Nitedor

Package Leaflet: Information for the Patient

Nitedor, 25 mg, Coated Tablets

Doxylamine Hydrogen Succinate

For Adult Use

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Nitedor and what is it used for
• 2. Important information before taking Nitedor
• 3. How to take Nitedor
• 4. Possible side effects
• 5. How to store Nitedor
• 6. Contents of the pack and other information

1. What is Nitedor and what is it used for

Nitedor is a sedating antihistamine (sleep-inducing medicine).
Nitedor is used for the short-term, symptomatic treatment of occasional insomnia (difficulty falling asleep, frequent nocturnal awakenings) in adults.

2. Important information before taking Nitedor

When not to take Nitedor:

• if you are allergic to doxylamine, other antihistamines, or any of the other ingredients of this medicine (listed in section 6),
• in case of acute asthma attack,
• if you have narrow-angle glaucoma,
• if you have a pheochromocytoma (a tumor of the adrenal gland),
• if you have an enlarged prostate with urinary retention,
• if you have acute alcohol intoxication, sleeping pills, painkillers, or psychotropic drugs (neuroleptics, sedatives, antidepressants, lithium),
• if you have epilepsy,
• if you are taking monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression, Parkinson's disease, or other medicines such as moclobemide, phenelzine, tranylcypromine, isocarboxazid, linezolid, methylene blue, procarbazine, rasagiline, and selegiline).

Warnings and precautions

Before taking Nitedor, discuss with your doctor or pharmacist if:

• you have liver or kidney problems,
• you have pre-existing heart problems and high blood pressure (regular heart monitoring may be necessary),
• you have chronic respiratory diseases and asthma,
• you have gastroesophageal reflux disease (GERD),
• you have gastric or duodenal ulcers, or pyloric stenosis (difficulty passing food from the stomach to the intestine).

Patients should ensure they have sufficient sleep time (at least 8 hours) to avoid reduced alertness the next morning.
Particular caution should be exercised when using doxylamine in patients with neurological damage and a history of seizures, as even small doses of doxylamine may cause tonic-clonic seizures (grand mal seizures).
Caution is recommended in patients over 65 years of age due to the increased risk of side effects. These patients are at increased risk of falls.
Effect on diagnostic tests
This medicine may affect the results of skin tests for allergy diagnosis, so it is recommended to discontinue this medicine at least 3 days before the planned test and inform the doctor about its use.

Children and adolescents

Nitedor should not be used in children and adolescents, as the safety and efficacy of doxylamine as a sleep-inducing medicine have not been established in children and adolescents under 18 years of age.

Nitedor and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
Do not take Nitedor with monoamine oxidase inhibitors. Concomitant use of Nitedor and monoamine oxidase inhibitors may cause a decrease in blood pressure, increased sedative effect on the central nervous system, and respiratory system.
Concomitant use of doxylamine and the following medicines may increase their effects:

• centrally acting medicines (such as psychotropic medicines, sleeping pills, painkillers, anesthetics, antiepileptics),
• other medicines with anticholinergic effects (e.g., biperiden used in the treatment of Parkinson's disease, tricyclic antidepressants), leading to life-threatening intestinal paralysis, urinary retention, and acute increase in intraocular pressure.

The effect of the following medicines may be reduced:

• phenytoin (used to treat seizures),
• neuroleptics.

During concomitant use of Nitedor:

• with centrally acting antihypertensive medicines (guanabenz, clonidine, alpha-methyldopa) may cause increased fatigue and weakness.
• symptoms of initial inner ear damage caused by other medicines (e.g., aminoglycoside antibiotics, some painkillers, some diuretics) may be masked.
• you may get false negative results in skin tests.
• do not give adrenaline (as it may cause vasodilation, decreased blood pressure, and increased heart rate).

Using Nitedor with food, drink, and alcohol

Alcohol may affect the action of doxylamine in an unpredictable way.
Avoid consuming alcohol while taking Nitedor.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.
Nitedor should only be used during pregnancy if your doctor recommends it.
During treatment, breastfeeding should be discontinued, as the active substance in the medicine passes into human milk.

Driving and using machines

Even when taken as recommended, this medicine may affect your ability to react, causing impaired ability to participate in traffic and operate machinery. Symptoms may worsen, especially when taken with alcohol. In such cases, it is not possible to react quickly and effectively to unexpected situations.
Do not drive a car or other vehicles, or use any electrical appliances or machines. Do not perform any work without ensuring safe support.

Nitedor contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

Nitedor contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Nitedor

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose:
Adult patients should take 1 tablet once a day (corresponding to 25 mg of doxylamine succinate) about half to one hour before bedtime. In case of severe sleep disorders, the maximum dose is 2 tablets once a day (corresponding to 50 mg of doxylamine succinate).
In patients with impaired renal or hepatic function, elderly or debilitated patients who are more sensitive to the effects of doxylamine, the dose should be reduced.
If the dose cannot be administered with Nitedor, other medicines with established doses are available.
Method of administration
Nitedor is taken orally.
Swallow the tablet with a glass of water.
The score line on the tablet is only for breaking the tablet to facilitate swallowing.

Taking more Nitedor than prescribed

Initial symptoms of overdose may include symptoms from the central nervous system, such as restlessness, increased muscle reflexes, loss of consciousness, respiratory failure, and cardiac arrest. Other symptoms of overdose include dilated pupils, rapid heartbeat (tachycardia), fever, feeling of heat, flushing of the skin, and dryness of mucous membranes. If these symptoms occur, contact your doctor immediately.
Additionally, after an overdose, rhabdomyolysis (breakdown of muscle fibers) has been reported.
Your doctor will decide what actions to take.
In case of gastrointestinal disorders, central nervous system disorders, dry mouth, urinary disorders, or vision disorders, your doctor will decide on the course of action, depending on the symptom.

Missing a dose of Nitedor

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nitedor can cause side effects, although not everybody gets them.
Rare side effects (may affect up to 1 in 1,000 people):

• seizures.

Very rare side effects (may affect up to 1 in 10,000 people):

• blood disorders (such as abnormal breakdown of red blood cells, decreased platelet count, or decreased white blood cell count),
• life-threatening intestinal paralysis.

Frequency not known (frequency cannot be estimated from the available data):

• in patients with pheochromocytoma (a tumor of the adrenal gland) that may release substances with a very strong effect on the cardiovascular system,
• concentration disorders, depression, prolonged reaction time,
• 'paradoxical' reactions, such as restlessness, excitement, tension, insomnia, nightmares, disorientation, hallucinations, tremors,
• dizziness, drowsiness, headache,
• vegetative side effects, such as difficulty concentrating, dry mouth, stuffy nose, increased intraocular pressure, constipation, urinary disorders, nausea, vomiting, diarrhea, loss or increased appetite, abdominal pain,
• vertigo of labyrinthine origin, tinnitus,
• rapid or irregular heartbeat, worsening of existing heart failure, changes in ECG,
• high or low blood pressure,
• respiratory function may be impaired due to thick mucus, bronchial obstruction, or bronchial constriction,
• liver function disorders (cholestatic jaundice),
• skin allergic reactions and hypersensitivity to light (avoid direct exposure to sunlight),
• muscle weakness,
• weakness, body temperature regulation disorders.

After prolonged daily use, sleep disorders may reappear when treatment is stopped abruptly.
Note:
The frequency and severity of side effects can be reduced by careful and individual adjustment of the daily dose.
The risk of side effects is higher in elderly patients; the risk of falls may also be increased in these patients.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nitedor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after 'EXP'. The expiry date refers to the last day of that month.
There are no special precautions for storage.
Medicines should 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 Nitedor contains

The active substance is doxylamine succinate.
Each coated tablet contains 25 mg of doxylamine succinate.
The other ingredients are lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E 171), macrogol 400 in the tablet coating. See section 2 'Nitedor contains lactose', 'Nitedor contains sodium'.

What Nitedor looks like and contents of the pack

Nitedor is a white or almost white, round, biconvex, coated tablet with a score line on one side. The tablet dimensions are: 12 mm x 6 mm. The score line is only for breaking the tablet to facilitate swallowing, not for dividing the tablet into two equal doses.
Nitedor is available in packs of 7, 10, 14, and 20 coated tablets in blisters, in a carton. Not all pack sizes may be marketed.

Marketing authorization holder:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Krka Polska Sp. z o.o.
Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: