Package leaflet: Information for the user

Noctis Forte
25 mg, coated tablets
Doxylamine hydrogen succinate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Noctis Forte is and what it is used for
What you need to know before taking Noctis Forte
How to take Noctis Forte
Possible side effects
How to store Noctis Forte
Contents of the pack and other information

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

The active substance in Noctis Forte is doxylamine, which belongs to a group of medicines called
antihistamines. These medicines have a sedative effect, meaning they are effective as sleep-inducing agents.
Indication:
Noctis Forte is indicated for short-term, symptomatic treatment of occasional insomnia,
particularly in cases of difficulty falling asleep, frequent night-time awakenings, or early morning awakening.

2. Important information before using Noctis Forte

When not to use Noctis Forte

if the patient is allergic to doxylamine succinate or any of the other ingredients of this medicine (listed in section 6);
if the patient is allergic to other antihistamine (antiallergic) medicines;
if the patient has a respiratory disorder, such as asthma, bronchitis (persistent cough producing thick saliva (sputum) and mucus), or emphysema (inflammation of the lung alveoli 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 disorder), 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 using antiepileptic drugs, antidepressants, antibiotics, antiviral drugs, antifungal drugs, antiarrhythmic drugs, or calcium channel blockers (medicines used for hypertension and heart disorders), proton pump inhibitors and/or other medicines for gastrointestinal disorders; if the patient is concurrently using monoamine oxidase inhibitors (medicines used in depression and Parkinson's disease) and within 2 weeks after discontinuation of such treatment;
during pregnancy and breastfeeding.

Warnings and precautions
Before starting Noctis Forte, discuss this with a doctor or pharmacist:

do not drink alcohol while taking Noctis Forte – see section below "Noctis Forte 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;
if the patient experiences daytime drowsiness – dose reduction may be necessary (see section 3. How to take Noctis Forte);
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 (for treatment or prevention of malaria), or certain antibiotics (for treatment of infections) such as erythromycin or parenteral aminoglycosides. Noctis Forte may mask the toxic effects of these drugs, so regular ear examinations are recommended;
if the patient has liver or kidney disease – dose adjustment may be necessary (see section 3. How to take Noctis Forte);
if the patient has heart failure, hypertension, or has been diagnosed with a pheochromocytoma (a rare tumor causing high blood pressure);
if the patient experiences a sudden increase in heart rate in response to physical exertion or stress (so-called prolonged QT interval syndrome);
if the patient has previously experienced visual disturbances or seizures, as even small doses of Noctis Forte may trigger epileptic seizures.

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

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

Noctis Forte with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Do not use Noctis Forte 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, 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 cardiac arrhythmias (amiodarone, quinidine), antiviral protease inhibitors (indinavir, ritonavir, telaprevir), antifungal azole compounds (fluconazole, ketoconazole, itraconazole), other antifungals (terbinafine), and certain lipid-lowering agents (gemfibrozil).

Patients should avoid using Noctis Forte while taking the following medicines, as this may intensify their effects or lead to adverse reactions:

alcohol and other central nervous system depressants, e.g. 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;
medicines known to be ototoxic, such as certain antibiotics (parenteral aminoglycosides, chloroquine, erythromycin) or anticancer drugs (carboplatin, cisplatin), as doxylamine may mask these effects;
other anticholinergic medicines, such as antipsychotics (used to treat psychiatric disorders), tricyclic antidepressants (used to treat depression, e.g. amitriptyline), or medicines used in Parkinson's disease (e.g. benztropine or trihexyphenidyl);
antihistamines applied to the skin (diphenhydramine in cream, ointment, or aerosol), antispasmodics (e.g. atropine, belladonna alkaloids), and scopolamine;
medicines with a narrow therapeutic index (small difference between therapeutic and toxic dose), such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin.

Noctis Forte with food, drink and alcohol
There are no special instructions regarding taking this medicine before or after meals.
Grapefruit juice is not recommended during treatment with Noctis Forte.
Do not drink alcohol while taking Noctis Forte.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Noctis Forte is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery
Noctis Forte may cause drowsiness the day after administration, which may affect the ability to drive or operate machinery. Therefore, driving vehicles or operating machinery is not recommended while taking this medicine.

3. How to use Noctis Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Adults
The recommended dose is one 12.5 mg tablet taken 30 minutes before bedtime.
The dose may be increased up to a maximum of two 12.5 mg tablets (or one 25 mg tablet)
taken 30 minutes before bedtime, if the initial dose does not provide sufficient relief of insomnia symptoms.
Maximum daily dose is two 12.5 mg tablets (or one 25 mg tablet).
If daytime drowsiness occurs, it is recommended to reduce the dose to one 12.5 mg tablet or ensure at least an 8-hour interval between taking the medicine and planned awakening.
Noctis Forte should not be used for longer than 7 days without re-evaluation by a physician.
Elderly patients (over 65 years of age)
The maximum daily dose is 12.5 mg (one tablet).
Patients with impaired kidney or liver function
Noctis Forte is contraindicated in patients with severe kidney or liver disease.
The use of Noctis Forte is not recommended in patients with moderate kidney or liver disease.
In patients with mild kidney or liver disease, the maximum daily dose should be reduced 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 may be divided into two equal doses.
Taking more Noctis Forte than recommended
If more than the recommended dose is taken, contact a physician immediately.
The physician will decide whether and what measures should be taken.
Symptoms of overdose may include states ranging from depression to nervous system excitation.
Most commonly observed symptoms include drowsiness, anxiety, agitation, delirium, seizures, hallucinations, and stupor. Other possible symptoms are dilated pupils and elevated body temperature. Tachycardia (rapid heartbeat) and arrhythmia (irregular heartbeat) may also occur. In cases of significant overdose, symptomatic treatment is required, along with supportive care to maintain vital functions.
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), leading to kidney failure.
There is no specific antidote in case of overdose with antihistamines. If necessary, symptomatic and supportive treatment should be administered. The physician will decide whether to induce vomiting, perform gastric lavage, or prescribe medications to raise blood pressure.
Missing a dose of Noctis Forte
Do not take a double dose to make up for a missed dose.
Stopping Noctis Forte
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The medicine 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 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 pain during urination, contact a doctor 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 Forte.

Adverse effects are listed below by frequency of occurrence:
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 passing urine (urinary retention)
increased mucus secretion in the bronchi

Uncommon (1 to 10 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 to standing (orthostatic hypotension)
tinnitus

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

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

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Noctis Forte

Keep this medicine out of sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack.
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 Noctis Forte contains

The active substance is doxylamine hydrogen succinate. Each coated tablet contains 25 mg of doxylamine hydrogen succinate.
Other ingredients are:
Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, low-substituted hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate;
Tablet coating: hypromellose 6 mPa\s, titanium dioxide (E171), talc, macrogol 6000; indigo carmine,
lake (E132).

What Noctis Forte looks like and contents of the pack
Blue, oblong coated tablets, with a division line on one side.
The tablet can be divided into two equal doses.
Noctis Forte tablets are packed in PVC/Aluminium blisters, placed together with the patient leaflet in a cardboard carton.
Pack sizes: 7, 10, 14 or 20 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
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]

Manufacturer
LABORATORIOS NORMON S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain

BIOFARM Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań