Delorazepam Alter: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

Delorazepam
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Delorazepam Alter is and what it is used for
What you need to know before taking Delorazepam Alter
How to take Delorazepam Alter
Possible side effects
How to store Delorazepam Alter
Contents of the pack and other information

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

Delorazepam Alter contains the active substance delorazepam, which belongs to a group of medicines called benzodiazepines.
Benzodiazepines are used to relieve severe anxiety states that cause significant distress to the patient.
This medicine is indicated for the treatment of:

anxiety, tension, and other anxiety-related disorders
sleep disorders (insomnia)

2. What you should know before taking Delorazepam Alter

Do not take Delorazepam Alter

if you are allergic to the active substance, to other similar medicines (benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6)
if you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue
if you suffer from severe respiratory insufficiency
if you have severe liver problems (hepatic insufficiency)
if you have breathing difficulties 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 medical supervision in the following cases:

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

Tolerance: If after a few weeks you feel that the medicine is no longer working as well as it did at the beginning of treatment, consult your doctor.
Dependence: Taking this medicine may lead to dependence, meaning a need to continue taking the medicine. The risk increases with higher doses and longer duration of treatment. The risk is greater if you have previously suffered from psychiatric disorders 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 detached from the surrounding environment), intolerance to sound (hyperacusis), numbness and tingling in hands and feet, increased sensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that do not exist), or epileptic seizures.
When stopping treatment, a transient syndrome may occur in which the symptoms that led to benzodiazepine treatment reappear in a worsened 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 substitution is not recommended.
Duration of treatment: The treatment duration should be as short as possible and should not exceed 4 weeks for insomnia and 8–12 weeks for anxiety, including a gradual discontinuation period.
Amnesia: When using benzodiazepines, you may experience episodes of amnesia. To reduce the risk of amnesia (memory loss), ensure an uninterrupted sleep of 7–8 hours.
Behavioral reactions: If you experience behavioral disturbances such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations (seeing or hearing things that do not exist), or psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), inform your doctor, who will immediately discontinue the medicine (see section 4 “Possible side effects”). These reactions are more frequent in children and elderly patients.
Benzodiazepines are not recommended for psychotic disorders and should not be used alone to treat depression or insomnia associated with depression, as suicidal thoughts may occur in such patients.
For those engaged in sports: the use of medicines containing ethyl alcohol may result in positive anti-doping test results, depending on the alcohol concentration limits set by certain sports federations.
Children and adolescents
In children and adolescents under 18 years of age, Delorazepam Alter should be used only in cases of absolute necessity, and the treatment duration should be as short as possible.
Other medicines and Delorazepam Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform 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, tranquillizers, and sedatives, used to treat anxiety
antiepileptics, used for epilepsy
antihistamines with sedative effect, used to treat allergies
anesthetics, used during surgical procedures
medicines that increase or decrease delorazepam metabolism.
some strong painkillers (opioids),
- Concomitant use of Delorazepam Alter and opioids (strong analgesics, medicines for addiction therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not feasible. However, if your doctor prescribes Delorazepam Alter together with opioids, the dose and duration of concomitant treatment must be limited by the doctor. Inform your doctor about all opioid medicines you are taking and carefully follow the doctor’s dosage recommendations. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
- They may 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 and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may enhance the sedative effect of the medicine. This negatively affects your ability to drive vehicles and operate machinery.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Delorazepam Alter during the first trimester of pregnancy. During the remainder of pregnancy, use this medicine only when strictly necessary and under direct medical supervision.
If your doctor considers it necessary for you to take this medicine during the later stages of pregnancy, your baby may develop the floppy infant syndrome, characterized by low body temperature, loss of muscle tone, and breathing difficulties.
Moreover, if you have regularly taken Delorazepam Alter during the later stages of pregnancy, your baby may develop physical dependence and withdrawal symptoms.
If you start treatment with Delorazepam Alter during your fertile years, consult your doctor both if you plan to become pregnant and if you suspect you are pregnant, as it may be necessary to discontinue 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 must be taken regularly.
Driving and using machines
The use of Delorazepam Alter may affect your ability to drive vehicles and operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects are more pronounced if you have not slept enough. If this happens, avoid driving or using machinery.
Consuming alcohol during treatment with this medicine negatively affects your ability to drive vehicles and operate machinery.
Delorazepam Alter tablets contain:

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

Delorazepam Alter oral drops contain:

ethanol (alcohol) This medicine contains 13 vol% ethanol (alcohol), e.g., up to 211 mg per dose (2 ml), equivalent to 5.2 ml of beer or 2.16 ml of wine per dose. It may be harmful to alcoholics. This should be considered in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
propylene glycol This medicine contains 748 mg of propylene glycol per 1 ml of solution (equal to 26 drops). If the child is under 5 years of age, 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. Your doctor may perform additional monitoring during treatment. If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How to take Delorazepam Alter

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must continue taking this medicine until your doctor tells you to stop.
Your doctor will adjust the dose according to your needs.

Treatment of anxiety, tension, and other anxiety-related disorders: 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, taken 2 or 3 times daily.
Oral drops: The recommended average dose is 13–26 drops, taken 2 or 3 times daily.

In neuropsychiatry, the dose may be increased to 1 tablet of 1–2 mg or 26–52 drops, taken 2 or 3 times daily, as prescribed by the doctor.
The duration of treatment should be as short as possible and generally should not exceed 8–12 weeks, including a period of gradual withdrawal.
In certain cases, the doctor may decide to extend the treatment after evaluating your health condition.

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, 1 mg, or 2 mg daily, taken in the evening before going to bed.
Oral drops: The recommended average dose is 13 drops (equivalent to 0.5 mg of delorazepam), 26 drops, or 52 drops daily, taken in the evening before going to bed, diluted with a small amount of 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, the doctor may decide to extend the treatment after evaluating your health condition.
Treatment should be initiated with the lowest recommended dose. The maximum dose must not be exceeded.
Your doctor will regularly monitor your condition at the beginning of treatment to reduce, if necessary, the dose or frequency of administration.

Use in elderly patients and in patients with kidney or liver problems
In elderly and debilitated patients, a reduced dose should be administered, with close monitoring of the patient.

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 suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
Overdose may cause severe depression of the central nervous system, with symptoms such as drowsiness, lethargy, confusion, fatigue, progressive loss of muscle coordination (ataxia), reduced muscle tone (hypotonia), low blood pressure (hypotension), breathing difficulties (respiratory depression), and central nervous system depression that may worsen to coma and death.
Take this leaflet, the bottle, and its container with you to the hospital or doctor so that they know which medicine has been taken.

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

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

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

Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may reappear even more intensely than before (rebound insomnia and rebound anxiety). The risk of developing these symptoms is higher if you stop taking Delorazepam Alter abruptly. You may also experience mood changes, anxiety, restlessness, and sleep disturbances.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience: depression and behavioural reactions such as restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), or changes in behaviour. If any of these side effects occur, treatment must be discontinued. These reactions are more frequent in children and elderly patients (see section “Warnings and precautions”).

The following side effects may occur, especially at the beginning of treatment, and usually disappear with continued administration:

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:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
The expiry date refers to the product stored in its original, intact packaging and kept under proper storage conditions.
Oral drops should be used within 12 months after first opening the bottle. Any excess product should be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Delorazepam Alter contains
Delorazepam Alter 0.5 mg tablets

The active substance is delorazepam. Each tablet contains 0.5 mg of delorazepam.
The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate, sodium dioctyl sulfosuccinate.

Delorazepam Alter 1 mg tablets

The active substance is delorazepam. Each tablet contains 1 mg of delorazepam.
The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate, sodium dioctyl sulfosuccinate, orange yellow S (E110).

Delorazepam Alter 2 mg tablets

The active substance is delorazepam. Each tablet contains 2 mg of delorazepam.
The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate, sodium dioctyl sulfosuccinate, erythrosine.

Delorazepam Alter 1 mg/ml oral drops, solution

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

Description of the appearance of Delorazepam Alter and contents of the package
Pack containing 20 0.5 mg divisible tablets in blister packs.
Pack containing 20 1 mg divisible tablets in blister packs.
Pack containing 20 2 mg divisible tablets in blister packs.
Pack containing 1 20 ml bottle of oral solution, with screw cap and dropper.
Marketing Authorization Holder
Laboratori Alter S.r.l., Via Egadi, 7 – 20144 Milano
Manufacturer
ICE S.p.A. – Canton Moretti 29, Località San Bernardo – 10090 Ivrea (TO)
Consorzio Farmaceutico e Biotecnologico Bioprogress-Strada Paduni 240-03012 Anagni (FR)
January 2026