Package leaflet: Information for the patient

Noctofer, 0.5 mg, tablets
Noctofer, 1 mg, tablets
Lormetazepam
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are identical.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Noctofer is and what it is used for
Important information before taking Noctofer
How to take Noctofer
Possible side effects
How to store Noctofer
Contents of the package and other information

1. What Noctofer is and what it is used for

Noctofer contains lormetazepam as the active substance, which belongs to a group of medicines called benzodiazepines. Lormetazepam has a hypnotic effect.
Indications for use

Short-term and transient treatment of sleep disorders (difficulty falling asleep, frequent awakenings, early morning awakenings).
Preparation for surgical procedures or uncomfortable diagnostic examinations.

2. Important information before using Noctofer

When not to use Noctofer:

if the patient is allergic to lormetazepam or other benzodiazepines or any of the other ingredients of this medicine (listed in section 6);
if the patient has severe respiratory insufficiency regardless of cause;
if the patient has sleep apnoea syndrome (breathing disorders/pauses during sleep);
if the patient has disturbances of consciousness;
if the patient suffers from myasthenia gravis (a disease causing muscle weakness and excessive fatigue);
if the patient suffers from narrow-angle glaucoma (an eye disease);
if the patient suffers from acute porphyria (a rare metabolic disorder related to blood);
if the patient has alcohol or drug intoxication due to alcohol or central nervous system depressants.

Warnings and precautions
Before starting treatment with Noctofer, discuss this with your doctor or pharmacist.
General information regarding effects observed during treatment with benzodiazepines
and other drugs with similar action to benzodiazepines, which should be considered when using Noctofer.
➢ Tolerance
After several weeks of treatment with Noctofer, its effectiveness may decrease.
➢ Dependence
Prolonged use of Noctofer may lead to psychological and physical dependence. The risk of developing dependence increases with higher doses and longer duration of treatment, and is greater in patients with alcohol or drug dependence, as well as in patients with personality disorders.
➢ Withdrawal symptoms
If the medicine is stopped abruptly, withdrawal symptoms may occur, such as:
headache, muscle pain, increased anxiety, tension, agitation, restlessness, disorientation, sleep disturbances, irritability. In more severe cases, the following may occur: loss of reality perception, personality disturbances, hypersensitivity to sound, touch, light, noise, tingling sensations and numbness of limbs, hallucinations and delusions, epileptic seizures.
➢ Rebound phenomenon and anxiety
During discontinuation of Noctofer, a temporary recurrence of intensified symptoms that were the reason for using 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, gradual dose reduction is recommended.
➢ Anterograde amnesia (inability to remember events after taking the medicine)
Noctofer may cause anterograde amnesia (difficulty in learning and remembering new information – new data are not permanently stored). This condition most commonly occurs within a few hours after taking the medicine, especially at high doses. If your doctor has prescribed Noctofer once daily, to reduce the risk of amnesia, it is recommended to take the medicine half an hour before going to bed and ensure appropriate conditions for continuous, uninterrupted sleep lasting 7–8 hours.
➢ Psychological and paradoxical reactions
In children and elderly patients, the risk of abnormal psychological and paradoxical (opposite to expected) reactions increases, such as: anxiety, excitement, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychoses, behavioral disturbances.
If such symptoms occur, contact your doctor immediately.
Special patient groups
➢ Elderly patients should receive lower doses of Noctofer (see section 3), due to the possibility of increased adverse effects, mainly disturbances of orientation and motor coordination (falls, injuries).
➢ Patients with liver or kidney impairment or chronic respiratory insufficiency should inform their doctor about these conditions before taking Noctofer (see section 3).
➢ Use in depression
Before using Noctofer, inform your doctor about any mental illnesses. Patients with symptoms of depression or anxiety associated with depression should be treated with multiple medications. Administering Noctofer alone to patients with depression may worsen depressive symptoms, including suicidal thoughts.
➢ Patients dependent on alcohol, narcotics or drugs should inform their doctor about these addictions before taking Noctofer. These patients have a high risk of developing psychological and physical dependence. Therefore, this group of patients should use Noctofer only under strict medical supervision.
➢ Use of Noctofer in individuals grieving the loss of loved ones does not improve well-being.

Noctofer and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should also inform your doctor if you drink alcohol.
This is particularly important if you are taking any of the following medicines or drinking alcohol:

fluvoxamine, fluoxetine, and other medicines used to treat mental disorders;
medicines used for insomnia;
medicines used for allergic conditions that may cause drowsiness;
medicines used for epilepsy (e.g. carbamazepine, phenytoin, hydantoin);
rifampicin (a medicine used to treat tuberculosis);
ketoconazole (an antifungal medicine);
medicines used for general anaesthesia;
strong opioid analgesics (e.g. morphine, codeine);
muscle relaxants (e.g. baclofen);
alcohol: drinking alcohol while taking Noctofer may enhance its effects and lead to paradoxical reactions such as psychomotor agitation and aggressive behaviour (see section 2; Warnings and precautions).

Concomitant use of Noctofer and opioids (strong painkillers, medicines used in substitution therapy [addiction treatment], some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may even be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
If your doctor prescribes Noctofer together with opioids, the dose and duration of concomitant treatment should be limited.
Inform your doctor about all opioid medicines you are taking and strictly follow your doctor's instructions. It may be helpful to inform friends or family members so they are aware of the possibility of these symptoms occurring. If such symptoms occur, contact your doctor immediately.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Pregnancy
Noctofer should not be taken during pregnancy.
Breastfeeding
Noctofer passes into human milk. If treatment is necessary, breastfeeding should be discontinued.

Driving and operating machinery
During treatment with Noctofer, patients should not drive or operate machinery.
The ability to drive and operate machinery may be impaired due to possible drowsiness, concentration disturbances or other adverse effects reducing concentration (see section 4. Possible side effects).

Noctofer contains lactose monohydrate
Noctofer 0.5 mg contains 57 mg of lactose monohydrate.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Noctofer 1 mg contains 114 mg of lactose monohydrate.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

3. How to use Noctofer

This medicine should always be taken as directed by the physician.
If in doubt, consult your doctor.
The dosage and duration of treatment are determined individually for each patient by the physician.

Adults

Sleep disorders: the usual dose is 0.5 mg to 1 mg taken half an hour before bedtime. In individual cases where lower doses are ineffective, the physician may increase the dose up to a maximum of 2 mg per day.
Preparation for surgery or uncomfortable diagnostic procedures: usually 1 mg is administered before the surgical procedure or diagnostic examination, or 2 mg half an hour before bedtime on the day preceding the procedure or examination.

Patients with renal and/or hepatic impairment: the physician will decide whether a dose reduction is necessary.
Elderly patients (over 65 years of age): the physician will recommend reducing the dose by half.
Children and adolescents
The safety and efficacy of Noctofer have not been established in patients under 18 years of age.

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

Duration of treatment
The duration of treatment is determined by the physician.

Method of administration
Noctofer tablets should be swallowed with a small amount of water, 30 minutes before bedtime.
The physician will start treatment with the lowest effective dose and, if necessary, gradually increase it.

Overdose of Noctofer
Symptoms of overdose include disturbances in consciousness, drowsiness, confusion, and slurred speech.
In severe cases of poisoning, symptoms may include motor incoordination, hypotension, muscle weakness, respiratory depression, coma, and even death.
In case of overdose with Noctofer, seek immediate medical attention by contacting a physician or going to the nearest hospital emergency department. Bring the medicine in its original packaging so that the medical staff can clearly identify which medicine was taken.

Missed 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 scheduled dose, the missed dose should be skipped and the next dose taken as prescribed. If the patient forgets two or more doses, they should contact their physician.
Do not take a double dose to make up for a missed dose.

Discontinuation of Noctofer
Do not stop taking this medicine unless instructed by the physician. Symptoms of the condition may recur. If the physician decides to discontinue treatment, the dose should always be gradually reduced over several days.

If you have any further questions about the use of this medicine, consult your physician, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
If any of the following adverse symptoms occur, you should immediately
contact your doctor or go to the nearest hospital emergency department.
➢ Severe allergic reaction with itching, swelling of the lips or tongue, or wheezing
or shortness of breath. These symptoms have been reported very rarely (in fewer than 1 in 10,000 patients).
➢ Disorientation, excitement and agitation, depression with suicidal tendencies, restlessness,
irritability, hallucinations, nightmares, illusions (seeing or hearing things that do not exist),
psychoses (loss of contact with reality), unusual behaviour. These disorders occur
rarely (in fewer than 1 in 1,000 patients) – most often after alcohol consumption, in elderly
patients or in patients with psychiatric disorders.
Other adverse effects that may occur during treatment with Noctofer
The following adverse effects occur frequently (in fewer than 1 in 10 patients):

Drowsiness, dizziness, slowed reactions may occur during the first few days of treatment in elderly patients and usually resolve during continued treatment.

The following adverse effects occur rarely (in fewer than 1 in 1,000 patients):

Skin rashes, itching, urticaria
Loss of appetite
Psychological and physical dependence may develop during treatment at therapeutic doses. Abrupt discontinuation of treatment may lead to withdrawal syndrome. Patients who abuse alcohol or drugs are more susceptible to developing dependence. Treatment with Noctofer may unmask previously existing, undiagnosed depression.
Drowsiness, memory disturbances, motor coordination disorders, speech disturbances, changes in libido – these symptoms mainly affect patients taking high doses of the medicine.
Visual disturbances (blurred or double vision)
Nausea, stomach discomfort, dry mouth
Muscle tremor, muscle weakness
Urinary retention, urinary incontinence
Menstrual disorders
General weakness

The following adverse effects occur very rarely (in fewer than 1 in 10,000 patients):

Changes in the count of certain blood cells
Low blood pressure
Slight increase in liver enzyme activity, liver function disorders with jaundice (yellowing of the skin and whites of the eyes)
Fainting

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, more information on the safety of the medicine can be collected.

5. How to store Noctofer

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Noctofer contains
The active substance 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 contents of the pack
Noctofer, 0.5 mg: white, round, biconvex tablets in a cardboard box.
Pack: 1 blister containing 20 tablets
Noctofer, 1 mg: white, round, biconvex tablets in a cardboard box.
Pack: 2 blisters containing 10 tablets each
Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw
Telephone number: 22 811-18-14
For more detailed information about this medicinal product, please contact the representative of the Marketing Authorisation Holder.