- Indications
Noctis Noc is indicated for the short-term, symptomatic treatment of sporadic insomnia in adults, especially in the case of difficulty falling asleep, frequent nocturnal awakenings or early morning awakenings. - Composition
The active substance is doxylamine hydrosuccinate.
One coated tablet contains: 12.5 mg doxylamine hydrosuccinate.
The other ingredients of the drug 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, macrogol 3350, polydextrose, talc, Allura red (E129), erythrosine (E127).
Dosage
Always use this medicine exactly as described in this patient information 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 going to bed.
The dose can be increased to a maximum of 25 mg (2 tablets) taken 30 minutes before going to bed 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 that you have enough time to sleep (8 hours) to avoid drowsiness the next morning.
- Contraindications
When not to use Noctis Noc
if you are allergic to doxylamine hydrosuccinate or any of the other ingredients of this medicine (listed in section 6);
if you are allergic to other antihistamines (antiallergic medicines);
if you have a respiratory disease such as asthma, bronchitis (a persistent cough that produces thick saliva (sputum and mucus)) or emphysema (inflammation of the air sacs in the lungs that causes difficulty breathing);
if you have glaucoma (increased pressure in the eye);
if you have prostatic hyperplasia (an abnormal enlargement of the prostate), bladder neck obstruction (a disease of the urinary system) or difficulty passing urine;
if you have scarring of a 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 the patient is taking certain medications at the same time, e.g. antidepressants (fluoxetine, fluvoxamine, paroxetine), antibiotics (clarithromycin, erythromycin, telithromycin), antiviral medications (indinavir, ritonavir, telaprevir), antifungal medications (fluconazole, ketoconazole, itraconazole, voriconazole), antiarrhythmic medications (amiodarone), terbinafine, quinidine, nefazodone, bupropion, gemfibrozil (see Noctis Noc and other medications);
if the patient is taking monoamine oxidase inhibitors (drugs used in depression and Parkinson’s disease) at the same time and within 2 weeks after stopping their use;
during pregnancy and breastfeeding.
Packaging
14 tablets
Responsible entity
Biofarm® Sp. z o.o.,
ul. Wałbrzyska 13,
60-198 Poznań
Before use, read the leaflet, which contains indications, contraindications, data on adverse effects and dosage, and information on the use of the medicinal product, or consult a doctor or pharmacist, because any drug used improperly threatens your life or health.
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