DELORAZEPAM 0.5 MG Tabletki

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1. Delorazepam Aurobindo Italia 0,5 mg tablets, 1 mg tablets, 2 mg tablets, 1 mg/ml oral drops, solution
   1. What is Delorazepam Aurobindo Italia and what is it used for
   2. What you need to know before taking Delorazepam Aurobindo Italia
   3. How to take Delorazepam Aurobindo Italia
   4. Possible side effects
   5. How to store Delorazepam Aurobindo Italia
   6. Contents of the pack and other information

Delorazepam Aurobindo Italia 0,5 mg tablets, 1 mg tablets, 2 mg tablets, 1 mg/ml oral drops, solution

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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Delorazepam Aurobindo Italia and what is it used for

Delorazepam Aurobindo Italia is a medicine that contains delorazepam, an active ingredient belonging
to the class of benzodiazepines, drugs that reduce anxiety and help sleep. Benzodiazepines are
usually used for serious disorders, which cause severe discomfort or which prevent the performance of
normal daily activities.
Delorazepam Aurobindo Italia is indicated to treat:

• anxiety, tension and other disorders associated with anxiety;
• insomnia, a condition in which you have difficulty falling asleep or maintaining adequate sleep.

2. What you need to know before taking Delorazepam Aurobindo Italia

Do not take Delorazepam Aurobindo Italia if:

• you are allergic to the active ingredient or to other medicines belonging to the same class (benzodiazepines) or to any of the other ingredients of this medicine (listed in section 6);
• you have severe breathing problems;
• you suffer from sleep apnea syndrome (pauses in breathing during sleep);
• you have taken high doses of alcohol or medicines that act on the central nervous system such as hypnotics, analgesics (pain relievers) or psychotropics (e.g. neuroleptics, antidepressants, lithium);
• you suffer from myasthenia gravis, a disease characterized by muscle weakness and fatigue;
• you have narrow-angle glaucoma, a disease characterized by an increase in pressure inside the eye with possible worsening of vision;
• you have severe liver problems;
• you are pregnant or if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Delorazepam Aurobindo Italia if:

• you have or have had dependencies on drugs or alcohol;
• you have heart problems or suffer from low blood pressure;
• you have severe kidney problems;
• you have liver problems;
• you have had psychiatric disorders;
• you suffer from depression;
• you have suicidal thoughts;
• you have breathing difficulties;
• you are elderly, as this medicine can cause dizziness, drowsiness, fatigue, weakness, muscle weakness and coordination disorders, increasing the risk of falls.

Other information

• Mental side effects- contact your doctor if you experience side effects such as agitation, irritability, restlessness, aggression or self-harm, nightmares or hallucinations, changes in behavior or memory, fainting and sleepwalking. These side effects are more likely in children and the elderly.
• Amnesia(total or partial memory loss) - during therapy with Delorazepam Aurobindo Italia, you may have difficulty remembering recent events or memorizing new information (anterograde amnesia), especially a few hours after taking the medicine. To reduce this risk, take Delorazepam Aurobindo Italia immediately before going to sleep.
• Dependence- during therapy with Delorazepam Aurobindo Italia, you may develop physical and psychological dependence; this risk increases with increasing dose and duration of treatment, or if you have had psychiatric disorders or dependencies on drugs or alcohol. For this reason, therapy with Delorazepam Aurobindo Italia should be as short as possible.
• Withdrawal syndrome- if you have developed dependence and suddenly stop therapy with Delorazepam Aurobindo Italia or reduce the dose too quickly, symptoms due to withdrawal syndrome such as headache, muscle pain, anxiety, tension, restlessness, confusion and irritability may occur. In severe cases, derealization and depersonalization (feeling of perceiving the external world or oneself in an altered way), numbness and tingling of the extremities, increased sensitivity to light, noise and physical contact, hallucinations or epileptic seizures may manifest. Other symptoms are depression, sleep disturbance, sweating, persistent ringing in the ears, involuntary movements, vomiting, changes in sensitivity, abdominal or muscle cramps, tremor, muscle pain, agitation, palpitations, panic attacks, dizziness, increased reflexes, short-term memory loss, increased body temperature. If this condition occurs, see your doctor.
• Tolerance- contact your doctor if during treatment with Delorazepam Aurobindo Italia you notice a reduction in the effectiveness or duration of the sedative/hypnotic effect.
• Rebound symptoms- treatment with Delorazepam Aurobindo Italia should be discontinued gradually, with a progressive reduction in dose. An abrupt interruption of therapy may cause the reappearance or worsening of the symptoms (insomnia or anxiety) for which you started therapy (see section 3, “If you stop taking Delorazepam Aurobindo Italia”). Be careful when using the medicine as it can cause serious breathing problems that are life-threatening (respiratory depression) and serious allergic reactions (anaphylactic/anaphylactoid reactions) associated with swelling of the tongue, larynx and throat that can cause problems with breathing and swallowing (angioedema), shortness of breath (dyspnea), throat closure, nausea and vomiting. These problems have been reported after taking the first or subsequent doses of benzodiazepines. The doctor will continuously assess the need to continue therapy and, in case of angioedema, will tell you not to resume treatment.

