Details for: PRO-VALACYCLOVIR
Company: PRO DOC LIMITEE
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02315173 | PRO-VALACYCLOVIR | VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) | 500 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
PRO-VALACYCLOVIR is an antiviral medicine. It is used to lower the ability of herpes viruses to multiply in your body. PRO-VALACYCLOVIR does not cure herpes infections.
What it does
Treatment of shingles (herpes zoster)
PRO-VALACYCLOVIR is used to treat shingles (herpes
zoster) infections. Shingles is caused by the varicella-zoster
virus which damages nerves and skin. PRO-VALACYCLOVIR
helps stop the virus from multiplying,
therefore reducing the damage.
Treatment or suppression of genital herpes
PRO-VALACYCLOVIR 500 mg caplets are used to treat
genital herpes which is caused by the herpes simplex virus
(HSV).
HSV causes small, fluid-filled blisters in the genital area
which break down into ulcers/sores which may be itchy or
painful. The blisters contain many infectious HSV particles.
PRO-VALACYCLOVIR helps stop HSV from multiplying
which helps to shorten the time that the virus is shed from the
skin and mucous membranes. It reduces the number of painful
blisters and also helps them to heal more quickly.
If you start taking PRO-VALACYCLOVIR as soon as you
feel an infection starting, you may actually prevent the blisters
from developing. This type of treatment is called episodic
therapy.
When taken every day, PRO-VALACYCLOVIR can also be
used to prevent the HSV infection from coming back. This
type of treatment is called suppressive therapy.
Reduction of transmission of genital herpes
PRO-VALACYCLOVIR taken every day and in combination
with safer sex practices can reduce the risk of transmitting
genital herpes to your sexual partner. This type of treatment is
for reduction of transmission.
Sometimes the herpes simplex virus (HSV) may be released to
the skin at levels too low to cause blisters – this is called viral
shedding.
With no visible symptoms, viral shedding can occur anywhere
in the “boxer short” area (from just below the waistline down
to the upper thighs, including the buttocks). This means it is
possible to transmit genital herpes through skin-to-skin contact
with the “boxer short” area, even in the absence of blisters.
PRO-VALACYCLOVIR helps stop HSV from multiplying
which helps to shorten the time that the virus is shed from the
skin and mucous membranes.
Treatment of cold sores (herpes labialis)
PRO-VALACYCLOVIR is used to treat cold sores (herpes
labialis) which are caused by the herpes simplex virus (HSV).
Cold sores are small, fluid-filled blisters that you get in or
around your mouth. The blisters then break down into
ulcers/sores which may be itchy or painful. The blisters
contain many infectious HSV particles. Cold sores may be
spread by kissing or other physical contact with the infected
area of the skin.
PRO-VALACYCLOVIR helps stop HSV from multiplying
which helps to shorten the time that the virus is released from
the skin and mucous membranes. It reduces the number of
painful blisters and also helps them to heal more quickly.
When it should not be used
You should not use PRO-VALACYCLOVIR if you are allergic to or react badly to valacyclovir or acyclovir or any other components of the formulation of PRO-VALACYCLOVIR (see “What the non-medicinal ingredients are” section). Tell your doctor if you have ever had an allergic reaction to any of these ingredients.
What the medicinal ingredient is
Valacyclovir hydrochloride
What the non-medicinal ingredients are
Crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, titanium dioxide. In addition to the above listed ingredients, PRO-VALACYCLOVIR 500 mg caplets also contain: FD&C blue #2 aluminum lake.
What dosage form it comes in
Caplets: 500 mg
Warnings and precautions
Before using PRO-VALACYCLOVIR, tell your doctor if:
- You have kidney problems or you are 65 years of age
or older. Your doctor may give you a lower dose of
PRO-VALACYCLOVIR.
- You are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. Your doctor may decide not to prescribe PRO-VALACYCLOVIR depending on your condition.
Proper use of this medication
You must take PRO-VALACYCLOVIR as prescribed by your
doctor. If you are not sure how many caplets to take, or how
often to take them, consult your doctor or pharmacist.
You should not increase or decrease the prescribed dose or
frequency unless advised by your doctor.
For shingles, genital herpes (initial and recurrent episodes) and
cold sores, for best effect, start taking your PRO-VALACYCLOVIR
caplets as soon as possible after your
symptoms start.
Swallow the caplets with some water. It is important to drink
enough water to prevent dehydration when you are taking
PRO-VALACYCLOVIR. It does not matter if you take them
with or without food.
Usual adult dose
Shingles (herpes zoster):
For the treatment of shingles, the usual dose of PRO-VALACYCLOVIR
is 1000 mg orally three times a day for 7
days. Most people take one dose when they get up in the
morning, one dose mid-afternoon and one dose before they go
to bed at night. Spreading the doses evenly throughout the day
will help to shorten your rash and discomfort.
Genital herpes:
- Episodic Therapy
- Suppressive Therapy
- Reduction of Transmission
For the treatment of an initial (first) episode of genital herpes,
the usual dose of PRO-VALACYCLOVIR is 1000 mg orally
two times a day. The treatment is usually taken for 10 days.
For the treatment of recurrent episodes of genital herpes, the
usual dose of PRO-VALACYCLOVIR is 500 mg orally two
times a day for 3 days. Take one dose in the morning and one
in the evening. Take your PRO-VALACYCLOVIR caplets as
soon as you get the warning signs of an outbreak (i.e., itching,
burning, swelling or pain in your genital area). This may
actually prevent the blisters from developing.
For the suppression of genital herpes, the usual dose of PRO-VALACYCLOVIR
is 1000 mg orally once a day. If you have
a history of 9 or fewer recurrences per year, your doctor may
prescribe an alternative dose of 500 mg orally once a day. You
should continue to take this medicine every day and follow
your doctor’s instruction.
For the suppression of genital herpes in HIV-infected patients
with CD4 cell count > 100 cells/mm3, the recommended
dosage of PRO-VALACYCLOVIR is 500 mg orally two
times a day.
For the reduction of transmission of genital herpes in patients
with a history of 9 or fewer recurrences per year, the usual
dose of PRO-VALACYCLOVIR is 500 mg once a day for the
partner with the infection. Note that the efficacy of PRO-VALACYCLOVIR
for reducing transmission of genital
herpes has not been established in individuals with multiple
partners, non-heterosexual couples, and couples not
counselled to use safer sex practices.
Cold sores (herpes labialis):
For the treatment of cold sores, the usual dose of PRO-VALACYCLOVIR
is 2000 mg orally two times a day for 1
day (24-hour period). The second dose should be taken around
12 hours after the first dose, but not less than 6 hours after the
first dose. Do not exceed 1 day of treatment. Take your PRO-VALACYCLOVIR
caplets as soon as you get the warning
signs of an outbreak (i.e., tingling, itching or burning).
Overdose
Missed Dose
If you forget to take a dose, take it as soon as you remember.
Then continue with the next dose at the proper time interval.
Do not double doses.
Side effects and what to do about them
PRO-VALACYCLOVIR does not often have side effects.
Some people may feel sick (nausea, vomiting, diarrhea and
stomach pain) or have a mild headache. These side effects are
generally mild and do not usually cause patients to stop taking
PRO-VALACYCLOVIR.
If you experience any of the following side effects, contact
your doctor as soon as possible:
- Skin rash (which may also occur after exposure to UV light e.g., sunbathing or using a sun bed)
- Pain in the side (between ribs and hip) or kidney area of your back
Tell your pharmacist or doctor if you notice any other side
effects from your medicine which are not mentioned here. A
complete listing of adverse events that have been reported is
contained in the Product Monograph supplied to your doctor
and pharmacist.
If you feel worse, or if you have taken all the caplets and do
not feel better, tell your doctor as soon as possible.
PRO-VALACYCLOVIR can alter liver function tests. This is
a blood test that lets your doctor know how well your liver is
working. If there are any significant changes due to PRO-VALACYCLOVIR,
your doctor will decide on the
appropriate course of action.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| Unknown | |||
| Blood clotting disorder with symptoms such as bruising, bleeding (from gums), fever, fatigue, headache, confusion, numbness, paralysis. | ✔ | ✔ | |
| Destruction of red blood cells creating anemia with symptoms such as bloody diarrhea, abdominal pain, fatigue, nausea, vomiting, confusion, swelling of hands and feet. | ✔ | ✔ | |
| Rare | |||
| Central nervous system effects with symptoms such as dizziness, confusion, agitation, hallucinations, particularly in those with kidney problems. | ✔ | ✔ | |
How to store
Store PRO-VALACYCLOVIR caplets between 15°C and
30°C. Keep the caplets away from direct heat and sunlight.
Keep your PRO-VALACYCLOVIR caplets in a safe place
where children cannot reach or see them.
Do not take any caplets after the expiry date.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
More facts about genital herpes
What is genital herpes?
Genital herpes, one of the most common sexually transmitted
infections, is caused by the herpes simplex virus (HSV), the
same family of viruses that causes cold sores or fever blisters.
You can get genital herpes by having sex (skin-to-skin contact
including genital, anal, and/or oral contact) with a person who
has herpes. Genital herpes does not always occur on the
genitals. It may occur anywhere in the “boxer short” area for
both men and women (from just below the waistline down to
the upper thighs, including the buttocks).
Are there any warning signs of a genital herpes outbreak?
