Sonoxen Forte

Package Leaflet: Information for the User

Sonoxen, 25 mg, coated tablets

Doxylamine hydrogen succinate

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

• 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the package 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 pack 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 a sedative effect. The medicine is indicated for short-term, symptomatic treatment of occasional insomnia in adults over 18 years of age.

2. Important information before taking Sonoxen

When not to take Sonoxen

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other antihistamine medicines.
• If you are breastfeeding.
• If you have respiratory disorders such as asthma, chronic bronchitis (persistent cough with mucus and phlegm production) or chronic obstructive pulmonary disease (difficulty breathing).
• If you have glaucoma (increased eye pressure).
• If you have prostate enlargement (benign prostatic hyperplasia), difficulty urinating, or urinary retention.
• If you have peptic ulcer disease or narrowing of the pyloric or duodenal area (difficulty passing food from the stomach to the intestine).
• If you are taking monoamine oxidase inhibitors (used to treat depression, Parkinson's disease, or other conditions).
• If you are taking certain medicines, such as antidepressants, certain antibiotics, heart medicines (e.g., used to treat arrhythmias), certain antiviral or antifungal medicines, or certain cholesterol-lowering medicines.
• If you have severe kidney or liver impairment.

Warnings and precautions

Before taking Sonoxen, discuss it with your doctor or pharmacist.

• You must inform your doctor before taking the medicine if you have:
• mild or moderate liver or kidney impairment, as this may require dose adjustment;
• epilepsy (antihistamines may sometimes cause overexcitement and 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 or other electrolyte disturbances;
• heart disease or high blood pressure.
• If you experience drowsiness during the day, it is recommended to reduce the dose or take it earlier to ensure at least 8 hours between taking the medicine and waking up.
• If you are taking other medicines that may be harmful to your hearing, such as carboplatin or cisplatin (used to treat cancer), chloroquine (used to treat or prevent malaria), or certain antibiotics (used to treat infections), 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 decreased sweating, especially during heatwaves.
• Do not drink alcohol during treatment.
• Patient over 65 years may be more prone to side effects. Therefore, attention should be paid to treatment effects (see section 4).
• Avoid consuming grapefruits while taking doxylamine.
• If you are taking medicines such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, or vancomycin, avoid taking doxylamine, as it may cause acute poisoning.

Do not take Sonoxen for more than 7 days, unless your doctor recommends it.

Children and adolescents

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

Sonoxen and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• Do not take Sonoxen with the following medicines:
• monoamine oxidase inhibitors (e.g., 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 cholesterol-lowering medicines (gemfibrozil), certain antidepressants (such as fluoxetine, fluvoxamine, paroxetine, nefazodone, bupropion), protease inhibitors (indinavir, ritonavir, telaprevir), and antifungal medicines (fluconazole, ketoconazole, itraconazole, voriconazole, terbinafine).

Patients should avoid taking Sonoxen 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 antihistamines;
• certain diuretics (medicines that increase urine production);
• alcohol and other medicines that act on the central nervous system, such as barbiturates, sedatives, anxiolytics, or other sleep aids (alprazolam, diazepam, zolpidem), opioid painkillers (codeine), or psychotropic medicines (chlorpromazine, risperidone, amitriptyline, trazodone) or procarbazine;
• antihypertensive medicines that act on the central nervous system, such as guanabenz, clonidine, or methyldopa;
• other anticholinergic medicines, such as antipsychotics (used to treat mental disorders), medicines used to treat spasms (e.g., atropine, belladonna alkaloids), or dyssopiramides (used to treat certain heart conditions);
• antihistamines 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 tests

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

Sonoxen with food, drink, and alcohol

Do not drink alcohol during treatment with Sonoxen.

It is not known whether grapefruit juice inhibits the metabolism of doxylamine. Patients should avoid consuming grapefruits while taking doxylamine.

See section 3. How to take Sonoxen.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.

There is insufficient data on the use of doxylamine in pregnant women, so Sonoxen should be avoided in pregnant women.

Due to the risk associated with the use of antihistamines 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 effect on the ability to drive and use machines, as it causes drowsiness. During the first few days of treatment, do not drive or operate machinery until you know how Sonoxen affects you.

