DORMINOX

Before using this medicine, read the leaflet carefully and familiarize yourself with the
"Patient Information Guide" included in the medicine package. To use the medicine safely,
you must answer all the questions contained in the guide. This medicine is intended only for adult patients.

Package leaflet: Information for the patient

Dorminox, 12.5 mg, coated tablets
Doxylamine hydrogen succinate
Please read this leaflet carefully 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 a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, contact your doctor.

Contents of the leaflet

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

1. What Dorminox is and what it is used for

Dorminox is a medicine containing doxylamine as the active substance. Doxylamine belongs to a group of antihistamine medicines with sedative and calming effects.
This medicine is used for short-term, symptomatic treatment of occasional insomnia in adults, particularly in cases involving:

• difficulty falling asleep,
• frequent awakenings during the night,
• early morning awakening associated with stress or changes in time zones.

Sleep is extremely important. Sleep disturbances may negatively affect physiological processes and lead to reduced psycho-physical performance. Insomnia is defined, among other criteria, as:
a sleep onset time exceeding half an hour, total wakefulness during the night lasting longer than half an hour, such disturbances occurring at least three nights per week, and poor sleep quality leading to fatigue or reduced daytime psycho-physical performance.
Transient sleep disturbances usually last for several days and are associated with certain factors such as illness, anxiety, noise, inappropriate ambient temperature, or time zone changes.
Taking medicines is not the primary method of treating sleep disorders and should be limited to short-term use only.
Persistent poor sleep quality may be a symptom of psychological or physical disorders requiring different treatment approaches, which should be evaluated by a doctor. Consulting a doctor is also necessary if symptoms other than insomnia are present. Failure to properly diagnose and treat the underlying cause of sleep disturbances may pose a health risk. Treating the underlying condition causing sleep disturbances is essential for achieving lasting improvement in sleep quality.
This medicine must not be used to treat chronic sleep disorders.
Treatment duration should be as short as possible. Treatment usually lasts from a few days to 1 week. This medicine should not be used for longer than 7 days without consulting a doctor.
If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

2. Important information before taking Dorminox

When not to take 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 (antiallergy medicines).
• If the patient has respiratory disorders such as asthma, chronic bronchitis (persistent cough associated with sputum and mucus production), or emphysema (difficulty breathing).
• If the patient has glaucoma (increased pressure in the eye).
• If the patient has benign prostatic hyperplasia (enlarged prostate), difficulty passing urine from the bladder (urinary tract disorder), or has trouble urinating.
• If the patient has narrowing of the gastrointestinal tract due to peptic ulcer or pyloroduodenal stenosis (difficulty in food passage from the stomach to the intestine).
• If the patient has severe kidney or liver impairment.
• If the patient is taking monoamine oxidase inhibitors (see section Dorminox and other medicines).
• If the patient is taking certain medicines, e.g. antidepressants, some antibiotics, cardiac medicines such as those used to treat cardiac arrhythmias, some antiviral and antifungal medicines, some lipid-lowering agents, or quinidine (a medicine used to treat seizures) (see section Dorminox and other medicines).
• If the patient is breastfeeding.

Warnings and precautions
Before starting to take Dorminox, consult a doctor or pharmacist if:

• The patient has mild or moderate liver or kidney impairment, as this may require dose adjustment.
• The patient has epilepsy (antihistamines may sometimes cause hyperexcitability and consequently lower the seizure threshold).
• The patient has QT interval prolongation on ECG (a heart condition leading to sudden changes in heart rate in response to exertion or stress).
• The patient has low blood potassium levels or other electrolyte imbalances.
• The patient has urinary retention.
• The patient has heart disease.
• The patient is taking other medicines that may be ototoxic, such as carboplatin or cisplatin (medicines used in cancer treatment), chloroquine (used to treat or prevent malaria), or certain antibiotics (used to treat infections) such as erythromycin or parenteral aminoglycosides, because Dorminox may mask the ototoxic effects of these medicines.

