LORANS 1 mg Tablet

Зміст інструкції

1. Lorans 2mg/ml oral drops, solution
   1. What is Lorans and what is it used for?
   2. What you need to know before taking Lorans
   3. How to take Lorans
   4. Possible side effects
   5. How to store Lorans
   6. Contents of the pack and other information
2. Lorans 1mg tablets, 2.5mg tablets
   1. What is Lorans and what is it used for?
   2. What you need to know before taking Lorans
   3. How to take Lorans
   4. Possible side effects
   5. How to store Lorans
   6. Contents of the pack and other information

Lorans 2mg/ml oral drops, solution

Lorazepam

Read this leaflet carefully before taking this medicine as it contains important information for you.

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

Contents of this leaflet:

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

1. What is Lorans and what is it used for?

Lorans contains the active ingredient lorazepam and belongs to a group of medicines called
benzodiazepines, which can help relieve anxiety.
Lorazepam is indicated as therapy for anxiety, for disorders associated with it and for sleep disorders.
Benzodiazepines are used only when the disorder is severe and causes discomfort in normal
daily life.

2. What you need to know before taking Lorans

Do not take Lorans

• if you are allergic to lorazepam, to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from a disease called myasthenia gravis which causes muscle weakness and fatigue
• if you have severe liver problems (severe hepatic insufficiency)
• if you have severe breathing problems (severe respiratory insufficiency)
• if you have breathing problems when you sleep (sleep apnea)
• if you suffer from an eye disease characterized by pain and increased pressure inside the eye, called narrow-angle glaucoma
• if you are or think you might be pregnant
• if you are breastfeeding.

If any of these conditions apply to you, do not take Lorans and consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lorans.
It is particularly important that you talk to your doctor or pharmacist before taking Lorans:

• if you have breathing or heart problems as benzodiazepines can cause respiratory depression, which, in the most severe cases, can also lead to death,
• if you suffer from or have ever suffered from allergic reactions to benzodiazepines. This medicine can cause serious and rapid allergic reactions (anaphylactic/anaphylactoid 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,
• if you abuse or have abused drugs or alcohol in the past. In these cases, you may be more likely to become dependent on Lorans (feel the need to continue taking the medicine), (see sections 3 “How to take Lorans” and 4 “Possible side effects”),
• if you suffer from depression as Lorans may bring out or increase suicidal thoughts that you may have due to this illness,
• if you have kidney or liver problems: your doctor will prescribe checks and indicate the most suitable dosage for your condition.

Tolerance and dependence
The effectiveness of Lorans may decrease after a few weeks of use. Lorans is recommended for
short-term treatments.
The use of benzodiazepines can lead to the development of physical dependence (physical disorders
that decrease or disappear only after taking the medicine) and psychological dependence (increasing need,
desire or exaggerated search for taking the medicine). The risk of dependence increases with the
dose and duration of treatment; it is greater in patients with a history of drug abuse,
medicines or alcohol, or marked personality disorders.
Once physical dependence has developed, abrupt discontinuation of treatment will be
accompanied by withdrawal symptoms (see section 3 “If you stop taking Lorans”).
Do not stop taking Lorans suddenly. Consult your doctor who will assess whether and how to
interrupt treatment with this medicine (see section 3 “If you stop taking Lorans”).
Memory disorders
Lorans can cause an inability to remember events that occur after taking the
medicine (anterograde amnesia). To reduce the risk of this occurring, make sure you can have
7-8 hours of uninterrupted sleep after taking this medicine.
Paradoxical reactions
Lorans can cause mental reactions and effects opposite to those expected (paradoxical effects),
such as states of anxiety and sleep disorders (see section 4 Possible side effects). These
effects are more common in children and the elderly.
If you experience these effects, consult your doctor.
If you are elderly and/or suffer from particular health conditions
If you are elderly and/or your general health conditions are very weak or if you suffer from important
brain diseases (especially cerebral arteriosclerosis), you are more sensitive to the effect of
Lorans.
Lorans can cause fatigue, weakness and drowsiness, which can increase the risk of
falls, with often serious consequences.
If you suffer from low blood pressure, this medicine may cause an increase
of episodes of low blood pressure.
If you have severe liver problems
If you suffer from severe liver problems, associated or not with cerebral symptoms such as mental confusion,
altered level of consciousness or coma, you should not take Lorans because it could
worsen your condition (see also section 2 Do not take Lorans).

Children
Lorans should not be given to children under 12 years of age.

Other medicines and Lorans
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Lorans can affect the way other medicines work. In particular, tell your
doctor if you are already taking:

• sleeping pills (hypnotics, barbiturates),
• medicines for mental disorders (neuroleptics, especially clozapine and loxapine),
• medicines for anxiety/tranquilizers (anxiolytics and sedatives),
• antidepressants,
• strong pain relievers (narcotic analgesics, such as opioids),
• antiepileptics (e.g. valproate),
• anesthetics,
• medicines for allergies that cause drowsiness (sedating antihistamines),
• probenecid (drug for the treatment of gout),
• drugs for mood or mental disorders (e.g. loxapine),
• medicines for bronchial asthma (theophylline and aminophylline),
• baclofen (medicine used as a muscle relaxant),
• sodium oxybate (medicine for sleep disorders),
• caffeine.

The concomitant use of Lorans and opioids (strong pain relievers, medicines for substitution therapy and
some medicines for cough) increases the risk of drowsiness, breathing difficulties
(respiratory depression), coma and can be life-threatening. For this reason, concomitant use should be considered only when other treatment options are not possible.
In any case, if the doctor prescribes Lorans together with opioids, the dose and duration of concomitant treatment
must be limited by the doctor.
Tell your doctor about all opioid medicines you are taking and carefully follow the dose
recommended by your doctor. It may be helpful to inform friends or relatives to pay attention
to the signs and symptoms reported above. Contact your doctor when these symptoms occur.
Tell your doctor or pharmacist that you are taking Lorans before taking any other
medicine.

Lorans with food, drinks and alcohol
You should not drink alcohol during treatment with benzodiazepines. The sedative effect may
be increased when the medicine is taken together with alcohol.
Tell your doctor or pharmacist if you take caffeine (a substance contained mainly in
coffee, but also in numerous energy drinks), because it can reduce the effects of Lorans.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Lorans during pregnancy, as benzodiazepines, including lorazepam,
can cause harm to the fetus if taken during the first trimester of pregnancy (see
section 2 “Do not take Lorans”).
If the doctor decides that Lorans must be taken during the last period of pregnancy or
during childbirth, the newborn, after birth, may present a decreased muscle tone,
breathing difficulties, feeding problems, decreased motor activity, low
body temperature. If Lorans is taken in the late stages of pregnancy, the newborn may
develop withdrawal symptoms after birth.
Breastfeeding
Do not take Lorans if you are breastfeeding, as benzodiazepines, including lorazepam, can
pass into breast milk and cause drowsiness and reduced ability to take breast milk
in the newborn (see section 2 “Do not take Lorans”).

Driving and operating machinery
Lorans can cause sedation, reduced attention, memory disorders, difficulty
concentration, altered muscle function. These effects can negatively affect
your ability to perform tasks that require attention, such as driving or
using machinery. Furthermore, if the duration of sleep during the intake of Lorans is not sufficient,
it is more likely that difficulty concentrating will be increased.
Do not drive vehicles or operate machinery during treatment with Lorans.
Avoid the concomitant intake of alcohol because the sedative effect may be increased when the
medicine is taken together with alcohol. This negatively affects the ability to drive or
operate machinery.

Lorans contains ethanol
This medicine contains 70 vol % ethanol (alcohol), e.g. up to 707 mg per dose, equivalent to
17 ml of beer, 7 ml of wine per dose. It may be harmful to alcoholics.
To be taken into consideration in pregnant or breastfeeding women, children and groups
at high risk such as people affected by liver disease or epilepsy.

Anti-doping tests
For those who engage in sports activities, the use of medicines containing ethyl alcohol may determine
positive results in anti-doping tests in relation to the limit of alcohol concentration indicated by some
sports federations.

3. How to take Lorans

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The doctor will prescribe the dose of Lorans suitable for your needs and will have you use the dose
minimum necessary to control your symptoms.
Treatment should be as short as possible to avoid the risk of developing dependence (when the
body gets used to a substance to the point of no longer being able to do without it) (see paragraphs 2
“Warnings and precautions” and 4 “Undesirable effects”). Taking the medicine must always be
gradually interrupted.

Adults and children starting from 12 years of age

• Anxiety:the recommended dose is 10-20 drops 1 or 3 times a day. In particularly severe cases, your doctor will tell you to increase the dosage up to 50 drops 1 or 3 times a day. The doctor will tell you how to divide the daily dose into more administrations during the

day. The overall duration of treatment should not exceed 8-12
weeks, including a period of gradual discontinuation.

• Sleep disorders:the recommended dose is 20-50 drops of Lorans to be taken in the evening. The duration of treatment generally varies from a few days to two weeks, up to a maximum of four weeks, including a period of gradual discontinuation.

Children
Lorans should not be used in children under 12 years of age.

Elderly patients (over 65 years of age) or with liver or kidney problems
If you are a patient over 65 years of age or if you suffer from hepatic insufficiency or kidney problems,
your doctor may prescribe you lower doses.
Instructions for use of the bottle:

• To open the bottle, press and unscrew simultaneously.
• Then press the plastic cap to release the powder and shake until completely dissolved.
• To obtain the release of drops, remove the cap and turn the bottle upside down.
• To close, press and screw simultaneously.
• To reopen, press and unscrew simultaneously.

If you take more Lorans than you should
If you have taken a quantity of Lorans drops greater than that prescribed by your doctor, go to the
nearest emergency room for assistance. Tell them you are taking Lorans oral drops, solution and
bring the package with you, even if it is empty.

If you forget to take Lorans
Do not take a double dose to make up for a missed dose. If you forget to
take a dose of Lorans to treat sleep disorders, take the missed dose only if
you can then sleep for 7-8 hours.

If you stop taking Lorans
Do not stop taking Lorans suddenly.
The number of Lorans drops and the frequency of their intake should always be
slowly reduced before stopping treatment. This allows the body to get used to
the lack of administration of the drops and reduces the risk of developing symptoms that
may appear when you stop taking Lorans. The doctor will tell you how to slowly reduce
the intake of the medicine.
If you stop taking Lorans abruptly, you may experience withdrawal symptoms such as
headache, muscle pain, anxiety, tension, nervousness, confusion, irritability, mood changes, dizziness, nausea, diarrhea and loss of appetite or more serious symptoms, such as mental changes, hypersensitivity to noises, light and physical contact, hallucinations, seizures,
numbness and tingling of the extremities.
In addition, if you stop treatment, the symptoms for which you took Lorans may reappear but
in a more severe form (rebound insomnia and anxiety).
If you have any doubts 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.
The most common side effects that appear mainly at the beginning of therapy and
usually disappear with subsequent administrations are:

• reduction in the ability to perceive emotions,
• mental confusion,
• drowsiness,
• headache,
• dizziness,
• instability when walking (ataxia),
• muscle weakness,
• fatigue,
• double vision (diplopia).

Other side effects observed occasionally are:

• reduction in the number of blood cells called platelets or thrombocytes (thrombocytopenia),
• severe reduction in the number of blood cells called white blood cells or granulocytes (agranulocytosis),
• reduction in the number of all blood cells, namely red blood cells, white blood cells and platelets (pancytopenia),
• severe allergic reactions (hypersensitivity, anaphylactic/anaphylactoid reactions, allergic dermatitis, angioedema),
• syndrome caused by increased release into the blood of the antidiuretic hormone (SIADH),
• reduced levels of sodium in the blood (hyponatremia),
• changes in appetite,
• sleep disturbances,
• changes in sexual desire,
• agitation, aggressiveness, mood swings, disorientation, depression, unmasking of pre-existing depression, irritability, delirium, anger, nightmares, hallucinations, psychosis (a mental disorder that can include hallucinations, incoherent or disorganized speech and agitated behavior), psychological and physical dependence, behavioral changes, disinhibition, benzodiazepine abuse, delusion, euphoria, restlessness,
• suicidal ideation / suicide attempt,
• extrapyramidal symptoms, such as involuntary movements,
• tremors,
• convulsions/seizures,
• coma,
• difficulty articulating words (dysarthria),
• balance disorders and autonomic nervous system disorders (for example, a drop in blood pressure when assuming an upright position),
• amnesia,
• loss of concentration/attention
• visual disturbances, eye function disorders,
• low blood pressure (hypotension),
• respiratory depression up to complete cessation of breathing (apnea),
• worsening of nocturnal apnea,
• worsening of chronic lung diseases with difficulty breathing,
• dry mouth, excessive salivation (sialorrhea),
• nausea,
• constipation,
• yellowing of the skin (jaundice),
• skin reactions,
• increased bilirubin, increased transaminases, increased alkaline phosphatase,
• falls and resulting injuries.

Lorans can also induce a state of dependence, i.e. a state in which the body becomes so accustomed to the
medicine that it cannot do without it. In these cases, when attempting to discontinue
treatment with the medicine, withdrawal symptoms appear (see section 3 “If
you stop taking Lorans”).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly to
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Lorans

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 pack after Exp.
The expiry date refers to the last day of that month.
Before opening the vial, the medicine does not require any particular storage conditions.
After the first opening and the dissolving of the powder contained in the cap in the solvent contained in the vial, the vial must be stored in a refrigerator (2°C – 8°C) for a maximum period of 30 days.
Do not dispose of any medicine in 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 Lorans contains
The active ingredient is lorazepam.
The reservoir stopper of each bottle of Lorans oral drops, solution contains 20mg of lorazepam.
20 drops (0.5 ml) contain 1 mg of lorazepam.
The other ingredients are:

• reservoir stopper: mannitol,
• bottle with the solvent: ethanol, purified water.

Description of the appearance of Lorans and contents of the pack
Lorans oral drops, solution is packaged in a cardboard box containing a glass bottle with the solvent solution and the reservoir stopper containing the active substance in powder form. The reconstituted solution of Lorans oral drops is clear and colorless.

Marketing authorisation holder
Teofarma s.r.l.
Via Fratelli Cervi, 8
27010 Valle Salimbene (Pavia) – Italy

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

Lorans 1mg tablets, 2.5mg tablets

Lorazepam

Read this leaflet carefully before taking this medicine as it contains important information for you.

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

Contents of this leaflet:

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

1. What is Lorans and what is it used for?

Lorans contains the active ingredient lorazepam and belongs to a group of medicines called
benzodiazepines, which can help relieve anxiety.
Lorazepam is indicated as therapy for anxiety, for disorders associated with it and for sleep disorders.
Benzodiazepines are used only when the disorder is severe and causes discomfort in normal
daily life.

2. What you need to know before taking Lorans

Do not take Lorans

• if you are allergic to lorazepam, to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from a disease called myasthenia gravis which causes muscle weakness and fatigue
• if you suffer from severe liver problems (severe hepatic insufficiency)
• if you suffer from severe breathing problems (severe respiratory insufficiency)
• if you suffer from breathing problems when you sleep (sleep apnea)
• if you suffer from an eye disease characterized by pain and increased pressure inside the eye, called narrow-angle glaucoma
• if you are or think you might be pregnant
• if you are breastfeeding.

If any of these conditions apply to you, do not take Lorans and consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lorans.
It is particularly important that you talk to your doctor or pharmacist before taking Lorans:

• if you suffer from respiratory or heart problems, as benzodiazepines can cause respiratory depression, which, in the most severe cases, can also lead to death,
• if you suffer from or have ever suffered from allergic reactions to benzodiazepines. This medicine can cause severe and rapid allergic reactions (anaphylactic/anaphylactoid 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, if you abuse or have abused drugs or alcohol in the past. In these cases, you may be more likely to become dependent on Lorans (feel the need to continue taking the medicine), (see sections 3 “How to take Lorans” and 4 “Possible side effects”),
• if you suffer from depression as Lorans may bring to light or increase suicidal thoughts that you may have due to this illness,
• if you suffer from kidney or liver problems: your doctor will prescribe you checks and indicate the most suitable dosage for your condition.

Tolerance and dependence
The effectiveness of Lorans may decrease after a few weeks of use. Lorans is recommended for
short-term treatments.
The use of benzodiazepines can lead to the development of physical dependence (physical disorders that
decrease or disappear only after taking the medicine) and psychological dependence (increasing need,
desire or exaggerated search to take the medicine). The risk of dependence increases with the
dose and duration of treatment; it is greater in patients with a history of drug, medicine or alcohol abuse, or marked personality disorders. Once physical dependence has
developed, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms
(see section 3 “If you stop taking Lorans”).
Do not stop taking Lorans suddenly. Consult your doctor who will assess whether and how
to interrupt the treatment with this medicine (see section 3 “If you stop the
treatment with Lorans”).
Memory disorders
Lorans can induce an inability to remember the events that happen after taking the
medicine (anterograde amnesia). To reduce the risk of this occurring, make sure you can have
an uninterrupted sleep of 7-8 hours after taking this medicine.
Paradoxical reactions
Lorans can cause mental reactions and effects opposite to those expected (paradoxical effects),
such as anxiety and sleep disorders (see section 4 Possible side effects). These
effects are more common in children and the elderly.
If you experience these effects, consult your doctor.
If you are elderly and/or suffer from particular health conditions
If you are elderly and/or your general health conditions are very weak or if you suffer from important
brain diseases (especially cerebral arteriosclerosis), you are more sensitive to the effect of
Lorans.
Lorans can cause fatigue, weakness and drowsiness, which can increase the risk of
falls, with often serious consequences.
If you suffer from low blood pressure, this medicine may cause an increase
of episodes of low blood pressure.
If you have severe liver problems
If you suffer from severe liver problems, associated or not with cerebral symptoms such as confusion
mental, altered level of consciousness or coma, you should not take Lorans because it could
worsen your condition (see also section 2 Do not take Lorans).

Children
Lorans should not be given to children under 12 years of age.

Other medicines and Lorans
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Lorans can affect the way other medicines work. In particular, tell your
doctor if you are already taking:

• sleeping pills (hypnotics, barbiturates),
• medicines for mental disorders (neuroleptics, especially clozapine and loxapine),
• medicines for anxiety/tranquilizers (anxiolytics and sedatives),
• antidepressants,
• strong painkillers (narcotic analgesics, such as opioids),
• antiepileptics (e.g. valproate),
• anesthetics,
• medicines for allergies that cause drowsiness (sedating antihistamines),
• probenecid (drug for the treatment of gout),
• drugs for mood or mental disorders (e.g. loxapine),
• medicines for bronchial asthma (theophylline and aminophylline),
• baclofen (medicine used as a muscle relaxant),
• sodium oxybate (medicine for sleep disorders),
• caffeine.

The concomitant use of Lorans and opioids (strong painkillers, medicines for substitution therapy and
some medicines for cough) increases the risk of drowsiness, breathing difficulties
(respiratory depression), coma and can be life-threatening. For this reason, concomitant use should be considered only when other treatment options are not possible.
In any case, if the doctor prescribes Lorans together with opioids, the dose and duration of treatment
concomitant must be limited by the doctor.
Tell the doctor all the opioid medicines you are taking and carefully follow the dose
recommended by the doctor. It may be helpful to inform friends or relatives to pay attention
to the signs and symptoms reported above. Contact your doctor when these symptoms occur.
Tell your doctor or pharmacist that you are taking Lorans before taking any other
medicine.

