Arrow - Diazepam 2

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Diazepam 2mg

Dostępny od:

Teva Pharma (New Zealand) Limited

INN (International Nazwa):

Diazepam 2 mg

Dawkowanie:

2 mg

Forma farmaceutyczna:

Tablet

Skład:

Active: Diazepam 2mg Excipient: Lactose Magnesium stearate Maize starch Purified water

Sztuk w opakowaniu:

Blister pack, PVC/Al 50 dose units, 50 tablets

Klasa:

Class C5 Controlled Drug

Typ recepty:

Class C5 Controlled Drug

Wyprodukowano przez:

F.I.S. Fabbrica Italiana Sintetici SpA

Wskazania:

Adults: Short term (2-4 weeks) symptomatic treatment of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness. Short term (2-4 weeks) treatment of conditions where anxiety may be a precipitating or aggravating factor e.g. tension headaches or migraine attack. Symptomatic treatment of acute alcohol withdrawal. Muscle spasm. As an adjunct to the control of muscle spasm in tetanus. May be useful in the management of cerebral spasticity in selected cases. As a adjunct to the management of some types of epilepsy, e.g. myoclonus. Premedication. Children: Night terrors and somnambulism. May be useful in controlling tension and irritability in cerebral spasticity in selected cases. As an adjunct to the control of muscle spasm in tetanus. Premedication.

Podsumowanie produktu:

Package - Contents - Shelf Life: Blister pack, PVC/Al 50 dose units - 50 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with PP screw cap 200 tablets - 200 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with HDPE cap with tamper evident ring - 500 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with PP/HDPE child resistant cap & Al seal, 500 tablets - 500 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with PP screw cap 500 tablets - 500 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Data autoryzacji:

2009-01-23

Ulotka dla pacjenta

NEW ZEALAND CONSUMER MEDICINE INFORMATION
ARROW - DIAZEPAM
Diazepam 2mg and 5mg tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ARROW - DIAZEPAM.
It does not contain all of the available information. It does not take
the place of
talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the
risks of
you taking ARROW - DIAZEPAM against the benefits they expect it will
have
for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE. YOU MAY NEED TO READ IT AGAIN.
WHAT ARROW - DIAZEPAM IS USED FOR
ARROW - DIAZEPAM contains diazepam. It belongs to a group of medicines
called benzodiazepines. These medicines are thought to work by their
actions
on brain chemicals.
ARROW - DIAZEPAM is a sedative, muscle relaxant and anticonvulsant,
used
for the following conditions:
•
severe anxiety, occurring alone or related to insomnia or mental
illness
•
tension headaches and migraine attacks where anxiety is the cause or
aggravating factor
•
symptoms of alcohol withdrawal, such as trembling, confusion or
anxiety
•
muscle spasm, including spasms of tetanus or cerebral spasticity
(selected cases)
•
some types of epilepsy
•
premedication
•
night terrors and sleep-walking, especially in children.
Like other benzodiazepines, ARROW - DIAZEPAM is not recommended as
the sole treatment of severe mental illnesses and should not be used
alone to
treat depression.
Your doctor may have prescribed ARROW - DIAZEPAM for another reason.
Ask your doctor if you have any questions about why ARROW - DIAZEPAM
has been prescribed for you.
ARROW - DIAZEPAM is not recommended in children less than 6 months
old.
In general, benzodiazepines should be taken for short periods only
(around 2
to 4 weeks). Continuous long-term use is not recommended unless
advised
by your doctor.
THE USE OF BENZODIAZEPINES MAY LEAD TO DEPENDENCE OF THE MEDICINE.
ARROW - DIAZEPAM is available only with a doctor's pres

Charakterystyka produktu

Version 2.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Arrow – Diazepam 2, tablets, 2 mg
Arrow – Diazepam 5, tablets, 5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg or 5 mg of diazepam.
Excipient with known effect:
lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Arrow - Diazepam 2:
White, round, flat-bevel edged tablet embossed with ‘D2’ on one
side and
breakline on the other side. Each tablet contains diazepam 2 mg.
Arrow - Diazepam 5:
Yellow, round, flat-bevel edged tablet embossed with ‘D5’ on one
side and
breakline on the other side. Each tablet contains diazepam 5 mg.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults_
Short-term (2 to 4 weeks) symptomatic treatment of anxiety that is
severe, disabling or subjecting the
individual to unacceptable distress, occurring alone or in association
with insomnia or short-term
psychosomatic, organic or psychotic illness.
Short-term (2 to 4 weeks) treatment of conditions where anxiety may be
a precipitating or aggravating
factor, e.g. tension headaches or migraine attacks.
Symptomatic treatment of acute alcohol withdrawal.
Muscle spasm. As an adjunct to the control of muscle spasm in tetanus.
May be useful in the management of cerebral spasticity in selected
cases.
As an adjunct to the management of some types of epilepsy, e.g.
myoclonus.
Premedication.
_Children_
Night terrors and somnambulism.
May be useful in controlling tension and irritability in cerebral
spasticity in selected cases.
As an adjunct to the control of muscle spasm in tetanus.
Premedication.
4.2
DOSE AND METHOD OF ADMINISTRATION
This product may not be interchangeable with other products containing
this ingredient in the New
Zealand's market.
Version 2.0
2
ANXIETY STATES
Adults: Usual dose: 2 mg three times daily.
Maximum dose: Up to 30 mg daily in divided doses. Adjusted on an
individual basis.
Insomnia associated with anxiety: 5 to 15 mg before retiring.
The lowest dose which