Benzodiazepines are not recommended for psychotic illnesses and should not be used alone to treat depression or insomnia associated with depression.

Children and adolescents
Delorazepam Aurobindo Italia should not be given to patients under the age of 18 without careful assessment of the actual need for treatment and only under strict medical supervision.

Other medicines and Delorazepam Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, as some medicines can interact with Delorazepam Aurobindo Italia or increase the risk of adverse events, including serious ones.
In particular, contact your doctor if you are using:

• medicines that act on the nervous system, such as antipsychotics, sedatives, anxiolytics, hypnotics, anesthetics, sedative antihistamines, narcotic analgesics;
• medicines used to treat depression (antidepressants);
• medicines used to treat epilepsy (antiepileptics);
• medicines used to treat asthma (e.g. theophylline, aminophylline); as these medicines can change the effect of Delorazepam Aurobindo Italia.

The concomitant use of Delorazepam Aurobindo Italia and opioids (strong painkillers, medicines for addiction therapy and some medicines for cough) increases the risk of drowsiness, difficulty 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 Aurobindo Italia together with opioids, the dose and duration of concomitant treatment must be limited by the doctor.
Tell your doctor about all opioid medicines you are taking and carefully follow your doctor's recommendations on dosage. It may be helpful to inform friends or relatives to pay attention to the signs and symptoms listed above.
See your doctor if you experience these symptoms.

Delorazepam Aurobindo Italia with alcohol
Do not drink alcohol or take medicines containing alcohol during treatment with this medicine, as this may worsen some side effects on the nervous system (e.g. sedation, drowsiness).

Pregnancy and breastfeeding
Do not take Delorazepam Aurobindo Italia during pregnancy or if you are breastfeeding.
If you suspect or are planning a pregnancy, ask your doctor for advice before taking this medicine.

Driving and using machines
Delorazepam Aurobindo Italia can cause sedation, memory loss, impaired concentration and muscle function. Be particularly careful before driving vehicles or using machines.

Delorazepam Aurobindo Italia oral drops contains ethanol (alcohol)
This medicine contains 13 vol% ethanol (alcohol), for example up to 211 mg per dose, equivalent to 5.2 ml of beer and 2.16 ml of wine per dose. This may be harmful to people who suffer from alcoholism or who have a defect in processing alcohol. To be taken into consideration in pregnant or breastfeeding women, children and high-risk groups, such as patients with liver problems or who suffer from epilepsy.

Delorazepam Aurobindo Italia oral drops contains propylene glycol
This medicine contains up to 1.492 mg of propylene glycol per maximum single dose.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor (see section “Pregnancy and breastfeeding”).
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor.
The doctor may perform further checks during therapy.

Delorazepam Aurobindo Italia tablets contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Delorazepam Aurobindo Italia 1 mg tablets contains the colourant yellow orange (E110)
This medicine contains the yellow orange colourant which may cause allergic reactions.

Delorazepam Aurobindo Italia and sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to take Delorazepam Aurobindo Italia

Take this medicine following the instructions of your doctor exactly, who, based on the severity of your
symptoms and your general condition (for example if you have problems with the liver, kidneys, lungs), will establish
the correct dose and duration of treatment.
If you have doubts, consult your doctor or pharmacist.
The doctor will prescribe the shortest possible treatment duration.

If you take Delorazepam Aurobindo Italia because you suffer from anxiety
The usual dose is;
1 tablet (0.5 - 1 mg), 2-3 times a day

or

• 13 - 26 drops, 2-3 times a day.

The doctor will tell you which tablet or how many drops to use.
The duration of treatment should not exceed 8-12 weeks.

If you take Delorazepam Aurobindo Italia because you suffer from insomnia
The usual dose is;
1 tablet (0.5 - 1 - 2 mg), in the evening before going to bed

or

• 13 - 26 - 52 drops, in the evening before going to bed.

The doctor will tell you which tablet or how many drops to use.
The duration of treatment ranges from a few days to 2 weeks, up to a maximum of 4 weeks.

Method of administration
Delorazepam Aurobindo Italia tablets - take the tablets by mouth, swallowing them with a little water.
Delorazepam Aurobindo Italia drops - take the drops of Delorazepam Aurobindo Italia as follows:

• To open the bottle: press down on the cap and unscrew simultaneously (Fig. 1).
• Drop the drops into a glass while holding the bottle in a vertical position with the opening facing downwards. (Fig. 2).
• To close the bottle: screw the cap on tightly (Fig. 3).

Fig. 1Fig. 2Fig. 3
The doctor will adjust the dose according to your needs.

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 Aurobindo Italia than you should, you may notice drowsiness, fatigue or
difficulty with coordination, vision problems such as blurred vision, mental confusion and lethargy. In
severe cases, the following may occur: deep sleep, unconsciousness, coordination disorders, lowering
of blood pressure (hypotension), muscle weakness (hypotonia), difficulty breathing or coma. Excessive doses of
this medicine can also cause death.
In case of accidental ingestion/taking of an excessive dose of Delorazepam Aurobindo Italia, immediately inform
your doctor or go to the nearest hospital, as appropriate measures may be necessary.

If you forget to take Delorazepam Aurobindo Italia
Do not take a double dose to make up for a missed dose. Take the dose you forgot
as soon as you remember and continue with therapy as normal.

If you stop treatment with Delorazepam Aurobindo Italia
Do not abruptly stop treatment with Delorazepam Aurobindo Italia, as withdrawal symptoms may appear
(see section 2, “Other information”). When it is necessary
to discontinue therapy, the doctor will gradually reduce the dose.
If you have any doubts about the use of 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.

Stop taking Delorazepam Aurobindo Italia immediatelyand contact your doctor if you experience severe allergic reactions, which manifest with swelling (angioedema) of the eyes, face, tongue, throat with difficulty breathing, shortness of breath, skin rash with possible nausea, vomiting, a sudden drop in blood pressure (anaphylactic reactions) (see paragraph 2, “Further information”).
Inform your doctor if you notice during therapy with Delorazepam Aurobindo Italia:

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

• loss of coordination of movements (ataxia).

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

• confusion, reduced alertness, reduced emotions;
• increased heart rate (tachycardia);
• muscle weakness, fatigue, tiredness;
• drowsiness, sedation,

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

• changes in sexual desire.

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

• extrapyramidal symptoms including tremors, dizziness, headache, difficulty speaking, amnesia, coma;
• skin rashes such as patchy and widespread spots or lesions such as blisters;
• disinhibition, excessive happiness (euphoria), thoughts or attempts to take your own life;
• reduction in the number of platelets (thrombocytopenia), white blood cells (agranulocytosis) or all blood components (pancytopenia);
• decreased blood pressure (hypotension);
• vision changes such as double vision (diplopia) or blurred vision;
• nausea or difficulty evacuating (constipation);
• patchy hair loss (alopecia);
• involuntary loss of urine (urinary incontinence);
• yellowing of the skin or eyes (jaundice), increased bilirubin, increased liver transaminases, increased alkaline phosphatase;
• SIADH (syndrome of inappropriate antidiuretic hormone secretion), a condition characterized by an increase in a hormone called “antidiuretic hormone”;
• decreased temperature (hypothermia).

Side effects with unknown frequency(frequency cannot be estimated based on available data):

• changes in appetite;
• decreased sodium in the blood (hyponatremia);
• appearance of skin lesions more or less suddenly (skin reactions);
• swelling of the eyes, face, tongue, throat with difficulty breathing (angioedema)
• hypersensitivity reactions, anaphylactic/anaphylactoid reactions;
• breathing problems such as respiratory depression, breathlessness (apnea) or worsening of pre-existing lung diseases;
• stomach or intestinal disorders;
• convulsions or seizures, balance disorders, decreased attention or concentration, disorientation;
• anxiety, agitation, sleep disorders.

Other side effects(see paragraph 2, “Further information”)
Some side effects that have occurred with other benzodiazepines may also occur during treatment with Delorazepam Aurobindo Italia:

• insomnia and anxiety (rebound symptoms);
• dependence and withdrawal syndrome;
• anterograde amnesia;
• mental side effects.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Aurobindo Italia

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP.”. 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 the first opening of 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 the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Delorazepam Aurobindo Italia contains
Delorazepam Aurobindo Italia 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 Aurobindo Italia 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 Aurobindo Italia 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 Aurobindo Italia 1 mg/ml oral drops, solution

• The active ingredient is delorazepam. 1 ml of solution contains 1 mg of delorazepam.
• The other ingredients are: 96 percent ethanol, glycerol, purified water, glycasol N, sodium saccharin, propylene glycol.

Description of the appearance of Delorazepam Aurobindo Italia and contents of the pack
Pack containing 20 divisible tablets of 0.5 mg.
Pack containing 20 divisible tablets of 1 mg.
Pack containing 20 divisible tablets of 2 mg
Pack containing 1 bottle of 20 ml of oral solution.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102 – 21047 Saronno (VA)

Manufacturer
ABC Farmaceutici S.p.A., Canton Moretti 29, Località San Bernardo, 10090 Ivrea (TO)
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG)