Dorminox

Before starting to use this medicine, read the leaflet carefully and familiarize yourself

with the "Patient Information" attached to the medicine packaging. To use the medicine safely,
you must answer all the questions contained in the information. The medicine is intended only for adult patients.

Leaflet attached to the packaging: patient information

Dorminox, 12.5 mg, coated tablets

Doxylamine hydrogen succinate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Dorminox and what is it used for
• 2. Important information before using Dorminox
• 3. How to use Dorminox
• 4. Possible side effects
• 5. How to store Dorminox
• 6. Contents of the packaging and other information

1. What is Dorminox and what is it used for

Dorminox is a medicine that contains doxylamine as the active substance. Doxylamine belongs to a group of sedating antihistamines.
The medicine is used for short-term, symptomatic treatment of occasional insomnia in adults, especially in cases of:

• difficulty falling asleep,
• frequent nighttime awakenings,
• early morning awakenings related to stress or time zone changes.

Sleep is extremely important. Sleep disorders can negatively affect physiological processes and lead to a decrease in psychophysical fitness. We talk about insomnia, among other things, when:
the time it takes to fall asleep exceeds half an hour, the total time spent awake during the night lasts longer than half an hour,
such disruption occurs at least three nights a week and poor sleep quality causes fatigue or decreased psychophysical fitness during the day.
Transient sleep disorders usually last a few days and are related to the occurrence of certain factors, such as illness, anxiety, noise, inappropriate ambient temperature, or time zone changes.
Taking medication is not the primary method of treating sleep disorders and should be limited to short-term use only.
Prolonged poor sleep quality may be a symptom of psychological and physical disorders that require other treatment methods, which should be assessed by a doctor. Consulting a doctor is also necessary in case of symptoms other than insomnia. Failure to properly diagnose the cause of sleep disorders and their treatment may pose a risk to health. Treating the underlying disease that causes sleep disorders is a necessary condition for lasting improvement in sleep quality.
The medicine should not be used to treat chronic sleep disorders.
The treatment period should be as short as possible. Treatment usually lasts from a few days to 1 week. The medicine should not be used for more than 7 days without consulting a doctor.
If after 7 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before using Dorminox

When not to use Dorminox

• -If the patient is allergic to doxylamine or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to other antihistamines (anti-allergic medicines).
• If the patient has respiratory disorders such as asthma, chronic bronchitis (persistent cough with sputum production), or chronic obstructive pulmonary disease (difficulty breathing).
• If the patient has glaucoma (increased eye pressure).
• If the patient has an enlarged prostate (excessive prostate growth), difficulty urinating, or urinary retention.
• If the patient has narrowing of the gastrointestinal tract due to stomach ulcers or pyloric stenosis (difficulty passing food from the stomach to the intestine).
• If the patient has severe kidney or liver disorders.
• If the patient is taking monoamine oxidase inhibitors (see section "Dorminox and other medicines").
• If the patient is taking certain medicines, such as antidepressants, certain antibiotics, heart medicines (e.g., those used to treat arrhythmias), certain antiviral or antifungal medicines, or certain medicines that affect lipid levels in the blood or quinidine (a medicine used to treat arrhythmias) (see section "Dorminox and other medicines").
• If the patient is breastfeeding.

Warnings and precautions

Before starting to use Dorminox, you should discuss it with your doctor or pharmacist in case of:

• mild or moderate liver or kidney disorders, as this may require dose adjustment;
• epilepsy (antihistamines may sometimes cause overexcitement and, as a result, lower the seizure threshold);
• prolonged QT interval on the ECG (a heart condition that can lead to sudden changes in heart rate in response to exertion or stress);
• low potassium levels in the blood or other electrolyte disturbances;
• urinary retention;
• heart disease;
• taking other medicines that can be harmful to the ear, such as carboplatin or cisplatin (medicines used to treat cancer), chloroquine (a medicine used to treat or prevent malaria), or certain antibiotics (used to treat infections) such as erythromycin or aminoglycosides in injectable form, as Dorminox may mask the harmful effects of these medicines on hearing.

Patient over 65 years of age are more likely to experience side effects (see section 4).
You should always take the medicine as described in the patient leaflet or as directed by your doctor or pharmacist. Improper use of the medicine, including taking it for too long or exceeding the recommended doses, may cause side effects. The patient should observe their reaction to the medicine, including possible side effects (see section 4) or symptoms of overdose (see section 3 "Taking a higher dose of Dorminox than recommended").
You should not exceed the recommended dose. You should not take Dorminox for a period longer than 7 days unless advised by a doctor.
If you experience drowsiness during the day, it is recommended to reduce the dose or take it earlier to ensure at least an 8-hour interval between taking the medicine and waking up.
Dorminox may exacerbate dehydration and heat stroke due to decreased sweating, especially during heatwaves. Caution should be exercised, especially in elderly patients.
You should not drink alcohol while taking Dorminox (see section "Dorminox with food, drink, and alcohol").

Children and adolescents

Dorminox is not indicated for use in children and adolescents under 18 years of age and should not be used in this patient group.

Dorminox and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should nottake Dorminox if you are taking the following medicines:

• monoamine oxidase inhibitors (e.g., medicines used to treat depression, Parkinson's disease, or other conditions, such as moclobemide, phenelzine, and tranylcypromine, isocarboxazid, linezolid, methylene blue, procarbazine, rasagiline, and selegiline);
• medicines used to treat arrhythmias (amiodarone);
• certain macrolide antibiotics (clarithromycin, erythromycin, telithromycin);
• certain medicines that affect lipid levels in the blood (gemfibrozil);
• certain medicines used to treat depression (such as fluoxetine, fluvoxamine, paroxetine, nefazodone, bupropion);
• protease inhibitors (indinavir, ritonavir, telaprevir);
• antifungal agents from the azole group (fluconazole, ketoconazole, itraconazole, voriconazole) and terbinafine,
• quinidine (an anti-arrhythmic medicine).

You should avoid taking Dorminox if you are taking the following medicines, as it may increase their effect or cause side effects:

• adrenaline (used to treat low blood pressure);
• certain medicines used to treat malaria;
• certain antihistamines;
• certain diuretics (medicines that increase urine production);
• other medicines that act on the central nervous system, such as barbiturates, other sedatives, anxiolytics, or medicines used to treat insomnia or anxiety disorders (alprazolam, diazepam, zolpidem), opioid analgesics (codeine), psychotropic medicines (chlorpromazine, risperidone, amitriptyline, trazodone), or procarbazine (an anticancer medicine);
• medicines used to treat hypertension, such as guanabenz, clonidine, or methyldopa;
• antipsychotic medicines (used to treat mental disorders);
• medicines used to treat spasms (e.g., atropine, belladonna alkaloids, scopolamine);
• disopyramide (an anti-arrhythmic medicine);
• antihistamines used on the skin (diphenhydramine in cream, ointment, or spray form);
• medicines where there is a small difference between the therapeutic dose and the toxic dose (e.g., phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin).

Dorminox with food, drink, and alcohol

There are no special recommendations for taking this medicine before or after a meal.
It is not recommended to drink grapefruit juice while taking Dorminox.
You should not drink alcohol while taking Dorminox.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Dorminox should not be used in pregnant women unless advised by a doctor.
Dorminox passes into breast milk. Due to the risk associated with the use of antihistamines in small children, the medicine should not be used in breastfeeding women.
There is no available data on the effect of Dorminox on fertility.

Driving and using machines

Dorminox has a significant impact on the ability to drive and use machines, as it causes drowsiness. During the first few days of treatment, until it is determined how Dorminox affects the patient, you should not drive or operate machines.

Dorminox contains yellow orange, lake (E 110), red carnation, lake (E 124), and sodium

The medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to use Dorminox

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.

Adults (18 years and older)

The recommended initial dose is 12.5 mg (1 tablet) taken 30 minutes before bedtime.
The dose can be increased to 25 mg (2 tablets) if the initial dose does not provide sufficient relief from insomnia symptoms.
Before taking doxylamine, you should ensure that there is enough time for sleep (8 hours) to avoid drowsiness the next morning.
If you experience drowsiness during the day, it is recommended to take the dose earlier to ensure at least an 8-hour interval between taking the medicine and waking up or, in the case of a 25 mg dose, reduce the dose to 12.5 mg (1 tablet) the next time.
You should not take more than 2 tablets (25 mg) per day.
Patient with persistent sleep problems should consult their doctor.
Tablets should be swallowed 30 minutes before planned sleep, with a sufficient amount of liquid (e.g., a glass of water). The medicine can be taken with or after food.
The dividing line on the tablet is only to facilitate breaking it, to make it easier to swallow, and not to divide it into equal doses.

Use in elderly patients

In patients over 65 years of age, it is more likely that other diseases will occur that may require a dose reduction. The recommended initial dose is 12.5 mg (1 tablet), given 30 minutes before bedtime. The dose can 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 per day (1 tablet). Therefore, you should pay attention to the effects of treatment (see section 4).

