Temelor 4 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Temelor 4 mg/ml injection solution EFG

lorazepam

Read the entire leaflet carefully before you start taking this medicine, because 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 should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Temelor is and what it is used for

This medicine belongs to a certain group of sedative-hypnotic medicines called benzodiazepines.

This medicine is used in adults and adolescents over 12 years of age as a sedative prior to certain procedures (premedication), such as minor or major surgical procedures or certain extensive physical examinations.

This medicine is used in adults and adolescents over 12 years of age who suffer from intense fear or severe anxiety and who, for any reason, cannot take oral tablets.

This medicine is used in adults, adolescents, children, and infants from 1 month of age for the management of status epilepticus.

2. What you need to know before using 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 causing muscle weakness due to impaired transmission of nerve impulses to muscles);
• if you suffer from severe respiratory difficulty;
• if you have sleep apnea syndrome (serious breathing disturbances during sleep may occur);
• if you have severe liver problems.

This medicine must not be injected into an artery.

Children

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

Warnings and precautions

Consult your doctor or nurse before using this medicine:

• If you suffer from chronic respiratory problems.
• If you have impaired 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 must remain under observation. Early ambulation (within 8 hours after administration of this medicine) may lead to falls and injuries.

Reduced alertness may also last longer than 24 hours, for example, if you are an elderly patient or are taking other medicines.

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

You must not drive vehicles or perform activities requiring attention for 24 to 48 hours after administration.

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

Patients with mental disorders

This medicine is not a first-line treatment for mental disorders. This medicine must not 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 may cause suicidal tendencies.

Treatment with this medicine must be gradually tapered off.

Use of Temelor may lead to dependence

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

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

The symptoms for which you temporarily received this medicine may also temporarily return (see also "If you stop using Temelor" in section 3).

Elderly patients and children

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

Elderly patients and children may experience reactions completely opposite to the expected effects of treatment with this medicine, such as: restlessness, excitement, aggression, delirium, rage attacks, nightmares, certain mental disorders (psychosis), and other paradoxical reactions. If such reactions occur, your doctor will discontinue treatment.

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

Other medicines and Temelor

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

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

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

• psychotropic agents,
• sleeping medicines,
• sedatives and/or tranquilizers,
• antidepressants,
• certain highly active prescription painkillers (narcotic analgesics),
• antiepileptic medicines,
• agents causing general or local anesthesia (anesthetics),
• agents used for allergies or travel sickness (antihistamines),
• agents used to treat gout and hyperuricemia (e.g., probenecid).

Concomitant use of lorazepam and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all opioid medicines you are taking and follow your doctor's dosage recommendations carefully. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Taking Temelor with food, alcohol, and drinks

The calming/sedative effect of this medicine may be increased by drinking alcohol at the same time. This effect may persist up to 48 hours after administration of this medicine.

You must 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 plan to become pregnant, consult your doctor before using this medicine.

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

Lorazepam passes into breast milk in small amounts. Breastfeeding is not recommended during treatment with this medicine.

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

In addition, this medicine contains benzyl alcohol, a preservative that may 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 machinery, you must be able to respond quickly and make sound decisions. You must also be able to move quickly and precisely.

If you take this medicine, your ability to perform these skills may be reduced because Temelor may negatively affect alertness, reaction capacity, memory, and precision of muscle movements.

Therefore, you must not drive a vehicle or perform other activities requiring 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.

Seek advice from your doctor or pharmacist 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 may cause adverse effects. Your doctor may need to adjust the dose if you or your child are taking other medicines containing benzyl alcohol, propylene glycol, or alcohol.

Benzyl alcohol may cause allergic reactions.

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

If you are pregnant or breastfeeding, or if you have liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring 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 recommended by your doctor.

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

3. How to take Temelor

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor again.

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

Use as premedication

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

The recommended intramuscular dose is 0.05 mg per kg of body weight, with a maximum total of 4 mg, administered at least 2 hours before the intended procedure.

Use in the treatment of severe anxiety and tension symptoms in patients unable to 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

Dosage for adults: 4 mg intravenously.

Elderly patients (over 65 years of age): elderly patients may respond to lower doses; therefore, half the normal adult dose may be sufficient.

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

If the seizure lasts longer than 10–15 minutes, the doctor may decide to administer another dose. A maximum of 2 doses may be given.

Your child should not receive more than two repeated doses in a single day if 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, it should not be used in neonates (see also section 2).

Use in elderly or debilitated patients

Clinical studies have shown that elderly patients aged 50 years and over experience a deeper and longer-lasting reduction in consciousness when lorazepam is administered intravenously. Under 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 impairment

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

If you use more Temelor than you should

If you have been given more medicine 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.

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

If you forget to use Temelor

Since Temelor injectable solution is administered in hospital, this information does not apply.

If you stop using Temelor

You must stop or discontinue treatment only following your doctor's instructions.

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

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

In addition, the symptoms for which you received this medicine may temporarily reappear to a large extent.

To minimize the risk of these symptoms occurring, it is recommended to gradually reduce the dose before discontinuing treatment.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

The following adverse effects have been reported after using lorazepam:

Very common: may affect more than 1 in 10 people

• tiredness.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• confusion,
• depression,
• emotional blunting,
• sleep disturbances,
• 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 dyscrasia,
• temporary memory loss,
• paradoxical reactions,
• decreased blood pressure (hypotension),
• elevated blood pressure (hypertension),
• abnormalities related to liver disease.
• psychiatric disorders: excitement (agitation), nervousness, irritability, aggressiveness, suspicion, rage attacks, nightmares, seeing things that do not exist (hallucinations), severe mental illness involving loss of behavioral control and conduct (psychosis), inappropriate behavior. These side effects occur mainly in children and elderly patients.

Other adverse effects:

• Pain, burning sensation, redness, and inflammation at the injection site have been reported.
• Dependence may occur after repeated use over several weeks (see section 2).
• Breathing difficulties may occur under deep anesthesia.
• Withdrawal symptoms may occur after stopping treatment (see section “If you stop treatment with Temelor”).
• Acidification of the blood due to tissue hypoxia, disturbance of fluid and electrolyte balance, decreased blood pressure, and death of certain kidney cells (acute tubular necrosis), caused by the excipients in this medicine. These symptoms are more likely to occur in patients with renal impairment and in children (see also “Warnings and precautions”).

Reporting of adverse effects

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

5. Storage of the medicine

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

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be handed over to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Temelor

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

Nature of the product and contents of the container

A hypertonic, transparent, colourless or almost colourless solution, free from visible particles.

Temelor is supplied in clear type I glass ampoules (Ph.Eur) with a fill capacity of 2 ml. Each ampoule contains 1 ml of solution. The ampoules are placed in thermoformed trays made of polyvinyl chloride, which are then sealed with a transparent protective polyethylene (PE) foil.

The polyvinyl chloride trays are packed into a cardboard box together with a package leaflet.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Macure Healthcare Ltd.

Flat 2, Arhlight, 62,

Tri-L-Gharbiel Swieqi, SWQ 3251,

Malta

Manufacturer

Medochemie Ltd,

Ampoule Injectable Facility

48 Iapetou Street,

Agios Athanassios Industrial Area,

4101 Agios Athanassios, Limassol

Cyprus

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

Netherlands	Temelor 4 mg/ml solution for injection
Cyprus	Temelor 4 mg/ml ενέσιμο διάλυμα
Bulgaria	TEMEΛOΡ 4 mg/ml инжекционен разтвор
Czech Republic	Temelor 4 mg/ml injekční roztok
Croatia	Temelor 4 mg/ml otopina za injekciju
Lithuania	Lirezid 4 mg/ml injekcinis tirpalas
Latvia	Temelor 4 mg/ml šķīdums injekcijām
Malta	Temelor 4 mg/ml solution for injection
Romania	Temelor 4 mg/ml soluție injectabilă
Estonia	Temelor 4 mg/ml süstelahus
Portugal	Lorazepam Macure 4 mg/ml solução injetável
Spain	Temelor 4 mg/ml solución inyectable EFG

Date of the most recent review of this leaflet: February 2025

Other sources of information

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 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 is recommended, such as sodium chloride 9 mg/mL (0.9%) injection solution, 5% glucose solution, or water for injection.

Temelor may also be administered undiluted, provided it is injected deeply into a large muscle mass.

Intravenous administration:

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

The injection rate must not exceed 2 mg/min. Parenteral medicinal products should be visually inspected for the presence of particles or discoloration prior to administration.

Dilution instructions for intravenous use.

Withdraw the desired amount of Temelor into the syringe, then slowly aspirate the desired volume of diluent. Pull back the plunger slightly to create additional mixing space. Immediately mix the contents by repeatedly rotating the syringe until a homogeneous solution is obtained. Do not shake vigorously, as this may cause air bubbles.

Temelor must not be mixed with other medicinal products 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 must be disposed of in accordance with local requirements.