ALPRALID 1

Israel - English - Ministry of Health

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Active ingredient:
ALPRAZOLAM
Available from:
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
ATC code:
N05BA12
Pharmaceutical form:
TABLETS
Composition:
ALPRAZOLAM 1 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
Therapeutic group:
ALPRAZOLAM
Therapeutic area:
ALPRAZOLAM
Therapeutic indications:
Treatment of symptoms of tension and anxiety, anxiety accompanied by depression and in panic states with or without phobia.
Authorization number:
137 12 28373 00
Authorization date:
2013-10-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

20-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-08-2016

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986

The medicine is dispensed with a doctor's prescription only

Alpralid Tablets

0.25, 0.5, 1 mg

Alpralid 0.25: Each tablet contains:

Alprazolam 0.25 mg

Alpralid 0.5: Each tablet contains:

Alprazolam 0.50 mg

Alpralid 1: Each tablet contains:

Alprazolam 1.00 mg

Inactive ingredients and allergens in the preparation - see section 6.

Read this leaflet carefully in its entirety before taking 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 for the treatment of your

ailment. Do not pass it on to others; it may harm them, even if it

seems to you that their medical condition is similar.

Do not use this medicine in children under 6 years of age.

This medicine is not usually intended for children and adolescents

under 18 years of age. The safety and effectiveness of the medicine

for this age group have not been proven.

This medicine belongs to the benzodiazepines group, which has

special characteristics that require extra caution with its use.

It is especially important to be under close medical surveillance

when taking this medicine.

When taking this medicine, be sure to refer to the doctor after

2-4 weeks, as the treatment is only intended for short durations

(up to 12 weeks, including the time during which the dosage is

reduced until discontinuing use of the medicine).

Prolonged use of the medicine may reduce the effect of the

medicine.

Such use may cause severe dependence, 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.

Occasionally, prolonged use of the medicine can cause changes

in behavior patterns and troublesome thoughts.

Especially in the elderly, care should be taken while walking,

since the medicine impairs alertness and, occasionally,

coordination of body movements, and there is therefore concern

of slipping or falling.

1.

WHAT IS THE MEDICINE INTENDED FOR?

The medicine is intended to relieve anxiety and tension.

Therapeutic group: The active ingredient belongs to the

benzodiazepines group.

2.

BEFORE USING THE MEDICINE:

Do not use the medicine if:

you are pregnant, planning to become pregnant, or are

breastfeeding.

you are sensitive (allergic) to the active ingredient or to any

of the other ingredients contained in the medicine or to other

medicines from the benzodiazepines group.

you suffer from severe muscle weakness (myasthenia gravis),

breathing difficulties, sleep apnea, severe liver disease.

you suffer from closed-angle glaucoma.

Do not use the medicine in children under 6 years of age.

you are taking medicines to treat fungal infections, such as:

ketoconazole and itraconazole.

Special warnings regarding use of the medicine:

Do not use the medicine without consulting the doctor before

commencing treatment, if you are suffering, or have suffered

in the past, from impaired function of: the respiratory system

(e.g., asthma), the eyes (e.g. severe closed-angle glaucoma,

open-angle glaucoma being treated with medications), the liver,

the kidney/urinary tract, if you suffer from epilepsy or spasms.

Do not use the medicine without consulting the doctor before

commencing treatment, if you are suffering, or have suffered in

the past, from addiction to drugs, medicines or alcohol, from

a feeling of depression accompanied by suicidal thoughts, if

you have suffered from a mental disease that required hospital

treatment.

Prolonged use may cause dependence!

Use of this medicine may cause blurring of vision.

If you are sensitive to any food or medicine, especially

benzodiazepines, inform the doctor before taking the

medicine.

If you are scheduled to undergo surgery under general

anesthesia, you must notify the doctor that you are taking

alprazolam.

If you are taking, or if you have recently taken, other

medicines, including non-prescription medicines and nutritional

supplements, tell the doctor or pharmacist. Especially inform

the doctor or pharmacist if you are taking:

medicines which affect the central nervous system (for example:

sedatives, hypnotics, medicines for Parkinson's, epilepsy).

surgical anesthetics.

strong analgesics (propoxyphene, morphine, codeine).

anti-allergics (antihistamines).

medicines for treatment of anxiety and depression (for example,

nefazodone, sertraline, fluvoxamine),

medicines for treatment of cough and cold.

oral contraceptives.

antacids.

antibiotics (for example, erythromycin, clarithromycin).

cimetidine (for ulcer).

rifampicin, isoniazid (for tuberculosis).

zidovudine, ritonavir (for AIDS).

antipsychotics, such as medicines for treatment of schizophrenia

(from the phenothiazines group).

antifungals (ketoconazole, itraconazole).

alcohol.

grapefruit juice – may raise concentrations of Apralid in the

blood.

medicines to lower blood pressure and for treatment of angina

pectoris (diltiazem).

Digoxin (to treat heart conditions), since digoxin level in the

blood may rise when taken in combination with Alpralid.

Use of the medicine and alcohol consumption

During the course of treatment with the medicine, do not consume

wines or alcoholic beverages. Alcohol increases the effect of the

medicine.

Pregnancy and breastfeeding

Consult the doctor if you are pregnant or planning to become

pregnant, since this preparation may harm the unborn baby.

Do not use the medicine if you are breastfeeding.

Driving and use of machines

Use of this medicine may impair alertness, and therefore caution

should be exercised when driving, operating dangerous machinery

or in any activity that requires alertness.

Smoking

If you smoke, inform your doctor before taking this medicine.

Important information about some of the ingredients in this

medicine

This preparation contains lactose which may cause allergic

reaction in people sensitive to lactose.

Alpralid 0.25: Each tablet contains: 97.4 mg lactose.

Alpralid 0.5: Each tablet contains: 97 mg lactose.

Alpralid 1: Each tablet contains: 96.6 mg lactose.

3.

HOW SHOULD YOU USE THE MEDICINE?

Always use according to your 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 recommended dosage is usually: initial dosage is

one 0.25 mg tablet or one 0.5 mg tablet, three times a day. The daily

dosage can be increased up to 1 mg, three times a day.

If a larger dosage is required, the dose given before bedtime can

be increased so as to remain alert during the day.

If you are elderly or suffer from liver or kidney problems, it is

possible to commence with a dosage of 0.25 mg two to three

times daily. The dosage may be increased as required if no side

effects appear.

Do not exceed the recommended dose.

Do not chew! Swallow the tablet with a little water.

If necessary, the tablet can be halved or crushed.

Tests and follow up: During prolonged treatment with this

medicine (if approved by the doctor), blood, urine and liver function

tests should be performed.

Palpitations, vertigo, gastrointestinal discomfort, abdominal pain,

malaise, upper respiratory tract infection, chest pain, back pain,

muscle contractions and cramps, anxiety, derealization, difficulty

passing urine, nasal congestion, hyperventilation, shortness of

breath, increased sweating, involuntary movements, increased

appetite, anorexia, joint pains, limb pains, hot flashes, allergic

rhinitis.

Additional side effects that occur infrequently:

Agitation, motor problems, epilepsy, random ovulation and

menstrual irregularities in women, muscle cramps, weight

changes, elated or excited mood, leading to unusual behaviour,

hallucinations, feeling hostile and angry, abnormal thoughts,

abdominal pains or cramps, upset stomach, hyperactivity, liver

function problems, hepatitis, jaundice, allergic reactions and

anaphylactic shock, increased intraocular pressure, impaired

muscle tone (dystonia), swelling of breasts in men.

Tinnitus, ear pains, dilated pupils, falls, pyrexia, feeling hot

and cold, edema, sluggishness, exhaustion, feeling drunk, chest

tightness, sensation of increased energy, feeling of relaxation,

hangover, lack of control in the legs, muscle stiffness, clumsiness,

loss of consciousness, depressed level of consciousness, sleep

apnea syndrome, sleep talking, stupor, abnormal dreams, apathy,

euphoria, slowness of thought, excessive talkativeness, homicidal

thoughts, suicidal thoughts, uncontrolled impulses, psycho motor

retardation, urinary frequency, choking sensation, nosebleed,

clammy skin, urticaria, high levels of prolactin (hormone) in the

blood, decrease in blood pressure.

Additional side effects that occur at an unknown frequency:

Imbalance in part of the nervous system. Symptoms can include:

rapid heartbeat and uncontrolled blood pressure (dizziness,

fainting).

Serious allergic reaction causing swelling in the face or throat.

Swelling of ankles, soles of the feet or fingers.

If one of these side effects worsens, or should you suffer from

any other side effects not mentioned in this insert, 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 of children and/or infants to

avoid poisoning. Do not induce vomiting unless explicitly instructed

to do so by your doctor.

Do not use the medicine after the expiry date (exp. date) that

appears on the package. The expiry date refers to the last day

of that month.

Store at a temperature below 25°C.

6.

FURTHER INFORMATION:

In addition to the active ingredient, the medicine also contains:

Alpralid 0.25: Lactose, Microcrystalline Cellulose (PH-101),

Pregelatinized Oxidized Potato Starch, Microcrystalline Cellulose

(PH-102), Magnesium stearate, Docusate Sodium, Colloidal

Silicone Dioxide, Sodium Benzoate.

Alpralid 0.5: Lactose, Microcrystalline Cellulose (PH-101),

Pregelatinized Oxidized Potato Starch, Microcrystalline Cellulose

(PH-102), Magnesium stearate, Docusate Sodium, Colloidal

Silicone Dioxide, Sodium Benzoate, Iron Yellow Oxide.

