DIAZEPAM 5 mg /Ml Oral Solution

Зміст інструкції

1. Diazepam Aurobindo 5 mg/ml oral drops, solution
   1. What is Diazepam Aurobindo and what is it 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

Diazepam Aurobindo 5 mg/ml oral drops, solution

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Diazepam Aurobindo and what is it used for

Diazepam Aurobindo contains the active ingredient diazepam, which belongs to the group of anxiolytics derived
from benzodiazepines (used to treat and cure states of anxiety and distress).
Diazepam Aurobindo is indicated to treat:

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

Diazepam Aurobindo is indicated only when the disorder is severe and causes discomfort in normal daily
life.

2. What you need to 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 can cause weakness and lead to paralysis (myasthenia gravis);
• if you suffer from severe breathing problems, that is, a condition in which the respiratory system fails to ensure gas exchange and therefore maintain an adequate level of oxygen and/or carbon dioxide in the blood (severe respiratory failure);
• if you suffer from a severe liver disease (severe hepatic insufficiency);
• if your breathing stops one or more times or slows down during sleep (sleep apnea syndrome); If you are planning a pregnancy or if you are pregnant, see paragraph: “Pregnancy and breastfeeding”

Warnings and precautions
Talk to your doctor or pharmacist before using Diazepam Aurobindo.
Therapy with Diazepam Aurobindo must be carried out under the supervision of the doctor and its duration must
be as short as possible. The doctor will prescribe the dose suitable for your case to obtain the best result
avoiding the onset of side effects. The treatment will be of limited duration and the doctor will explain how to
gradually reduce the dose until discontinuation.
Following repeated use of this medicine for a few weeks, a decrease in its effectiveness (tolerance) may occur. If, after a few weeks of treatment with this
medicine, you feel that the symptoms are not improving, consult your doctor.
Pay particular attention and consult your doctor if:

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

The use of Diazepam Aurobindo can cause physical and psychological dependence, that is, the uncontrollable need to
continue taking the medicine, as happens with other medicines similar to diazepam. This risk
increases with the dose and duration of treatment and is more frequent in patients with a history of
drug or alcohol abuse, as they are more likely to develop habit and dependence on this medicine.
Once physical dependence has developed, abrupt discontinuation of treatment will be accompanied
by withdrawal symptoms such as depression, nervousness, mood changes, insomnia,
sweating, diarrhea, headache, muscle pain, extreme anxiety, tension, restlessness, confusion and
irritability .In severe cases of withdrawal, derealization (feeling that things are not
real), depersonalization (feeling of detachment from the surrounding environment), intolerance to
sounds (hyperacusis), numbness and tingling of hands and feet, sensitivity to light, noise and contact
physical, hallucinations (seeing and hearing things that do not exist) or seizures (neurological alterations that
cause sudden and uncontrollable movements) may also occur.
Once treatment with Diazepam Aurobindo has been discontinued, insomnia and anxiety may manifest in a more severe form (rebound insomnia and anxiety). These symptoms may be accompanied by other
undesirable effects such as restlessness, mood changes, sleep disturbances (see paragraph “Possible
side effects”).
Since the risk of withdrawal or rebound symptoms is greater after abrupt discontinuation of
treatment, the doctor will explain how to gradually reduce the dose until therapy is discontinued.
If you use Diazepam Aurobindo you may experience memory disorders (anterograde amnesia):
difficulty remembering past events or learning new things. To reduce the risk, before taking this
medicine, make sure you can have a sufficient period of uninterrupted sleep of 7-8 hours (see
paragraph “How to take Diazepam Aurobindo”).
If the following adverse reactions occur, the medicine must be discontinued, therefore contact
your doctor if you experience:

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

Children
The doctor will carefully assess the use of Diazepam Aurobindo in children and will prescribe it only in case of
actual need. In these cases, the duration of treatment must be as short as possible.

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

• antipsychotics, medicines for treating mental disorders
• anxiolytics/sedatives, medicines for treating anxiety and for inducing sedation
• antidepressants such as fluvoxamine, fluoxetine, medicines for treating depression
• hypnotics, medicines that induce sleep
• antiepileptics, medicines for treating epilepsy (a disease characterized by uncontrolled body movements and loss of consciousness)
• narcotic analgesics, medicines for treating pain
• anesthetics, medicines used during surgical operations to make you fall asleep
• antihistamines, medicines for treating allergies that cause drowsiness.
• antifungals such as ketoconazole, medicines used to treat infections caused by fungi
• medicines used to treat stomach disorders such as omeprazole and cimetidine

The concomitant use of Diazepam Aurobindo and opioids (powerful painkillers, medicines for
substitute therapy and some medicines for cough) increases the risk of drowsiness, breathing difficulties
(respiratory depression) and coma, and is potentially life-threatening. For this reason, it is necessary
to consider the concomitant use only when other therapeutic options are not possible.
However, if the doctor prescribes Diazepam Aurobindo together with opioids, he must limit the dose
and duration of concomitant treatment. Tell your doctor all opioid-based medicines you are taking and follow
his recommendations regarding the dose carefully. It may be helpful to
inform friends or relatives so that they are aware of the signs and symptoms mentioned above. If
you experience these symptoms, contact your doctor.

Diazepam Aurobindo with alcohol
You must not drink alcohol during treatment with Diazepam Aurobindo.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before being prescribed this medicine.
Pregnancy

Do not take Diazepam Aurobindo in the first 3 months of pregnancy.
If this medicine is prescribed during the last period of pregnancy or during labor, the
newborn may experience a lowering of body temperature, reduced muscle tone and
difficulty breathing.
In addition, the newborn may develop physical dependence and present a certain risk of developing withdrawal symptoms
after birth.
Breastfeeding
Since the active ingredient of Diazepam Aurobindo passes into breast milk, do not take Diazepam
Aurobindoor do not breastfeedduring treatment with Diazepam Aurobindo.

Driving and using machines
Diazepam Aurobindo alters the ability to drive vehicles, to use machinery because during treatment
amnesia (a memory disorder), sedation, alteration of concentration and
muscle function may occur. Also, if the duration of sleep is insufficient or if alcohol is taken, the risk
that vigilance is altered may be increased.

Diazepam Aurobindo contains ethanol
This medicine contains 11.9% vol of ethanol (alcohol), e.g. up to 188 mg per 10 mg dose,
equivalent to 4.8 ml of beer, 2 ml of wine. The amount of alcohol in this medicine does not seem to have an effect
on adults and adolescents and its effects in children are not evident. Some effects may occur in
small children, for example feeling sleepy. 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 an alcohol addiction, 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 less than 5 years old, 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 paragraph “Pregnancy
and breastfeeding”).
If you suffer from liver or kidney diseases, do not take this medicine unless otherwise
recommended by your doctor.

3. How to take Diazepam Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Treatment is started with the lowest recommended dose. Your doctor will regularly monitor you
from the start of treatment and will prescribe the dose most suitable for your clinical condition.
Do not exceed the maximum dose.

Adults
The recommended dose is from 2 mg (10 drops) two or three times a day to 5 mg (25 drops) once or twice a
day.
The maximum dose is 10 mg per day. Do not exceed the maximum dose.
In 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 manifestations associated with a state of agitationThe overall duration of treatment should not exceed 8-12 weeks, including a period of gradual discontinuation.
• InsomniaFrom a few days to 2 weeks, up to a maximum of 4 weeks, including a period of gradual discontinuation. In certain cases, the doctor, after re-evaluating your health status, may decide to extend the treatment duration indicated above.

Use in the elderly or debilitated patients
The recommended dose is 2 mg (or 10 drops) twice a day.

Hospital treatment of anxiety states
The recommended dose is 10-20 mg three times a day.

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 increases will be established by the doctorbased on the child's weight and age.
From 2 to 12 years: the recommended dose is 1-2 mg (or 5-10 drops), three times a day.
Do not exceed the maximum dose.
From 12 to 18 years: the recommended initial dose is 2 mg (10 drops), three times a day. If necessary
and if tolerated, it is possible to increase the dose up to a maximum of 10 mg (50 drops)
per day. Do not exceed the maximum dose.
Method of administration
Hold the bottle upright with the opening facing down to allow the correct dose of medicine to descend. If the liquid does not descend, shake the bottle or turn it over several times and repeat
the operation as indicated above.
Dilute the drops of Diazepam Aurobindo in water or another beverage.
Each drop(0.04 ml) of Diazepam Aurobindo contains 0.2 mg of diazepam.

If you use more Diazepam Aurobindo than you should
If you use an excessive dose of Diazepam Aurobindo, contact your doctor or go to hospital immediately.
An excessive dose of Diazepam Aurobindo, if taken alone, is rarely life-threatening, unless there is
concurrent use of other substances that act in a way that depresses the
central nervous system (including alcohol).
If you use excessive doses of Diazepam Aurobindo, you may experience the following symptoms:

• drowsiness,
• reduced ability to articulate words (dysarthria),
• involuntary eye movements (nystagmus),
• loss of lucidity,
• mental confusion,
• deep and continuous sleep (lethargy),
• progressive loss of muscle coordination making movements difficult (ataxia),
• loss of reflexes (areflexia)
• slowing, up to cessation, of breathing (apnea)
• decreased muscle tone (hypotonia),
• lowering of blood pressure (hypotension),
• decreased lung activity (respiratory depression),
• prolonged loss of consciousness (coma),
• death. Coma (loss of consciousness), if it occurs, usually lasts for a few hours but can last longer and be cyclic, especially in elderly patients. The depressive respiratory effects associated with benzodiazepines are more severe in patients with respiratory diseases.

Treatment
Your vital functions (heart rate, breathing and brain activity) will be monitored and the
symptoms that have arisen will be treated.
If you are conscious, vomiting will be induced within one hour of taking the drug by gastric lavage or
activated charcoal will be administered, and if necessary, an antidote (a substance that
counteracts the effects of the medicine) will be administered under strict monitoring.
The doctor will control the symptoms with specific therapies.
In case of accidental ingestion/intake of an excessive dose of Diazepam Aurobindo, immediately warn
your doctor or go to the nearest hospital.

If you forget to take Diazepam Aurobindo
Do not take a double dose to make up for a missed dose.

If you stop taking Diazepam Aurobindo
Donot stop treatment with Diazepam Aurobindo, as withdrawal or
rebound symptoms may occur, i.e. a worsening of the symptoms that prompted the start of treatment (see paragraph
“Warnings and precautions”)
The dose of Diazepam Aurobindo must be reduced gradually; consult your doctor
before stopping treatment.
Do not suddenly replace Diazepam Aurobindo with another similar medicine without first
agreeing with your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately inform your doctorwho will advise you if and how to stoptreatment
if you experience:

• restlessness,
• agitation,
• irritability,
• aggression,
• delusion,
• anger,
• nightmares,
• feeling of seeing or hearing things that do not exist (hallucinations),
• manias (psychosis),
• abnormal behaviour,
• other behavioural side effects. Immediately inform your doctor who will explain how to stoptreatment. These effects are more common in children and the elderly.

Furthermore, the following may occur:

Effects involving the nervous system:
progressive loss of muscle coordination that makes movements difficult (ataxia)*,
difficulty speaking (dysarthria),
difficulty expressing oneself in words,
headache*,
tremors,
dizziness.

Effects involving mental disorders

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

Effects involving trauma

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

Effects involving the mouth, stomach and intestines

• nausea,
• dry mouth or increased saliva production,
• constipation
• other disorders involving the mouth, stomach and intestines.

Effects involving the eye

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

Effects involving blood vessels

• low blood pressure (hypotension),
• when not enough blood flows through the blood vessel system (circulatory depression).

Laboratory tests

• increased levels of transaminases and increased alkaline phosphatase, detectable in blood tests.

Effects involving the kidney and urinary tract

• inability to retain urine (incontinence),
• inability to empty the bladder of urine (urinary retention).

Effects involving the skin

• skin reactions.

Effects involving the ear:

• vertigo*.

Effects involving the heart:

• irregular heartbeat
• when the heart does not pump enough blood to meet the body's needs (heart failure) including heart attack (cardiac arrest). Effects involving the lungs:
• decreased lung activity, which does not send enough oxygen to the body (respiratory depression including respiratory failure).

Effects involving the liver:

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

Effects involving multiple organs of the body and the site of administration:

• feeling of fatigue*.

Effects involving muscles and bones:

• muscle weakness*.

*These may occur at the beginning of therapy and usually disappear with subsequent administrations.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through 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 which is stated on the packaging and label after
“Exp.”.
The expiry date refers to the last day of that month.
The product must be used within 3 months of first opening the bottle. Excess product must
be discarded.
This medicine does not require any special storage conditions.
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 Diazepam Aurobindo contains
1 drop (0.04 ml) of Diazepam Aurobindo contains 0.2 mg of diazepam.
1 ml (= 25 drops) contains:

• The active ingredient is diazepam 5 mg
• The other ingredients are: ethanol 96%, glycerol, propylene glycolsaccharin, soluble orange essence, soluble lemon essence, erythrosine (E 127), purified water.

Description of the appearance of Diazepam Aurobindo and contents of the pack
Pack containing a 20 ml bottle of 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, 10090 S.Bernardo d'Ivrea (TO) - Italy