Details for: MYLAN-VALACYCLOVIR
Company: MYLAN PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02351579 | MYLAN-VALACYCLOVIR | VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) | 500 MG | TABLET | ORAL |
| 02351560 | MYLAN-VALACYCLOVIR | VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) | 1000 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
Mylan-Valacyclovir (valacyclovir hydrochloride) is an antiviral medicine. It is used to lower the ability of herpes viruses to multiply in your body. Mylan-Valacyclovir does not cure herpes infections.
Treatment of shingles (herpes zoster)
Mylan-Valacyclovir is used to treat shingles (herpes zoster) infections. Shingles is caused by the varicella-zoster virus which damages nerves and skin. Mylan-Valacyclovir helps stop the virus from multiplying, therefore reducing the damage.
Treatment or suppression of genital herpes
Mylan-Valacyclovir is 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. Mylan-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 Mylan-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.
Reduction of transmission of genital herpes
Mylan-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.
Mylan-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)
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.
Mylan-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 Mylan-Valacyclovir if you are allergic to or react badly to valacyclovir or acyclovir or any other components of the formulation of Mylan-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
Mylan-Valacyclovir caplets contain the active ingredient valacyclovir hydrochloride.
What the non-medicinal ingredients are
Mylan-Valacyclovir 500 mg caplets contain the non-medicinal ingredients magnesium stearate, microcrystalline cellulose. Coating: F&C blue #2/ indigo carmine aluminum lake, hydroxypropyl methylcellulose, polyethylene glycol and titanium dioxide The blue, film-coated caplets are printed with ink which contains isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze and titanium dioxide.
Mylan-Valacyclovir 1000 mg caplets contain non-medicinal ingredients Magnesium stearate, and microcrystalline cellulose. Coating: hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide. The white, film-coated caplets are printed with ink which contains ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.
What dosage form it comes in
Mylan-Valacyclovir is available in caplets containing 500 mg or 1000 mg of valacyclovir.
Warnings and precautions
Before using Mylan-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 Mylan-Valacyclovir.
- You are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. Your doctor may decide not to prescribe Mylan-Valacyclovir depending on your condition.
Proper use of this medication
You must take Mylan-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 Mylan-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 Mylan-Valacyclovir. It does not matter if you take them with or without food.
Usual adult dose
Shingles (herpes zoster):
For the treatment of shingles (herpes zoster), the usual dose of Mylan-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
For the treatment of an initial (first) episode of genital herpes, the usual dose of Mylan-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 Mylan-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 Mylan-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.
- Suppressive Therapy In Patients Infected with HIV
For the suppression of genital herpes in HIV-infected patients with CD4 cell count > 100 cells/mm3, the recommended dosage of Mylan-Valacyclovir is 500 mg orally two times a day.
- Reduction of Transmission
For the reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year, the usual dose of Mylan-Valacyclovir is 500 mg once a day for the partner with the infection. Note that the efficacy of Mylan-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 Mylan-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 Mylan-Valacyclovir caplets as soon as you get the warning signs of an outbreak (i.e., tingling, itching or burning).
Overdose
It is important to follow the dosage instructions on the label of your medicine. In the event of an overdose, you should IMMEDIATELY contact either your doctor, the nearest hospital emergency department or poison control centre.
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
Mylan-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 Mylan-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.
Mylan-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 Mylan-Valacyclovir, your doctor will decide on the appropriate course of action.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor 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. | ✔ | ✔ | |
This is not a complete list of side effects. For any unexpected effects while taking Mylan-Valacyclovir, contact your doctor or pharmacist.
How to store
Store Mylan-Valacyclovir caplets between 15° and 30°C. Keep the caplets away from direct heat and sunlight.
Keep your Mylan-Valacyclovir caplets in a safe place where children cannot reach them.
Do not take any caplets after the expiry date.
Reporting side effects
You can help improve the safe use of health products for
Canadians by reporting serious and unexpected side
effects to Health Canada. Your report may help to
identify new side effects and change the product safety
information.
3 ways to report:
- Online at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect
Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator
0701E
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice
More information
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800- 575-1379
This leaflet was prepared by Mylan Pharmaceuticals ULC Etobicoke, Ontario M8Z 2S6
Revised on: October 19, 2015
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-800-575-1379
www.mylan.ca