Patients aged over 65 years are more susceptible to adverse effects (see section 4).
Always take the medicine exactly as stated in this patient information leaflet or as directed by a doctor or pharmacist. Improper use of the medicine, including prolonged use or exceeding recommended doses, may cause adverse effects. The patient should monitor their response to the medicine, including possible adverse effects (see section 4) or symptoms of overdose (see section 3 "If you take more Dorminox than you should").
Do not exceed the recommended dose. Do not take Dorminox for longer than 7 days unless otherwise advised by a doctor.
If daytime drowsiness occurs, the patient is advised to reduce the dose or take it earlier, ensuring at least an 8-hour interval between taking the medicine and waking up.
Dorminox may increase the risk of dehydration and heat stroke due to reduced sweating, especially during hot weather. Extra caution is required, particularly in elderly patients.
Do not drink alcohol while taking this medicine (see section Dorminox with food, drink and alcohol).

Effect on laboratory tests
Dorminox may affect the results of allergic skin tests. Patients are advised to discontinue Dorminox at least 3 days before undergoing such tests.

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
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Dorminox if you are taking any of 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 used to treat cardiac arrhythmias (amiodarone).
• Certain macrolide antibiotics (clarithromycin, erythromycin, telithromycin).
• Certain lipid-lowering agents (gemfibrozil).
• Certain antidepressants (such as fluoxetine, fluvoxamine, paroxetine, nefazodone, bupropion).
• Antiviral protease inhibitors (indinavir, ritonavir, telaprevir).
• Antifungal azole compounds (fluconazole, ketoconazole, itraconazole, voriconazole) and terbinafine.
• Quinidine (an antiarrhythmic medicine).

Avoid taking Dorminox if you are taking any of the following medicines, as this may increase their effects or lead to adverse reactions:

• Adrenaline (used to treat low blood pressure).
• Certain medicines used to treat malaria.
• Certain antihistamines.
• Certain diuretics (medicines that increase urine excretion).
• Other medicines with central nervous system depressant effects, e.g. barbiturates, other sleeping medicines, sedatives, other medicines used for 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 psychiatric disorders).
• Medicines used to treat spastic conditions (e.g. atropine, belladonna alkaloids, scopolamine).
• Disopyramide (an antiarrhythmic medicine).
• Topical antihistamines (diphenhydramine in cream, ointment, or aerosol form).
• Medicines with a narrow therapeutic index (small difference between therapeutic and toxic dose), e.g. phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin.

Dorminox with food, drink and alcohol
There are no special instructions regarding taking this medicine before or after meals.
Do not drink grapefruit juice while taking Dorminox.
Do not drink alcohol while taking Dorminox.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before taking this medicine.
Dorminox should not be used during pregnancy unless advised by a doctor.
Dorminox passes into breast milk. Due to the risk associated with antihistamine use in infants, Dorminox must not be used in breastfeeding women.
There are no available data on the effect of Dorminox on fertility.

Driving and using machines
Dorminox has a marked effect on the ability to drive and operate machinery due to drowsiness. During the first few days of treatment, until the patient knows how Dorminox affects them, they should not drive or operate machinery.

Dorminox contains Sunset Yellow, Lake (E 110), Carmoisine, Lake (E 124) and sodium
This medicine may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. this 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 a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults (aged 18 years and older)
The recommended initial 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 does not provide sufficient relief of insomnia symptoms.
Before taking doxylamine, ensure that there is sufficient time available for sleep (8 hours) to avoid next-day drowsiness.
If daytime drowsiness occurs, 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 case of taking a 25 mg dose, to reduce the dose next time to 12.5 mg (1 tablet).
Do not take more than 2 tablets (25 mg) per day.
Patients with persistent sleep problems should consult a doctor.
Tablets should be swallowed whole, 30 minutes before planned sleep, with an adequate amount of liquid (e.g. a glass of water). The medicine may be taken with or without food.
The break line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dose division.

Use in elderly patients
In patients over 65 years of age, other medical conditions are more likely, which may require dose reduction. The recommended initial 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 proves ineffective. If adverse reactions occur, the dose should be reduced to 12.5 mg per day (1 tablet). Therefore, treatment effects should be carefully monitored (see section 4).

Use in patients with hepatic and/or renal impairment
Dorminox is contraindicated in patients with severe impairment of liver and/or kidney function.
In patients with moderate liver and/or kidney disease, consult a doctor before taking the medicine; the doctor will decide on appropriate treatment. In patients with mild hepatic and/or renal impairment, the doctor may 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 several days to one week.
Do not use this medicine for longer than 7 days without consulting a doctor.

Taking more than the recommended dose of Dorminox
If more than the recommended dose of Dorminox has been taken, seek immediate medical advice.
Symptoms of overdose include: drowsiness, central nervous system depression or stimulation, anticholinergic effects (dilated pupils, fever, dry mouth, reduced smooth muscle tone in the intestines), hot flushes, increased or altered heart rate, elevated blood pressure, nausea, vomiting, restlessness, ataxia, dizziness, irritability, sedation, disorientation, and hallucinations.
Severe poisoning may lead to delirium, psychotic disturbances, hypotension, seizures, reduced respiratory rate, loss of consciousness, coma, and may be life-threatening.
A serious complication is rhabdomyolysis (muscle breakdown), which may lead to kidney 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.

Missed dose of Dorminox
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time.

Stopping Dorminox
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 will experience them.
Adverse reactions caused by doxylamine are usually mild and transient, and occur more frequently during the first few days of treatment.

Very common adverse reactions (occur in more than 1 in 10 people):

• drowsiness.

Common adverse reactions (occur in less than 1 in 10 people):

• blurred vision,
• vertigo (dizziness of labyrinthine origin),
• increased mucus secretion in the bronchi,
• dry mouth, constipation,
• urinary retention,
• insomnia, restlessness,
• dizziness, headache,
• upper abdominal pain,
• fatigue.

Uncommon adverse reactions (occur in less than 1 in 100 people):

• double vision,
• tinnitus (ringing in the ears),
• orthostatic hypotension (low blood pressure caused by changes in body position),
• nausea, vomiting, diarrhoea,
• skin rash,
• asthenia (feeling of weakness), peripheral oedema (swelling of hands and feet),
• nightmares,
• dyspnoea (shortness of breath),
• dyspepsia,
• feeling of relaxation.

Rare adverse reactions (occur in less than 1 in 1,000 people):

• decreased number of red blood cells, white blood cells or platelets,
• restlessness (especially in elderly people),
• tremor, convulsions.

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

• malaise (general feeling of being unwell).

Other adverse reactions usually associated with antihistamine medicines, which have not been observed with doxylamine, include: cardiac arrhythmias (changes in heart rate), palpitations, biliary reflux, liver function disorders (cholestatic jaundice), QT interval prolongation in ECG (heart disease), loss of appetite, increased appetite, muscle pain, coordination disorders, extrapyramidal disorders (movement disorders), paraesthesia (sensory disturbances), psychomotor disturbances (sensory or motor coordination), depression, decreased mucus secretion in the bronchi, alopecia, allergic dermatitis, excessive sweating, photosensitivity, hypotension (low blood pressure).

The severity and frequency of adverse reactions can be controlled by reducing the daily dose.

Adults over the age of 65 are more susceptible to adverse reactions, as they may suffer from other medical conditions or be taking other medicines. These individuals are also at increased risk of falls.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: +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 provide more information on the safety of the medicine.

5. How to store Dorminox

Keep Dorminox out of the sight and reach of children.
No special storage instructions are required for this medicinal product.
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 the sewage system 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 Dorminox contains

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

What Dorminox looks like and contents of the pack
Red, round coated tablet with a breakline on one side, 7.5 mm in diameter.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure division into equal doses.
The medicine is available in aluminium/PVC/PCTFE blisters containing 7, 14 or 20 coated tablets, packed in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares, Madrid
Spain
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba