Lorazepam Mylan Generics

Italy
Brand name Lorazepam Mylan Generics
Form tablets
Active substance / Dosage
LORAZEPAM
Prescription type Prescription only
ATC code
N05BA06
Registration number 035992
Manufacturer MYLAN S.P.A.
Lorazepam Mylan Generics tablets

Table of Contents

Package leaflet: Information for the patient

Lorazepam Mylan Generics 1 mg tablets, 2.5 mg tablets

lorazepam
Generic medicine
Please 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, contact 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 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

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

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

  • Anxiety and emotional tension states 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 causing muscle weakness and fatigue (myasthenia gravis);
  • if you have serious breathing problems (respiratory failure);
  • if you have serious liver problems (hepatic insufficiency);
  • if you suffer from episodes of interrupted breathing for several seconds during sleep (sleep apnea);
  • if you have high eye pressure (narrow-angle glaucoma);
  • if you are or think you may be pregnant or if you 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 includes also the period
necessary for gradual dose reduction. See section 3 How to take Lorazepam Mylan Generics.
Talk to your doctor or pharmacist before taking 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 may reduce your spontaneous 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, either during exertion or at rest (chronic respiratory insufficiency and chronic obstructive pulmonary disease);
    • if you have breathing difficulties during the night (sleep apnea syndrome). If you have any of these conditions and need to start treatment with Lorazepam Mylan Generics, your doctor will monitor you regularly;
  • you have or have ever had allergic reactions to benzodiazepines. This medicine may cause severe and rapidly occurring allergic reactions (anaphylactic reactions) or swelling of the face, tongue, and throat with difficulty swallowing and breathing (angioedema), shortness of breath (dyspnea), nausea and vomiting. Sometimes, these reactions can be fatal. If one or more of these symptoms occur, go immediately to the nearest emergency room. In such cases, your doctor will advise you not to take lorazepam-containing medicines again and to continue treatment of your condition with other medicines;
  • you have or have had problems with alcohol, drug, or medicine abuse and dependence, because Lorazepam Mylan Generics may also cause dependence (see section “Development of dependence”);
  • you suffer or have ever suffered from depression, because Lorazepam Mylan Generics may worsen your condition and increase suicidal tendencies;
  • you have or have ever had difficulties in 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 primary treatment for this condition;
  • you have or have ever had liver problems (hepatic insufficiency, hepatic encephalopathy), because this medicine could worsen your condition. Your doctor will advise you on the most appropriate dosage for your condition;
  • you have or have ever had kidney problems (renal insufficiency). Your doctor will advise you on the most appropriate dosage for your condition;
  • if you have reduced blood flow to the brain (arteriosclerosis).

Memory disturbances
After taking Lorazepam Mylan Generics, you may have difficulty remembering events that occurred
after taking the medicine. Therefore, it is advisable to ensure an uninterrupted sleep of 7–8 hours
after taking this medicine.
Paradoxical reactions
Lorazepam Mylan Generics may 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 elderly people.
If you experience these effects, consult your doctor, who will advise you on the correct way to stop taking this medicine.
Development of tolerance and dependence, withdrawal reactions, and drug abuse
The effectiveness of this medicine (tolerance) may decrease after continuous use. This medicine is recommended for short-term treatment only.
Treatment with this medicine also increases sensitivity to the effects of alcohol and other medicines affecting brain function. Therefore, talk to your doctor if you are taking alcohol or such medicines.
The use of benzodiazepines, including Lorazepam Mylan Generics, may lead to dependence.
The risk of dependence increases with higher doses and prolonged use.
The risk of dependence is also higher if you have a history of alcohol or drug abuse, or if you have significant personality disorders.
Talk to your doctor if:

  • you have previously or currently used drugs;
  • you have previously or currently consumed alcoholic beverages frequently and/or in large quantities;
  • you have previously or currently had a desire to take large amounts of medicines;
  • you suffer or have ever suffered from personality disorders, for example, difficulties in 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 should agree with your doctor on how long to take the medicine.
If you abruptly stop taking the medicine or rapidly reduce the dose, withdrawal reactions may occur. Do not stop this medicine abruptly. Consult your doctor on how to discontinue treatment.
Some withdrawal reactions may be life-threatening.
Withdrawal symptoms may range from mild depression and insomnia to a more severe 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/epileptic fits 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 reactions may include: headache, anxiety, restlessness, tension, confusion, irritability, depressed mood, dizziness, feelings of detachment and alienation from oneself and the external world, increased sensitivity to noise, tinnitus, tingling and numbness in the limbs, sensitivity to light, noise, and physical touch / changes in perception, involuntary movements, stomach pain, diarrhea, loss of appetite, panic attacks, muscle pain, states of excitement, heightened awareness of heartbeat (palpitations), increased heart rate (tachycardia), sensation of loss of balance, exaggerated reflexes, loss of ability to memorize 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. Store this medicine safely so that it cannot harm others.
If you are elderly and/or have specific health conditions
If you are elderly and/or your general health condition is very weak, 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 increase episodes of low blood pressure.
Therefore, it is recommended to use this medicine at the lowest possible dose or to avoid its use altogether.
If you have severe liver problems
If you suffer from severe liver problems, with or without brain-related symptoms such as mental confusion, altered consciousness, or coma, Lorazepam Mylan Generics must 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 is unknown. Your doctor will decide whether Lorazepam Mylan Generics can be administered to children based on their condition. The duration of treatment should be as short as possible.
Other medicines and Lorazepam Mylan Generics
Inform 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 substitution therapy, 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 possible.
However, if your doctor prescribes Lorazepam Mylan Generics together with opioids, your doctor will limit the dose and duration of concomitant therapy.
Inform your doctor about all opioid medicines you are taking and carefully follow your doctor’s dosage recommendations. It may be helpful to inform friends or family members so they are aware of the above-mentioned signs and symptoms. Contact your doctor if such symptoms occur.
Inform your doctor or pharmacist if you are taking any of the following medicines together with Lorazepam Mylan Generics, as caution is required:

  • medicines that strongly reduce all brain functions, such as:
    • sedatives and sleep-inducing medicines (barbiturates, hypnotics/sedatives);
    • medicines for treating certain mental illnesses (antipsychotics);
  • medicines for treating anxiety (anxiolytics);
  • medicines for treating depression (antidepressants);
  • medicines for treating acute or chronic severe pain (narcotic analgesics, opioids);
  • medicines for treating epileptic seizures (antiepileptics);
  • anaesthetics;
  • medicines to counteract allergic manifestations (sedating antihistamines).

Lorazepam Mylan Generics, when administered together with anaesthetic medicines, may cause euphoria, increasing the likelihood of developing psychological dependence;

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

Lorazepam Mylan Generics and alcohol
Avoid consuming alcohol during treatment with this medicine, as it increases drowsiness and reduced consciousness caused by this medicine.
This may also severely impair your ability to drive vehicles and operate machinery (see section “Driving and use of machines”).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
This medicine must not be taken during pregnancy, especially during the first 3 months, as it may 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 (labour), or during delivery, the newborn may show the following symptoms:
    • excessive reduction in motor activity;
    • poor muscle tone;
    • moderate reduction in breathing rate;
  • low body temperature;
  • breathing suspension for several seconds (apnea);
  • feeding difficulties;
  • reduced cold resistance and consequent metabolic disturbances;
  • yellow/yellowish discoloration of the skin and mucous membranes (jaundice).
    • If you take this medicine for a prolonged period during the final stage of pregnancy, the newborn may develop physical dependence or withdrawal symptoms immediately after birth (see section “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 suckle breast milk.
Driving and use of machines
Do not drive or operate machinery if, during treatment with Lorazepam Mylan Generics, you experience drowsiness or dizziness. Lorazepam Mylan Generics may also cause amnesia, impaired concentration, and altered muscle function. Your alertness may be impaired, especially if you have not slept sufficiently after taking Lorazepam Mylan Generics.
Lorazepam Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Lorazepam Mylan Generics

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
The dose and duration of treatment should be adjusted according to your individual condition. Your doctor will advise you on the appropriate dose, the number of daily doses, and how long you should take Lorazepam Mylan Generics, aiming to use the lowest possible dose for the shortest possible time.
Do not change or exceed the prescribed dose. To stop treatment, the dose must be gradually reduced under medical supervision. This reduces the risk of withdrawal reactions, which in some cases may be life-threatening (see section 2).
If you need to increase the dose of this medicine, your doctor will advise you on how to do so gradually to avoid unwanted effects. When increasing the dose of Lorazepam Mylan Generics, the evening dose should be increased first, followed by the morning dose if necessary.
This medicine should be taken orally.
The tablet may be divided into equal parts.

