PATIENT
INFORMATION LEAFLET
Alprazolam 250 microgram Tablets
Alprazolam 500 microgram Tablets
Please read
this entire leaflet carefully before you start using
this medicine.
If you have
further questions, please ask your doctor or your
pharmacist.
This
medicine has been prescribed for you personally and you
should not pass it on to others.
It may harm
them, even if their symptoms are the same as yours.
What is
in your medicine?
The name of
your medicine is Alprazolam Tablets. The tablets are
available in 2 strengths.
Alprazolam
250 microgram Tablets: White, oblong, scored tablets.
Each tablet contains 250 microgram alprazolam as the
active ingredient.
Alprazolam
500 microgram Tablets: Pink, oblong, scored tablets.
Each tablet contains 500 microgram alprazolam as the
active ingredient.
The other
ingredients are docosate sodium, sodium benzoate (E211),
pregelatinised starch, microcrystalline cellulose,
lactose monohydrate, magnesium stearate and colloidal
anhydrous silica. Alprazolam 500 microgram Tablets also
contain erythrosine aluminium lake (E127) - which
consists of erythrosine and aluminium hydroxide.
Alprazolam
tablets are available in blister packs of 60 tablets.
Marketing Authorisation Holder:
What are
Alprazolam Tablets and what are they used for?
Alprazolam
belongs to a group of medicines known as anxiolytics
that are used to treat severe anxiety. It has a rapid
onset on anxiety symptoms such as agitation,
restlessness and tension.
Before
you take this medicine
Do
not take Alprazolam Tablets if:
-
you are allergic to alprazolam or to any of the
other ingredients (see section “What is in your
medicine?”)
-
you suffer from a condition known as sleep
apnoea - where your breathing stops or gets very
shallow whilst you are sleeping
-
you suffer from a weakness of the muscles that
often improves with rest and worsens with
activity (Myasthenia Gravis)
-
you have severe breathing or liver problems
-
You have problems with alcohol or drugs that act
upon the nervous system
-
you are pregnant or breast-feeding.
Take
special care with Alprazolam Tablets and inform your
doctor if:
-
you will be taking the medicine over a period of
several weeks
-
you have a history of alcohol and drug abuse
-
you suffer loss of memory relating to events
that occur after taking your medicine
-
you suffer from mood swings, insomnia,
restlessness, agitation, fits of rage,
nightmares or hallucinations
-
you suffer from a personality disorder
-
you suffer from difficulty in breathing or have
breathing problems
-
you suffer from psychosis - a severe mental
condition characterized by a loss of contact
with reality.
Alprazolam Tablets should be withdrawn gradually.
Alcohol should be avoided whilst being treated with
Alprazolam Tablets since it will increase sedation,
loss of memory and alter your concentration and
muscular function.
This
medicine contains lactose. If you have been told by
your doctor that you have an intolerance to some
sugars, contact your doctor before taking this
medicine.
Pregnancy
Alprazolam Tablets should not be taken if you are
pregnant. If you are planning to become pregnant or
have become pregnant, you should inform your doctor
immediately.
Breast-feeding
Alprazolam Tablets should not be taken if you are
breast-feeding since alprazolam passes into breast
milk.
Driving and use of machines
Alprazolam Tablets may affect your ability to drive
or operate machinery by causing sedation, loss of
memory and alteration of concentration and muscular
function during treatment. If affected, do not drive
or operate machinery and consult your doctor.
Are
you taking any other medicines?
Please
inform your doctor or pharmacist if you are taking
or have recently taken any other medicines, even
those not prescribed.
You
should especially inform your doctor if you are
taking any of the following:
-
medicines affected by cytochrome P450 enzyme
(e.g. Diltiazem)
-
medicines known as antifungals that treat fungal
infections (e.g. Itraconazole and Ketoconazole)
-
medicines used to treat infection (e.g.
Erythromycin or Troleandomycin)
-
medicine used to treat depression (e.g.
Fluoxetine, Nefazodone, Fluvoxamine, Imipramine,
Desipramine or Sertraline)
-
medicine used to lower the immune system in
order to prevent organ rejection (e.g.
Ciclosporin)
-
medicine used for the treatment of AIDS
-
medicine used to relieve mild pain (e.g.
Dextropropoxyphen)
-
oral contraceptives
-
medicine used to treat epilepsy (e.g.
Carbamazepine)
-
medicine used to treat ulcers (e.g. Cimetidine)
-
medicine used for schizophrenia (e.g. Clozapine)
-
medicine used for the treatment of heart failure
and abnormal heart rhythms (e.g. Digoxin)
-
medicine used to prevent and treat wheezing,
shortness of breath and difficulty in breathing
caused by asthma and other breathing conditions
(e.g. Theophylline)
-
medicines used to prevent blood clotting (e.g.
Warfarin).
Caution
should be exercised when taking Alprazolam Tablets
with painkillers (known as narcotic analgesics),
since this could bring an exaggerated feeling of
mental and physical well-being and also lead to
dependence.
There
will be an increased muscle relaxing effect if
Alprazolam Tablets are taken with a muscle relaxant.
Please read
the back of this leaflet
How to
take your medicine
Please take
your tablets according to your doctor’s instructions.
Your doctor will tell you how long your treatment will
last.
Alprazolam
Tablets are taken orally with some fluid. They can be
taken with or without food. Your overall treatment
should not last more than 8-12 weeks including the
tapering off process.
Adults:
The
initial dose is 250 microgram - 500 microgram three
times a day.
The
maintenance dosage is 500 microgram - 3mg per day in
divided doses. The maximum daily dosage of 3mg per
day must not be
exceeded. If you experience side-effects, your
doctor will prescribe a suitable dose for your
specific condition.
Chronic alcoholism & those new to this kind of
medicine:
Your
doctor will prescribe the lowest effective dosage.
Children and adolescents:
Alprazolam Tablets are not recommended for children
and adolescents under 18 years old.
Elderly, sensitive, weakened patients or patients
with liver or kidney problems:
The
initial dose is 250 microgram two to three times a
day. If you experience side-effects, your doctor
will prescribe a suitable dose for your specific
condition.
The
maintenance dosage is 500 microgram - 750 microgram
per day taken in divided doses.
Your
doctor may gradually increase the dosage by a
maximum of 500 microgram every three days if needed.
The maximum daily dose is 750 microgram - 1.5mg.
Discontinuation of treatment:
If your
doctor feels that your treatment should be stopped,
then your dose will be gradually reduced rather than
being immediately stopped.
What
if you forget to take your tablets?
If you
miss a dose do not worry, just ignore it and take
the next dose at the normal time. Do not take two
doses together to make up for the one you have
missed.
What
if you have taken too many tablets?
If you
or anyone else has taken too many tablets, call a
doctor or go to the nearest Accident & Emergency
department immediately. Take this leaflet and any
remaining tablets with you to the hospital.
Possible
side-effects
Like all
medicines Alprazolam Tablets may cause some unwanted
side-effects in some people. Please consult your doctor
if you experience any of the following:
Common (occurring in more
than 1% but less than 10% of patients):
Uncommon (occurring in more
than 0.1% but less than 1% of patients):
-
dizziness
-
uncoordination
-
skin reactions
-
constipation, diarrhoea
-
the sensation of feeling sick (nausea)
-
vomiting
-
blurred vision.
Rare (occurring in more than
0.01% but less than 0.1% of patients):
-
agitation, aggressiveness
-
hallucinations
-
fits of rage
-
nightmares
-
loss of memory (amnesia)
-
sleep disorders.
Very rare (occurring in less
than 0.01% of patients):
-
increased pressure within the eye.
Further
unwanted effects have been reported which include:
reduced alertness, confusion, fatigue, headache, muscle
weakness, lack of appetite for food, weight gain,
difficulty in swallowing, low blood pressure, a
decreased sexual drive, dry mouth, increased salivation,
nasal congestion, rapid heartbeat, difficulty in
concentration, muscle tone abnormality, speech
disturbances, difficulty in passing urine, inability to
control excretion (incontinence), liver problems and a
yellowing of the whites of the eyes & skin (jaundice).
How you
should store this medicine
Do not store
above 30°C.
Store in the
original package.
Do not take
the tablets after the expiry date printed on the carton
and blister.
Please
return any tablets you have not used to the pharmacist.
Keep all medicines out of the reach
and sight of children.
Remember: this medicine has
been prescribed for you personally. Please do not give
it to anyone else. It may harm them, even if they have
the same symptoms as you.