Patient Information Leaflet

Temelor4mg/ml injectable solution EFG

Lorazepam

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

This medication belongs to a specific group of hypnotic sedatives called benzodiazepines.

This medication is used for adults and adolescents over 12 years old as a sedative to initiate certain interventions (premedication), such as small or large surgical procedures or certain extensive physical examinations.

This medication is used for adults and adolescents over 12 years old who suffer from intense fears or anxiety and for any reason cannot take any tablets.

This medication is used for adults, adolescents, children, and infants over 1 month old in the control of epileptic status.

Do not use Temelor:

• if you are allergic to the active ingredient, to other benzodiazepines, to similar substances to benzodiazepines, or to any of the other components of this medication (listed in section 6);
• if you have myasthenia gravis (a disease in which muscle weakness occurs due to the alteration of nerve impulse transmission to muscles);
• if you have severe respiratory difficulty;
• if you have sleep apnea syndrome (severe respiratory disturbances may occur during sleep);
• if you have severe liver problems.

This medication cannot be injected into an artery.

Children

Children under 12 years old cannot use this medication, except for the treatment of epilepsy.

Warnings and precautions

Consult your doctor or nurse before using this medication:

• If you have chronic respiratory problems.
• If you have altered liver or kidney function.
• If you are an elderly or debilitated patient.
• If you have epilepsy or "green star" (acute angle-closure glaucoma).

During the 24 hours following administration of this medication, you must remain under observation. Walking early (within 8 hours after using this medication) may cause falls and injuries.

A reduction in alertness may also last longer than 24 hours, for example, if you are an elderly patient or use other medications.

If you are an outpatient and this medication is used for a short procedure, you must be accompanied by an adult responsible at the time of hospital discharge.

You cannot drive vehicles or perform activities that require attention for 24 to 48 hours after administration.

You may not remember what you experienced during a certain period of time after administration of this medication.

Patients with mental disorders

This medication is not a first option for the treatment of mental disorders. This medication cannot be used as a single agent for the treatment of depression or fears associated with hypersensitivity.

Benzodiazepines can have a disinhibiting effect on depressed patients and may cause suicidal tendencies.

You must gradually reduce treatment with this medication.

The use of Temelor may cause dependence

The use of benzodiazepines may result in physical or psychological dependence. To reduce the risk of dependence, the lowest effective dose of this medication should be used and the duration of treatment should be as short as possible.

If you interrupt treatment abruptly, you may experience withdrawal symptoms: headache, muscle pain, extreme fear, tension, restlessness, confusion, irritability, mood changes, depression, and insomnia.

You may also temporarily return to the symptoms for which you received this medication temporarily (see also "If you interrupt treatment with Temelor" in section 3).

Patients of advanced age and children

Your doctor will prescribe a lower dose. In addition, your doctor will regularly monitor and adjust the dose according to your response (see "How to use Temelor").

Older patients and children may experience completely opposite reactions to the expected treatment with this medication, such as: restlessness, excitement, aggression, delirium, outbursts of anger, nightmares, certain mental disorders (psychosis), and other contrary behavior. If these reactions occur, your doctor will interrupt treatment.

Children may be especially allergic to the excipients of this medication (see section "Temelor contains benzyl alcohol and propylene glycol").

Other medications and Temelor

Inform your doctor if you are using, have used recently, or may need to use any other medication.

You should not use this medication at the same time as scopolamine (a medication for traveler's disease).

The concomitant use of the following medications may potentiate the calming/relieving effect of this medication:

• psyotropic agents,
• sleeping pills,
• sedatives and/or tranquilizers,
• antidepressants,
• highly active prescription analgesics (narcotic analgesics),
• antiepileptic medications,
• agents used for general or local anesthesia (anesthetics),
• agents used for allergies or travel diseases (antihistamines),
• agents used to treat gout and hyperuricemia (e.g., probenecid).

The concomitant use of lorazepam and opioids (strong analgesics, medication for substitution therapy, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal.

Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes this medication along 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 and follow your doctor's dosage recommendations closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Administration of Temelor with food, drinks, and alcohol

The calming/relieving effect of this medication may be increased with the simultaneous use of alcoholic beverages. This may persist for up to 48 hours after administration of this medication.

You should not consume alcohol 48 hours after administration of this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

You should only use this medication during pregnancy if it is strictly necessary, for the shortest possible duration, and at the lowest possible dose.

Lorazepam passes in small amounts into breast milk. During the use of this medication, breastfeeding is not recommended.

There are no data on the possible effects of lorazepam administered by injection or infusion on female fertility.

In addition, this medication contains benzyl alcohol, a preservative that can cross the placenta and pass into breast milk. This medication also contains propylene glycol (see "Temelor contains benzyl alcohol and propylene glycol").

Driving and operating machines

To drive a vehicle or operate a machine, you must be able to respond and make decisions well and quickly. You must also be able to move quickly and precisely.

If you use this medication, the control of these skills may be reduced because Temelor may negatively affect alertness, response ability, memory, and muscle movement precision.

Therefore, you cannot drive a vehicle or perform other activities that require attention for 24 to 48 hours after administration.

Temelor contains benzyl alcohol and propylene glycol

This medication contains 21 mg of benzyl alcohol in each 1 ml of injectable solution.

This medication contains 840 mg of propylene glycol in each 1 ml of injectable solution.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of severe side effects, including respiratory problems (called "breathing syndrome") in young children. Do not give it to your newborn baby (up to 4 weeks old) and do not use it for more than a week in young children (under 3 years old), unless your doctor recommends it.

Consult your doctor if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause side effects (called "metabolic acidosis").

If your child is under 5 years old, consult your doctor or pharmacist before administering this medication, especially if you use other medications that contain propylene glycol or alcohol.

If you are pregnant or breastfeeding, or if you have liver or kidney disease, do not take this medication unless your doctor recommends it. Your doctor may perform additional checks while you are taking this medication.

You should not use this medication if you are taking disulfiram (a medication used to treat chronic alcoholism) or metronidazole (an antibiotic), unless your doctor recommends it.

There have been reports of polyethylene glycol toxicity (e.g., acute tubular necrosis) during the administration of lorazepam, even at doses higher than recommended.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor again.

This medication will be administered by a healthcare professional. It will be administered through a vein (intravenously) or into a muscle (intramuscularly). The dose will be determined by your doctor and will be based on your body weight. The medication will be administered 15 to 20 minutes before the procedure (intravenously) or at least 2 hours before the procedure (intramuscularly).

Use as premedication

The recommended dose through a vein (intravenously) is based on body weight (0.044 mg per kg of body weight), up to a total of 2 mg, 15 to 20 minutes before the expected procedure. Sometimes, larger doses of up to 4 mg may be administered.

The recommended dose into a muscle (intramuscularly) is 0.05 mg per kg of body weight, with a maximum of 4 mg in total, at least 2 hours before the planned procedure.

Use in the treatment of severe anxiety and tension symptoms in people who cannot take tablets

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

Use in status epilepticus

Adult dose: 4 mg intravenously.

Geriatric patients (over 65 years): elderly patients may respond to lower doses; therefore, half the normal dose for adults may be sufficient.

Posology in adolescents, children, and infants from 1 month of age: 0.1 mg/kg of body weight intravenously with a maximum of 4 mg/dose.

If the convulsion lasts more than 10-15 minutes, the doctor may decide to administer another dose. A maximum of 2 doses may be administered.

Use in children

This medication should not be used in children under 12 years, except for the treatment of status epilepticus (see also section 2).

Use in elderly or debilitated patients

Clinical studies have shown that patients aged 50 years have a deeper and longer-lasting reduction in consciousness when lorazepam is administered intravenously. In normal circumstances, an initial dose of 2 mg should be sufficient unless a greater degree of sedation and/or amnesia is desired.

Use in patients with renal or hepatic insufficiency.

This medication should not be used in patients with severe hepatic insufficiency. When this medication is used in patients with mild to moderate renal or hepatic insufficiency, a reduced initial dose of 0.05 mg/kg (but not more than 2 mg) is recommended.

If you take more Temelor than you should

If you have been given more medication than you should, you may experience symptoms such as drowsiness, mental confusion, and lethargy, in mild cases of overdose and low blood pressure, difficulty controlling movements, respiratory depression, and coma, in severe cases.

The treatment of an overdose will mainly consist of supportive measures, including maintaining respiration and controlling your fluid balance (how much fluid you ingest and lose).

If you forget to take Temelor

Since the injectable solution of Temelor is administered in the hospital, this information is not applicable.

If you interrupt treatment with Temelor

You should interrupt or discontinue treatment only following the instructions of your doctor.

If you are being treated for severe anxiety symptoms and treatment is suddenly discontinued, you should consider the possible appearance of one or more of the following withdrawal symptoms: headache, muscle pain, extreme fear, anxiety, tension, excitement, restlessness, confusion, irritability, mood changes, sweating, depression, and insomnia.

In severe cases, withdrawal symptoms may include: loss of feelings, loss of reality, where the environment (familiar) seems unreal, alienation from oneself and self-esteem (dissociation), numbness and tingling in arms and legs, increased sensitivity to light, sound, and touch, increased hearing, ear pain, involuntary movements, vomiting, delirium (hallucinations) or seizures (epileptic attacks).

Additionally, the symptoms for which you received this medication may reappear temporarily to a large extent.

To minimize the risk of these symptoms, it is recommended to gradually reduce the dose and discontinue treatment.

If you have any other doubts about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them..

Side effects usually occur at the beginning of treatment and gradually disappear during treatment or when the dose is reduced.

The following side effects were reported after using lorazepam:

Very common:can affect more than 1 in 10 people

• fatigue.

Common:can affect up to 1 in 10 people

• daytime drowsiness,
• drowsiness,
• dizziness,
• coordination problems (ataxia),
• muscle weakness.

Uncommon:can affect up to 1 in 100 people

• confusion,
• depression,
• emotional flattening,
• sleep disorders,
• headache,
• diminished alertness,
• visual disturbances,
• double vision (diplopia),
• nausea,
• gastrointestinal problems,
• skin reactions,
• change in sexual desire.

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

• blood disorder (discrasia),
• temporary memory loss,
• contradictory reactions,
• decreased blood pressure (hypotension),
• high blood pressure (hypertension),
• liver disease-related anomalies.
• psychiatric disorders: excitement (agitation), nervousness, irritability, aggression, suspicion, anger attacks, nightmares, observation of things that do not exist (hallucinations), severe mental illness in which behavior and conduct are altered (psychosis), inappropriate behavior. These side effects occur mainly in children and the elderly.

Other side effects:

• Pain, burning sensation, redness, and inflammation have been reported at the injection site.
• Dependence may occur after repeated use over several weeks (see section 2).
• Respiratory difficulties may occur in the case of intense anesthesia.
• Abstinence symptoms occur after treatment interruption (see section “If you stop taking Temelor”)
• Acidification of the blood due to tissue hypoxia, alteration of the water and electrolyte balance, decreased blood pressure, acute tubular necrosis, caused by the excipients of this medicine. This is more likely to occur in patients with renal insufficiency and in children (see also “Warnings and precautions”).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Store and transport refrigerated (2°C – 8°C). Store in the original packaging to protect it from light.

The chemical and physical stability has been demonstrated during 1 hour at 2-8°C. From a microbiological standpoint, unless the opening/dilution method excludes the risk of microbial contamination, the product must be used immediately. If not used immediately, storage times and conditions in use are the responsibility of the user.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Temelor

• The active principle is lorazepam; each 1 ml of solution contains 4 mg of lorazepam.
• The other components are macrogol 400, benzyl alcohol, and propylene glycol.

Appearance of the product and contents of the package

Clear, colourless or almost colourless hypertonic solution, free of visible particles.

Temelor is presented in transparent type I glass ampoules (Ph.Eur) with a filling capacity of 2 ml. Each ampoule contains 1 ml of solution. The ampoules are placed in moulded PVC trays, which are then sealed with a transparent PE protective sheet.

The PVC trays are introduced into a cardboard box together with a leaflet.

Temelor is presented in packs of 5 and 10 ampoules of 1 ml solution.

Only some pack sizes may be marketed.

Marketing authorisation holder

Medochemie Iberia, S.A.

Rua José Maria Nicolau, no 6, 7oB,

1500 662 Lisboa

Portugal

Responsible for manufacturing

Medochemie Ltd,

Ampoule Injectable Facility

48 Iapetou Street,

Agios Athanassios Industrial Area,

4101 Agios Athanassios, Limassol

Cyprus

This medicinal product is authorised in the Member States of the EEA with the following names:

Last update of the summary of product characteristics: December 2023.

Other sources of information

The detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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The following information is intended only for healthcare professionals:

Instructions for use

Temelor is slightly viscous when cold.

Intramuscular administration:

To facilitate intramuscular administration, it is recommended to dilute with an equal volume of a compatible solution, such as a 9 mg/ml sodium chloride injection (0.9%), 5% glucose solution or water for injection.

Temelor can also be administered without dilution, if administered deeply in a large muscle mass.

Intravenous administration:

In case of intravenous administration, Temelor must always be diluted with an equal volume of sodium chloride injection 9 mg/ml (0.9%), 5% glucose solution or water for injection.

The injection rate should not exceed 2 mg/min. Parenteral drugs should be visually inspected for the presence of particles or discoloration before administration.

Instructions for dilution for intravenous use.

Draw the desired amount of Temelor into the syringe and then slowly aspirate the desired volume of diluent. Retract the plunger slightly to provide additional mixing space. Mix the contents immediately by rotating the syringe repeatedly until a homogeneous solution is formed. Do not shake vigorously as this will cause air bubbles.

Temelor should not be mixed with other medications in the same syringe. Do not use if the solution has developed a colour or precipitate.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.