DIAZEPAM 5 mg /Ml Оральные Капли, Раствор

Содержание инструкции

1. DIAZEPAM EG 10 mg/2 ml injectable solution
   1. What is DIAZEPAM EG and what is it used for
   2. What you need to know before using DIAZEPAM EG
   3. How to use DIAZEPAM EG
   4. Possible side effects
   5. How to store DIAZEPAM EG
   6. Package Contents and Other Information
2. DIAZEPAM EG 5 mg/ml oral drops, solution
   1. What is DIAZEPAM EG and what is it used for
   2. What you need to know before taking DIAZEPAM EG
   3. How to take DIAZEPAM EG
   4. Possible side effects
   5. How to store DIAZEPAM EG
   6. Contents of the pack and other information

DIAZEPAM EG 10 mg/2 ml injectable solution

Generic medicine

Read this leaflet carefully before using 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, pharmacist or nurse.
• 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 any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is DIAZEPAM EG and what is it used for

DIAZEPAM EG contains the active ingredient diazepam, which belongs to a group of medicines
called benzodiazepines.
This medicine is indicated for the treatment of:

• states of agitation;
• hyperactivity of the muscles (motor excitement) due to various causes, such as hallucinations and other mental problems (paranoid-hallucinatory clinical pictures);
• epilepsy;
• repeated and involuntary muscle contractions (severe muscle spasms, of various rheumatic origin or following tetanus infection);
• convulsions due to fever in children over 2 years of age.

2. What you need to know before using DIAZEPAM EG

Do not use DIAZEPAM EG

• if you are allergic to diazepam, to other similar medicines (benzodiazepines) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a disease that causes muscle weakness and fatigue (myasthenia gravis);
• if you suffer from severe liver problems (severe, acute or chronic hepatic insufficiency);
• if you suffer from severe breathing problems (severe respiratory insufficiency);
• if you have breathing problems that occur during sleep (sleep apnea syndrome).

Warnings and precautions
Talk to your doctor or pharmacist before using DIAZEPAM EG.
As with other medicines similar to DIAZEPAM EG (psychotropic drugs), the dose must be established based on your health conditions if you suffer from brain problems (altered brain functions, in particular due to atherosclerosis) breathing and heart problems (cardiorespiratory insufficiency). If you suffer from these types of conditions, administration by injection (parenteral route) is not recommended except in emergency cases such as heart failure (myocardial infarction) and convulsions.
This medicine may cause a slight decrease in blood pressure or breathing difficulties (transient respiratory crises).
Also, if you are undergoing prolonged treatment with this medicine, your doctor will advise you to periodically undergo blood tests (hematological picture) and liver function tests.
DIAZEPAM EG must be used with caution if:

• you are an elderly or debilitated person;
• you suffer from liver or kidney problems (hepatic and renal insufficiency). Do not take this medicine if you have severe liver problems (severe hepatic insufficiency, acute or chronic) as it may cause brain damage (encephalopathy);
• you have previously abused alcohol or drugs;
• you suffer from persistent breathing problems (chronic respiratory insufficiency), in these cases it is necessary to reduce the dose;
• you suffer from blood circulation problems (arteriosclerosis).

Avoid using DIAZEPAM EG if:

• you have taken alcohol or if you are taking other medicines with a calming effect on the nervous system (depressive action on the nervous system); in these cases, deep sedation, breathing problems (respiratory depression), heart and circulation problems (cardiovascular depression) may occur;
• you have received treatments with other medicines that act on the nervous system and have developed the need to continue taking them, a condition called dependence, or if you have developed a dependence on alcohol; in these cases, you can only use this medicine to treat withdrawal crises.

If DIAZEPAM EG is administered to you in an outpatient clinic by injection, the doctor must keep you under control for at least one hour after administration. In these cases, it is recommended, if possible, to be accompanied when leaving the clinic. In these cases, avoid driving vehicles for at least the following 12 hours.
During treatment with DIAZEPAM, you may experience:

• a loss of effectiveness of this medicine after a few weeks of treatment;
• the need to continue taking this medicine (physical and psychological dependence) which increases with the duration of treatment and with the dose, especially if you have habitually consumed alcohol and drugs in the past;
• decreased attention and memory (anterograde amnesia), these effects may be associated with inappropriate behavior;
• alteration of the mind (psychiatric and paradoxical reactions). These effects are more likely to occur in children and the elderly. If this should occur, your doctor will tell you to stop treatment with this medicine (see section “If you stop taking DIAZEPAM EG”).

Keep in mind that after stopping treatment with this medicine you may experience symptoms called rebound symptoms (see section “If you stop taking DIAZEPAM EG”), in particular these effects may occur between one administration and the next, especially if you take high doses.

Children
The duration of treatment should be as short as possible.

Other medicines and DIAZEPAM EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Use this medicine with caution and consult your doctor if you are taking:

• cimetidine, omeprazole, medicines used to treat some stomach disorders;
• ketoconazole, a medicine used to treat fungal infections;
• medicines used to treat depression (fluoxetine, fluvoxamine);
• medicines used to treat mental problems (antipsychotics) and tranquilizing, hypnotic, anxiolytic/sedative medicines;
• medicines used to relieve pain (narcotic analgesics). In this case, you may experience an increase in euphoria and dependence (psychological dependence);
• medicines used to treat epilepsy (antiepileptics);
• medicines used to induce anesthesia (anesthetics and sedative antihistamines).

The concomitant use of DIAZEPAM EG and opioids (strong painkillers, medicines for substitution therapy and some cough medicines) 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 therapeutic options are not possible.
However, if your doctor prescribes DIAZEPAM EG together with opioids, the dose and duration of concomitant therapy 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 family members of the signs and symptoms mentioned above. Contact your doctor when these symptoms occur.

DIAZEPAM EG with alcohol
Avoid taking alcohol during treatment with this medicine as it can cause deep sedation, breathing problems (respiratory depression), heart and circulation problems (cardiovascular depression).
In addition, consuming alcohol during treatment with this medicine may impair your ability to drive vehicles (see section “Driving and using machinery”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use this medicine if you are in the first trimester of pregnancy.
If you are prescribed this medicine for serious reasons during the last period of pregnancy and at high doses, effects on the newborn may occur, such as decreased body temperature (hypothermia), muscle weakness (hypotonia) and difficulty breathing (respiratory depression).
If you have taken this medicine during pregnancy, the newborn may experience dependence (psychological dependence) and withdrawal crises. This medicine can cause changes in the fetal heart rate if taken during pregnancy. The doctor will take this into account when interpreting the fetal heart rate recording.
Do not use this medicine if you are breastfeeding as DIAZEPAM EG passes into breast milk.

Driving and using machinery
This medicine can impair your ability to drive vehicles or use machinery as it can reduce your ability to judge and react in dangerous situations. Therefore, be careful before driving and using machinery.

DIAZEPAM EG contains benzyl alcohol
This medicine contains 31.4 mg of benzyl alcohol per vial.
Benzyl alcohol can cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious side effects including breathing problems (respiratory distress syndrome) in young children.
Do not administer to infants under 4 weeks of age unless otherwise recommended by the doctor.
Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by the doctor or pharmacist.
Ask your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (such as metabolic acidosis).
Ask your doctor or pharmacist if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (such as metabolic acidosis).

DIAZEPAM EG contains ethanol
This medicine contains 220 mg of alcohol (ethanol) per vial. The amount in each vial of this medicine is equivalent to less than 6 ml of beer or 3 ml of wine.
The amount of alcohol in this medicine does not appear to have an effect on adults and adolescents and its effects in children are not evident. Some effects may occur in young 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 are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. If you have an alcohol dependence, talk to your doctor before taking this medicine.

DIAZEPAM EG contains propylene glycol
This medicine contains 828 mg of propylene glycol per vial.
If the child is less than 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, do not take this medicine unless otherwise recommended by the doctor. The doctor may perform further checks during therapy.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by the doctor. The doctor may perform further checks during therapy.

