Delorazepam Mylan Pharma

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Delorazepam Mylan Pharma 1 mg/ml oral drops, solution

Delorazepam
EQUIVALENT MEDICINE
Read this entire leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Delorazepam Mylan Pharma is and what it is used for

Delorazepam Mylan Pharma contains the active substance delorazepam, which belongs to a
group of medicines called benzodiazepines.
Benzodiazepines are used to relieve severe anxiety states, which cause significant distress to the
individual.
This medicine is indicated for the treatment of:

• anxiety, tension, and other anxiety-related disorders
• sleep disorders (insomnia)

2. What you should know before taking 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 causing muscle weakness and fatigue
• if you have severe respiratory insufficiency
• if you have severe liver problems (hepatic insufficiency)
• if you have breathing difficulties during sleep (sleep apnea)
• if you have a type of eye disease called narrow-angle glaucoma
• if you have alcohol intoxication or intoxication from other medicines that depress the central nervous system (hypnotics, analgesics, neuroleptics, antidepressants, lithium)
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”)

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

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

Tolerance: If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence: There is a risk of dependence when taking this medicine, meaning a need to continue taking it. The risk increases with higher doses and longer duration of treatment. The risk is greater if you have previously suffered from psychiatric disorders or have abused drugs or alcohol. Drug dependence may occur even at therapeutic doses and even in the absence of risk factors.
Withdrawal: When stopping treatment with 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 recommended doses and for a short period (see section “If you stop taking Delorazepam Mylan Pharma”). In severe cases, the following may occur: derealization (feeling that things are unreal), depersonalization (feeling of detachment from the surrounding environment), sound intolerance (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical touch, hallucinations (seeing or hearing things that do not exist), or epileptic seizures.
To minimize these symptoms, it is recommended to gradually reduce the dose.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.
Other symptoms include: depression, insomnia, sweating, persistent ringing in the ears (tinnitus), involuntary movements, vomiting, altered sensation in hands and feet (paresthesia), altered perception, abdominal and muscle pain, tremor, muscle inflammation (myalgia), agitation, sensation of increased heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, dizziness, increased reflexes (hyperreflexia), short-term memory loss, and increased body temperature (hyperthermia).
Amnesia:
Amnesia (memory loss) may occur. This is more common several hours after taking the medicine. To reduce these risks, it is recommended to take the medicine immediately before going to sleep. Ensure an uninterrupted sleep of 7–8 hours.
Behavioral reactions: If you experience behavioral disturbances, stop taking the medicine immediately (see section 4. “Possible side effects”). These reactions are more frequent in children and elderly patients.
In some patients, a syndrome may develop involving various memory and behavioral disturbances, such as restlessness, agitation, irritability, aggressiveness, delirium, rage, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a severe mental condition in which a person loses touch with reality and the ability to think and judge clearly), and behavioral changes. This syndrome may be accompanied by potentially dangerous behaviors toward oneself or others, such as unusual behavior, self-harm (self-injury), or aggression (especially toward people trying to limit one’s activities). If you think this condition may apply to you, consult your doctor to stop taking the medicine immediately (see section 4. Possible side effects). These reactions are more frequent in children and elderly patients.
Benzodiazepines are not recommended for psychotic disorders 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
Delorazepam Mylan Pharma should be used in children and adolescents under 18 years of age only when absolutely necessary, and treatment duration should be as short as possible.
Other medicines and Delorazepam Mylan Pharma
Inform 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 (neuroleptics) and antidepressants, used to treat psychiatric disorders
• hypnotics, medicines used to promote sleep
• anxiolytics, tranquillizers, and sedatives, used to treat anxiety
• certain strong painkillers (opioids), which may cause increased feelings 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 sedative effects, used to treat allergies
• anesthetics, used during surgical procedures
• medicines that increase or decrease delorazepam metabolism
• theophylline and aminophylline, used to treat asthma or other respiratory diseases, especially in the elderly

Concomitant use of Delorazepam Mylan Pharma and opioids (strong analgesics, medicines for addiction treatment, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Delorazepam Mylan Pharma together with opioids, the dose and duration of concomitant treatment must be strictly limited by the doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow the prescribed dosage recommendations. It may be helpful to inform friends or family members to watch for the symptoms listed above.
Contact your doctor if you experience any of these symptoms.
Delorazepam Mylan Pharma and alcohol
Avoid alcohol consumption during treatment with this medicine, as it may enhance the sedative effect. This negatively affects your ability to drive vehicles or operate machinery.
Fertility, pregnancy, and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Fertility
If you start treatment with Delorazepam Mylan Pharma and are of childbearing age, consult your doctor if you plan to become pregnant, as treatment may need to be discontinued.
Pregnancy
Do not take Delorazepam Mylan Pharma during pregnancy, as it may harm the unborn child.
If your doctor considers it necessary for you to take this medicine in the late stages of pregnancy, your baby may develop the floppy infant syndrome, characterized by low body temperature, loss of muscle tone, and breathing difficulties.
If Delorazepam Mylan Pharma has been taken regularly during late pregnancy, your baby may develop physical dependence and withdrawal symptoms.
Breastfeeding
Do not take this medicine while breastfeeding, as delorazepam passes into breast milk.
It is advisable to stop breastfeeding if regular use of the medicine is required.
Driving and using machines
The use of Delorazepam Mylan Pharma may impair your ability to drive vehicles or operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects may worsen if you have not had sufficient sleep. If this occurs, avoid driving or operating machinery. Alcohol consumption during treatment with this medicine negatively affects your ability to drive and use machinery.
Delorazepam Mylan Pharma oral drops contain ethanol (alcohol), sodium (from sodium saccharin), and propylene glycol.
This medicine contains 201.6 mg of alcohol (ethanol) per 52 drops (2 mL) dose. 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 is not expected to produce significant effects.
Delorazepam Mylan Pharma contains less than 1 mmol (23 mg) of sodium (as sodium saccharin) per dose (52 drops, 2 mL), i.e., essentially ‘sodium-free’.
Delorazepam Mylan Pharma contains 1503.2 mg of propylene glycol per 52-drop dose (2 mL).
If the child is under 5 years of age, consult 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, or if you have liver or kidney disease, do not take this medicine unless otherwise advised by your doctor. Your doctor may perform additional monitoring during treatment.

3. How to take Delorazepam Mylan Pharma

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
You must continue taking this medicine for as long as your doctor tells you to do so.
Your doctor will adjust the dose according to your individual needs.

Treatment of anxiety, tension, and other anxiety-related disorders: The dose varies depending on your individual needs and as prescribed by your doctor. The recommended average dose is 13–26 drops, taken 2 or 3 times daily.
In neuropsychiatry, the dose may be increased to 26–52 drops, 2 or 3 times daily, as prescribed by the doctor.
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, the doctor may decide to extend the treatment after evaluating your health condition.

Treatment of insomnia: The dose varies depending on your individual needs and as prescribed by your doctor. The recommended average dose is 13, 26, or 52 drops daily, taken in the evening before going to bed, diluted with a small amount of 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 withdrawal.
In certain cases, the doctor may decide to extend the treatment after evaluating your health condition.

Treatment should be initiated with the lowest recommended dose. The maximum dose must not be exceeded.
Your doctor will regularly monitor your condition at the beginning of treatment and may reduce the dose or frequency of administration if necessary.

Use in elderly patients and in patients with kidney or liver problems
In elderly and debilitated patients, a reduced dose should be administered, with close monitoring of the patient.

If you take more Delorazepam Mylan Pharma than you should
If you have taken an excessive dose of Delorazepam Mylan Pharma or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause profound depression of the central nervous system, with symptoms such as drowsiness, fatigue, progressive loss of muscle coordination (ataxia), visual disturbances, confusion, lethargy, unconsciousness, reduced muscle tone (hypotonia), low blood pressure (hypotension), breathing difficulties (respiratory depression), nervous system depression which may worsen to coma and death.
Take this leaflet, the bottle, and its container with you to the hospital or doctor so that they know which medicine has been taken.

If you forget to take Delorazepam Mylan Pharma
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your 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 discussing it with your doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, they will gradually reduce your 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), sound intolerance (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical touch, hallucinations (seeing or hearing things that are not real), or epileptic seizures. Other symptoms include: depression, insomnia, sweating, persistent ringing in the ears (tinnitus), involuntary movements, vomiting, altered sensation in hands and feet (paresthesia), altered perception, abdominal and muscle pain, tremor, muscle inflammation (myalgia), agitation, sensation 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 return more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is higher if you stop taking Delorazepam Mylan Pharma suddenly. You may also experience mood changes, anxiety, restlessness, and sleep disturbances.

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 immediately if you experience:

• depression and behavioural reactions such as restlessness, agitation, irritability, aggression, delirium, rage, 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), behavioural changes, sleepwalking, and temporary loss of consciousness (syncope). If any of these side effects occur, treatment must be discontinued. These reactions are more frequent in children and elderly patients (see section "Warnings and precautions").

Other possible side effects include:
Very common (may affect more than 1 in 10 people):

• loss of muscular coordination (ataxia)

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

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

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

• altered sexual desire

Rare (may affect up to 1 in 1,000 people):

• decrease in platelets (thrombocytopenia), decrease in white blood cells (agranulocytosis), decrease in all blood cells (pancytopenia)
• disturbance in the secretion of antidiuretic hormone (SIADH)
• disinhibition, euphoria, suicidal thoughts/attempts (suicidal ideation/suicide attempts)
• tremors, dizziness, headache (cephalalgia), speech problems (dysarthria/difficulty articulating speech), memory loss, coma
• paradoxical reactions and amnesia (see section "Warnings and precautions")
• double vision, blurred vision
• reduced blood pressure (hypotension)
• nausea, constipation
• jaundice, a condition characterized by yellowing of the skin and whites of the eyes
• increased liver enzyme levels (transaminases), increased bilirubin, increased alkaline phosphatase
• skin rash, hair loss (alopecia)
• involuntary loss of urine (incontinence)
• reduced body temperature (hypothermia)

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

• sudden potentially life-threatening allergic reactions (anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing or swallowing (angioedema)
• changes in appetite, reduced sodium levels in the blood (hyponatraemia)
• anxiety, agitation, sleep disturbances
• seizures, epileptic fits, disturbances in balance, attention and concentration, disorientation
• respiratory depression, apnoea, breathing difficulties during sleep (sleep apnoea), worsening of lung diseases (pulmonary obstructive disease)
• stomach and intestinal disorders
• skin reactions

The use of benzodiazepines may lead to the development of physical and psychological dependence, drug abuse, and withdrawal symptoms (see sections "Warnings and precautions" and "If you stop taking Delorazepam Mylan Pharma").
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 STATED ON THE
PACKAGING AFTER “EXP.”
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, stored correctly.
Oral drops must be used within 12 months after first opening the bottle. Any remaining product should be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Delorazepam Mylan Pharma contains

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

Description of the appearance of Delorazepam Mylan Pharma and package contents
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)