Sonoxen

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

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

Leaflet attached to the packaging: information for the user

Sonoxen, 12.5 mg, coated tablets

Doxylamine hydrogen succinate

Read the contents of the leaflet carefully before taking 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 advised by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, 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 Sonoxen and what is it used for
• 2. Important information before taking Sonoxen
• 3. How to take Sonoxen
• 4. Possible side effects
• 5. How to store Sonoxen
• 6. Contents of the packaging and other information

1. What is Sonoxen and what is it used for

Sonoxen is a medicine that contains the active substance doxylamine succinate. Doxylamine belongs to a group of antihistamine medicines with sedative and calming effects. The medicine is indicated for short-term, symptomatic treatment of occasional insomnia in adults over 18 years of age, especially when there are difficulties falling asleep, frequent nighttime awakenings, or early morning awakenings. Sleep disorders can negatively affect physiological processes and lead to a decrease in psychophysical performance. Insomnia is said to occur when the time to fall asleep exceeds half an hour, the total time awake during the night lasts longer than half an hour, such disturbances occur at least three nights a week, and poor sleep quality causes fatigue or decreased psychophysical performance during the day. Transient sleep disturbances usually last a few days and are associated with the occurrence of certain factors, such as illness, anxiety, noise, inappropriate ambient temperature, or a change in time zone. 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 mental 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 lead to health risks. Treating the underlying disease causing 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 one 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 taking Sonoxen

When not to take Sonoxen

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to other antihistamine medicines (anti-allergic medicines).
• If the patient is breastfeeding.
• 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 prostate enlargement (benign prostatic hyperplasia), difficulty urinating, or urinary retention.
• If the patient has peptic ulcer disease or narrowing of the pyloric or duodenal area (difficulty passing food from the stomach to the intestine).
• If the patient is taking monoamine oxidase inhibitors (medicines used to treat depression and Parkinson's disease).
• If the patient is taking certain medicines, such as antidepressants, certain antibiotics, heart medicines (e.g., those used to treat arrhythmias), certain antiviral medicines, and certain antifungal medicines.
• If the patient has severe kidney or liver impairment.

Warnings and precautions

Before starting to take Sonoxen, discuss it with a doctor or pharmacist.

• The patient must inform their doctor before starting to take the medicine if they have:
• mild or moderate liver or kidney impairment, as this may require dose adjustment;
• epilepsy (antihistamine medicines may sometimes cause overexcitement and thus lower the seizure threshold);
• prolonged QT interval (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;
• heart disease and high blood pressure.
• In case of daytime drowsiness, the patient is advised to reduce the dose or take the dose earlier to ensure at least an 8-hour interval between taking the medicine and waking up.
• In case of taking other medicines that may be harmful to hearing, such as:

carboplatin or cisplatin (medicines used to treat cancer), chloroquine (a medicine used to treat or prevent malaria), and certain antibiotics (used to treat infections) such as erythromycin or aminoglycosides in injection form, Sonoxen may mask the harmful effects of these medicines. Therefore, regular hearing tests should be performed.

• Sonoxen may exacerbate dehydration and heat stroke due to reduced sweating, especially during heatwaves.
• Alcohol should not be consumed during treatment.
• Patient over 65 years of age may be more susceptible to side effects. Therefore, the effects of treatment should be monitored (see section 4).
• During treatment with doxylamine, grapefruit should be avoided.
• If the patient is taking medicines such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, or vancomycin, they should avoid taking doxylamine, as it may cause acute poisoning.

Sonoxen should not be taken for more than 7 days without consulting a doctor.

Children and adolescents

Sonoxen is not indicated for use in children and adolescents under 18 years of age.

Sonoxen and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Sonoxen should not be taken during treatment with 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 such as those used to treat arrhythmias (amiodarone, quinidine), certain macrolide antibiotics (clarithromycin, erythromycin, telithromycin), certain medicines that lower lipid levels in the blood (gemfibrozil), certain antidepressants (such as fluoxetine, fluvoxamine, paroxetine, nefazodone, and bupropion), protease inhibitors (indinavir, ritonavir, telaprevir), and antifungal agents from the azole group (fluconazole, ketoconazole, itraconazole, voriconazole, terbinafine).

Patients should avoid taking Sonoxen during treatment with the following medicines, as it may increase their effects or cause side effects:

• adrenaline (used to treat low blood pressure);
• certain medicines used to treat malaria or certain antihistamine medicines;
• certain diuretics (medicines that increase urine production);
• alcohol and other medicines that act on the central nervous system, such as barbiturates, sleeping pills, sedatives, other medicines used to treat insomnia or anxiety disorders (alprazolam, diazepam, zolpidem), opioid painkillers (codeine), psychotropic medicines (chlorpromazine, risperidone, amitriptyline, trazodone), or procarbazine;
• antihypertensive medicines that act on the central nervous system, such as guanabenz, clonidine, or methyldopa;
• other cholinolytic medicines, such as antipsychotic medicines (used to treat mental disorders), medicines used to treat spastic conditions (e.g., atropine, belladonna alkaloids), or disopyramide (used to treat certain heart conditions);
• antihistamine medicines used on the skin (diphenhydramine cream, ointment, spray) and scopolamine;
• medicines with a narrow therapeutic index (e.g., phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin).

Effect on laboratory test results

Doxylamine may affect the results of allergic skin tests. Patients are advised to stop taking Sonoxen 3 days before undergoing such tests.

