Lymecycline 408mg capsules

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Download 환자 정보 전단 (PIL)
21-04-2020
Download 제품 특성 요약 (SPC)
02-07-2018
Download 공공 평가 보고서 (PAR)
27-07-2018

유효 성분:

Lymecycline

제공처:

Somex Pharma

ATC 코드:

J01AA04

INN (국제 이름):

Lymecycline

복용량:

408mg

약제 형태:

Oral capsule

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 05010300; GTIN: 15060089610851

환자 정보 전단

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
LYMECYCLINE 408 MG CAPSULES, HARD
Lymecycline
200 mm
350 mm
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. See section 4.
WHAT IS IN THIS LEAFLET
1. What Lymecycline Capsule is and what it is
used for
2. What you need to know before you take
Lymecycline Capsules
3. How to take Lymecycline Capsules
4. Possible side effects
5. How to store Lymecycline Capsules
6. Contents of the pack and other information
1. WHAT LYMECYCLINE CAPSULE IS AND WHAT IT
IS USED FOR
Lymecycline belongs to a group of medicines
called tetracycline antibiotics.
The main use of Lymecycline is to treat acne.
Acne appears as blackheads and whiteheads
which people often refer to as pimples or
spots.
Lymecycline attacks the bacteria that are one
of the main causes of acne. The name of these
bacteria is propionibacterium acnes.
This medicine can also be used to treat many
other infections caused by bacteria. If you are
not sure why you have been prescribed this
medicine, talk to your doctor.
You must talk to a doctor if you do not feel
better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LYMECYCLINE CAPSULES
DO NOT TAKE LYMECYCLINE CAPSULES
t
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tetracycline antibiotics such as doxycycline
or any of the other ingredients of this
medicine (listed in section 6). An allergic
reaction may include either a rash or itching
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pregnant or are breast-feeding
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Lymecycline capsules must not be given t
                                
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제품 특성 요약

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lymecycline 408mg Capsules, Hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 408mg of Lymecycline equivalent to 300mg
tetracycline base.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, Hard.
Hard gelatin capsule, red cap and yellow body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lymecycline is indicated for the treatment of infections caused by
tetracycline
sensitive organisms (please see section 4.4 and 5.1) including the
following:
• Acne
• Ear, nose and throat infections
• Acute exacerbation of chronic bronchitis
• Gastro-intestinal infection
• Urinary tract infection
• Non-gonococcal urethritis
• Trachoma
• Rickettsial fever
• Soft tissue infection
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ Posology: _
Adults:
The usual dosage for the chronic treatment of acne is 1 capsule daily:
treatment
should be continued for at least 8 weeks.
For other infections, the usual dosage is 1 capsule b.d. If higher
doses are
required, 3-
4 capsules may be given over 24 hours. Lower doses may be given for
prophylaxis.
In the management of sexually transmitted disease both partners should
be
treated.
Older people:
As for other tetracyclines, no specific dose adjustment is required.
Paediatric population:
The safety and efficacy of lymecycline in children aged under 12 years
of age
have
not been established. No data are available.
For children over the age of 12 years the adult dosage may be given.
For children under the age of 8 years, see section 4.3.
_ _
_Method of administration: _
Oral use
_WARFARIN: _In healthy male volunteers, the co-administration of
amlodipine does not
significantly alter the effect of warfarin on prothrombin response
time. Co- administration of
amlodipine with warfarin did not change the warfarin prothrombin
response time.
_CYCLOSPORIN: _Pharmacokinetic studies
                                
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