Diazepam Eg

Package leaflet: Information for the patient

DIAZEPAM EG 10 mg/2 ml injection solution

Generic medicine
Please read all of this leaflet carefully before you use 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, pharmacist or nurse.
• 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 using 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 DIAZEPAM EG is and what it is used for

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

• states of agitation;
• muscle hyperactivity (motor excitement) due to various causes, such as hallucinations and other mental disorders (paranoid-hallucinatory clinical conditions);
• epilepsy;
• severe repeated and involuntary muscle contractions (muscle spasms of various origin, including rheumatic or following tetanus infection);
• febrile seizures 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 causing muscle weakness and fatigue (myasthenia gravis);
• if you have severe liver problems (severe, acute or chronic hepatic insufficiency);
• if you have severe breathing problems (severe respiratory insufficiency);
• if you have breathing disorders that occur during sleep (sleep apnoea 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 should be adjusted
according to your health condition if you suffer from brain disorders (impaired brain function,
particularly due to atherosclerosis), breathing or heart problems (cardiorespiratory insufficiency).
If you have any of these conditions, parenteral (injection) administration is not recommended except
in emergencies such as cardiac arrest (myocardial infarction) or seizures.
This medicine may cause a slight decrease in blood pressure or breathing difficulties (transient
respiratory crises).
Additionally, if you are undergoing prolonged treatment with this medicine, your doctor will
advise you to have regular blood tests (haematological monitoring) and liver function checks.
DIAZEPAM EG should be used with caution if:

• you are elderly or debilitated;
• you suffer from liver or kidney problems (hepatic or renal insufficiency). Do not take this medicine if you have severe liver problems (severe, acute or chronic hepatic insufficiency), as it may cause brain damage (encephalopathy);
• you have previously abused alcohol or drugs;
• you suffer from chronic respiratory disorders (chronic respiratory insufficiency); in such cases the dose should be reduced;
• you suffer from circulatory disorders (arteriosclerosis).

Avoid using DIAZEPAM EG if:

• you have consumed alcohol or are taking other medicines that depress the central nervous system (central nervous system depressants); in such cases, profound sedation, breathing difficulties (respiratory depression), or heart and circulation problems (cardiovascular depression) may occur;
• you have previously been treated with other medicines acting on the central nervous system and have developed dependence, or if you are alcohol-dependent; in such cases, this medicine may only be used to treat withdrawal symptoms.

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

• reduced effectiveness of the medicine after several weeks of treatment;
• the need to continue taking the medicine (physical and psychological dependence), which increases with the duration of treatment and dosage, especially if you have previously consumed alcohol or drugs regularly;
• reduced attention and memory (anterograde amnesia); these effects may be associated with inappropriate behaviour;
• mental disturbances (paradoxical psychiatric reactions). These effects are more likely to occur in children and elderly patients. If this occurs, your doctor will advise you to stop treatment with this medicine (see section “If you stop taking DIAZEPAM EG”).

Please note that after stopping treatment with this medicine, you may experience symptoms known as rebound symptoms (see section “If you stop taking DIAZEPAM EG”), particularly between doses, especially if you are taking 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 certain stomach disorders;
• ketoconazole, a medicine used to treat fungal infections;
• medicines used to treat depression (fluoxetine, fluvoxamine);
• medicines used to treat mental disorders (antipsychotics) and tranquilizers, hypnotics, anxiolytics/sedatives;
• medicines used to relieve pain (narcotic analgesics); in this case, you may experience increased euphoria and dependence (psychological dependence);
• medicines used to treat epilepsy (antiepileptics);
• medicines used to induce anaesthesia (anaesthetics and sedative antihistamines).

The concomitant use of DIAZEPAM EG and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other therapeutic options are available.
However, if your doctor prescribes DIAZEPAM EG together with opioids, the dose and duration of concomitant therapy must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if these symptoms occur.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine during the first trimester of pregnancy.
If this medicine is prescribed during the last stage of pregnancy and at high doses, effects on the newborn may occur, such as decreased body temperature (hypothermia), muscle weakness (hypotonia), and breathing difficulties (respiratory depression).
If you have taken this medicine during pregnancy, the newborn may show signs of dependence (psychological dependence) and withdrawal symptoms. This medicine may affect the fetal heart rate if taken during pregnancy. Your doctor will take this into account when interpreting the fetal heart monitoring.
Do not use this medicine while breastfeeding, as DIAZEPAM EG passes into breast milk.

Driving and using machines
This medicine may impair your ability to drive vehicles or operate machinery, as it may reduce your judgment and reactivity in dangerous situations. Therefore, exercise caution before driving or operating machinery.

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

DIAZEPAM EG contains ethanol
This medicine contains 220 mg of alcohol (ethanol) in each 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 is unlikely to affect adults and adolescents, and its effects in children are not clearly evident. 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 are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. If you are alcohol-dependent, 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 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, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.

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 may 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 (a key component of table salt) per 20 mg dose (2 vials). This corresponds to 1.5% of the maximum daily recommended dietary intake for an adult.

3. How to use DIAZEPAM EG

This medicine will be administered to you by a doctor or nurse, either into a muscle (intramuscular route) or into a vein (intravenous route).
Intravenous administration of DIAZEPAM EG is preferred only when the intramuscular route is not feasible (for example, in patients in shock, with hemorrhagic manifestations, hematological disorders, severe burns or reduced muscle mass, or those with myeloproliferative disorders).
The doctor will adjust the dose according to your age and your general health condition.

If you use more DIAZEPAM EG than you should
This medicine will be administered by a doctor or nurse, so overdose is unlikely. However, if you think that you have been given too much of this medicine, inform your doctor immediately or go to the nearest hospital.
Overdose with this medicine rarely poses a life-threatening risk unless alcohol or other medicines acting on the nervous system (central nervous system depressants) have also been taken.
The most common symptoms are drowsiness, muscle coordination problems (ataxia), speech disorders (dysarthria), and rapid, involuntary eye movements (nystagmus).
Overdose with DIAZEPAM EG may cause breathing problems (apnea), which are more severe if you already suffer from respiratory disorders, absence of nervous reflexes (areflexia), low blood pressure (hypotension), reduced heart function and breathing difficulties (cardiorespiratory depression), and coma. Coma, if it occurs, usually lasts a few hours but may last longer and may be cyclical, especially in elderly patients.
In case of ingestion/absorption of 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 by a doctor or nurse, so it is unlikely that a dose will be missed. However, do not use a double dose to make up for a forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

If you stop treatment with DIAZEPAM EG
This medicine will be administered by a doctor or nurse, so it is unlikely that treatment will be abruptly interrupted. The risk of withdrawal symptoms or rebound effects (such as rebound anxiety) is higher following abrupt discontinuation of treatment.
Stopping treatment may lead to a marked return 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:

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

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

• loss of coordination in movements (ataxia);
• speech disorders (dysarthria);
• headache;
• tremors;
• dizziness;
• memory problems, especially at higher doses (anterograde amnesia);
• confusion;
• lack of emotions;
• reduced attention;
• depression;
• reduced or increased sexual desire;
• an increased risk of falls and fractures, particularly in elderly patients and in patients treated with sedatives (including alcoholic beverages);
• nausea;
• dry mouth or increased salivation (hypersalivation);
• constipation and other stomach and intestinal disturbances;
• vision problems (double vision, diplopia) and blurred vision;
• low blood pressure (hypotension);
• circulatory disorders (circulatory depression);
• changes in heart rhythm (irregular heartbeat);
• changes in levels of certain liver enzymes (increased blood alkaline phosphatase, increased transaminase levels);
• increased or decreased need to urinate (incontinence, urinary retention);
• skin reactions;
• dizziness;
• heart problems (heart failure, cardiac arrest);
• breathing problems (respiratory depression, respiratory failure);
• breathing and heart problems (cardiorespiratory depression), if administered rectally;
• liver problems characterised by yellowing of the skin and whites of the eyes (jaundice).

During the use of benzodiazepines, a pre-existing depressive state may be unmasked, with the following symptoms:

• restlessness, agitation, irritability, aggression, frustration, anger, nightmares, hallucinations, mental disturbances (psychosis), and behavioural changes. If you experience any of these symptoms, your doctor will immediately stop treatment. These reactions occur more frequently in children and elderly patients.

The following side effects may occur especially after rapid intravenous injection:

• formation of blood clots in 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 experience any side effects, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps 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 stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store the ampoules at a temperature not exceeding 30°C, in the original packaging to protect the medicine from light.
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 EG contains

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

Description of the appearance of DIAZEPAM EG and contents of the pack
Pack containing 3 vials of 10 mg/2 ml.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan
Manufacturer
Doppel Farmaceutici S.r.l. Via Volturno 48 – Quinto de Stampi – Rozzano (Milan)

The following information is intended exclusively for healthcare professionals:

Special warnings and precautions for use
As with any psychotropic drug, the dosage of DIAZEPAM EG must be adjusted according to the highly variable individual tolerance in patients with organic cerebral disorders (particularly arteriosclerotic) or with cardiorespiratory insufficiency. In such patients, parenteral administration should generally be avoided for outpatient treatment (exceptions being emergency cases, e.g. myocardial infarction, intramuscular injection; convulsive states, intravenous injection). In a hospital setting, however, parenteral treatment may be used; in the case of intravenous injection, doses should be reduced and the injection administered slowly.

In most cases requiring parenteral therapy with DIAZEPAM EG, intramuscular injection of the medicinal product is sufficient. Under these circumstances, it should be borne in mind that, like many drugs, DIAZEPAM EG may increase serum creatine phosphokinase activity (within 12–24 hours after injection) when administered intramuscularly. This should be taken into account in the differential diagnosis of myocardial infarction.

Pregnancy and breastfeeding
Like other drugs with central nervous system depressant activity, DIAZEPAM EG may induce characteristic changes in fetal heart rate (disappearance of short-term variability) when administered to the mother. This is not harmful to the fetus. However, this effect must be considered when interpreting fetal heart rate monitoring, since short-term variability of heart rate – used as a criterion to assess fetal well-being – disappears under the effect of DIAZEPAM EG.

Dosage
The recommended dose varies depending on the indication for diazepam administration:

Agitation states: 1–2 vials (10–20 mg) 3 times daily by intramuscular or intravenous route, until acute symptoms resolve.

Status epilepticus: initial dose of 1–2 vials (10–20 mg) intravenously; subsequently, as needed, 2 vials (20 mg) by intramuscular injection or slow intravenous infusion.

Muscle spasms: one vial (10 mg) 1–2 times by intramuscular injection.

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

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

Incompatibilities
In principle, DIAZEPAM EG should be administered alone, as it is usually poorly compatible with most other medicinal products.

Diazepam may be absorbed into plastic infusion bags and infusion sets containing PVC, resulting in a reduction of diazepam concentration by 50% or more, particularly when the bags are stored for 24 hours under warm environmental conditions after preparation, or when long tubing sets or slow infusion rates are used. Infusion bags and sets containing PVC should be avoided for diazepam administration. Since PVC components may absorb part of the diazepam content in solution, dosage adjustments may be necessary when switching from PVC-containing infusion bags and sets to those without PVC.

Special precautions for disposal and handling
Unused medicine and waste materials derived from this 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, provided the following procedure is followed: the solution contained in the DIAZEPAM EG vials (no more than 4 ml = 2 vials) should be added rapidly to the total volume of infusion fluid (which must not be less than 250 ml), and the infusion should be started immediately.

For further information, please consult the Summary of Product Characteristics.

Patient Information Leaflet

DIAZEPAM EG 5 mg/ml oral drops, solution

Equivalent medicine
Please 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 give it to others, even if their symptoms are the same as yours, as 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 DIAZEPAM EG is and what it is 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

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

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

• for the treatment of anxiety, tension, and other conditions associated with anxiety (both physical and psychological);
• for the treatment of 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 causing 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 apnoea syndrome).

Warnings and precautions
Talk to your doctor or pharmacist before taking DIAZEPAM EG.
Avoid taking this medicine if you have an addiction to alcohol or to medicines that depress the central nervous system, unless absolutely necessary.
Take this medicine with caution and always under medical supervision 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 or lung problems (cardiorespiratory insufficiency). Your doctor may decide to reduce the dose;
• if you have previously abused alcohol or drugs;
• if you have liver or kidney problems (hepatic or renal insufficiency). Do not take this medicine if you have severe liver problems (severe, acute or chronic hepatic insufficiency), as it may cause brain damage (encephalopathy).

Tolerance: If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence: There is a risk of dependence when taking this medicine, meaning a need to continue taking it. The risk increases with higher doses and longer duration of treatment. The risk is greater if you have previously abused drugs or alcohol.
Withdrawal: When stopping DIAZEPAM EG, you may experience withdrawal or rebound symptoms, even if you have taken the medicine at recommended doses and for a short period (see section “If you stop taking DIAZEPAM EG”). To minimize these symptoms, your doctor will gradually reduce the dose.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.
Duration of treatment: Your doctor will advise you to take benzodiazepines for the shortest possible time needed to treat your condition, and in any case not longer than four weeks for insomnia, or eight to twelve weeks for anxiety, including a gradual discontinuation period.
Amnesia: When using benzodiazepines, you may experience episodes of amnesia. To reduce the risk of amnesia (memory loss), ensure an uninterrupted sleep of 7–8 hours.
Behavioural reactions: If you experience behavioural disturbances, your doctor will instruct you to stop taking the medicine immediately (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 undergoing a procedure requiring anaesthetics, inform the hospital or doctor that you are taking DIAZEPAM EG.