Sonoxen with food, drink, and alcohol

During treatment with Sonoxen, do not drink alcohol.
It is not known whether grapefruit juice inhibits the metabolism of doxylamine. Patients should avoid consuming grapefruit during treatment with doxylamine.
See section 3. How to take Sonoxen.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Sonoxen should not be used in pregnant women.
Due to the risk associated with the use of antihistamine medicines in small children, Sonoxen should not be used in breastfeeding women.
There is no available data on the effect of Sonoxen on fertility.

Driving and using machines

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

Sonoxen contains cochineal red (E 124) and orange yellow (E 110)

This medicine may cause allergic reactions.

3. How to take Sonoxen

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

Adults (over 18 years of age)

The recommended dose is 1 to 2 tablets (12.5 mg to 25 mg) per day, taken 30 minutes before bedtime. In case of daytime drowsiness, the dose should be reduced to 1 tablet (12.5 mg) or taken earlier to ensure at least an 8-hour interval between taking the medicine and waking up. Do not take more than 2 tablets (25 mg) per day.

Use in the elderly

Sonoxen is not recommended for use in patients over 65 years of age. Elderly patients are more susceptible to other conditions that may be associated with sleep disorders, and therefore, appropriate therapy requires medical consultation.

Use in patients with liver or kidney impairment

The medicine is contraindicated in patients with severe liver or kidney impairment. In patients with moderate and mild liver and/or kidney disease, before taking the medicine, they should consult a doctor who will decide on the treatment. In patients with mild kidney and liver impairment, the recommended daily dose should be reduced to 12.5 mg, and the dose should be taken earlier to avoid daytime drowsiness.

Use in children and adolescents

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

Route and method of administration

Oral administration. The tablets should be taken 30 minutes before bedtime, with a sufficient amount of liquid (preferably water). Sonoxen can be taken with or after 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 more than 7 days without consulting a doctor.

Taking a higher dose of Sonoxen than recommended

In case of taking a higher dose of Sonoxen than recommended, the patient 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 poisoning can cause delirium, psychotic disorders, decreased blood pressure, seizures, decreased respiratory rate, loss of consciousness, coma, and can be life-threatening. A serious complication is rhabdomyolysis (muscle breakdown), followed by kidney failure. There is no specific antidote in case of antihistamine overdose. 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 Sonoxen

A double dose should not be taken to make up for a missed dose. The next dose should be taken at the usual time the following day.

Stopping treatment with Sonoxen

In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Sonoxen 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(occurring in more than 1 in 10 people): drowsiness. Common side effects(occurring in less than 1 in 10 people): symptoms such as dry mouth, constipation, blurred vision, urinary retention, increased mucus production in the bronchi, dizziness, drowsiness, headaches, abdominal pain, fatigue, insomnia, nervousness. Uncommon side effects(occurring in less than 1 in 100 people): weakness (feeling of fatigue), peripheral edema (swelling of hands and feet), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (decrease in blood pressure due to changes in body position), diplopia (double vision), dyspepsia (indigestion), feeling of relaxation, nightmares, and shortness of breath. Rare side effects(occurring in less than 1 in 1000 people): stimulation (especially in elderly patients), tremors, seizures, or hematologic disorders such as hemolytic anemia, thrombocytopenia, leukopenia, or agranulocytosis (decrease in the number of certain types of blood cells). Side effects with unknown frequency(cannot be estimated from the available data): general malaise. Other side effectsusually caused by antihistamine medicines, which have not been observed with doxylamine, include: cardiac arrhythmias (changes in heart rate), palpitations, bile reflux, liver dysfunction (cholestatic jaundice), QT interval prolongation (heart condition), loss of appetite, increased appetite, muscle pain, coordination disorders, extrapyramidal disorders (movement disorders), paresthesia (sensory disturbances), psychomotor disorders (sensory/motor coordination), depression, decreased mucus production in the bronchi, hair loss, allergic skin inflammation, excessive sweating, hypersensitivity to light, or hypotension (low blood pressure). The intensity and frequency of side effects can be controlled by reducing the daily dose. Patients over 65 years of age are more susceptible to side effects, as they may have other conditions or take other medicines. These patients are also more susceptible to falls.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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, more information can be collected on the safety of the medicine.

5. How to store Sonoxen

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month. The medicine does not require special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask a 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 Sonoxen contains

• The active substance of the medicine is doxylamine succinate. One coated tablet contains 12.5 mg of doxylamine succinate.
• Other ingredients are: Core excipients: Calcium hydrogen phosphate dihydrate, Microcrystalline cellulose, Sodium carboxymethylcellulose (Type A), Colloidal anhydrous silica, Magnesium stearate

Coating excipients:
Hypromellose
Polidekstroza
Talc
Titanium dioxide (E 171)
Maltodextrin
Medium-chain triglycerides
Cochineal red, lake (E 124)
Orange yellow, lake (E 110)
Quinoline yellow, lake (E 104)

What Sonoxen looks like and contents of the pack

Sonoxen is a red, round, coated tablet with a diameter of 7.5 mm and a notch on one side. The notch is not a dividing line for the tablet and serves only a decorative purpose. Aluminum/PVC/PCTFE blister pack in a cardboard box. The pack contains 7 or 14 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
"Polski Lek – Dystrybucja" Sp. z o.o.
ul. Chopina 10
34-100 Wadowice
Tel.: +48 33 870 83 01
e-mail: [email protected]
Manufacturer
Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82, Alcalá de Henares,
28802 Madrid
Spain

Date of last revision of the leaflet: