Delorazepam Aurobindo Italia

Package leaflet: Information for the patient

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 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 adverse reaction, including those not listed in this leaflet, contact 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 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

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

Delorazepam Aurobindo Italia is a medicine containing delorazepam, an active substance belonging to the class of benzodiazepines, drugs which reduce anxiety and help sleep. Benzodiazepines are usually used for severe disorders that cause significant distress or interfere with the performance of normal daily activities.
Delorazepam Aurobindo Italia is indicated for the treatment of:

• anxiety, tension, and other anxiety-related disorders;
• insomnia, a condition characterized by difficulty falling asleep or maintaining adequate sleep.

2. What you should know before taking Delorazepam Aurobindo Italia

Do not take Delorazepam Aurobindo Italia if:

• you are allergic to the active substance or to other medicines of the same class (benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
• you have severe respiratory problems;
• you suffer from sleep apnoea syndrome (interruptions in breathing during sleep);
• you have taken large amounts of alcohol or medicines acting on the central nervous system such as hypnotics, analgesics (painkillers), or psychotropic drugs (e.g. neuroleptics, antidepressants, lithium);
• you have myasthenia gravis, a disease characterised by muscle weakness and fatigue;
• you have narrow-angle glaucoma, a condition characterised by increased pressure inside the eye possibly leading to worsening of vision;
• you have severe liver problems;
• you are pregnant or 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 drug or alcohol dependence;
• 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 may cause dizziness, drowsiness, tiredness, fatigue, muscle weakness, and coordination problems, increasing the risk of falls.

Other information

• Mental side effects – contact your doctor if you experience side effects such as restlessness, irritability, agitation, aggressiveness, self-harm, nightmares or hallucinations, changes in behaviour or memory, fainting, or sleepwalking. These side effects are more likely in children and elderly patients.
• Amnesia (partial or complete memory loss) – during treatment with Delorazepam Aurobindo Italia, you may have difficulty remembering recent events or forming new memories (anterograde amnesia), especially a few hours after taking the medicine. To reduce this risk, take Delorazepam Aurobindo Italia immediately before going to bed.
• Dependence – during treatment with Delorazepam Aurobindo Italia, you may develop physical and psychological dependence; this risk increases with higher doses and longer treatment duration, or if you have had psychiatric disorders or drug or alcohol dependence. For this reason, treatment with Delorazepam Aurobindo Italia should be as short as possible.
• Withdrawal syndrome – if you have developed dependence and suddenly stop taking Delorazepam Aurobindo Italia or reduce the dose too quickly, withdrawal symptoms may occur, such as headache, muscle pain, anxiety, tension, restlessness, confusion, and irritability. In severe cases, derealisation and depersonalisation (a distorted perception of the external world or of oneself), numbness and tingling in the extremities, increased sensitivity to light, noise, and physical touch, hallucinations, or epileptic seizures may occur. Other symptoms include depression, sleep disturbances, sweating, persistent ringing in the ears, involuntary movements, vomiting, altered sensation, abdominal or muscle cramps, tremor, muscle pain, agitation, palpitations, increased heart rate, panic attacks, dizziness, increased reflexes, short-term memory loss, and increased body temperature. If you experience these symptoms, consult your doctor.
• Tolerance – contact your doctor if during treatment with Delorazepam Aurobindo Italia you notice a reduced effectiveness or shorter duration of the sedative/sleep-inducing effect.
• Rebound symptoms – treatment with Delorazepam Aurobindo Italia should be discontinued gradually, with a progressive reduction in dose. Abruptly stopping treatment may cause the return or worsening of symptoms (such as insomnia or anxiety) for which the treatment was started (see section 3, “If you stop taking Delorazepam Aurobindo Italia”).

Be cautious when using this medicine, as it may cause serious, life-threatening breathing problems
(respiratory depression) and severe allergic reactions (anaphylactic/anaphylactoid reactions) associated with
swelling of the tongue, larynx, and throat, which may cause breathing or swallowing difficulties (angioedema),
shortness of breath (dyspnoea), throat closure, nausea, and vomiting. These problems have been reported after
taking the first dose or subsequent doses of benzodiazepines. Your doctor will continuously assess the need to
continue treatment and, in case of angioedema, will instruct you not to restart treatment.
Benzodiazepines are not recommended for psychotic disorders and should not be used alone to treat depression or
insomnia associated with depression.
Children and adolescents
Delorazepam Aurobindo Italia must not be administered to patients under 18 years of age without careful
assessment of the actual need for treatment and only under strict medical supervision.
Other medicines and Delorazepam Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as some drugs may interact with Delorazepam Aurobindo Italia or increase the risk of adverse events, even serious ones.
In particular, contact your doctor if you are taking:

• medicines acting on the central nervous system, such as antipsychotics, sedatives, anxiolytics, hypnotics, anaesthetics, sedative antihistamines, narcotic analgesics;
• medicines used for depression (antidepressants);
• medicines used for epilepsy (antiepileptics);
• medicines used to treat bronchial asthma (e.g. theophylline, aminophylline); as these medicines may alter the effect of Delorazepam Aurobindo Italia.

Concomitant use of Delorazepam Aurobindo Italia and opioids (strong painkillers, medicines for addiction treatment, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Delorazepam Aurobindo Italia 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 recommendations regarding dosage. 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.
Delorazepam Aurobindo Italia and alcohol
Do not consume alcohol or medicines containing alcohol during treatment with this medicine, as this may worsen certain side effects affecting the central nervous system (e.g. sedation, drowsiness).
Pregnancy and breastfeeding
Do not take Delorazepam Aurobindo Italia during pregnancy or while breastfeeding.
If you suspect you are pregnant or are planning a pregnancy, consult your doctor before taking this medicine.
Driving and using machines
Delorazepam Aurobindo Italia may cause sedation, memory loss, impaired concentration, and altered muscle function. Exercise particular caution before driving vehicles or operating machinery.
Delorazepam Aurobindo Italia oral drops contain 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 for people suffering from alcoholism or with impaired alcohol metabolism. This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver problems or epilepsy.
Delorazepam Aurobindo Italia oral drops contain 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 have liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor.
Your doctor may perform additional monitoring during treatment.
Delorazepam Aurobindo Italia tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Delorazepam Aurobindo Italia 1 mg tablets contain the colouring agent orange yellow (E110)
This medicine contains the colouring agent orange yellow, 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 exactly as directed by your doctor, who will determine the correct dose and duration of treatment based on the severity of your symptoms and your general condition (for example, if you have liver, kidney or lung problems).
If you have any doubts, consult your doctor or pharmacist.
Your doctor will prescribe the shortest possible duration of treatment.

If you are taking Delorazepam Aurobindo Italia for anxiety
The usual dose is:
1 tablet (0.5 - 1 mg), 2-3 times daily
or
13 - 26 drops, 2-3 times daily.
Your doctor will tell you which tablet strength or how many drops to use.
The treatment duration should not exceed 8-12 weeks.

If you are taking Delorazepam Aurobindo Italia for 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.
Your doctor will tell you which tablet strength or how many drops to use.
The treatment duration 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 orally, 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 it at the same time (Fig. 1).
• Let the drops fall into a glass, holding the bottle in an upright position with the opening facing downwards (Fig. 2).
• To close the bottle: screw the cap tightly until it is securely sealed (Fig. 3).

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

Use in elderly patients and 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 Aurobindo Italia than you should
You may experience drowsiness, fatigue, or difficulty with coordination, visual disturbances such as blurred vision, confusion, and lethargy. In severe cases, symptoms may include deep sleep, unconsciousness, coordination disorders, low blood pressure (hypotension), muscle weakness (hypotonia), breathing difficulties, or coma. Excessive doses of this medicine may also result in death.
In case of accidental ingestion or overdose of Delorazepam Aurobindo Italia, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be required.

If you forget to take Delorazepam Aurobindo Italia
Do not take a double dose to make up for the missed dose. Take the forgotten dose as soon as you remember, then continue your treatment as usual.

If you stop taking Delorazepam Aurobindo Italia
Do not stop treatment with Delorazepam Aurobindo Italia abruptly, as withdrawal symptoms may occur (see section 2, "Other information"). When discontinuation is necessary, your doctor will gradually reduce the dose.

If you have any questions 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 will experience them.
Stop taking Delorazepam Aurobindo Italia immediately and contact your doctor if you experience severe allergic reactions, which may manifest as swelling (angioedema) of the eyes, face, tongue, or throat, accompanied by breathing difficulties, shortness of breath, skin rash possibly with nausea and vomiting, or a sudden drop in blood pressure (anaphylactic reactions) (see section 2, "Other information").

Inform your doctor if, during treatment with Delorazepam Aurobindo Italia, you notice the following:

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 emotional responsiveness;
• 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 eruptions such as patchy, widespread spots or lesions such as blisters;
• disinhibition, excessive happiness (euphoria), thoughts or attempts of suicide;
• reduction in the number of platelets (thrombocytopenia), white blood cells (agranulocytosis), or of all blood components (pancytopenia);
• low blood pressure (hypotension);
• visual disturbances such as double vision (diplopia) or blurred vision;
• nausea or difficulty passing stools (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 excessive release of a hormone called "antidiuretic hormone";
• decreased body temperature (hypothermia).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• changes in appetite;
• low sodium levels in the blood (hyponatremia);
• more or less sudden appearance of skin lesions (skin reactions);
• swelling of the eyes, face, tongue, or throat with breathing difficulties (angioedema);
• hypersensitivity reactions, anaphylactic/anaphylactoid reactions;
• breathing problems such as respiratory depression, breathlessness (apnoea), worsening of nocturnal apnoea, or worsening of pre-existing lung diseases;
• stomach or intestinal problems;
• seizures or epileptic fits, balance disorders, reduced attention or concentration, disorientation;
• anxiety, restlessness, sleep disturbances.

Other side effects (see section 2, "Other information")
Some side effects observed with other benzodiazepines may also occur during treatment with Delorazepam Aurobindo Italia:

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

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 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 special storage conditions.
Do not use this medicine after the expiry date stated on the pack after "EXP.". The expiry date refers to the
last day of that month.
The expiry date applies to the product in its original unopened packaging, stored correctly.
The oral drops should be used within 12 months after first opening the bottle. Any remaining product should be discarded.
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 Delorazepam Aurobindo Italia contains
Delorazepam Aurobindo Italia 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 carboxymethylcellulose, colloidal silica, magnesium stearate, sodium dioctyl sulfosuccinate.

Delorazepam Aurobindo Italia 1 mg tablets

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

Delorazepam Aurobindo Italia 2 mg tablets

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

Delorazepam Aurobindo Italia 1 mg/ml oral drops, solution

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

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

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102 – 21047 Saronno (VA)
Manufacturer
ICE S.p.A., Cantone Moretti, 29, 10015 (TO) – Ivrea – Italy
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG)