Patient Information Leaflet

Lorazepam Accord 1 mg film-coated tablets, 2.5 mg film-coated tablets

Generic Medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lorazepam Accord is and what it is used for
What you need to know before taking Lorazepam Accord
How to take Lorazepam Accord
Possible side effects
How to store Lorazepam Accord
Contents of the pack and other information

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

Lorazepam Accord 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 normal sleep (hypnotic effect), improving mood, and reducing the intensity of emotional responses to psychological stress (tranquillizing effect).
Lorazepam Accord 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 should know before taking Lorazepam Accord

Do not take Lorazepam Accord

if you are allergic to lorazepam, to other medicines of a similar type (benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue;
if you have severe breathing problems (respiratory failure);
if you have severe liver problems (hepatic failure);
if you have breathing difficulties during sleep (sleep apnea);
if you have high eye pressure due to a disease of the optic nerve (narrow-angle glaucoma);
if you are pregnant (see section Pregnancy and breastfeeding).

Warnings and precautions
The duration of treatment with Lorazepam Accord 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 the period required for
gradual dose reduction. See section 3 How to take Lorazepam Accord.
Talk to your doctor or pharmacist before taking Lorazepam Accord 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 breathing interruption lasting several seconds during sleep (sleep apnea). If you have any of these conditions and need to start treatment with Lorazepam Accord, 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 to stop taking lorazepam-containing medicines 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 Accord may also cause dependence (see section “Development of dependence”);
you suffer or have ever suffered from depression, because Lorazepam Accord may worsen your condition and increase suicidal tendencies;
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 Accord is not recommended as the main treatment for this condition;
you have or have ever had liver problems (hepatic failure), 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 failure). Your doctor will advise you on the most appropriate dosage for your condition.

Memory disturbances
After taking Lorazepam Accord, you may experience difficulty remembering events that occurred
after taking the medicine. Therefore, it is advisable to ensure you can sleep for 7–8 hours after
taking this medicine.
Paradoxical reactions
Lorazepam Accord 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
discontinue this medicine.
Development of tolerance
After repeated use of this medicine for several weeks, its effectiveness may decrease (tolerance).
Lorazepam Accord is recommended for short-term treatment only.
Furthermore, treatment with this medicine increases sensitivity to the effects of alcohol and other
medicines that depress brain functions. Therefore, when taking Lorazepam Accord, concomitant
use of alcohol and such medicines should be avoided or reduced.
Development of dependence
The use of benzodiazepines, including Lorazepam Accord, may lead to dependence, which may
manifest as an increasing need, desire, or excessive urge to take the medicine (psychological
dependence), or the development of physical symptoms that decrease or disappear only after taking
the medicine (physical dependence). The likelihood of developing psychological and physical
dependence on this medicine increases with higher doses and longer treatment duration.
You are more likely to develop dependence on Lorazepam Accord if:

you have previously or currently use drugs;
you have previously or currently drink alcohol frequently and/or in large quantities;
you have previously or currently have a desire to take medicines in excessive amounts;
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. If treatment with Lorazepam Accord is abruptly stopped after dependence has developed, you may experience withdrawal symptoms such as:
severe symptoms (more likely after long-term use of high-dose Lorazepam Accord): feeling detached or estranged from oneself or the external world, increased sensitivity to sounds, numbness and tingling in the legs or arms, hypersensitivity to light, noise, and physical contact, hallucinations, delirium, epileptic seizures, convulsions. Seizures and convulsions may occur more easily if you are taking antidepressants together with Lorazepam Accord;
other symptoms: headache, muscle pain, extreme anxiety, emotional tension, restlessness, confusion, irritability, dizziness, nausea, diarrhea, loss of appetite, mood changes with a tendency toward sadness, depression, insomnia, sweating, persistent ringing in the ears (tinnitus), involuntary body movements, vomiting, tingling sensations, altered perceptions, abdominal and muscle cramps, tremor, agitation, heightened awareness of heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, dizziness, exaggerated reflexes, inability to remember recent events, high increase in body temperature;
rebound symptoms: insomnia and anxiety. These are the same symptoms for which you were prescribed Lorazepam Accord, but if treatment is abruptly stopped, they may temporarily reappear in a more severe form than before starting treatment. Additionally, you may experience mood changes, restlessness, anxiety, and sleep disturbances.

Do not stop taking Lorazepam Accord suddenly. Consult your doctor or pharmacist,
who will advise you on the correct way to discontinue treatment with this medicine.
See section 3 If you stop taking Lorazepam Accord.
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 effects of
Lorazepam Accord.
If you suffer from low blood pressure, this medicine may increase episodes of blood pressure drop.
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 Accord must not be used because it
could worsen your condition (see also section 2 Do not take Lorazepam Accord).
Children and adolescents
The efficacy and safety of Lorazepam Accord in children under 12 years of age are unknown.
Your doctor will decide whether Lorazepam Accord can be administered to children based on their
individual condition. The duration of treatment should be as short as possible.
Other medicines and Lorazepam Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
The concomitant use of Lorazepam Accord 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
available.
However, if your doctor prescribes Lorazepam Accord 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 carefully follow your doctor’s
instructions regarding dosage. It may be helpful to inform friends or family members so they are
aware of 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 Accord, 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)
anesthetics
medicines to counteract allergic reactions (sedating antihistamines). Lorazepam Accord, when administered together with anesthetic medicines, may cause euphoria, increasing the risk of developing psychological dependence;
clozapine (a medicine used for thought disorders), because taking it together with Lorazepam Accord 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 Accord. In this case, your doctor may decide to halve the dose of Lorazepam Accord;
probenecid (a medicine used for gout), because it may enhance the effects of Lorazepam Accord. In this case, your doctor may decide to halve the dose of Lorazepam Accord;
theophylline and aminophylline (medicines used for bronchial asthma), because they may reduce the effects of Lorazepam Accord;
loxapine (a medicine used for thought disorders), because taking it together with Lorazepam Accord may cause a state characterized by excessive passivity and inertia toward events and people (e.g., immobility and mutism), markedly reduced 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 Accord.

Lorazepam Accord and alcohol
Do not drink alcohol while taking Lorazepam Accord, because alcohol 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 machines).
Pregnancy, breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
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 reasons, you take this medicine at high doses during the last 3 months of pregnancy, during the period before childbirth (labor), 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 pauses lasting several seconds (apnea)
feeding difficulties
reduced cold tolerance 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
Accord while breastfeeding.
If you breastfeed while taking this medicine, the newborn may experience drowsiness and reduced
ability to feed.
Driving and use of machines
Do not drive or operate machinery if you experience drowsiness or dizziness during treatment
with Lorazepam Accord. Lorazepam Accord may also cause amnesia, impaired concentration, and
muscle function disturbances. Your alertness may be impaired, especially if you have not slept for a
sufficient time after taking Lorazepam Accord.
Lorazepam Accord contains lactose
This medicine 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 Accord

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
Depending on your condition and illness, your doctor will advise you on the correct dose, how many times a day to take the medicine, and the duration of treatment with Lorazepam Accord, so that you take the lowest possible dose for the shortest possible time.
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 Accord, the evening dose should first be increased, followed, if necessary, by an increase in the morning dose.

Treatment of anxiety: The duration of treatment should generally not exceed 8–12 weeks, including a period of gradual withdrawal. In certain cases, your doctor may decide to extend the treatment after evaluating your health condition. 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 recommended dose is 3–4 tablets of 2.5 mg per day.

Treatment of insomnia: The duration of treatment is generally from a few days up to a maximum of 4 weeks, including a period of gradual withdrawal. In certain cases, your doctor may decide to extend the treatment after evaluating your health condition.

The recommended dose is 1 or 2 tablets of 1 mg per day.
For persistent insomnia, the recommended dose is 1 or 2 tablets of 2.5 mg per day 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 insufficiency)
Your doctor will determine the most appropriate dose for you on a case-by-case basis and will subject you to frequent monitoring.

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

If you take more Lorazepam Accord 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;
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, such as when large quantities 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 coordination of movement;
reduced muscle tone;
low blood pressure;
excessive drowsiness;
effects opposite to those expected from this medicine (paradoxical symptoms);
reduction 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 Accord 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 the absorption of Lorazepam Accord, or flumazenil, a medicine that counteracts the effects of Lorazepam Accord.

If you forget to take Lorazepam Accord
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 a missed dose. If you think you have missed more than one dose, consult your doctor.

If you stop taking Lorazepam Accord
Do not stop taking Lorazepam Accord suddenly, as the doses must be gradually reduced. Your doctor will advise you on how to discontinue treatment.
If you stop taking Lorazepam Accord 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 continuation of treatment or by reducing the dose.

Contact your doctor immediately if you experience any of the following side effects, as treatment with Lorazepam Accord must be discontinued:

paradoxical reactions (opposite to the expected effects) (see section 2, Paradoxical disorders), such as:
depression or unmasking of pre-existing depression
restlessness
agitation
irritability
aggressiveness
feelings of disappointment
anger
nightmares
hallucinations
difficulty in correctly perceiving reality and thought disturbances
behavioural 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, as they may be serious:

severe allergic reaction (anaphylactic shock)
swelling of the face, tongue and throat leading to difficulty swallowing and breathing
difficulty remembering events that occurred after taking the medicine (anterograde amnesia). This may also be accompanied by behavioural changes (see section 2, Memory disorders)
physical dependence on the medicine (see section 2, Development of dependence)
psychological dependence on the medicine (see section 2, Development of dependence)
withdrawal symptoms (see section 2, Development of dependence)
rebound symptoms (see section 2, Development of dependence)
coma
suicidal thoughts, suicide attempts
excessive use of Lorazepam Accord (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 frequency not known (frequency cannot be estimated from the available data):

reduction in all blood cells
reduction in blood platelet count
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, which 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
reduction in blood arterial pressure
respiratory depression
temporary suspension of breathing for several seconds (apnoea)
worsening of pre-existing sleep apnoea before taking the medicine
worsening of chronic lung diseases with breathing difficulties
stomach and intestinal problems
constipation
allergic skin reactions
patchy hair loss (alopecia)
yellow/yellowish skin and mucous membrane colouration (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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lorazepam Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine 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 Accord contains
Lorazepam Accord 1 mg film-coated tablets

The active substance is lorazepam. Each film-coated tablet contains 1 mg of lorazepam.
The other components are: monohydrate lactose, microcrystalline cellulose, polacriline potassium, magnesium stearate. Film coating: hypromellose, macrogol 6000, titanium dioxide, talc.

Lorazepam Accord 2.5 mg film-coated tablets

The active substance is lorazepam. Each film-coated tablet contains 2.5 mg of lorazepam.
The other components are: monohydrate lactose, microcrystalline cellulose, polacriline potassium, magnesium stearate. Film coating: hypromellose, macrogol 6000, titanium dioxide, talc.

Description of the appearance of Lorazepam Accord and package contents
1 mg film-coated tablets in blister packs containing 20 divisible tablets.
2.5 mg film-coated tablets in blister packs containing 20 divisible tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Doppel Farmaceutici S.r.l. – Via Volturno, 48 Quinto De’ Stampi – 20089 Rozzano (MI) – Italy.