Diazepam Aurobindo

Patient Information Leaflet

Diazepam Aurobindo 5 mg/ml oral drops, solution

Equivalent medicinal product
Please read all of 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Diazepam Aurobindo is and what it is used for

Diazepam Aurobindo contains the active substance diazepam, which belongs to the group of anxiolytic benzodiazepine derivatives (used to treat and manage anxiety and distress).
Diazepam Aurobindo is indicated for the treatment of:

• anxiety, tension, and other mental or physical symptoms associated with agitation.
• sleep disorders that make it difficult or impossible to fall asleep or stay asleep (insomnia) in adults.

Diazepam Aurobindo is indicated only when the condition is severe and causes significant disturbance in everyday life.

2. What you should know before taking Diazepam Aurobindo

Do not take Diazepam Aurobindo

• if you are allergic to diazepam, to medicines similar to Diazepam Aurobindo (other benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a muscle disease that may cause weakness and lead to paralysis (severe myasthenia gravis);
• if you have severe respiratory problems, i.e. a condition in which the respiratory system fails to ensure gas exchange and thus maintain adequate levels of oxygen and/or carbon dioxide in the blood (severe respiratory insufficiency);
• if you have severe liver disease (severe hepatic insufficiency);
• if during sleep your breathing stops one or more times or slows down (sleep apnoea syndrome). If you are planning a pregnancy or are pregnant, see section “Pregnancy and breastfeeding”.

Warnings and precautions
Talk to your doctor or pharmacist before using Diazepam Aurobindo.
Treatment with Diazepam Aurobindo must be carried out under medical supervision and should last for the shortest possible duration. Your doctor will prescribe the dose appropriate for your condition to achieve the best results while minimizing the risk of side effects. Treatment will be short-term, and your doctor will explain how to gradually reduce the dose before stopping treatment.
After repeated use of this medicine for several weeks, its effectiveness may decrease (tolerance). If, after several weeks of treatment, you feel that your symptoms have not improved, consult your doctor.
Be especially careful and contact your doctor if:

• you are taking medicines that reduce the activity of the central nervous system, as they may enhance the effects of Diazepam Aurobindo (see section “Other medicines and Diazepam Aurobindo”);
• you have previously abused alcohol or drugs;
• you are elderly. Your doctor may reduce your dose;
• you are debilitated. Your doctor may reduce your dose;
• you have liver or kidney disease;
• you have a brain disorder such as arteriosclerosis (due to reduced blood supply);
• you have heart or lung problems affecting breathing (respiratory insufficiency);
• you have a mental illness. Diazepam Aurobindo is not indicated for the treatment of these disorders;
• you suffer from depression or anxiety associated with depression.

The use of Diazepam Aurobindo may lead to physical and psychological dependence, i.e. an uncontrollable need to continue taking the medicine, as occurs with other drugs similar to diazepam. This risk increases with higher doses and longer treatment duration, and is more common in patients with a history of drug or alcohol abuse, who are more likely to develop habituation and dependence on this medicine.
Once physical dependence has developed, abruptly stopping treatment may result in withdrawal symptoms such as depression, nervousness, mood changes, insomnia, sweating, diarrhoea, headache, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability. In severe cases of withdrawal, derealization (feeling that things are not real), depersonalization (feeling detached from the surrounding environment), sound intolerance (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical touch, hallucinations (seeing or hearing things that do not exist), or epileptic seizures (neurological disturbances causing sudden, uncontrolled movements) may also occur.
After stopping treatment with Diazepam Aurobindo, you may experience worsening insomnia and anxiety (rebound insomnia and rebound anxiety). These symptoms may be accompanied by other adverse effects such as restlessness, mood changes, and sleep disturbances (see section “Possible side effects”).
Since the risk of withdrawal or rebound symptoms is higher after abrupt discontinuation of treatment, your doctor will explain how to gradually reduce the dose before stopping therapy.
If you take Diazepam Aurobindo, you may experience memory disturbances (anterograde amnesia): difficulty remembering past events or learning new information. To reduce this risk, ensure you have an uninterrupted sleep period of 7–8 hours before taking this medicine (see section “How to take Diazepam Aurobindo”).
If any of the following adverse reactions occur, stop taking the medicine and contact your doctor immediately:

• restlessness;
• agitation;
• anxiety;
• irritability;
• aggression;
• delirium (misinterpretation of reality);
• anger;
• nightmares;
• hallucinations (seeing or hearing things that do not exist);
• psychosis (thought disorders);
• behavioural changes. These effects are more common in children and the elderly.

Children
Your doctor will carefully evaluate the use of Diazepam Aurobindo in children and will prescribe it only if strictly necessary. In such cases, treatment duration should be as short as possible.

