PROSPECTUS

Prospectus: Information for the Patient

Lormetazepam Koehler 0.2 mg/ml Injectable Solution and for Infusion EFG

Lormetazepam

Read this entire prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep the prospectus, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See Section 4.

Lormetazepam, the active ingredient of Lormetazepam Koehler, is a sedative, anxiolytic, and sleep-inducing medication that belongs to the group of benzodiazepines.

Adults:

Lormetazepam Koehler is indicated for

• treatment of acute symptoms of tension, excitement, and anxiety during surgical and diagnostic interventions, as well as in intensive care
• induction of anesthesia

Pediatric population:

In children 2 years of age or older and in adolescents, Lormetazepam Koehler is only indicated for administration before diagnostic or surgical interventions (anesthesia, intensive care).

You will receive Lormetazepam Koehler exclusively from a doctor or under their supervision.

Lormetazepam Koehler should not be administered

• if you are allergic to lormetazepam, other benzodiazepines, or any of the other components of this medication (listed in section 6)
• if you have a known dependence or a personal history of dependence on alcohol and other medications or drugs
• if you have an acute alcohol intoxication, sleep-inducing medications (hypnotics), pain-relieving medications (analgesics), or psychotropic medications (neuroléptics, antidepressants, lithium)
• if you have a specific type of muscle weakness (myasthenia gravis)
• if your respiratory function is interrupted during sleep (sleep apnea syndrome)
• if you have a severe and chronic respiratory difficulty and/or lack of air (severe respiratory alteration)
• if you have a severe liver insufficiency (severe hepatic disorder).

Warnings and precautions

Consult with your doctor before receiving Lormetazepam Koehler if you have

• coordination and movement disorders (spinal or cerebellar ataxia)
• renal function limitations (renal alteration).

For more information on the possible occurrence of tolerance, dependence, amnesia, psychiatric reactions or paradoxical reactions, or adverse effects upon repeated administration, consult your doctor.

Children and elderly patients

Lormetazepam Koehler should not be administered to children over 2 years old or to adolescents, unless it is applied before diagnostic procedures (clinical examination) or surgical procedures (anesthesia, intensive care).

Lormetazepam Koehler will be administered initially at the lowest possible dose (see posology) to children and adolescents under 18 years old, as well as to elderly patients or those with poor general health, particularly those with psycho-organic disorders, circulatory insufficiency, or respiratory insufficiency.

Before continuing with the injection, wait, if necessary, to observe the reaction of each patient.

Use of Lormetazepam Koehler with other medications

Inform your doctor if you are taking or have taken recently or may need to take any other medication, including those acquired without a prescription

The administration of Lormetazepam Koehler with other central-acting medications (of the type of psychopharmaceuticals, sleep-inducing medications (hypnotics), pain-relieving medications (analgesics), narcotics, and allergy-fighting medications (antihistamines)) may potentiate the effects of these medications in a reciprocal manner.

Lormetazepam Koehler may potentiate the effects of muscle-relaxing medications.

The nature and degree of interaction cannot be predicted with certainty if you receive continuous treatment with other medications, such as blood pressure-lowering medications (anti-hypertensives), beta-blockers, digitalis glycosides, asthma bronchial medications (methylxanthines), oral contraceptives, and some antibiotics.

Therefore, extreme caution will be exercised when administering Lormetazepam Koehler with these medications. Additionally, when concomitant treatment with Lormetazepam Koehler and certain antibiotics is applied, the efficacy of lormetazepam may vary.

Remember that this precaution also applies when a recent treatment with these medications has been followed.

The concomitant use of Lormetazepam Koehler and opioids (potent analgesics, medication for substitution therapy, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Lormetazepam Koehler with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all the opioid medications you are taking. Contact your doctor if you experience the previously mentioned symptoms.

Use of Lormetazepam Koehler with food and beverages and alcohol

Do not consume alcohol during treatment with Lormetazepam Koehler, as it may potentiate the efficacy of lormetazepam, which is modified unpredictably by alcohol.

Pregnancy and lactation

During pregnancy, Lormetazepam Koehler should only be administered exceptionally and for medical reasons justified, as there is still no experience with the administration of lormetazepam during pregnancy.

Consult your doctor before starting this treatment if you are pregnant.

If you receive Lormetazepam Koehler repeatedly during pregnancy, the baby may experience physical dependence and withdrawal symptoms after birth.

If Lormetazepam Koehler is administered for medical reasons justified in the last phase of pregnancy or during delivery and childbirth, the newborn may experience effects such as decreased body temperature (hypothermia), respiratory difficulties (respiratory insufficiency), decreased muscle tone, and difficulty breastfeeding.

Apparently, the risk of malformation, when therapeutic doses of benzodiazepines are applied in the early stages of human pregnancy, is low, but, according to some studies, the risk of cleft palate increases. Cases of congenital anomalies and mental retardation have been described with benzodiazepine overdoses and intoxications.

Lormetazepam Koehler passes into human breast milk. Therefore, breastfeeding should be interrupted temporarily or definitively if Lormetazepam Koehler is administered repeatedly or in high doses.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

If you receive treatment with Lormetazepam Koehler, you will not be able to drive vehicles or operate machinery.

Lormetazepam Koehler modifies your reaction time and decisively affects your ability to drive vehicles or operate machinery, even if you receive a therapeutic dose.

Therefore, do not drive vehicles or operate machinery or engage in any other hazardous activity during the first days of treatment.

If lormetazepam is administered to prepare for an outpatient diagnostic procedure (before a medical examination), the patient's discharge will only be given if they are accompanied; the patient should not drive any type of vehicle.

Lormetazepam Koehler will be prescribed and administered by a doctor or under their supervision.

At the end of this leaflet, in the corresponding sections, information is provided for doctors and healthcare professionals.

Ask your doctor if you notice a too strong or too weak effect of Lormetazepam Koehler.

Higher levels of the drug were observed in patients with mild or moderate hepatic insufficiency. Patients with hepatic insufficiency should be treated with caution.

If you receive more Lormetazepam Koehler than you should

This medication will be administered by healthcare professionals. If a overdose or accidental administration occurs, contact your doctor or consult the Toxicological Information Service, Phone (91) 562.04.20.

Additional questions:

If you have any further questions about this medication, ask your doctor or pharmacist.

At the end of this leaflet, in the corresponding sections, information is provided for doctors and healthcare professionals.

Like all medications, this medication may produce adverse effects, although not everyone may experience them.

The following adverse reactions have been observed:

• suicidal thoughts or plans
• angioedema (rapid swelling of the skin and mucous membranes, which may cause respiratory tract blockage), difficulty breathing
• palpitations (tachycardia)
• hallucinations, delirium, inappropriate behavior
• dependence (the use of this medication may cause physical or mental dependence on lormetazepam)
• irritability, aggression, agitation, restlessness
• memory loss or tendency to forget (amnesia), confusion
• oblivion, weakness
• depressive mood, emotional disorders, anxiety, acute psychosis
• thrombosis, venous inflammation
• coordination disorders (ataxia), increased risk of falls, muscle weakness
• reduced vigilance, concentration disorders, prolonged reaction times, slow thoughts
• speech problems
• vomiting, nausea
• constipation, stomach pain
• urination difficulties
• headache
• fatigue, dizziness, numbness
• abstinence symptoms (sleep problems), nightmares
• vision problems
• dry mouth
• loss of taste (disgeusia)
• skin problems such as rash, itching
• excessive sweating (hyperhidrosis)
• swelling and pain at the injection site (extravasation symptoms)

If you experience any side effect, inform your doctor so they can treat it.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your pharmacist or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system:

Spanish Medication Vigilance System for Human Use:http://www.notificaram.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

At the end of this prospectus, in the corresponding sections, information is provided for doctors and healthcare professionals.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and the box after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Do not freeze.

Do not use this medication if you notice the solution is cloudy or if it has frozen.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of medications that you no longer need. This will help protect the environment.

Composition of Lormetazepam Koehler

• The active ingredient is lormetazepam.
• One 10 ml ampoule contains 2 mg of lormetazepam, which is equivalent to 0.2 mg of lormetazepam per ml.
• The other components are macrogol-15-hydroxystearate and water for injectable preparations.

Adding to infusion solutions:

Lormetazepam Koehler can be added to a 5% glucose solution, a 0.9% physiological sodium chloride solution, or a Ringer's solution, respectively.

The obtained infusion solutions remain stable at room temperature for up to 24 hours.

Appearance of the product and contents of the packaging

Lormetazepam Koehler is a transparent to slightly opalescent, colorless to pale yellowish aqueous solution, contained in transparent glass ampoules with a volume of 10 ml.

Lormetazepam Koehler is available in boxes with 5, 25, 50, and 100 (clinical pack) ampoules.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Dr. Franz Köhler Chemie GmbH

Werner-von Siemens-Strasse 14 - 28

D - 64625 Bensheim

GERMANY

Responsible for manufacturing

Dr. Franz Köhler Chemie GmbH

Werner-von Siemens-Strasse 14 – 28

D – 64625 Bensheim

GERMANY

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Cardiolink S.L.

Córcega 270, 3º 2ª

08008 Barcelona/Spain

Phone: +34 93 237 38 50

This medication is authorized in the member states of the European Economic Area with the following names:

AustriaSedalor 2 mg/10 ml Injektions- /Infusionslösung

SpainLormetazepam Koehler 0.2 mg/ml injectable and infusion solution EFG

MaltaSedalor 2 mg/10 ml solution for injection or for infusion

CyprusSedalor 2 mg/10 mlεν?σιμοδι?λυμα/δι?λυμαγια?γχυση

Last review date of this leaflet: May 2019.

The following information is part of the patient leaflet and is intended exclusively for doctors and healthcare professionals:

For more information aboutthis medication, also consult the product characteristics summary.

Guidelines and recommendations for dosage

The dosage and duration of treatment will be adjusted according to the response of each patient and the nature and severity of the disease.

Generally, the minimum effective dose will be administered for the shortest possible period.

The following dosage recommendations are suggested:

a)Premedication before interventions under general anesthesia

On the days before, the night before, and/or on the day of the intervention:

b)Sedation before surgical interventions under general anesthesia

c)Sedation (induction of sleep) during diagnostic interventions

d)Treatment of acute anxiety, agitation, and tension crises and

basic sedation before interventions under local anesthesia

Before anesthesia:

And, in addition, during the intervention, depending on the desired depth of sedation:

e)Treatment of acute anxiety, agitation, and tension crises

during diagnostic interventions

f)Basic sedation in intensive care

Up to a depth of sedation RASS of 0/−1 and, if necessary, up to RASS −3.

Special populations

Geriatric patients:

Administer and dose with caution, especially if cardiac or respiratory function is impaired (cardiorespiratory insufficiency). Often, elimination is delayed in elderly patients, so the effect of benzodiazepines may be potentiated.

Patients with poor general condition:

Patients with poor general condition, especially those with organic psychopathies, circulatory or respiratory insufficiency:

Pediatric population (see also section 4.1)

Children aged 2 to 10 years (see also section 1 of this leaflet "What is Lormetazepam Koehler and what is it used for"):

Considering each age group, administer the injectable solution slowly into a large vein (not more than 5 ml/min). Respect the recommended dosage and closely monitor respiration, blood pressure, and heart rate.

The daily dose for children should not exceed 3.5 mg (see also below "Maintenance of effect").

Children and adolescents aged 10 to 18 years receive the adult dosage.

The dosage recommendations for children under 10 years are based on limited clinical experience in this age group.

Maintenance of effect

Lormetazepam Koehler can be administered repeatedly. Generally, however, daily doses should not exceed 5 mg of lormetazepam for adults, 4 mg for high-risk patients, and 3.5 mg for children and adolescents.

Administration form

Administer the injectable solution slowly (approx. 5 ml/min) into a large vein. During administrationmonitor respiration, blood pressure, and heart rate closely.

Lormetazepam Koehler can be administered undiluted and also with the infusion solutions mentioned above (see below).

• Instructions for administration by undiluted injection:

Lormetazepam Koehler is administered undiluted.

Lormetazepam Koehler can only be administered intravenously. It cannot be injected intramuscularly. Avoid intraarterial application. In case of accidental intraarterial injection of Lormetazepam Koehler, wash the affected artery with 50 ml of physiological saline solution through the needle. Then, remove the needle and cover the puncture site with a compressive dressing.

Before opening the ampoule, clean the neck of the ampoule with medicinal alcohol (in aerosol or swab).

Dispose of broken ampoules after administering the medication.

Lormetazepam Koehler does not contain antimicrobial preservatives. Therefore, immediately after opening the ampoule, transfer its contents, under aseptic conditions, to a sterile syringe.

The administration of Lormetazepam Koehler will begin immediately. The contents of each ampoule of Lormetazepam Koehler will only be administered once to a patient.

After administration, discard any remaining solution.

• Instructions for administration after addition to infusion solutions:

Lormetazepam Koehler can be added to a 5% glucose solution, a 0.9% physiological sodium chloride solution, or a Ringer's solution, respectively.

The application of other medications or infusions in the same vein as lormetazepam will be performed using a three-way stopcock or a Y-connector immediately adjacent to the infusion tube.

Before opening the ampoule, clean the neck of the ampoule with medicinal alcohol (in aerosol or swab).

Lormetazepam Koehler does not contain antimicrobial preservatives. Therefore, immediately after opening the ampoule, transfer its contents, under aseptic conditions, to a sterile infusion system.

When infusing Lormetazepam Koehler, use a burette, a dropper, a syringe pump, or a volumetric pump to control the infusion rate.

During the infusion of Lormetazepam Koehler, respect the aseptic conditions of the medication and the infusion apparatus.

The contents of each ampoule, syringe, or infusion system of Lormetazepam Koehler will only be administered once to a patient.

After completing the infusion or changing the infusion system, discard any remaining Lormetazepam Koehler.

Duration of administration:

The designated initial dose of Lormetazepam Koehler will be administered in 2 minutes to achieve the desired effect. The choice of maintenance dose will depend on the required level of effect and the patient's cooperation.

Unless there is a valid reason, Lormetazepam Koehler should not be administered for more than one week. Therefore, the duration of administration and treatment will depend on medical needs and will be determined by the responsible physician.

Guidelines for overdose

As with other benzodiazepines, lormetazepam overdose should not pose a life-threatening risk, unless combined with other central nervous system depressants (including alcohol).

Lormetazepam overdose typically manifests, depending on the dose applied, by a variable depression of the central nervous system ranging from somnolence, mental confusion, lethargy, visual disturbances, and dystonia to ataxia, loss of consciousness, central respiratory depression, and coma. Other symptoms include: decreased consciousness, paradoxical reactions, agitation, and hallucinations.

The treatment of overdose is essentially symptomatic:

Patients with mild symptoms of intoxication will be observed for respiratory and circulatory function during sleep. In severe cases, additional measures will be taken, such as gastric lavage, stabilization of cardiovascular function, and observation in an intensive care unit.

If necessary, the specific antagonist of benzodiazepines, flumazenil, can be used to treat a patient admitted with overdose. Before administration, consult the flumazenil technical data sheet.

Given its high plasma protein binding and high volume of distribution, forced diuresis and hemodialysis have little utility in isolated lormetazepam overdose.

Possible adverse reactions, warnings, and precautions, and guidelines for repeated administration

Tolerance

The hypnotic effects of lormetazepam may be reduced after repeated administration for several weeks.

Dependence

Lormetazepam, like other benzodiazepines, carries a risk of primary physical and psychological dependence. The risk of dependence exists even with daily doses for a few weeks. This occurs not only with high abuse doses but also with therapeutic doses.

Brusque discontinuation of lormetazepam treatment after daily administration may be associated with withdrawal symptoms, such as headache, muscle pain, extreme anxiety, tension, agitation, confusion, and irritability, sleep disturbances, and daydreaming.

In severe cases, disorientation, depersonalization, hyperacusis, numbness, and tingling in the extremities, hypersensitivity to light, sound, and physical contact, hallucinations, or epileptic seizures may occur.

These symptoms may include physical reactions (convulsive crises) and psychological reactions (psychotic symptoms, such as delirium).

Amnesia

Benzodiazepines sometimes induce anterograde amnesia. This state occurs (almost always, a few hours) after medication administration. The patient may not always remember what they were doing. To reduce the risk of anterograde amnesia, ensure the patient has a sufficient, uninterrupted 7-8 hour sleep.

Psychiatric reactions

Sometimes, during benzodiazepine treatment, a pre-existing depression may be unmasked and emerge. This reaction may precipitate suicidal tendencies in these patients. Between patients, whose anxiety overlaps with depression, benzodiazepine treatment, even if not primarily used as an anxiolytic, may cause severe manifestations of depression that, once anxiety is alleviated, may reveal suicidal tendencies. The physician will take the necessary precautions.

Reactions such as restlessness, agitation, irritability, aggression, delirious ideas, rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse conduct effects occur, as is known, with benzodiazepine use.

Paradoxical reactions

The possibility of paradoxical reactions, such as increased aggression, acute excitement, anxiety, suicidal intent, muscle spasms, sleep disturbances, such as discoimesis and disphalaxia, must be taken into account.

In the event of these reactions, the physician will discontinue Lormetazepam Koehler administration.

Paradoxical reactions occur more frequently in children and elderly patients.

Repeated administration:

When necessary, exceptionally, repeated administration of Lormetazepam Koehler, the benefit of treatment should be weighed against the risk of physical and psychological dependence.

Generally, injections and, especially, infusions will be administered in large veins. In principle, avoid injecting and infusing into a small vein to minimize the risk of venous irritation, which increases as the vein diameter decreases.

In isolated cases, skin reactions (exanthema) may occur in the skin and other areas.

Patients with respiratory obstruction and brain damage may experience respiratory depression.

Ordinarily, patients should be monitored for 6 to12 hours after administering Lormetazepam Koehler.

In some cases, especially when high doses of lormetazepam are administered or repeated treatment is applied, reversible alterations, such as delayed or unintelligible speech (speech articulation disorders), motor disorders, unstable gait, visual disturbances/anomalies (diplopia), and nystagmus, may occur.

The risk of adverse effects increases more in elderly patients. These patients should be warned of the risk of falls due to the muscle-relaxing effect of lormetazepam.