NOUMED VALACICLOVIR valaciclovir (as hydrochloride hydrate) 500 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valaciclovir hydrochloride hydrate, Quantity: 556.275 mg (Equivalent: valaciclovir, Qty 500 mg)

Available from:

AVALLON PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: crospovidone; magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; macrogol 400

Administration route:

Oral

Units in package:

100, 20, 42, 30, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. For the treatment of ophthalmic zoster. For the treatment of clinical episodes of genital herpes simplex infections. For the prevention of recurrent genital herpes in immunocompromised patients with creatinine clearance of >15mL/min. Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.

Product summary:

Visual Identification: White to off-white capsule shaped film coated tablets with "500" debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-02-28

Patient Information leaflet

Noumed Valaciclovir
1
NOUMED VALACICLOVIR
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING NOUMED VALACICLOVIR?
Noumed Valaciclovir contains the active ingredient valaciclovir
hydrochloride hydrate. Noumed Valaciclovir is used to treat
herpes zoster (shingles) in adult patients who commence therapy within
72 hours of the onset of rash, ophthalmic zoster,
recurrent herpes labialis (cold sores), clinical episodes of genital
herpes simplex infections and the prevention of recurrent
genital herpes. It also used to prevent cytomegalovirus (CMV)
infection and disease following solid organ transplantation. CMV
is another type of herpes virus that can cause symptoms similar to
glandular fever (high temperature, sore throat and swollen
glands). For more information, see Section 1. Why am I using Noumed
Valaciclovir? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE NOUMED VALACICLOVIR?
Do not take if you have ever had an allergic reaction to valaciclovir
hydrochloride hydrate or any of the ingredients listed at the
end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR
PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information,
see Section 2. What should I know before I use
Noumed Valaciclovir? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Noumed Valaciclovir and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE NOUMED VALACICLOVIR?
•
Your doctor will tell you how many tablets to take each day.
•
Swallow the tablets whole with a glass of water and take Noumed
Valaciclovir at about the same time each day.
More instructions can be found in Section 4. How do I take Noumed
Valaciclovir? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING NOUMED VALACICLOVIR?
THINGS YOU
SHOULD

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
NOUMED VALACICLOVIR
(VALACICLOVIR HYDROCHLORIDE HYDRATE)
FILM- COATED TABLETS
Noumed Valaciclovir-pi
Page
1
of
26
1
NAME OF THE MEDICINE
Valaciclovir hydrochloride hydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Noumed Valaciclovir tablets contain the active ingredient valaciclovir
hydrochloride hydrate.
3
PHARMACEUTICAL FORM
Noumed Valaciclovir 500 mg capsule shaped film coated tablets - White
to off-white capsule
shaped film coated tablets with ‘500’ debossed on one side and
plain on other side.
Noumed Valaciclovir
1000 mg capsule shaped film coated tablets
*
-White to off-white, capsule
shaped film coated tablets with “1000” debossed on one side and
plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the treatment of herpes zoster (shingles) in adult patients who
commence therapy within
72 hours of the onset of rash
For the treatment of ophthalmic zoster
For the treatment of recurrent herpes labialis (cold sores)
For the treatment of clinical episodes of genital herpes simplex
infections
For the prevention of recurrent genital herpes
Reduction of transmission of genital herpes in patients suffering from
recurrent genital herpes.
In addition to therapy with valaciclovir, it is recommended that
patients use safer sex practices
(see Section 4.4 Special warnings and precautions for use)
Prophylaxis
of
cytomegalovirus
(CMV)
infection
and
disease
following
solid
organ
transplantation in patients at risk of CMV disease.
4.2
D
OSE AND METHOD OF ADMINISTRATION
_DOSAGE _
_ADULTS _
_Herpes Zoster_
: 1000 mg of valaciclovir three times a day for seven days.
_Cold sores: _
Recommended dosage is 2000 mg of valaciclovir twice daily for 1 day
with the
second dose taken about 12 hours (no sooner than 6 hours) after the
first dose. Therapy should
be initiated at the earliest symptom of a cold sore (e.g. tingling,
itching, or burning).
Noumed Valaciclovir-pi
Page 2 of 26
_Genital Herpes_
: First clinical presentation, 500 mg of valaciclovir twice a day for
5 to 1