Noctis

Package leaflet: Information for the user

Noctis
12.5 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. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

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

2. Important information before using Noctis

When not to use Noctis

• 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, e.g. 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 benign prostatic hyperplasia (abnormal enlargement of the prostate), urinary bladder neck obstruction (a urinary tract disorder), or difficulty in 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 currently taking anticonvulsants, antidepressants, antibiotics, antiviral drugs, antifungal drugs, antiarrhythmics 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 currently taking or has discontinued within the previous 2 weeks monoamine oxidase inhibitors (medicines used in depression and Parkinson's disease)
• during pregnancy and breastfeeding.

Warnings and precautions
Before starting treatment with Noctis, consult your doctor or pharmacist:

• do not drink alcohol while taking Noctis – see section below "Noctis with food, drink and alcohol";
• in 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);
• 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 may mask (hide) the toxic effects of these medicines, therefore 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);
• if the patient has heart failure, hypertension, or has been diagnosed with a pheochromocytoma (a rare type of tumour causing high blood pressure);
• if the patient experiences sudden increase in heart rate in response to physical exertion or stress (so-called QT prolongation syndrome);
• if the patient has previously experienced visual disturbances or seizures, as even small doses of Noctis may trigger epileptic seizures.

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

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

Noctis with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned to be used.

Do not take Noctis while using 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 antifungal medicines (terbinafine), and certain lipid-lowering agents (gemfibrozil).

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

• alcohol and other medicines that depress the central nervous system, e.g. barbiturates, sleeping pills, sedatives, other medicines used for insomnia or anxiety disorders (alprazolam, diazepam, zolpidem), anticonvulsants (e.g. carbamazepine), muscle relaxants, opioid analgesics (codeine), psychotropic medicines (chlorpromazine, risperidone, amitriptyline, trazodone), or procarbazine;
• medicines known to be ototoxic, such as certain antibiotics (parenteral aminoglycosides, chloroquine, erythromycin) or anticancer medicines (carboplatin, cisplatin), as doxylamine may mask these effects;
• other medicines with anticholinergic properties, 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);
• topical antihistamines (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 with food, drink and alcohol
There are no special instructions regarding taking this medicine before or after meals.
Drinking grapefruit juice is not recommended during treatment with Noctis.
Do not drink alcohol while taking Noctis.

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

Driving and operating machinery
Noctis may cause drowsiness, even the following day after administration, and may therefore impair the ability to drive or operate machinery. For this reason, driving and operating machinery are not recommended while taking this medicine.

Noctis contains a colouring agent – cochineal red, lake (E124)
This medicine may cause allergic reactions. It may also cause asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take Noctis

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor 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.
The 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 should not be used for longer than 7 days without reconsulting a doctor.

Elderly patients (over 65 years of age)
The maximum daily dose is 12.5 mg (one tablet).

Patients with renal or hepatic impairment
Noctis is contraindicated in patients with severe renal or hepatic disease.
The use of Noctis is not recommended in patients with moderate renal or hepatic disease.
In patients with mild renal or hepatic disease, the maximum daily dose should be reduced 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 more Noctis than recommended
If you take more Noctis than recommended, contact your doctor immediately.
The doctor will decide whether and what measures should be taken.
Symptoms of overdose may range from depression to nervous system stimulation.
The most commonly observed symptoms include drowsiness, anxiety, agitation, hallucinations, seizures, delirium, and stupor. Other possible symptoms include 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, and vital functions must be maintained.
Severe poisoning may lead to delirium, psychotic disturbances, hypotension (low 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 renal 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.

If you miss a dose of Noctis
Do not take a double dose to make up for a missed dose.

Stopping Noctis
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.
Noctis 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 such as fever and serious deterioration in general condition, or
fever with local signs of infection such as sore throat or pain in the urinary tract, medical advice must be sought immediately.
A blood test will be performed to check for a possible reduction in the number of white blood cells
(agranulocytosis). It is important to inform the doctor about the use of Noctis.
Adverse reactions are listed below according to their frequency of occurrence:
Very common (occurs in more than 1 in 10 people):

• somnolence

Common (occurs in 1 to 10 in 100 people):

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

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

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

Rare (occurs in 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 reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 medicine

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Noctis contains

• The active substance is doxylamine succinate. Each coated tablet contains 12.5 mg of doxylamine succinate.
• Other ingredients are:
  Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, colloidal anhydrous silica, magnesium stearate;

Coating: hypromellose 6 mPa*s, titanium dioxide (E171), talc, macrogol 6000; carmine red, lac (E124).

What Noctis looks like and contents of the pack
Pink, round, biconvex coated tablets.
Noctis tablets are packed in PVC/Aluminium blisters, placed together with the patient leaflet in a cardboard box.
Pack sizes: 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.
Wałbrzyska Street 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.
Wałbrzyska Street 13
60-198 Poznań