Noctofer

Leaflet attached to the packaging: patient information

Noctofer, 0.5 mg, tablets

Noctofer, 1 mg, tablets

Lormetazepam

Table of contents of the leaflet

• 1. What is Noctofer and what is it used for
• 2. Important information before taking Noctofer
• 3. How to take Noctofer

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

• 4. Possible side effects
• 5. How to store Noctofer
• 6. Contents of the packaging and other information

1. What is Noctofer and what is it used for

Noctofer contains the active substance lormetazepam, which belongs to a group of medicines called benzodiazepines. Lormetazepam has a sedative effect.

Indications for use

• Short-term treatment of sleep disorders (difficulty falling asleep, frequent awakenings, early morning awakenings).
• Preparation for surgical procedures or stressful diagnostic tests.

2. Important information before taking Noctofer

When not to take Noctofer:

Warnings and precautions

Before starting treatment with Noctofer, you should discuss it with your doctor or pharmacist.

General information about the effects observed after treatment with benzodiazepines and other medicines with similar effects to benzodiazepines, which should be taken into account when taking Noctofer.

• Tolerance

After taking Noctofer for several weeks, its effectiveness may decrease.

• Dependence

Taking Noctofer for a longer period may lead to psychological and physical dependence. The risk of developing dependence increases with the increase in dose and treatment time and is higher in patients addicted to alcohol or drugs, as well as in patients with personality disorders.

• Withdrawal symptoms

In case of sudden withdrawal of the medicine, the patient may experience withdrawal symptoms, such as headaches, muscle pain, increased anxiety, tension, excitement, restlessness, disorientation, sleep disturbances, irritability. In more severe cases, the following may occur: loss of sense of reality, personality disorders, hypersensitivity to sound, touch, light, noise, feeling of tingling and numbness of limbs, hallucinations, and delusions, epileptic seizures.

• Rebound phenomenon and anxiety

When stopping Noctofer, a transient recurrence of intensified symptoms that were the reason for taking the medicine may occur (so-called rebound phenomenon). These symptoms are often accompanied by mood changes, anxiety, sleep disturbances, and insomnia. To minimize the risk of these symptoms, it is recommended to gradually reduce the dose of the medicine.

• Anterograde amnesia (inability to remember events after taking the medicine)

Noctofer may cause anterograde amnesia (difficulty learning and remembering new information - new data is not permanently stored). This condition usually occurs within a few hours of taking the medicine, especially in high doses. If the doctor has prescribed Noctofer to be taken once a day, to reduce the risk of anterograde amnesia, it is recommended to take the medicine half an hour before going to bed and ensure adequate conditions for continuous, uninterrupted sleep lasting 7-8 hours.

• Psychiatric and paradoxical reactions

In children and the elderly, the risk of abnormal psychiatric and paradoxical reactions (opposite to expected) increases, such as anxiety, excitement, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychoses, behavioral disorders.

In case of such symptoms, you should immediately contact your doctor.

Special patient groups

• Elderly patients should receive lower doses of Noctofer (see section 3), due to the possibility of increased side effects, mainly orientation and coordination disorders (falls, injuries).

• Patients with liver or kidney failure or chronic respiratory failure should inform their doctor about these conditions before taking Noctofer (see section 3).

• Use in depression Before taking Noctofer, you should inform your doctor about any mental illnesses. Patients with symptoms of depression or anxiety related to depression should take several medicines at the same time. Administering Noctofer to patients with depression alone may exacerbate symptoms of depression, including suicidal thoughts.

• Patients addicted to alcohol, drugs, or medicines should inform their doctor about these addictions before taking Noctofer. These patients are at high risk of developing psychological and physical dependence. Therefore, this group of patients should take Noctofer only under strict medical supervision.

• Taking Noctofer in people who are grieving after the loss of loved ones does not improve their well-being.

Noctofer and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as medicines you plan to take.

You should also inform your doctor if you drink alcohol.

This is especially important if you are taking any of the following medicines or drinking alcohol:

• Fluvoxamine, fluoxetine, and other medicines used to treat mental illnesses;
• Medicines used to treat insomnia;
• Medicines used to treat allergic diseases that may cause drowsiness;
• Medicines used to treat epilepsy (e.g., carbamazepine, phenytoin, hydantoin);
• Rifampicin (a medicine used to treat tuberculosis);
• Ketoconazole (an antifungal medicine);
• Medicines used for general anesthesia;
• Strong painkillers (e.g., morphine, codeine);
• Muscle relaxants (e.g., baclofen);
• Alcohol: drinking alcohol while taking Noctofer may enhance its effect and lead to paradoxical reactions, such as psychomotor excitement, aggressive behavior (see section 2; Warnings and precautions).

Concomitant use of Noctofer and opioids (strong painkillers, substitution therapy, some cough medicines) increases the risk of somnolence, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.

If the doctor prescribes Noctofer concomitantly with opioids, they should also limit the dose and duration of concomitant treatment.

You should inform your doctor about all opioid medicines you are taking and strictly follow the doctor's instructions. It may be helpful to inform friends or relatives to be aware of the possibility of these symptoms. In case of such symptoms, you should contact your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.

Pregnancy

Noctofer should not be taken during pregnancy.

Breastfeeding

Noctofer passes into breast milk. If there is a need to administer the medicine, breastfeeding should be discontinued.

Driving and using machines

During treatment with Noctofer, you should not drive vehicles or operate machines.

The ability to drive vehicles and operate machines may be impaired due to the possibility of somnolence, impaired concentration, or other side effects that reduce concentration (see section 4. Possible side effects).

Noctofer contains lactose monohydrate

Noctofer, 0.5 mg contains 57 mg of lactose monohydrate.

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Noctofer, 1 mg contains 114 mg of lactose monohydrate.

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Noctofer contains sodium

Noctofer, 0.5 mg contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Noctofer, 1 mg contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Noctofer

This medicine should always be taken according to the doctor's instructions.

In case of doubts, you should consult a doctor.

The dosage and treatment duration are determined by the doctor individually for each patient.

Adults

• Sleep disorders:usually 0.5 mg to 1 mg is administered half an hour before bedtime. In individual cases, when lower doses are not effective, the doctor may increase the dose to a maximum of 2 mg per day.
• Preparation for surgery or stressful diagnostic tests:usually 1 mg is administered before the surgical procedure or diagnostic test, or 2 mg half an hour before bedtime on the day before the procedure or test.

Patient with renal and/or hepatic impairment: the doctor will decide on the possible need to reduce the dose.

Elderly patients (over 65 years): the doctor will recommend reducing the dose by half.

Children and adolescents

The safety and efficacy of Noctofer in patients under 18 years of age have not been established.

If, during treatment, the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Treatment duration

The treatment duration is determined by the doctor.

Method of administration

Noctofer tablets should be swallowed with a small amount of water, 30 minutes before bedtime.

The doctor will start treatment with the lowest effective dose and, if necessary, will gradually increase it.

Taking a higher dose of Noctofer than recommended

Symptoms of overdose are impaired consciousness, somnolence, confusion, slurred speech.

In severe cases of poisoning, the following may occur: ataxia, hypotension, muscle weakness, respiratory disorders, coma, and even death.

In case of taking a higher dose of Noctofer than recommended, you should immediately contact your doctor or go to the nearest emergency department in a hospital. You should take the medicine in its original packaging, so that the medical staff can accurately check which medicine was taken.

Missing a dose of Noctofer

If the patient forgets to take a dose, they should take the next dose as soon as they remember. However, if it is almost time for the next dose, they should skip the missed dose and take the next one according to the instructions. If the patient forgets to take two or more doses, they should contact their doctor.

You should not take a double dose to make up for a missed dose.

Stopping treatment with Noctofer

You should not stop taking Noctofer unless it is in accordance with the doctor's instructions. It is possible that the symptoms of the disease will recur. If the doctor decides to stop treatment, the dose of the medicine should always be gradually reduced over several days.

In case of any further doubts related to the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Noctofer can cause side effects, although not everybody gets them.

Severe side effects

If any of the following side effects occur, you should immediately inform your doctor or go to the nearest emergency department in a hospital.

• Severe allergic reaction in the form of itching, swelling of the lips or tongue, or wheezing, or shortness of breath. These symptoms have been reported very rarely (less than 1 in 10,000 patients).

• Disorientation, excitement, and agitation, depression with suicidal tendencies, anxiety, irritability, delusions, nightmares, hallucinations, psychoses (loss of contact with reality), abnormal behavior. These disorders occur rarely (less than 1 in 1,000 patients) - most often after consuming alcohol, in the elderly, or in patients with mental illnesses.

Other side effects that may occur after treatment with Noctofer

The following side effects occur frequently (less than 1 in 10 patients)

• Feeling of somnolence, dizziness, slowed reactions may occur during the first few days of treatment in elderly patients and usually disappear during further treatment.

The following side effects occur rarely (less than 1 in 1,000 patients)

• Rashes, itching, urticaria
• Lack of appetite
• Psychological and physical dependence may develop during treatment with therapeutic doses. Sudden withdrawal of treatment may cause withdrawal syndrome. Patients who abuse alcohol or drugs are more prone to developing dependence. During treatment with Noctofer, previously undiagnosed depression may be revealed.
• Somnolence, memory disorders, coordination disorders, speech disorders, changes in libido - these symptoms mainly concern patients taking high doses of the medicine.
• Visual disturbances (blurred or double vision)
• Nausea, stomach problems, dry mouth
• Muscle tremors, muscle weakness
• Urinary retention, incontinence
• Menstrual disorders
• General weakness

The following side effects occur very rarely (less than 1 in 10,000 patients)

• Changes in the number of some blood cells
• Decreased blood pressure
• Slightly elevated activity of liver enzymes, liver function disorders with the occurrence of jaundice (yellowing of the skin, whites of the eyes)
• Fainting

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Noctofer

The medicine should be stored in a place that is invisible and inaccessible to children.

Store in a temperature below 25°C.

Store in the original packaging to protect from light and moisture.

Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Noctofer contains

The active substance of the medicine is lormetazepam.

Noctofer, 0.5 mg: one tablet contains 0.5 mg of lormetazepam.

Other ingredients are: potato starch, sodium carboxymethyl starch (type A), gelatin, talc, magnesium stearate, lactose monohydrate.

Noctofer, 1 mg: one tablet contains 1 mg of lormetazepam.

Other ingredients are: potato starch, sodium carboxymethyl starch (type A), gelatin, talc, magnesium stearate, lactose monohydrate.

What Noctofer looks like and what the packaging contains

Noctofer, 0.5 mg: white, round, flat tablets in a cardboard box.

Packaging:1 blister pack of 20 tablets

Noctofer, 1 mg: white, round, flat tablets in a cardboard box.

Packaging:2 blister packs of 10 tablets

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna

ul. A. Fleminga 2

03-176 Warsaw

Phone number: 22 811-18-14

To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder.

Date of the last update of the leaflet: