Noctis noc

Before starting to use this medicine, read the leaflet carefully and familiarize yourself
with the "Patient Information Leaflet" included in the medicine package. To ensure safe
use of the medicine, answer all questions contained in the leaflet. This medicine is intended
only for adult patients.

Package leaflet: Information for the user

Noctis Noc, 12.5 mg, coated tablets
Doxylamine hydrogenosuccinate
Please read the leaflet carefully before taking this 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 a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

Contents of the leaflet

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

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

The active substance in Noctis Noc is doxylamine, which belongs to a group of medicines called antihistamines. This medicine has a calming effect and is effective as an aid to help with falling asleep.
Noctis Noc is indicated for the short-term, symptomatic treatment of occasional insomnia in adults, particularly in cases of difficulty falling asleep, frequent nocturnal awakenings, or early morning waking.
Sleep disturbances can significantly impair daytime functioning, manifesting as mental slowing, reduced concentration, memory problems, and decreased motivation. Insomnia is diagnosed, among other criteria, when: the time to fall asleep exceeds 30 minutes, total wakefulness during the night lasts longer than 30 minutes, such disturbances occur at least three nights per week, and poor sleep quality leads to fatigue or reduced psycho-physical performance during the day.
Transient sleep disturbances usually last a few days and represent a physiological response to, for example, stress, time zone changes, certain transient somatic illnesses, shift work, psychological tension, or noise.
Medicines should not be the primary method of treating sleep disorders and should only be used short-term. Prolonged poor sleep quality may be a symptom of psychological or physical disorders requiring different treatment approaches, which should be evaluated by a doctor.
Consultation with a doctor is also necessary if symptoms other than insomnia are present.
This medicine must not be used to treat chronic sleep disorders. Treatment duration should be as short as possible. Treatment typically lasts from a few days up to 1 week. This medicine should not be used for longer than 7 days without consulting a doctor. If there is no improvement after 7 days, or if your condition worsens, consult your 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 antihistamines (antiallergic medicines);
• if the patient has a respiratory condition, such as asthma, bronchitis (persistent cough producing thick mucus (sputum and phlegm)) or emphysema (inflammation of the air sacs in the lungs causing breathing difficulties);
• if the patient has glaucoma (increased pressure in the eye);
• if the patient has prostate enlargement (abnormal prostate enlargement), urinary bladder neck obstruction (a urinary tract condition), or difficulty passing urine;
• if the patient has peptic ulcer (damage to the mucous lining of the stomach or the initial part of the intestine) or pyloroduodenal stenosis (difficulty in food passage from the stomach to the intestine);
• if the patient has severe kidney or liver disease;
• if the patient is concurrently taking certain medicines, e.g. antidepressants (fluoxetine, fluvoxamine, paroxetine), antibiotics (clarithromycin, erythromycin, telithromycin), antiviral drugs (indinavir, ritonavir, telaprevir), antifungal medicines (fluconazole, ketoconazole, itraconazole, voriconazole), antiarrhythmic drugs (amiodarone), terbinafine, quinidine, nefazodone, bupropion, gemfibrozil (see section "Noctis Noc and other medicines"); if the patient is currently taking or has discontinued within the last 2 weeks monoamine oxidase inhibitors (medicines used in depression and Parkinson's disease);
• during pregnancy and breastfeeding.

Warnings and precautions
Before starting to use Noctis Noc, discuss with your doctor or pharmacist:

• if the patient experiences daytime drowsiness – it is recommended to reduce the dose or ensure at least an 8-hour interval between taking the medicine and the planned time of waking up (see section 3. How to take Noctis Noc);
• do not drink alcohol while taking Noctis Noc – see section below "Noctis Noc with food, drink and alcohol";
• during hot weather, this medicine may increase the risk of dehydration and symptoms of heat stroke;
• if the patient has epilepsy (antihistamines may sometimes cause hyperexcitability and consequently lower the seizure threshold);
• if the patient is over 65 years of age, as they may be more susceptible to adverse effects;
• if the patient is taking other medicines that are ototoxic (toxic to the ear), such as carboplatin or cisplatin (used in cancer treatment), chloroquine (used to treat or prevent malaria), or certain antibiotics (used to treat infections) such as erythromycin or parenteral aminoglycosides. Noctis Noc may mask the toxic effects of these medicines, so periodic ear examinations are recommended;
• if the patient has liver or kidney disease – dose adjustment may be necessary (see section 3. How to take Noctis Noc);
• if the patient has heart failure, hypertension, or has been diagnosed with a pheochromocytoma (a rare type of tumour causing increased blood pressure);
• if the patient experiences a sudden increase in heart rate in response to physical exertion or stress (so-called QT prolongation syndrome);
• if the patient has low blood potassium levels or other electrolyte imbalances;
• if the patient has previously experienced visual disturbances or seizures, as even small doses of Noctis Noc may trigger epileptic seizures;
• during doxylamine use, grapefruit and grapefruit juice should be avoided;
• if the patient is taking medicines such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, or vancomycin, doxylamine should be avoided as it may lead to acute poisoning.

Always take this medicine exactly as described in the patient leaflet or as instructed by your doctor or pharmacist. Improper use of the medicine, including prolonged use or exceeding recommended doses, may cause adverse effects. The patient should monitor their response to the medicine, including possible adverse effects (see section 4) or symptoms of overdose (see section 3 "Taking more Noctis Noc than you should").
If the patient experiences daytime drowsiness, it is recommended to reduce the dose or take it earlier to ensure at least an 8-hour interval between taking the medicine and waking up.

Effect on diagnostic test results
Noctis Noc may alter the results of skin allergy tests. If the patient is referred for such tests, Noctis Noc should be discontinued at least 3 days before the tests and the doctor should be informed.

Children and adolescents
Noctis Noc is not recommended for use in children and adolescents under 18 years of age – see also section "Use in children and adolescents".

Noctis Noc and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Do not take Noctis Noc while using the following medicines:

• monoamine oxidase inhibitors (e.g. medicines used in 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), antiviral protease inhibitors (indinavir, ritonavir, telaprevir), antifungal azole compounds (fluconazole, ketoconazole, itraconazole, voriconazole), other antifungal medicines (terbinafine), and certain lipid-lowering agents (gemfibrozil).

Patients should avoid taking Noctis Noc while using the following medicines, as this may intensify their effects or cause adverse effects:

• adrenaline (used to treat low blood pressure);
• certain antimalarial medicines or certain antihistamines;
• certain diuretics (medicines that increase urine output);
• alcohol and other medicines that depress the central nervous system, such as barbiturates, sleeping pills, sedatives, other medicines used for insomnia or anxiety disorders (alprazolam, diazepam, zolpidem), anticonvulsants (e.g. carbamazepine), muscle relaxants, opioid painkillers (codeine), psychotropic medicines (chlorpromazine, risperidone, amitriptyline, trazodone), or procarbazine;
• antihypertensive medicines (medicines used to treat high blood pressure) acting on the central nervous system, such as guanabenz, clonidine or methyldopa;
• medicines known to be ototoxic (toxic to hearing), such as certain antibiotics (parenteral aminoglycosides, chloroquine, erythromycin) or medicines used in cancer treatment (carboplatin, cisplatin), as doxylamine may mask these effects;
• other medicines in the anticholinergic group, such as antipsychotics (used to treat psychiatric disorders), tricyclic antidepressants (used to treat depression, e.g. amitriptyline), medicines used in Parkinson's disease (e.g. benztropine or trihexyphenidyl);
• topical antihistamines (e.g. diphenhydramine in cream, ointment, or aerosol), scopolamine, antispasmodics (e.g. atropine, belladonna alkaloids), or disopyramide (used to treat certain heart conditions);
• medicines with a narrow therapeutic index (small differences between therapeutic and toxic doses), such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin.

Noctis Noc with food, drink and alcohol
There are no special instructions regarding taking this medicine before or after meals.
Do not drink grapefruit juice while taking Noctis Noc.
Do not drink alcohol while taking Noctis Noc.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
There are insufficient data on the use of doxylamine in pregnant women; therefore, the use of Noctis Noc during pregnancy is contraindicated.
Due to the risk associated with the use of antihistamines in young children, Noctis Noc must not be used during breastfeeding.
There are no available data on the effect of Noctis Noc on fertility.

Driving and operating machinery
Noctis Noc may cause drowsiness the following day after administration, which may affect the ability to drive or operate machinery. For this reason, driving and operating machinery should be avoided during treatment with this medicine.

Noctis Noc contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

Noctis Noc contains Allura Red (E129)
This medicine may cause allergic reactions.