Treatment of anxiety
The recommended treatment duration should not exceed 8–12 weeks. This period includes the time needed to gradually reduce the dose of Lorazepam Mylan Generics before stopping. Your doctor will decide whether treatment can continue beyond this 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 up to 3–4 tablets of 2.5 mg per day.

Treatment of insomnia
The recommended treatment duration ranges from a few days to a maximum of 4 weeks. This period includes the time needed to gradually reduce the dose of Lorazepam Mylan Generics before stopping. Your doctor will decide whether treatment can continue beyond this maximum recommended period.
It is advisable not to exceed the maximum daily dose.
The recommended dose is 1–2 tablets of 1 mg taken at bedtime.
In cases of persistent insomnia, the recommended dose is 1 or 2 tablets of 2.5 mg taken at bedtime.

If you are elderly and/or your general health condition is very weak
The recommended starting dose is 1 mg or 2 mg per day, divided into several doses.

If you have kidney or liver problems (renal or hepatic impairment)
Your doctor will determine the most appropriate dose for you and will monitor you regularly.

Preparation of patients awaiting surgery
Major surgery: the recommended dose is 2–4 mg of Lorazepam Mylan Generics, taken the evening before the procedure.
Minor surgery: the recommended dose is 2–4 mg, taken 1–2 hours before the surgical procedure.

Duration of treatment
The duration of treatment is determined by your doctor. You will be prescribed the lowest effective dose for the shortest possible time, as there is a risk of becoming dependent on this medicine. Your doctor will frequently review your treatment.
It is essential to stop taking this medicine or reduce the dose gradually and under medical supervision to prevent 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 suspect a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department. Bring this leaflet, the container, and its packaging with you so that medical staff can identify the medicine taken.
It is important never to take more medicine than prescribed. Generally, there is no life-threatening risk if you accidentally take more than the prescribed dose, unless you also consume alcohol or other medicines at the same time.

Symptoms
In mild cases, symptoms may include:

  • blurred vision, drowsiness, disorientation, and reduced sensory function;
  • difficulty speaking;
  • mental confusion;
  • prolonged sleep and reduced response to normal stimuli;
  • inability to completely empty the bladder;
  • changes in sexual desire.

In more severe cases, such as when large amounts of the medicine are taken with suicidal intent, or when taken together with alcoholic beverages or other medicines that reduce consciousness and major brain functions, symptoms may include:

  • loss of coordination;
  • reduced muscle tone;
  • low blood pressure;
  • excessive drowsiness;
  • paradoxical reactions (opposite to the expected effects of the medicine);
  • depression of all central nervous system functions;
  • reduced heart function;
  • reduced breathing;
  • coma;
  • death.

Treatment
Contact your doctor immediately or go to the nearest emergency department if you take more Lorazepam Mylan Generics than prescribed. If you are conscious, vomiting will be induced within one hour of taking the medicine; if you are unconscious, gastric lavage will be performed. If these measures are insufficient, activated charcoal may be administered to reduce 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 ensure you can rest immediately afterwards for a sufficiently long period (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, as the dose must be gradually reduced. Your doctor will advise you on how to discontinue treatment.
If you think you are experiencing a serious side effect, contact your doctor immediately. If you stop taking Lorazepam Mylan Generics or reduce the dose suddenly, you may temporarily develop withdrawal symptoms or rebound symptoms (see section 2 “Development of dependence”).

If you have any questions about using 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.
Normally, side effects occur at the beginning of treatment and usually
decrease in intensity or disappear with continued treatment or by reducing the
dose.
Contact your doctor immediately if you experience any of the following side effects, as treatment with Lorazepam Mylan Generics must be discontinued:

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

Contact your doctor immediately if you experience any of the following side effects, as they may be serious:

  • severe allergic reaction (anaphylactic shock)
  • swelling of the face, tongue, and throat which may cause difficulty in swallowing or breathing (angioedema)
  • difficulty remembering events that occurred after taking the medicine (anterograde amnesia). This may also be accompanied by behavioural changes (see section 2 “Memory disturbances”)
  • drug abuse and drug dependence (see section 2 “Development of tolerance and dependence, withdrawal reactions, and drug abuse”)
  • withdrawal symptoms (see section 2 “Development of tolerance and dependence, withdrawal reactions, and drug abuse”)
  • rebound symptoms (see section 2 “Development of tolerance and dependence, withdrawal reactions, and drug abuse”)
  • coma
  • suicidal thoughts, suicide attempts
  • excessive use of this medicine (abuse) or of similar medicines (benzodiazepines)
  • severe decrease in white blood cell count, which may 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 from the available data):

  • reduction in all blood cells
  • decrease in the number of blood platelets
  • hypersensitivity reactions
  • a disease characterized by excessive secretion of antidiuretic hormone, causing water retention in the body and reduced sodium levels in the blood
  • changes in appetite
  • decreased sodium levels in the blood
  • disinhibition
  • disorientation
  • euphoria
  • reduced ability to experience emotions
  • disturbance of nervous centres controlling instinctive movements. This may cause: tremors, vertigo, difficulty in articulating speech (extrapyramidal symptoms)
  • seizures/epileptic fits
  • amnesia
  • reduced attention and/or reduced ability to concentrate
  • reduced level of alertness
  • changes in skin colour, blood pressure, heart rate, salivation, and other involuntary nervous functions, as manifestations that may accompany an epileptic seizure
  • balance disorders
  • sensation of instability
  • headache
  • visual disturbances such as double vision or blurred vision
  • disturbances in eye function
  • lowering of body temperature
  • reduced blood pressure
  • respiratory depression
  • temporary cessation of breathing for several seconds (apnoea)
  • worsening of pre-existing sleep apnoea
  • worsening of chronic lung diseases with breathing difficulties
  • stomach and intestinal problems
  • constipation
  • skin allergic reactions
  • patchy hair loss (alopecia)
  • yellow/yellowish discoloration of the skin and mucous membranes (jaundice)
  • inability to completely empty the bladder of urine (urinary retention)
  • increased blood levels of bilirubin, transaminases, and alkaline phosphatase (substances produced by the liver)

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 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 stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Lorazepam Mylan Generics contains

  • The active substance is lorazepam. Each tablet of Lorazepam Mylan Generics 1 mg contains 1 mg of lorazepam. Each tablet of Lorazepam Mylan Generics 2.5 mg contains 2.5 mg of lorazepam.
  • The other components are: lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, potassium polacrilin.

Description of the appearance of Lorazepam Mylan Generics and package contents
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 Milan
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)

Patient information leaflet

Lorazepam Mylan Generics 2 mg/ml oral drops, solution

lorazepam
Generic medicine
Please 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 give it to others, even if their symptoms are the same as yours, as 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 Lorazepam Mylan Generics is 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

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

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

  • anxiety and emotional tension states 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 causing muscle weakness and fatigue (myasthenia gravis);
  • if you have serious breathing problems (respiratory failure);
  • if you have serious liver problems (hepatic insufficiency);
  • if you suffer from episodes of breathing interruption lasting several seconds during sleep (sleep apnoea);
  • if you have high eye pressure (narrow-angle glaucoma);
  • if you are or think you may be pregnant or if you 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 includes also the period
required for gradual dose reduction. See section 3 How to take Lorazepam Mylan Generics.
Talk to your doctor or pharmacist before taking 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 may reduce 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, either during exertion or at rest (chronic respiratory failure and chronic obstructive pulmonary disease);
    • if you have breathing difficulties during the night (sleep apnoea syndrome). If you have any of these conditions and need to start treatment with Lorazepam Mylan Generics, your doctor will monitor you regularly;
  • you have or have ever had allergic reactions to benzodiazepines. This medicine may cause severe and rapidly occurring allergic reactions (anaphylactic reactions) or swelling of the face, tongue and throat with difficulty swallowing and breathing (angioedema), shortness of breath (dyspnoea), nausea and vomiting. Sometimes, these reactions can be fatal. If one or more of these symptoms occur, go immediately to the nearest emergency room. In such cases, your doctor will advise you not to take lorazepam-containing medicines again and to continue treatment of your condition with other medicines;
  • you have or have had problems with alcohol, drug or medicine abuse and dependence, because Lorazepam Mylan Generics may also cause dependence (see section “Development of dependence”);
  • you suffer or have ever suffered from depression, because Lorazepam Mylan Generics may worsen your condition and increase suicidal tendencies;
  • you have or have ever had difficulties in 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 insufficiency, hepatic encephalopathy), because this medicine could worsen your condition. Your doctor will recommend the most suitable dosage for your condition;
  • you have or have ever had kidney problems (renal insufficiency). Your doctor will recommend the most suitable dosage for your condition;
  • if you have reduced blood flow to the brain (arteriosclerosis).

Memory disturbances
After taking Lorazepam Mylan Generics, you may have difficulty remembering events that occurred
after taking the medicine. Therefore, it is advisable to ensure uninterrupted sleep of 7–8 hours after
taking this medicine.
Paradoxical reactions
Lorazepam Mylan Generics may 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
elderly people.
If you experience these effects, consult your doctor, who will advise you on the correct way to stop taking
this medicine.
Development of tolerance and dependence, withdrawal reactions and drug abuse
Reduced effectiveness (tolerance) of this medicine may occur after continuous use. This medicine is
recommended for short-term treatment only.
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, may cause dependence.
The risk of dependence increases with higher doses and prolonged use.
The risk of dependence is also higher if you have a history of alcohol or drug abuse, or if you have
significant personality disorders.
Talk to your doctor if:

  • you have previously or currently used drugs;
  • you have previously or currently consumed alcoholic beverages frequently and/or in large quantities;
  • you have previously or currently felt the urge to take large amounts of medicines;
  • you suffer or have ever suffered from personality disorders, for example, difficulties in 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 should discuss with your doctor how long you should take the medicine.
If you stop taking the medicine abruptly or reduce the dose rapidly, withdrawal reactions may occur. Do
not stop taking this medicine suddenly. Ask your doctor for advice on how to discontinue treatment.
Some withdrawal reactions may be life-threatening.
Withdrawal symptoms may range from mild depression and insomnia to a more severe syndrome with
muscle cramps and abdominal pain, vomiting, sweating, tremors and seizures. More severe withdrawal
symptoms, including life-threatening reactions, may include delirium tremens, depression, hallucinations,
mania, psychosis, seizures and suicide. Seizures/epileptic fits 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 or alienated from oneself and the outside world, increased
sensitivity to noise, tinnitus, tingling and numbness of limbs, sensitivity to light, noise and physical touch /
perceptual changes, involuntary movements, stomach pain, diarrhoea, loss of appetite, panic attacks, muscle
pain, states of excitement, heightened awareness of heartbeat (palpitations), increased heart rate
(tachycardia), sensation of loss of balance, exaggerated reflexes, loss of ability to memorize recent events,
and increased body temperature.
The symptoms for which you were prescribed this medicine may also reappear briefly (rebound phenomena).
Do not give Lorazepam Mylan Generics to family members or friends. Store this medicine safely so that it
cannot harm other people.
If you are elderly and/or have specific health conditions
If you are elderly and/or your general health condition is very weak, or if you suffer from significant brain
diseases (especially cerebral arteriosclerosis), you are more sensitive to the effects of Lorazepam Mylan
Generics.
If you have low blood pressure, this medicine may increase episodes of low blood pressure.
Therefore, it is recommended to use the lowest possible dose of this medicine or to avoid its use.
If you have severe liver problems
If you suffer from severe liver problems, with or without brain-related symptoms such as mental
confusion, altered level of consciousness or coma, Lorazepam Mylan Generics must 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. Your
doctor will decide whether Lorazepam Mylan Generics can be administered 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 analgesics, medicines for
addiction therapy 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 if no other treatment options are available.
However, if your doctor prescribes Lorazepam Mylan Generics together with opioids, your doctor will
limit the dose and duration of concomitant therapy.
Inform your doctor about all opioid medicines you are taking and follow your doctor’s dosage
recommendations carefully.
It may be helpful to inform friends or relatives so they are aware of the signs and symptoms listed above.
Contact your doctor if such symptoms occur.
Tell your doctor or pharmacist if you are taking any of the following medicines together with Lorazepam
Mylan Generics, as caution is required:

  • medicines that strongly reduce all brain functions, such as:
    • sedatives and sleep-inducing medicines (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 severe pain (narcotic analgesics, opioids);
  • medicines for the treatment of epileptic seizures (antiepileptics);
  • anaesthetics;
  • medicines to counteract allergic reactions (sedating antihistamines).

Lorazepam Mylan Generics, when administered together with anaesthetic medicines, may cause euphoria,
increasing the likelihood of developing psychological dependence;

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

Lorazepam Mylan Generics and alcohol
Avoid consuming alcohol during treatment with this medicine, as it increases drowsiness and reduced
consciousness caused by this medicine.
This may also severely impair your ability to drive or operate machinery (see section “Driving and use of
machinery”).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy or are breastfeeding, consult
your doctor or pharmacist before taking this medicine.
Pregnancy
This medicine must not be taken during pregnancy, especially during the first 3 months, because
it may cause congenital malformations in the foetus.

  • If, for serious reasons, you take this medicine at high doses during the last 3 months of pregnancy, during the period before childbirth (labour) or during delivery, the newborn may show the following symptoms:
    • excessive reduction in motor activity;
    • poor muscle tone;
    • moderate reduction in breathing rate;
  • low body temperature;
  • breathing interruption for several seconds (apnoea);
  • feeding problems;
  • reduced cold resistance and consequent metabolic disturbances;
  • yellow/yellowish discoloration of the skin and mucous membranes (jaundice).
    • If you take this medicine for a long time during the late stages of pregnancy, the newborn may develop physical dependence or withdrawal symptoms immediately after birth (see section “Development of dependence”).

Breastfeeding
This medicine passes into breast milk. Your doctor will decide whether you can take Lorazepam Mylan
Generics while breastfeeding.
If you breastfeed while taking this medicine, the newborn may experience drowsiness and reduced ability
to suckle breast milk.
Driving and use of machinery
Do not drive or operate machinery if, during treatment with Lorazepam Mylan Generics, you
experience drowsiness or dizziness. Lorazepam Mylan Generics may also cause amnesia, impaired
concentration and altered muscle function. Your alertness may be impaired, especially if you have not
slept long enough after taking Lorazepam Mylan Generics.
Lorazepam Mylan Generics contains ethanol (alcohol)
This medicine contains up to 284 mg of alcohol (ethanol) per 20-drop dose (1 mg), 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 exactly as directed by your doctor. If you have any doubts, consult your doctor.
The dose and duration of treatment must be adjusted according to your individual condition. Your doctor will advise you on the appropriate dose, the number of daily administrations, and the length of treatment with Lorazepam Mylan Generics, ensuring that you take the lowest possible dose for the shortest possible time. Do not change or exceed the prescribed dose. To discontinue treatment, the dose must be gradually reduced under medical supervision. This reduces the risk of withdrawal reactions, which in some cases may be life-threatening (see section 2).
If you need to increase the dose of this medicine, your doctor will advise you on how to do so gradually to avoid unwanted effects. When increasing the dose of Lorazepam Mylan Generics, the evening dose should first be increased, followed if necessary by an increase in the morning dose.
This medicine is taken orally.

Treatment of anxiety
The recommended duration of treatment should not exceed 8–12 weeks. This period includes the time needed to gradually reduce the dose of Lorazepam Mylan Generics before stopping. Your doctor will decide whether treatment can continue beyond the recommended maximum period.
It is advised not to exceed the maximum daily dose.
The recommended dose is 20 drops (1 mg) 2–3 times daily.
In severe cases, the dose may be increased up to 50 drops (2.5 mg) 3–4 times daily.

Treatment of insomnia
The recommended duration of treatment ranges from a few days up to a maximum of 4 weeks. This period includes the time required to gradually reduce the dose of Lorazepam Mylan Generics before stopping. Your doctor will decide whether treatment can be continued beyond the recommended maximum period.
It is advised not to exceed the maximum daily dose.
The recommended dose is 20–40 drops (1–2 mg), taken at bedtime.

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

If you have kidney or liver problems (renal or hepatic impairment)
Your doctor will determine the most appropriate dose for you and will monitor you regularly.

Preparation of patients awaiting surgery
Major surgical procedures: the recommended dose is 40–80 drops (2 mg–4 mg) of Lorazepam Mylan Generics, the evening before surgery.
Minor surgical procedures: the recommended dose is 40–80 drops (2 mg–4 mg) of Lorazepam Mylan Generics, 1–2 hours before surgery.

Duration of treatment
The duration of treatment is determined by your doctor. You will be prescribed the lowest effective dose for the shortest possible time, as there is a risk of becoming dependent on this medicine. Your doctor will frequently review your treatment.
It is necessary to stop taking this medicine or reduce the dose gradually and under medical supervision to prevent withdrawal reactions (see section 2).

Instructions for use

  1. Press on the cap and simultaneously unscrew to open the bottle;
  2. Press the white plug to release the powder into the bottle;
  3. Shake the bottle until the powder is completely dissolved;
  4. The resulting solution is stable for 30 days. Remove the cap and pour the drops into a glass.
  5. To close, press and screw the cap back on simultaneously.
Four sequential drawings show how to unscrew the cap, press the dropper tip, shake the bottle, and pour the medication drops

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, contact your doctor immediately or go to the nearest hospital emergency department. Take this leaflet, the bottle, and its packaging with you so that the medical staff can identify the medicine taken.
It is important that you never take more medicine than prescribed. Generally, there is no life-threatening risk if you accidentally take more than the prescribed dose, unless you also consume alcohol or other medicines at the same time.

Symptoms
In mild cases, symptoms may include:

  • blurred vision, drowsiness, disorientation, and reduced sensory function;
  • slurred speech;
  • mental confusion;
  • prolonged sleep and reduced response to normal stimuli;
  • inability to completely empty the bladder;
  • changes in sexual desire.

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

  • loss of motor coordination;
  • reduced muscle tone;
  • low blood pressure;
  • excessive drowsiness;
  • paradoxical reactions (opposite to the expected effects of the medicine);
  • depression of all functions of the central nervous system;
  • reduced heart function;
  • reduced breathing;
  • coma;
  • death.

Treatment
Contact your doctor immediately or go to the nearest emergency department if you take more Lorazepam Mylan Generics than prescribed. If you are conscious, vomiting will be induced within one hour of taking the medicine; if unconscious, gastric lavage will be performed. If these measures are insufficient, activated charcoal may be administered to reduce 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 ensure that you can rest immediately afterwards for a sufficiently long period (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, as doses must be gradually reduced. Your doctor will advise you on how to discontinue treatment.
If you think you are experiencing a serious side effect, contact your doctor immediately. If you stop taking Lorazepam Mylan Generics or reduce the dose suddenly, you may temporarily develop withdrawal symptoms or rebound symptoms (see section 2 “Development of dependence”).
If you have any questions 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.
Usually, side effects occur at the beginning of treatment and generally decrease in intensity or disappear
with continued treatment or by reducing the dose.
Contact your doctor immediately if you experience any of the following side effects, because
treatment with Lorazepam Mylan Generics must be discontinued:

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

Contact your doctor immediately if you experience any of the following side effects, as they may be serious:

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

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

  • reduction in all blood cells
  • reduction in the number of blood platelets
  • hypersensitivity reactions
  • condition characterised by excessive secretion of antidiuretic hormone, causing water retention in the body and reduced sodium levels in the blood
  • changes in appetite
  • decreased sodium levels in the blood
  • disinhibition
  • disorientation
  • euphoria
  • reduced ability to experience emotions
  • disturbance of nervous centres controlling instinctive movements. This may cause: tremors, dizziness, difficulty in articulating speech (extrapyramidal symptoms)
  • seizures/epileptic fits
  • amnesia
  • reduced attention and/or reduced concentration ability
  • reduced level of alertness
  • changes in skin colour, blood pressure, heart rate, salivation and other involuntary nervous functions, as manifestations that may accompany an epileptic seizure
  • balance disorders
  • sensation of instability
  • headache
  • visual disturbances such as double vision or blurred vision
  • eye function disorders
  • lowering of body temperature
  • reduced blood arterial pressure
  • respiratory depression
  • temporary cessation of breathing for several seconds (apnoea)
  • worsening of pre-existing sleep apnoea
  • worsening of chronic lung diseases with breathing difficulties
  • stomach and intestinal problems
  • constipation
  • allergic skin reactions
  • patchy hair loss (alopecia)
  • yellow/yellowish discoloration of the skin and mucous membranes (jaundice)
  • inability to completely empty the bladder of urine (urinary retention)
  • increased blood levels of bilirubin, transaminases and alkaline phosphatase (substances produced by the liver)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell 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 Lorazepam Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
The product must be used within 30 days of first opening the vial (reconstitution of the solution). Any excess product should be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lorazepam Mylan Generics contains

  • The active substance is lorazepam. 10 ml of reconstituted solution contain 20 mg of lorazepam.
  • The other components are: mannitol, ethanol, purified water.

Description of the appearance of Lorazepam Mylan Generics and contents of the pack
10 ml vial with reservoir cap (containing the powder) and dropper.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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)