DIAZEPAM 5 mg /Ml Oral Drops, Solution

Содержание инструкции

1. Diazepam Sandoz 5 mg/ml oral drops, solution
   1. What is Diazepam Sandoz and what is it used for
   2. What you need to know before taking Diazepam Sandoz
   3. How to take Diazepam Sandoz
   4. Possible side effects
   5. How to store Diazepam Sandoz
   6. Contents of the pack and other information

Diazepam Sandoz 5 mg/ml oral drops, solution

Equivalent Medicinal Product

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

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

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

• to treat anxiety, tension and other disorders associated with anxiety;
• to treat sleep disorders (insomnia).

Benzodiazepines are used only when the disorders are severe, cause significant distress to the subject
and limit their normal activity.

2. What you need to know before taking Diazepam Sandoz

Do not take Diazepam Sandoz

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Diazepam Sandoz.
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 Sandoz - Use in the elderly and debilitated patients). The doctor may decide to reduce the dose;
• if you have reduced blood flow to the brain (arteriosclerosis). The doctor may decide to reduce the dose;
• if you have heart and lung problems (cardiorespiratory insufficiency). The doctor may decide to reduce the dose;
• if you have previously abused alcohol or drugs;
• if you have liver or kidney problems (hepatic and renal insufficiency).

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

Dependence:When you take this medicine there is a risk of dependence, i.e. the need to
continue taking the medicine. The risk increases with the dose and duration of treatment. It is
higher 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 can also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.

Duration of treatment:The duration of treatment should be as short as possible and should not exceed
four weeks for the treatment of insomnia and eight to twelve weeks for the treatment of anxiety,
including a period of gradual discontinuation.

Amnesia: To reduce the risk of amnesia (memory loss), make sure you get an uninterrupted sleep of 7-8 hours.

Behavioral reactions: If you experience behavioral 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 those who play sports: the use of medicines containing ethyl alcohol may result in positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.

Children
Diazepam Sandoz should only be used in children when absolutely necessary and the duration of
treatment should be as short as possible. Because safety and efficacy have not been established in
children under six months, Diazepam Sandoz should be used with extreme caution in this age group
and only if alternative treatments are not available.

Other medicines and Diazepam Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The concomitant use of Diazepam Sandoz and opioids (strong painkillers, medicines for the treatment of
dependence and some medicines for cough) 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 treatment options are not possible.
However, if your doctor prescribes Diazepam Sandoz together with opioids, the dose and duration of concomitant treatment
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 to watch for
the signs and symptoms listed above.
Contact your doctor if you experience these symptoms.
Be particularly careful and tell 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 can cause an increased sense of well-being when taken with Diazepam Sandoz. This can increase your desire to continue taking these medicines (dependence).
• antiepileptics, used for epilepsy;
• anaesthetics, used during surgical operations;
• antihistamines with a sedative effect, used to treat allergies;
• cimetidine, and omeprazole, used to treat stomach injuries (ulcers);
• ketoconazole, used for fungal infections.

Diazepam Sandoz 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 may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Diazepam Sandoz during the first 3 months of pregnancy.
If your doctor believes you should take Diazepam Sandoz in the later stages of pregnancy or during
labor, your baby may experience low body temperature, loss of muscle tone and
difficulty breathing.
If Diazepam Sandoz has been taken regularly during the later stages of pregnancy, your baby
may experience 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
The use of Diazepam Sandoz can affect your ability to drive vehicles and operate machinery because it may
make you 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 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 to people
suffering from alcoholism or who have a defect in processing alcohol. This should be taken into consideration in
pregnant or breastfeeding women, children and high-risk groups, such as patients with liver problems or
suffering from epilepsy.

3. How to take Diazepam Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
You must continue to take this medicine until your doctor tells you to stop.
The drops must be diluted with a little water or other beverage. In the treatment of insomnia, the
medicine should be taken just before going to bed.
The 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) once or twice
a day.

How to use the dropper bottle:to dispense the correct dose of medicine, it is necessary to hold the
bottle in a vertical position with the opening facing downwards.
If the liquid does not come out, shake the bottle or turn it over several times, repeating the dispensing operation as
described above.

Anxiety, tension and other disorders associated with anxiety
The duration of treatment should be as short as possible. The duration of treatment, generally, should not
exceed 8-12 weeks, including a period of gradual discontinuation.
In certain cases, the doctor may decide to prolong the treatment, after assessing your health
condition.
In hospital treatment of anxiety states, the dose is 10-20 mg (50-100 drops) three times a day.

Insomnia
The duration of treatment should be as short as possible. The duration of treatment, generally, varies
from a few days to 2 weeks, up to a maximum of 4 weeks, including a period of gradual discontinuation.
In certain cases, the doctor may decide to prolong the treatment, after assessing your health
condition.
Treatment should be started with the lowest recommended dose. The maximum dose should not be
exceeded.
The doctor will regularly check your condition at the beginning of treatment to decrease, if necessary, the
dose or frequency of intake.

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 aged 4 to 14 years: the recommended dose is 4-12 mg (20-60 drops) per day.

Use in the elderlyand debilitated patients
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 Sandozthan you should
If you (or someone else) have taken an excessive dose of Diazepam Sandoz or if you think a child may
have taken this medicine, immediately inform 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, clouding
of the senses and reason (obnubilation), mental confusion, a tendency to continuous sleepiness (lethargy),
muscle problems (ataxia, hypotonia), unconsciousness, lowering of blood pressure, hypnosis,
difficulty breathing, rarely coma, very rarely death.
Bring this leaflet, the bottle and its container to the hospital or doctor so they know
which medicine has been consumed.

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 to take the next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Diazepam Sandoz
Donot suddenly stop treatment with Diazepam Sandoz or without first agreeing with
your doctor, because withdrawal symptomsmay occur.
If the doctor has decided to stop the 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 appear.

Treatment should 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 Sandoz. You may also
experience mood changes, anxiety, restlessness and sleep disturbances.
If you have any doubts about using 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: mental disorders, such as restlessness, agitation,
irritability, aggressiveness, feeling disappointed, 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, the
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;
• depression;
• reduced emotional capacity;
• headache, dizziness;
• fatigue, muscle weakness, difficulty controlling movements (ataxia), tremors;
• double or blurred vision;
• difficulty speaking;
• stomach and intestinal disorders, nausea, constipation, dry mouth, excessive saliva production;
• changes in sexual desire;
• skin reactions;
• if you believe you are abusing or are dependent on this medicine. Stopping therapy may cause withdrawal symptoms or rebound (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 greater in the elderly and in patients taking sedatives at the same time;
• low 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 Sandoz

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 pack after “Exp.”.
The expiry date refers to the last day of that month.
The product must be used within 3 months of first opening the bottle. Excess product must
be discarded.
Do not dispose of any medicine in waste water 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 Sandoz contains

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

Description of the appearance of Diazepam Sandoz and contents of the pack
Pack containing a 20 ml bottle of solution.

Marketing Authorisation 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