Alpralid 1: Lactose, Microcrystalline Cellulose (PH-101),

Pregelatinized Oxidized Potato Starch, Microcrystalline Cellulose

(PH-102), Magnesium stearate, Docusate Sodium, Colloidal

Silicone Dioxide, Sodium Benzoate, Indigo Carmine (E132).

ּWhat the medicine looks like and the contents of the package:

Alpralid 0.25: An elongated, white-yellowish tablet, with a score

line and "CTS" imprinted on it.

Alpralid 0.5: An elongated, light yellow tablet, with a score line

and "CTS" imprinted on it.

Alpralid 1: An elongated, light blue tablet, with a score line and

"CTS" imprinted on it.

Packs of 10, 20, 30, 60, 100, 1000 tablets are available.

Not all pack sizes may be marketed.

License holder, manufacturer and address: CTS Chemical

Industries Ltd., 3 Hakidma Street, Kiryat Malachi

This leaflet was checked and approved by the Ministry of Health

in 08.2014.

Registration number of the medicines in the

National Drug Registry of the Ministry of

Health: Alpralid 0.25:

1030128371

Alpralid 0.5:

1030228372

Alpralid 1:

1030328373

Alprazolam may cause dependence when taken regularly at high

dosages for a prolonged period.

There may also be a reduction in its effect over time. For these

reasons, the effectiveness of treatment with the medicine is

evaluated at regular intervals. Stay in regular contact with your

doctor, who will determine, in accordance with the periodic

meetings between you, the individualized dosage appropriate

for you.

If you accidentally took a higher dosage, or if a child has

accidentally swallowed the medicine, proceed immediately to a

hospital emergency room and bring the package of the medicine

with you. Possible side effects from an overdose include:

sleepiness, confusion, a feeling of coldness, slurred speech, a

drop in blood pressure and breathing difficulties.

If you forgot to take the medicine at the required time, take a

dose as soon as you remember, unless it is time for the next dose.

Do not take a double dose.

Adhere to the treatment regimen as recommended by the

doctor.

Even if there is an improvement in your health, do not abruptly

discontinue treatment, rather, do so gradually, as per the doctor's

instructions.

There have been isolated cases of withdrawal effects, primarily after

taking high dosages or after prolonged treatment (as authorized

by the doctor). Therefore, if you experience withdrawal symptoms

such as anxiety, restlessness, sleep difficulties or any other effect,

consult the doctor.

Do not take medicines in the dark! Check the label and the dose

each time you take a 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 Alpralid may cause side effects in

some patients. Do not be alarmed when reading the list of side

effects. You may not suffer from any of them.

Discontinue use and refer to a doctor immediately if the following

effects occur:

Treatment with Alpralid can infrequently cause serious behavioral

or psychiatric effects – for example, agitation, restlessness,

aggressiveness, nervousness, violent anger, false beliefs,

nightmares and hallucinations, forgetfulness, confusion,

depression or other inappropriate behavior.

Sudden wheeziness, difficulty in swallowing or breathing,

swollen eyelids, face or lips, rash or itching (especially affecting

the whole body), hives, increased and irregular heart rate, urinary

incontinence and retention.

Refer to a doctor as soon as possible if the following effects

occur:

Hallucinations, skin rash or itching, behavioral changes, fever,

sore throat, mouth or throat ulcers, unusual bleeding, yellowing

of the skin and eyes, muscle weakness, restlessness, irritability,

aggressive behavior, sleep disturbances, spasms, mood changes,

impaired body movement coordination, tremor, tiredness, marked

weakness, memory loss (amnesia), or yellowing of the skin or the

whites of the eyes (jaundice).

Addiction and withdrawal symptoms:

Withdrawal symptoms appear if you discontinue treatment with

Alpralid suddenly, are taking high dosages, are taking the medicine

for prolonged periods, or if you suffer or have suffered from

addiction to alcohol or medicines. This may lead to effects such

as headache, muscle pain, extreme anxiety, tension, restlessness,

confusion, mood changes, sleep difficulties and nervousness.

In severe cases of withdrawal, the following effects may occur:

nausea, vomiting, sweating, abdominal pain, muscle cramps, a

feeling of unreality or detachment, sensitivity to sound, touch or

light, numbness and a tingling sensation in the soles of the feet

and hands, hallucinations, tremor or epileptic fits.

Additional side effects that occur very frequently:

Drowsiness, sleepiness, instability and dizziness.

Additional side effects that occur frequently:

Loss of appetite, increased thirst, disorientation, depression, altered

sex drive (in men and women), difficulty controlling movements

(ataxia), coordination problems, balance problems, memory

problems, speech disturbances, concentration disturbances,

inability to stay awake, apathy, headache, double or blurred vision,

constipation, diarrhea, dry mouth, nausea, vomiting, excessive

production of saliva.

LFL 343 08/14

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