DIAZEPAM EG contains benzoic acid and sodium benzoate
This medicine contains 2.4 mg of benzoic acid and 97.6 mg of sodium benzoate per vial. Benzoic acid and sodium benzoate can increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

DIAZEPAM EG contains sodium
This medicine contains approximately 30 mg of sodium (the main component of table salt) per 20 mg dose (2 vials). This is equivalent to 1.5% of the recommended daily intake of salt with the diet of an adult.

3. How to use DIAZEPAM EG

This medicine will be administered to you by a doctor or nurse, into a muscle (intramuscular route) or into a vein (intravenous route).
The administration of DIAZEPAM EG via the intravenous route is preferred only when the intramuscular route is not possible (for example in patients in shock, with bleeding manifestations, hematological disorders, severe burns or reduced muscle mass, carriers of myeloproliferative disorders).
The doctor will adjust the dose taking into account your age and health conditions.

If you use more DIAZEPAM EG than you should
This medicine will be administered to you by a doctor or nurse, so an overdose is unlikely to occur. However, if you think you have been given an excessive amount of this medicine, inform your doctor immediately or go to the nearest hospital.
Overdosage with this medicine rarely poses a life risk, unless you have also taken alcohol or other medicines that act on the nervous system (nervous system depressants).
The most common symptoms are drowsiness, problems with muscle coordination (ataxia), speech disorders (dysarthria) and rapid, involuntary eye movements (nystagmus).
Overdosage with DIAZEPAM EG can cause breathing problems (apnea) which are more severe if you already suffer from breathing problems, loss of nerve reflexes (areflexia), decreased blood pressure (hypotension), decreased heart function and breathing problems (cardiorespiratory depression) and coma. The coma, if it occurs, usually lasts for a few hours but can be prolonged and cyclic, especially if you are an elderly person.
In case of ingestion/taking an excessive dose of this medicine, inform your doctor immediately or go to the nearest hospital.

If you forget to use DIAZEPAM EG
This medicine will be administered to you by a doctor or nurse, so it is unlikely that you will forget to use it. However, do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

If you stop taking DIAZEPAM EG
This medicine will be administered to you by a doctor or nurse, so it is unlikely that you will suddenly stop the treatment. The risk of withdrawal symptoms or relapse (rebound anxiety) is greater after abrupt discontinuation of treatment.
Discontinuation of treatment may cause a marked appearance of the symptoms for which you are taking this medicine (rebound effects or withdrawal symptoms), such as mood changes, anxiety, restlessness and sleep disturbances.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• psychic dependence (see section “Warnings and precautions”);
• drowsiness;
• fatigue and muscle weakness;
• dizziness.

These phenomena mainly occur at the beginning of therapy and usually disappear with
subsequent administrations.
In addition, the following may occur:

• loss of coordination of movements (ataxia);
• speech disorders (dysarthria);
• headache;
• tremors;
• vertigo;
• memory disorders, especially at high doses (anterograde amnesia);
• confusion;
• lack of emotions;
• decreased attention;
• depression;
• reduction or increase in sexual desire;
• an increased risk of falls and fractures, especially in elderly patients and in patients treated with sedatives (including alcoholic beverages);
• nausea;
• dry mouth or increased salivation (hypersalivation);
• constipation and other gastrointestinal disorders;
• visual disturbances (diplopia) and blurred vision;
• lowering of blood pressure (hypotension);
• circulatory disorders (circulatory depression);
• alteration of heart rate (irregular heartbeat);
• alteration of the levels of some enzymes produced by the liver (increased alkaline phosphatase in the blood, increased transaminase levels);
• increase or decrease in the need to urinate (incontinence, urinary retention);
• skin reactions;
• dizziness;
• heart problems (heart failure, cardiac arrest);
• breathing problems (respiratory depression, respiratory failure);
• cardiorespiratory problems (cardiorespiratory depression), if administered rectally;
• liver problems characterized by yellowing of the skin and whites of the eyes (jaundice).

During the use of benzodiazepines, a pre-existing depressive state may be unmasked, the symptoms
are as follows:

• restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations and mental problems (psychosis) and altered behavior. If you experience such symptoms, your doctor will immediately discontinue treatment. These reactions are more common in children and the elderly;

The following effects may occur especially after rapid intravenous injection:

• formation of blood clots in the veins (venous thrombosis);
• inflammation of a vein (phlebitis);
• irritation and swelling at the injection site;
• circulatory disorders;
• hiccups.

