LYRINEL 10 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OXYBUTYNIN CHLORIDE

Available from:

J-C HEALTH CARE LTD

ATC code:

G04BD04

Pharmaceutical form:

TABLETS PROLONGED RELEASE

Composition:

OXYBUTYNIN CHLORIDE 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

JANSSEN CILAG S.P.A., ITALY

Therapeutic group:

OXYBUTYNIN

Therapeutic area:

OXYBUTYNIN

Therapeutic indications:

Once daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Authorization date:

2011-06-30

Patient Information leaflet

SIDE EFFECTS:
In addition to the desired effect of the
medicine, adverse reactions may occur
during the course of taking this medicine,
such as:
Very common side effects (reported in more
than 1 in 10 users):
Dry mouth.
Common side effects (reported in less than
1 in 10 users):
Pain on passing urine, delay when passing
urine, feeling of incomplete emptying of the
bladder; constipation, diarrhea, indigestion,
nausea, vomiting, stomach pain, flatulence,
heartburn; problems sleeping, feeling drowsy,
feeling tired; cough, sore throat, dry throat,
dry nose; change in the way things taste;
dry eyes, blurred vision; dry skin, itchy skin;
dizziness; headache.
Uncommon side effects (reported in less
than 1 in 100 users):
Loss of appetite, more frequent bowel
movements, difficulty swallowing; voice
problems such as hoarseness; flushing, hot
flashes; chest discomfort; water retention;
thirst; rash.
Rare side effects (reported in less than 1 in
1,000 users):
Auditory hallucinations, visual hallucinations;
erection problems; irregular heartbeat,
increased heart rate; convulsions.
Very rare side effects (reported in less than
1 in 10,000 users):
Allergic reaction including hives (skin disease)
or swelling of the face, lips, tongue or throat;
difficulty breathing, feeling agitated, feeling
confused, difficulty remembering; heartbeat
awareness; urinary tract infection; high blood
pressure; mental problems; nasal congestion;
glaucoma; falling.
Side effects that require special attention:
Contact your doctor immediately if you
experience an allergic reaction and difficulties
breathing.
If you take too much of the medicine
(overdose) you may experience: restlessness,
tremor, irritability, confusion, hallucinations,
flushing (usually of the face or neck), fever,
dehydration, heart beat irregularities,
vomiting, and difficulty emptying your bladder
completely. If you have taken an overdose of
the medicine, contact your doctor.
If any of these symptoms occur, seek medical
attention immediately.
In the event that you experience side ef

Summary of Product characteristics

Lyrinel_PI_22_July_12_CL
1
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
ילויב
2012
1.
NAME OF THE MEDICINAL PRODUCT
TRADENAME
LYRINEL 5MG, 10MG
®
INTERNATIONAL NON-PROPRIETARY NAME
Oxybutynin chloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each extended [
_prolonged_
] release tablet contains 5 mg or 10 mg of oxybutynin chloride
3.
PHARMACEUTICAL FORM
Extended [
_prolonged_
] release tablets for oral use:
•
5 mg: Pale yellow, round, tablet with “5 XL” printed on one side
with black ink.
•
10 mg: Pink, round, tablet with “10 XL” printed on one side with
black ink.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Once daily controlled-release tablet indicated for the treatment of
overactive bladder
with symptoms of urge urinary incontinence, urgency and frequency.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
LYRINEL is administered orally once daily.
The recommended starting dose of LYRINEL is 5 or 10 mg once daily.
Dosage may be
adjusted in 5-mg increments to achieve a balance of efficacy and
tolerability (up to a maximum
of 30 mg/day). In general, dosage adjustment may proceed at
approximately weekly intervals.
[
_Patients _
_already _
_taking _
_immediate _
_release _
_oxybutynin _
_may _
_be _
_switched _
_to _
_the _
_nearest _
_equivalent total daily dose of _
LYRINEL.]
Lyrinel_PI_22_July_12_CL
2
LYRINEL must be swallowed whole with the aid of liquids, and must not
be chewed, divided,
or crushed.
LYRINEL may be administered with or without food (see Section 5.2,
Pharmacokinetic
Properties).
ELDERLY
[≥
_65 years old_
]:
Same as for adults.
4.3.
CONTRAINDICATIONS
LYRINEL is contraindicated:
•
- Hypersensitivity to oxybutynin or any of the excipients
•
- Narrow-angle glaucoma or shallow anterior chamber
•
- Myasthenia gravis
•
_- _
Urinary retention
•
- Gastrointestinal obstructive disorder, paralytic ileus or intestinal
atony
•
- Severe ulcerative colitis
•
- Toxic megacolon
•
- Urinary frequency and nocturia due to