PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed
with a doctor’s prescription only
Introduction to the patient insert for
benzodiazepines
This medicine belongs to the benzodiazepine group,
which has special characteristics that require great
caution with its use.
• It is especially important to be under close medical
surveillance when taking this medicine.
• When you take this medicine, you must refer to your
doctor after 2-4 weeks, as the treatment is intended
for short periods of time only.
• Prolonged use of this medicine may reduce its
effect. Such use may cause a severe dependency
effect, which will make it difficult for the patient to
discontinue taking the medicine.
• Uncontrolled discontinuation of treatment is
accompanied by withdrawal symptoms, such as:
tension, nervousness, confusion, tremor, insomnia,
abdominal pain, vomiting, nausea, sweating,
spasms.
• Especially in elderly patients, it is recommended
that great care be taken while walking, since
the medicine impairs alertness and occasionally
coordination of body movements, and there is
therefore concern of slipping or falling.
XANAGIS 0.25 mg
Tablets
XANAGIS 0.5 mg
Tablets
XANAGIS 1 mg
Tablets
The active ingredient:
Each tablet contains the active ingredient alprazolam in
the amout of 0.25 mg or 0.5 mg or 1 mg.
Each tablet also contains 96 mg lactose monohydrate.
Inactive ingredients: see section 6 in the leaflet.
Read this package insert carefully in its entirety
before using the medicine. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat your medical
condition. 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 not intended for children and adolescents
below the age of 18.
• Xanagis is a tranquilizer containing the active ingredient
alprazolam which belongs to the benzodiazepine group
of medicines. These substances affect the chemical
activity in the brain for promotion of the sleeping
process and reduction of tension and anxiety.
• Xanagis is used only for treatment of severe anxiety and
severe anxiety accompanied by depression. Xanagis is
not recommended for treatment of depression.
• Xanagis should be taken only for short-term treatment
of anxiety. The overall duration of treatment with the
medicine should not exceed 12 weeks, including the
period in which the dosage is gradually tapered.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for treatment of anxiety
accompanied by depression. Treatment of panic states
with or without accompanying phobia.
Therapeutic group: Benzodiazepines.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
• you are sensitive (allergic) to the active ingredient
or to any of the other ingredients contained in the
medicine (see section 6 in the leaflet).
• you are suffering from a disease called myasthenia
gravis characterized by severe muscle weakness.
• you suffer from severe chest problems or breathing
difficulties (e.g., chronic bronchitis or emphysema).
• you suffer from severe liver problems.
• you suffer from sleep apnea – a condition in which
breathing is not regular and even stops for a few
moments during sleep.
• you are pregnant, think you may be pregnant
or are planning to become pregnant or if you
are breastfeeding (see section “Pregnancy and
breastfeeding”).
• in patients suffering from narrow-angle glaucoma.
Use in children and adolescents:
• This medicine is not intended for children and
adolescents below the age of 18.
Special warnings regarding use of the medicine
Before treatment with Xanagis, tell the doctor if:
• you have suffered from severe depression to the point
of suicidal thoughts.
• you have suffered from mental illness that necessitated
in-hospital treatment.
• you suffer from problems with your lungs, kidneys or
liver.
• you have abused drugs or alcohol or you had difficulty
discontinuing medicinal treatment, drinking and use
of drugs. Your doctor may suggest special help when
stopping treatment with these tablets.
• you have been prescribed medicines for severe anxiety
before, because your body can quickly develop
dependence to this type of medicines so that it no
longer helps you.
If you are taking, or have recently taken, other
medicines including non-prescription medicines and
nutritional supplements, tell the doctor or pharmacist.
It is especially important to inform the doctor or pharmacist
if you are taking any of the medicines in the following
list, since the effect of Xanagis may be stronger when it
is taken concomitantly with them:
• Medicines for treatment of anxiety, depression
or medicines that aid sleep (e.g., nefazodone,
fluvoxamine, fluoxetine).
• Strong analgesics (e.g., morphine, codeine or
propoxyphene).
• Antipsychotics used to treat mental illnesses such as:
schizophrenia.
• Medicines for treatment of epilepsy.
• Antihistamines for relief of allergies.
• Antifungals (e.g., ketoconazole).
• Birth control pills.
• Certain antibiotics (e.g., erythromycin).
• Cimetidine (to treat stomach ulcer).
• Diltiazem (to treat angina pectoris and high blood
pressure).
• Ritonavir or other medicines for treatment of AIDS
(HIV).
If you are due to undergo surgery under general anesthetic,
tell the attending doctor or the anesthesiologist that you
are being treated with Xanagis.
Use of the medicine and alcohol consumption
Do not consume any alcohol while using Xanagis, since
alcohol increases the effect of the medicine!!! If you
consume alcohol tell the doctor.
Pregnancy and breastfeeding
Xanagis may harm the developing fetus. Therefore, the
medicine should not be taken if you are pregnant or
planning to become pregnant. If you suspect you may
be pregnant, refer to the doctor immediately.