Children
DIAZEPAM EG should be used in children only when absolutely necessary, 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 special 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;
• certain strong painkillers, which may cause increased feelings of well-being when taken with DIAZEPAM EG. This may increase your desire to continue taking these medicines (dependence);
• antiepileptics, used for epilepsy;
• anaesthetics, used during surgical procedures;
• sedating antihistamines, 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, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other therapeutic options are possible.
However, if your doctor prescribes DIAZEPAM EG together with opioids, the dose and duration of concomitant treatment must be limited by your 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 about the signs and symptoms listed above. Contact your doctor if these symptoms occur.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take DIAZEPAM EG during the first 3 months of pregnancy.
If your doctor considers it necessary for you to take DIAZEPAM EG in the later stages of pregnancy or during labour, your baby may experience low body temperature (hypothermia), loss of muscle tone (hypotonia), and breathing difficulties.
If DIAZEPAM EG has been taken regularly during the later stages of pregnancy, your baby may experience withdrawal symptoms.
Talk to 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 using machines
The use of DIAZEPAM EG may affect your ability to drive vehicles or operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle weakness. These effects may be worse if you have not had enough sleep. If this happens, avoid driving 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 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 are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. If you are dependent on alcohol, 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, i.e. essentially ‘sodium-free’.

DIAZEPAM EG contains propylene glycol
This medicine contains up to 1200 mg of propylene glycol per 50-drop dose (10 mg diazepam).
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, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
Propylene glycol in this medicine may cause effects similar to those of alcohol consumption and may increase the likelihood of side effects.
Use this medicine only if recommended by your doctor. Your doctor may perform additional monitoring during treatment.

3. How to take DIAZEPAM EG

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Continue taking this medicine for as long as your doctor tells you to.
The drops must be diluted with a small amount of water or another drink. 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 daily to 5 mg (25 drops)
once or twice daily.
Take DIAZEPAM EG drops as follows:

• open the bottle;
• let the drops fall into a glass, holding the bottle in an upright position with the opening facing downwards. If the liquid does not flow, shake the bottle or turn it upside down several times and repeat the procedure as indicated above.

Anxiety, tension and other anxiety-related disorders
Your doctor will advise 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 withdrawal.
In certain cases, your doctor may decide to extend the treatment after evaluating your health condition.
Insomnia
Your doctor will advise 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 withdrawal.
In certain cases, your doctor may decide to extend the treatment after evaluating your health condition.
Your doctor will advise 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 and may reduce the dose or frequency of administration if necessary.
Use in children
This medicine should be used in children only when absolutely necessary.
Children under 3 years of age: the recommended dose is 1–6 mg (5–30 drops) per day.
Children aged 4 to 14 years: the recommended dose is 4–12 mg (20–60 drops) per day.
Use in elderly patients
In elderly and debilitated patients, a reduced dose should be administered.
The recommended dose is 2 mg (10 drops) twice daily.
If you take more DIAZEPAM EG than 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, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause severe depression of the central nervous system, with symptoms such as
drowsiness (lethargy), confusion, muscle problems (ataxia, hypotonia), low blood pressure, breathing difficulties, coma, or even death.
Take this leaflet, the bottle and its container with you to the hospital or doctor so that they know which medicine has been taken.
If you forget to take DIAZEPAM EG
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking DIAZEPAM EG
Do not stop treatment with DIAZEPAM EG suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, they will gradually reduce your 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 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 are not there), or epileptic seizures.

Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may return even more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is greater if you stop taking DIAZEPAM EG abruptly.
You may also experience mood changes, anxiety, restlessness and sleep disturbances.
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 everyone will experience them.
Contact your doctor immediately if you experience:

• depression and mental disorders such as restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), behavioural changes. If you experience these side effects, treatment must be discontinued. These reactions are more frequent in children and elderly patients.

Contact your doctor if you experience any of the following side effects:

• drowsiness, reduced alertness, confusion;
• reduced emotional responsiveness;
• headache, dizziness, vertigo;
• 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. Stopping treatment may lead to withdrawal symptoms or rebound effects (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 elderly patients and in patients taking sedatives concomitantly;
• low blood pressure (hypotension), circulatory failure;
• irregular heartbeat;
• involuntary loss of urine (incontinence), difficulty urinating;
• reduced cardiac function, cardiac arrest;
• breathing difficulties (respiratory depression, including respiratory failure).

Very rarely, jaundice (yellowing of the skin and whites of the eyes) and increased liver enzyme levels may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store DIAZEPAM EG

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Use the product within 3 months after first opening the bottle. Dispose of any excess product.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DIAZEPAM EG contains
The active substance is diazepam. 1 ml (25 drops) of solution contains 5 mg of diazepam.
The other components are: ethanol 96%, glycerol 85%, 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 one 20 ml bottle of solution.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri Delle Foibe, 1 – 29016 Cortemaggiore (PC)
Vamfarma S.r.l. – Via Kennedy, 5 – 26833 Comazzo (LO)