Noctis Noc

Before starting to use this medicine, read the leaflet carefully and familiarize yourself with it

with the "Patient Information" attached to the packaging of the medicine. To use the medicine safely,
you must answer all the questions contained in the information. The medicine is intended only for adult patients.

Leaflet attached to the packaging: information for the user

Noctis Noc, 12.5 mg, coated tablets

Doxylamine hydrogen succinate

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

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• 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.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Noctis Noc and what is it used for
• 2. Important information before using Noctis Noc
• 3. How to use Noctis Noc
• 4. Possible side effects
• 5. How to store Noctis Noc
• 6. Contents of the pack and other information

1. What is Noctis Noc and what is it used for

The active substance in Noctis Noc is doxylamine, which belongs to the group of antihistamine medicines. This medicine has a sedative effect, which means it is effective as a sleep aid.

Noctis Noc is indicated for short-term, symptomatic treatment of occasional insomnia in adults, especially when there are difficulties falling asleep, frequent nocturnal awakenings, or early morning awakenings.

Sleep disorders can have a significantly negative impact on a person's functioning during the day, which manifests as mental slowing, decreased concentration, memory problems, and decreased motivation. We talk about insomnia, among other things, when: the time to fall asleep exceeds half an hour, the total time awake during the night lasts longer than half an hour, such disruption occurs at least three nights a week, and poor sleep quality causes fatigue or decreased psychophysical performance during the day.

Transient sleep disturbances usually last a few days and are a physiological reaction that occurs, for example, in situations of stress, time zone changes, certain transient somatic diseases, shift work, mental tension, or noise.

The use of medicines is not the primary method of treating sleep disorders and should be limited to short-term use only. Prolonged poor sleep quality may be a symptom of psychological and physical disorders that require other treatment methods, which should be assessed by a doctor.

Consulting a doctor is also necessary in case of symptoms other than insomnia.

The medicine should not be used to treat chronic sleep disorders. The treatment period should be as short as possible. Treatment usually lasts from a few days to 1 week. The medicine should not be used for more than 7 days without consulting a doctor. If after 7 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before using Noctis Noc

When not to use Noctis Noc

• if the patient is allergic to doxylamine hydrogen succinate or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other antihistamine medicines (anti-allergic);
• if the patient has a respiratory disease, such as asthma, bronchitis (persistent cough that produces thick mucus) or pulmonary emphysema (inflammation of the air sacs in the lungs that causes breathing difficulties);
• if the patient has glaucoma (increased pressure in the eye);
• if the patient has prostate enlargement (abnormal enlargement of the prostate), urethral stricture (urinary tract disease) or difficulty urinating;
• if the patient has a peptic ulcer (damage to the lining of the stomach or the beginning of the small intestine) or pyloric stenosis (difficulty moving food from the stomach to the small intestine);
• if the patient has severe kidney or liver disease;
• if the patient is taking certain medicines, such as antidepressants (fluoxetine, fluvoxamine, paroxetine), antibiotics (clarithromycin, erythromycin, telithromycin), antiviral medicines (indinavir, ritonavir, telaprevir), antifungal medicines (fluconazole, ketoconazole, itraconazole, voriconazole), and certain medicines that lower lipid levels in the blood (gemfibrozil) (see section "Noctis Noc and other medicines"); if the patient is taking monoamine oxidase inhibitors (medicines used to treat depression and Parkinson's disease) and for 2 weeks after stopping their use;
• during pregnancy and breastfeeding.

