DELORAZEPAM 0.5 MG Таблетки

Содержание инструкции

1. Delorazepam Alter 0.5 mg tablets, 1 mg tablets, 2 mg tablets, 0.1% oral drops, solution
   1. What is Delorazepam Alter and what is it used for?
   2. What you need to know before taking Delorazepam Alter
   3. How to take Delorazepam Alter
   4. Possible side effects
   5. How to store Delorazepam Alter
   6. Contents of the pack and other information

Delorazepam Alter 0.5 mg tablets, 1 mg tablets, 2 mg tablets, 0.1% oral drops, solution

Delorazepam

Generic medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Delorazepam Alter is and what it is used for
• 2. What you need to know before you take Delorazepam Alter
• 3. How to take Delorazepam Alter
• 4. Possible side effects
• 5. How to store Delorazepam Alter
• 6. Contents of the pack and other information

1. What is Delorazepam Alter and what is it used for?

Delorazepam Alter contains the active ingredient delorazepam, which belongs to a group of medicines
called benzodiazepines.
Benzodiazepines are used to relieve severe states of anxiety, which subject the individual to severe
discomfort.
This medicine is indicated for the treatment of:

• anxiety, tension and other disorders associated with anxiety
• sleep disorders (insomnia)

2. What you need to know before taking Delorazepam Alter

Do not take Delorazepam Alter

• if you are allergic to the active ingredient, to other similar medicines (benzodiazepines) or to any of the other components of this medicine (listed in section 6)
• if you suffer from myasthenia gravis, a disease that causes muscle weakness and fatigue
• if you suffer from severe respiratory failure
• if you have serious liver problems (hepatic insufficiency)
• if you have problems breathing during sleep (sleep apnea)

Warnings and precautions
Talk to your doctor or pharmacist before taking Delorazepam Alter.
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you are elderly or debilitated (see section 3). In this case, the doctor may decide to reduce the dose
• if you have respiratory problems (respiratory insufficiency). In this case, the doctor may decide to reduce the dose
• if you have serious liver problems (hepatic insufficiency) or suffer from mental confusion due to hepatic insufficiency (hepatic encephalopathy)
• if you have serious kidney problems (renal insufficiency)
• if you suffer from depression or if you have abused alcohol or drugs in the past.

Tolerance:If after a few weeks you feel that the medicine no longer works as well as it did at the beginning of
treatment, consult your doctor.

Dependence:When you take this medicine, there is a risk of dependence, that is, the need to
continue taking the medicine. The risk increases with the dose and duration of treatment. It is
greater if you have suffered from psychiatric disorders in the past or have abused drugs or alcohol.

Withdrawal:When you stop taking Delorazepam Alter, you may experience withdrawal or rebound symptoms (such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion and
irritability), even if you have taken the medicine at the recommended doses and for a short period of time (see
section “If you stop taking Delorazepam Alter”).
In severe cases, the following symptoms may occur: derealization (feeling that things are not
real), depersonalization (feeling of detachment from the surrounding environment), intolerance to sounds
(hyperacusis), numbness and tingling of hands and feet, increased sensitivity to light, noise and
physical contact, hallucinations (seeing and hearing things that do not exist) or epileptic seizures.
When treatment is stopped, a transient syndrome may occur in which the symptoms that led to
treatment with benzodiazepines recur in an aggravated form. It may be accompanied by other reactions,
including mood changes, anxiety, restlessness or sleep disturbances.
To minimize these symptoms, it is recommended to gradually reduce the dose.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine (such as Delorazepam Alter) to a short-acting one. Therefore, such a substitution is not
recommended.

Duration of treatment:The duration of treatment should be as short as possible and should not exceed
4 weeks for the treatment of insomnia and 8-12 weeks for the treatment of anxiety, including a
period of gradual withdrawal.

Amnesia: With the use of benzodiazepines, you may experience episodes of amnesia. To reduce the risk of
amnesia (memory loss), make sure you get 7-8 hours of uninterrupted sleep.

Behavioral reactions: If you experience behavioral disturbances, such as restlessness, agitation,
irritability, aggression, delirium, anger, nightmares, hallucinations (seeing and hearing things that do not exist), psychosis
(a serious condition of the mind in which a person loses contact with reality and the ability to think
and judge clearly), inform your doctor, who will immediately stop taking the
medicine (see section 4 “Possible side effects”). These reactions are more common in children and
the elderly.
Benzodiazepines are not recommended for psychotic illnesses and should not be used alone to
treat depression or insomnia associated with depression, as suicidal thoughts may occur in such patients.
For those who play sports: the use of medicines containing ethyl alcohol may result in positive doping tests in relation to the concentration limits of alcohol indicated by some sports federations.

Children and adolescents
In children and adolescents under the age of 18, Delorazepam Alter should only be used in
cases of absolute necessity and the duration of treatment should be as short as possible.

