Package leaflet: Information for the user

TAVOR 2 mg/ml oral drops, solution

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

1. What Tavor is and what it is used for

Tavor 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 (tranquillizing effect).
Tavor is used for the short-term treatment of the following conditions when they are severe and cause distress in everyday life:

Anxiety and emotional tension states associated with anxiety
Insomnia.

2. What you need to know before taking Tavor

Do not take Tavor:

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 and during breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions
The duration of treatment with Tavor should be as short as possible. It is recommended not to
exceed 4 weeks for the treatment of insomnia and 8–12 weeks for the treatment of anxiety. The
recommended duration of treatment includes also the period required for gradual dose reduction.
See section 3 How to take Tavor.
Talk to your doctor or pharmacist before taking Tavor if you think any of the following conditions
apply to you (also see 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:
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 Tavor, your doctor will monitor you regularly;
you have 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 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 Tavor may also cause dependence (see section Development of dependence);
you suffer or have ever suffered from depression, because Tavor 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. Tavor 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 dose for your condition;
you have or have ever had kidney problems (renal insufficiency). Your doctor will recommend the most appropriate dose for your condition.

Memory disturbances
After taking Tavor, you may have difficulty remembering events that occurred after taking the
medicine. Therefore, it is advisable that you are able to sleep for 7–8 hours after taking this medicine.
Paradoxical reactions
Tavor 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
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 Tavor, 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 taken or are currently taking illegal substances;
you regularly consume alcohol or have frequently consumed large amounts of alcohol in the past;
you have previously or currently have a desire to take large amounts of medicines;
you have personality disorders, e.g. difficulties 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 dose too quickly, withdrawal reactions may
occur. Do not stop this medicine suddenly. Ask your doctor for advice on how to discontinue treatment.
Some withdrawal reactions may be life-threatening.
Withdrawal reactions may range from mild depressed mood and insomnia to a more severe syndrome
with muscle and abdominal cramps, vomiting, sweating, tremors, and seizures. 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 reactions may include: headache, anxiety, restlessness, tension, confusion and
irritability, depressed mood, dizziness, feelings of detachment or alienation from oneself and the
external world, excessive increase in noise perception, tinnitus, tingling and numbness of limbs,
sensitivity to light, noise, and physical contact / changes in perception, involuntary movements, stomach
pain, loss of appetite, diarrhoea, panic attacks, muscle pain, states of excitement, increased awareness
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).
Do not give Tavor 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 effects of Tavor.
If you suffer from low blood pressure, this medicine may increase the frequency of 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, Tavor must not be used because it could worsen
your condition (also see section 2 Do not take Tavor).
Children and adolescents
The efficacy and safety of Tavor in children under 12 years of age are unknown. Your doctor will decide
whether Tavor can be administered to children based on their condition. The duration of treatment must
be as short as possible.
Other medicines and Tavor
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The concomitant use of Tavor 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 Tavor 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
recommendations regarding dosage. 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 Tavor,
because caution is required:

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

Tavor with alcohol
Do not drink alcohol while taking Tavor because alcohol 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 using machines).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your
doctor or pharmacist for advice 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 delivery (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 pauses lasting several seconds (apnea);
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 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 can take Tavor during
breastfeeding.
If you breastfeed while taking this medicine, the newborn may experience drowsiness and reduced
ability to feed.
Driving and using machines
Do not drive or operate machinery if you experience drowsiness or dizziness during treatment with
Tavor. Tavor 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 Tavor.
Tavor contains ethanol (ethyl alcohol)
This medicine contains ethanol.
This medicine contains 284 mg of alcohol (ethanol) per 0.5 ml dose (20 drops) or 710 mg of alcohol
(ethanol) per 1.25 ml dose (50 drops), equivalent to 567 mg of alcohol (ethanol) per ml of solution.
The amount of alcohol in 20 drops of this medicine is equivalent to 7 ml of beer or 3 ml of wine.
The amount of alcohol in 50 drops of this medicine is equivalent to 18 ml of beer or 7 ml of wine.
The amount of alcohol in this medicine does not appear to have an effect on adults and adolescents,
and its effects in children are not evident. Some effects may occur in young children, for example,
drowsiness.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist
if you are taking other medicines.
If you are alcohol-dependent, talk to your doctor before taking this medicine.

3. How to take Tavor

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 duration of treatment with Tavor, 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).
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 Tavor, first increase the evening dose, and then, if necessary, also increase the morning dose.
Tavor should be 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 Tavor until discontinuation. Your doctor will decide whether treatment can be continued beyond the recommended maximum period. It is advisable not to exceed the maximum daily dose.

The recommended dose is 20 drops 2–3 times daily.
In severe cases, the recommended dose is 50 drops 3–4 times daily.

Treatment of insomnia The recommended treatment duration ranges from a few days up to a maximum of 4 weeks. This period includes the time needed to gradually reduce the dose of Tavor until discontinuation. Your doctor will decide whether treatment can be continued beyond the recommended maximum period. It is advisable not to exceed the maximum daily dose.

The recommended dose is 20–40 drops, taken at bedtime.
If you are elderly and/or your general health condition is very weak
The recommended initial dose is 1 mg (20 drops) or 2 mg (40 drops) 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 carry out frequent monitoring.

Preparation of patients awaiting surgery Major surgery: the recommended dose is 2 mg–4 mg (40–80 drops) of Tavor, the evening before the procedure. Minor surgery: the recommended dose is 2 mg–4 mg (40–80 drops) of Tavor, 1–2 hours before the 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, 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).
Instructions for use

Press simultaneously on the plastic cap of the bottle and unscrew it;
Press on the white stopper to release the powder;
Shake until a homogeneous solution is obtained;
To dispense the drops, remove the white stopper and invert the bottle;
To close the bottle, press and screw the cap back on.

Four diagrams illustrate how to press the cap and unscrew, press the plug, shake the bottle, and pour the drops

If you take more Tavor than you should
It is important that you never take more medicine than prescribed. Generally, there is no life-threatening danger 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;
impaired speech articulation;
mental confusion;
prolonged sleep and reduced response to normal stimuli;
inability to completely empty the bladder;
changes in sexual desire. In more severe cases, when large amounts of the medicine 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, symptoms may include:
loss of motor coordination;
reduced muscle tone;
low blood pressure;
excessive drowsiness;
paradoxical reactions (opposite to the expected effects of this medicine);
depression of all central nervous system functions;
reduced heart function;
reduced breathing;
coma;
death. Treatment Immediately contact your doctor or go to the nearest emergency room if you take more Tavor 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 Tavor, or flumazenil, a medicine that counteracts the effects of Tavor.

If you forget to take Tavor
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 Tavor
Do not stop taking this medicine suddenly unless you suspect a serious side effect, because the 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 Tavor 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 everyone 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 Tavor should 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 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, as 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 occurring after taking the medicine (anterograde amnesia). This may also be accompanied by behavioral changes (see section 2, Memory disorders)
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 Tavor (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 frequency not known (frequency cannot be estimated from the available data):

reduction in all blood cells
decrease in blood platelet count
hypersensitivity reactions
condition 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
disturbances in nerve centers controlling instinctive movements. This may cause: tremors, vertigo, difficulty in speech articulation (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 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
reduction in blood arterial pressure
respiratory depression
temporary suspension of breathing for several seconds (apnea)
worsening of pre-existing sleep apnea
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 (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 may 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 Tavor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after
"Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C.

Reconstituted solution
Store in the refrigerator (2°C–8°C). The reconstituted solution is valid for 30 days.

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 Tavor contains
The active substance is lorazepam.
10 ml of reconstituted solution contain 20 mg of lorazepam.
The other components are: mannitol, ethanol (ethyl alcohol) (see section "Tavor contains ethanol (ethyl alcohol)"), and deionized water.

Description of the appearance of Tavor and contents of the pack
Tavor 2 mg/ml oral drops are available in a glass bottle with reservoir cap (containing the powder) and dropper.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Italy

Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de' Stampi-Rozzano (MI)
Italy

Package leaflet: Information for the user

TAVOR 1 mg film-coated tablets, 2.5 mg film-coated tablets

Lorazepam
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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tavor is and what it is used for

Tavor 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 (tranquilizing effect).
Tavor 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 Tavor

Do not take Tavor:

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 failure);
if you suffer from episodes of breathing interruption 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 Tavor should be as short as possible. It is recommended not to
exceed 4 weeks for insomnia treatment and 8–12 weeks for anxiety treatment. The recommended
treatment duration includes the time needed for gradual dose reduction. See section 3 How to take Tavor.
Talk to your doctor or pharmacist before taking Tavor if you think any of the following
conditions apply to you (also see section 4 Possible side effects):

you have or have ever had breathing problems, as 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 difficulties, chronic inability to breathe adequately and regularly, either during exertion or at rest;
you suffer from episodes of breathing interruption for several seconds during sleep (sleep apnea). If you have any of these conditions and need to start treatment with Tavor, your doctor will monitor you regularly;
you have or have ever suffered from allergic reactions to benzodiazepines. This medicine may cause severe and rapidly developing 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 Tavor may also cause dependence (see section Development of dependence);
you suffer or have ever suffered from depression, as Tavor 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. Tavor is not recommended as the main treatment for this condition;
you have or have ever had liver problems (hepatic failure), as this medicine could worsen your condition. Your doctor will advise you on the most suitable dosage;
you have or have ever had kidney problems (renal failure). Your doctor will advise you on the most suitable dosage.

Memory disturbances
After taking Tavor, 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
Tavor 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 may decrease (tolerance) after prolonged use. This medicine is recommended for short-term treatment only.
The use of 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 Tavor, 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 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 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.

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 Tavor.
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 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, Tavor must not be used, as it could worsen your condition (also see section 2 Do not take Tavor).

Children and adolescents
The efficacy and safety of Tavor in children under 12 years of age are unknown. Your doctor will decide whether Tavor can be administered to children based on their individual condition. The duration of treatment should be as short as possible.

Other medicines and Tavor
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The concomitant use of Tavor and opioids (strong painkillers, substitution therapy medicines, 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 Tavor 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 so they are aware of the above-mentioned signs and symptoms. Contact your doctor if such symptoms occur.
Tell your doctor or pharmacist if you are taking any of the following medicines together with Tavor, as caution is required:

medicines causing strong depression of 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 (sedative antihistamines).
Tavor, when administered together with anaesthetic medicines, may cause euphoria, increasing the likelihood of developing psychological dependence;
clozapine (a medicine used for thought disorders), as co-administration with Tavor may cause marked sedation, increased salivation, and loss of motor coordination;
valproate (a medicine used for epileptic seizures), as it may enhance the effects of Tavor. In this case, your doctor may decide to halve the dose of Tavor;
probenecid (a medicine used for gout), as it may enhance the effects of Tavor. In this case, your doctor may decide to halve the dose of Tavor;
theophylline and aminophylline (medicines used for bronchial asthma), as they may reduce the effects of Tavor;
loxapine (a medicine used for thought disorders), as co-administration with Tavor 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), as it may reduce the effects of Tavor.

Tavor and alcohol
Do not drink alcohol while taking Tavor, as 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 and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice 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 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 pauses lasting several seconds (apnea)
feeding difficulties
reduced cold tolerance and consequent metabolic disturbances
yellowish/yellow discoloration of the skin and mucous membranes (jaundice)
If you take this medicine for a prolonged period during the late stages 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 can take Tavor while breastfeeding.
If you breastfeed while taking this medicine, the newborn may become drowsy and have reduced ability to suckle breast milk.

Driving and use of machines
Do not drive or operate machinery if you experience drowsiness or dizziness during treatment with Tavor. Tavor 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 Tavor.

Tavor contains lactose
Tavor contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Tavor

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 doses, and the duration of treatment with Tavor, 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 Tavor, first increase the evening dose, then, if necessary, also increase the morning dose.

Tavor should be taken orally. Each film-coated tablet has a score line to allow splitting, if needed. The score line is intended to facilitate breaking the tablet in case you have difficulty swallowing it whole.

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 Tavor before stopping. Your doctor will decide whether treatment can 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 up to a maximum of 4 weeks. This period includes the time needed to gradually reduce the dose of Tavor before stopping. Your doctor will decide whether treatment can 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 in 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 closely with regular check-ups.

Preparation of patients awaiting surgery
Major surgery: the recommended dose is 2 mg–4 mg of Tavor the evening before the procedure.
Minor surgery: the recommended dose is 2 mg–4 mg, 1–2 hours before the procedure.
Duration of treatment
The duration of treatment will be 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).

If you take more Tavor than you should
It is important never to 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;
slurred speech;
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 are taken with suicidal intent, or when this medicine is taken together with alcoholic drinks or other medicines that reduce consciousness and major brain functions—the symptoms may include:

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

Treatment
Contact your doctor immediately or go to the nearest emergency room if you take more Tavor 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 Tavor, or flumazenil, a medicine that counteracts the effects of Tavor.

If you forget to take Tavor
If you forget to take a dose, take it as soon as you remember, but only if you are able to rest immediately afterwards for a sufficient 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 Tavor
Do not stop taking this medicine abruptly 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 Tavor 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 continued treatment or by reducing the dose.
Contact your doctor immediately if you experience any of the following side effects, as
Tavor treatment must be discontinued :

paradoxical effects (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
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 in swallowing and breathing
difficulty remembering events occurring 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)
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 Tavor (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
decrease in blood platelet count
hypersensitivity reactions
a condition 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 concentration ability
reduced level of alertness
changes in skin colour, blood pressure, heart rate, salivation, and other nervous functions not under voluntary control, 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
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
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 levels in the blood 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 following 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 Tavor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Tavor contains
The active substance is lorazepam.
One 1 mg film-coated Tavor tablet contains 1 mg of lorazepam.
One 2.5 mg film-coated Tavor tablet contains 2.5 mg of lorazepam.
The other components are: lactose (see section 2, Tavor contains lactose), microcrystalline cellulose, polacrilin potassium, magnesium stearate. The coating contains hypromellose, polyethylene glycol 6000, titanium dioxide, talc.

Description of the appearance of Tavor and contents of the pack
The 1 mg film-coated Tavor tablets are round, flat, with bevelled edges, white to off-white in colour, marked with "1.0" on one side and a score line on the other side. The film-coated tablets are available in PVC/aluminum blisters in packs of 20 and 30 tablets.
The 2.5 mg film-coated Tavor tablets are round, flat, with bevelled edges, white to off-white in colour, marked with "2.5" on one side and a score line on the other side. The film-coated tablets are available in PVC/aluminum blisters in packs of 20 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Italy

Manufacturer
Pfizer Ireland Pharmaceuticals
Little Connell, Co Kildare
Newbridge
Ireland
Pfizer Manufacturing Deutschland GmbH
Freiburg site
Mooswaldallee 1 -D-79090 Freiburg
Germany

Patient Information Leaflet: Information for the user

TAVOR 1 mg orodispersible tablets, 2.5 mg orodispersible tablets

Lorazepam
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, because 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:

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

1. What Tavor is and what it is used for

Tavor 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).
Tavor is used for the short-term treatment of the following conditions when they are severe and cause significant distress in everyday life:

Anxiety and emotional tension states associated with anxiety
Insomnia.

2. What you need to know before taking Tavor

Do not take Tavor:

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 breathing interruption 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 Tavor 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 Tavor.
Talk to your doctor or pharmacist before taking Tavor if you think any of the following conditions apply to you (see also section 4 Possible side effects):

you have or have ever had breathing problems, because this medicine can reduce your spontaneous 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 for several seconds during sleep (sleep apnea). If you have any of these conditions and need to start treatment with Tavor, 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 Tavor may also cause dependence (see section Development of dependence);
you suffer or have ever suffered from depression, because Tavor 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 were not always aware of these difficulties. Tavor is not recommended as the primary 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.

Paradoxical reactions
Tavor 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 patients.
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 (tolerance) of this medicine may decrease after continuous use. This medicine is recommended for short-term treatment only.
The use of 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 Tavor, 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 are currently taking or have taken illegal substances;
you regularly consume alcohol or have previously consumed large amounts frequently;
you have previously or currently have a desire to take large amounts of medicines;
you have personality disorders, e.g., difficulties in interacting with others 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 suddenly. 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 reactions 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 of limbs, sensitivity to light, noise, and physical contact/perceptual changes, involuntary movements, stomach pain, loss of appetite, diarrhea, 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 you were prescribed this medicine may also reappear briefly (rebound phenomena).
Do not give Tavor to family members or friends. Store this medicine securely so that it cannot harm others.

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, Tavor must not be used because it could worsen your condition (see also section 2 Do not take Tavor).

Children and adolescents
The efficacy and safety of Tavor in children under 12 years of age are unknown. Your doctor will decide whether Tavor can be administered to children based on their condition. The duration of treatment should be as short as possible.

Other medicines and Tavor
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Concomitant use of Tavor and opioids (strong painkillers, substitution therapy medicines, 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 Tavor 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 dosage recommendations. 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 Tavor, as caution is required:

medicines causing strong reduction of 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). Tavor, when administered together with anaesthetics, may cause euphoria, increasing the likelihood of developing psychological dependence;
clozapine (a medicine used for thought disorders), because taking it together with Tavor 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 Tavor. In this case, your doctor may decide to halve the dose of Tavor;
probenecid (a medicine used for gout), because it may enhance the effects of Tavor. In this case, your doctor may decide to halve the dose of Tavor;
theophylline and aminophylline (medicines used for bronchial asthma), because they may reduce the effects of Tavor;
loxapine (a medicine used for thought disorders), because taking it together with Tavor may cause a state characterized by excessive passivity and inertia towards events and people (e.g., immobility 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 Tavor.

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.

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 (apnea);
feeding problems;
reduced cold resistance and consequent metabolic disturbances;
yellow/yellowish skin and mucous membrane discoloration (jaundice).
If you take this medicine for a prolonged period during the late stages 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 can take Tavor 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 Tavor. Tavor may also cause amnesia, impaired concentration ability, and altered muscle function. Your alertness may be impaired, especially if you have not slept long enough after taking Tavor.

3. How to take Tavor

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 Tavor, 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 Tavor, first increase the evening dose, and then, if necessary, also increase the morning dose.

Tavor should be taken by mouth. The orodispersible tablets can be taken without water, as they dissolve rapidly under the tongue without the need to swallow them.
Each orodispersible tablet has a score line to allow splitting if needed. The score line is intended to facilitate breaking the tablet in case you have difficulty swallowing it whole.

Treatment of anxiety
The recommended treatment duration should not exceed 8–12 weeks. This period includes the time needed to gradually taper the dose of Tavor 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 orodispersible tablets of 1 mg per day.
In severe cases, the recommended dose is 3 or 4 orodispersible tablets of 2.5 mg per day.
Treatment of insomnia
The recommended treatment duration ranges from a few days up to a maximum of 4 weeks. This period includes the time needed to gradually taper the dose of Tavor 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 1 or 2 orodispersible tablets of 1 mg, taken at bedtime.
For persistent insomnia, the recommended dose is 1 or 2 orodispersible tablets of 2.5 mg, taken at bedtime.

If you are elderly and/or in 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 closely.

Preparation of patients awaiting surgery
Major surgery: the recommended dose is 2 mg–4 mg of Tavor, taken the evening before the procedure.
Minor surgery: the recommended dose is 2 mg–4 mg, taken 1–2 hours before the procedure.
Duration of treatment
The duration of treatment will be 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 essential to stop taking this medicine gradually and under medical supervision to prevent withdrawal reactions (see section 2).
Instructions for use
Tavor orodispersible tablets are much more fragile than standard tablets and must therefore be handled with care.
How to remove the orodispersible tablets from the packaging:

Lift the side tab;
Remove the tab;
Push the tablet out by pressing on the blister

Four-step diagram illustrating how to remove an orosoluble tablet from a blister pack by lifting and peeling

If you take more Tavor than you should
It is important that you never take more medicine than prescribed. In general, 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;
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 depress consciousness and major brain functions, symptoms may include:
loss of motor coordination;
reduced muscle tone;
low blood pressure;
excessive drowsiness;
effects opposite to those expected from this medicine (paradoxical symptoms);
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 Tavor 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 Tavor, or flumazenil, a medicine that counteracts the effects of Tavor.

If you forget to take Tavor
If you forget to take a dose, take it as soon as you remember, but ensure that you can rest immediately afterwards for a sufficient 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 Tavor
Do not stop taking this medicine abruptly 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 Tavor or suddenly reduce the dose, you may experience temporary withdrawal symptoms or rebound symptoms (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 everyone experiences 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, as treatment with Tavor 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
aggression
feelings of disappointment
anger
nightmares
hallucinations
difficulty correctly interpreting reality and thought disturbances
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, 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 behavioral changes (see section 2, Memory disorders)
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 Tavor (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 determined from available data):

reduction in all blood cells
decrease in blood platelet count
hypersensitivity reactions
condition 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 nerve 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 voluntarily, 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
reduction in blood arterial 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
allergic skin reactions
patchy hair loss (alopecia)
yellow/yellowish discoloration of the skin and mucous membranes (jaundice)
inability to completely empty the urinary bladder (urinary retention)
increased levels in the blood 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 the following 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 Tavor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
"Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C. Protect the medicine from light.
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. Pack contents and other information

What Tavor contains
The active substance is lorazepam.
One 1 mg orodispersible tablet of Tavor contains 1 mg of lorazepam.
One 2.5 mg orodispersible tablet of Tavor contains 2.5 mg of lorazepam.
The other components are: gelatin and mannitol.

Description of the appearance of Tavor and contents of the pack
The 1 mg and 2.5 mg orodispersible tablets of Tavor are circular tablets, white to almost white in colour, with a score line imprinted on them. The tablets are available in blisters, pack size: 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Italy

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
Münster
Germany