Warnings and precautions

Before starting to use Noctis Noc, you should discuss it with your doctor or pharmacist:

• if the patient experiences daytime sleepiness - it is recommended to reduce the dose or ensure at least an 8-hour interval between taking the medicine and the planned wake-up time (see section 3. How to use Noctis Noc);
• you should not drink alcohol while using Noctis Noc - see below "Noctis Noc with food, drink, and alcohol";
• in hot weather, this medicine may increase the risk of dehydration and heat stroke;
• if the patient has epilepsy (antihistamine medicines can sometimes cause overexcitement and thus lower the seizure threshold);
• if the patient is over 65 years old, as they may be more prone to side effects;
• if the patient is taking other medicines that are toxic to the ear, such as carboplatin or cisplatin (used to treat cancer), chloroquine (to treat or prevent malaria) and certain antibiotics (used to treat infections) like erythromycin or aminoglycosides in injection form. Noctis Noc may mask the toxic effects of these medicines, so it is necessary to periodically check the condition of the ears.
• if the patient has liver or kidney disease - it may be necessary to adjust the dose (see section 3. How to use Noctis Noc);
• if the patient has heart failure, high blood pressure, or has been diagnosed with a pheochromocytoma (a rare type of tumor that causes high blood pressure);
• if the patient has a sudden increase in heart rate in response to physical exertion or stress (so-called long QT syndrome);
• if the patient has low potassium levels in the blood or other electrolyte disturbances;
• if the patient has had vision disturbances or seizures, as even small doses of Noctis Noc can cause seizures;
• while taking doxylamine, you should avoid consuming grapefruits and grapefruit juice;
• if the patient is taking medicines such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin, they should avoid taking doxylamine, as it may cause acute poisoning.

You should always take the medicine according to the information provided in the patient leaflet or as directed by your doctor or pharmacist. Improper use of the medicine, including taking it for too long or exceeding the recommended doses, may cause side effects. The patient should observe their reaction to the medicine, including possible side effects (see section 4) or symptoms of overdose (see section 3 "Using a higher dose of Noctis Noc than recommended").

In case of daytime sleepiness, it is recommended to reduce the dose or take the dose earlier to ensure at least an 8-hour interval between taking the medicine and waking up.

Effect on diagnostic tests

Noctis Noc may change the results of skin allergy tests. If the patient is referred for such tests, they should stop using Noctis Noc 3 days before the tests and inform their doctor.

Children and adolescents

Noctis Noc is not recommended for use in children and adolescents under 18 years of age and should not be used in this patient group.

Noctis Noc and other medicines

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

You should not use Noctis Noc while taking the following medicines:

• monoamine oxidase inhibitors (e.g., medicines used to treat depression, Parkinson's disease, or other conditions, such as moclobemide, phenelzine, and tranylcypromine, isocarboxazid, linezolid, methylene blue, procarbazine, rasagiline, and selegiline);
• medicines such as certain antidepressants (e.g., fluoxetine, fluvoxamine, paroxetine, bupropion, nefazodone), certain macrolide antibiotics (clarithromycin, erythromycin, telithromycin), medicines used to treat heart rhythm disorders (amiodarone, quinidine), protease inhibitors (indinavir, ritonavir, telaprevir), azole antifungals (fluconazole, ketoconazole, itraconazole, voriconazole), and certain other antifungal medicines (terbinafine) and certain medicines that lower lipid levels in the blood (gemfibrozil).

Patients should avoid using Noctis Noc while taking the following medicines, as it may increase their effect or cause side effects:

• adrenaline (used to treat low blood pressure);
• certain medicines used to treat malaria or certain antihistamine medicines;
• certain diuretic medicines (medicines that increase urine production);
• alcohol and other medicines that have a sedative effect on the central nervous system, such as barbiturates, sleeping pills, tranquilizers, other medicines used to treat insomnia or anxiety disorders (alprazolam, diazepam, zolpidem), antiepileptic medicines (e.g., carbamazepine), muscle relaxants, opioid painkillers (codeine), psychotropic medicines (chlorpromazine, risperidone, amitriptyline, trazodone), or procarbazine;
• antihypertensive medicines that act on the central nervous system, such as guanabenz, clonidine, or methyldopa;
• medicines with known ototoxic effects, such as certain antibiotics (aminoglycosides given parenterally, chloroquine, erythromycin) or cancer medicines (carboplatin, cisplatin), as doxylamine may mask this effect;
• other cholinolytic medicines, such as antipsychotic medicines (used to treat mental disorders), tricyclic antidepressants (used to treat depression, e.g., amitriptyline), medicines used to treat Parkinson's disease (e.g., benzatropine or trihexyphenidyl);
• antihistamine medicines used on the skin (diphenhydramine in cream, ointment, or spray), scopolamine, antispasmodic medicines (e.g., atropine, belladonna alkaloids), or disopyramide (used to treat certain heart conditions);
• medicines for which there are small differences between the therapeutic dose and the toxic dose (e.g., phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin).

