Tetralysal

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Lymecycline 408mg equivalent to 300 mg tetracycline base

Tillgänglig från:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International namn):

Lymecycline 408 mg (equivalent to 300 mg tetracycline base)

Dos:

300 mg

Läkemedelsform:

Capsule

Sammansättning:

Active: Lymecycline 408mg equivalent to 300 mg tetracycline base Excipient: Erythrosine Gelatin Hydrated silica Indigo carmine Magnesium stearate Quinoline yellow Sulfur dioxide Titanium dioxide

Enheter i paketet:

Blister pack, Polyethylene/Aluminium 28 caps, 28 capsules

Klass:

Prescription

Receptbelagda typ:

Prescription

Tillverkad av:

Olon SpA

Terapeutiska indikationer:

Tetralysal is a broad spectrum antibiotic and is recommended for the treatment of all infections caused by tetracycline sensitive organisms and may be utilised in all conditions where tetracycline therapy is indicated. In common with other tetracyclines it is indicated in penicillin-sensitive patients for the treatment of staphylococcal infections. Typical infections include: Ear, nose and throat infections; Acute and chronic bronchitis (including prophylaxis); Infections of the gastrointestinal and urinary tracts; Non-gonococcal urethritis of chlamydial origin; and other chlamydial infections such as trachoma; acne; rickettsial fevers; soft tissue infections.

Produktsammanfattning:

Package - Contents - Shelf Life: Blister pack, Polyethylene/Aluminium - 28 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 100 capsules - 18 months from date of manufacture stored at or below 25°C

Tillstånd datum:

1964-02-20

Bipacksedel

NEW ZEALAND CONSUMER MEDICINE INFORMATION
TETRALYSAL
®
LYMECYCLINE 300MG CAPSULE
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about TETRALYSAL. Please
read
this leaflet carefully before you start taking the capsules. It does
not contain all the
information available on this medicine. It does not take the place of
talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you
taking TETRALYSAL against the benefits it might have for you.
IF YOU HAVE CONCERNS ABOUT USING THIS MEDICINE ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with your pack of TETRALYSAL. You may wish to read
it again later.
WHAT TETRALYSAL IS USED FOR AND HOW IT WORKS
TETRALYSAL contains an antibiotic used to treat certain infections
such as acne.
The active ingredient in TETRALYSAL is lymecycline, which belongs to
the group of
medicines called tetracyclines. These medicines work by killing or
stopping growth of
bacteria which cause infections.
BEFORE YOU USE TETRALYSAL
_WHEN YOU MUST NOT USE IT _
Do not use TETRALYSAL if:
•
if you have an allergy to lymecycline or medicines containing other
tetracyclines or any of the ingredients listed at the end of this
leaflet;
•
if you have kidney problems. Tell your doctor if you have a condition
affecting
your kidneys;
•
to treat your child if he or she is younger than 8 years old;
•
if you are pregnant or breast feeding;
if you are currently using other medicines commonly referred to as
oral retinoids
(such as isotretinoin) to treat your acne or other skin conditions.
Some of the symptoms of an allergic reaction may include:
•
shortness of breath
2
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue or other parts of the body
•
rash, itching or hives of the skin
•
redness of skin
DO NOT USE TETRALYSAL AFTER THE USE BY (EXPIRY) DATE PRINTED ON THE
PACK OR IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is
damaged,
return it to your pharmacist for disposal.
_

Produktens egenskaper

NEW ZEALAND DATASHEET
1 PRODUCT NAME
TETRALYSAL
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lymecycline capsules 300 mg
3 PHARMACEUTICAL FORM
Yellow
and
red
hard
gelatin
capsules
containing
lymecycline
equivalent
to
300mg
tetracycline base.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Tetralysal is a broad spectrum antibiotic and is recommended for the
treatment of all
infections caused by tetracycline sensitive organisms and may be
utilised in all conditions
where tetracycline therapy is indicated. In common with other
tetracyclines it is indicated in
penicillin-sensitive patients for the treatment of staphylococcal
infections.
Typical infections include: Ear, nose and throat infections; Acute and
chronic bronchitis
(including prophylaxis); Infections of the gastrointestinal and
urinary tracts; Non-gonococcal
urethritis of chlamydial origin; and other chlamydial infections such
as trachoma; acne;
rickettsial fevers; soft tissue infections.
4.2 Dose and method of administration
ADULTS
One capsule morning or night with or without milk or food. The usual
recommended dose for
indications other than acne in the adult is 600 mg/day. Lower doses
may be given for
prophylaxis and for the treatment of recalcitrant acne;
The recommended dose for acne is
300 mg/day. The usual duration of treatment is 12 weeks In the
management of sexually
transmitted diseases both partners should be treated.
It should be taken with an adequate amount of fluid in order to reduce
the risk of esophageal
irritation and ulceration (see section 4.4).
CHILDREN
Tetralysal should not be administered to children under the age of 8
years.
4.3 Contraindications
Hypersensitivity to lymecycline or any other tetracycline or to any of
the excipients.
Tetracyclines are selectively absorbed by developing bones and teeth
and may cause dental
staining and enamel hypoplasia. In addition these compounds readily
cross the placental
barrier and therefore Tetralysal should not be administered to
pregnant women or children
below the age of 8 years. As Tetralysa