PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LORAZEPAM ALTER 1 mg film-coated tablets, 2.5 mg film-coated tablets

Lorazepam
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 their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LORAZEPAM ALTER is and what it is used for

LORAZEPAM ALTER contains the active substance lorazepam, which belongs to a group of medicines called benzodiazepines.
Benzodiazepines are used to relieve severe anxiety states that cause significant distress and impair the patient's normal functioning.
This medicine is indicated:

for the treatment of anxiety, tension, and other anxiety-related disorders;
for the treatment of sleep disorders (insomnia).

2. What you need to know before taking LORAZEPAM ALTER

Do not take LORAZEPAM ALTER

if you are allergic to lorazepam, 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 have severe breathing problems (respiratory failure), for example, severe chronic obstructive pulmonary disease;
if you have breathing difficulties during sleep (sleep apnea);
if you have high eye pressure due to optic nerve disease (narrow-angle glaucoma);
if you have severe liver problems (hepatic insufficiency);
if you suffer from acute intoxication due to alcohol, hypnotic medicines (medicines taken to induce sleep), analgesics (medicines taken to relieve pain), or psychotropic medicines including neuroleptics (medicines used to treat psychosis such as schizophrenia or bipolar disorder), antidepressants, or lithium;
if you are pregnant or breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions
Talk to your doctor or pharmacist before taking LORAZEPAM ALTER.
Avoid taking this medicine if you have alcohol or drug dependence affecting the central nervous system, unless absolutely necessary.
Be cautious when using this medicine, as it may cause severe breathing problems (respiratory depression), severe allergic reactions (anaphylactic reactions) with swelling of the tongue, larynx, and throat (angioedema), shortness of breath (dyspnea), nausea, and vomiting; such reactions may cause airway obstruction which can be fatal, especially if the tongue, throat, or larynx are affected. If you experience angioedema, your doctor must discontinue treatment with benzodiazepines.
Take this medicine with caution and always under medical supervision in the following cases:

if you are elderly or debilitated. In this case, your doctor may decide to reduce the dose or avoid treatment (see section 3 How to take LORAZEPAM ALTER – Use in the elderly).
if you have heart problems (heart failure);
if you have low blood pressure;
if you have breathing or lung problems (chronic respiratory insufficiency);
if you have previously abused alcohol or drugs;
if you have liver problems (hepatic insufficiency) or suffer from mental confusion due to liver failure (hepatic encephalopathy);
if you have severe kidney problems (renal insufficiency).

Tolerance: If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence: While taking this medicine, you may develop dependence, meaning you feel a need to continue taking it. The risk increases with higher doses and longer duration of treatment. The risk is greater if you have previously abused drugs or alcohol. Long-term continuous use is not recommended.
Withdrawal: When you stop taking LORAZEPAM ALTER, you may experience withdrawal or rebound symptoms. This may occur even if you have taken the medicine at recommended doses and for a short period (see section “If you stop taking LORAZEPAM ALTER”).
To minimize these symptoms, you should gradually reduce the dose.
Duration of treatment: The treatment duration should be as short as possible and must not exceed 4 weeks for insomnia treatment, including a gradual withdrawal period, and 8–12 weeks for anxiety treatment, including a gradual withdrawal period.
Amnesia: To reduce the risk of amnesia (memory loss), you must sleep uninterrupted for at least 7–8 hours.
Behavioral reactions: If you experience behavioral disturbances, stop taking the medicine immediately (see section 4. Possible side effects). These reactions are more frequent in children, the elderly, and patients with reduced mental function (organic brain syndrome).
Benzodiazepines should not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.
Children and adolescents
In children under 18 years of age, LORAZEPAM ALTER should be used only when absolutely necessary, and treatment duration should be as short as possible.
Other medicines and LORAZEPAM ALTER
Tell 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 (e.g., clozapine, loxapine), used to treat psychiatric disorders;
hypnotics/tranquilizers/sedatives, medicines used to promote sleep;
anxiolytics, used to treat anxiety;
certain strong painkillers (narcotic analgesics), which may cause a strong sense of well-being when taken with LORAZEPAM ALTER. This may increase your desire to continue taking these medicines (dependence);
antiepileptics, used for epilepsy (e.g., valproate);
anesthetics, used during surgical procedures;
sedating antihistamines, used to treat allergies;
probenecid, used to treat gout; theophylline and aminophylline, used to treat asthma; medicines that inhibit certain liver enzymes (especially cytochrome P450).

Concomitant use of Lorazepam Alter and opioids (strong painkillers, 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 no other therapeutic alternatives are available.
However, if your doctor prescribes Lorazepam Alter together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow your 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.
LORAZEPAM ALTER with 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 or operate machinery.
Pregnancy and breastfeeding
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 LORAZEPAM ALTER during pregnancy, as it may harm your baby.
If your doctor considers it necessary for you to take LORAZEPAM ALTER during the last stages of pregnancy or during labor, your baby may experience low body temperature, loss of muscle tone, low blood pressure, breathing difficulties, and feeding problems.
If LORAZEPAM ALTER has been taken regularly during the last stages of pregnancy, your baby may experience withdrawal symptoms.
Do not take this medicine if you are breastfeeding, as lorazepam passes into breast milk.
Driving and using machines
The use of LORAZEPAM ALTER may impair your ability to drive vehicles or operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle weakness. These effects are worsened if you have not slept enough or if you have consumed alcohol. If this occurs, avoid driving or operating machinery.
LORAZEPAM ALTER contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take LORAZEPAM ALTER

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You should start treatment with the lowest dose prescribed by your doctor. Do not exceed the maximum
recommended dose.
Your doctor will regularly monitor your condition at the beginning of treatment and may reduce the dose or
frequency of administration if necessary.
Treatment of anxiety: The duration of treatment should be as short as possible. Generally, treatment should
not last longer than 8–12 weeks, including a gradual withdrawal period.
Take the highest dose preferably in the evening before going to bed.
In certain cases, your doctor may decide to extend the treatment after evaluating your health status.
The recommended dose is 1 tablet of 1 mg, taken 1–3 times daily, or half or 1 tablet of 2.5 mg, taken 1–3
times daily.
Treatment of insomnia: The duration of treatment should be as short as possible. Treatment duration
generally ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual withdrawal
period.
In certain cases, your doctor may decide to extend the treatment after evaluating your health status.
The recommended dose is 1 tablet of 1 mg or 2.5 mg daily, taken just before going to bed.
Use in elderly patients and in patients with kidney or liver problems
In elderly patients or those with severe kidney or liver problems (renal or hepatic insufficiency), the dosage
should be reduced according to the patient's response.
If you take more LORAZEPAM ALTER than you should
If you (or someone else) have taken an excessive dose of LORAZEPAM ALTER, or if you suspect that a child
has taken this medicine, contact your doctor immediately or go to the nearest hospital.
An overdose may cause profound depression of the central nervous system, with symptoms such as drowsiness,
difficulty speaking (dysarthria), confusion, muscle problems (ataxia, hypotonia), low blood pressure, heart and
circulatory problems (cardiovascular depression), breathing difficulties, coma, or even death.
If you forget to take LORAZEPAM ALTER
Do not take a double dose to make up for the missed dose.
If you stop taking LORAZEPAM ALTER
Do not stop treatment with LORAZEPAM 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;
mood disturbances (dysphoria), dizziness;
nausea, diarrhoea, loss of appetite;
in severe cases of withdrawal, derealization (feeling that things are not real), depersonalization (feeling of detachment from the surrounding environment), intolerance to sound (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise and physical touch, hallucinations (seeing or hearing things that are not real), or seizures.

Other symptoms include: depression, insomnia, sweating, ringing in the ears (persistent tinnitus), involuntary
movements, vomiting, altered sensation in hands and feet (paraesthesia), perceptual disturbances, abdominal
and muscle pain, tremor, muscle inflammation (myalgia), agitation, sensation of increased heartbeat
(palpitations), increased heart rate (tachycardia), panic attacks, vertigo, increased reflexes (hyperreflexia),
short-term memory loss, and increased body temperature (hyperthermia).
Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may
reappear more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms
is higher if you stop taking LORAZEPAM 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 everyone will experience them.
Contact your doctor immediately if you experience:
depression and mental disorders 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), behavioural changes,
anxiety, hostility, excitement, sleep disturbances/insomnia, sexual excitement, sedation, fatigue, drowsiness,
loss of muscle coordination (ataxia), confusion, depression, unmasking of depression, dizziness, changes in
sexual desire, impotence, reduced orgasm.
Treatment must be discontinued if any of these side effects occur. These reactions are more frequent in
children and elderly patients.

Other possible side effects include:
Very common (may affect more than 1 in 10 people):

loss of muscle coordination (ataxia).

Common (may affect up to 1 in 10 people):

reduced alertness, confusion;
reduced emotional responsiveness;
drowsiness, sedation;
increased heart rate (tachycardia);
muscle weakness and asthenia;
fatigue;

Uncommon (may affect up to 1 in 100 people):

altered sexual desire;

Rare (may affect up to 1 in 1,000 people):

disinhibition, euphoria;
suicidal thoughts and suicide attempts;
tremors and muscle rigidity (extrapyramidal symptoms);
dizziness, headache;
difficulty speaking (dysarthria);
memory loss (amnesia) (see section Warnings and precautions); coma;
double or blurred vision and other visual disturbances;
low blood pressure (hypotension);
nausea, constipation;
jaundice (yellowing of the skin and whites of the eyes) and increased liver enzyme levels (transaminases or phosphatases) or bilirubin, due to liver problems;
skin rashes;
decreased platelets or white blood cells (thrombocytopenia, agranulocytosis);
reduction in all blood cells (pancytopenia);
disturbances in antidiuretic hormone secretion (SIADH);
hair loss (alopecia);
reduced body temperature (hypothermia);
urinary incontinence;

Frequency not known (frequency cannot be estimated from the available data):

sudden potentially life-threatening allergic reactions (anaphylactic/anaphylactoid reactions);
swelling of the face, lips, mouth, tongue, or throat which may cause potentially life-threatening difficulty in swallowing or breathing (angioedema);
reduced sodium levels in the blood (hyponatremia);
changes in appetite;
anxiety, agitation;
depression;
sleep disturbances;
seizures, epileptic fits;
balance disorders, attention and concentration problems;
disorientation;
difficulty breathing (respiratory depression, including respiratory failure and worsening of pre-existing obstructive lung disease);
worsening of breathing problems during sleep (apnea);
stomach and intestinal disorders;
skin allergic reactions.

Stopping treatment may lead to dependence on the medicine, resulting in withdrawal or rebound symptoms
(see sections Warnings and precautions and If you stop taking LORAZEPAM ALTER).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://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 LORAZEPAM 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.
Do not store above 25°C.
Do not dispose of any medicine 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 LORAZEPAM ALTER contains
LORAZEPAM ALTER 1 mg film-coated tablets

The active substance is lorazepam. Each tablet contains 1 mg of lorazepam.
The other components are: monohydrate lactose, microcrystalline cellulose, polacrilin potassium, magnesium stearate. Coating: hypromellose, macrogol 6000, titanium dioxide, talc.

LORAZEPAM ALTER 2.5 mg film-coated tablets

The active substance is lorazepam. Each tablet contains 2.5 mg of lorazepam.
The other components are: monohydrate lactose, microcrystalline cellulose, polacrilin potassium, magnesium stearate. Coating: hypromellose, macrogol 6000, titanium dioxide, talc.

Description of the appearance of LORAZEPAM ALTER and contents of the pack
Pack containing 20 divisible tablets of 1 mg.
Pack containing 30 divisible tablets of 1 mg.
Pack containing 20 divisible tablets of 2.5 mg.

Marketing Authorization Holder
Laboratori Alter S.r.l. – Via Egadi, 7 – 20144 Milan
Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto De’ Stampi, 20089 Rozzano (MI)
ICE S.p.A., Canton Moretti 29, 10090 S. Bernardo d'Ivrea (TO)
January 2026