Do not breastfeed while under treatment with Xanagis
since the medicine may pass into the breastmilk.
Driving and use of machines
Do not drive or operate dangerous machinery while using
the medicine until you find out how the medicine affects
you, since Xanagis may cause a feeling of drowsiness,
confusion, or lack of concentration.
Important information about some of the medicine’s
ingredients
Xanagis contains the sugar lactose monohydrate. If the
doctor has told you about intolerance to certain sugars,
refer to the doctor before starting to use the medicine.
3. HOW SHOULD YOU USE THE MEDICINE?
• Always use according to the doctor’s instructions.
• Check with the doctor or pharmacist if you are
uncertain.
• The dosage and treatment regimen will be determined
by the doctor only. The doctor will tell you how many
tablets to take and when to take them. Information also
appears on the medicine package.
• As a rule of thumb, do not halve the tablet. If you have
a hard time swallowing, you can halve the tablet and
swallow the two halves one after the other.
• Do not take the tablets with an alcoholic beverage.
The dosage of Xanagis to be taken:
Adults:
Generally, treatment will begin with taking one 0.25 mg
or one 0.5 mg tablet 3 times daily. The daily dosage will
therefore include 0.75 mg to 1.5 mg. This dosage can
be raised gradually (every 3-4 days the dose can be
increased by 1 mg) up to a total daily dosage of 3 mg,
divided throughout the day.
When there is a need to raise the dosage, it is customary
to first raise the nighttime dosage before raising the
daytime dosage, in order to ensure you will be more alert
during the course of the day. If you begin to experience
side effects, the doctor may reduce the dosage.
The elderly:
In elderly patients who suffer from kidney or liver problems
and need a lower dosage, the usual starting dosage is 0.25
mg two to three times daily. This dosage can be raised
gradually as needed, and if there are no side effects.
• If you have accidentally taken a higher dosage, you
may experience drowsiness, confusion, a sensation
of cold, inarticulate speech, a drop in blood pressure
and breathing difficulties. If you have taken an
overdose or if a child has accidentally swallowed the
medicine, refer to the doctor immediately or proceed
to a hospital emergency room and bring the package
of the medicine with you.
• Adhere to the treatment as recommended by the
doctor.
• If you forget to take this medicine at the required
time, take the next dose as soon as you remember,
unless it is nearly the time to take the next dose. Do
not take a double dose to compensate for a missed
dose.
• Do not exceed the recommended dose. Do not
increase the dosage without consulting the doctor,
even if you think you are not responding to the
medicine. Benzodiazepines may cause emotion or
physical dependence, even if they were recommended
for your use.
Duration of treatment:
Xanagis is intended for short-term treatment only (no
more than 12 weeks).
Generally, you will not receive a prescription for more
than 4 weeks and you will visit the doctor for regular
check-ups. A decreased effect of the medicine may
develop if used for more than a few weeks.
If you stop taking the medicine:
Even if there is an improvement in your health, do not
stop treatment with the medicine without consulting the
doctor, since the dosage has to be lowered gradually.
If you stop taking the tablets or reduce the dosage all
at once (and not gradually), you may suffer withdrawal
symptoms that may temporarily cause you to be more
anxious or restless or cause sleeping difficulties. These
effects will pass as the body will become readjusted.
If you are concerned about these effects, consult the
doctor in order to receive further information.
Do not take medicines in the dark! Check the label and
the dose each time you take your medicine. Wear glasses
if you need them.
If you have further questions regarding use of the
medicine, consult the doctor or pharmacist.
4. SIDE EFFECTS
As with any medicine, use of Xanagis may cause side
effects in some users. Do not be alarmed when reading
the list of side effects. You may not suffer from any of
them. Side effects can be manifested with different
intensities in different people.
Reasons for discontinuing treatment with Xanagis
immediately:
Refer to the doctor immediately for discontinuation
of treatment if you experience any of the following
symptoms. The doctor will advise you regarding how
to stop the treatment.
• Frequently, treatment with Xanagis may cause
severe behavioral and psychiatric effects such as
emotional upset, restlessness, aggressiveness,
nervousness, violent anger, false beliefs, nightmares
and hallucinations or other unsuitable behavior.
• Sudden wheezing; difficulty swallowing or breathing;
swelling of the eyelids, face or lips; rash or itching
(particularly when affecting the whole body).
Refer to the doctor immediately if you notice any of
the following symptoms, since adjusting the dosage
and the treatment will be necessary:
• Loss of memory (amnesia)
• Yellowing of the skin or whites of the eyes (jaundice)
Symptoms of dependence and withdrawal:
• There is a possibility of developing dependence when
taking medicines such as Xanagis, which increases the
probability of withdrawal effects when discontinuing
treatment.
• Withdrawal effects are more common in the following
cases:
⚪ Abrupt discontinuation of the treatment.
⚪ Taking high dosages.
⚪ Taking the medicine for a prolonged period.
⚪ History of alcohol and drug abuse.
