LORAZEPAM 4 mg /Ml Roztwór Do Wstrzykiwań

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1. Lorazepam Macure 4 mg/ml injectable solution
   1. What is Lorazepam Macure and what is it used for
   2. What you need to know before using Lorazepam Macure
   3. How to use Lorazepam Macure
   4. Possible side effects
   5. How to store Lorazepam Macure
   6. Package contents and other information

Lorazepam Macure 4 mg/ml injectable solution

lorazepam

Generic medicine

Read this leaflet carefully before using 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 nurse.
• 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 nurse. See section 4.

Contents of this leaflet

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

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

Lorazepam Macure belongs to a group of sedative-hypnotic medicines called benzodiazepines.
Lorazepam Macure can be used in adults and adolescents over the age of 12 years:

• as a sedative to start some procedures (premedication), such as minor or major surgical procedures or some extensive physical examinations;
• in people who suffer from severe phobias or tension and who for any reason cannot take tablets.

Lorazepam Macure can also be used in adults, adolescents, children and infants from
1 month of age:

• for the control of epileptic status.

2. What you need to know before using Lorazepam Macure

Do not use Lorazepam Macure:

• if you are allergic to the active ingredient or to any other benzodiazepine, substance similar to benzodiazepine or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from myasthenia gravis (a disease that causes muscle weakness and excessive fatigue);
• if you suffer from severe breathing disorders;
• if you suffer from sleep apnea syndrome (problems with breathing during sleep);
• if you have severe liver problems.

Lorazepam Macure cannot be injected into an artery.

Children
Lorazepam Macure cannot be used in children under 12 years of age, unless for the control
of status epilepticus. For status epilepticus, Lorazepam Macure should not be used in newborns.

Warnings and precautions
Talk to your doctor or nurse before using Lorazepam Macure:

• if you suffer from chronic breathing disorders.
• if your liver or kidney function is reduced.
• if you are elderly or debilitated.
• if you suffer from epilepsy.
• if you suffer from "glaucoma" (acute narrow-angle glaucoma).
• if you are planning a pregnancy or are currently pregnant.
• if you are breastfeeding, as the medicine can pass into breast milk.

For 24 hours after the administration of Lorazepam Macure, you must be under observation. Walking
soon (within 8 hours after use of Lorazepam Macure) may cause you to fall and cause injury.
A reduction in alertness may last for more than 24 hours, for example if you are elderly or use other
medicines.
If you are an outpatient and Lorazepam Macure is used for a short procedure, you must
be accompanied by a responsible adult upon discharge from the hospital.
You should not drive vehicles or perform activities that require attention for 24-48 hours after
administration.
You may not remember what you did for a certain period of time after the administration of
Lorazepam Macure.
After treatment, you may not remember what you did for a certain period of time after the
administration of Lorazepam Macure.

Patients with mental disorders
Lorazepam Macure is not the first choice in the treatment of mental disorders. Lorazepam Macure should not
be used without adequate antidepressant therapy in depressed patients.
Benzodiazepines can have a disinhibiting effect in depressed patients and can lead to suicidal tendencies.
You should gradually reduce the treatment with Lorazepam Macure.

The use of Lorazepam Macure can lead to dependence.
The use of benzodiazepines can lead to physical or psychological dependence. To reduce the risk of
dependence, the lowest effective dose of Lorazepam Macure should be used and the duration of therapy
should be as short as possible.
If you suddenly stop treatment, you may experience withdrawal symptoms: headache, muscle pain,
phobia, tension, restlessness, confusion, irritability, mood swings, depression and insomnia.
You may also temporarily experience a recurrence of the symptoms for which you received Lorazepam Macure (see
also "If you stop taking Lorazepam Macure" in section 3).

Tolerance
This medicine may lose its effectiveness with repeated use for several weeks.

Elderly or debilitated patients and children
Elderly and children may experience reactions that are completely opposite to what is expected with
treatment with Lorazepam Macure, such as: restlessness, excitement, aggression, delusional ideas, attacks
of anger, nightmares, some mental disorders (psychosis), inappropriate and oppositional behaviors.
If these reactions occur, the doctor will stop the treatment.
Children may be allergic to some of the excipients contained in Lorazepam Macure (see
paragraph “Lorazepam Macure contains benzyl alcohol, polyethylene glycol and propylene glycol”).

