Package Insert: Information for the User

Noctamid2,5mg/ml Oral Solution Drops

Lormetazepam

Noctamid is a medication in the group of hypnotics that promotes sleep: normalizes the time needed to fall asleep and its total duration, while reducing the number of interruptions of the same. It is indicated for:

• Treatment of short duration insomnia.
• Induction of sleep in pre and postoperative periods.

Noctamid belongs to a group of hypnotic medications called benzodiazepines. Benzodiazepines are only indicated for the treatment of an intense disorder, which limits the patient's activity or subjects them to an important stress situation.

Do not take Noctamid 2.5 mg/ml, oral drops solution.

• If you are allergic (hypersensitive) to lormetazepam, benzodiazepines, or any of the other components of this medication (listed in section 6).
• If you have myasthenia gravis (a disease characterized by the appearance of an abnormal degree of muscle weakness).
• If you have severe respiratory insufficiency.
• If you have sleep apnea syndrome (interruption of breathing during sleep).
• In case of acute intoxication with alcohol, hypnotics, analgesics, or medications that act on the central nervous system (neuroleptics, antidepressants, lithium).

Warnings and precautions:

• If you have chronic respiratory insufficiency, as you should receive a lower dose than usual.
• If you have liver insufficiency.
• If you have severe renal insufficiency.
• Noctamid should not be used as a first-line treatment for psychiatric disease or as a single treatment for anxiety or sleep disorders associated with depression.
• Noctamid should be administered with caution to patients with medullary or cerebellar ataxia.

Consult your doctor or pharmacist before starting to take this medication.

Tolerance

• After continuous use for several weeks, a certain degree of loss of efficacy with respect to hypnotic effects may be detected.

Dependence

• Noctamid may induce the appearance of physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment and is also higher in patients with a history of substance abuse or alcohol consumption. Abrupt termination of treatment may be accompanied by withdrawal symptoms, such as severe anxiety, tension, restlessness, confusion, irritability, headaches, and muscle pain. In severe cases, derealization, depersonalization, hallucinations, paresthesia in the extremities, intolerance to light, sound, and physical contact, hyperacusis, and epileptic seizures may occur. Follow exactly the administration instructions for Noctamid indicated by your doctor to avoid these symptoms as much as possible.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient reappearance of symptoms that led to the initiation of treatment). The probability of appearance of a withdrawal/rebound phenomenon is higher after abrupt termination of treatment, so it is recommended to gradually reduce the dose until its definitive suppression.

Follow exactly the recommended use and administration instructions for Noctamid indicated by your doctor to avoid these symptoms as much as possible.

Amnesia

• Noctamid may induce anterograde amnesia, that is, difficulty remembering recent events; this occurs more frequently in the first hours after taking the medication, so to reduce this risk, you should ensure that you can sleep uninterrupted for 7-8 hours (see section 4).

Psychiatric and paradoxical reactions

• Noctamid may produce restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, abnormal and inadequate behavior, and other adverse effects on behavior. These reactions occur more frequently in children, the elderly, and patients with organic brain syndrome (physical disorders that produce a decrease in mental functions). Your doctor will suspend your treatment with Noctamid if these reactions appear.
• Inform your doctor if you have depression. Noctamid should not be used as a single treatment for sleep disorders associated with depression.
• Noctamid should not be used as a first-line treatment for psychiatric disease (see section 4).

Children and adolescents

Noctamid should not be administered to patients under 18 years of age for the treatment of insomnia without a careful evaluation of the need for it by your doctor. Additionally, the duration of treatment should be the minimum possible (see section 3).

Use in the elderly

Elderly patients should receive a lower dose than usual as they are more susceptible to the effects of the medication. Your doctor will recommend the most suitable dosage (see section 3).

Use of Noctamid 2.5 mg/ml, oral drops solution with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

A potentiation of the depressive effect of Noctamid may occur when administered concomitantly with the following medications:

• Medications used in the treatment of psychiatric disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).
• Medications used to relieve strong pain (narcotic analgesics). With these medications, an increase in the sensation of euphoria may also occur, which may increase the risk of psychological dependence.
• Medications used in the treatment of epilepsy (antiepileptics).
• Anesthetics.
• Medications used to treat allergic symptoms (sedating antihistamines).
• Medications used to treat cardiovascular diseases (calcium antagonists, cardiac glycosides).
• Medications used to treat hypertension (beta-blockers).
• Oral contraceptives.
• Certain antibiotics (such as rifampicin).

Interactions have also been reported with some medications used to treat hypertension (beta-blockers) and with central nervous system stimulants (methylxanthines).

The concomitant use of lormetazepam and opioids (potent analgesics, substitution therapy medications, 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 lormetazepam along with opioids, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all the opioid medications you are taking and follow your doctor's recommendation strictly regarding the dose. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

Consult your doctor if you are taking other medications.

Taking Noctamid 2.5 mg/ml, oral drops solution with food, drinks, and alcohol

Avoid drinking alcoholic beverages during treatment with Noctamid.

Benzodiazepines should be used with extreme caution in patients with a history of substance abuse or alcohol consumption. The sedative effect may be potentiated when this medication is administered in combination with alcohol, so it is recommended to avoid consuming alcoholic beverages. This should be taken into account especially since it affects the ability to drive or operate machinery (see section "Driving and operating machinery").

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

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

If, by strict medical necessity, the medication is administered during the third trimester of pregnancy or during delivery, it is predictable that there may be effects on the newborn such as hypothermia, hypotonia, and moderate respiratory depression, and difficulties in breastfeeding.

Children born to mothers who take benzodiazepines chronically during the last trimester of pregnancy may develop physical dependence, which may trigger a withdrawal syndrome in the postnatal period.

Breastfeeding

Due to the fact that benzodiazepines pass into breast milk, their use is contraindicated in lactating mothers.

Driving and operating machinery

Noctamid is a medication that induces sleep, so it significantly affects the ability to drive or operate machinery. Do not drive or operate machinery if you feel drowsy or if you notice that your attention and reaction time are reduced. Pay special attention to the start of treatment or if the dose is increased.

Important information about some of the components of Noctamid 2.5 mg/ml, oral drops solution

This medication contains 8% ethanol at 96% (alcohol), which corresponds to 32 mg of ethanol at 96% in each dose of 10 drops of solution.

Follow exactly the administration instructions for Noctamid as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

It is essential to note that 10 drops of Noctamid solution are equivalent to 1 mg of lormetazepam.

The administration in drops facilitates administration, as it allows the dose to be divided.

Treatment of short duration insomnia

The duration of treatment should be as short as possible. Generally, it varies between a few days and two weeks, with a maximum period, including a gradual dose reduction, of four weeks.

Adults

It is recommended to administer 10 drops of Noctamid drops (1 mg of lormetazepam) in a single dose.

In cases of severe or persistent insomnia and always according to strict medical criteria, the dose can be increased to 2 mg of lormetazepam (20 drops of Noctamid drops).

Senior patients

It is recommended to administer 5 drops of Noctamid drops (0.5 mg of lormetazepam) in a single dose.

In elderly patients, benzodiazepines may be associated with a higher risk of falls due to muscle weakness, dizziness, drowsiness, and fatigue. Therefore, your doctor will indicate the dose that best suits your condition.

Noctamid drops can be taken with a small amount of liquid before going to bed.

Children and adolescents

Noctamid should not be used in children and adolescents under 18 years of age without a careful evaluation of the need for treatment.

If you estimate that the action of Noctamid is too strong or too weak, consult your doctor or pharmacist.

Induction of sleep in pre- and postoperative periods

The doses will depend on the age, weight, and general condition of the patient.

Adults

It is recommended to administer a daily dose of 2 mg of lormetazepam (20 drops of Noctamid drops per day). The dose range is 0.5 to 3 mg, which is equivalent to 5-30 drops of Noctamid drops.

Children

It is recommended to administer a dose of 0.5 to 1 mg of lormetazepam per day (which corresponds to 5-10 drops of Noctamid drops).

Senior patients and patients at risk

It is generally recommended to administer a dose of 1 mg per day (10 drops of Noctamid drops per day). An hour before the operation, it is recommended to administer half of these doses.

Consider reducing the dose in patients with mild or moderate respiratory difficulties or in patients with liver insufficiency.

Instructions for the correct administration of Noctamid 2.5 mg/ml, oral drops in solution

To open the Noctamid drops bottle, press and turn the cap in the direction indicated in the diagram.

The Noctamid drops bottle has a safety cap to prevent it from being opened by children.

If you take more Noctamid 2.5 mg/ml, oral drops in solution than you should

Overdose does not represent a vital threat unless its administration is combined with other central nervous system depressants (including alcohol). In case of overdose, consider the possibility that the patient has ingested multiple products.

Benzodiazepine overdose generally manifests by different degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more serious cases, ataxia (coordination disorder), visual disturbances, hypotonia (muscle tone decrease), hypotension (low blood pressure), respiratory depression, rarely coma, and very rarely death.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Noctamid 2.5 mg/ml, oral drops in solution

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Noctamid 2.5 mg/ml, oral drops in solution

Your doctor will indicate the duration of treatment with Noctamid. Do not suspend treatment prematurely, as you may not achieve the desired effect.

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

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

If the dosage is not adapted to the individual conditions of each patient, side effects may appear due to excessive sedation and muscle relaxation.

At the beginning of treatment, daytime drowsiness, emotional alteration, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (alteration of movement coordination) or double vision may appear. All these side effects predominantly appear at the beginning of treatment and usually disappear with repeated administration.

The most serious adverse reactions observed in patients treated with Noctamid are angioedema (swelling), completed or attempted suicide, usually associated with the masking of a pre-existing depression.

The most frequently observed adverse reactions in patients treated with Noctamid are headache, sedation, and anxiety.

Very common side effects

(may affect more than 1 in 10 patients)

Common side effects

(may affect up to 1 in 10 patients)

Side effects of unknown frequency

(cannot be estimated from available data)

For more information on the following points, see the "Warnings and precautions" section.

Dependence:

The administration of Noctamid and other benzodiazepines may induce the development of physical and psychological dependence (see "Warnings and precautions" section).

Mental disorders:

Rebound insomnia may appear when the medication is discontinued (see "Warnings and precautions" section).

- Psychiatric and paradoxical reactions: When using Noctamid, reactions such as restlessness, agitation, irritability, aggression, delirium (false ideas that are believed to be true and cannot be proven), anger attacks, nightmares, hallucinations (false perceptions of the senses), psychosis (a type of mental disorder), abnormal and inappropriate behavior, and other conduct alterations may appear.

- Depression: The use of benzodiazepines may mask a pre-existing depression. In these patients, suicides may be triggered. Noctamid should be used with caution in patients with depression.

Nervous system disorders

- Amnesia: Noctamid may cause anterograde amnesia (difficulty remembering recent events). (See "Warnings and precautions" section).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. 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 reach and sight of children.

Noctamid 2,5 mg/ml, oral drops inssolution should be stored in a cool and dry place.

Do not use Noctamid after the expiration date that appears 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 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 Noctamid 1 mg tablets

The active ingredient is lormetazepam. Each tablet contains 1 mg of lormetazepam. The other components are lactose monohydrate, cornstarch, povidone 25000, and magnesium stearate.

Appearance of the product and content of the packaging

Noctamid 1 mg tablets: white, round, scored tablets with the anagram “CF” inscribed in a hexagon on the other side. The tablet can be divided into equal doses. It is presented in blisters, in packs of 30 tablets.

Other presentations:

Noctamid 2 mg tablets, 20 tablets.

Noctamid 2.5 mg/ml oral drops in solution, containing 20 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teofarma, S.R.L.

Via F. Lli Cervi, 8

I-27010- Valle Salimbene (Pavia). Italy

Responsible for manufacturing:

TEOFARMA, S.R.L.

Viale Certosa 8 /a, Pavia I-27100 Italy

This leaflet was approved in February 2022

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