Noctis Forte

Leaflet attached to the packaging: information for the user

Noctis Forte

25 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 Forte and what is it used for
• 2. Important information before taking Noctis Forte
• 3. How to take Noctis Forte
• 4. Possible side effects
• 5. How to store Noctis Forte
• 6. Package contents and other information

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

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

2. Important information before taking Noctis Forte

When not to take Noctis Forte

• 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 initial part of the intestine) or pyloric stenosis (difficulty moving food from the stomach to the intestine);
• if the patient has severe kidney or liver disease;
• if the patient is taking antiepileptic medicines, antidepressants, 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
• in pregnancy and breastfeeding.

Warnings and precautions

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

• do notdrink alcohol while taking Noctis Forte - see below "Noctis Forte 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 Forte);
• 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 injectable form. Noctis Forte 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 Forte);
• 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 syndrome);
• if the patient has experienced vision disturbances or seizures, as even small doses of Noctis Forte may cause seizures.

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

Children and adolescents

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

Noctis Forte and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Do not take Noctis Forte 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, methylthioninium chloride, procarbazine, rasagiline and selegiline);
• medicines such as: certain antidepressants (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), azole antifungals (fluconazole, ketoconazole, itraconazole), other antifungals (terbinafine) and certain lipid-lowering medicines (gemfibrozil).

Patients should avoid taking Noctis Forte while taking the following medicines, as it may enhance 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, sedatives, other medicines used in insomnia or anxiety disorders (alprazolam, diazepam, zolpidem), antiepileptic medicines (e.g. carbamazepine), muscle relaxants, opioid analgesics (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 cholinolytic medicines, such as antipsychotic medicines (used in the treatment of mental disorders), tricyclic antidepressants (used in the treatment of depression, e.g. amitriptyline), medicines used in the treatment of Parkinson's disease (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 Forte with food, drink and alcohol

There are no special recommendations for taking this medicine before or after a meal.
Grapefruit juice should not be consumed while taking Noctis Forte.
Do not drink alcohol while taking Noctis Forte.

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 Forte is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Noctis Forte 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 operate machines if the patient is taking this medicine.

3. How to take Noctis Forte

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 daytime sleepinessoccurs, it is recommended to reduce the dose of the medicine to one 12.5 mg tabletor ensure an interval of at least 8 hours between taking the medicine and the planned wake-up time.
Noctis Forte 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).
Patient with kidney or liver impairment
Noctis Forte is contraindicated in patients with severe kidney or liver disease.
It is not recommended to take Noctis Forte 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 Forte is not indicated for use in children under 18 years of age and should not be used in this patient group.
The tablet can be divided into two equal doses.

Overdose of Noctis Forte

In case of overdose, the patient should immediately contact their doctor.
The doctor will decide what measures should be taken.
Overdose symptoms may include states ranging from depression to nervous system stimulation.
The most common symptoms observed are: drowsiness, anxiety, stimulation, hallucinations, seizures, delirium and stupor. Other possible symptoms are dilated pupils and elevated body temperature. Tachycardia (rapid 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 apply symptomatic and supportive treatment. The doctor will decide whether to induce vomiting, perform gastric lavage or prescribe medicines to increase blood pressure.

Missing a dose of Noctis Forte

A double dose should not be taken to make up for a missed dose.

Stopping Noctis Forte

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 Forte can cause side effects, although not everybody gets them.
Noctis Forte may cause a significant decrease in the number of white blood cells in the blood and reduce 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 Forte.
Side effects are ranked according to their frequency:

• Very common(more than 1 in 10 people):

Common(between 1 in 100 and 1 in 10 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 1,000 and 1 in 100 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 body position from lying to standing (orthostatic hypotension)
• ringing in the ears

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

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

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 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 Forte

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. Package contents and other information

What Noctis Forte contains

• The active substance of the medicine is doxylamine succinate. Each coated tablet contains 25 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; indigo carmine, lacquer (E132).

What Noctis Forte looks like and what the package contains

Blue, elongated coated tablets with a dividing line on one side.
The tablet can be divided into two equal doses.
Noctis Forte tablets are packaged in PVC/Aluminum blisters, together with the patient leaflet, in a cardboard box.
Package size: 7, 10, 14 or 20 coated tablets.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: