NOVITROPAN 5 MG TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OXYBUTYNIN HYDROCHLORIDE

Available from:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC code:

G04BD04

Pharmaceutical form:

TABLETS

Composition:

OXYBUTYNIN HYDROCHLORIDE 5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

OXYBUTYNIN

Therapeutic area:

OXYBUTYNIN

Therapeutic indications:

Relief of symptoms associated with voiding in patients with uninhibited neurogenic and reflux neurogenic bladder.

Authorization date:

2014-08-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
Novitropan 5 mg tablets
Each tablet contains: oxybutynin chloride 5 mg
Inactive ingredients and allergens in the preparation – see the
subsection “Important information about some of the ingredients
of the medicine” and section 6.
Read the entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine.
If you have any other questions, refer to the doctor or the
pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them even if it seems to you that their
medical condition is similar.
This medicine is usually not recommended for infants and
children under 5 years of age.
1. What is the medicine intended for?
For the relief of symptoms caused by urinary incontinence (such
as: urgency, frequency, leakage, inability to control the bladder,
difficulty urinating) in adults and children.
Therapeutic class: anticholinergic and antispasmodic.
The medicine works by relaxing the muscles of the bladder and
stopping sudden muscle contractions, and thus helps controlling
the release of urine.
2. Before using the medicine
Do not use this medicine if you have:
•
Sensitivity (allergy) to the active ingredient or to any of
the other ingredients this medicine contains (see section 6).
Signs of an allergic reaction include: rash, swallowing
difficulties or breathing difficulties, swelling of the lips, face,
throat or tongue
•
A rare muscle disease called myasthenia gravis
•
Glaucoma (increased intraocular pressure), sometimes
painful or sudden, accompanied by blurred vision or loss
of vision
•
Blockage, perforation or problem in the function of the gut
(stomach or intestine)
•
Severe ulcerative colitis
•
Sudden widening of the colon which causes abdominal
pain, fever or shock (called toxic megacolon)
•
Blockage in the urinary tract which makes it difficult to pass
urine
Spec