MINOCYCLINE 100 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

MINOCYCLINE AS HYDROCHLORIDE

Tilgængelig fra:

RAFA LABORATORIES LTD

ATC-kode:

J01AA08

Lægemiddelform:

CAPSULES

Sammensætning:

MINOCYCLINE AS HYDROCHLORIDE 100 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

RAFA LABORATORIES LTD, JERUSALEM

Terapeutisk gruppe:

MINOCYCLINE

Terapeutisk område:

MINOCYCLINE

Terapeutiske indikationer:

Treatment of infections caused by minocycline-sensitive micro-organisms including acne, gonorrhea and prophylaxis of asymptomatic meningococcal carrie.

Autorisation dato:

2014-11-30

Indlægsseddel

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
MINOCYCLINE 50 MG
MINOCYCLINE 100 MG
CAPSULES
ACTIVE INGREDIENT:
Each capsule of Minocycline 50 mg contains:
Minocycline 50 mg (as Hydrochloride)
Each capsule of Minocycline 100 mg contains:
Minocycline 100 mg (as Hydrochloride)
For the list of the additional ingredients, see section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions,
please refer to your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is active against bacteria susceptible to minocycline,
e.g.: acne.
THERAPEUTIC GROUP: antibiotic medicine belonging to the tetracycline
group.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive (allergic) to the active ingredient, to other
antibiotics of the tetracycline group
(such as tetracycline, doxycycline), or to any of the additional
ingredients the medicine contains
(for the list of the additional ingredients, see section 6).
• You have Systemic Lupus Erythematosus (SLE).
• You are pregnant or breastfeeding.
• You suffer from kidney failure.
• Do not use in children under 12 years of age.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
BEFORE (AND DURING) THE TREATMENT WITH MINOCYCLINE, TELL YOUR DOCTOR
IF:
•
You suffer from myasthenia gravis (a condition manifested by muscular
weakness, difficulty
chewing and swallowing and impaired speech).
•
You suffer or have suffered in the past from impaired function of the
liver or kidneys.
•
You have systemic lupus erythematosus, a condition characterized by a
rash (especially on the
face), hair loss, fever, a feeling of general discomfort and illness,
joint pain - see 'Do not use the
med

Produktets egenskaber

MINOCYCLINE -DL-Feb 2022-03
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
MINOCYCLINE 50 mg
MINOCYCLINE 100 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Minocycline 50 mg contains: 50 mg minocycline (as hydrochloride).
Minocycline 100 mg contains: 100 mg minocycline (as hydrochloride).
3. PHARMACEUTICAL FORM
Capsules.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of infections caused by minocycline-sensitive
micro-organisms including
acne, gonorrhea and prophylaxis of asymptomatic meningococcal carrier.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Unlike earlier tetracyclines, absorption of minocycline is not
significantly impaired by
food or moderate amounts of milk.
_Adults:_
_Routine antibiotic use:_ 200mg daily in divided doses.
_Acne:_ 50mg twice daily (or 100 mg once daily). Treatment should
continue for a
minimum of six weeks. If, after six months, there is no satisfactory
response
minocycline should be discontinued and other therapies considered. If
minocycline is
to be continued for longer than six months, patients should be
monitored at least at
three monthly intervals thereafter for signs and symptoms of hepatitis
or SLE or
unusual pigmentation of the skin. (See other special warnings and
precautions).
_Gonorrhoea:_ In adult males: 200mg initially followed by 100mg every
12 hours for a
minimum of 4 days with post-therapy cultures within 2-3 days. Adult
females may
require more prolonged therapy.
_Prophylaxis of asymptomatic meningococcal carriers:_ 100mg twice
daily for five days,
usually followed by a course of rifampicin.
_PAEDIATRIC POPULATION:_
_Children over 12 years:_ 50mg every 12 hours (or 100 mg once daily).
_Children under 12 years:_ Not recommended.
_ELDERLY_:
_ _
2
Dose selection for an elderly patient should be cautious, reflecting
the greater
frequency of decreased hepatic, renal, or cardiac function, and of
concomitant
disease or other drug therapy.
_ _
_Renal Impairment:_ minocycline may be used at the normal recommended
dosage in
mild to