Lorazepam ABC

Italy
Brand name Lorazepam ABC
Form tablets, film-coated
Active substance / Dosage
LORAZEPAM
Prescription type Prescription only
ATC code
N05BA06
Registration number 035931
Manufacturer ABC FARMACEUTICI S.P.A.
Lorazepam ABC tablets, film-coated

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LORAZEPAM ABC 1 mg film-coated tablets, 2.5 mg film-coated 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 their symptoms are the same as yours, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lorazepam ABC is and what it is used for

Lorazepam ABC 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 that closely resembles natural sleep (hypnotic effect), improving mood and
reducing the intensity of emotional responses to psychological stress (tranquilizing effect).
Lorazepam ABC is used for the short-term treatment of the following conditions when they are severe and
cause distress in normal daily life:

  • Anxiety and states of emotional tension associated with anxiety;
  • Insomnia.

2. What you need to know before taking Lorazepam ABC

Do not take Lorazepam ABC

  • if you are allergic to lorazepam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
  • if you suffer from a disease causing severe muscle weakness and easy 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 increased pressure inside the eye (narrow-angle glaucoma);
  • if you are or think you may be pregnant (see section Pregnancy and breastfeeding).

Warnings and precautions
The duration of treatment with Lorazepam ABC 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 needed for
gradual dose reduction. See section 3, How to take Lorazepam ABC.
Talk to your doctor or pharmacist before taking Lorazepam ABC 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:
  • you suffer from heart problems (heart failure);
  • you suffer from low blood pressure;
  • you suffer from general breathing problems, chronic inability to breathe adequately and regularly, either during exertion or at rest;
  • you suffer from episodes of interrupted breathing for several seconds during sleep (sleep apnea). If you have any of these conditions and need to start treatment with Lorazepam ABC, your doctor will monitor you regularly;
  • you suffer or have ever suffered from 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). 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 ABC may also cause dependence (see section Development of dependence);
  • you suffer or have ever suffered from depression, because Lorazepam ABC may worsen your condition and tendency towards suicide;
  • you suffer or have ever suffered from difficulties in relating to other people or to various life situations, even if you have not always been aware of these difficulties. Lorazepam ABC is not recommended as the main treatment for this condition;
  • you have or have ever had liver problems (hepatic insufficiency), because this medicine could worsen your condition. Your doctor will recommend the most appropriate dosage for your condition;
  • you have or have ever had kidney problems (renal insufficiency). Your doctor will recommend the most appropriate dosage for your condition.

Memory disturbances
After taking Lorazepam ABC, you may have difficulty remembering what happened after taking the
medicine. Therefore, it is advisable that you are able to sleep for 7–8 hours after taking this medicine.
Paradoxical reactions
Lorazepam ABC 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, contact 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
A reduction in effectiveness (tolerance) of this medicine may occur after prolonged 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 medicines of this type.
The use of benzodiazepines, including Lorazepam ABC, 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, and in patients with significant personality disorders.
Talk to your doctor if:

  • you have taken or are currently taking illegal substances;
  • you regularly consume alcohol or have previously frequently consumed large amounts of alcohol;
  • you have previously or currently have a desire to take large amounts of medicines;
  • you have personality disorders, e.g. difficulties in interacting with other people or difficulties in certain life situations, even if you were not aware of these problems.

In principle, benzodiazepines should only be used for short periods and discontinued gradually.
Before starting treatment, you and your doctor should agree on how long you will take the medicine.
If you stop taking the medicine abruptly or reduce the dosage rapidly, 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 depressed mood 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 symptoms may include: headache, anxiety, restlessness, tension, confusion, irritability, depressed mood, dizziness, feeling of detachment or alienation from oneself and the outside world, excessive increase in noise perception, tinnitus, tingling and numbness of limbs, sensitivity to light, noise, and physical contact/perceptual changes, involuntary movements, stomach pain, loss of appetite, diarrhoea, panic attacks, muscle pain, states of excitement, increased perception of heartbeat (palpitations), rapid heartbeat (tachycardia), feeling of loss of balance, exaggerated reflexes, loss of ability to recall recent events, and increased body temperature.
The symptoms for which this medicine was prescribed may also reappear briefly (rebound phenomena).
Do not give Lorazepam ABC to family members or friends. Store this medicine safely so that it cannot harm others.
If you are elderly and/or suffer from 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 ABC.
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 associated brain symptoms such as mental confusion, altered level of consciousness, or coma, Lorazepam ABC must not be used because it could worsen your condition (see also section 2 Do not take Lorazepam ABC).
Children and adolescents
The efficacy and safety of Lorazepam ABC in children under 12 years of age are unknown. Your doctor will decide whether Lorazepam ABC can be administered to children based on their individual condition. The duration of treatment should be as short as possible.
Other medicines and Lorazepam ABC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Lorazepam ABC 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 ABC together with opioids, the dose and duration of concomitant therapy must be limited by your doctor.
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 about the signs and symptoms listed above.
Contact your doctor if such symptoms occur.
Inform your doctor or pharmacist if you are taking any of the following medicines together with Lorazepam ABC, 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 reactions (sedating antihistamines).

Lorazepam ABC, 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 ABC may cause marked sedation, increased salivation, and loss of movement coordination;
  • valproate (a medicine used for epileptic seizures), because it may enhance the effects of Lorazepam ABC. In this case, your doctor may decide to halve the dose of Lorazepam ABC;
  • probenecid (a medicine used for gout), because it may enhance the effects of Lorazepam ABC. In this case, your doctor may decide to halve the dose of Lorazepam ABC;
  • theophylline and aminophylline (medicines used for bronchial asthma), because they may reduce the effects of Lorazepam ABC;
  • loxapine (a medicine used for thought disorders), because taking it together with Lorazepam ABC 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 ABC.

Lorazepam ABC and alcohol
Do not drink alcohol while taking Lorazepam ABC because alcohol increases drowsiness and reduced consciousness caused by this medicine. This may also lead to a serious impairment of the ability to drive vehicles and operate machinery (see section Driving and using machines).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, 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 fetus.

  • If, for serious medical 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 experience the following symptoms:
  • excessive reduction in motor activity
  • poor muscle tone
  • moderately reduced breathing rate
  • low body temperature
  • breathing pauses lasting several seconds (apnea)
  • feeding difficulties
  • reduced cold resistance and consequent metabolic disturbances
  • increased bilirubin in the blood (jaundice)
  • If you take this medicine for a prolonged period during the last stage of pregnancy, the newborn may develop physical dependence or withdrawal symptoms shortly after birth (see section Development of dependence).

Breastfeeding
This medicine passes into breast milk. Your doctor will decide whether you may take Lorazepam ABC during breastfeeding.
If you breastfeed while taking this medicine, the newborn may experience drowsiness and reduced ability to feed.
Driving and using machinery
Do not drive or operate machinery if you experience drowsiness or dizziness during treatment with Lorazepam ABC. Lorazepam ABC 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 ABC.
Lorazepam ABC contains lactose
Lorazepam ABC contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Lorazepam ABC

Take this medicine exactly as prescribed 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 duration of treatment with Lorazepam
ABC, ensuring that you take the lowest possible dose for the shortest possible time. Do not alter or exceed
the prescribed dose. To discontinue treatment, the dose must be gradually reduced under the guidance of your
doctor. 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 ABC, the evening dose should be increased first, followed by a possible increase in the morning dose.

Lorazepam ABC is taken orally.

  • 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 ABC before stopping. Your doctor will decide whether treatment may continue beyond the maximum recommended period. It is advised not to exceed the maximum daily dose.
    The recommended dose is 2 or 3 tablets of 1 mg per day. In severe cases, the recommended dose is 3 or 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 required to gradually reduce the dose of Lorazepam ABC before discontinuation. Your doctor will decide whether treatment may continue beyond the maximum recommended period.

It is advised not to exceed the maximum daily dose.
The recommended dose is 1 or 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 have very poor general health
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 frequently.

  • Preparation of patients awaiting surgery
  • Major surgery: the recommended dose is 2 mg – 4 mg of Lorazepam ABC, taken the evening before surgery.
  • Minor surgery: the recommended dose is 2 mg – 4 mg, taken 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, because there is a risk of becoming dependent on this medicine. Your doctor will regularly review your treatment.
It is necessary to stop taking this medicine or to reduce the dose gradually and under medical supervision to prevent withdrawal reactions (see section 2).

If you take more Lorazepam ABC than you should
It is important that you never take more medicine than prescribed. Generally, there is no life-threatening risk if you accidentally take a higher dose than prescribed, 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;
  • speech difficulties;
  • 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 quantities are taken with suicidal intent, or when this medicine is taken together with alcoholic beverages or other medicines that depress consciousness and major brain functions—the symptoms may include:

  • loss of coordination;
  • reduced muscle tone;
  • low blood pressure;
  • excessive drowsiness;
  • paradoxical reactions (effects opposite to those expected from this 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 ABC 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 ABC, or flumazenil, a medicine that counteracts the effects of Lorazepam ABC.

If you forget to take Lorazepam ABC
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). Do not take a double dose to make up for the missed dose. If you think you have missed more than one dose, consult your doctor.

If you stop taking Lorazepam ABC
Do not stop taking this medicine 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 ABC or suddenly reduce the dose, temporary withdrawal symptoms or rebound symptoms may occur (see section 2).
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 will experience them.
Usually, side effects occur at the beginning of treatment and generally decrease in intensity or disappear
with continuation of treatment or by reducing the dose.
Contact your doctor immediately if you experience any of the following side effects, because taking Lorazepam ABC must be discontinued:

  • paradoxical reactions (opposite to the expected effects) (see section 2, Paradoxical reactions), such as:
  • depression or unmasking of pre-existing depression
  • restlessness
  • agitation
  • irritability
  • aggressiveness
  • feelings of disappointment
  • anger
  • nightmares
  • hallucinations
  • difficulty in correctly interpreting reality and disturbances in thinking
  • behavioral changes
  • drowsiness, even during the day
  • dizziness
  • loss of ability to coordinate movements
  • 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 because they may be serious:

  • severe allergic reaction (anaphylactic shock)
  • swelling of the face, tongue, and throat leading to difficulty in swallowing and breathing
  • difficulty remembering events after taking the medicine (anterograde amnesia). This may also be accompanied by behavioral changes (see section 2, Memory disturbances)
  • drug abuse and drug dependence (see section 2, Development of tolerance and dependence, withdrawal reactions, and drug abuse)
  • drug 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 Lorazepam ABC (abuse) or other 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
  • reduced 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 capacity to experience emotions
  • disturbance of the nervous centers controlling instinctive movements. This may cause: tremors, vertigo, difficulty in articulating speech (extrapyramidal symptoms)
  • seizures/epileptic fits
  • amnesia
  • reduced attention and/or reduced concentration ability
  • reduced level of alertness
  • changes in skin color, blood pressure, heart rate, salivation, and other nervous functions not controlled by will, as manifestations that may accompany an epileptic seizure
  • balance disorders
  • feeling of instability
  • headache
  • visual disturbances such as double vision or blurred vision
  • disturbances in eye function
  • lowering of body temperature
  • reduced arterial blood pressure
  • respiratory depression
  • temporary cessation of breathing for several seconds (apnea)
  • worsening of pre-existing sleep apnea before taking the medicine
  • 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 (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, contact 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 ABC

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 ABC Contains
Lorazepam ABC 1 mg film-coated tablets
The active substance is lorazepam. Each tablet contains 1 mg of lorazepam.
The other components are:

  • core: monohydrate lactose, microcrystalline cellulose, polacrillin potassium, magnesium stearate;
  • film coating: hypromellose, macrogol 6000, titanium dioxide, talc.

Lorazepam ABC 2.5 mg film-coated tablets
The active substance is lorazepam. Each tablet contains 2.5 mg of lorazepam.
The other components are:

  • core: monohydrate lactose, microcrystalline cellulose, polacrillin potassium, magnesium stearate;
  • film coating: hypromellose, macrogol 6000, titanium dioxide, talc.

Description of the Appearance of Lorazepam ABC and Contents of the Package
1 mg film-coated tablets in blister packs containing 20 or 30 tablets
2.5 mg film-coated tablets in blister packs containing 20 tablets

Marketing Authorization Holder
ABC Farmaceutici S.p.A. Corso Vittorio Emanuele II, 72 10121 Torino

Manufacturers
ABC Farmaceutici S.p.A. - Canton Moretti, 29 - 10015 San Bernardo d’Ivrea (TO)
Doppel Farmaceutici S.P.A. – Via Volturno, 48 – Quinto de Stampi – 20089 Rozzano (MI)