Other medicines and Delorazepam Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Pay particular attention and tell your doctor if you are taking the following medicines:

• antipsychotics (neuroleptics) and antidepressants, used to treat mental disorders
• hypnotics, medicines used to promote sleep
• anxiolytics, tranquilizers and sedatives, used to treat anxiety
• antiepileptics, used for epilepsy
• antihistamines with a sedative effect, used to treat allergies
• anesthetics, used during a surgical operation
• medicines that increase or decrease the metabolism of delorazepam.
• some strong painkillers (opioids),
• The concomitant use of Delorazepam Alter and opioids (strong analgesics, medicines for the therapy of dependence and some medicines for cough) increases the risk of drowsiness, difficulty in breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Delorazepam Alter together with opioids, the dose and duration of concomitant treatment must be limited by the doctor. Tell your doctor about all the opioid medicines you are taking and carefully follow your doctor's recommendations on the dose. It may be helpful to inform friends or family members to pay attention to the signs and symptoms listed above. Contact your doctor if you experience these symptoms.
• They can cause an increased sense of well-being when taken with Delorazepam Alter. This may increase your desire to continue taking these medicines (dependence)

Delorazepam Alter with alcohol
Avoid drinking alcohol during treatment with this medicine, as it can increase the sedative
effect of the medicine. This negatively affects the ability to drive vehicles and use machinery.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Delorazepam Alter during the first trimester of pregnancy, while in the further period of
pregnancy use this medicine only in cases of actual necessity and under direct medical supervision.
If your doctor believes you should take this medicine in the later stages of pregnancy, your
baby may develop floppy baby syndrome, characterized by low body temperature,
loss of muscle tone, difficulty breathing.
Furthermore, if you have taken Delorazepam Alter regularly during the later stages of pregnancy, your
baby may develop physical dependence and withdrawal symptoms.
If you start treatment with Delorazepam Alter in your fertile age, consult your doctor both if you intend to
become pregnant and if you suspect you are pregnant, because it will be necessary to decide on a possible suspension of
treatment.
Do not take this medicine if you are breastfeeding, as delorazepam passes into breast milk. It is
advisable to stop breastfeeding if the medicine needs to be taken regularly.

Driving and using machines
The use of Delorazepam Alter can affect your ability to drive vehicles and use machinery because
you may feel confused, forgetful, sleepy, with muscle tone problems. These effects increase if
you haven't slept enough. If this happens to you, avoid driving vehicles or using machinery.
Drinking alcohol during treatment with this medicine negatively affects the ability to
drive vehicles and use machinery.

Delorazepam Alter tablets contain:

• lactoseIf your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.
• less than 1 mmol (23mg) of sodiumper dose, i.e. essentially ‘sodium-free’.
• yellow orange S dye (E110)which may cause allergic reactions (only 1 mg tablets).

Delorazepam Alter oral drops contain:

• ethanol (alcohol)This medicine contains 13 vol% of ethanol (alcohol), for example up to 211 mg per dose (2 ml), equivalent to 5.2 ml of beer and 2.16 ml of wine per dose. It may be harmful to alcoholics. To be considered in women during pregnancy or breastfeeding, in children and in high-risk groups, such as people affected by liver or epilepsy diseases.
• propylene glycolThis medicine contains 748 mg of propylene glycol per 1 ml of solution (equal to 26 drops). If the child is less than 5 years old, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol. If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor. The doctor may perform further checks during therapy. If you suffer from liver or kidney diseases, do not take this medicine unless otherwise recommended by your doctor. The doctor may perform further checks during therapy.
• less than 1 mmol (23mg) of sodiumper dose, i.e. essentially ‘sodium-free’.

3. How to take Delorazepam Alter

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must continue to take this medicine until your doctor tells you to stop.
The doctor will adjust the dose according to your needs.

Treatment of anxiety, tension and other disorders associated with anxiety:the dose varies according to your
needs, as prescribed by your doctor:

• tablets: the recommended average dose is 1 tablet of 0.5 mg or 1 mg 2 or 3 times a day.
• drops: the recommended average dose is 13-26 drops, 2 or 3 times a day.

In neuropsychiatry the dose may be increased to 1 tablet of 1-2 mg or 26-52 drops, 2 or 3
times a day, as prescribed by your doctor.
The duration of treatment should be as short as possible and generally should not exceed 8-12
weeks, including a period of gradual discontinuation.
In certain cases, your doctor may decide to prolong the treatment, after assessing your health
conditions.

Treatment of insomnia:the dose varies according to your needs, as prescribed by your doctor:

• tablets: the recommended average dose is 1 tablet of 0.5 mg or 1 mg or 2 mg per day, to be taken in the evening, before going to bed.
• drops: the recommended average dose is 13 drops (corresponding to 0.5 mg of delorazepam) or 26 drops or 52 drops per day to be taken in the evening before going to bed, diluted with a little water.

The duration of treatment should be as short as possible and generally ranges from a few days to 2
weeks, up to a maximum of 4 weeks, including a period of gradual discontinuation.
In certain cases, your doctor may decide to prolong the treatment, after assessing your health
conditions.
Treatment should be started with the lowest recommended dose. The maximum dose should not be
exceeded.
Your doctor will regularly check your condition at the beginning of treatment to decrease, if necessary, the
dose or frequency of intake.