These effects may be expressed by headache, muscle
pain, extreme anxiety, tension, restlessness, confusion,
mood changes, difficulty sleeping and nervousness.
In severe withdrawal cases, the following symptoms
may also occur: nausea; vomiting; sweating; abdominal
cramps; muscle cramps; a feeling of unreality or
detachment; sensitivity to sound, light or touch; numbness
and tingling of the feet and hands; hallucinations (seeing
or hearing things that are not there while you are awake);
tremor or epileptic fits.
Other side effects:
Very common side effects - appear in more than one
user out of ten:
• Feeling tired and drowsy
Common side effects - appear in up to one user out
of ten:
• Loss of appetite
• Confusion and disorientation
• Depression
• Changes in sexual desire (men and women)
• Jerky movements (spasms), uncoordinated
movements
• Balance problems, unsteadiness (drunk feeling)
especially in the course of the day
• Inability to remember bits of information
• Unclear speech
• Lack of alertness or concentration
• Inability to remain awake, a feeling of slowness
• Dizziness
• Headache
• Double or blurred vision
• Constipation, dry mouth, nausea
• Tiredness
• Nervousness
Uncommon side effects - appear in frequency of up to
one user out of one hundred:
• Nervousness, anxiety or emotional upset
• Insomnia (inability to sleep or sleep disturbances)
• Unsteadiness or tremor
• In women – irregular menstruation or overproduction of
prolactin (a hormone that promotes production of milk)
• Muscle cramps or weakness
• Weight changes
• Elated mood or overexcitement, causing unusual
behavior
• Hallucinations (seeing or hearing things that are not
there)
• Feelings of hostility and anger
• Unusual thoughts
• Spastic or jerky movements
• Hyperactivity
• Stomach upsets
• Liver function problems (revealed in blood tests),
inflammation of the liver (hepatitis)
• Skin reactions
• Difficulty passing urine or controlling the urinary
bladder
• Increased pressure in the eyes, which may affect vision
Side effects of unknown frequency - their frequency
cannot be evaluated based on the available data:
• Imbalance to part of the nervous system. The symptoms
may include: rapid heartbeat and unstable blood pressure
(dizziness or weakness)
• Severe allergic reaction causing swelling of the face or
throat
• Swelling of the ankles, feet or toes
• Skin reaction caused by sensitivity to sunlight
If you experience any of these side effects or if any of
the effects worsens, or if you suffer from a side effect not
mentioned in the leaflet, consult the doctor.
5. HOW SHOULD THE MEDICINE BE STORED?
• Avoid poisoning! This medicine and any other medicine
must be kept in a safe place out of the reach and sight
of children and/or infants to avoid poisoning. Do not
induce vomiting unless explicitly instructed to do so by
the doctor.
• Do not use the medicine after the expiry date (exp. date)
that appears on the inner blister pack and the outer
carton package. The expiry date refers to the last day of
that month.
• Keep the inner blister pack safely in the outer package.
• Store in a cool place below 25°C.
Do not discard medicines in the waste water or household
waste. Ask the pharmacist how to get rid of medicines that
are no longer needed. Taking these steps will help preserve
the environment.
6. FURTHER INFORMATION
• In addition to the active ingredient, the medicine also
contains the following inactive ingredients:
Xanagis 0.25 mg:
Lactose monohydrate, Microcrystalline cellulose,
Docusate sodium (85%) + Sodium benzoate (15%),
Colloidal anhydrous silica, Maize starch, Magnesium
stearate
Xanagis 0.5 mg:
Lactose monohydrate, Microcrystalline cellulose,
Docusate sodium (85%) + Sodium benzoate (15%),
Colloidal anhydrous silica, Maize starch, Erythrosine
sodium aluminium lake, Magnesium stearate
Xanagis 1 mg:
Lactose monohydrate, Microcrystalline cellulose,
Docusate sodium (85%) + Sodium benzoate (15%),
Colloidal anhydrous silica, Maize starch, Erythrosine
sodium aluminium lake, F.D. and C. Blue Nr.2 aluminium
lake, Magnesium stearate
• What the medicine looks like and the contents of the
package:
The tablets are supplied in a carton package containing
10/30/50 tablets packed in blisters. Each blister contains
10 tablets.
Xanagis 0.25 mg: oval, white tablets, with a score line on
one side and with “UPJOHN 29” imprinted on the other
side.
Xanagis 0.5 mg: Oval, pink tablets, with a score line on
one side and with “UPJOHN 55” imprinted on the other
side.
Xanagis 1 mg: Oval, light purple tablets, with a score
line on one side and with “UPJOHN 90” imprinted on
the other side.
• The manufacturer, registration holder and address:
Perrigo Israel Pharmaceuticals Ltd., P.O.B. 16,
Yeruham.
• This leaflet was checked and approved by the Ministry
of Health in September 2014.
• Registration numbers of the medicine in the National
Drug Registry of the Ministry of Health:
• Xanagis 0.25 mg:6348.26906
• Xanagis 0.5 mg: 6346.26908
• Xanagis 1 mg: 6347.26907