Noctamid 2.5 mg/ml oral solution in drops

Patient Information Leaflet

Introduction

Patient Information Leaflet

Noctamid 2.5 mg/ml oral drops solution

Lormetazepam

Package leaflet contents:

1. What Noctamid 2.5 mg/ml oral solution drops is and what it is used for.
2. What you need to know before taking Noctamid 2.5 mg/ml oral solution drops.
3. How to take Noctamid 2.5 mg/ml oral solution drops.
4. Possible side effects.
5. How to store Noctamid 2.5 mg/ml oral solution drops.
6. Contents of the pack and other information.

1. What Noctamid 2.5 mg/ml oral solution drops is and what it is used for

Noctamid is a medicine belonging to the group of hypnotics that promote sleep: it normalizes the time required to fall asleep and total sleep duration, 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 known as benzodiazepines. Benzodiazepines are only indicated for the treatment of severe disorders that significantly impair the patient's daily activities or subject them to considerable stress.

2. What you need to know before taking Noctamid 2.5 mg/ml, oral solution drops

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

• If you are allergic (hypersensitive) to lormetazepam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from myasthenia gravis (a disease characterized by abnormal muscle weakness).
• If you suffer from severe respiratory insufficiency.
• If you suffer from sleep apnea syndrome (interruption of breathing during sleep).
• In cases 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 reduced 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 extremities, sensory intolerance to light, sound, and physical contact, hyperacusis, and epileptic seizures may occur. Follow exactly the administration instructions for Noctamid provided by your doctor in order to minimize the possibility of these symptoms occurring.

Rebound insomnia and anxiety

• You may experience a rebound episode (transient recurrence of symptoms that led to initiating treatment). The likelihood of withdrawal/rebound phenomena is higher after abrupt discontinuation of treatment; therefore, it is recommended to gradually reduce the dose until definitive discontinuation.

Follow exactly the usage recommendations and administration instructions for Noctamid provided by your doctor in order 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, you should 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 a decline in mental functions). Your doctor will discontinue your treatment with Noctamid if these 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 should not be administered to patients under 18 years of age for the treatment of insomnia without careful medical assessment of the necessity. Additionally, 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).

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

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

The depressant effect of Noctamid may be enhanced when administered 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, an increased sensation of euphoria may also occur, potentially increasing psychological dependence.
• Medicines used to treat epilepsy (antiepileptics).
• Anesthetics.
• 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, substitution therapy medicines, and some cough medicines) increases the risk of sedation, 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 recommendations regarding dosage. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if you experience such symptoms.

If you are taking other medicines, consult your doctor.

Taking Noctamid 2.5 mg/ml, oral solution drops 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 beverages is not recommended. This should be particularly considered 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 might 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 delivery, 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 withdrawal syndrome in the postnatal period.

Breastfeeding

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 your attention and reaction capacity are reduced. Pay special attention at the beginning of treatment or when the dose is increased.

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

This medicine contains 8% ethanol at 96% (alcohol); this small amount corresponds to 32 mg of 96% ethanol in each 10-drop dose of solution.

3. How to take Noctamid 2.5 mg/ml, oral solution drops

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

Please note that 10 drops of Noctamid solution are equivalent to 1 mg of lormetazepam.

The drop formulation facilitates administration, as it allows for precise dose adjustment.

Short-term treatment of insomnia

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

Adults

The recommended dose is 10 drops of Noctamid drops (1 mg of lormetazepam) 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 (20 drops of Noctamid drops).

Elderly patients

The recommended dose is 5 drops of Noctamid drops (0.5 mg of lormetazepam) as a single dose.

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

The drops may be taken with a small amount of liquid before going to bed.

Children and adolescents

Noctamid must not be used in children and adolescents under 18 years of age without careful assessment of the necessity of 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

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

Adults

A recommended daily dose of 2 mg of lormetazepam (20 drops of Noctamid drops per day) is advised. The dose range is 0.5 to 3 mg, equivalent to 5–30 drops of Noctamid drops per day.

Children

A daily dose of 0.5 to 1 mg of lormetazepam (corresponding to 5–10 drops of Noctamid drops) is recommended.

Elderly patients and patients at risk

A daily dose of 1 mg (10 drops of Noctamid drops per day) is generally recommended. One hour before surgery, half of this dose is recommended.

Dose reduction should be considered in patients with mild or moderate respiratory difficulties or in those with hepatic impairment.

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

To open the bottle of Noctamid drops, press down and simultaneously unscrew the cap in the direction indicated in the illustration.

The Noctamid drops bottle is equipped with a child-resistant cap to prevent opening by children.

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

Overdose is not usually life-threatening unless combined with other central nervous system depressants (including alcohol). In cases of overdose, consider the possibility that the patient may have ingested multiple substances.

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 severe cases, ataxia (impaired coordination), visual disturbances, hypotonia (reduced muscle tone), hypotension (low blood pressure), respiratory depression, and rarely coma or, very rarely, death.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine and the amount ingested.

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

Do not take a double dose to make up for a missed dose.

If you stop taking Noctamid 2.5 mg/ml, oral solution drops

Your doctor will determine 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences 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 drowsiness, emotional disturbance, fainting, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (impaired coordination of movements), or double vision may occur. All of 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 completion or suicide attempt, 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 in 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 disorders.
• Asthenia (lack of energy), 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 sensory perceptions), dependence, depression (masking of a 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 further 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 upon discontinuation of 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 a pre-existing depression. In such patients, suicide may be triggered. Noctamid should be used with caution in patients with depression.

Nervous system disorders

• Amnesia: Noctamid may cause anterograde amnesia (difficulty in 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 they are adverse effects not listed in this leaflet. You may also report them directly via 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 2.5 mg/ml, oral solution drops

Keep out of the reach and sight of children.

Noctamid 2.5 mg/ml, oral solution drops should be stored in a cool, dry place.

Do not use Noctamid after the expiry date stated on the packaging 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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. 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 monogram “CF” inscribed within a hexagon on the other. 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 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

This leaflet was approved in February 2022

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