LORAZEPAM 1 mg Film-Coated Tablets

Зміст інструкції

1. Lorazepam Mylan Generics 1 mg tablets, 2.5 mg tablets
   1. What is Lorazepam Mylan Generics and what it is used for
   2. What you need to know before taking Lorazepam Mylan Generics
   3. How to take Lorazepam Mylan Generics
   4. Possible side effects
   5. How to store Lorazepam Mylan Generics
   6. Contents of the pack and other information
2. Lorazepam Mylan Generics 2 mg/ml oral drops, solution
   1. What is Lorazepam Mylan Generics and what is it used for
   2. What you need to know before taking Lorazepam Mylan Generics
   3. How to take Lorazepam Mylan Generics
   4. Possible side effects
   5. How to store Lorazepam Mylan Generics
   6. Contents of the pack and other information

Lorazepam Mylan Generics 1 mg tablets, 2.5 mg tablets

lorazepam

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

1. What is Lorazepam Mylan Generics and what it is used for

Lorazepam Mylan Generics contains the active ingredient lorazepam. Lorazepam belongs to a group
of medicines called benzodiazepines and acts on the central nervous system by reducing anxiety (anxiolytic effect), facilitating sleep that is entirely comparable to normal sleep (hypnotic effect), improving
mood and decreasing the intensity of emotional reactions to psychological stress (tranquilizing effect).
This medicine is used for short-term treatment of the following conditions when
they are severe and cause discomfort in normal daily life:

• anxietyand states of emotional tension associated with anxiety;
• insomnia.

2. What you need to know before taking Lorazepam Mylan Generics

Do not take Lorazepam Mylan Generics

• if you are allergic to lorazepam or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other similar medicines (benzodiazepines);
• if you suffer from a disease that causes muscle weakness and fatigue (myasthenia gravis);
• if you have serious breathing problems (respiratory failure);
• if you have serious liver problems (hepatic failure);
• if you suffer from episodes of interrupted breathing for several seconds during sleep (sleep apnea);
• if you have high pressure in the eye (narrow-angle glaucoma);
• if you are or think you might be pregnant or are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
The duration of treatment with Lorazepam Mylan Generics should be as short as possible. It is
recommended not to exceed 4 weeks for the treatment of insomnia and 8-12 weeks for the
treatment of anxiety. The recommended treatment duration also includes the period
necessary for the gradual reduction of the dosage.See section 3 How to take Lorazepam
Mylan Generics.
Talk to your doctor or pharmacist beforetaking Lorazepam Mylan Generics if you think any of
the following conditions apply to you (see also section 4 Possible side effects):

• you have or have ever had breathing problems because this medicine can decrease your natural ability to breathe. Breathing problems may also be associated with the following conditions:
• if you have heart problems (heart failure);
• if you have low blood pressure;
• if you have general breathing problems, chronic inability to breathe adequately and regularly, during exertion or at rest (chronic respiratory failure and/or chronic obstructive pulmonary disease);
• if you have trouble breathing at night (sleep apnea syndrome). If you experience any of these conditions and need to start treatment with Lorazepam Mylan Generics, your doctor will perform regular check-ups;
• you have or have ever had allergic reactions to benzodiazepines. This medicine can cause serious and rapid allergic reactions (anaphylactic reactions) or swelling of the face, tongue and throat with inability to swallow and breathe (angioedema), shortness of breath (dyspnea), nausea and vomiting. Sometimes, these reactions can be fatal. As soon as one or more symptoms appear, go to the nearest emergency room. In these cases, your doctor will advise you not to take any more medicines containing lorazepam and to continue treating the disease with other medicines;
• you have or have had problems with alcohol, drug or medicine abuse, because Lorazepam Mylan Generics can also cause dependence (see section “Development of tolerance and dependence”);
• you suffer or have ever suffered from depression, because Lorazepam Mylan Generics may worsen your condition and suicidal tendencies;
• you have or have ever had difficulty relating to other people or various life situations, even if you haven't always been aware of these difficulties. Lorazepam Mylan Generics is not recommended as the primary treatment for this condition;
• you have or have ever had liver problems (hepatic failure, hepatic encephalopathy), because this medicine could worsen your condition. Your doctor will advise you on the most suitable dosage for your condition;
• you have or have ever had kidney problems (renal failure). Your doctor will advise you on the most suitable dosage for your condition;
• if you have reduced blood flow to the brain (arteriosclerosis).

Memory disorders
After taking Lorazepam Mylan Generics you may have difficulty remembering what happened

aftertaking the medicine. Therefore, it is advisable to ensure uninterrupted sleep of
7-8 hours after taking this medicine.
Paradoxical reactions
Lorazepam Mylan Generics can cause mental reactions and effects opposite to those expected
(paradoxical effects) (see section 4 Possible side effects). These effects are more common in
children and the elderly.
If you experience these effects, see your doctor who will advise you on how to stop
taking this medicine.

Development of tolerance and dependence, withdrawal reactions and drug abuse
A reduction in effectiveness (tolerance) of this medicine may occur after continuous use.
This medicine is recommended for short-term treatment.
Treatment with this medicine also increases sensitivity to the effects of alcohol and other
medicines that affect brain function. Therefore, talk to your doctor if you are taking alcohol
or medicines of this type.
The use of benzodiazepines, including Lorazepam Mylan Generics, can cause dependence.
The risk of dependence increases with higher doses and continuous use.
The risk of dependence also increases if you have a history of alcohol or drug abuse and in patients with
significant personality disorders.
See your doctor if:

• you have taken drugs in the past or are currently taking drugs;
• you have drunk alcohol in the past or currently drink alcohol frequently and/or in large quantities;
• you have wanted to take large amounts of medicine in the past or currently have this desire;
• you suffer or have ever suffered from personality disorders, such as difficulty relating to other people or various life situations, even if you haven't always been aware of these difficulties.

In principle, benzodiazepines should only be used for short periods and discontinued
gradually. Before starting treatment, you must agree with your doctor how long
to take the medicine.
If you stop taking the medicine abruptly or quickly reduce the dosage, you may
experience withdrawal reactions. Do not stop this medicine abruptly. Ask your doctor for advice on how to stop the treatment.
Some withdrawal reactions can be life-threatening.
Withdrawal symptoms can range from mild depression and insomnia to a major syndrome
with muscle and abdominal cramps, vomiting, sweating, tremors and seizures. More severe withdrawal signs and symptoms, including life-threatening reactions, may include delirium tremens,
depression, hallucinations, mania, psychosis, seizures and suicide. Seizures/convulsions may
occur more frequently in patients with pre-existing seizure disorders or in patients taking other
medicines that lower the seizure threshold, such as antidepressants.
Other withdrawal symptoms may include: headache, anxiety, restlessness, tension, confusion,
irritability, depressed mood, dizziness, feeling detached and alienated from oneself and the world
around, excessive increase in the perception of noise, tinnitus, tingling and numbness of the limbs,
sensitivity to light, noise and touch / changes in perception, involuntary movements,
stomach pain, diarrhea, loss of appetite, panic attacks, muscle pain, states of excitement,
increased awareness of heartbeat (palpitations), increased heart rate
(tachycardia), feeling of loss of balance, increased reflexes, loss of ability to
remember recent events, and increased body temperature.
The symptoms for which this medicine was prescribed may also reappear for a short
period (rebound phenomena).
Do not give Lorazepam Mylan Generics to family members or friends. Keep this medicine safely
so that it cannot cause harm to others.
If you are elderly and/or suffer from particular health conditions
If you are elderly and/or your general health conditions are very poor or if you suffer from significant brain
diseases (especially cerebral arteriosclerosis), you are more sensitive to the effect of Lorazepam Mylan
Generics.
If you suffer from low blood pressure, this medicine may cause an increase
in episodes of low blood pressure.
Therefore, it is recommended to use this medicine at the lowest possible dosage or to avoid its use.
If you have seriousliver problems
If you suffer from serious liver problems associated or not with brain symptoms such as mental confusion,
altered level of consciousness or coma, Lorazepam Mylan Generics should not be used
because it could worsen your condition (see also section 2 “Do not take Lorazepam Mylan
Generics”).

Children and adolescents
The efficacy and safety of Lorazepam Mylan Generics in children under 12 years of age are not known.
The doctor will decide whether Lorazepam Mylan Generics can be given to children based on
their condition. The duration of treatment should be as short as possible.

Other medicines and Lorazepam Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The concomitant use of Lorazepam Mylan Generics and opioids (strong painkillers, medicines for
substitute therapy and some cough medicines) increases the risk of drowsiness, difficulty breathing
(respiratory depression), coma and can be life-threatening.
For this reason, concomitant use should only be considered when other treatment options are not
possible.
However, if your doctor prescribes Lorazepam Mylan Generics together with opioids, the dose and duration
of concomitant therapy must be limited by your doctor.
Tell 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 to make them
aware of the above signs and symptoms. Contact your doctor if these symptoms occur.
Tell your doctor or pharmacist if you are taking any of the following medicines together with Lorazepam
Mylan Generics because caution is required:

• medicines that cause a strong reduction of all brain functions, such as:
• sedatives and sleep aids (barbiturates, hypnotics/sedatives);
• medicines for the treatment of some mental illnesses (antipsychotics);
• medicines for the treatment of anxiety (anxiolytics);
• medicines for the treatment of depression (antidepressants);
• medicines for the treatment of acute or chronic pain of high intensity (narcotic analgesics, opioids);
• medicines for the treatment of seizures (antiepileptics);
• anesthetics;
• medicines to counteract allergic reactions (sedating antihistamines).

Lorazepam Mylan Generics, when administered together with anesthetic medicines, can cause euphoria, with
increased probability of developing psychic dependence;

• clozapine (a medicine used against thought disorders), because taking it together with Lorazepam Mylan Generics can cause marked sedation, increased salivation and loss of coordination of movements;
• valproate (a medicine used against seizures), because it can increase the effects of Lorazepam Mylan Generics. In this case, the doctor may decide to halve the dose of Lorazepam Mylan Generics;
• probenecid (a medicine used against gout), because it can increase the effects of Lorazepam Mylan Generics. In this case, the doctor may decide to halve the dose of Lorazepam Mylan Generics;
• theophylline and aminophylline (medicines used against bronchial asthma), because they can decrease the effects of Lorazepam Mylan Generics;
• loxapine (a medicine used against thought disorders), because taking it together with Lorazepam Mylan Generics can cause a state characterized by excessive passivity and inertia towards events and people (e.g. inability to move and mutism), significant reduction in breathing rate and lowering of blood pressure;
• baclofen (a medicine used as a muscle relaxant);
• caffeine (a substance contained mainly in coffee, but also in numerous energy drinks), because it can reduce the effects of Lorazepam Mylan Generics.

Lorazepam Mylan Generics with alcohol
Avoid drinking alcohol while taking this medicine, as it increases drowsiness and
reduction of consciousness induced by this medicine.
This can also lead to a serious impairment of the ability to drive vehicles and use
machinery (see section “Driving and using machines”).

Pregnancy and breastfeeding
If you are pregnant, suspect you might be pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy

This medicine should not be taken during pregnancy, especially during the first 3 months,because
it can cause congenital malformations in the fetus.

• If, for serious reasons, you take this medicine at high doses during the last 3 months of pregnancy, during the period preceding childbirth (labor) or during childbirth, the following symptoms may appear in the newborn:
• excessive decrease in motor activity;
• poor muscle tone;
• moderate reduction in breathing rate;
• low body temperature;
• suspension of breathing for a period of several seconds (apnea);
• feeding problems;
• decreased resistance to cold and subsequent alterations of metabolism;
• yellow/yellowish discoloration of the skin and mucous membranes (jaundice).
• If you take this medicine for a long time during the last period of pregnancy, the newborn may develop immediately after birth symptoms of physical dependence or withdrawal (see paragraph “Development of dependence”).

Breastfeeding
This medicine passes into breast milk. Your doctor will decide if you can take Lorazepam Mylan
Generics during breastfeeding.
If you breastfeed while taking this medicine, the newborn may experience drowsiness and
reduced ability to take breast milk.

Driving and operating machinery
Donot drive or operate machinery if you experience drowsiness and dizziness during treatment with Lorazepam Mylan Generics. Lorazepam Mylan Generics can also cause amnesia, impairment of
concentration ability and alterations in muscle function. Your vigilance may be altered
especially if you have not slept for a sufficient time after taking Lorazepam Mylan Generics.

Lorazepam Mylan Generics contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking this
medicine.

3. How to take Lorazepam Mylan Generics

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor.
The dose and duration of administration must be adapted to your individual condition. Your doctor will advise you on the dose and the number of daily administrations and the duration of treatment with
Lorazepam Mylan Generics, so that you take the lowest possible dose for the shortest possible time.
Do not change or exceed the prescribed dose. To stop treatment, the dose must be reduced
gradually as agreed with your doctor. This reduces the risk of withdrawal reactions, which in some
cases can be life-threatening (see section 2).
If you need to increase the dose of this medicine, your doctor will suggest how to
proceed gradually to avoid unwanted effects. If the dose of
Lorazepam Mylan Generics is increased, it is necessary to first increase the evening dose and then possibly increase
also the morning dose.
This medicine must be taken by mouth.
The tablet can be divided into equal parts.

Treatment of anxiety
The recommended duration of therapy should not exceed 8-12 weeks. This period includes
also the time needed to gradually reduce the dose of Lorazepam Mylan Generics until
suspension. The doctor will decide if the treatment can be continued beyond the maximum
recommended period.
It is advisable not to exceed the maximum daily dose.
The recommended dose is 2-3 tablets of 1 mg per day.
In severe cases, the dose may be increased to 3-4 tablets of 2.5 mg per day.

Treatment of insomnia
The recommended duration of treatment ranges from a few days to a maximum of 4 weeks. This
period also includes the time needed to gradually reduce the dose of Lorazepam Mylan
Generics until suspension. The doctor will decide if the treatment can be continued beyond the
recommended maximum period.
It is advisable not to exceed the maximum daily dose.
The recommended dose is 1-2 tablets of 1 mg at bedtime.
In cases of persistent insomnia, the recommended dose is 1 or 2 tablets of 2.5 mg at bedtime.

If you are elderly and/or your general health conditions are very poor
The recommended initial dose is 1 mg or 2 mg per day, to be divided into several doses.

If you suffer from kidney or liver problems (renal or hepatic insufficiency)
The doctor will decide from time to time the most suitable dose for you and will subject you to frequent checks.

Preparation of patients awaiting surgery
Major surgeries: the recommended dose is 2-4 mg of Lorazepam Mylan Generics, the evening
before the surgery.
Minor surgeries: the recommended dose is 2-4 mg, 1-2 hours before the surgery.
Duration of treatment
The duration of treatment is decided by the doctor. You will be prescribed the minimum effective dose for the shortest
possible time because there is a risk of becoming dependent on this medicine. The doctor will evaluate the
treatment frequently.
It is necessary to stop taking this medicine or reduce the dose slowly and under
the supervision of the doctor to prevent any withdrawal reactions (see section 2).

If you take more Lorazepam Mylan Generics than you should
If you (or someone else) have taken an excessive dose of Lorazepam Mylan Generics 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. Bring this leaflet, the bottle and its container with you
to the hospital or to the doctor so they know which medicine has been consumed.
It is important that you never take more medicine than prescribed. Generally, there are no dangers to
life if you accidentally take a dose of medicine higher than prescribed, unless you also take alcohol or other medicines.
Symptoms
In mild cases, the symptoms may be:

• confusion, drowsiness, disorientation and weakening of sensory functions;
• difficulty in articulating speech;
• mental confusion;
• continuous sleep and reduced response to normal stimuli;
• inability to completely empty the bladder;
• changes in sexual desire.

In more severe cases, when large amounts of medicine are taken with suicidal intent or when
this medicine is taken together with alcoholic beverages or other medicines that reduce the state
of consciousness and the main brain functions, the symptoms may be:

• loss of ability to coordinate movements;
• poor muscle tone;
• low blood pressure;
• excessive drowsiness;
• symptoms opposite to those expected from the effects of this medicine (paradoxical symptoms);
• reduction of all functions of the central nervous system;
• reduction of heart function;
• reduction of breathing;
• coma;
• death.

Treatment
Contact your doctor immediately or go to the nearest emergency room if you take more Lorazepam
Mylan Generics than prescribed by your doctor. If you are conscious, you will be induced to vomit within one hour
from when you took the medicine; if you are unconscious you will undergo gastric lavage. If
these procedures are not sufficient, you may be given activated charcoal to reduce
the absorption of Lorazepam Mylan Generics, or flumazenil, a medicine that counteracts the effects
of Lorazepam Mylan Generics.

If you forget to take Lorazepam Mylan Generics
Do not take a double dose to make up for a missed dose. If you forget to take a
dose, take it as soon as you remember, but make sure you can rest immediately afterwards and for a long time (7-8 hours). If you think you have missed more than one dose, consult your doctor.

If you stop taking Lorazepam Mylan Generics
Do not suddenly stop taking Lorazepam Mylan Generics unless you suspect
a serious side effect, because the doses must be reduced gradually. Your doctor will advise you
how to stop treatment.
If you think you have a serious side effect, seek immediate medical attention. If you stop
taking Lorazepam Mylan Generics or reduce the dose suddenly, you may develop
temporarily withdrawal symptoms or rebound symptoms (see section 2 “Development of
dependence”).
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.

Normally, side effects are observed at the beginning of treatment and generally
decrease in intensity or disappear with the continuation of treatment or by reducing the
dose.
Contact your doctor immediatelyif you experience any of the following side effects because
the intake of Lorazepam Mylan Generics must be stopped:

• opposite effects to those expected (paradoxical effects) (see paragraph 2 “Paradoxical reactions”) such as:
• depression or unmasking of existing depression
• restlessness
• agitation
• irritability
• aggression
• feeling of frustration
• anger
• nightmares
• hallucinations (seeing or hearing things that do not exist)
• difficulty in correctly interpreting reality and thought disorders (psychosis)
• behavioral changes
• drowsiness, even during the day
• dizziness
• loss of muscle coordination (ataxia)
• sleep disorders, insomnia
• confusion
• changes in sexual desire
• anxiety states
• feelings of hostility
• state of general excitement
• sexual excitement
• decreased ability to reach the peak of sexual excitement (orgasm)
• fatigue
• impotence

Contact your doctor immediatelyif you experience any of the following side effects because they can
be serious:

• severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue and throat that can cause difficulty swallowing or breathing (angioedema)
• difficulty remembering what happened after taking the medicine (anterograde amnesia). This may also be accompanied by behavioral changes (see paragraph 2 “Memory disorders”)
• drug abuse and drug dependence (see paragraph 2 “Development of tolerance and dependence, withdrawal reactions and drug abuse”)
• withdrawal symptoms (see paragraph 2 “Development of tolerance and dependence, withdrawal reactions and drug abuse”)
• rebound symptoms (see paragraph 2 “Development of tolerance and dependence, withdrawal reactions and drug abuse”)
• coma
• thoughts of suicide, suicide attempts
• excessive use of this medicine (abuse) or other similar medicines (benzodiazepines)
• severe decrease in the number of white blood cells in the blood, which can increase susceptibility to infections

Contact your doctor if you experience any of the following side effects:
Common side effects (may affect up to 1 in 10 people):

• muscle weakness

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

• nausea

Side effects with unknown frequency (frequency cannot be estimated based on available data):

• reduction of all cells present in the blood
• reduction in the number of platelets in the blood
• hypersensitivity reactions
• disease characterized by excessive secretion of the antidiuretic hormone that causes water retention in the body and reduced sodium levels in the blood
• changes in appetite
• decreased sodium in the blood
• disinhibition
• disorientation
• euphoria
• decreased ability to experience emotions
• alteration of the nerve centers that control instinctive movements. This can cause: tremors, dizziness, difficulty in articulating speech (extrapyramidal symptoms)
• convulsions/seizures
• amnesia
• reduced attention and/or reduced ability to concentrate
• reduced state of alertness
• changes in skin color, blood pressure, heart rate, salivation and other functions of the nerves not controlled by will, such as manifestations that may accompany an epileptic seizure
• balance disorders
• feeling of instability
• headache
• visual disturbances such as double vision or blurred vision
• eye function disorders
• lowering of body temperature
• reduction of blood pressure
• depression of breathing
• suspension of breathing for a period of several seconds (apnea)
• worsening of pre-existing nocturnal apnea before taking the medicine
• worsening of chronic lung diseases with difficulty breathing
• problems with the stomach and intestines
• constipation
• allergic skin reactions
• patchy hair loss (alopecia)
• yellowing/yellowish discoloration of the skin and mucous membranes (jaundice)
• inability to completely empty the bladder of urine (urinary retention)
• increased levels of bilirubin, transaminases and alkaline phosphatase in the blood (substances produced by the liver)

Reporting ofside effects
If you experience any side effects, including those not listed in this leaflet, please 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 Lorazepam Mylan Generics

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 pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
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 Lorazepam Mylan Generics contains

• The active ingredient is lorazepam. Each Lorazepam Mylan Generics 1 mg tablet contains 1 mg of lorazepam. Each Lorazepam Mylan Generics 2.5 mg tablet contains 2.5 mg of lorazepam.
• The other ingredients are: lactosemonohydrate, microcrystalline cellulose, corn starch, magnesium stearate, potassium polacrilin.

Description of the appearance of Lorazepam Mylan Generics and contents of the pack
1 mg tablets in blister packs containing 20 divisible tablets.
2.5 mg tablets in blister packs containing 20 divisible tablets.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
ABC Farmaceutici S.p.A., Canton Moretti 29, 10015 S. Bernardo d'Ivrea (TO)
Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto De’ Stampi, 20089 Rozzano (MI)

Lorazepam Mylan Generics 2 mg/ml oral drops, solution

lorazepam

Equivalent medicine

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

1. What is Lorazepam Mylan Generics and what is it used for

Lorazepam Mylan Generics contains the active ingredient lorazepam. Lorazepam belongs to a group
of medicines called benzodiazepines and acts on the central nervous system by reducing anxiety (anxiolytic effect), facilitating a sleep that is entirely comparable to normal sleep (hypnotic effect), improving
mood and decreasing the intensity of emotional reactions to mental stress (sedative effect).
This medicine is used for short-term treatment of the following conditions when they are
severe and cause discomfort in normal daily life:

• anxietyand states of emotional tension associated with anxiety
• insomnia.

2. What you need to know before taking Lorazepam Mylan Generics

Do not take Lorazepam Mylan Generics

• if you are allergic to lorazepam or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other similar medicines (benzodiazepines);
• if you suffer from a disease that causes muscle weakness and fatigue (myasthenia gravis);
• if you have severe breathing problems (respiratory failure);
• if you have severe liver problems (hepatic failure);
• if you suffer from episodes of interrupted breathing for several seconds during sleep (sleep apnea);
• if you have high pressure in the eye (narrow-angle glaucoma);
• if you are or think you might be pregnant or are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
The duration of treatment with Lorazepam Mylan Generics should be as short as possible. It is
recommended not to exceed 4 weeks for the treatment of insomnia and 8-12 weeks for the
treatment of anxiety. The recommended duration of treatment also includes the period
necessary for the gradual reduction of the dosage.See section 3 How to take Lorazepam
Mylan Generics.
Consult your doctor or pharmacist beforetaking Lorazepam Mylan Generics if you think that any
of the following conditions applies to you (see also section 4 Possible side effects):

• you have or have ever had breathing problems because this medicine can decrease your spontaneous breathing capacity. Breathing problems may also be associated with the following conditions:
• if you have heart problems (heart failure);
• if you have low blood pressure;
• if you have general breathing problems, chronic inability to breathe adequately and regularly, during exertion or at rest (chronic respiratory failure and chronic obstructive pulmonary disease);
• if you have trouble breathing at night (sleep apnea syndrome). If you experience any of these conditions and need to start treatment with Lorazepam Mylan Generics, your doctor will subject you to regular check-ups;
• you have or have ever had allergic reactions to benzodiazepines. This medicine can cause severe and rapid allergic reactions (anaphylactic reactions) or swelling of the face, tongue and throat with inability to swallow and breathe (angioedema), shortness of breath (dyspnea), nausea and vomiting. Sometimes, these reactions can be fatal. As soon as one or more symptoms appear, go to the nearest emergency room. In these cases, your doctor will advise you not to take any more medicines containing lorazepam and to continue treating your condition with other medicines;
• you have or have had problems with alcohol, drug or medicine abuse, because Lorazepam Mylan Generics can also cause dependence (see section “Development of dependence”);
• you suffer or have ever suffered from depression, because Lorazepam Mylan Generics can worsen your condition and suicidal tendencies;
• you have or have ever had difficulty relating to other people or to various life situations, even if you have not always been aware of these difficulties. Lorazepam Mylan Generics is not recommended as the main treatment for this condition;
• you have or have ever had liver problems (hepatic failure, hepatic encephalopathy), because this medicine could worsen your condition. Your doctor will advise you on the most suitable dosage for your condition;
• you have or have ever had kidney problems (renal failure). Your doctor will advise you on the most suitable dosage for your condition;
• if you have reduced blood flow to the brain (arteriosclerosis).

Memory disorders
After taking Lorazepam Mylan Generics you may have difficulty remembering what happened

aftertaking the medicine. Therefore, it is advisable to ensure uninterrupted sleep of
7-8 hours after taking this medicine.
Paradoxical reactions
Lorazepam Mylan Generics can cause mental reactions and effects opposite to those expected
(paradoxical effects) (see section 4 Possible side effects). These effects are more common in
children and the elderly.
If you experience these effects, consult your doctor who will advise you on how to stop
taking this medicine.

Development of tolerance and dependence, withdrawal reactions and drug abuse
A reduction in effectiveness (tolerance) of this medicine may occur after continuous use.
This medicine is recommended for short-term treatment.
Treatment with this medicine also increases sensitivity to the effects of alcohol and other
medicines that affect brain function. Therefore, talk to your doctor if you are taking alcohol
or such medicines.
The use of benzodiazepines, including Lorazepam Mylan Generics, can cause dependence.
The risk of dependence increases with higher doses and continuous use.
The risk of dependence also increases if you have a history of alcohol or drug abuse and in patients with
significant personality disorders.
Consult your doctor if:

• you have taken drugs in the past or are currently taking drugs;
• you have drunk alcohol in the past or currently drink alcohol frequently and/or in large quantities;
• you have had a desire to take large amounts of medicine in the past or currently have such a desire;
• you suffer or have ever suffered from personality disorders, such as difficulty relating to other people or to various life situations, even if you have not always been aware of these difficulties.

In principle, benzodiazepines should only be used for short periods and discontinued
gradually. Before starting treatment, you must agree with your doctor how long
you will take the medicine.
If you suddenly stop taking the medicine or rapidly reduce the dosage, withdrawal reactions may occur. Do not suddenly stop this medicine. Ask your doctor for advice on how to stop treatment.
Some withdrawal reactions can be life-threatening.
Withdrawal symptoms can range from mild depression and insomnia to a major syndrome
with muscle and abdominal cramps, vomiting, sweating, tremors and convulsions. More severe
withdrawal signs and symptoms, including life-threatening reactions, can include delirium tremens,
depression, hallucinations, mania, psychosis, seizures and suicide. Seizures/convulsions may
occur more frequently in patients with pre-existing seizure disorders or in patients taking other
medicines that lower the seizure threshold, such as antidepressants.
Other withdrawal symptoms can include: headache, anxiety, restlessness, tension, confusion,
irritability, depressed mood, dizziness, feeling detached or alienated from oneself and the world
around, excessive perception of noise, tinnitus, tingling and numbness of the limbs,
sensitivity to light, noise and touch / changes in perception, involuntary movements,
stomach pain, diarrhea, loss of appetite, panic attacks, muscle pain, states of excitement,
increased awareness of heartbeat (palpitations), increased heart rate
(tachycardia), feeling of loss of balance, increased reflexes, loss of ability to
remember recent events, and increased body temperature.
The symptoms for which this medicine was prescribed may also reappear briefly
(rebound phenomena).
Do not give Lorazepam Mylan Generics to family members or friends. Keep this medicine safely
so that it cannot cause harm to others.

If you are elderly and/or suffer from particular health conditions
If you are elderly and/or your general health conditions are very poor or if you suffer from significant
brain diseases (especially cerebral arteriosclerosis), you are more sensitive to the effect of Lorazepam Mylan
Generics.
If you suffer from low blood pressure, this medicine may cause an increase
in episodes of low blood pressure.
Therefore, it is recommended to use this medicine at the lowest possible dosage or to avoid using it.
If you have severeliver problems
If you suffer from severe liver problems associated or not with brain symptoms such as confusion,
altered level of consciousness or coma, Lorazepam Mylan Generics should not be used
because it could worsen your condition (see also section 2 “Do not take Lorazepam Mylan
Generics”).

Children and adolescents
The efficacy and safety of Lorazepam Mylan Generics in children under 12 years of age are not known.
The doctor will decide whether Lorazepam Mylan Generics can be given to children based
on their condition. The duration of treatment should be as short as possible.

Other medicines and Lorazepam Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The concomitant use of Lorazepam Mylan Generics and opioids (strong painkillers, medicines for
addiction therapy and some medicines for cough) increases the risk of drowsiness, breathing difficulties
(respiratory depression), coma and can be life-threatening. For this reason,
concomitant use should only be considered if other treatment options are not possible.
However, if your doctor prescribes Lorazepam Mylan Generics together with opioids, the dose and duration
of concomitant therapy must be limited by your doctor.
It may be helpful to inform friends or family members to make them aware of the above
signs and symptoms. Contact your doctor if these symptoms occur.
Tell your doctor or pharmacist if you are taking any of the following medicines together with Lorazepam
Mylan Generics because caution is required:

• medicines that cause strong reduction of all brain functions, such as:
• sedatives and sleep aids (barbiturates, hypnotics/sedatives);
• medicines for the treatment of certain mental illnesses (antipsychotics);
• medicines for the treatment of anxiety (anxiolytics);
• medicines for the treatment of depression (antidepressants);
• medicines for the treatment of acute or chronic pain of high intensity (narcotic analgesics, opioids);
• medicines for the treatment of seizures (antiepileptics);
• anesthetics;
• medicines to counteract allergic reactions (sedating antihistamines).

Lorazepam Mylan Generics, when administered together with anesthetic medicines, can cause euphoria, with
increased probability of developing psychic dependence;

• clozapine (medicine used against thought disorders), because taking it together with Lorazepam Mylan Generics can cause marked sedation, increased salivation and loss of coordination of movements;
• valproate (medicine used against seizures), because it can increase the effects of Lorazepam Mylan Generics. In this case, the doctor may decide to halve the dose of Lorazepam Mylan Generics;
• probenecid (medicine used against gout), because it can increase the effects of Lorazepam Mylan Generics. In this case, the doctor may decide to halve the dose of Lorazepam Mylan Generics;
• theophylline and aminophylline (medicines used against bronchial asthma), because they can decrease the effects of Lorazepam Mylan Generics;
• loxapine (medicine used against thought disorders), because taking it together with Lorazepam Mylan Generics can cause a state characterized by excessive passivity and inertia towards events and people (e.g. inability to move and mutism), a significant reduction in breathing rate and a decrease in blood pressure;
• baclofen (medicine used as a muscle relaxant);
• caffeine (a substance contained mainly in coffee, but also in numerous energy drinks), because it can reduce the effects of Lorazepam Mylan Generics.

Lorazepam Mylan Generics with alcohol
Avoid drinking alcohol during treatment with this medicine, because it increases drowsiness and
the reduction of consciousness induced by this medicine.
This can also lead to a serious impairment of the ability to drive vehicles and use
machinery (see section “Driving and using machines”).

Pregnancy and breastfeeding
If you are pregnant, suspect you might be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy

This medicine should not be taken during pregnancy, especially during the first 3 months,because
it can cause congenital malformations in the fetus.

• If, for serious reasons, you take this medicine at high doses during the last 3 months of pregnancy, during the period preceding delivery (labor) or during delivery, the following symptoms may appear in the newborn:
• excessive decrease in motor activity;
• poor muscle tone;
• moderate reduction in breathing rate;
• low body temperature;
• suspension of breathing for a period of several seconds (apnea);
• feeding problems;
• decreased resistance to cold and subsequent alterations in metabolism;
• yellow/yellowish discoloration of the skin and mucous membranes (jaundice).
• If you take this medicine for a long time during the last period of pregnancy, the newborn may develop immediately after birth symptoms of physical dependence or withdrawal (see paragraph “Development of dependence”).

Breastfeeding
This medicine passes into breast milk. Your doctor will decide whether you can take Lorazepam Mylan
Generics during breastfeeding.
If you breastfeed while taking this medicine, the newborn may experience drowsiness and
reduced ability to take breast milk.

Driving and operating machinery
Donot drive or operate machinery if you experience drowsiness and dizziness during treatment with Lorazepam Mylan Generics. Lorazepam Mylan Generics can also cause amnesia, impairment of
concentration ability and changes in muscle function. Your vigilance may be altered
especially if you have not slept for a sufficient time after taking Lorazepam Mylan
Generics.

Lorazepam Mylan Generics contains ethanol (alcohol)
This medicine contains up to 284 mg of alcohol (ethanol) in each dose of 20 drops (1 mg), which is
equivalent to 70 vol %. The amount in a 20-drop dose of this medicine is equivalent to 7 ml of
beer or 3 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

3. How to take Lorazepam Mylan Generics

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor.
The dose and duration of administration must be adapted to your individual condition. The
doctor will advise you on the dose and the number of daily administrations and the duration of treatment with
Lorazepam Mylan Generics, so that you take the lowest possible dose for the shortest possible time.
Do not modify or exceed the prescribed dose. To stop treatment, the dose must be
gradually reduced in agreement with your doctor. This reduces the risk of withdrawal reactions, which
in some cases can be life-threatening (see paragraph 2).
If you need to increase the dose of this medicine, the doctor will suggest how to
proceed gradually to avoid unwanted effects. If the dose of
Lorazepam Mylan Generics is increased, it is necessary to first increase the evening dose and then possibly increase
also the morning dose.
This medicine must be taken by mouth.

Treatment of anxiety
The recommended duration of therapy should not exceed 8-12 weeks. This period includes
also the time needed to gradually reduce the dose of Lorazepam Mylan Generics until
suspension. The doctor will decide if the treatment can be continued beyond the maximum
recommended period.
It is advisable not to exceed the maximum daily dose.
The recommended dose is 20 drops (1 mg) 2-3 times a day.
In severe cases, the dose may be increased to 50 drops (2.5 mg) 3-4 times a day.

Treatment of insomnia
The recommended duration of treatment ranges from a few days to a maximum of 4 weeks. This
period also includes the time needed to gradually reduce the dose of Lorazepam Mylan
Generics until suspension. The doctor will decide if the treatment can be continued beyond the
recommended maximum period.
It is advisable not to exceed the maximum daily dose.
The recommended dose is 20-40 drops (1-2 mg) at bedtime.

If you are elderly and/or your general health conditions are very poor
The recommended initial dose is 20 drops (1 mg) or 40 drops (2 mg) per day, divided into several
doses.

If you suffer from kidney or liver problems (renal or hepatic insufficiency)
The doctor will decide from time to time the most suitable dose for you and will subject you to frequent checks.

Preparation of patients awaiting surgery
Major surgeries: the recommended dose is 40-80 drops (2 mg-4 mg) of Lorazepam Mylan
Generics, the evening before the surgery.
Minor surgeries: the recommended dose is 40-80 drops (2 mg-4 mg) of Lorazepam Mylan
Generics, 1-2 hours before the surgery.
Duration of treatment
The duration of treatment is decided by your doctor. You will be prescribed the minimum effective dose for
the shortest possible time because there is a risk of becoming dependent on this medicine. The doctor
will evaluate your treatment frequently.
It is necessary to stop taking this medicine or reduce the dose slowly and under the
supervision of the doctor to prevent any withdrawal reaction (see paragraph 2).

Instructions for use

• 1. Press on the cap and simultaneously unscrew, to open the bottle;
• 2. Press on the white cap to drop the powder into the bottle;
• 3. Shake the bottle until completely dissolved;
• 4. The solution obtained is valid for 30 days. Remove the cap and pour the drops into a glass.
• 5. To close, apply the cap by pressing and screwing simultaneously.

If you take more Lorazepam Mylan Generics than you should
If you (or someone else) have taken an excessive dose of Lorazepam Mylan Generics 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. Bring with you this leaflet, the bottle and its container in
hospital or to the doctor so they know which medicine has been consumed.
It is important that you never take more medicine than prescribed. In general, there are no dangers to
life if you accidentally take a dose of medicine higher than the prescribed one, unless you also take alcohol or other medicines.
Symptoms
In mild cases, the symptoms may be:

• blurred vision, drowsiness, disorientation and weakening of sensory functions;
• difficulty in articulating speech;
• mental confusion;
• continuous sleep and reduced response to normal stimuli;
• inability to completely empty the bladder;
• changes in sexual desire.

In more severe cases, when large amounts of medicine are taken for suicidal purposes or when
this medicine is taken together with alcoholic beverages or other medicines that reduce the state
of consciousness and the main brain functions, the symptoms may be:

• loss of ability to coordinate movements;
• poor muscle tone;
• low blood pressure;
• excessive sleepiness;
• opposite symptoms to those expected by the effects of this medicine (paradoxical symptoms);
• reduction of all functions of the central nervous system;
• reduction of heart function;
• reduction of breathing;
• coma;
• death.

Treatment
Contact your doctor immediately or go to the nearest emergency room if you take more Lorazepam
Mylan Generics than prescribed by your doctor. If you are conscious, you will be induced to vomit within one hour
from when you took the medicine; if you are unconscious you will undergo gastric lavage. If
these procedures are not sufficient, you may be given activated charcoal to reduce
the absorption of Lorazepam Mylan Generics, or flumazenil, a medicine that counteracts the effects
of Lorazepam Mylan Generics.

If you forget to take Lorazepam Mylan Generics
Do not take a double dose to make up for a missed dose. If you forget to take a
dose, take it as soon as you remember, but make sure you can rest immediately afterwards and for a long time (7-8 hours). If you think you have missed more than one dose, consult your doctor.

If you stop taking Lorazepam Mylan Generics
Do not stop taking Lorazepam Mylan Generics suddenly unless you suspect
a serious side effect, because the doses must be gradually reduced. The doctor will advise you
how to stop the treatment.
If you think you have a serious side effect, go to your doctor immediately. If you stop
taking Lorazepam Mylan Generics or reduce the dose suddenly, you may develop
temporarily withdrawal symptoms or rebound symptoms (see paragraph 2 “Development of
dependence”).
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.

Usually, side effects are observed at the beginning of treatment and generally
decrease in intensity or disappear with the continuation of treatment or by reducing the
dose.
Contact your doctor immediatelyif you experience any of the following side effects because
the intake of Lorazepam Mylan Generics must be stopped:

• opposite effects to those expected (paradoxical effects) (see paragraph 2 “Paradoxical reactions”) such as:
• depression or unmasking of existing depression
• restlessness
• agitation
• irritability
• aggression
• feeling of frustration
• anger
• nightmares
• hallucinations (seeing and hearing things that do not exist)
• difficulty in correctly interpreting reality and thought disorders (psychosis)
• behavioral changes
• drowsiness, even during the day
• dizziness
• loss of muscle coordination (ataxia)
• sleep disorders, insomnia
• confusion
• changes in sexual desire
• anxiety states
• feelings of hostility
• state of general excitement
• sexual excitement
• decreased ability to reach the peak of sexual excitement (orgasm)
• fatigue
• impotence

Contact your doctor immediatelyif you experience any of the following side effects because they can be
serious:

• severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue and throat which can cause difficulty in swallowing or breathing (angioedema)
• difficulty remembering what happened after taking the medicine (anterograde amnesia). This may also be accompanied by behavioral changes (see paragraph 2 “Memory disorders”)
• drug abuse and drug dependence (see paragraph 2 “Development of tolerance and dependence, withdrawal reactions and drug abuse”)
• withdrawal symptoms (see paragraph 2 “Development of tolerance and dependence, withdrawal reactions and drug abuse”)
• rebound symptoms (see paragraph 2 “Development of tolerance and dependence, withdrawal reactions and drug abuse”)
• coma
• thoughts of suicide, suicide attempts
• excessive use of this medicine (abuse) or other similar medicines (benzodiazepines)
• severe decrease in the number of white blood cells in the blood, which can increase susceptibility to infections

Contact your doctor if you experience any of the following side effects:
Side effects common(may affect up to 1 in 10 people):

• muscle weakness

Side effects uncommon(may affect up to 1 in 100 people):

• nausea

Side effects with unknown frequency(frequency cannot be estimated on the basis of available
data):

• reduction of all cells present in the blood
• reduction in the number of platelets in the blood
• hypersensitivity reactions
• disease characterized by excessive secretion of the antidiuretic hormone causing water retention in the body and reduced sodium levels in the blood
• changes in appetite
• decreased sodium in the blood
• disinhibition
• disorientation
• euphoria
• decreased ability to experience emotions
• alteration of the nervous centers that control instinctive movements. This can cause: tremors, dizziness, difficulty in articulating speech (extrapyramidal symptoms)
• convulsions/seizures
• amnesia
• reduced attention and/or reduced ability to concentrate
• decreased state of alertness
• changes in skin color, blood pressure, heart rate, salivation and other functions of the nervous system not controlled by the will, as manifestations that may accompany a seizure
• balance disorders
• feeling of instability
• headache
• visual disturbances such as double vision or blurred vision
• visual impairment
• lowering of body temperature
• reduction of blood pressure
• depression of breathing
• suspension of breathing for a period of several seconds (apnea)
• worsening of pre-existing sleep apnea before taking the medicine
• worsening of chronic lung diseases with difficulty breathing
• problems with the stomach and intestines
• constipation
• allergic reactions on the skin
• patchy hair loss (alopecia)
• yellowing/yellowish discoloration of the skin and mucous membranes (jaundice)
• inability to completely empty the bladder of urine (urinary retention)
• increased levels of bilirubin, transaminases and alkaline phosphatase in the blood (substances produced by the liver)

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 Lorazepam Mylan Generics

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 pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
The product must be used within 30 days of first opening the bottle (reconstitution of the
solution). Any 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 Lorazepam Mylan Generics contains

• The active ingredient is lorazepam. 10 ml of reconstituted solution contains 20 mg of lorazepam.
• The other ingredients are: mannitol, ethanol, purified water.

Description of the appearance of Lorazepam Mylan Generics and contents of the pack
10 ml bottle with reservoir cap (containing the powder) and dropper.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto De’ Stampi, 20089 Rozzano (MI)
ITC Production S.r.l. - via Pontina Km 29, 00071 Pomezia (RM)