Patient Information Leaflet

Diazepam Sandoz 5 mg/ml oral drops, solution

Generic Medicine
Please read all of 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 give it to others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Diazepam Sandoz is and what it is used for
What you need to know before taking Diazepam Sandoz
How to take Diazepam Sandoz
Possible side effects
How to store Diazepam Sandoz
Contents of the pack and other information

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

Diazepam Sandoz contains the active substance diazepam, which belongs to a group of medicines called
benzodiazepines.
This medicine is indicated:

for the treatment of anxiety, tension, and other anxiety-related disorders;
for the treatment of sleep disorders (insomnia).

Benzodiazepines are used only when the disorders are severe, cause significant distress to the individual,
and limit normal daily activities.

2. What you should know before taking Diazepam Sandoz

Do not take Diazepam Sandoz

if you are allergic to the active substance, to other similar medicines (benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
if you have myasthenia gravis, a disease causing muscle weakness and fatigue;
if you have severe breathing problems (severe respiratory insufficiency);
if you have severe liver problems (severe hepatic insufficiency), as it may cause mental confusion (hepatic encephalopathy);
if you have breathing difficulties during sleep (sleep apnoea).

Warnings and precautions
Talk to your doctor or pharmacist before taking Diazepam Sandoz.
Avoid taking this medicine if you have alcohol or drug dependence, 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 Sandoz – Use in the elderly and debilitated patients). Your doctor may decide to reduce the dose;
if you have reduced blood flow to the brain (arteriosclerosis). Your doctor may decide to reduce the dose;
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).

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 treatment duration. The risk is greater if you have previously abused drugs or alcohol.
Withdrawal: When you stop taking Diazepam Sandoz, 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 3 If you stop taking Diazepam Sandoz). To minimize these symptoms, it is recommended to 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: Treatment duration should be as short as possible and should not exceed four weeks for insomnia and eight to twelve weeks for anxiety, including a gradual discontinuation period.
Amnesia: To reduce the risk of amnesia (memory loss), ensure an uninterrupted sleep of 7–8 hours.
Behavioural reactions: If you experience behavioural disturbances, 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.
For athletes: the use of medicines containing ethanol may result in positive anti-doping tests, depending on the alcohol concentration limits set by certain sports federations.
Children
Diazepam Sandoz should be used in children only when absolutely necessary, and treatment duration should be as short as possible. As safety and efficacy have not been established in children under six months of age, Diazepam Sandoz should be used with extreme caution in this age group and only if no alternative treatments are available.

Other medicines and Diazepam Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Diazepam Sandoz and opioids (strong analgesics, medicines for addiction treatment, 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 treatment options are available.
However, if your doctor prescribes Diazepam Sandoz 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 follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Be particularly careful and inform your doctor if you are taking the following medicines:

antipsychotics (neuroleptics), used to treat mental disorders;
antidepressants (fluvoxamine, fluoxetine);
hypnotics, medicines used to promote sleep;
anxiolytics/sedatives, used to treat anxiety;
some strong painkillers (opioids), which may cause increased feelings of well-being when taken with Diazepam Sandoz. 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.

Diazepam Sandoz and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine. This negatively affects your ability to drive or operate machinery.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Diazepam Sandoz during the first three months of pregnancy.
If your doctor considers it necessary for you to take Diazepam Sandoz in the later stages of pregnancy or during labour, your baby may experience low body temperature, reduced muscle tone, and breathing difficulties.
If Diazepam Sandoz has been taken regularly during the later stages of pregnancy, your baby may develop physical dependence and 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 using machines
Taking Diazepam Sandoz may affect your ability to drive or operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle weakness. These effects are worse if you have not had enough sleep. If this happens, avoid driving or operating machinery.
Diazepam Sandoz contains ethanol (alcohol)
This medicine contains 9.4% ethanol (alcohol), e.g. up to 148 mg per 10 mg dose (50 drops), equivalent to 3.76 ml of beer and 1.56 ml of wine per dose. This may be harmful for people suffering from alcoholism or with impaired alcohol metabolism. This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver problems or epilepsy.

3. How to take Diazepam Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You must continue taking this medicine until your doctor tells you to stop.
The drops should be diluted with a small amount of water or another drink. For the treatment of insomnia, the
medicine should be taken 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) one to two
times daily.
Method of use of the dropper bottle: to deliver the correct dose of medicine, the
bottle must be held 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, then repeat the dispensing procedure as
described above.
Anxiety, tension and other anxiety-related disorders
The duration of treatment should be as short as possible. Generally, treatment should 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.
In the hospital treatment of anxiety states, the dose is 10–20 mg (50–100 drops) three times daily.
Insomnia
The duration of treatment should be as short as possible. Generally, treatment varies
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.
Treatment should be started with the lowest recommended dose. The maximum dose must not be exceeded.
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 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 and debilitated 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 Sandoz than you should
If you (or someone else) have taken an excessive dose of Diazepam Sandoz or if you suspect that 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
mental and sensory dulling (obnubilation), confusion, excessive drowsiness (lethargy),
muscle problems (ataxia, hypotonia), unconsciousness, low blood pressure, hypnosis,
breathing difficulties, rarely coma, and very rarely death.
Take this leaflet, the bottle and its packaging with you to the hospital or doctor so that they know
which medicine has been taken.
If you forget to take Diazepam Sandoz
If you forget to take a dose of the medicine, 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 Sandoz
Do not stop treatment with Diazepam Sandoz 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 of detachment from the surrounding environment), sound intolerance (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise and physical contact, hallucinations (seeing or hearing things that do not exist), or epileptic seizures.

Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may reappear more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is higher if you stop taking Diazepam Sandoz suddenly. You may also experience mood changes, anxiety, restlessness and sleep disturbances.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience: mental disturbances such as restlessness, agitation, irritability, aggression, feelings of despair, 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), or behavioural changes. If any of these side effects occur, treatment must be discontinued. These reactions are more likely to occur in children and elderly patients.

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

drowsiness, reduced alertness, confusion;
depression;
reduced emotional responsiveness;
headache, dizziness;
fatigue, muscle weakness, difficulty controlling movements (ataxia), tremors;
double or blurred vision;
speech difficulties;
stomach and intestinal disorders, nausea, constipation, dry mouth, excessive salivation;
changes in sexual desire;
skin reactions;
if you think you are misusing or dependent on this medicine. Stopping treatment may lead to withdrawal or rebound symptoms (see sections Warnings and precautions and If you stop taking Diazepam Sandoz);
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 levels of liver enzymes 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 can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diazepam Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
The product should be used within 3 months of first opening the bottle. Any excess product should be discarded.
Do not dispose of medicines 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 Sandoz contains

The active substance is diazepam. 1 ml (25 drops) of solution contains 5 mg of diazepam.
The other components are: ethyl alcohol 96%, glycerol, saccharin, propylene glycol, orange soluble essence, lemon soluble essence, erythrosine (E 127), purified water.

Description of the appearance of Diazepam Sandoz and contents of the pack
Pack containing one 20 ml solution vial.
Marketing Authorization Holder
Sandoz S.p.A. – Largo Umberto Boccioni, 1 - 21040 Origgio (VA) - Italy
Manufacturers
Consorzio Farmaceutico e Biotecnologico Bioprogress - Strada Paduni 240 - 03012 Anagni (FR) - Italy
ABC Farmaceutici Spa – Via Cantone Moretti, 29 – 10090 San Bernardo d’Ivrea (TO) - Italy