Other medicines and Diazepam Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking medicines that reduce central nervous system activity, such as:

• antipsychotics, medicines used to treat mental disorders;
• anxiolytics/sedatives, medicines used to treat anxiety and induce sedation;
• antidepressants such as fluvoxamine, fluoxetine, medicines used to treat depression;
• hypnotics, medicines that induce sleep;
• antiepileptics, medicines used to treat epilepsy (a condition characterized by uncontrolled body movements and loss of consciousness);
• narcotic analgesics, medicines used to treat pain;
• anaesthetics, medicines used during surgical procedures to induce sleep;
• antihistamines, allergy medicines that cause drowsiness;
• antifungals such as ketoconazole, medicines used to treat fungal infections;
• medicines used to treat stomach disorders such as omeprazole and cimetidine.

Concomitant use of Diazepam Aurobindo and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, and may be potentially life-threatening. Therefore, concomitant use should only be considered when no other therapeutic options are available.
However, if your doctor prescribes Diazepam Aurobindo together with opioids, the dose and duration of concomitant treatment should be minimized. Inform your doctor about all opioid-containing medicines you are taking and follow their dosage recommendations carefully. It may be helpful to inform friends or family members so they are aware of the signs and symptoms listed above. If you experience these symptoms, contact your doctor.

Diazepam Aurobindo and alcohol
You must not consume alcohol during treatment with Diazepam Aurobindo.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Diazepam Aurobindo during the first 3 months of pregnancy.
If this medicine is prescribed during the late stages of pregnancy or during labour, the newborn may experience low body temperature, reduced muscle tone, and breathing difficulties.
In addition, the newborn may develop physical dependence and may be at risk of experiencing withdrawal symptoms after birth.
Breastfeeding
Since the active ingredient of Diazepam Aurobindo passes into breast milk, do not take Diazepam Aurobindo or do not breastfeed during treatment with Diazepam Aurobindo.

Driving and using machines
Diazepam Aurobindo affects your ability to drive vehicles or operate machinery, as it may cause memory impairment (amnesia), sedation, impaired concentration, and altered muscle function during treatment. The risk of impaired alertness may be increased if sleep duration is insufficient or if alcohol is consumed.

Diazepam Aurobindo contains ethanol
This medicine contains 11.9 vol% ethanol (alcohol), e.g. up to 188 mg per 10 mg dose, equivalent to 4.8 ml of beer or 2 ml of wine. The amount of alcohol in this medicine is unlikely to have an effect in adults and adolescents, and its effects in children are not clearly evident. However, some effects may occur in young children, for example drowsiness. The alcohol in this medicine may alter the effects of other medicines.
Talk to your doctor or pharmacist if you are taking other medicines.
If you have alcohol dependence, talk to your doctor before taking this medicine.

Diazepam Aurobindo contains propylene glycol
This medicine contains 600 mg of propylene glycol per 1 ml.
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, talk to your doctor or pharmacist (see also section “Pregnancy and breastfeeding”).
If you have liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor.

3. How to take Diazepam Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Treatment is started with the lowest recommended dose. Your doctor will monitor you regularly
from the beginning of treatment and will prescribe the dose best suited to your clinical condition.
Do not exceed the maximum dose.
Adults
The recommended dose is 2 mg (10 drops) two or three times daily to 5 mg (25 drops) one or two times
daily.
The maximum dose is 10 mg per day. Do not exceed the maximum dose.
For the treatment of insomnia, take Diazepam Aurobindo just before going to bed.
Duration of treatment
Treatment should be as short as possible.

• Anxiety, tension and other mental or physical symptoms associated with agitation
  The total duration of treatment should not exceed 8–12 weeks, including a period of gradual withdrawal.
• Insomnia
  From a few days to 2 weeks, up to a maximum of 4 weeks, including a period of gradual withdrawal. In certain cases, after reassessing your health status, your doctor may decide to extend the treatment duration indicated above.

Use in elderly or debilitated patients
The recommended dose is 2 mg (or 10 drops) twice daily.
Hospital treatment of anxiety states
The recommended dose is 10–20 mg three times daily.
Children from 2 years of age and adolescents
Diazepam Aurobindo should not be given to children without careful assessment of the actual need for
treatment; the duration of treatment should be as short as possible.
Anxiety
The initial dose and any dose increases will be determined by the doctor according to the child's weight and age.
From 2 to 12 years: The recommended dose is 1–2 mg (or 5–10 drops), three times daily.
Do not exceed the maximum dose.
From 12 to 18 years: The recommended initial dose is 2 mg (10 drops), three times daily. If necessary and tolerated, the dose may be increased up to a maximum of 10 mg (50 drops)
per day. Do not exceed the maximum dose.
Method of administration
Hold the bottle in an upright position with the opening facing downwards to allow the correct dose of
medicinal product to flow out. If the liquid does not flow, shake the bottle or turn it upside down several times and repeat the procedure as indicated above.
Dilute the drops of Diazepam Aurobindo in water or another drink.
Each drop (0.04 ml) of Diazepam Aurobindo contains 0.2 mg of diazepam.
If you take more Diazepam Aurobindo than you should
If you take too much Diazepam Aurobindo, contact your doctor or go to hospital immediately.
An overdose of Diazepam Aurobindo, when taken alone, is rarely life-threatening, unless other substances that depress the central nervous system (including alcohol) are also taken.
If you take an excessive dose of Diazepam Aurobindo, you may experience the following symptoms:

• drowsiness;
• reduced ability to articulate words (dysarthria);
• uncontrolled eye movements (nystagmus);
• reduced alertness;
• confusion;
• deep and prolonged sleep (lethargy);
• progressive loss of muscle coordination making movements difficult (ataxia);
• absence of reflexes (areflexia);
• slowed breathing, up to respiratory arrest (apnea);
• decreased muscle tone (hypotonia);
• low blood pressure (hypotension);
• reduced lung function (respiratory depression);
• prolonged loss of consciousness (coma);
• death.
  Coma (loss of consciousness), if it occurs, usually lasts a few hours but may last longer and may be cyclical, especially in elderly patients. Respiratory depressant effects associated with benzodiazepines are more severe in patients with pre-existing respiratory disorders.

Treatment
Your vital functions (heart rate, respiration, and brain activity) will be monitored and symptoms treated accordingly.
If you are conscious, and within one hour of ingestion, vomiting may be induced, gastric lavage performed, or activated charcoal administered. If necessary, an antidote (a substance that counteracts the effects of the medicine) may be given under close medical supervision.
Your doctor will manage symptoms with specific therapies.
In case of accidental ingestion/overdose of Diazepam Aurobindo, contact your doctor immediately or go to the nearest hospital.
If you forget to take Diazepam Aurobindo
Do not take a double dose to make up for the forgotten dose.
If you stop taking Diazepam Aurobindo
Do not stop treatment with Diazepam Aurobindo abruptly, as withdrawal or rebound symptoms may occur, meaning a worsening of the symptoms that led to starting treatment (see section “Warnings and precautions”).
The dose of Diazepam Aurobindo should be gradually reduced; consult your doctor before stopping treatment.
Do not suddenly replace Diazepam Aurobindo with another similar medicine without first discussing it with your doctor.
If you have any questions 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.
Tell your doctor immediately – the doctor will advise you whether and how to discontinue treatment – if you experience:

• restlessness;
• agitation;
• irritability;
• aggression;
• delusions;
• anger;
• nightmares;
• sensation of seeing or hearing things that do not exist (hallucinations);
• manic episodes (psychosis);
• abnormal behaviour;
• other behavioural side effects.

Tell your doctor immediately – the doctor will explain how to discontinue treatment. These effects are more likely to occur in children and elderly patients.

Other side effects may also occur:

Nervous system effects:

• progressive loss of muscle coordination making movements difficult (ataxia)*;
• difficulty speaking (dysarthria);
• difficulty expressing oneself in words;
• headache*;
• tremors;
• dizziness.

Mental disorder effects:

• confusion*;
• reduced emotional responsiveness*;
• reduced alertness*;
• depression;
• increased or decreased sexual desire;
• drowsiness, even during daytime*;
• difficulty in remembering recent events (anterograde amnesia), which may be associated with inappropriate behaviours;
• dependence (see section “Warnings and precautions”);
• withdrawal symptoms (see section “Warnings and precautions”).

Trauma-related effects:

• falls and fractures.
  The risk of falls and fractures is increased if you are elderly.

Effects related to mouth, stomach and intestine:

• nausea;
• dry mouth or increased salivation;
• constipation;
• other disturbances affecting mouth, stomach and intestine.

Eye-related effects:

• double vision (diplopia)*;
• blurred vision.

Blood vessel-related effects:

• low blood pressure (hypotension);
• inadequate blood flow through the circulatory system (circulatory depression).

Laboratory tests:

• increased transaminase levels and increased alkaline phosphatase, detectable through blood tests.

Kidney and urinary tract effects:

• inability to control urine (incontinence);
• inability to empty the bladder (urinary retention).

Skin effects:

• skin reactions.

Ear-related effects:

• vertigo*.

Heart-related effects:

• irregular heartbeat;
• when the heart does not pump enough blood to meet the body's needs (heart failure), including heart attack (cardiac arrest).

Lung-related effects:

• reduced lung activity, resulting in insufficient oxygen supply to the body (respiratory depression including respiratory failure).

Liver-related effects:

• yellowing of the skin and whites of the eyes (jaundice).

Effects affecting multiple body organs and the site of administration:

• feeling of fatigue*.

Muscle and bone effects:

• muscle weakness*.

* May occur at the beginning of therapy and usually disappear with continued administration.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please tell your doctor. You may 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 Diazepam Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container and label after "EXP". The expiry date refers to the last day of that month.
The product should be used within 3 months of first opening the bottle. Any excess product should be discarded.
This medicine does not require any special storage conditions.
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 Diazepam Aurobindo contains
1 drop (0.04 ml) of Diazepam Aurobindo contains 0.2 mg of diazepam.
1 ml (= 25 drops) contains:

• The active substance is diazepam 5 mg.
• The other components are: ethanol 96%, glycerol, propylene glycol, saccharin, soluble orange flavour, soluble lemon flavour, erythrosine (E 127), purified water.

Description of the appearance of Diazepam Aurobindo and package contents
Pack containing one 20 ml bottle of solution.
Marketing Authorisation 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