Lorans with food, drinks and alcohol
You should not drink alcohol during treatment with benzodiazepines. The sedative effect may
be increased when the medicine is taken together with alcohol.
Tell your doctor or pharmacist if you take caffeine (a substance mainly contained in
coffee, but also in numerous energy drinks), because it can reduce the effects of Lorans.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Lorans during pregnancy, as benzodiazepines, including lorazepam,
can cause harm to the fetus if taken during the first trimester of pregnancy (see
section 2 “Do not take Lorans”).
If the doctor decides that Lorans must be taken during the last period of pregnancy or
during childbirth, the newborn, after birth, may present a decreased muscle tone,
difficulty breathing, feeding problems, decreased motor activity, low
body temperature. If Lorans is taken in the late stages of pregnancy, the newborn may
develop withdrawal symptoms after birth.
Breastfeeding
Do not take Lorans if you are breastfeeding, as benzodiazepines, including lorazepam, can
pass into breast milk and cause drowsiness and reduced ability to take breast milk
in the newborn (see section 2 “Do not take Lorans”).

Driving and operating machinery
Lorans can cause sedation, reduced attention, memory disorders, difficulty of
concentration, alteration of muscle function. These effects can negatively affect
your ability to perform tasks that require attention, such as driving or
using machinery.
Furthermore, if the duration of sleep during the intake of Lorans is not sufficient, it is
more likely that the difficulty of concentration is increased.
Do not drive vehicles or use machinery during treatment with Lorans.
Avoid the concomitant intake of alcohol because the sedative effect may be increased when the
medicine is taken together with alcohol. This negatively affects the ability to drive or
use machinery.

Lorans contains lactose monohydrate
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

3. How to take Lorans

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The doctor will prescribe the dose of Lorans suitable for your needs and will make you use the dose
minimum necessary to control your symptoms.
The treatment should be as short as possible to avoid the risk of developing dependence (when the
body gets used to a substance to the point of no longer being able to do without it) (see paragraphs 2
“Warnings and precautions” and 4 “Undesirable effects”). Taking the medicine must always be
gradually interrupted.

Adults and children from 12 years of age

• Anxiety:the recommended dose is 1-3 Lorans 1 mg tablets per day. In particularly severe cases, your doctor will tell you to increase the dose. The maximum dose is 3 Lorans 2.5 mg tablets per day. Your doctor will tell you how to divide the daily dose into multiple administrations during the day. The overall duration of treatment should not exceed 8-12 weeks, including a gradual withdrawal period.
• Sleep disorders:the recommended dose is 1 to 2.5 mg per day to be taken in the evening. The duration of treatment generally varies from a few days to two weeks, up to a maximum of four weeks, including a gradual withdrawal period.

Children
Lorans should not be used in children under 12 years of age.

Elderly patients (over 65 years of age) or with liver or kidney problems
If you are a patient over 65 years of age or if you suffer from hepatic insufficiency or kidney
problems, your doctor may prescribe you lower doses.

If you take more Lorans than you should
If you have taken a quantity of Lorans tablets greater than that prescribed by your doctor,
go to the nearest emergency room to receive assistance. Tell them you are taking Lorans
tablets and bring the package with you, even if it is empty.

If you forget to take Lorans
Do not take a double dose to make up for the missed dose.
If you forget to take a Lorans tablet to treat sleep disorders, take the
forgotten tablet only if you can subsequently sleep for 7-8 hours.

If you stop taking Lorans
Do not stop taking the tablets suddenly.
The number of Lorans tablets and the frequency of their intake should always
be reduced slowly before stopping treatment. This allows the body to
get used to the lack of administration of the tablets and reduces the risk of developing
symptoms that may appear when you stop taking Lorans. Your doctor will tell you how to
slowly reduce the intake of the medicine.
If you suddenly stop taking Lorans, you may experience withdrawal symptoms such as
headache, muscle pain, anxiety, tension, nervousness, confusion, irritability, mood changes, dizziness, nausea, diarrhea and loss of appetite or more serious symptoms, such as mental changes, hypersensitivity to noises, light and physical contact, hallucinations, seizures,
numbness and tingling of the extremities.
Furthermore, if you stop treatment, the symptoms for which you took Lorans may reappear but
in a more severe form (rebound insomnia and anxiety).
If you have any doubts 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 will experience them.
The most common side effects that appear mainly at the beginning of therapy and
usually disappear with subsequent administrations are:

• reduction in the ability to perceive emotions,
• mental confusion,
• drowsiness,
• headache,
• dizziness,
• instability while walking (ataxia),
• muscle weakness,
• fatigue,
• double vision (diplopia).

Other side effects observed occasionally are:

• reduction in the number of blood cells called platelets or thrombocytes (thrombocytopenia),
• severe reduction in the number of blood cells called white blood cells or granulocytes (agranulocytosis),
• reduction in the number of all blood cells, namely red blood cells, white blood cells and platelets (pancytopenia),
• severe allergic reactions (hypersensitivity, anaphylactic/anaphylactoid reactions, allergic dermatitis, angioedema),
• syndrome caused by increased release into the blood of the antidiuretic hormone (SIADH),
• reduced levels of sodium in the blood (hyponatremia),
• changes in appetite,
• sleep disorders,
• changes in sexual desire,
• agitation, aggression, mood swings, disorientation, depression, unmasking of pre-existing depression, irritability, delirium, anger, nightmares, hallucinations, psychosis (a mental disorder that may include hallucinations, incoherent or disorganized speech, and agitated behavior), psychological and physical dependence, behavioral changes, disinhibition, benzodiazepine abuse, delusion, euphoria, restlessness,
• suicidal ideation / suicide attempt,
• extrapyramidal symptoms, such as involuntary movements,
• tremors,
• convulsions/seizures,
• coma,
• difficulty articulating words (dysarthria),
• balance disorders and autonomic nervous system disorders (for example, a drop in blood pressure when assuming an upright position),
• amnesia,
• loss of concentration/attention,
• visual disturbances, impaired eye function,
• low blood pressure (hypotension),
• respiratory depression, up to complete cessation of breathing (apnea),
• worsening of nocturnal apnea,
• worsening of chronic lung diseases with difficulty breathing,
• dry mouth, excessive salivation (sialorrhea),
• nausea,
• constipation,
• yellowing of the skin (jaundice),
• skin reactions, increased bilirubin, increased transaminases, increased alkaline phosphatase,
• falls and subsequent injuries.

Lorans can also induce a state of dependence, i.e. a state in which the body becomes so accustomed to the
medicine that it cannot do without it. In these cases, when attempting to discontinue
treatment with the medicine, withdrawal symptoms appear (see section 3 “If
you stop taking Lorans”).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly to
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store Lorans

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Scad.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lorans contains
The active ingredient is lorazepam.
Each Lorans 1 mg tablet contains 1 mg of lorazepam.
Each Lorans 2.5 mg tablet contains 2.5 mg of lorazepam.
The other ingredients are: lactose monohydrate, pregelatinized corn starch, povidone,
magnesium stearate, coloring agents*.
*The coloring agents are:
Lorans 1 mg tablets: sunset yellow (E110)
Lorans 2.5 mg tablets: no additional coloring agents.

Description of Lorans and contents of the pack
Lorans 1 mg tablets are orange, oval-shaped, with an incision on one side and the inscription “1”
on the other side.
Lorans 2.5 mg tablets are white, oval-shaped, with an incision on one side and the inscription “2.5”
on the other side.
Lorans tablets are packaged in blisters contained in cardboard boxes containing:

• Lorans 1mg: 20 or 30 tablets
• Lorans 2.5mg: 20 or 30 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teofarma s.r.l.
Via Fratelli Cervi, 8
27010 Valle Salimbene (Pavia) – Italy

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