Use in patients with liver or kidney disorders

The medicine is contraindicated in patients with severe liver or kidney disorders.
In patients with moderate liver or kidney disease, before taking the medicine, you should consult a doctor who will decide on treatment. In the case of patients with mild liver or kidney disorders, the doctor will recommend reducing the daily dose to 12.5 mg.

Use in children and adolescents

Dorminox is not indicated for use in children and adolescents under 18 years of age and should not be used in this patient group.

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 a period longer than 7 days without consulting a doctor.

Taking a higher dose of Dorminox than recommended

In case of taking a higher dose of Dorminox than recommended, you should immediately consult a doctor.
Symptoms of overdose are: drowsiness, central nervous system depression or stimulation, anticholinergic effects (dilated pupils, fever, dry mouth, decreased smooth muscle tone in the intestines), heat stroke, increased or changed heart rate, elevated blood pressure, nausea, vomiting, stimulation, unsteady gait, dizziness, irritability, sedation, disorientation, and hallucinations.
Severe poisonings can cause delirium, psychotic disorders, decreased blood pressure, seizures, decreased respiratory rate, loss of consciousness, coma, and can be life-threatening.
A severe complication is rhabdomyolysis (muscle breakdown), followed by kidney failure.
There is no specific antidote in case of overdose of antihistamines. If necessary, symptomatic and supportive treatment should be applied. The doctor will decide whether to induce vomiting, perform gastric lavage, or prescribe medicines to increase blood pressure.

Missing a dose of Dorminox

You should not take a double dose to make up for a missed dose.
You should take the next dose at the usual time.

Stopping Dorminox treatment

If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects caused by doxylamine are usually mild and transient and occur more frequently during the first few days of treatment.
Very common side effects (more than 1 in 10 people):

• drowsiness.

Common side effects (less than 1 in 10 people):

• blurred vision,
• vertigo of vestibular origin,
• increased mucus production in the bronchi,
• dry mouth, constipation,
• urinary retention,
• insomnia, stimulation,
• vertigo, headache,
• upper abdominal pain,
• fatigue.

Uncommon side effects (less than 1 in 100 people):

• double vision,
• tinnitus (ringing in the ears),
• orthostatic hypotension (decreased blood pressure due to changes in body position),
• nausea, vomiting, diarrhea,
• skin rash,
• weakness (feeling of fatigue), peripheral edema (hands and feet),
• nightmares,
• shortness of breath (shortness of breath),
• indigestion,
• feeling of relaxation.

Rare side effects (less than 1 in 1000 people):

• decreased red blood cell count, white blood cell count, or platelet count,
• stimulation (especially in elderly people),
• tremors, seizures.

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

• general malaise.

Other side effects usually caused by antihistamines, which have not been observed with doxylamine, include: arrhythmias (changes in heart rate), palpitations, bile reflux, liver disorders (cholestatic jaundice), prolonged QT interval on the ECG (heart disease), loss of appetite, increased appetite, muscle pain, coordination disorders, extrapyramidal disorders (movement disorders), paresthesia (sensory disturbances), psychomotor disorders (sensory or motor coordination), depression, decreased mucus production in the bronchi, hair loss, allergic skin inflammation, excessive sweating, hypersensitivity to light, hypotension (low blood pressure).
The intensity and frequency of side effects can be controlled by reducing the daily dose.
Adults over 65 years of age are more likely to experience side effects, as they may have other diseases or be taking other medicines. These people are also more likely to experience falls.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should 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
Website: https://smz.ezdrowie.gov.pl
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 Dorminox

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storing the 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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does Dorminox contain

• The active substance of the medicine is doxylamine succinate. Each coated tablet contains 12.5 mg of doxylamine succinate.
• The other ingredients are: calcium hydrogen phosphate dihydrate; microcrystalline cellulose; sodium carboxymethylcellulose (type A); colloidal anhydrous silica; magnesium stearate; hypromellose (15 mPa s), polydextrose; talc; titanium dioxide (E 171); maltodextrin; medium-chain triglycerides; red carnation lake (E 124); yellow orange lake (E 110); quinoline yellow lake (E 104).

What does Dorminox look like and what does the pack contain

Red, round, coated tablet with a dividing line on one side, with a diameter of 7.5 mm.
The dividing line on the tablet is only to facilitate breaking it, to make it easier to swallow, and not to divide it into equal doses.
The medicine is available in aluminum/PVC/PCTFE blisters containing 7, 14, or 20 coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares Madrid
Spain

Date of last revision of the leaflet: