DIAZEPAM 5 mg /Ml Oral Drops, Solution

Зміст інструкції

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

DIAZEPAM ZENTIVA 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 their symptoms are the same as yours, as it could 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 Zentiva is and what it is used for
• 2. What you need to know before you take Diazepam Zentiva
• 3. How to take Diazepam Zentiva
• 4. Possible side effects
• 5. How to store Diazepam Zentiva
• 6. Contents of the pack and other information

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

Diazepam Zentiva contains the active ingredient diazepam, which belongs to a group of medicines
called benzodiazepines.
Benzodiazepines are used to relieve severe states of anxiety, which cause significant distress or limit normal activities.
This medicine is indicated:

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

2. What you need to know before taking Diazepam Zentiva

Do not take Diazepam Zentiva

• 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 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 failure);
• if you have breathing problems during sleep (sleep apnea).

Warnings and precautions
Talk to your doctor or pharmacist before taking Diazepam Zentiva.
Avoid taking this medicine if you consume alcohol or medicines that depress the nervous system
(sedative effect on the brain), unless in cases of absolute necessity (e.g. acute withdrawal crises) because the medicine may cause excessive sedation (deep sedation),
difficulty breathing (respiratory depression), heart malfunction and low blood pressure (cardiovascular depression).
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you are elderly or very debilitated (weakened) (see section 3 - Use in the elderly), in these cases the 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 or chronic respiratory failure). The doctor may decide to reduce the dose;
• if you have previously abused alcohol or drugs;
• if you have liver (even if not severe) or kidney problems. Tolerance:If after a few weeks it seems to you that the medicine does not work as well as at the beginning of treatment, consult your doctor. Dependence and withdrawal: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 greater if you have previously abused drugs or alcohol. Once dependence has developed, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms which may consist of:
• headache, muscle pain,
• severe anxiety, tension, restlessness, confusion and irritability. In severe cases of withdrawal, derealization (feeling that things are not real), depersonalization (feeling of detachment from the surrounding environment), intolerance to sounds (hyperacusis), numbness and tingling of hands and feet, sensitivity to light, noise and physical contact, hallucinations (seeing and hearing things that do not exist) or seizures (sudden and uncontrollable movements) 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). You may also experience mood changes and sleep disturbances. Withdrawal symptoms (or rebound) may also appear when the medicine has been taken at the recommended doses and for a short period of time (see section 3 - If you stop taking Diazepam Zentiva). To minimize the occurrence of these symptoms, it is recommended to gradually reduce the dose (see section 3 - If you stop taking Diazepam Zentiva). For certain medicines (benzodiazepines with a short duration of action), withdrawal symptoms may occur in the interval between two doses, especially with high dosages. Withdrawal symptoms may also appear 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.
It is important to avoid abrupt discontinuation of treatment and switching from one benzodiazepine to
another (see section 3 - If you stop taking Diazepam Zentiva).

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 such as restlessness, agitation,
irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, immediately stop
taking the medicine and consult your doctor (see section 4). These reactions are more
common in children and the elderly.
For athletes: 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
The doctor will prescribe Diazepam Zentiva in children only if he/she deems it absolutely necessary; the
duration of treatment will be as short as possible.

Other medicines and Diazepam Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Be particularly careful and tell your doctor if you are taking the following medicines:

• antipsychotics (neuroleptics) and antidepressants (such as: fluvoxamine, fluoxetine), used to treat mental disorders;
• hypnotics, medicines used to promote sleep;
• anxiolytics/sedatives, used to treat anxiety;
• some strong painkillers (narcotic analgesics) that can cause an excessive sense of well-being when taken with Diazepam Zentiva. This may 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 Zentiva and opioids (strong painkillers, medicines for the
treatment of dependence and some medicines for cough) increases the risk of drowsiness, difficulty in
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 Zentiva 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 relatives to pay
attention to the signs and symptoms listed above.
Contact your doctor if you experience these symptoms.

Diazepam Zentiva with alcohol
Avoid drinking alcohol during treatment with this medicine, as it can increase the
sedative effect of the medicine and lead to difficulty breathing (respiratory depression),
heart malfunction and low blood pressure (cardiovascular depression). This negatively
affects the ability to drive vehicles and operate machinery.

Diazepam Zentiva contains propylene glycol
This medicine contains 600 mg of propylene glycol per ml equivalent to 25 drops. .
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. 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.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Diazepam Zentiva during the first 3 months of pregnancy.
If your doctor believes that you need to take Diazepam Zentiva in the later stages of pregnancy or
during labor (at high doses), your baby may experience low body temperature,
muscle weakness and some difficulty breathing immediately after birth.
If Diazepam Zentiva has been taken regularly during the later stages of pregnancy, your
baby may experience physical dependence and withdrawal.
Do not take this medicine if you are breastfeeding, as diazepam passes into breast milk.
If the medicine needs to be taken regularly, breastfeeding should be discontinued.

Driving and using machines
The use of Diazepam Zentiva may affect your ability to drive vehicles and operate machinery
because you may feel forgetful, sleepy, have muscle problems and have difficulty concentrating.
These effects are increased if you have not had enough sleep. If this happens to you, avoid driving
vehicles or operating machinery. Drinking alcohol during treatment with this medicine,
negatively affects the ability to drive vehicles and operate machinery.

Diazepam Zentiva contains ethanol (alcohol)
This medicine contains 10 vol% of ethanol (alcohol), each 10 mg dose (50 drops) contains 200
mg of ethanol equivalent to 5 ml of beer and 2 ml of wine per dose. This may be harmful to
people who suffer from alcoholism. To 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 Zentiva

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have 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.
Your doctor will establish the correct dose for you.
Adult patients: the recommended dose ranges from 2 mg (10 drops) two to three times a day to 5 mg (25 drops)
one to two times a day.
In case of hospital treatment for anxiety states, the dose may be increased to 10-20 mg three
times a day.
Take the drops of Diazepam Zentiva as follows:

• To open the bottle: press on the cap and unscrew simultaneously (Fig. 1).
• Let the drops fall into a glass holding the bottle in a vertical position with the opening facing downwards. If the liquid does not flow, it is advisable to shake the bottle and turn it over several times (Fig. 2).
• To close the bottle: screw the cap on tightly (Fig. 3).

Fig. 1Fig. 2Fig. 3
Anxiety, tension and other disorders associated with anxiety
The duration of treatment should be as short as possible and, generally, should not exceed 8-12
weeks, including a period of gradual withdrawal.
In certain cases, your doctor may decide to prolong the treatment, after reassessing
your health conditions.

Insomnia
The duration of treatment should be as short as possible. 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 prolong the treatment, after
reassessing your health conditions. During treatment, your doctor may
modify the dosage: always carefully follow the prescribed dosage.
In the treatment of insomnia, the medicine should be taken just before going to bed.

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 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 Zentiva than you should
In case of accidental ingestion/intake of this medicine, consult your doctor
immediately or go immediately to the nearest hospital.
As with other benzodiazepines, an excessive dose taken together with other medicines for
nervous system disorders (CNS depressants) or alcohol can be life-threatening.
An overdose can cause a severe slowing (depression) of the nervous system with symptoms
such as drowsiness, confusion and, in more severe cases, muscle problems (ataxia, hypotonia), lowering
of blood pressure, difficulty breathing, rarely coma, very rarely death.

If you forget to take Diazepam Zentiva
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 Zentiva
Do not stop treatment with Diazepam Zentiva suddenly or without first having
agreed it with your doctor, as withdrawal symptoms or rebound anxiety and insomnia may occur (see paragraph 2 - Warnings and precautions).
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.
Always contact your doctor if you experience any of the following side effects.
Contact your doctor immediately 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 touch with reality and the ability to think and judge clearly), changes in behavior. These reactions are more likely to occur in children and the elderly. The following side effects mainly appear at the beginning of therapy and usually disappear with continued treatment:
• drowsiness (during the day), reduced alertness, confusion;
• reduced emotional capacity;
• headache, dizziness, lightheadedness;
• fatigue, muscle weakness, difficulty controlling movements (ataxia), tremors;
• double vision (diplopia) or blurred vision. You may also experience:
• difficulty speaking (dysarthria);
• stomach and intestinal disorders, nausea, constipation, dry mouth, excessive salivation;
• changes in sexual desire;
• skin irritations;
• excessive use of the medicine (abuse) and dependence;
• withdrawal symptoms or rebound (see section 3 - If you stop treatment with Diazepam Zentiva);
• memory loss (amnesia) sometimes associated with changes in behavior (see section 2 - Warnings and precautions);
• falls and subsequent fractures. The risk of fractures is greater in the elderly;
• lowering of blood pressure (hypotension), with reduced heart function (heart failure and circulatory depression) up to cardiac arrest;
• irregular heartbeat;
• involuntary loss of urine (incontinence), difficulty urinating (urinary retention);
• difficulty breathing (respiratory depression, respiratory failure);
• dizziness, tremor, blurred vision. Very rarely, the following may occur:
• altered blood tests with increased values of those relating to the liver (transaminases and alkaline phosphatase);
• jaundice (yellowing of the skin and whites of the eyes). Reporting ofside effectsIf 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 www.agenziafarmaco.gov.it/content/come-segnalare- una-sospetta-reazione-avversa. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Diazepam Zentiva

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.
The medicine must be used within 3 months of first opening the bottle. Excess medicine must be discarded.
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 Zentiva contains
The active ingredient is diazepam. 1 ml (25 drops) of solution contains 5 mg of diazepam.
The other ingredients are: ethyl alcohol, 85% glycerol, saccharin, propylene glycol, soluble orange essence, soluble lemon essence, erythrosine (E 127), purified water.

Description of the appearance of Diazepam Zentiva and contents of the pack
Pack containing a 20 ml bottle of solution.
The bottle has a safety closure to protect it from tampering by children.

Marketing Authorisation Holder
Zentiva Italia S.r.l.- Viale Bodio, 37/b – 20158 Milano

Manufacturer
ABC Farmaceutici S.p.A., Via Cantone Moretti 29, Località San Bernardo, 10015 Ivrea (TO)