EPIVIR ORAL SOLUTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LAMIVUDINE

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J05AF05

Pharmaceutical form:

SOLUTION (ORAL)

Composition:

LAMIVUDINE 10 MG/ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

VIIV HEALTHCARE UK LIMITED, UK

Therapeutic group:

LAMIVUDINE

Therapeutic area:

LAMIVUDINE

Therapeutic indications:

Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.

Authorization date:

2014-03-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician’s
prescription only.
EPIVIR ORAL SOLUTION
EACH ML OF ORAL SOLUTION CONTAINS LAMIVUDINE 10 MG.
For the list of the inactive and allergenic ingredients, see section
2 - “Important information about some of the ingredients of
Epivir”
and section 6 - “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine.
If you have any other questions, refer to the physician or the
pharmacist.
This medicine has been prescribed for you or for your child. Do
not pass it on to others. It may harm them even if it seems to
you that their illness is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
EPIVIR IS USED TO TREAT HIV INFECTION (HUMAN IMMUNODEFICIENCY
VIRUS) IN ADULTS AND CHILDREN.
THERAPEUTIC GROUP: Epivir is a type of medicine known as an
anti-retroviral. It belongs to a group of medicines called _nucleoside
_
_analogue reverse transcriptase inhibitors (NRTIs)._
Epivir does not completely cure HIV infection; it reduces the
amount of virus in your body, and keeps it at a low level. It also
increases the CD4 cell count in your blood. CD4 cells are a type
of white blood cells that are important in helping your body to
fight infection.
Not everyone responds to treatment with Epivir in the same way.
Your physician will monitor the effectiveness of your treatment.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
•
If you are sensitive (allergic) to lamivudine or to any of the
additional ingredients contained in the medicine (listed in
section 6).
→ CHECK WITH YOUR PHYSICIAN if you think this applies to
you.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
Some people taking Epivir or other combination treatments for
HIV are more at risk of serious side effects. You need to be aware
of the extra risks:
•
if you have ever had LIVER DISEASE, including hepatitis B or
C (if you have hepati

Summary of Product characteristics

Page 1 of 15
EPIVIR ORAL SOLUTION
1.
NAME OF THE MEDICINAL PRODUCT
Epivir oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 10 mg of lamivudine.
Excipient(s) with known effect:
Each 15 ml dose contains 3 g sucrose (20% w/v).
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Each 15 ml dose contains 300 mg propylene glycol.
Each 15 ml dose contains 39 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epivir is indicated as part of antiretroviral combination therapy for
the treatment of Human
Immunodeficiency Virus (HIV) infected adults and children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The therapy should be initiated by a physician experienced in the
management of HIV
infection.
Epivir may be administered with or without food.
_ _
Epivir is also available as a tablet formulation for patients who
weigh at least 14 kg (see
section 4.4).
Patients changing between lamivudine tablets and lamivudine oral
solution should follow the
dosing recommendations that are specific for the formulation (see
section 5.2).
For patients who are unable to swallow tablets, the tablet(s) may be
crushed and added to a
small amount of semi-solid food or liquid, all of which should be
consumed immediately (see
section 5.2).
_Adults, adolescents and children (weighing at least 25 kg): _
Page 2 of 15
_ _
The recommended dose of Epivir is 300 mg daily. This may be
administered as either 150 mg
(15 ml) twice daily or 300 mg (30 ml) once daily (see section 4.4).
_Children (weighing less than 25 kg): _
_ _
_Children from one year of age: _
The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily,
or 1 mL/kg (10 mg/kg) once daily (see sections 4.4 and 4.5).
_Children from three months to one year of age:_
The recommended dose is 0.5 mL/kg (5
mg/kg) twice daily. If a twice daily regimen is not feasible, a once
daily regimen (10
mg/kg/day) could be considered.