ANSIOLIN 5 мг/мл Капли оральные, раствор

Содержание инструкции

1. Ansiolin 5 mg film-coated tablets, 5 mg/ml oral drops, solution
   1. What is Ansiolin and what is it used for
   2. What you need to know before taking Ansiolin
   3. How to take Ansiolin
   4. Possible side effects
   5. How to store Ansiolin
   6. Package contents and other information

Ansiolin 5 mg film-coated tablets, 5 mg/ml oral drops, solution

diazepam
Read 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 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 mentioned in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Ansiolin and what is it used for

Ansiolin contains diazepam, which belongs to a class of medicines called “benzodiazepines”.
Ansiolin is used in the treatment of anxiety, tension and other physical or
mental manifestations associated with anxiety and in the treatment of sleep problems (insomnia).
Medicines of the same class as Ansiolin (benzodiazepines) are indicated only when the disorder is
severe, disabling or leads to significant distress.

2. What you need to know before taking Ansiolin

Do not take Ansiolin

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from an autoimmune disease characterized by muscle weakness (myasthenia gravis),
• if you suffer from severe breathing problems (severe respiratory failure),
• if you suffer from severe liver problems (severe hepatic failure),
• if you suffer from a disorder characterized by interruption or excessive slowing of breathing during sleep (sleep apnea syndrome).

Warnings and precautions
Consult your doctor or pharmacist before taking Ansiolin.
The doctor will carefully choose the dose of Ansiolin that you must take if you are:

• an elderly person,
• debilitated or have brain diseases (organic brain diseases especially arteriosclerotic) or severe heart and breathing problems (cardiorespiratory insufficiency).

The doctor will prescribe a lower dose of Ansiolin if you suffer from respiratory problems
(chronic respiratory failure) due to the risk of respiratory depression.
Benzodiazepines are not recommended for the treatment of a mental illness called “psychotic
illness” and should not be used alone to treat depression or anxiety associated with
depression (because it can increase the risk of suicide).
While taking Ansiolin, avoid the concomitant use of alcohol or medicines that depress
the activity of the central nervous system because it can increase the sedative action of diazepam, as well as
cause depression of respiratory and/or cardiovascular function (see “Other medicines and
Ansiolin”).
Use Ansiolin with extreme caution if you have previously abused drugs or alcohol.

Tolerance
A certain loss of effectiveness to the hypnotic effects of benzodiazepines can develop after repeated
use for several weeks.

Dependence
The use of benzodiazepines can lead to the development of physical and psychological dependence on these
medicines. The risk of dependence increases with the dose and duration of treatment and is greater if
you have a history of drug or alcohol abuse.
Once physical dependence has developed, if you suddenly stop treatment, the following withdrawal symptoms may appear: headache, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability. In severe cases, you may experience the following symptoms: feeling out of reality (derealization), feeling estranged from your own body (depersonalization), auditory disturbances with increased sensitivity and intolerance to sounds (hyperacusis), temporary loss of sensitivity (numbness) and tingling in the extremities, hypersensitivity to light, noise, and physical contact, hallucinations, or seizures (see “Possible side effects”).
There is evidence to suggest that, in the case of benzodiazepines with a short duration of action, withdrawal symptoms may become apparent within the dosing interval between one dose and the next, especially at high doses.
It is not recommended to switch from long-acting benzodiazepines to benzodiazepines with a short duration of action as withdrawal symptoms may occur.

Rebound insomnia and anxiety
When you stop treatment, a transient syndrome may occur in which the symptoms that led to treatment with benzodiazepines recur in an aggravated form. It may be accompanied by other reactions, including mood changes, anxiety, restlessness, or sleep disturbances. Because the risk of withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, the dosage of the medicine should be gradually reduced.

Laboratory tests
In case of prolonged treatment, the doctor will subject you to blood tests and liver function tests.

Memory loss (amnesia)
Benzodiazepines can induce memory loss with an inability to memorize new information (anterograde amnesia). This is more likely to occur several hours after ingestion of the medicine and, therefore, to reduce the risk, make sure you can sleep uninterruptedly for 7-8 hours (see section “Possible side effects”).

Psychiatric and paradoxical reactions
When using benzodiazepines, it is known that reactions such as restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, and behavioral changes can occur. If this should happen, the doctor will discontinue the treatment with Ansiolin. These reactions are more common in children and the elderly (see “Possible side effects”).

Children and adolescents
Benzodiazepines should not be given to children without the doctor having made a careful assessment of the actual need for treatment; the duration of treatment should be as short as possible.
Safety and efficacy in children under 6 months have not been established.

Other medicines and Ansiolin
Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.
The effects of Ansiolin may be influenced by or influence the following medicines:

• medicines that depress the central nervous system, such as medicines used to treat certain psychoses (neuroleptics), medicines that facilitate sleep (hypnotics), medicines used to treat anxiety states (anxiolytics/sedatives) or depression (antidepressants), pain medicines (narcotic analgesics), medicines for the treatment of epilepsy (antiepileptics), anesthetics, and medicines for allergies (sedative antihistamines); the use together with Ansiolin can increase the depressive effect on the central nervous system. In the case of narcotic analgesic medicines, an increase in euphoria may occur leading to an increase in psychological dependence.
• The concomitant use of Ansiolin and opioids (strong painkillers, medicines for substitution therapy and some medicines for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For these reasons, concomitant use should only be considered when other treatments are not possible. However, if your doctor prescribes Ansiolin together with opioids, the dose and duration of concomitant treatment should be limited by your doctor. Inform your doctor about all opioid medicines you are taking, and carefully follow their instructions on dosage. It may be helpful to inform your friends or relatives to pay attention to the symptoms listed above. Consult your doctor if you experience such symptoms.
• medicines that inhibit certain liver enzymes (especially cytochrome P450) such as cimetidine and omeprazole (used to reduce stomach acidity), ketoconazole (used to treat fungal infections), fluvoxamine and fluoxetina (used to treat depression or some psychiatric disorders): the use of these medicines together with Ansiolin can increase the activity of benzodiazepines leading to an increased and prolonged sedative action.

Ansiolin with alcohol
Do not take Ansiolin together with alcohol because the sedative effect may be increased. This negatively affects the ability to drive or operate machinery.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Ansiolin in the first trimester of pregnancy; in the further period, the medicine should only be administered if absolutely necessary and under the direct control of the doctor.
If, for serious reasons, you are taking Ansiolin during the last period of pregnancy or during labor at high doses, effects on the newborn such as lowering of body temperature (hypothermia), reduction of muscle tone (hypotonia) and moderate respiratory depression due to the pharmacological action of the medicine may occur.
In addition, newborns born to mothers who have taken benzodiazepine-class medicines chronically during the advanced stages of pregnancy may develop physical dependence and may be at some risk of developing withdrawal symptoms in the immediate postnatal period.

Breastfeeding
Ansiolin passes into breast milk, do not take this medicine if you are breastfeeding.

Driving and using machines
Sedation, amnesia, alteration of concentration and muscle function can negatively affect the ability to drive and operate machinery. If the duration of sleep has been insufficient, the probability that vigilance is altered may be increased.
Ansiolin can affect the motor and mental reaction ability by reducing, for example, the aptitude for driving a vehicle or altering individual behavior in road traffic or in the performance of delicate work activities.
Do not drive a vehicle during the day, or at least for the 12 hours following the administration of Ansiolin.

Ansiolin tablets contains:
lactose and glucose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Ansiolin drops contains:
This medicine contains 21 vol % ethanol (alcohol),equivalent to 170 mg per dose, equivalent to 4.2 ml of beer, 1.8 ml of wine per dose.
It 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 600 mg of propylene glycolper ml.
If the child is less than 5 years old, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
This medicine contains less than 1 mmol (23 mg) of sodiumper dose, i.e. it is essentially ‘sodium-free’

3. How to take Ansiolin

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Film-coated tablets
Adults:
The recommended dose is:
1 to 3 tablets per day, or more, according to the doctor's judgement.

Oral drops, solution
Adults:
The recommended dose is:
20 drops, 1 to 3 times a day, or more, according to the doctor's judgement.
Children:
up to 3 years: 4-24 drops, equivalent to 1-6 mg of diazepam, per day.
from 4 to 14 years: 16-48 drops, equivalent to 4-12 mg of diazepam, per day.
The drops can be diluted in a small amount of liquid.
If you are an elderly person, your doctor will assess a possible reduction of the dosages mentioned above.

Insomnia
The maximum dose must not be exceeded.
In the treatment of insomnia, take Ansiolin just before going to bed.
Your doctor will regularly evaluate you at the beginning of the treatment to reduce, if necessary, the dose or the frequency of administration to avoid excessive dosage.
Duration of treatment
The duration of treatment should be as short as possible depending on the indication:

• Anxiety, tension and other somatic or psychiatric manifestations with anxious syndrome The overall duration of treatment, generally, should not exceed 8-12 weeks, including a period of gradual discontinuation. Your doctor may need to re-evaluate you regularly. In certain cases, your doctor may decide to increase the maximum treatment period.
• Insomnia Treatment should be as short as possible. The duration of treatment, generally, varies from a few days to two weeks, up to a maximum of four weeks, including a period of gradual discontinuation. In certain cases, your doctor may decide to increase the maximum treatment period. Treatment should be started with the lowest dose.

How to use the dropper bottle:
To dispense the correct dose of medicine, 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 and repeat the dispensing operation as indicated above.

If you take more Ansiolin than you should
Taking an excessive dose of Ansiolin with other substances that depress the central nervous system (including alcohol) can be life-threatening.
Taking an excessive dose of benzodiazepines can cause depression of the central nervous system of varying degrees, ranging from loss of sensory and intellectual abilities (obnubilation) to coma. In mild cases, symptoms include sensory and intellectual abilities (obnubilation), mental confusion and a continuous feeling of sleepiness (lethargy).
In more severe cases, symptoms may include loss of muscle coordination (ataxia), loss of muscle tone (hypotonia), lowering of blood pressure (hypotension), serious breathing problems (respiratory depression), rarely coma and very rarely death.
In case of ingestion/taking an excessive dose of Ansiolin, immediately contact your doctor or the nearest hospital for the actions to be taken (inducing vomiting, within one hour if you are conscious, gastric lavage if you are unconscious, administration of medicines).

If you forget to take Ansiolin
Do not take a double dose to make up for the missed dose.
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.
Drowsiness, blunting of emotions, reduced alertness,
confusion, fatigue, headache, dizziness, muscle weakness, loss of
muscle coordination (ataxia), double vision. These effects occur mainly
at the beginning of therapy and usually disappear with subsequent administrations.
With Ansiolin, the following side effects have also been observed, the frequency of which cannot be
defined based on the available data:

Psychiatric disorders:increased or decreased sexual desire (libido)

Nervous system disorders:speech disorders (dysarthria), difficulty expressing verbally,
tremors, vertigo

Eye disorders:blurred vision

Cardiac disorders:serious heart problems (including heart failure and cardiac arrest)

Vascular disorders:low blood pressure (hypotension), circulation problems
(circulatory depression)

Respiratory, thoracic and mediastinal disorders:serious breathing problems (respiratory depression
including respiratory failure)

Gastrointestinal disorders:nausea, dry mouth or increased salivation, constipation and
other gastrointestinal disorders

Hepatobiliary disorders:jaundice

Skin and subcutaneous tissue disorders:skin (cutaneous) reactions

Renal and urinary disorders:incontinence, urinary retention

Systemic disorders and conditions related to the site of administration:
Diagnostic tests:irregular heartbeat; increased values in laboratory tests
(levels of transaminases, blood alkaline phosphatase)

Injury, poisoning and procedural complications:fractures (
)
With medicines that belong to the same class as Ansiolin (benzodiazepines), the following effects have also been
observed:

Memory impairment (Amnesia)
Benzodiazepines can cause memory impairment (anterograde amnesia) at the doses used
for therapy; the risk increases at higher doses. These effects may be associated with
behavioral changes (see “What you need to know before taking Ansiolin”).

Depression
During the use of benzodiazepines, a pre-existing depressive state may be unmasked (see
section “What you need to know before taking Ansiolin”).

Paradoxical reactions
Benzodiazepines or benzodiazepine-like compounds can cause reactions such as: restlessness,
agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, mental disorders (psychosis),
behavioral changes. Such reactions can be quite serious and are more likely in
children and the elderly (see “What you need to know before taking Ansiolin”).

Dependence
Benzodiazepines, even at therapeutic doses, can lead to the development of physical dependence
(the need to continue taking the medicine): discontinuation of therapy can cause the
reappearance of symptoms (rebound phenomena) or withdrawal (see section “What you need to know before
taking Ansiolin”). Psychological dependence can occur. Abuse of benzodiazepines has been reported.

Reporting of side 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 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 Ansiolin

Do not store at a temperature above 30°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Expires on:”
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Ansiolin contains

Film-coated tablets

• The active ingredient is diazepam. One tablet contains 5 mg of diazepam.
• The other ingredients are: lactose,corn starch, magnesium stearate, methylhydroxypropylcellulose, glucoseanhydrous, propylene glycol, polyethylene glycol.

Oral drops, solution

• The active ingredient is diazepam. 100 ml of solution contains 0.500 g of diazepam.
• The other ingredients are 96% ethanol,propylene glycol, ammonium glycyrrhizate, saccharin, sodiumhydroxide, wild cherry flavour, purified water.

Description of the appearance of Ansiolin and package contents
Ansiolin is available in the following forms:

• Film-coated tabletspack of 40 tablets
• Oral drops, solution1 bottle of 30 ml

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47, 63100 - Ascoli Piceno (AP), Italy

Manufacturer

Film-coated tablets
Industrias Farmaceuticas Almirall S.A., Ctra. Nacional II, km 593 – 08740 Sant Andreu de la Barca –
Barcelona (SPAIN)

Oral drops, solution
Industrias Farmaceuticas Almirall S.A., Ctra. Nacional II, km 593 – 08740 Sant Andreu de la Barca –
Barcelona (SPAIN)
Almirall Hermal GmbH, Scholtzstraße 3, 21465 – Reinbek Germany

Warning
The bottle of the drop formulation is equipped with a child-resistant closure system (Circular of the Ministry of Health no. 49/84); carefully observe the instructions: