Noctis Night 12.5 mg, 20 tablets

The active substance in Noctis Noc is doxylamine, which belongs to the group of antihistamines. This drug has a calming effect, which means that it is effective as a sleep aid.

Noctis Noc is indicated for the short-term, symptomatic treatment of occasional insomnia in adults, especially in the case of difficulty falling asleep, frequent night-time awakenings or early morning awakenings.

The active substance is doxylamine hydrosuccinate. One film-coated tablet contains 12.5 mg doxylamine hydrosuccinate.
The other ingredients are:
Excipients: hydroxypropylcellulose, 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).

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults (aged 18 years and over)
The recommended dose is 12.5 mg (1 tablet) taken 30 minutes before bedtime.
The dose may be increased to a maximum of 25 mg (2 tablets) taken 30 minutes before bedtime if the initial dose does not provide sufficient relief from insomnia symptoms.
The maximum daily dose is 25 mg (2 tablets).

Before taking Noctis Noc, make sure you have enough time to sleep (8 hours) to avoid drowsiness the next morning.

If drowsiness occurs during the day, it is recommended to reduce the dose to 12.5 mg (1 tablet) or ensure at least an 8-hour break between taking the drug and the planned wake-up time.

Do not take more than 2 tablets (25 mg) per day.
Patients with persistent sleep problems should consult a doctor.

Elderly (over 65 years)
Adults over 65 years of age are more likely to have other medical conditions that may require a dose reduction. The recommended starting 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 is ineffective. If side effects occur, the dose should be reduced to 12.5 mg (1 tablet) daily. Therefore, attention should be paid to the effects of the treatment (see section 4). If side effects occur, talk to your doctor.

Patients with impaired kidney or liver function
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, it is recommended to reduce the maximum daily dose to 12.5 mg (1 tablet).

Route and method of administration
Oral administration.
Tablets should be taken 30 minutes before going to bed, with an appropriate amount of fluid (preferably water).
Noctis Noc can 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.
The medicine should not be used for longer than 7 days without consulting a doctor.

Noctis Noc is not recommended for use in children and adolescents under 18 years of age.

When not to use Noctis Noc:
if you are allergic to doxylamine hydrosuccinate or any of the other ingredients of this medicine;

• if you are allergic to other antihistamines (antiallergics);
• if you have a respiratory disease such as asthma, bronchitis (persistent cough that produces thick saliva (sputum and phlegm)) or emphysema (inflammation of the air sacs in the lungs, causing difficulty breathing);
• if you have glaucoma (increased pressure in the eye);
• if you have an enlarged prostate (abnormal enlargement of the prostate), bladder neck obstruction (urinary tract disease) or difficulty in passing urine;
• if you have a scarring peptic ulcer (damage to the lining of the stomach or first part of the intestine) or pyloroduodenal stenosis (difficulty moving food from the stomach to the intestine);
• if you have severe kidney or liver disease;
• if you are taking certain medications at the same time, e.g. antidepressants (fluoxetine, fluvoxamine, paroxetine), antibiotics (clarithromycin, erythromycin, telithromycin), antiviral drugs (indinavir, ritonavir, telaprevir), antifungal drugs (fluconazole, ketoconazole, itraconazole, voriconazole), antiarrhythmic drugs (amiodarone), terbinafine, quinidine, nefazodone, bupropion, gemfibrozil;
• if you are taking monoamine oxidase inhibitors (medicines used to treat depression and Parkinson’s disease) at the same time as well as within 2 weeks after stopping their treatment;
• during pregnancy and breastfeeding.