Noctis Noc with food, drink, and alcohol

There are no special recommendations for taking this medicine before or after a meal.

It is not recommended to drink grapefruit juice while using Noctis Noc.

You should not drink alcohol while using Noctis Noc.

Pregnancy, breastfeeding, and fertility

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

There is insufficient data on the use of doxylamine in pregnant women, so the use of Noctis Noc in pregnant women is contraindicated.

Due to the risk associated with the use of antihistamine medicines in small children, Noctis Noc should not be used in breastfeeding women.

There is no available data on the effect of Noctis Noc on fertility.

Driving and using machines

Noctis Noc may cause sleepiness the next day after its use, which may affect the ability to drive vehicles and operate machinery. Therefore, you should not drive vehicles or operate machinery during the use of this medicine.

Noctis Noc contains lactose

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

Noctis Noc contains Allura Red (E129)

The medicine may cause allergic reactions.

Noctis Noc contains sodium

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

3. How to use Noctis Noc

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.

Adults (over 18 years of age)

The recommended dose is 12.5 mg (1 tablet) taken 30 minutes before bedtime.

The dose may be increased to a maximum of 25 mg (2 tablets) taken 30 minutes before bedtime if the initial dose does not provide sufficient relief from insomnia symptoms.

The maximum daily dose is 25 mg (2 tablets).

Before taking Noctis Noc, you should ensure that there is enough time for sleep (8 hours) to avoid daytime sleepiness the next morning.

In case of daytime sleepiness, it is recommended to reduce the dose to 12.5 mg (1 tablet) or ensure at least an 8-hour interval between taking the medicine and the planned wake-up time.

You should not take more than 2 tablets (25 mg) per day.

Patients with persistent sleep problems should consult their doctor.

Elderly patients (over 65 years of age)

In adult patients over 65 years of age, it is more likely that other diseases will occur that may require dose reduction. The recommended initial dose is 12.5 mg (1 tablet), given 30 minutes before bedtime. The dose can be increased to 25 mg (2 tablets) if the initial dose is ineffective. In case of side effects, the dose should be reduced to 12.5 mg (1 tablet) per day. Therefore, you should pay attention to the effects of treatment (see section 4).

In case of side effects, you should consult your doctor.

Patients with kidney or liver impairment

Noctis Noc is contraindicated in patients with severe kidney or liver disease.

Noctis Noc should not be used in patients with moderate kidney or liver disease.

In patients with mild kidney or liver disease, the maximum daily dose should be reduced to 12.5 mg (1 tablet).

Use in children and adolescents

Noctis Noc is not indicated for use in children and adolescents under 18 years of age and should not be used in this patient group.

Route and method of administration

Oral use.

Tablets should be taken 30 minutes before bedtime, with a sufficient amount of liquid (preferably water).

Noctis Noc can be taken with or without food.

Duration of treatment

Treatment should be as short as possible. Treatment usually lasts from a few days to one week.

The medicine should not be used for more than 7 days without consulting a doctor.

Using a higher dose of Noctis Noc than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately contact your doctor.

The doctor will decide whether and what measures should be taken.

Symptoms of overdose are: sleepiness, inhibition or stimulation of the central nervous system, anticholinergic effects (dilated pupils, fever, dry mouth, decreased smooth muscle tone in the intestines), increased or changed heart rate, increased blood pressure, nausea, vomiting, stimulation, disorientation, and hallucinations.

Severe poisonings can cause delirium, psychotic disorders, decreased blood pressure, seizures, decreased respiratory rate, loss of consciousness, coma, and can be life-threatening. A serious complication is rhabdomyolysis (muscle breakdown), followed by kidney failure.

There is no specific antidote in case of overdose of antihistamine medicines. If necessary, symptomatic and supportive treatment should be used. The doctor will decide whether to induce vomiting, perform gastric lavage, or prescribe medicines to increase blood pressure.

Missing a dose of Noctis Noc

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

You should take the next dose the next day at the usual time.

Stopping the use of Noctis Noc

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

4. Possible side effects

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

Side effects caused by doxylamine are usually mild and transient and occur more frequently during the first few days of treatment.

Noctis Noc may cause a significant decrease in the number of white blood cells in the blood and reduce resistance to infections.

If the patient develops an infection with symptoms of fever and severe deterioration of general condition or fever with local symptoms of infection, such as sore throat or urinary tract pain, they should immediately contact their doctor. A blood test will be performed to check for a possible decrease in the number of white blood cells (agranulocytosis). It is essential to inform the doctor about the use of Noctis Noc.

Side effects are ranked according to their frequency of occurrence:

Very common(more than 1 in 10 people):

• sleepiness

Common(between 1 in 10 and 1 in 100 people):

• dry mouth, constipation, upper abdominal pain
• blurred vision
• dizziness, headache
• fatigue, insomnia, stimulation
• difficulty urinating (urinary retention)
• increased mucus production in the bronchi

Uncommon(between 1 in 100 and 1 in 1,000 people):

• weakness, peripheral edema
• nausea, vomiting, diarrhea, indigestion
• rash
• feeling of relaxation
• nightmares
• shortness of breath
• double vision
• sudden drop in blood pressure, especially when changing position from lying down to standing (orthostatic hypotension)
• ringing in the ears

Rare(between 1 in 1,000 and 1 in 10,000 people):

• tremors, seizures
• paradoxical excitement (especially in children and the elderly)
• decrease in the number of red blood cells, white blood cells, or platelets

Frequency not known(frequency cannot be estimated from the available data):

• -general malaise

Other side effects usually caused by the use of antihistamine medicines, which do not have a specific relationship to doxylamine, include: heart rhythm disorders (changes in heart rate), palpitations, bile reflux, liver function disorders (cholestatic jaundice), prolonged QT interval in the ECG (heart disease), loss of appetite, increased appetite, muscle pain, coordination disorders, extrapyramidal disorders (movement disorders), depression, decreased mucus production in the bronchi, hair loss, allergic skin inflammation, excessive sweating, hypersensitivity to light or hypotension (low blood pressure).

The intensity and frequency of side effects can be controlled by reducing the daily dose.

Adults over 65 years of age are more prone to side effects, as they may have other diseases or be taking other medicines. These people are also more prone to falls.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

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

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

5. How to store Noctis Noc

The medicine should be stored out of sight and reach of children.

Store in a temperature below 30°C.

Do not use this medicine after the expiry date stated on the carton and blister.

The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. 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 pack and other information

What Noctis Noc contains

• The active substance of the medicine is doxylamine hydrogen succinate. One coated tablet contains 12.5 mg of doxylamine hydrogen succinate.
• The other ingredients of the medicine are: Excipients: hydroxypropyl cellulose, lactose monohydrate, crospovidone (type A), microcrystalline cellulose (type 102), colloidal anhydrous silica, talc, sodium stearyl fumarate.
• Tablet coating: hypromellose 6 mPa·s, titanium dioxide (E171), macrogol 3350, polydextrose, talc, Allura Red (E129), erythrosine (E127).

What Noctis Noc looks like and contents of the pack

The tablets are round, coated, pink, and biconvex.

PVC/PVDC/Aluminum blister in a cardboard box.

Package sizes:

7, 10, 14, 20 coated tablets.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.

ul. Wałbrzyska 13

60-198 Poznań

tel.: +48 61 66 51 500

fax: +48 61 66 51 505

e-mail: biofarm@biofarm.pl

Date of last revision of the leaflet: 22.05.2024