Many people have genital herpes and don’t even know it. Here
are some of the signs and symptoms that may signal a genital
herpes outbreak:
- Swelling, pain, itching, or burning in your genital area
- Redness, tiny blisters, or sores
- Burning feeling when urinating
- Genital discharge
- Muscle aches, tiredness, or headaches
There is no cure for genital herpes. Once the herpes virus
enters the body, it is present throughout life, alternating
between active (outbreak or viral shedding) and inactive
states.
Why outbreaks recur is still unknown. Some people know
what triggers their genital herpes infection to become active
again, while others do not. Some factors that may trigger the
virus into activity are lack of sleep, poor diet, stress and
menstruation.
Try to notice if these factors cause your infection to return, as
you may be able to avoid some of them. Taking your PRO-VALACYCLOVIR
caplets as soon as you get the warning
signs may actually prevent the blisters from developing.
How did I get genital herpes?
Genital herpes is passed from one person to another through
direct intimate contact. It can be transmitted sexually, by
direct contact with blisters or sores, which contain many
infectious virus particles. It can also be transmitted through
skin-to-skin contact with the “boxer short” area even in the
absence of blisters, because the virus can be active on the skin
without causing symptoms.
Small cuts or scratches in the skin or mucous membranes
allow the virus to gain entry into the body more easily. These
may not be visible to the naked eye.
Genital herpes cannot be transmitted via handshakes, toilet
seats, swimming pools, saunas, hot tubs or blood transfusions.
Can I transmit genital herpes to other people?
Yes. It is important to remember that the herpes virus can be
shed from your skin even when you do not have any signs or
symptoms. For this reason, you can transmit the infection to
your partner through skin-to-skin contact with the “boxer
short” area even in the absence of blisters or sores. In 70% of
cases, genital herpes is transmitted when there are no signs or
symptoms.
How can I reduce the risk of transmitting genital herpes to
other parts of my body or to other people?
You do not have to stop having sex if you have genital herpes.
However, here are some things you should consider in order to
reduce the risk of transmission:
- Avoid sexual contact with your partner when you have an outbreak of genital herpes, or think you are about to have an outbreak.
- Use latex or polyurethane condoms each time you engage in sexual intercourse even when there are no signs of infection.
- Avoid touching or breaking the blisters or sores and do not pick the scabs when they form.
- Always wash your hands if you touch the blisters, sores, or scabs.
- If you or your partner has an active genital herpes infection (or even the warning signs), avoid contact with the blisters or sores.
- When combined with safer sex practices, including condoms, daily therapy with PRO-VALACYCLOVIR reduces the risk of transmitting genital herpes to your partner.
- Talk to your doctor about the best options for you and your partner.
What about genital herpes and pregnancy?
There is no evidence that having genital herpes affects fertility
in men or women and is unlikely to complicate a pregnancy.
The measures described above will also help to reduce the risk
of transmitting genital herpes during pregnancy. Special
precautions should be taken during pregnancy to avoid
transmission to a pregnant woman if her partner has genital
herpes. Care is needed at the time of birth if there is an active
infection present. Discuss the options available with your
doctor.
How can you treat (or manage) your genital herpes?
There are 3 different ways to manage genital herpes with
PRO-VALACYCLOVIR :
Episodic therapy: Episodic therapy involves taking
PRO-VALACYCLOVIR for a specific number of days during
an outbreak to help speed the healing of blisters, shorten the
duration of pain and discomfort, and reduce viral shedding
(the stage during which herpes virus is secreted). If treatment
with PRO-VALACYCLOVIR is started before the appearance
of any sores, it may prevent sores from occurring.
Suppressive therapy: PRO-VALACYCLOVIR can also be
used to help prevent outbreaks of genital herpes. PRO-VALACYCLOVIR
will not cure genital herpes, but, if taken
every day, it may prevent genital herpes outbreaks before they
start. Suppressive therapy can significantly reduce the
frequency of outbreaks, although results will vary from person
to person. Many people can remain recurrence-free while on
suppressive treatment.
Reduction of Transmission: When taken every day, PRO-VALACYCLOVIR
in combination with safer sex practices
can also reduce the risk of transmitting genital herpes to your
sexual partner.
Talk to your doctor if you have questions about treatment with
PRO-VALACYCLOVIR and if you are concerned about
transmitting genital herpes to your partner. Your physician
will help you decide which type of therapy is best for you.
This document plus the full product monograph, prepared for
health professionals, can be obtained by contacting Pro Doc
Ltée at 1-800-361-8559, www.prodoc.qc.ca or
info@prodoc.qc.ca.
This leaflet was prepared by
Pro Doc Ltée, Laval, Québec, H7L 3W9
Last revised: January 3, 2017