NOCTAMID 2 mg TABLETS

2. What you need to know before you take Noctamid 2 mg tablets

Do not take Noctamid 2 mg tablets:

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

Warnings and precautions:

• If you have chronic respiratory failure, you should receive a lower dose than usual.
• If you have liver failure.
• If you have severe kidney failure.
• Noctamid should not be used as a first-line treatment for psychotic illness or as the sole 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 medicine.

Tolerance

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

Dependence

• Noctamid may induce physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment and is also greater in patients with a history of drug or alcohol abuse. Abrupt termination of treatment may be accompanied by withdrawal symptoms, such as anxiety, tension, restlessness, confusion, irritability, headaches, and muscle pain. In more severe cases, even depersonalization, derealization, hallucinations, paresthesia in the limbs, sensory intolerance to light, sounds, and physical contact, hyperacusis, and epileptic convulsions. Follow your doctor's instructions for administration of Noctamid exactly to avoid these symptoms as much as possible.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient reappearance of the symptoms that determined the start of treatment). The probability of a withdrawal/rebound phenomenon is greater after abruptly stopping treatment, so it is recommended to gradually decrease the dose until its final suppression.

Follow your doctor's recommendations for use and administration of Noctamid exactly to avoid these symptoms as much as possible.

Amnesia

• Noctamid may induce anterograde amnesia, i.e., difficulty remembering recent events; this occurs more frequently in the first hours after taking the medicine, 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, rage, 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 discontinue your treatment with Noctamid if these reactions appear.
• Tell your doctor if you have depression. Noctamid should not be used as the sole treatment for sleep disorders associated with depression.
• • Noctamid should not be used as a first-line treatment for psychotic illness (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 treatment by the doctor. Furthermore, the duration of treatment should be as short as possible (see section 3).

Use in elderly patients

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

Using Noctamid 2 mg tablets with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

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

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

Interactions have also been reported with some medicines used in the treatment of arterial hypertension (beta-blockers) and with central nervous system stimulants (methylxanthines).

The concomitant use of lormetazepam and opioids (potent analgesics, substitution therapy medicines, and some cough medicines) increases the risk of somnolence, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes lormetazepam together with opioids, your doctor should limit the dose and duration of concomitant treatment.

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

If you are taking other medicines, consult your doctor.

Taking Noctamid 2 mg tablets with food, drinks, and alcohol

Avoid alcoholic beverages during treatment with Noctamid.

Benzodiazepines should be used with extreme caution in patients with a history of drug or alcohol abuse. The sedative effect may be potentiated when this medicine 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 using machines").

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

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

If, for strict medical reasons, the medicine is administered during the third trimester of pregnancy or during childbirth, it is foreseeable that effects on the newborn may appear, such as hypothermia, hypotonia, and moderate respiratory depression, as well as difficulties during breastfeeding.

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

Breastfeeding

Since benzodiazepines pass into breast milk, their use is contraindicated in breastfeeding mothers.

Driving and using machines

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

Important information about some of the ingredients of Noctamid 2 mg tablets

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Noctamid 2 mg tablets

Follow your doctor's instructions for administration of Noctamid exactly. Consult your doctor or pharmacist if you have any doubts. Remember to take your medicine.

Short-term treatment of insomnia

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

The tablets should be taken with a little liquid shortly before bedtime.

Adults

It is recommended to administer 1 mg of lormetazepam (½ tablet of Noctamid 2 mg or 1 tablet of the alternative presentation Noctamid 1 mg) in a single dose.

In cases of severe or persistent insomnia and always according to strict medical criteria, the dose may be increased to 2 mg of lormetazepam (two tablets of Noctamid 1 mg or one tablet of Noctamid 2 mg).

Elderly patients

It is recommended to administer 0.5 mg of lormetazepam as a single dose. There are other presentations of lormetazepam that allow for adjustment to this 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.

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 think the action of Noctamid is too strong or too weak, consult your doctor or pharmacist.

Induction of sleep in pre- and post-operative periods

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

Adults

It is recommended to administer a medium dose of 2 mg of lormetazepam per day. The dose range is 0.5 to 3 mg of lormetazepam per day.

Children

A dose of 0.5 mg to 1 mg of lormetazepam per day is recommended.

Elderly patients and patients at risk

A dose of 1 mg of lormetazepam per day is generally recommended. One hour before the operation, half of these doses is recommended.

A reduction in dose should be considered in patients with mild or moderate breathing difficulties or in patients with liver failure.

If you take more Noctamid 2 mg tablets than you should

Overdose is not life-threatening unless it is combined with other central nervous system depressants (including alcohol). In case of overdose, it should be taken into account that the patient may have ingested multiple products.

Overdose with benzodiazepines is generally manifested by different degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more severe cases, ataxia, vision disorders, hypotonia, hypotension, 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 medicine and the amount ingested.

If you forget to take Noctamid 2 mg tablets

Do not take a double dose to make up for forgotten doses.

If you stop taking Noctamid 2 mg tablets

Your doctor will indicate the duration of treatment with Noctamid. Do not stop treatment before this, as the desired effect may not be achieved.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

At the beginning of treatment, drowsiness, emotional changes, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (alteration of movement coordination), or double vision may appear. All these effects appear predominantly 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 Adverse Effects

(may affect more than 1 in 10 patients)

• Headache

Common Adverse Effects

(may affect up to 1 in 10 patients)

• • Angioedema (swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing).
  • Anxiety, decreased libido (sexual desire).
  • Dizziness, sedation, somnolence (drowsiness), attention disorder, amnesia, visual disorder, speech disorder, dysgeusia, mental slowing.
  • Tachycardia (accelerated heart rate).
  • Vomiting, nausea, upper abdominal pain, constipation, dry mouth.
  • Pruritus (itching).
• Urination disorder.
• • Asthenia (lack of strength), excessive sweating.

Adverse Effects of Unknown Frequency

(cannot be estimated from available data)

• Suicide attempt or completed suicide (masking of a pre-existing depression), acute psychosis (a type of mental disorder), hallucinations (false perceptions of the senses), dependence, depression (masking of a pre-existing depression), delirium (false ideas that are believed to be true and cannot be proven), withdrawal syndrome (rebound insomnia), agitation, aggression, irritability, restlessness, anger attacks, nightmares, inappropriate behavior, emotional changes.
• Confusion, decreased level of consciousness, ataxia (alteration of movement coordination), muscle weakness.
• Urticaria, exanthema (rash).
• Fatigue.
• Falls.

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).

Psychiatric disorders:

Rebound insomnia may appear when withdrawing the medication (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 inappropriate behavior, and other changes in behavior 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 Adverse Effects

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

5. Storage of Noctamid 2 mg Tablets

Keep out of the reach and sight of children.

Noctamid does not require special storage conditions.

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 thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 Package Contents

Noctamid 1 mg Tablets: white, round tablets, scored on one side and the anagram "CF" inscribed in a hexagon on the other. The tablet can be divided into equal doses. It is presented in blisters, in packages 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.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teofarma, S.R.L.

Via F. Lli Cervi, 8

I-27010- Valle Salimbene (Pavia). Italy

Manufacturer:

TEOFARMA, S.R.L.

Viale Certosa 8 /a, Pavia I-27100 Italy

or

DOPPEL FARMACEUTICI S.r.l.

Via Volturno, 48

20089 Quinto de’ Stampi – Rozzano, Italy

This prospectus was approved in February 2022

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