Noctis

Leaflet attached to the packaging: information for the user

Noctis

12.5 mg, coated tablets

Doxylamine hydrogen succinate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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.

Table of contents of the leaflet

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

1. What is Noctis and what is it used for

The active substance in Noctis is doxylamine, which belongs to the group of antihistamine medicines. These medicines are characterized by a sedative effect, which means they are effective as aids to falling asleep.

Indication:

Noctis is indicated for short-term, symptomatic treatment of occasional insomnia, especially in cases of difficulty falling asleep, frequent nocturnal awakenings, or early morning awakening.

2. Important information before taking Noctis

When not to take Noctis

• if the patient is allergicto doxylamine succinate or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergicto 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 mucous membrane of the stomach or the initial section of the intestine) or pyloric stenosis (difficulty in moving food from the stomach to the intestine);
• if the patient has severe kidney or liver disease;
• if the patient is taking antiepileptic medicines, antidepressant medicines, antibiotics, antiviral medicines, antifungal medicines, antiarrhythmic medicines or calcium antagonists (medicines used in hypertension and heart rhythm disorders), proton pump inhibitors and/or other medicines for the treatment of gastrointestinal disorders; if the patient is taking monoamine oxidase inhibitors (medicines used in depression and Parkinson's disease) and within 2 weeks after stopping their use
• during pregnancy and breastfeeding.

Warnings and precautions

Before starting to take Noctis, the patient should discuss it with their doctor or pharmacist:

• do notdrink alcohol while taking Noctis - see below "Noctis with food, drink and alcohol";
• in hot weather, this medicine may increase the risk of dehydration and heat stroke;
• if the patient has epilepsy;
• if the patient experiences daytime sleepiness - it may be necessary to reduce the dose of the medicine (see section 3. How to take Noctis);
• 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 in cancer treatment), chloroquine (for malaria treatment or prevention) and some antibiotics (used in infection treatment) like erythromycin or aminoglycosides in injection form. Noctis may mask the toxic effect 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 take Noctis);
• if the patient has heart failure, hypertension 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 QT interval prolongation);
• if the patient has experienced vision disturbances or seizures, as even small doses of Noctis may cause seizures.

Effect on diagnostic test results
Noctis may change the results of skin allergy tests. If the patient is referred for such tests, they should stop taking Noctis for 3 days before the tests and inform their doctor about it.

Children and adolescents

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

Noctis and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Do not take Noctis while taking 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 antidepressant medicines (e.g. fluoxetine, fluvoxamine, paroxetine, bupropion, nefazodone), certain macrolide antibiotics (clarithromycin, erythromycin, telithromycin), medicines used in heart rhythm disorders (amiodarone, quinidine), antiviral protease inhibitors (indinavir, ritonavir, telaprevir), antifungal medicines from the azole group (fluconazole, ketoconazole, itraconazole), other antifungal medicines (terbinafine) and certain medicines that reduce blood lipid levels (gemfibrozil).

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

• alcohol and other medicines that have a sedative effect on the central nervous system, e.g. barbiturates, sleeping pills, tranquilizers, other medicines used in 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;
• 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 medicines from the cholinolytic group, such as antipsychotic medicines (used in the treatment of mental disorders), tricyclic antidepressant medicines (used in depression treatment, e.g. amitriptyline), medicines used in Parkinson's disease treatment (e.g. benzatropine or trihexyphenidyl);
• antihistamine medicines used on the skin (diphenhydramine in cream, ointment, spray), antispasmodic medicines (e.g. atropine, belladonna alkaloids) and scopolamine;
• medicines where there is a small difference between the therapeutic dose and the toxic dose (e.g. phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin).

Noctis 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 taking Noctis.
Do notdrink alcohol while taking Noctis.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Noctis is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Noctis may cause drowsiness the next day after taking it, which may affect the ability to drive and use machines. Therefore, it is not recommended to drive or use machines if the patient is taking this medicine.

Noctis contains a colorant - cochineal red, lake (E124)

This medicine may cause allergic reactions. It may also cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Noctis

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Adults
The recommended dose is one 12.5 mg tablettaken 30 minutes before bedtime.
The dose may be increased to a maximum of 2 tablets of 12.5 mg(or one 25 mg tablet) taken 30 minutes before bedtime, if the initial dose does not provide sufficient relief from insomnia symptoms.
The maximum daily doseis 2 tablets of 12.5 mg(or one 25 mg tablet).
If the patient experiences daytime sleepiness, it is recommended to reduce the dose of the medicine to one 12.5 mg tabletor ensure at least an 8-hour interval between taking the medicine and the planned wake-up time.
Noctis should not be taken for more than 7 days without consulting a doctor again.
Elderly patients (over 65 years old)
The maximum daily dose is 12.5 mg (one tablet).
Patients with kidney or liver function disorders
Noctis is contraindicated in patients with severe kidney or liver disease.
It is not recommended to take Noctis in patients with moderate kidney or liver disease.
In patients with mild kidney or liver disease, it is recommended to reduce the maximum daily dose to one 12.5 mg tablet.

Use in children and adolescents

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

Taking a higher dose of Noctis than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately contact their doctor.
The doctor will decide what measures should be taken.
Symptoms of overdose may include states from depression to nervous system stimulation.
The most common symptoms observed are: drowsiness, anxiety, stimulation, hallucinations, seizures, delusions and stupor. Other possible symptoms are dilated pupils and elevated body temperature. Tachycardia (fast heart rate) and arrhythmia (irregular heartbeat) may also occur. In case of significant overdose, it is necessary to initiate symptomatic treatment and maintain vital functions.
Severe poisonings can cause hallucinations, 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), which can lead to kidney failure.
There is no specific antidote in case of overdose of antihistamine medicines. If necessary, the doctor will decide on the use of symptomatic and supportive treatment.

Missing a dose of Noctis

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

Stopping Noctis treatment

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Noctis can cause side effects, although not everybody gets them.
Noctis may cause a significant decrease in the number of white blood cells in the blood and reduce the resistance to infections.
If the patient experiences an infection with symptoms of fever and severe deterioration of general condition or fever with local symptoms of infection, such as sore throat or pain in the urinary tract, 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 important to inform the doctor about taking Noctis.
Side effects are ranked according to their frequency:

• very common (more than 1 in 10):

Very common(more than 1 in 10):

• drowsiness

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

• 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):

• 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 body position from lying to standing (orthostatic hypotension)
• tinnitus

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

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Noctis

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storing the medicine.
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. The patient should ask their 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 contains

• The active substance of Noctis is doxylamine succinate. Each coated tablet contains 12.5 mg of doxylamine succinate.
• The other ingredients of the medicine are: tablet core:calcium hydrogen phosphate dihydrate, microcrystalline cellulose, hypromellose with low substitution degree, colloidal anhydrous silica, magnesium stearate;

tablet coating:hypromellose 6 mPa*s, titanium dioxide (E171), talc, macrogol 6000; cochineal red, lake (E124).

What Noctis looks like and contents of the pack

Pink, round, biconvex coated tablets.
Noctis tablets are packaged in PVC/Aluminum blisters, together with the patient leaflet, in a cardboard box.
Pack size: 14 or 20 coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
BIOFARM Sp. z o.o.
Wałbrzyska 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]
Manufacturer
LABORATORIOS NORMON S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain
BIOFARM Sp. z o.o.
Wałbrzyska 13
60-198 Poznań

Date of last revision of the leaflet: