, the tablet dissolves.

• SITAVIG™ then:

  • Prevents the virus from multiplying.
  • This reduces the infection and symptoms such as burning, tingling, redness and itching.

What are the ingredients in SITAVIG™?

Medicinal ingredients: acyclovir

Non-medicinal ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, milk protein concentrate, povidone, sodium lauryl sulfate.

SITAVIG™ comes in the following dosage form:

Mucoadhesive buccal tablet, 50 mg

Do not use SITAVIG™ if you:

• are allergic to acyclovir, milk protein concentrate, or any other ingredient of the product (see What are the ingredients of SITAVIG™?).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SITAVIG™. Talk about any health conditions or problems you may have, including if you:

• have a weak immune system (become sick very easily).

• are pregnant or plan to become pregnant.

• are breastfeeding or plan to breastfeed.
• are under the age of 18 years.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with SITAVIG™:

Other medicines are unlikely to affect how SITAVIG™ works or increase the chance of side effects. Drug interaction studies have not been done with SITAVIG™.

How to use SITAVIG™:

• Use SITAVIG™ exactly as your healthcare professional tells you.
• Do not crush, suck, chew or swallow the tablets.

• Use SITAVIG™:

  • as soon as possible for best results.
  • at first signs of a cold sore, such as burning, itching, tingling, redness.
  • before a cold sore appears.
• Apply the rounded side of SITAVIG™ to the upper gum, just above the incisor tooth.
• Do not apply SITAVIG™ to the lip or cheek.

• If SITAVIG™ does not stick to the gum or falls off:

  • before 6 hours, then:

    • reapply, or
    • if this does not stick, apply a new tablet.
  • after 6 hours, then do not reapply or apply a new tablet.

• If you swallow SITAVIG™:

  • before 6 hours, then drink a glass of water and apply a new tablet.
  • after 6 hours, then do not apply a new tablet.

• While using SITAVIG™:

  • you may eat and drink.
  • drink more liquids if your mouth becomes dry.
  • do not chew gum, wear dentures, brush teeth, or do any similar activity which may move the tablet.
  • if the teeth need to be cleaned while you are using the tablet, rinse the mouth gently.

How to apply SITAVIG™:

Step 1: Before you apply SITAVIG™, find the area on your upper gum, just above either the left or the right incisor. The incisor tooth is the tooth just to the right or left of your two front teeth (See Figure A). This is where you should apply SITAVIG™.

Figure A

Step 2: Carefully PEEL back the cover of the blister pack. Take the SITAVIG™ tablet out of the blister pack. When removed from the blister pack, SITAVIG™ must be used right away. SITAVIG™ is round on one side and flat on the other side (See Figure B).

Figure B

Step 3: Place the flat side of SITAVIG™ on your dry fingertip. Apply the round side of SITAVIG™ to your upper gum (See Figure C). The flat side will be facing the inside of your lip.

Figure C

Step 4: Hold SITAVIG™ in place by pressing slightly with your finger on the outside of your upper lip, over the area where SITAVIG is placed, for 30 seconds. This will help SITAVIG™ stick to your gum (See Figure D).

Area to apply SITAVIG™ tablet

Figure D

Step 5: Leave the SITAVIG™ tablet in place until it dissolves, which can take about 14 hours.

Usual adult dose:

SITAVIG™ is a single dose therapy. This means that only one tablet is applied to the upper gum, just once.

One SITAVIG™ tablet should be applied as a single dose to the area of the upper gum.

Overdose:

What are possible side effects from using SITAVIG™?

These are not all the possible side effects you may feel when taking SITAVIG™. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

• Headache
• Pain, discomfort, redness or tingling at or near where tablet was applied
• Lip dryness or swelling
• Mouth dryness, pain or ulcer
• Acid reflux disease (condition where stomach acid comes back up into your esophagus (the muscular tube that connects your throat and stomach))
• Nosebleeds
• Dizziness
• Tiredness
• Pain or discomfort in the abdomen
• Diarrhoea
• Nausea
• Vomiting
• Flu-like illness
• Muscle pain
• Redness, flushing, rash or itching

Reporting Side Effects

Last Revised: March 27, 2020 1-800-499-4468.

• (www.healthcanada.gc.ca); the manufacturer’s website www.epihealth.com, or by calling this Patient Medication Information by visiting the Health Canada website • Find the full Product Monograph that is prepared for healthcare professionals and includes • Talk to your healthcare professional

If you want more information about SITAVIG™:

Keep out of reach and sight of children.

Store at 20 - 25°C. Protect from moisture.

Storage: