TEMELOR 4 mg/ml INJECTABLE SOLUTION

2. What you need to know before you use Temelor

Do not use Temelor:

• if you are allergic to the active substance, to other benzodiazepines, to substances similar to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6);
• if you have myasthenia gravis (a disease in which muscle weakness is produced due to the alteration of the transmission of nerve impulses to the muscles);
• if you have severe breathing difficulties;
• if you have sleep apnea syndrome (severe respiratory disorders can occur during sleep);
• if you have severe liver problems.

This medicine cannot be injected into an artery.

Children

Children under 12 years of age cannot use this medicine, except for the treatment of status epilepticus. For status epilepticus, Temelor should not be used in neonates.

Warnings and precautions

Consult your doctor or nurse before using this medicine:

• 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 narrow-angle glaucoma).

During the 24 hours following administration of this medicine, you should remain under observation. Early walking (within 8 hours after use of this medicine) can cause you to fall and get injured.

A reduction in alertness can also last more than 24 hours, for example, if you are an elderly patient or use other medicines.

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

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

It is possible that you will not remember what you experienced during a certain period after administration of this medicine.

Patients with mental disorders

This medicine is not a first choice in the treatment of mental disorders. This medicine cannot be used as a single agent in the treatment of depression or fears associated with hypersensitivity.

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

You should gradually reduce treatment with this medicine.

The use of Temelor can lead to dependence

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

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

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

Elderly and child patients

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

Elderly and child patients may experience completely opposite reactions to those expected from treatment with this medicine, such as: restlessness, excitement, aggression, delirium, fits of rage, nightmares, certain mental disorders (psychosis), and other contrary behavior. If these reactions occur, your doctor will stop treatment.

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

Other medicines and Temelor

Tell your doctor if you are using, have recently used, or might use any other medicines.

You should not use this medicine at the same time as scopolamine (a medicine for travel sickness).

Concomitant use of the following medicines may enhance the calming/relieving effect of this medicine:

• psychotropic agents,
• sleeping pills,
• sedatives and/or tranquilizers,
• antidepressants,
• certain highly potent prescribed painkillers (narcotic analgesics),
• antiepileptic medicines,
• agents that induce general or local anesthesia (anesthetics),
• agents used in allergies or travel sickness (antihistamines),
• agents used to treat gout and hyperuricemia (e.g., probenecid).

Concomitant use of lorazepam and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.

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

Tell your doctor about all opioid medicines you are taking and follow your doctor's dosage recommendation carefully. It may be useful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Taking Temelor with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

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

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

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

Driving and using machines

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

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

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

Temelor contains benzyl alcohol, propylene glycol, and polyethylene glycol.

Temelor contains 21 mg of benzyl alcohol, 840 mg of propylene glycol, and 189 mg of polyethylene glycol per ml.

Ask your doctor or pharmacist for advice if your child is under 5 years of age, if you have liver or kidney disease, or if you are pregnant or breastfeeding. This is because the excipients can cause adverse effects. Your doctor may need to adjust the dose if you or your child are using other medicines that contain benzyl alcohol, propylene glycol, or alcohol.

Benzyl alcohol can cause allergic reactions.

Benzyl alcohol has been linked to the risk of serious side effects, including respiratory problems (called "gasping syndrome") in small children. Do not give it to your newborn baby (up to 4 weeks of age) and do not use it for more than one week in small children (under 3 years) unless your doctor recommends it.

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

Do not use this medicine if you are taking disulfiram (a medicine 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.

3. How to take Temelor

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

This medicine will be administered by a healthcare professional. It will be administered into a vein (intravenously) or into a muscle (intramuscularly). The dose will be decided by the doctor and will be based on your body weight. The medicine 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 into 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 higher 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 symptoms of severe anxiety and tension 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 may be repeated after 2 hours. The injection will be administered into a vein (intravenously) or into a muscle (intramuscularly).

Use in status epilepticus

Dose for adults: 4 mg intravenously.

Elderly patients (over 65 years): elderly patients 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/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 can be administered.

Your child should not receive more than two repeated doses in one day if they are under 5 years of age.

Use in children

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

Use in elderly or debilitated patients

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

Use in patients with renal or hepatic insufficiency

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

If you use more Temelor than you should

If you have been administered more medicine than you should, you may have 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.

Treatment of an overdose will consist mainly of supportive measures, including maintenance of respiration and control of fluid balance (how much fluid you take in and excrete).

If you forget to use Temelor

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

If you stop treatment with Temelor

You should stop or suspend treatment only following your doctor's instructions.

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

In the most severe cases, withdrawal symptoms can include: loss of feelings, loss of reality, where the environment (familiar) seems unreal, alienation from oneself and one's self-esteem (depersonalization), numbness and tingling in arms and legs, great increased sensitivity to light, noise, and touch, increased hearing, earaches, involuntary movements, vomiting, delirium (hallucinations), or falling sickness (epileptic fits).

Additionally, the symptoms for which you received this medicine may temporarily return to a great extent.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The following side effects were reported after using lorazepam:

Very common:may affect more than 1 in 10 people

• fatigue.

Common:may affect up to 1 in 10 people

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

Uncommon:may affect up to 1 in 100 people

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

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

• blood disorders (dyscrasia),
• temporary memory loss,
• paradoxical reactions,
• low blood pressure (hypotension),
• high blood pressure (hypertension),
• liver-related disorders.
• psychiatric disorders: excitement (agitation), nervousness, irritability, aggression, suspicion, fits of rage, nightmares, observation of things that do not exist (hallucinations), severe mental illness in which control of behavior and conduct is altered (psychosis), inappropriate behavior. These side effects occur mainly in children and elderly patients.

Other side effects:

• 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 can occur in case of deep anesthesia.
• withdrawal symptoms occur after stopping treatment (see "If you stop treatment with Temelor")
• acidification of the blood due to lack of oxygen in the body tissues, alteration of the water and salt balance, decrease in blood pressure, death of certain cells in the kidneys (acute tubular necrosis), caused by the excipients of this medicine. These symptoms are more likely to occur in patients with kidney failure and in children (see also "Warnings and precautions").

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Temelor

Keep out of sight and reach of children.

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

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

Do not use this medicine after the expiry date stated on the label and on the carton after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicines at the pharmacy's SIGRE Point. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Temelor

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

Appearance of the Product and Package Contents

Clear, colorless or almost colorless hypertonic solution, free from visible particles.

Temelor is presented in transparent type I glass ampoules (Ph.Eur) with a fill volume of 2 ml. Each ampoule contains 1 ml of solution. The ampoules are placed in molded polyvinyl chloride trays, which are then sealed with a transparent PE protective film.

The polyvinyl chloride trays are inserted into a cardboard box along with a leaflet.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Medochemie Iberia, S.A.

Rua José Maria Nicolau, no 6, 7oB,

1500 662 Lisboa

Portugal

Manufacturer

Medochemie Ltd,

Ampoule Injectable Facility

48 Iapetou Street,

Agios Athanassios Industrial Area,

4101 Agios Athanassios, Limassol

Cyprus

This medicine is authorized in the EEA Member States under the following names:

Date of the last revision of this leaflet: February 2025

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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The following information is intended for healthcare professionals only:

Instructions for use

Temelor is slightly viscous when cold.

Intramuscular administration:

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

Temelor can also be administered undiluted if administered deeply into a large muscle mass.

Intravenous administration:

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

The injection rate should not exceed 2 mg/min. Parenteral medicines should be inspected visually for particulate matter or discoloration prior to administration.

Dilution instructions for intravenous use.

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

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

There are no special requirements for disposal.

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