Noctamid 2 mg tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Noctamid 2 mg tablets

Lormetazepam

Package leaflet:

1. What Noctamid 2 mg tablets are and what they are used for
2. What you need to know before taking Noctamid 2 mg tablets
3. How to take Noctamid 2 mg tablets
4. Possible side effects
5. How to store Noctamid 2 mg tablets
6. Contents of the pack and other information

1. What Noctamid 2 mg tablets are and what they are used for

Noctamid is a medicine belonging to the group of hypnotics that promote sleep: it normalizes the time required to fall asleep and the total duration of sleep, while reducing the number of sleep interruptions. It is indicated for:

• Short-term treatment of insomnia.
• Sleep induction in pre- and postoperative periods.

Noctamid belongs to a group of hypnotic medicines called benzodiazepines. Benzodiazepines are only indicated for the treatment of severe disorders that significantly impair the patient's activities or subject the patient to considerable stress.

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

Do not take Noctamid 2 mg tablets:

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

Warnings and precautions:

• If you have chronic respiratory insufficiency, as you should receive a lower than usual dose.
• If you have hepatic insufficiency.
• If you have severe renal insufficiency.
• Noctamid should not be used as first-line treatment for psychotic illness, nor as sole treatment for anxiety or sleep disorders associated with depression.
• Noctamid should be administered with caution in 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 regarding hypnotic effects may be observed.

Dependence

• Noctamid may lead to physical and psychological dependence. The risk of dependence increases with dose and duration of treatment, and is also higher in patients with a history of drug or alcohol abuse. Abrupt discontinuation of treatment may be accompanied by withdrawal symptoms such as marked anxiety, tension, restlessness, confusion, irritability, headache, and muscle pain. In more severe cases, derealization, depersonalization, hallucinations, paresthesia in the limbs, sensory intolerance to light, sounds, and physical contact, hyperacusis, and epileptic seizures may occur. Follow exactly the administration instructions for Noctamid given by your doctor to minimize the possibility of these symptoms occurring.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient recurrence of the symptoms that led to starting treatment). The likelihood of withdrawal/rebound phenomena is higher after abrupt discontinuation of treatment; therefore, gradual dose reduction is recommended until complete cessation.

Follow exactly the usage recommendations and administration instructions for Noctamid given by your doctor to minimize the possibility of these symptoms occurring.

Amnesia

• Noctamid may cause anterograde amnesia, i.e., difficulty in remembering recent events; this occurs more frequently within the first few hours after taking the medicine. To reduce this risk, ensure you will be able to sleep uninterrupted for 7–8 hours (see section 4).

Psychiatric and paradoxical reactions

• Noctamid may cause restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, abnormal and inappropriate behavior, and other adverse behavioral effects. These reactions occur more frequently in children, elderly patients, and patients with organic brain syndrome (physical disorders causing reduced mental function). Your doctor will discontinue Noctamid treatment if such reactions occur.
• Inform your doctor if you suffer from depression. Noctamid should not be used as the sole treatment for sleep disturbances associated with depression.
  • Noctamid should not be used as first-line treatment for psychotic illness (see section 4).

Children and adolescents

Noctamid must not be administered to patients under 18 years of age for the treatment of insomnia without careful medical assessment of the necessity. In addition, treatment duration should be as short as possible (see section 3).

Use in elderly patients

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

Taking Noctamid 2 mg tablets with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

The effect of Noctamid may be enhanced when taken concomitantly with the following medicines:

• Medicines used to treat psychiatric disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).
• Medicines used to relieve severe pain (narcotic analgesics). With these medicines, increased feelings of euphoria may also occur, potentially increasing psychological dependence.
• Medicines used to treat epilepsy (antiepileptics).
• Anaesthetics.
• Medicines used to treat allergic symptoms (sedating antihistamines).
• Medicines used to treat cardiovascular diseases (calcium antagonists, cardiac glycosides).
• Medicines used to treat hypertension (beta-blockers).
• Oral contraceptives.
• Certain antibiotics (such as rifampicin).

Interactions have also been reported with some medicines used to treat high blood pressure (beta-blockers) and with central nervous system stimulants (methylxanthines).

Concomitant use of lormetazepam and opioids (strong analgesics, 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 available.

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

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

If you are taking other medicines, consult your doctor.

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

During treatment with Noctamid, avoid alcoholic beverages.

Benzodiazepines should be used with extreme caution in patients with a history of drug or alcohol abuse. The sedative effect may be enhanced when this medicine is taken together with alcohol; therefore, consumption of alcoholic drinks is not recommended. This should be particularly noted as it affects the ability to drive or operate machinery (see section “Driving and use of 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, due to strict medical necessity, the medicine is administered during the third trimester of pregnancy or during childbirth, effects on the newborn such as hypothermia, hypotonia, moderate respiratory depression, and feeding difficulties may be expected.

Infants born to mothers who chronically take benzodiazepines during the last trimester of pregnancy may develop physical dependence, potentially leading to a postnatal withdrawal syndrome.

Lactation

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

Driving and use of machines

Noctamid is a medicine that causes drowsiness and therefore 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 ability are reduced. Pay particular attention at the beginning of treatment or when the dose is increased.

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

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Noctamid 2 mg tablets

Follow exactly the instructions for use of Noctamid given by your doctor. If you have any doubts, consult your doctor or pharmacist. Remember to take your medicine.

Short-term treatment of insomnia

The duration of treatment should be as short as possible. In general, it ranges from a few days to two weeks, with a maximum period, including gradual dose reduction, of four weeks.

The tablets should be taken with some liquid shortly before going to bed.

Adults

The recommended dose is 1 mg of lormetazepam (½ tablet of Noctamid 2 mg or 1 tablet of the alternative presentation Noctamid 1 mg) as a single dose.

In cases of severe or persistent insomnia and always according to strict medical judgment, 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

A single dose of 0.5 mg of lormetazepam is recommended. Other lormetazepam presentations are available that allow adjustment to this dose.

In elderly individuals, benzodiazepines may be associated with a higher risk of falls due to possible muscle weakness, dizziness, drowsiness, and fatigue. Therefore, your doctor will determine the dose best suited to your condition.

Children and adolescents

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

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

Induction of sleep in pre- and postoperative periods

Doses will depend on the patient's age, weight, and general condition.

Adults

A daily average dose of 2 mg of lormetazepam is recommended. The dose range is 0.5 to 3 mg of lormetazepam per day.

Children

A daily dose of 0.5 mg to 1 mg of lormetazepam is recommended.

Elderly patients and patients at risk

A daily dose of 1 mg of lormetazepam is generally recommended. One hour before surgery, half of this dose is recommended.

Dose reduction should be considered in patients with mild or moderate breathing difficulties or in patients with hepatic insufficiency.

If you take more Noctamid 2 mg tablets than you should

Overdose does not represent a life-threatening risk unless the drug is taken together with other central nervous system depressants (including alcohol). In case of overdose, consider the possibility that the patient may have ingested multiple products.

Overdose with benzodiazepines generally manifests as varying 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 (impaired coordination of movement), visual disturbances, hypotonia (reduced muscle tone), hypotension (low blood pressure), respiratory depression, rarely coma, and very rarely death.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 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 a missed dose.

If you stop taking Noctamid 2 mg tablets

Your doctor will advise you on the duration of treatment with Noctamid. Do not discontinue treatment prematurely, 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 produce adverse effects, although not everyone will experience them.

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

At the beginning of treatment, daytime somnolence, emotional disturbance, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (impaired coordination of movements), or double vision may occur. All these effects occur predominantly at the start of treatment and usually disappear with repeated administration.

The most serious adverse reactions observed in patients treated with Noctamid are angioedema (swelling), suicide 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 may cause difficulty swallowing or breathing).
  • Anxiety, decreased libido (sexual desire).
  • Dizziness, sedation, somnolence (drowsiness), attention disturbance, amnesia, visual disturbance, speech disorder, dysgeusia, mental slowing.
  • Tachycardia (increased heart rate).
  • Vomiting, nausea, upper abdominal pain, constipation, dry mouth.
  • Pruritus (itching).
• Urinary disorder.
  • Asthenia (lack of energy), excessive sweating.

Adverse effects with unknown frequency

(cannot be estimated from available data)

• Suicide attempt or completed suicide (masking of pre-existing depression), acute psychosis (a type of mental disorder), hallucinations (false sensory perceptions), dependence, depression (masking of pre-existing depression), delirium (false beliefs held as true and impossible to disprove), withdrawal syndrome (rebound insomnia), agitation, aggressiveness, irritability, restlessness, rage attacks, nightmares, inappropriate behavior, emotional disturbances.
• Confusion, decreased level of consciousness, ataxia (impaired coordination of movements), muscle weakness.
• Urticaria, exanthema (rash).
• Fatigue.
• Falls.

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

Dependence:

Administration of Noctamid and other benzodiazepines may lead to the development of physical and psychological dependence (see section “Warnings and precautions”).

Psychiatric disorders:

Rebound insomnia may occur when discontinuing the medicine (see section “Warnings and precautions”).

• Psychiatric and paradoxical reactions: When using Noctamid, reactions such as restlessness, agitation, irritability, aggressiveness, delirium (false beliefs held as true and impossible to disprove), rage attacks, nightmares, hallucinations (false sensory perceptions), psychosis (a type of mental disorder), inappropriate abnormal behavior, and other behavioral disturbances may occur.

• Depression: The use of benzodiazepines may mask pre-existing depression. In such 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 section “Warnings and precautions”).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 any special storage conditions.

Do not use Noctamid after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and any medicines you no longer need at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you do not need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Noctamid 1 mg tablets

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

Appearance of the product and contents of the pack

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

Other pack sizes:

Noctamid 2 mg tablets, 20 tablets.

Noctamid 2.5 mg/ml oral solution drops, 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 patient information leaflet was last approved in February 2022

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