DELORAZEPAM 1 mg /Ml Oral Drops, Solution

Зміст інструкції

1. Delorazepam Mylan Pharma 1 mg/ml oral drops, solution
   1. What is Delorazepam Mylan Pharma and what is it used for?
   2. What you need to know before you take Delorazepam Mylan Pharma
2. Delorazepam Mylan Pharma contains less than 1 mmol (23 mg) of sodium (as sodium saccharin) per dose (52 drops, 2 ml), which is essentially ‘sodium-free’.Delorazepam Mylan Pharma contains 1503.2 mg of propylene glycolper dose equivalent to 52drops (2 ml).If the child is less than 5 years of age, talk to your doctor or pharmacist beforeadministering this medicine, especially if the child is taking other medicinescontaining propylene glycol or alcohol.If you are pregnant or breastfeeding, if you suffer from liver or kidney diseases, do nottake this medicine unless otherwise recommended by your doctor. The doctor may performfurther checks during therapy.
   1. How to take Delorazepam Mylan Pharma
   2. Possible side effects
   3. HOW TO STORE Delorazepam Mylan Pharma
   4. Contents of the pack and other information

Delorazepam Mylan Pharma 1 mg/ml oral drops, solution

Delorazepam

EQUIVALENT MEDICINE
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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Delorazepam Mylan Pharma and what is it used for?

Delorazepam Mylan Pharma contains the active ingredient delorazepam, which belongs to a
group of medicines called benzodiazepines.
Benzodiazepines are used to relieve severe states of anxiety, which subject the
patient to severe discomfort.
This medicine is indicated for the treatment of:

• anxiety, tension and other disorders associated with anxiety
• sleep disorders (insomnia)

2. What you need to know before you take Delorazepam Mylan Pharma

Do not take Delorazepam Mylan Pharma

• if you are allergic to delorazepam, 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 suffer from severe respiratory failure
• if you have serious liver problems (hepatic insufficiency)
• if you have trouble breathing during sleep (sleep apnea)
• if you have an eye disease called narrow-angle glaucoma
• if you have an intoxication from alcohol or other medicines that depress the nervous system (hypnotics, analgesics, neuroleptics, antidepressants, lithium)
• if you are pregnant or if you are breastfeeding (see section “Pregnancy and breastfeeding”)

Warnings and precautions
Talk to your doctor or pharmacist before taking Delorazepam Mylan Pharma.
Be careful when using the medicine because it can cause serious breathing problems,
life-threatening (respiratory depression) and severe allergic reactions (anaphylactic/anaphylactoid reactions) associated with swelling of the tongue, larynx and throat that can cause
problems with breathing and swallowing (angioedema), shortness of breath (dyspnea), closure
of the throat, nausea and vomiting. The doctor will continuously assess the need to continue the
therapy.
These problems have been reported after taking the first dose or subsequent doses of
benzodiazepines. The doctor will continuously assess the need to continue therapy and, in
case of angioedema, will tell you not to resume treatment.
Take this medicine with caution and always under the supervision of your doctor in the following
cases:

• if you are elderly. In this case, the doctor may decide to reduce the dose to avoid side effects such as muscle weakness, dizziness, drowsiness, fatigue, exhaustion, progressive loss of muscle coordination (ataxia), which can increase the risk of falls and fractures
• if you have breathing problems (respiratory failure). In this case, the doctor may decide to reduce the dose
• if you have serious liver problems (hepatic insufficiency) or suffer from mental confusion due to liver failure (hepatic encephalopathy)
• if you have serious kidney problems (renal insufficiency)
• if you have low blood pressure or heart problems (heart failure). In this case, the doctor may decide to subject you to regular checks.
• if you suffer from depression or if you have abused alcohol or drugs in the past.

Tolerance:If after a few weeks you feel that the medicine is not working as well
as 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 suffered from psychiatric disorders in the past or have
abused drugs or alcohol. Dependence on the drug can manifest even at therapeutic doses and if you have no risk factors.

Withdrawal:When you stop taking Delorazepam Mylan Pharma, you may experience
withdrawal or rebound symptoms (such as headache, muscle pain, extreme anxiety,
tension, restlessness, confusion and irritability), even if you have taken the medicine at the recommended doses
and for a short period of time (see section “If you stop taking Delorazepam Mylan Pharma”). In severe cases, the following may occur: 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 epileptic seizures.
To minimize these symptoms, it is recommended to gradually reduce the dose.
Withdrawal symptoms can also occur 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.
Other symptoms are: depression, insomnia, sweating, persistent ringing in the ear
(tinnitus), involuntary movements, vomiting, altered sensitivity of hands and feet
(paresthesia), altered perception, abdominal and muscle pain, tremor,
muscle inflammation (myalgia), agitation, feeling of increased heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, dizziness,
increased reflexes (hyperreflexia), short-term memory loss, increased
body temperature (hyperthermia).

Amnesia:
amnesia (memory loss) may occur. This happens more often many hours after
ingestion of the medicine. To reduce these risks, it is recommended to take the medicine
immediately before going to sleep. Make sure you get 7-8 hours of uninterrupted sleep.

Behavioral reactions: If you experience behavioral disorders, stop
taking the medicine immediately (see section 4. “Possible side effects”). These reactions are more common in children and the elderly.
In some patients, a syndrome may occur that associates several disorders of
memory and behavior, such as restlessness, agitation, irritability, aggression,
delirium, anger, nightmares, hallucinations (seeing and hearing things that do not exist), psychosis (serious
condition of the mind in which a person loses contact with reality and the ability
to think and judge clearly), alterations in behavior. This syndrome may
be accompanied by behaviors potentially dangerous to themselves or others, such as: unusual behavior, self-harm (harming oneself),
aggression (especially towards people who try to limit their activity). If you think
this condition may concern you, consult your doctor to stop
taking the medicine immediately (see section 4. Possible side effects). These reactions are more common in children and the elderly.
Benzodiazepines are not recommended for psychotic illnesses and should not be
used alone to treat depression or insomnia associated with depression, as suicidal thoughts may occur in such
patients.

Children and adolescents
In children and adolescents under 18 years of age, Delorazepam Mylan Pharma must
be used only in cases of absolute necessity and the duration of treatment must be the
shortest possible.

Other medicines and Delorazepam Mylan Pharma
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, tranquilizers and sedatives, used to treat anxiety
• some strong painkillers (opioids), which can cause an increased sense of well-being when taken with Delorazepam Mylan Pharma. This may increase your desire to continue taking these medicines (dependence).
• antiepileptics, used for epilepsy
• antihistamines with a sedative effect, used to treat allergies
• anesthetics, used during a surgical operation
• medicines that increase or decrease the metabolism of delorazepam
• theophylline and aminophylline, used to treat asthma or other respiratory diseases, especially in the elderly.

The concomitant use of Delorazepam Mylan Pharma and opioids (strong painkillers, medicines for
addiction therapy 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 Delorazepam Mylan Pharma 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 follow
carefully the recommended dose that has been indicated to you. It may be helpful
to inform friends or family members to pay attention to the signs and symptoms listed above.
Contact your doctor if you experience these symptoms.

Delorazepam Mylan Pharma with alcohol
Avoid taking 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
use machinery.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Fertility
If you start treatment with Delorazepam Mylan Pharma while of childbearing potential, consult your doctor if
you intend to become pregnant, as the administration of the medicine will need to be discontinued.
Pregnancy
Do not take Delorazepam Mylan Pharma during pregnancy, as it can cause harm to
the baby.
If your doctor believes you should take this medicine in the late stages of
pregnancy, your baby may develop floppy baby syndrome, characterized by
low body temperature, loss of muscle tone, difficulty breathing.
If Delorazepam Mylan Pharma has been taken regularly during the late stages of
pregnancy, your baby may develop physical dependence and withdrawal symptoms.
Breastfeeding
Do not take this medicine if you are breastfeeding, as delorazepam passes into
breast milk.
It is appropriate to discontinue breastfeeding if the medicine needs to be taken
regularly.

Driving and using machines
The use of Delorazepam Mylan Pharma may affect your ability to drive vehicles and
use machinery because you may feel confused, forgetful, drowsy, with muscle tone problems. These effects are increased if you have not slept enough. If this
happens to you, avoid driving vehicles or using machinery. Taking alcohol during
treatment with this medicine negatively affects the ability to drive vehicles
and use machinery.

Delorazepam Mylan Pharma oral drops contains ethanol (alcohol), sodium (from sodium saccharin)
and propylene glycol.
This medicine contains 201.6 mg of alcohol (ethanol) per dose of 52 drops (2 ml). The
amount in 2 mL of this medicine is equivalent to 5 mL of beer or 2 mL of wine.
The small amount of alcohol in this medicine will not produce significant effects.

Delorazepam Mylan Pharma contains less than 1 mmol (23 mg) of sodium (as sodium saccharin) per dose (52 drops, 2 ml), which is essentially ‘sodium-free’.
Delorazepam Mylan Pharma contains 1503.2 mg of propylene glycolper dose equivalent to 52
drops (2 ml).
If the child is less than 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, if you suffer from liver or kidney diseases, do not
take this medicine unless otherwise recommended by your doctor. The doctor may perform
further checks during therapy.

sodica) per dose (52 gocce, 2 ml), cioè essenzialmente ‘senza sodio’.
Delorazepam Mylan Pharma contiene 1503.2 mg di glicole propilenicoper dose pari a 52
gocce (2 ml).
Se il bambino ha meno di 5 anni di età, parli con il medico o il farmacista prima di
somministrare questo medicinale, in particolare se il bambino sta assumendo altri medicinali
contenenti propilene glicole o alcol.
Se lei è in gravidanza o sta allattando, se soffre di malattie al fegato o ai reni, non prenda
questo medicinale se non diversamente raccomandato dal medico. Il medico potrà fare
ulteriori controlli durante la terapia.

3. How to take Delorazepam Mylan Pharma

Take this medicine following exactly the instructions of your doctor or pharmacist. 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 doctor will adjust the dose according to your needs.

Treatment of anxiety, tension and other disorders associated with anxiety:the dose varies according to
your needs, as prescribed by your doctor: the average recommended dose is 13-26 drops, 2 or 3 times a day.
In neuropsychiatry the dose may be increased to 26-52 drops, 2 or 3 times a day, as prescribed by your doctor.
The duration of treatment should be as short as possible and 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 conditions.

Treatment of insomnia:the dose varies according to your needs, as prescribed by the doctor: the average recommended dose is 13 drops or 26 drops or 52 drops per day to
be taken in the evening before going to bed, diluted with a little water.
The duration of treatment should be as short as possible and generally 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 conditions.
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 administration.

Use in the elderly and people with kidney and liver problems
In the elderly and debilitated patients, a reduced dose should be administered while keeping the
patient under close observation.

If you take more Delorazepam Mylan Pharma than you should
If you have taken an excessive dose of Delorazepam Mylan Pharma 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 depression of the nervous system with symptoms such as
drowsiness, fatigue, progressive loss of muscle coordination (ataxia), visual disturbances,
mental confusion, lethargy, unconsciousness, reduced muscle tone
(hypotonia), low blood pressure (hypotension), breathing problems
(respiratory depression), nervous system depression that can worsen to coma
and death.
Bring this leaflet, the bottle and its container to the hospital or doctor so that they know which medicine was taken.

If you forget to take Delorazepam Mylan Pharma
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 missed dose.

If you stop taking Delorazepam Mylan Pharma
Do not stop treatment with Delorazepam Mylan Pharma suddenly or without
first agreeing it with your doctor, as withdrawal symptoms may 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 occur. Other symptoms are: depression, insomnia, sweating, persistent ringing in the ear (tinnitus), involuntary movements, vomiting, altered sensitivity of hands and feet (paresthesia), altered perception, abdominal and muscle pain, tremor, muscle inflammation (myalgia), agitation, feeling of increased heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, dizziness, increased reflexes (hyperreflexia), short-term memory loss, increased body temperature (hyperthermia).

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 Delorazepam
Mylan Pharma. You may also experience mood changes, anxiety,
restlessness and sleep disturbances.

IF YOU HAVE ANY FURTHER QUESTIONS ON 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 everyone will experience them.
Seek immediate medical attention if you experience:

• depression and behavioral reactions, such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a serious condition of the mind in which a person loses contact with reality and the ability to think and judge clearly), changes in behavior, sleepwalking and temporary loss of consciousness (syncope). Treatment should be discontinued if these side effects occur. These reactions are more common in children and the elderly (see section “Warnings and precautions”).

The following side effects may also occur

Very common(may affect more than 1 in 10 people):

• loss of muscle coordination (ataxia)

Common(may affect up to 1 in 10 people):

• confusion, reduced alertness
• reduced emotional capacity
• drowsiness, sedation
• increased heart rate (tachycardia)
• muscle weakness
• fatigue, reduced muscle strength (asthenia)

Uncommon(may affect up to 1 in 100 people):

• alteration of sexual desire

Rare(may affect up to 1 in 1000 people):

• decreased platelets (thrombocytopenia), decreased white blood cells (agranulocytosis), decreased of all blood cells (pancytopenia)
• alteration of the secretion of the antidiuretic hormone (SIADH)
• disinhibition, euphoria, tendency to self-harm (suicidal ideation/attempts)
• tremors, dizziness, headache, speech problems (dysarthria/difficulty articulating speech), memory loss, coma
• paradoxical reactions and amnesia (see section “Warnings and precautions”)
• double vision, blurred vision
• decreased blood pressure (hypotension)
• nausea, constipation
• jaundice, a disease characterized by a yellowish discoloration of the skin and whites of the eyes
• increased levels of liver enzymes (transaminases), increased bilirubin, increased alkaline phosphatase
• skin rash, hair loss (alopecia)
• involuntary loss of urine (incontinence)
• decreased body temperature (hypothermia)

Frequency not known(the frequency cannot be estimated based on available data):

• sudden, life-threatening allergic reactions (anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat that can cause difficulty breathing and swallowing (angioedema)
• changes in appetite, decreased sodium levels in the blood (hyponatremia)
• anxiety, agitation, sleep disorders
• convulsions, seizures, balance disorders, attention and concentration disorders, disorientation
• respiratory depression, apnea, problems breathing during the night (sleep apnea), worsening of lung diseases (obstructive pulmonary disease)
• stomach and intestinal disorders
• skin reactions

The use of benzodiazepines can lead to the development of dependence (physical and psychological) on the medicine, drug abuse, withdrawal symptoms (see sections “Warnings and precautions” and “If you stop taking Delorazepam Mylan Pharma”)

Reporting of side effects
If you experience any side effects, including 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 Delorazepam Mylan Pharma

Keep this medicine out of the sight and reach of children.

DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE WHICH IS REPORTED ON THE
PACKAGING AFTER “EXP.”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly
stored.
Oral drops must be used within 12 months of first opening the bottle. Excess product 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 Delorazepam Mylan Pharma contains

• The active ingredient is delorazepam. 1 ml of solution contains 1 mg of delorazepam.
• The other ingredients are: purified water, 96 percent ethanol, glycamil N, glycerol, propylene glycol, sodium saccharin.

Description of the appearance of Delorazepam Mylan Pharma and contents of the pack
Pack containing 1 bottle of 20 or 30 ml of oral solution.

MARKETING AUTHORISATION HOLDER
Mylan S.p.A.
Via Vittor Pisani, 20

• 20124 - Milan

MANUFACTURER
ABC Farmaceutici S.p.A., Canton Moretti 29, Località San Bernardo, 10090 Ivrea (TO)