Direct intramuscular administration may cause pain and irritation at the injection site (erythema).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 EG

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 after “Exp.”.
The expiry date refers to the last day of that month.
Store the vials at a temperature not exceeding 30°C, in the original packaging to protect the
medicine from light.
Do not dispose of any medicine in 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 EG contains

• The active ingredient is diazepam. Each vial contains 10 mg of diazepam.
• The other ingredients are benzyl alcohol, 96% ethanol, propylene glycol, sodium benzoate, benzoic acid, water for injections.

Description of the appearance of DIAZEPAM EG and package contents
Package containing 3 vials of 10 mg/2 ml.

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan

Manufacturer
Doppel Farmaceutici S.r.l. Via Volturno 48 – Quinto de Stampi – Rozzano (Milan)

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The following information is intended exclusively for healthcare professionals:
Special Warnings and Precautions for Use
Like any psychotropic drug, the dosage of DIAZEPAM EG must be established based on
the highly variable tolerance from subject to subject in patients with organic brain changes
(especially arteriosclerotic) or with cardiorespiratory failure. In these patients, as a general rule, parenteral administration should be avoided for outpatient treatments
(except in emergency cases, for example, myocardial infarction, i.m. injection,
convulsive states, i.v. injection). In a hospital setting, these patients can instead be treated
parenterally; in case of intravenous injection, the doses must be reduced and the injection
performed slowly.
In most cases requiring parenteral therapy with DIAZEPAM EG, it is
sufficient to inject the medicine intramuscularly. In these circumstances, it should be remembered that, like many drugs, DIAZEPAM EG can increase the activity of
serum creatine phosphokinase (at the latest 12-24 hours after the injection) when administered intramuscularly. This should be taken into account in the differential diagnosis of myocardial infarction.

Pregnancy and breastfeeding
Like other drugs with a depressant effect on the central nervous system, DIAZEPAM EG can
cause characteristic changes in the fetal heart rate (disappearance of brief variations
in this frequency) when administered to the mother. This is not harmful to the fetus.
However, this fact should be taken into account when interpreting the recording of the fetal heartbeat as brief variations in heart rate - used as a criterion for assessing the
condition of the fetus - disappear under the effect of DIAZEPAM EG.

Dosage
The recommended dose varies depending on the reason for administering diazepam:

States of agitation:1-2 vials (10-20 mg) 3 times a day intramuscularly or intravenously,
until acute symptoms disappear.

Status epilepticus:initial dose 1-2 vials (10-20 mg) intravenously; in the following hours, as needed, 2 vials (20 mg) intramuscularly or slow intravenous infusion.

Muscle spasms:one vial (10 mg) 1-2 times intramuscularly.

Tetanus:one vial (10 mg) intravenously cancels the spastic state for about 8 hours.

Febrile convulsions in children over 2 years of age:0.5 mg /kg up to a maximum of 10
mg (1 vial) for rectal administration; a single administration is generally sufficient.

Incompatibilities
In principle, DIAZEPAM EG should be injected alone, as it is usually poorly compatible with most medications.
Diazepam can be absorbed through plastic infusion bags and infusion sets
containing PVC with a reduction in diazepam concentration of 50% or more, particularly
when, once prepared, the bags are stored for 24 hours under warm environmental conditions, or when a long set of tubes or a slow infusion rate is used. PVC bags and infusion sets should be avoided for diazepam infusion. Because PVC components can absorb some of the diazepam content
in solutions, dosage adjustments may be necessary when switching from PVC bags and sets
to PVC-free bags and sets.

Special precautions for disposal and handling
Unused medicine and waste derived from such medicine must be disposed of in
accordance with local regulations.
The injectable solution of DIAZEPAM EG remains stable in 5 or 10% glucose solution as
well as in isotonic sodium chloride solution, if the following precaution is observed: the
solution contained in the vials of DIAZEPAM EG (no more than 4 ml = 2 vials) must be added
quickly to the total volume of the infusion liquid (which must not be less than 250 ml) and the
infusion started immediately.

For further information, see the Summary of Product Characteristics.

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

1. What is DIAZEPAM EG and what is it used for

DIAZEPAM EG contains the active ingredient diazepam, which belongs to a group of medicines
called benzodiazepines.
Benzodiazepines are used to relieve severe states of anxiety, which subject the individual
to severe discomfort.
This medicine is indicated:

• for treating anxiety, tension and other disorders associated with anxiety (both physical and psychological);
• for treating sleep disorders (insomnia).

2. What you need to know before taking DIAZEPAM EG

Do not take DIAZEPAM EG

• if you are allergic to diazepam, to other similar medicines (benzodiazepines) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a disease that causes muscle weakness and fatigue (myasthenia gravis);
• if you suffer from severe liver problems (severe, acute or chronic hepatic insufficiency);
• if you suffer from severe breathing problems (severe respiratory insufficiency);
• if you have breathing problems that occur during sleep (sleep apnea syndrome).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIAZEPAM EG.
Avoid taking this medicine if you have a dependence on alcohol or drugs that depress the
central nervous system, unless absolutely necessary.
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you are elderly or debilitated (see section 3 How to take DIAZEPAM EG - Use in the elderly). Your doctor may decide to reduce the dose;
• if you have reduced blood flow to the brain (arteriosclerosis);
• if you have heart and lung problems (cardiorespiratory insufficiency). Your doctor may decide to reduce the dose;
• if you have previously abused alcohol or drugs;
• if you have problems with the liver or kidneys (hepatic and renal insufficiency). Do not take this medicine if you have severe liver problems (severe hepatic insufficiency, acute or chronic) as it may cause brain damage (encephalopathy).

Tolerance:if after a few weeks you feel that the medicine is not working as well as
at the beginning of treatment, talk to your doctor.

Dependence:when you take this medicine there is a risk of dependence, that is, the need
to continue taking the medicine. The risk increases with the dose and duration of treatment.
It is greater if you have previously abused drugs or alcohol.

Withdrawal:when you stop taking DIAZEPAM EG you may experience withdrawal or rebound symptoms, even if you have taken the medicine at the recommended doses and for a short
period of time (see section “If you stop taking DIAZEPAM EG”). To
minimize these symptoms, your doctor will gradually reduce the dose.
Withdrawal symptoms can also occur when switching from a benzodiazepine with a long
duration of action to one with a short duration of action. Therefore, such substitution is not recommended.

Duration of treatment:your doctor will tell you to take benzodiazepines for the shortest possible time
for the treatment of your problem and in any case not more than four weeks for the
treatment of insomnia and eight to twelve weeks for the treatment of anxiety, including a
period of gradual discontinuation.

Amnesia: with the use of benzodiazepines you may experience episodes of amnesia. To reduce the
risk of amnesia (memory loss), make sure you have an uninterrupted sleep of 7-8 hours.

Behavioral reactions: if you experience behavioral disturbances, your doctor will tell you to
immediately stop taking the medicine (see section 4 Possible side effects). These reactions are more common in children and the elderly.
Benzodiazepines should not be used alone to treat depression or anxiety associated with
depression, as suicidal thoughts may occur in such patients.
If you are going to have surgery that requires the use of anesthetics, inform the hospital or doctor that
you are taking DIAZEPAM EG.

Children
DIAZEPAM EG should be used in children only in cases of absolute necessity and the duration of
treatment should be as short as possible.

Other medicines and DIAZEPAM EG
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 and antidepressants (fluvoxamine, fluoxetine), used to treat mental disorders;
• hypnotics, medicines used to promote sleep;
• anxiolytics/sedatives, used to treat anxiety;
• some strong painkillers may cause an increased sense of well-being when taken with DIAZEPAM EG. This can increase your desire to continue taking these medicines (dependence);
• antiepileptics, used for epilepsy;
• anesthetics, used during surgical operations;
• antihistamines with a sedative effect, used to treat allergies;
• cimetidine and omeprazole, used to treat stomach lesions (ulcers);
• ketoconazole, used for fungal infections.

The concomitant use of DIAZEPAM EG and opioids (strong painkillers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, respiratory distress
(respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other therapeutic options are not possible.
However, if your doctor prescribes DIAZEPAM EG together with opioids, the dose and duration of
concomitant therapy 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 family about the signs and
symptoms above. Contact your doctor when these symptoms occur.

DIAZEPAM EG with alcohol
Avoid drinking alcohol during treatment with this medicine, as it can increase the sedative effect
of the medicine. This negatively affects the ability to drive vehicles and operate
machinery.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take DIAZEPAM EG in the first 3 months of pregnancy.
If your doctor believes you need to take DIAZEPAM EG in the later stages of pregnancy or
during labor, your baby may experience low body temperature (hypothermia),
loss of muscle tone (hypotonia) and difficulty breathing.
If DIAZEPAM EG has been taken regularly during the later stages of pregnancy, your
baby may experience withdrawal symptoms.
Consult your doctor or pharmacist before taking any medicine.
Breastfeeding
Do not take this medicine if you are breastfeeding, as diazepam passes into breast milk.

Driving and operating machinery
The use of DIAZEPAM EG may affect your ability to drive vehicles and operate machinery
because you may feel confused, forgetful, sleepy, with muscle tone problems. These effects
are increased if you have not slept enough. If this happens to you, avoid driving vehicles or
operating machinery.

DIAZEPAM EG contains ethanol (alcohol)
This medicine contains up to 192 mg of alcohol (ethanol) per 10 mg dose (50 drops). The
amount in 10 mg of this medicine is equivalent to less than 4.8 ml of beer or 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
are not evident in children. Some effects may occur in young 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 are pregnant or breastfeeding, talk to your doctor or
pharmacist before taking this medicine. If you have an alcohol dependence, talk to your doctor
before taking this medicine.

DIAZEPAM EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is, essentially ‘sodium-free’.

DIAZEPAM EG contains propylene glycol
This medicine contains up to 1200 mg of propylene glycol per 50 drops dose (10 mg of
diazepam).
If the child is less than 5 years old, talk to your doctor or pharmacist before giving
this medicine, especially if the child is taking other medicines containing propylene
glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks during therapy.
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.
Propylene glycol in this medicine can have the same effects as drinking alcohol and may
increase the likelihood of side effects.
Use this medicine only if recommended by your doctor. The doctor may perform further checks
during therapy.

3. How to take DIAZEPAM EG

Take this medicine exactly as your doctor or pharmacist has told you.
If you have doubts, consult your doctor or pharmacist.
Continue taking this medicine until your doctor tells you to stop.
The drops must be diluted with a little water or other beverage. If you are taking this
medicine for the treatment of insomnia, take it just before going to bed.
Your doctor will determine the correct dose for you.
The recommended dose in adults ranges from 2 mg (10 drops) two to three times a day to 5 mg (25 drops)
one to two times a day.
Take the drops of DIAZEPAM EG as follows:

• open the bottle;
• let the drops fall into a glass while holding the bottle in a vertical position with the opening facing downwards. If the liquid does not flow, shake the bottle or turn it over several times and repeat the operation as described above.

Anxiety, tension and other disorders associated with anxiety
Your doctor will tell you to take this medicine for the shortest possible time. The duration of
treatment should generally not exceed 8-12 weeks, including a period of
gradual discontinuation.
In certain cases, your doctor may decide to prolong the treatment, after assessing your
health conditions.

Insomnia
Your doctor will tell you to take this medicine for the shortest possible time. The duration of
treatment generally ranges from a few days to 2 weeks, up to a maximum of 4 weeks,
including a period of gradual discontinuation.
In certain cases, your doctor may decide to prolong the treatment, after assessing your
health conditions.
Your doctor will tell you to start treatment with the lowest dose. Never exceed the maximum dose.
Your doctor will regularly monitor your condition at the beginning of treatment to reduce, if
necessary, the dose or frequency of administration.

Use in children
This medicine should be used in children only in cases of absolute necessity.
Children under 3 years of age: the recommended dose is 1-6 mg (5-30 drops) per day.
Children between 4 and 14 years of age: the recommended dose is 4-12 mg (20-60 drops) per
day.

Use in the elderly
In the elderly and debilitated patients, a reduced dose should be administered.
The recommended dose is 2 mg (10 drops) 2 times a day.

If you take more DIAZEPAM EGthan you should
If you (or someone else) have taken an excessive dose of DIAZEPAM EG or if you think a
child may have taken this medicine, immediately notify your doctor or go to the
Emergency Room of the nearest hospital.
An overdose can cause severe depression of the nervous system with symptoms such as
drowsiness (lethargy), confusion, muscle problems (ataxia, hypotonia), low
blood pressure, difficulty breathing, coma, death.
Bring this leaflet, the bottle and its container to the hospital or doctor so that
they know which medicine has been consumed.

If you forget to take DIAZEPAM EG
If you forget to take a dose of the medicine, take it as soon as you remember, unless
it is almost time to take the next dose. Do not take a double dose to make up for the
forgotten dose.

If you stop taking DIAZEPAM EG
Donot stop treatment with DIAZEPAM EG suddenly or without first having
agreed with your doctor, because withdrawal symptomsmay occur.
If your doctor has decided to stop treatment, they will gradually reduce the dose to minimize
withdrawal symptoms, such as:

• headache, muscle pain, tension;
• severe anxiety, confusion, restlessness, 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 physical contact, hallucinations (seeing and hearing things that do not exist) or seizures may occur.

Treatment must be discontinued gradually otherwise the symptoms for which you were being treated may
reappear even more intensely than before (rebound insomnia and anxiety). The risk of developing
these symptoms is greater when you suddenly stop taking DIAZEPAM EG.
You may also experience mood changes, anxiety, restlessness and sleep disturbances.
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.
Seek immediate medical attention if you experience:

• depression and mental disorders, such as restlessness, agitation, irritability, aggressiveness, delusion, anger, nightmares, hallucinations (seeing and hearing things that do not exist), psychosis (a serious mental condition in which a person loses contact with reality and the ability to think and judge clearly), changes in behaviour. If any of these side effects occur, treatment should be discontinued. These reactions are more likely to occur in children and the elderly.

See a doctor if you experience any of the following side effects:

• drowsiness, reduced alertness, confusion;
• reduced emotional capacity;
• headache, dizziness, lightheadedness;
• fatigue, muscle weakness, difficulty controlling movements (ataxia), tremors;
• double or blurred vision;
• difficulty speaking (dysarthria);
• stomach and intestinal disorders, nausea, constipation, dry mouth, excessive salivation;
• changes in sexual desire;
• skin reactions;
• physical dependence. Discontinuation of therapy may cause withdrawal symptoms or rebound (see sections Warnings and precautions and If you stop taking DIAZEPAM EG);
• memory loss (amnesia) (see section Warnings and precautions);
• falls and fractures. The risk of fractures is higher in the elderly and in patients taking sedatives concurrently;
• lowering of blood pressure (hypotension), circulatory failure;
• irregular heartbeat;
• involuntary loss of urine (incontinence), difficulty urinating;
• reduced heart function, cardiac arrest;
• difficulty breathing (respiratory depression, including respiratory failure).

Very rarely, jaundice (yellowing of the skin and whites of the
eyes) and increased levels of liver enzymes may occur.

Reporting ofside effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. 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 EG

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 after “exp.”.
The expiry date refers to the last day of that month.
Use the product within 3 months of first opening the bottle. Discard any excess product.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DIAZEPAM EG contains
The active ingredient is diazepam. 1 ml (25 drops) of solution contains 5 mg of diazepam.
The other ingredients are: 96% ethanol, 85% glycerol, sodium saccharin, propylene glycol, orange/lemon flavour, erythrosine (E 127), purified water.
Description of the appearance of DIAZEPAM EG and contents of the pack
Pack containing a 20 ml bottle of solution.

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milano

Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri Delle Foibe, 1 – 29016 Cortemaggiore (PC)
Vamfarma S.r.l. – Via Kennedy, 5 – 26833 Comazzo (LO)