Other medicines and Lorazepam Macure
Tell your doctor if you are taking, have recently taken or might take any other medicines.
The concomitant use of the following medicines may increase the calming/relaxing effect of Lorazepam
Macure:

• scopolamine (a medicine for motion sickness and intestinal problems),
• antipsychotic medicines,
• sleeping pills,
• sedatives and/or tranquilizers,
• antidepressants,
• muscle relaxants,
• some highly potent prescription pain relievers (narcotic analgesics),
• antiepileptic medicines,
• medicines used for breathing problems (theophylline/aminophylline),
• medicines that cause general or local anesthesia (anesthetics),
• medicines used for allergies or motion sickness (antihistamines),
• medicines used for the treatment of gout and high levels of uric acid in the blood (e.g. probenecid),
• disulfiram (a medicine used for the treatment of chronic alcoholism),
• metronidazole (an antibiotic).

The concomitant use of lorazepam and opioids (strong painkillers, medicines for substitution therapy and
some medicines for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be potentially fatal. Because of this, the concomitant use should
be considered only when other treatment options are not possible.
However, if your doctor prescribes Lorazepam Macure together with opioids, your doctor must limit the dose
and duration of concomitant treatment.
Tell your doctor about all opioids you are taking and carefully follow your doctor's recommendation
on the dose. It may be helpful to inform friends and family to watch for the signs and symptoms indicated above.
If you experience these symptoms, contact your doctor.

Lorazepam Macure with food, drinks and alcohol
The calming/relieving effect of Lorazepam Macure may be increased by the simultaneous use of alcoholic
beverages. This can last up to 48 hours after the administration of Lorazepam Macure.
You should not consume alcohol for 48 hours after the administration of Lorazepam Macure.

Pregnancy, breastfeeding and fertility
If you are pregnant, or are breastfeeding, if you suspect or are planning a pregnancy,
ask your doctor for advice before taking this medicine.
You should use Lorazepam Macure during pregnancy only if strictly necessary, for the shortest
possible period and at the lowest possible dose.
Lorazepam passes into breast milk in small amounts. Breastfeeding is not recommended during
the intake of Lorazepam Macure.
There are no data on the possible effects of lorazepam on female fertility when administered
by injection or infusion.
In addition, Lorazepam Macure contains benzyl alcohol, a preservative that can cross the placenta and
pass into breast milk. Lorazepam Macure also contains propylene glycol (see “Lorazepam
Macure contains benzyl alcohol, propylene glycol and polyethylene glycol”).

Driving and operating machinery
To drive a vehicle or operate machinery you must be able to react and make decisions
correctly and quickly. You must also be able to move quickly and accurately.
If you receive Lorazepam Macure, control of these abilities may be reduced as Lorazepam Macure
can impair alertness, reactivity, memory and accuracy of muscle movements.
Therefore, you should not drive a vehicle or perform activities that require attention for 24-48 hours after
administration.

Lorazepam Macure contains benzyl alcohol, propylene glycol and polyethylene glycol
Lorazepam Macure contains 21 mg of benzyl alcohol, 840 mg of propylene glycol and 189 mg of polyethylene
glycol per ml.
Ask your doctor or pharmacist if the child is less than 5 years of age, if you have a liver or kidney disease, or if you are pregnant or breastfeeding. This is because the excipients may cause
undesirable effects. The doctor may need to adjust the dose if you or the child use other medicines
containing benzyl alcohol, propylene glycol or polyethylene glycol.
Benzyl alcohol can cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects including breathing problems
(wheezing respiratory syndrome) in young children. Medicines containing benzyl alcohol should not
be administered to newborns (up to 4 weeks of age) and should not be used for more than
one week in young children (less than 3 years of age) unless otherwise recommended by your doctor or
pharmacist.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks while you are taking this
medicine.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks while you are taking this
medicine.
Polyethylene glycol toxicity (e.g. acute tubular necrosis) has been reported during the
administration of Lorazepam Macure. This includes when lorazepam is administered at doses
higher than those recommended.

3. How to use Lorazepam Macure

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor.

• 1. Premedication

The recommended dose that will normally be administered to you intravenously is based on
body weight (0.044 mg per kg of body weight), up to a total of 2 mg, 15-20 minutes before the
scheduled procedure. Sometimes higher doses up to 4 mg may be administered.
The recommended dose administered into a muscle (intramuscularly) is 0.05 mg per kg of body
weight, with a maximum of 4 mg, at least 2 hours before the scheduled procedure.

• 2. Treatment of symptoms of severe anxiety and tension in people who cannot take tablets

The recommended dose is 2-4 mg, i.e. 0.05 mg per kg of body weight. If necessary, the dose may
be repeated after 2 hours. The injection will be administered intravenously or into a muscle
(intramuscularly).

• 3. Status epilepticus

Dose in adults: 4 mg intravenously.
Elderly (over 65 years of age): the elderly may respond to lower doses, therefore half the normal dose for
adults may be sufficient.
Dosage in adolescents, children and infants from 1 month of age: 0.1 mg per kg of body
weight intravenously, with a maximum of 4 mg/dose.
If the epileptic seizure lasts more than 10-15 minutes, the doctor may decide to administer another dose.
A maximum of 2 doses may be administered.
If the child is under 5 years of age, no more than two repeated doses should be administered in a single
day.

Use in children
Lorazepam Macure should not be used in children under 12 years of age unless for the control
of status epilepticus. For status epilepticus, it should not be used in newborns (see section 2).

Use in the elderly and debilitated patients
The doctor will prescribe a lower dose. In addition, the doctor will monitor you regularly and modify the
dose based on your response.

Patients with kidney or liver disorders.
Lorazepam Macure should not be used in patients with severe liver disorders. When Lorazepam
Macure is used in patients with mild to moderate liver or kidney disorders, the doctor may
prescribe a lower dose.

If you use more Lorazepam Macure than you should
If you are given more medicine than you should, you may experience symptoms such as drowsiness,
mental confusion and lethargy in cases of mild overdose, and low blood pressure, difficulty controlling
movements, breathing problems and coma in severe cases.
Treatment of overdose generally consists of supportive measures, including maintaining
breathing and monitoring fluid balance (how much fluid you take in and how much fluid you eliminate).

If you stop taking Lorazepam Macure
You should only stop or discontinue treatment following the doctor's instructions.
If you are being treated for severe anxiety symptoms and treatment is stopped abruptly, you should
consider the possibility of experiencing one or more of the following withdrawal symptoms: headache, muscle
pain, phobia, anxiety, tension, excitement, restlessness, confusion, irritability, sweating, depression and insomnia.
In more severe cases, withdrawal symptoms may include: loss of sensation, loss of reality, in
which the environment (family) seems unreal, alienation of the person and self-esteem (depersonalization),
numbness and tingling of arms and legs, marked increased sensitivity to light, noise and
touch, increased hearing, ear pain, involuntary movements, vomiting, delusional ideas (hallucinations)
or manifestations of worsening of the disease (seizures).
In addition, the symptoms for which you received Lorazepam Macure may return temporarily with a
greater degree.
To minimize the risk of these symptoms occurring, it is recommended to gradually reduce the dose
when stopping treatment.
If you have any doubts about using this medicine, contact your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Normally, side effects are observed at the beginning of treatment and gradually disappear
with the continuation of treatment or by reducing the dose.
The following side effects have been reported after the use of lorazepam:

Very common: may affect more than 1 in 10 people

• fatigue.

Common: may affect up to 1 in 10 people

• drowsiness during the day,
• sleepiness,
• dizziness,
• problems with coordination,
• vomiting,
• muscle weakness.

Uncommon: may affect up to 1 in 100 people

• confusional state,
• depression,
• emotional blunting,
• sleep disturbances,
• headache,
• decreased state of alertness,
• visual disturbances,
• double vision (diplopia),
• nausea,
• gastrointestinal problems,
• skin reactions, hair loss,
• changes in libido.

Rare: may affect up to 1 in 1,000 people

• blood abnormality (dyscrasia),
• temporary memory loss,
• paradoxical reactions,
• decreased blood pressure (hypotension),
• increased blood pressure (hypertension),
• abnormalities related to liver disease,
• psychiatric disorders: excitement (agitation), nervousness, irritability, aggressiveness, suspicion, outbursts of anger, nightmares, perception of things that are not present (hallucinations), severe mental illness in which control over behavior and behavior itself are altered (psychosis), inappropriate behavior. These side effects occur especially in children and the elderly.

Other side effects:

• sudden hypersensitivity reactions (within minutes or hours), including difficulty breathing, skin rashes and fainting (anaphylactic/anaphylactoid reactions). These can be fatal.
• blood abnormalities (thrombocytopenia, agranulocytosis, pancytopenia).
• pain, burning sensation, redness and inflammation at the injection site have been reported.
• dependence can occur after repeated use for several weeks (see section 2).
• breathing difficulties may occur in severe anesthesia.
• withdrawal symptoms occur after discontinuation of treatment (see section "If you stop taking Lorazepam Macure").
• swelling.
• suicidal thoughts or attempts.
• difficulty speaking.
• seizures.
• coma.
• decreased body temperature.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed
directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Lorazepam Macure

Keep this medicine out of the sight and reach of children.
Store and transport in a refrigerator (2– 8°C).
Store in the outer packaging to protect the medicine from light.
Chemical and physical stability has been demonstrated during use for 1 hour at 2-8 ⁰C. From a microbiological
point of view, unless the opening/dilution method precludes the risk of bacterial contamination,
the product must be used immediately. If not used immediately, the storage times and conditions
during use are the responsibility of the user.
Do not use this medicine after the expiry date stated on the label and on the pack after Scad.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice the presence of visible particles in the solution.
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. Package contents and other information

What Lorazepam Macure contains

• The active ingredient is lorazepam; each ml of solution contains 4 mg of lorazepam.
• The other ingredients are propylene glycol (E1520), polyethylene glycol 400 (macrogol 400), benzyl alcohol.

Description of the appearance of Lorazepam Macure and contents of the pack
Clear, colorless or almost colorless, hypertonic solution, free from visible particles.
Lorazepam Macure is packaged in transparent glass vials of Type I (Ph. Eur.) with a capacity of 2 ml.
Each vial contains 1 ml of solution.
The vials are placed in shaped trays made of polyvinyl chloride, sealed with a transparent protective sheet in
Lorazepam Macure is supplied in packs of 5 and 10 vials containing 1 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Macure Pharma ApS
Hejrevej 39
2400 Copenhagen NV
Denmark

Manufacturer
Medochemie Ltd.
Agios Athanassios Industrial Area, Iapetou 48, Factory B
4101 Agios Athanassios, Limassol
Cyprus

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:

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The following information is intended for healthcare professionals only:

Instructions for use
Lorazepam Macure is slightly viscous when cold.
Intramuscular administration:
To facilitate intramuscular administration, dilution with an equal volume of a
compatible solution, such as sodium chloride 9 mg/ml (0.9%) solution for injection, glucose 50 mg/ml (5%)
and water for injections, is recommended.
Lorazepam Macure can also be administered undiluted, by deep injection into a large
muscle mass.
Intravenous administration:
In case of intravenous administration, Lorazepam Macure must always be diluted with an equal
volume of one of the following diluents: sodium chloride 9 mg/ml (0.9%) solution for injection, glucose 50
mg/ml (5%) and water for injections.
The rate of injection should not exceed 2 mg/min. Parenteral medicines must be
visually inspected for particles or discoloration before administration. Do not
use if the solution has developed color or precipitate.

Instructions for dilution for intravenous use
Draw the desired amount of Lorazepam Macure into the syringe, then slowly draw the desired volume of diluent.
Slightly retract the plunger to provide additional mixing space.
Immediately mix the contents by repeatedly inverting the syringe until a
homogeneous solution is formed. Do not shake vigorously as this will cause air bubbles to form.
Lorazepam Macure should not be mixed with other medicines in the same syringe. Do not use if the
solution has developed color or precipitate (see section 4.2).
No special instructions for disposal. Unused medicine and waste derived from this
medicine should be disposed of in accordance with local regulations.