TRANQUIRIT 0.5 % Капли для приема внутрь, раствор

Содержание инструкции

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

TRANQUIRIT 5 mg/ml oral drops, solution

Diazepam

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

1. What is TRANQUIRIT and what is it used for

TRANQUIRIT 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:

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

2. What you need to know before you take TRANQUIRIT

Do not take TRANQUIRIT

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

Warnings and precautions
Talk to your doctor or pharmacist before taking TRANQUIRIT.
Avoid taking this medicine if you have an alcohol or drug addiction that depresses the central nervous
system, unless absolutely necessary.
Take this medicine with caution and always under the supervision of your doctor in the following cases:

• if you are elderly or debilitated (see section 3 How to take TRANQUIRIT - 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 or chronic respiratory failure). The doctor may decide to reduce the dose;
• if you have abused alcohol or drugs in the past;
• if you have liver (even if not severe) or kidney problems.

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 you run the risk of developing dependence, i.e. the need to
continue taking the medicine. The risk increases with the dose and duration of treatment. The risk is
higher if you have abused drugs or alcohol in the past. Once dependence has developed,
abrupt discontinuation of treatment will be accompanied by withdrawal symptoms (see: “Stopping treatment and withdrawal”).

Withdrawal: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. To minimize these symptoms, it is recommended to gradually reduce the dose (see section if you stop taking TRANQUIRIT). 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 withdrawal.

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 disorders, stop taking the medicine immediately
and see your doctor (see section 4. Possible side effects). Such
reactions are more common in children and the elderly.

Children
The doctor will prescribe TRANQUIRIT in children only if he deems it absolutely necessary; the duration
of treatment will be as short as possible.

Other medicines and TRANQUIRIT
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, used to treat mental disorders;
• hypnotics, medicines used to promote sleep;
• anxiolytics/sedatives, used to treat anxiety;
• some strong painkillers (narcotic analgesics) can cause an increased sense of well-being when taken with TRANQUIRIT. 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.

The concomitant use of Tranquirit and opioids (strong painkillers, medicines for the treatment of addiction 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 be
considered only when other treatment options are not possible.
However, if your doctor prescribes Tranquirit 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
the doctor's dosage recommendations. It may be helpful to inform friends or family to pay attention to
the above symptoms.
Contact your doctor if you experience such symptoms.

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

Driving and using machines
The use of TRANQUIRIT can affect your ability to drive vehicles and operate machinery because you may
feel confused, forgetful, drowsy, with muscle problems. These effects are increased if you have not slept
enough. 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.

TRANQUIRIT contains ethanol (alcohol), propylene glycol and sodium
This medicine contains 81.4 mg of alcohol (ethanol) in 25 drops, which is equivalent to 0.1 ml of ethanol in 1
ml of Tranquirit. 25 drops of Tranquirit are equivalent to approximately 2 ml of beer and less than 1 ml of wine. The
small amount of alcohol in this medicine will not produce significant effects. Some
effects may occur in small or underweight children, for example feeling sleepy.
This medicine contains 120 mg of propylene glycol in 5 drops. If the child is less than 5 years old,
talk to your doctor or pharmacist before giving this medicine, especially if the child is
taking other medicines containing propylene glycol or alcohol. If you suffer from liver or kidney disease, 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.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum dose (75 drops), i.e.
essentially “sodium-free”.

3. How to take TRANQUIRIT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult 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.
The recommended dose in adults is from 15 to 25 drops, two to three times 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, it is good to shake the
bottle or turn it over several times and repeat the dispensing operation as indicated 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 evaluating your health conditions.

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.
During the treatment, your doctor may modify the dosage: always follow the prescribed dosage carefully.
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 aged between 1 and 3 years: the recommended dose is 1-6 mg (5-30 drops) per day.
Children aged between 4 and 14 years: the recommended dose is 4-12 mg (20-60 drops) per day.

Use in the elderly and people with liver or kidney problems
In the elderly and debilitated patients, a reduced dose must be administered.
The recommended dose is 2 mg (10 drops) which, if necessary, can be repeated two to three times a day.

If you take more TRANQUIRITthan you should
If you (or someone else) have taken an excessive dose of TRANQUIRIT 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 a severe slowing down (depression) of the nervous system with symptoms such as
drowsiness, confusion, muscle problems (ataxia, hypotonia), lowering of blood pressure,
difficulty breathing, coma, death.

If you forget to take TRANQUIRIT
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 TRANQUIRIT
Do not stop treatment with TRANQUIRIT suddenly or without first agreeing with your
doctor, as withdrawal symptoms or rebound insomniamay occur (see section
Warnings and precautions).
If you have any doubts about the use of 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 if you experience any of the following side effects:

• depression and mental disorders, such as restlessness, agitation, irritability, aggressiveness, delusion, 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), behavioral changes. These reactions are more likely to occur in children and the elderly;
• stomach and intestinal disorders (rarely constipation and nausea);
• changes in sexual desire;
• skin irritation.

More rarely, the following may occur:

• difficulty speaking (dysarthria);
• low blood pressure (hypotension);
• involuntary loss of urine (incontinence), difficulty urinating;
• yellowing of the skin and whites of the eyes (jaundice);
• memory loss (amnesia), more likely at high doses, possibly with behavioral disturbances (see section Warnings and precautions);
• abuse or dependence; discontinuation of therapy may cause withdrawal symptoms or rebound (see sections Warnings and precautions).

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;
• fatigue, muscle weakness, difficulty controlling movements (ataxia);
• double vision (diplopia).

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 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 TRANQUIRIT

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.
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 TRANQUIRIT contains
The active ingredient is diazepam. 1 ml (25 drops) of solution contains 5 mg of diazepam.
The other ingredients are: ethanol, glycerol, propylene glycol, sodium saccharin, lemon essence, distilled water.

Description of the appearance of TRANQUIRIT and contents of the pack
Pack containing a 20 ml bottle of solution.
The bottle has a child-resistant closure.

Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan - Italy

Manufacturer

• A. NATTERMANN & Cie. GmbH Nattermannallee 1, 50829 Cologne