DIAZEPAM 5 mg /Ml Krople Doustne, Roztwór

Treść ulotki

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

Diazepam Alter 5 mg/ml oral drops, solution

Diazepam

Generic medicine

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

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

Diazepam Alter 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;
• for treating sleep disorders (insomnia).

2. What you need to know before you take Diazepam Alter

Do not take Diazepam Alter

• 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 serious breathing problems (respiratory failure);
• if you have serious liver problems (hepatic failure);
• if you have breathing problems during sleep (sleep apnea).

Warnings and precautions
Talk to your doctor or pharmacist before taking Diazepam Alter.
Avoid taking this medicine if you have an addiction to 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 Alter - Use in the elderly”). 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 failure). The doctor may decide to reduce the dose.
• if you have abused alcohol or drugs in the past.

Tolerance:If after a few weeks you feel that the medicine no longer works as well as it did at the beginning of
treatment, consult 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 abused drugs or alcohol in the past.

Withdrawal:When you stop taking Diazepam Alter, 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 Alter”). To minimize these symptoms, it is recommended to
gradually reduce the dose.
Withdrawal symptoms may also appear 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:The duration of treatment should be as short as possible and should not exceed
four weeks for the treatment of insomnia and 8-12 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 get 7-8 hours of uninterrupted sleep.

Behavioral reactions: If you experience behavioral disturbances, such as restlessness, agitation,
irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, inform your doctor, who will
tell you to stop taking the medicine. 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 to undergo surgery requiring the use of anesthetics, inform the hospital or doctor that you are
taking Diazepam Alter.

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

Other medicines and Diazepam Alter
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, 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 Alter. 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;

The concomitant use of Diazepam Alter 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 may be life-threatening. For this reason, concomitant use should be
considered only when other treatment options are not possible.
However, if your doctor prescribes Diazepam Alter together with opioids, the dose and duration of concomitant treatment
must be limited by the doctor.
Inform 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 to pay attention to
the signs and symptoms listed above. See a doctor if you experience these symptoms.

Diazepam Alter with food, drinks and alcohol
Avoid drinking alcohol during treatment with this medicine, as it may 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.
Do not take Diazepam Alter during the first 3 months of pregnancy.
If your doctor believes you should take Diazepam Alter 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 Alter has been taken regularly during the later stages of pregnancy, your baby
may develop physical dependence and develop withdrawal symptoms.
Avoid taking this medicine if you are breastfeeding, as diazepam passes into breast milk.

Driving and using machines
The use of Diazepam Alter 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 or if you have consumed alcohol. If this happens to you, avoid driving vehicles or operating
machinery.

Diazepam Alter contains ethanol (alcohol) and propylene glycol
This medicine contains 10 vol % ethanol (alcohol), e.g. up to 200 mg per dose of 10 mg (50 drops)
equivalent to 5 ml of beer and 2 ml of wine per dose.
May be harmful to alcoholics.
To be taken into consideration in pregnant or breastfeeding women, children and high-risk groups such as people affected by liver disease or epilepsy.
This medicine contains 618 mg of propylene glycol per 1 ml of solution (5 mg of diazepam).

3. How to take Diazepam Alter

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 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.

Anxiety, tension and other disorders associated with anxiety
The duration of treatment should be as short as possible. Your doctor will regularly reassess your
condition and the need to continue treatment. The duration of treatment generally should 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
condition.

Insomnia
The duration of treatment should be as short as possible. Generally, it 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
condition.
Treatment should be started with the lowest recommended dose. The maximum dose must not be
exceeded.
Your doctor will regularly check your condition at the beginning of treatment to reduce, 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 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.
The drops should 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 establish the correct dose for you.

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, it is advisable to shake the
bottle or turn it over several times and repeat the dispensing operation as described above.

If you take more Diazepam Alterthan you should
If you (or someone else) have taken an excessive dose of Diazepam Alter 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,
confusion, muscle problems (ataxia, hypotonia), low blood pressure, difficulty
breathing, coma, death.

If you forget to take Diazepam Alter
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 Alter
Donot stop treatment with Diazepam Alter suddenly or without first agreeing with your
doctor, as withdrawal symptomsmay occur.
If your 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 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 stop taking Diazepam Alter suddenly. 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:

• depression and mental disorders, such as restlessness, agitation, irritability, aggressiveness, delirium, anger, nightmares, hallucinations (seeing or 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.

Seek medical attention if you experience any of the following side effects:

• drowsiness, even during the day, reduced alertness, confusion;
• reduced emotional capacity;
• headache, dizziness;
• fatigue, muscle weakness, difficulty controlling movements (ataxia);
• double vision;
• stomach and intestinal disorders;
• changes in sexual desire;
• skin reactions;
• memory loss (amnesia) (see section Warnings and precautions).

The use of benzodiazepines (even at therapeutic doses) can lead to the development of physical dependence: stopping the therapy may cause withdrawal symptoms or rebound (see sections “Warnings and precautions” and “If you stop taking Diazepam Alter”).

Reporting ofside 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa. By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store Diazepam Alter

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 medicine within 3 months of first opening the bottle. Dispose of any excess medicine.
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 Alter contains

• The active ingredient is diazepam. 1 ml (25 drops) of solution contains 5 mg of diazepam.
• The other ingredients are: ethyl alcohol, glycerol, saccharin, propylene glycol, soluble orange essence, soluble lemon essence, erythrosine (E127), purified water.

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

Marketing authorisation holder and manufacturer
Laboratori Alter S.r.l. - Via Egadi, 7 – 20144 Milano

Manufacturer
ABC Farmaceutici S.p.A. - Canton Moretti, 29 - 10090 S. Bernardo d'Ivrea (TO)