Sonoxen contains lactose

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

3. How to take Sonoxen

Always take this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Adults (over 18 years)

The recommended dose is 1 tablet (25 mg) per day, taken 30 minutes before bedtime.

If you experience drowsiness during the day, it is recommended to reduce the dose to 12.5 mg or take it earlier to ensure at least 8 hours between taking the medicine and waking up.

The score line on the tablet is only for decorative purposes and does not divide the tablet into equal doses.

If the recommended dosing regimen cannot be achieved with Sonoxen FORTE 25 mg tablets, other doxylamine preparations with a dose of 12.5 mg are available on the market, e.g., Sonoxen 12.5 mg, coated tablets.

Do not take more than 1 tablet (25 mg) per day.

Elderly patients

In adults over 65 years, it is more likely that other conditions may require dose reduction. The recommended initial dose is 12.5 mg (1 tablet of 12.5 mg), taken 30 minutes before bedtime. The dose can be increased to 25 mg (1 tablet) if the initial dose is ineffective. If side effects occur, the dose should be reduced to 12.5 mg per day. Therefore, attention should be paid to treatment effects (see section 4).

The score line on the tablet is only for decorative purposes and does not divide the tablet into equal doses.

If the recommended dosing regimen cannot be achieved with Sonoxen FORTE 25 mg tablets, other doxylamine preparations with a dose of 12.5 mg are available on the market, e.g., Sonoxen 12.5 mg, coated tablets.

Patients with liver or kidney impairment

Doxylamine is contraindicated in patients with severe kidney or liver impairment, as well as in end-stage renal failure; it should also be avoided in patients with moderate kidney or liver impairment.

In patients with mild kidney or liver impairment, the recommended daily dose should be reduced to 12.5 mg.

Children and adolescents

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

Route and method of administration

Oral use.

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.

Do not take Sonoxen for more than 7 days, unless your doctor recommends it.

Overdose

If you take more than the recommended dose of Sonoxen, inform your doctor immediately.

Symptoms of overdose are: drowsiness, central nervous system depression or stimulation, anticholinergic effects (dilated pupils, fever, dry mouth, decreased gastrointestinal motility), heat stroke, increased or changed heart rate, high blood pressure, nausea, vomiting, excitement, unsteady gait, dizziness, irritability, sedation, disorientation, and hallucinations.

Severe poisonings can cause delirium, psychotic disorders, low 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.

Missed dose

Do not take a double dose to make up for a missed dose.

Take the next dose at the usual time.

Stopping treatment

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sonoxen can cause side effects, although not everybody gets them.

Sonoxen side effects are usually mild and temporary, and more frequently occur during the first few days of treatment.

Very common side effects (occurring in more than 1 in 10 people): daytime 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, headache, 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 (low blood pressure when changing 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): excitement (especially in elderly patients), tremors, seizures, or hematologic disorders such as hemolytic anemia, thrombocytopenia, leukopenia, or agranulocytosis (decreased white blood cell count).

Side effects with unknown frequency (cannot be estimated from available data): general malaise.

Other side effects that are usually caused by antihistamines, but not observed with doxylamine, include: arrhythmias (changes in heart rate), palpitations, bile reflux, liver function disorders (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.

Adults over 65 years are more prone to side effects, as they may have other conditions or take other medicines. They are also more prone to falls.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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.

By reporting side effects, you can help provide more information on the safety of this medicine.

Side effects can also be reported to the marketing authorization holder.

5. How to store Sonoxen

Keep this medicine out of the 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.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sonoxen contains

• The active substance is doxylamine succinate. One coated tablet contains 25 mg of doxylamine succinate.
• The other ingredients are: Core: Calcium hydrogen phosphate dihydrate, Microcrystalline cellulose, Sodium carboxymethylcellulose (Type A), Colloidal anhydrous silica, Magnesium stearate.

Coating: Hypromellose, Titanium dioxide (E 171), Lactose monohydrate, Macrogol 4000.

What Sonoxen looks like and contents of the pack

Sonoxen is a white, round, coated tablet with a diameter of 7.5 mm, with a score line on one side. The score line is only for decorative purposes and does not divide the tablet into equal doses.

Aluminium/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: