Patient Information Leaflet

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

Equivalent medicine
Please read all of 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 you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Lorazepam ratiopharm contains lorazepam, a substance belonging to a group of medicines called benzodiazepines, used to relieve severe emotional and psychological distress that causes significant discomfort and sometimes interferes with normal daily activities.
This medicine is therefore indicated for the treatment of:

anxiety, nervous tension, and other disorders associated with anxiety (somatic or psychiatric);
sleep disorders (insomnia).

2. What you should know before taking Lorazepam ratiopharm

Do not take Lorazepam ratiopharm

if you are allergic to the active substance, to other similar medicines (other benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from a disease causing muscle weakness and fatigue (myasthenia gravis);
if you have severe breathing problems (severe respiratory insufficiency);
if you have severe liver problems (severe hepatic insufficiency);
if you have breathing difficulties during sleep (sleep apnoea);
if you are taking other medicines with a calming effect on the central nervous system (such as antipsychotics, antidepressants, hypnotics) or other medicines used to promote sleep, unless your doctor considers it strictly necessary;
if you suffer from increased pressure inside the eye (narrow-angle glaucoma);
during pregnancy;
during breastfeeding;
to treat a child (see also section “Warnings and precautions”);
together with alcoholic beverages.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lorazepam ratiopharm.
Duration of treatment
The duration of treatment should be as short as possible and must not exceed 4 weeks
for the treatment of insomnia and 8–12 weeks for the treatment of anxiety, including a
gradual withdrawal period.
The treatment period may be extended following careful reassessment of your health status by your doctor.
Do not stop, increase, or decrease the dose of this medicine without first consulting your doctor.
Be especially careful and consult your doctor before taking Lorazepam ratiopharm:

if you are elderly;
if your respiratory capacity is impaired (chronic respiratory insufficiency). 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. If you have any of these conditions and need to start treatment with lorazepam, your doctor will monitor you regularly;
you have suffered or are suffering from allergic reactions to benzodiazepines. This medicine may cause severe, 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. As soon as one or more symptoms appear, go 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 may also cause dependence (see section “Development of dependence, withdrawal reactions, and medicine abuse”);
if your liver function is impaired or if your kidney function is impaired; your doctor will recommend the most appropriate dose for your condition;
if you suffer from a psychotic disorder (a serious mental condition in which a person loses contact with reality and the ability to think and judge clearly) or if you suffer from depression or anxiety states associated with depression. Following the use of benzodiazepines, an existing depression may emerge or worsen, potentially leading to suicide attempts.

Memory disturbances
After taking Lorazepam Ratiopharm, you may have difficulty remembering what happened after taking the medicine.
Benzodiazepines may cause anterograde amnesia (memory loss that does not affect past memories but greatly impairs the ability to memorize new information) or other memory disturbances.
This phenomenon occurs more frequently several hours after taking the medicine; therefore, to reduce the risk of this happening, you must ensure you can sleep uninterrupted for 7–8 hours after taking Lorazepam ratiopharm. Therefore, it is advisable to allow yourself to sleep for 7–8 hours after taking this medicine.
Paradoxical reactions
Lorazepam Ratiopharm may cause mental reactions and effects opposite to those expected (paradoxical effects) (see section 4). These effects are more frequent 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 and dependence, withdrawal reactions, and medicine 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 affecting brain function. Therefore, talk to your doctor if you are taking alcohol or medicines of this type.
The use of benzodiazepines, including Lorazepam ratiopharm, 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.
Consult your doctor if:

you have taken or are currently taking illegal substances;
you regularly consume alcohol or have previously consumed large amounts of alcohol frequently;
you have previously or currently have a desire to take large quantities of medicines;
you have personality disorders, e.g., difficulties in interacting with others or difficulties in certain life situations, even if you were unaware 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 abruptly stop taking the medicine or rapidly reduce the dosage, 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 symptoms may include: headache, anxiety, restlessness, tension, confusion, irritability, depressed mood, dizziness, feelings of detachment or alienation from oneself and the external world, excessive increase in noise perception, tinnitus, tingling and numbness in limbs, sensitivity to light, noise, and physical contact/perception changes, involuntary movements, stomach pain, loss of appetite, diarrhoea, panic attacks, muscle pain, states of excitement, increased perception of heartbeat (palpitations), rapid heartbeat (tachycardia), sensation 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).
Withdrawal symptoms may appear after discontinuation of the recommended treatment even after only one week of therapy.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine (such as lorazepam) to a short-acting one. Therefore, switching from one benzodiazepine to another is not recommended. Your doctor will advise you on the most appropriate treatment for your case.
It is important to know that after stopping treatment with this medicine, the same symptoms for which you were being treated (such as insomnia and anxiety) may reappear, sometimes even more intensely than before (rebound symptoms).
Since the onset of withdrawal or rebound symptoms is more likely with long-term treatment or high doses and when treatment is stopped abruptly, to minimize the occurrence of such symptoms (mood changes and sleep disturbances), it is recommended to gradually reduce the dose until treatment is discontinued. Do not give Lorazepam ratiopharm to family members or friends. Store this medicine securely so it cannot harm others.
In addition, you must stop treatment and immediately inform your doctor if you experience: behavioural disturbances such as restlessness, agitation, irritability, aggressiveness, feelings of disappointment, anger, nightmares, hallucinations, psychosis, and behavioural changes, anxiety states, hostility, excitement, sleep disturbances/insomnia, sexual excitement, sedation, fatigue, drowsiness, loss of muscle coordination, confusion, depression, dizziness, changes in libido, impotence, reduced orgasm. These reactions are more frequent in children and the elderly (see section 4).
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 this medicine. If you suffer from low blood pressure, this medicine may increase episodes of low blood pressure.
Therefore, use of this medicine at the lowest possible dose is recommended, or its use should be avoided.
If you have severe liver problems
If you suffer from severe liver problems, with or without cerebral symptoms such as mental confusion, altered level of consciousness, or coma, lorazepam should not be used because it could worsen your condition (see also section “Do not take Lorazepam ratiopharm”).
Children
The efficacy and safety of lorazepam use in children under 12 years of age are unknown.
The use of benzodiazepines in children is not recommended unless your doctor considers it strictly necessary. In such cases, the duration of treatment should be as short as possible.
Other medicines and Lorazepam ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Avoid taking this medicine if you are taking medicines that depress the central nervous system (calming effect on the brain) unless absolutely necessary, because taking these medicines together may cause excessive calming (deep sedation) or very serious effects on breathing (respiratory depression).
The concomitant use of Lorazepam ratiopharm and opioids (strong analgesics, medicines for substitution therapy, or 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 ratiopharm together with opioids, the dose and duration of concomitant treatment must be defined and limited by your doctor. Inform your doctor about all opioid medicines you are taking and carefully follow your doctor’s recommendations regarding dosage. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above. Contact your doctor if you experience these symptoms.
Be especially careful and inform your doctor if you are taking any of the following medicines, as they may increase or decrease the effect of lorazepam:

other psychotropic medicines (used to treat a wide variety of psychiatric and neurological disorders);
barbiturates, antipsychotics (neuroleptics), such as clozapine or loxapine, and antidepressants used to treat mental disorders;
hypnotics/sedatives used to promote sleep;
anxiolytics used to treat anxiety;
some strong painkillers (narcotic analgesics) that may cause excessive well-being when taken with Lorazepam ratiopharm. This may increase your need to continue taking these medicines (dependence);
antiepileptics used for epilepsy, such as valproate;
anaesthetics used during surgical procedures;
antihistamines with sedative effect used to treat allergies;
medicines capable of inhibiting certain liver enzymes (especially cytochrome P450); your doctor will inform you if any of these are among the medicines you are taking;
muscle relaxants such as baclofen or medicines for narcolepsy such as sodium oxybate;
medicines for gout such as probenecid;
medicines used for bronchial asthma, such as theophylline and aminophylline.

Lorazepam ratiopharm with food, drinks, and alcohol
DO NOT consume alcohol during treatment with this medicine, as alcohol may increase drowsiness and reduced consciousness caused by this medicine. This may also severely impair your ability to drive vehicles and operate machinery (see also section “Driving and use of machinery”).
Inform your doctor or pharmacist if you consume caffeine (a substance mainly found in coffee, but also in many energy drinks), as it may reduce the effects of lorazepam.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
This medicine must not be taken during pregnancy, especially during the first 3 months,
as it may cause congenital malformations in the fetus (see section “Do not take Lorazepam ratiopharm”).
If your doctor considers it strictly necessary for serious reasons and you have to take Lorazepam ratiopharm during the late stages of pregnancy or during labour at high doses, your baby may show the following symptoms:

excessive reduction in motor activity;
low body temperature (hypothermia);
loss of muscle strength (hypotonia);
breathing difficulties at birth, temporary suspension of breathing for several seconds (apnoea);
feeding problems;
reduced resistance to cold and consequent metabolic changes;
yellow/yellowish discoloration of the skin and mucous membranes (jaundice). If Lorazepam ratiopharm has been taken for a long time during the final period of pregnancy, the newborn may develop physical dependence or withdrawal symptoms immediately after birth (see section “Development of dependence, withdrawal reactions, and medicine abuse”).

Breastfeeding
Do not take this medicine if you are breastfeeding, as lorazepam passes into breast milk (see section “Do not take Lorazepam ratiopharm”).
Driving and use of machinery
Lorazepam ratiopharm may impair your ability to drive vehicles and operate machinery, as during treatment amnesia, sedation, reduced concentration, and muscle weakness may occur. In addition, if you have not rested sufficiently, the risk of impaired attention is higher.
Finally, remember that consuming alcohol during treatment with this medicine enhances the sedative effect of lorazepam and thus causes strong drowsiness and further reduced attention.
Lorazepam ratiopharm contains lactose: if your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take Lorazepam ratiopharm

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dose and duration of treatment must be adjusted according to your individual condition. Your doctor will advise you on the appropriate dose, how many times per day to take the medicine, and how long to continue treatment, so 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).
You must continue taking this medicine for as long as your doctor instructs.
During treatment, your doctor may adjust the dosage. 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, the evening dose should be increased first, followed, if necessary, by an increase in the morning dose.
Always follow the prescribed dosage carefully.

Anxiety, tension, and other anxiety-related disorders
Treatment duration should be as short as possible and generally should not exceed 8–12 weeks, including a gradual discontinuation period.
In certain cases, your doctor may decide to extend treatment after re-evaluating your health status.
The recommended dose for adults is 1 tablet of 1 mg or, in more severe cases, ½–1 tablet of 2.5 mg, 1–3 times daily, according to your doctor's instructions.

Insomnia
Treatment duration should be as short as possible, usually ranging from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual discontinuation period. In certain cases, your doctor may decide to extend treatment after re-evaluating your health status.
For the treatment of insomnia, the medicine should be taken in the evening.
The recommended dose for adults may range from 1 mg to 2.5 mg taken in the evening.

Preparation of patients awaiting surgery
Major surgery: the recommended dose is 2 mg–4 mg the evening before surgery.
Minor surgery: the recommended dose is 2 mg–4 mg, 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 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).

Elderly patients, debilitated patients, or patients with liver or kidney problems
In these patients, the dose must be carefully determined by the doctor.
If you are elderly and/or your general health condition is very weak, the recommended initial dose is generally 1 mg or 2 mg per day, divided into several doses.

Use in children
This medicine should be used in children only when absolutely necessary and under close medical supervision.

If you take more Lorazepam ratiopharm than you should
In case of accidental ingestion or overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
Taking an excessive dose of lorazepam together with other medicines that depress the central nervous system or with alcohol may result in fatal outcomes.
Symptoms of overdose may include:

marked slowing (depression) of the central nervous system, with symptoms such as temporary loss of sensory and intellectual functions (mental clouding, confusion), difficulty speaking (dysarthria), drowsiness, disorientation.

In more severe cases, the following may occur:

muscle problems (ataxia, hypotonia);
low blood pressure (hypotension);
excessive drowsiness;
paradoxical symptoms (opposite to the expected effects of this medicine);
reduced heart function;
depression of all central nervous system functions;
breathing difficulties;
coma;
death.

If you forget to take Lorazepam ratiopharm
Do not take a double dose to make up for the missed dose.
If you stop taking Lorazepam ratiopharm
Do not stop taking this medicine abruptly unless you suspect a serious side effect, because 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 ratiopharm 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 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.

Stop taking this medicine and contact your doctor immediately if you experience:
depression and mental disorders such as restlessness, agitation, irritability, aggressiveness, feelings of despair, anger, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), and behavioural changes (see section 2).
These reactions are more common in children and elderly patients.

In addition, contact your doctor immediately or go to the nearest emergency room if you experience:

severe allergic reaction (anaphylactic shock);
swelling of the face, tongue, and throat leading to difficulty swallowing or breathing;
difficulty remembering events after taking the medicine (anterograde amnesia) (see section 2, "Memory disturbances");
medication abuse and drug dependence (see section 2, "Development of tolerance and dependence, withdrawal reactions, and medication abuse"), which may also be accompanied by behavioural changes;
rebound symptoms (see section 2, "Development of tolerance and dependence, withdrawal reactions, and medication abuse");
suicidal thoughts or suicide attempts.

To help you recognize some of the side effects, it may be helpful to inform a relative or close friend that you are taking this medicine and ask them to read this leaflet. You may ask them to let you know if they notice any changes in your behaviour.

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

daytime drowsiness.

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

depression (pre-existing or emerging during treatment);
loss of muscle coordination (ataxia);
confusion;
muscle weakness;
fatigue.

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

disturbances in libido;
nausea.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

reduction in all blood cells (pancytopenia);
reduction in the number of white blood cells (agranulocytosis);
reduction in the number of blood platelets (thrombocytopenia);
hypersensitivity reactions;
a condition characterized by excessive secretion of antidiuretic hormone, causing water retention in the body and low sodium levels in the blood (SIADH);
low sodium levels in the blood (hyponatremia);
changes in appetite;
disinhibition;
sleep disturbances;
emotional disturbances;
disorientation;
euphoria;
coma;
disturbances in nerve centres controlling instinctive movements (extrapyramidal symptoms), tremors, difficulty in articulating speech (dysarthria);
seizures/epileptic fits (and autonomic seizures);
amnesia;
anterograde amnesia;
reduced attention and/or reduced concentration ability;
reduced level of alertness;
rebound effect;
withdrawal syndrome;
balance disorders, sensation of abnormality;
headache;
visual disturbances, double or blurred vision;
dizziness;
reduction in blood pressure (hypotension);
respiratory depression;
temporary suspension of breathing for several seconds (apnoea);
worsening of pre-existing sleep apnoea;
worsening of chronic lung diseases with breathing difficulties;
constipation;
stomach and intestinal problems;
yellow/yellowish discoloration of the skin and mucous membranes (jaundice);
allergic skin reactions, including very severe ones, allergic dermatitis;
patchy hair loss (alopecia);
inability to completely empty the bladder (urinary retention);
lowered body temperature;
increased levels in the blood of bilirubin, transaminases, and alkaline phosphatase (substances produced by the liver).

The following side effects occur at the beginning of therapy and usually disappear with continued treatment:

daytime drowsiness, reduced alertness, confusion;
progressive reduction in intellectual and sensory responsiveness (emotional blunting);
headache, dizziness;
fatigue, muscle weakness, difficulty controlling movements (ataxia);
double vision.

Reporting of side effects
If you experience any side effects, 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 ratiopharm

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
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 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. Contents of the pack and other information

What Lorazepam ratiopharm 1 mg film-coated tablets contains

The active substance is lorazepam. One film-coated tablet contains 1 mg of lorazepam.
The other components are: Tablet core: lactose monohydrate, microcrystalline cellulose, potassium polacrilin, magnesium stearate. Film coating: hypromellose, macrogols, titanium dioxide, talc.

What Lorazepam ratiopharm 2.5 mg film-coated tablets contains

The active substance is lorazepam. One film-coated tablet contains 2.5 mg of lorazepam.
The other components are: Tablet core: lactose monohydrate, microcrystalline cellulose, potassium polacrilin, magnesium stearate. Film coating: hypromellose, macrogols, titanium dioxide, talc.

Description of the appearance of Lorazepam ratiopharm and contents of the pack
Lorazepam ratiopharm film-coated tablets are supplied in a box containing 20
film-coated tablets in blister packs.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ratiopharm GmbH - Graf-Arco Strasse 3 - Ulm (Germany)
Manufacturer
ICE S.p.A. - Via Cantone Moretti, 29 10015 - Ivrea (TO) - Italy