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

3. How to use Noctis Noc

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults (aged over 18 years)
The recommended dose is 12.5 mg (1 tablet) taken 30 minutes before bedtime.
The dose may be increased up to a maximum of 25 mg (2 tablets) taken 30 minutes before bedtime, if the initial dose does not provide sufficient relief of insomnia symptoms.
The maximum daily dose is 25 mg (2 tablets).
Before taking Noctis Noc, ensure there is a sufficiently long period of time for sleep (8 hours) to avoid next-day drowsiness.
If daytime drowsiness occurs, 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 planned awakening.
Do not take more than 2 tablets (25 mg) per day.
Patients with persistent sleep problems should consult a doctor.

Elderly patients (aged over 65 years)
In adults over 65 years of age, other medical conditions are more likely, which may require dose reduction. The recommended initial dose is 12.5 mg (1 tablet), taken 30 minutes before bedtime. The dose may be increased to 25 mg (2 tablets) if the initial dose proves ineffective. If adverse effects occur, the dose should be reduced to 12.5 mg (1 tablet) per day. Therefore, close attention should be paid to treatment effects (see section 4).
If adverse effects occur, consult a doctor.

Patients with renal or hepatic 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 going to bed, with an adequate amount of fluid (preferably water).
Noctis Noc may 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.
Do not use this medicine for longer than 7 days without consulting a doctor.

Overdose of Noctis Noc
If more than the recommended dose is taken, contact a doctor immediately.
The doctor will decide whether and what measures should be taken.
Symptoms of overdose include: drowsiness, central nervous system depression or stimulation, anticholinergic effects (dilated pupils, fever, dry mouth, reduced smooth muscle tone in the intestines), increased or altered heart rate, elevated blood pressure, nausea, vomiting, agitation, disorientation, and hallucinations.
Severe poisoning may lead to delirium, psychotic disturbances, decreased blood pressure, seizures, reduced respiratory rate, loss of consciousness, coma, and may be life-threatening. Severe complications include rhabdomyolysis (muscle breakdown), which may lead to kidney failure.
There is no specific antidote for antihistamine overdose. If necessary, symptomatic and supportive treatment should be administered. The doctor will decide whether to induce vomiting, perform gastric lavage, or prescribe medications to raise blood pressure.

Missed dose of Noctis Noc
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time.

Discontinuation of Noctis Noc
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions caused by doxylamine are generally 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 may reduce
resistance to infections.
If a patient develops an infection with symptoms of fever and serious deterioration in general condition, or
fever with local signs of infection such as sore throat or urinary tract pain, medical advice should be sought immediately.
A blood test will be performed to check for a possible decrease in white blood cell count (agranulocytosis).
It is important to inform the doctor about the use of Noctis Noc.
Adverse reactions are listed below according to their frequency:
Very common (more than 1 in 10 people):

• drowsiness

Common (1 to 10 in 100 people):

• dry mouth, constipation, upper abdominal pain
• blurred vision
• dizziness, headache
• fatigue, insomnia, restlessness
• difficulty in passing urine (urinary retention)
• increased mucus secretion in the bronchi

Uncommon (1 to 10 in 1,000 people):

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

Rare (1 to 10 in 10,000 people):

• tremor, convulsions
• paradoxical excitation (especially in children and elderly patients)
• decrease in the number of red blood cells, white blood cells, or platelets

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

• general malaise

Other adverse reactions usually associated with antihistamine use, which are not specifically related to doxylamine, include: cardiac arrhythmias (changes in heart rate), palpitations, bile reflux, liver function disorders (cholestatic jaundice), QT interval prolongation in ECG (heart disease), loss of appetite, increased appetite, muscle pain, coordination disorders, extrapyramidal disorders (movement disorders), depression, decreased mucus secretion in the bronchi, alopecia, allergic dermatitis, excessive sweating, photosensitivity, or hypotension (low blood pressure).
The severity and frequency of adverse reactions can be controlled by reducing the daily dose.
Adults over the age of 65 are more susceptible to adverse reactions, as they may suffer from other diseases or be taking other medicines simultaneously. These individuals are also more prone to falls.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Noctis Noc

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Noctis Noc contains

• The active substance is doxylamine succinate. One coated tablet contains 12.5 mg of doxylamine succinate.
• Other ingredients are: hypromellose, 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
Round, pink, biconvex, film-coated tablets.
Packaged in PVC/PVDC/Aluminium blisters in a cardboard box.
Pack sizes:
7, 10, 14, 20 film-coated tablets.
Marketing Authorisation 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: [email protected]