Use in the elderly and people with kidney and liver problems
In the elderly and debilitated patients, a reduced dose should be administered while keeping the patient under
close observation.

If you take more Delorazepam Alter than you should
If you (or someone else) have taken an excessive dose of Delorazepam Alter or if you think a child may
have taken this medicine, immediately notify your doctor or go to the Emergency Room
of the nearest hospital.
An overdose can cause severe depression of the nervous system with symptoms such as drowsiness,
lethargy, mental confusion, fatigue, progressive loss of muscle coordination (ataxia),
reduction of muscle tone (hypotonia), lowering of blood pressure (hypotension), breathing problems
(respiratory depression), depression of the nervous system which can worsen to coma and death.
Bring this leaflet, the bottle and its container to the hospital or doctor so they know
which medicine was taken.

If you forget to take Delorazepam Alter
If you forget to take a dose of the medicine, take it as soon as you remember, unless it is almost
time to take the next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Delorazepam Alter
Do not stop treatment with Delorazepam Alter suddenly or without first agreeing with
your doctor, as withdrawal symptoms may occur.
If your doctor has decided to stop the treatment, they will reduce the dose gradually to minimize the
withdrawal symptoms, such as:

• headache, muscle pain, tension
• severe anxiety, confusion, restlessness, irritability
• in severe cases of withdrawal, derealization (feeling that things are not real), depersonalization (feeling of detachment from the surrounding environment), intolerance to sounds (hyperacusis), numbness and tingling of hands and feet, sensitivity to light, noise and physical contact, hallucinations (seeing and hearing things that do not exist) or seizures may occur.

Treatment should be discontinued gradually otherwise the symptoms for which you were being treated may
reappear even more intensely than before (rebound insomnia and anxiety). The risk of developing these
symptoms is greater when you stop taking Delorazepam Alter suddenly. You may also
experience mood changes, anxiety, restlessness and sleep disturbances.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek immediate medical attention if you experience: depression and behavioural reactions, such as
restlessness, agitation, irritability, aggressiveness, delirium, anger, nightmares, hallucinations (seeing and hearing things
that do not exist), psychosis (a serious mental condition in which a person loses contact with
reality and the ability to think and judge clearly), changes in behaviour. If any of these
side effects occur, treatment should be discontinued. These reactions are more likely to occur in children
and the elderly (see section “Warnings and precautions”).
The following side effects may occur, especially at the beginning of treatment, and usually
disappear with subsequent administrations:

• drowsiness, reduced alertness
• inability to experience emotions
• confusion, fatigue
• headache, dizziness
• muscle weakness, tremors, loss of muscle coordination (ataxia)
• double vision

The following side effects may also occur:

• problems with the stomach and intestines (gastrointestinal disorders), nausea
• decreased sexual desire
• skin diseases, skin rashes
• constipation, urinary incontinence
• tremors, states of excitement
• low blood pressure (hypotension)
• paradoxical states of excitement
• loss of memory (anterograde amnesia) (See section “Warnings and precautions”)
• dependence on the medicine, drug abuse, withdrawal symptoms (see sections “Warnings and precautions” and “If you stop taking Delorazepam Alter”)

Reporting ofside effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Delorazepam Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Oral drops must be used within 12 months of first opening the bottle. Excess product
must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Delorazepam Alter contains
Delorazepam Alter 0.5 mg tablets

• The active ingredient is delorazepam. Each tablet contains 0.5 mg of delorazepam.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylamide, colloidal silicon dioxide, magnesium stearate, sodium dioctylsulfosuccinate.

Delorazepam Alter 1 mg tablets

• The active ingredient is delorazepam. Each tablet contains 1 mg of delorazepam.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylamide, colloidal silicon dioxide, magnesium stearate, sodium dioctylsulfosuccinate, yellow orange S (E110).

Delorazepam Alter 2 mg tablets

• The active ingredient is delorazepam. Each tablet contains 2 mg of delorazepam.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylamide, colloidal silicon dioxide, magnesium stearate, sodium dioctylsulfosuccinate, erythrosine.

Delorazepam Alter 1 mg/ml oral drops, solution

• The active ingredient is delorazepam. 1 ml of solution contains 1 mg of delorazepam (13 drops = 0.5mg).
• The other ingredients are: 96 percent ethanol, glycerol, purified water, Glycasol N, sodium saccharin, propylene glycol.

Description of the appearance of Delorazepam Alter and contents of the pack
Pack containing 20 divisible 0.5 mg tablets in blisters.
Pack containing 20 divisible 1 mg tablets in blisters.
Pack containing 20 divisible 2 mg tablets in blisters.
Pack containing 1 20 ml bottle of oral solution, with screw cap and dropper.

Marketing Authorisation Holder
Laboratori Alter S.r.l., Via Egadi, 7 – 20144 Milano

Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti 29, Località San Bernardo – 10090 Ivrea (TO)
Consorzio Farmaceutico e Biotecnologico Bioprogress-Strada Paduni 240-03012 Anagni (FR)