Levo-Tech tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

levofloxacin (levofloxacin hemihydrate)

Available from:

PharmaTech CJSC

ATC code:

J01MA12

INN (International Name):

levofloxacin (levofloxacin hemihydrate)

Dosage:

500mg

Pharmaceutical form:

tablets film-coated

Units in package:

(10/1x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-04-23

Patient Information leaflet

PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVO-TECH
FILM-COATED TABLETS 500MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, or pharmacist.
This includes any possible side
effects not listed in this leaflet.
IN THIS LEAFLET:
1. What Levo-Tech is and what it is used for
2. What you need to know before you take Levo-Tech
3. How to take Levo-Tech
4. Possible side effects
5. How to store Levo-Tech
6. Contents of the pack and other information
1.
WHAT LEVO-TECH IS AND WHAT IT IS USED FOR
Levo-Tech contains a drug called levofloxacin. Levofloxacin is an
antibiotic which is used to treat
bacterial infections of the
sinuses
lungs, in people with long-term breathing problems or Pneumonia
urinary tract, including your kidneys or bladder
In urinary tract, including kidneys or bladder infections, lungs, in
people with long-term breathing
problems
or
Pneumonia,
sinuses.
Levo-Tech
should
be
used
only
when
it
is
considered
inappropriate to use other antibacterial agents that are commonly
recommended for the treatment of
these infections.
prostate gland, where you have a long lasting infection
skin and underneath the skin, including muscles. This is sometimes
called ‘soft tissue’
In some special situations, Levo-Tech may be used to lessen the
chances of getting a pulmonary
disease named anthrax or worsening of the disease after you are
exposed to the bacteria causing
anthrax.
PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
2
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVO-TEC

Summary of Product characteristics

PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
1
SUMMARY OF PRODUCT CHARACTERISTICS
LEVO-TECH
FILM-COATED TABLETS 500 MG
_1. NAME _
_1.1 NAME OF THE MEDICINAL PRODUCT _
Levo-Tech
_1.2 INTERNATIONAL NON-PROPRIETARY NAME (INN): _
Levofloxacin hemihydrate
_2. QUALITATIVE AND QUANTITATIVE COMPOSITION: _
Each film coated tablet contains 500 mg of levofloxacin as active
substance corresponding to 512.00 mg of
levofloxacin hemihydrate.
For the full list of excipients, see section 6.1
_3._
_ _
_PHARMACEUTICAL FORM _
Film-coated tablet
Brown biconvex oval shaped tablets, scored on one side and plain on
the other side.
_4._
_ _
_CLINICAL PARTICULARS _
_ _
_4.1 THERAPEUTIC INDICATIONS _
Levo-Tech is indicated in adults for the treatment of the following
infections (see sections 4.4 and 5.1):
• Acute bacterial sinusitis
• Acute exacerbation of chronic obstructive pulmonary disease
including bronchitis
In Acute exacerbations of chronic bronchitis
Levo-Tech should be used only when it is considered
inappropriate to use other antibacterial agents that are commonly
recommended for the treatment of these
infections.
• Community-acquired pneumonia
• Complicated skin and soft tissue infections
•Acute pyelonephritis and complicated urinary tract infections (see
section 4.4)
In Pyelonephritis and complicated urinary tract infections Levo-Tech
should be used only when it is
considered inappropriate to use other antibacterial agents that are
commonly recommended for the treatment
of these infections.
PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
2
• Chronic bacterial prostatitis
• Uncomplicated cystitis (see section 4.4)
In Uncomplicated cystitis Levo-Tech should be used only when it is
considered inappropriate to use other
antibacterial agents that are commonly recommended for the treatment
of these infections.
• Inhalation Anthrax: postexposure prophylaxis and curative
treatment (see section 4.4)
Levo-Tec