SONOXEN FORTE

Package leaflet: Information for the user

Sonoxen, 25 mg, coated tablets
Doxylamini hydrogenosuccinas
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Sonoxen is and what it is used for

Sonoxen is a medicine containing the active substance doxylamine hydrogen succinate.
Doxylamine belongs to a group of medicines called antihistamines with sedative properties.
The medicine is indicated for short-term, symptomatic treatment of occasional insomnia
in adults aged over 18 years.

2. Important information before taking Sonoxen

When not to take Sonoxen

• If the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to other antihistamines (antiallergy medicines).
• If the woman is breastfeeding.
• If the patient has respiratory disorders such as asthma, chronic bronchitis (persistent cough associated with expectoration of mucus and phlegm), or emphysema (difficulty breathing).
• If the patient has glaucoma (increased pressure in the eye).
• If the patient has benign prostatic hyperplasia (enlarged prostate gland), difficulty in passing urine from the bladder (urinary tract disorder), or has problems urinating.
• If the patient has peptic ulcer disease or duodenal erosion, or pyloroduodenal stenosis (difficulty in food passage from the stomach to the intestine).
• If the patient is taking monoamine oxidase inhibitors (medicines used in depression and Parkinson's disease).
• If the patient is taking certain medicines, e.g. antidepressants, certain antibiotics, cardiac medicines such as those used to treat cardiac arrhythmias, certain antiviral and antifungal medicines, certain lipid-lowering (fat-reducing) agents in blood, or quinidine (a medicine used to treat seizures).
• If the patient has severe kidney or liver function impairment.

Warnings and precautions
Before starting to take Sonoxen, discuss this with your doctor or pharmacist.

• The patient must inform the doctor before starting treatment if any of the following conditions are present:
  • mild or moderate impairment of liver or kidney function, as this may necessitate dose adjustment;
  • epilepsy (antihistamines may occasionally cause hyperexcitability and thus lower the seizure threshold);
  • prolonged QT interval (a heart condition leading to sudden changes in heart rate in response to exertion or stress);
  • low blood potassium levels or other electrolyte imbalances;
  • heart diseases and high blood pressure.
• 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.
• If the patient is taking other medicines that may be harmful to hearing, 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 injectable aminoglycosides, Sonoxen may mask the harmful effects of these drugs. Therefore, regular hearing tests should be performed.
• Sonoxen may worsen symptoms of dehydration and heat stroke caused by reduced sweating, especially during hot weather.
• Alcohol must not be consumed during treatment.
• Patients over 65 years of age may be more susceptible to adverse effects. Therefore, treatment effects should be closely monitored (see section 4).
• Grapefruit consumption should be avoided during use of doxylamine.
• If the patient is taking medicines such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, or vancomycin, doxylamine should be avoided, as this may lead to acute poisoning.

Do not take Sonoxen for longer than 7 days unless otherwise recommended by a physician.
Children and adolescents
Sonoxen is not indicated for use in children and adolescents under 18 years of age.
Sonoxen and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Do not take Sonoxen 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, tranylcypromine, isocarboxazid, linezolid, methylene blue, procarbazine, rasagiline, and selegiline);
• medicines such as: drugs used to treat cardiac arrhythmias (amiodarone, quinidine), certain macrolide antibiotics (clarithromycin, erythromycin, telithromycin), certain lipid-lowering agents (gemfibrozil), certain antidepressants (e.g. fluoxetine, fluvoxamine, paroxetine, nefazodone, bupropion), antiviral protease inhibitors (indinavir, ritonavir, telaprevir), and antifungal azole compounds (fluconazole, ketoconazole, itraconazole, voriconazole, terbinafine).

Patients should avoid taking Sonoxen while using the following medicines, as this may enhance their effects or lead to adverse reactions:

• adrenaline (used to treat low blood pressure);
• certain antimalarial medicines or certain antihistamines;
• certain diuretics (medicines increasing urine excretion);
• alcohol and other medicines acting as central nervous system depressants, e.g. barbiturates, sleeping pills, sedatives, other medicines used for insomnia or anxiety disorders (alprazolam, diazepam, zolpidem), opioid analgesics (codeine), psychotropic medicines (chlorpromazine, risperidone, amitriptyline, trazodone), or procarbazine;
• antihypertensive medicines (used to treat high blood pressure) acting on the central nervous system such as guanabenz, clonidine, or alpha-methyldopa;
• other anticholinergic medicines such as: antipsychotics (used to treat psychiatric disorders), antispasmodic medicines (e.g. atropine, belladonna alkaloids), or disopyramide (used to treat certain heart conditions);
• topical antihistamines (diphenhydramine in cream, ointment, or aerosol form) and scopolamine;
• medicines with a narrow therapeutic index (small difference between therapeutic and toxic dose), e.g. phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin.

Effect on laboratory test results
Doxylamine may affect the results of skin allergy tests. Patients are advised to discontinue Sonoxen at least three days before undergoing such tests.
Sonoxen with food, drink, and alcohol
Do not consume alcohol during treatment with Sonoxen.
It is unknown whether grapefruit juice inhibits doxylamine metabolism. Patients should avoid consuming grapefruit while taking doxylamine.
See section 3. How to take Sonoxen.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
There is insufficient data on the use of doxylamine in pregnant women; therefore, Sonoxen should be avoided during pregnancy.
Due to the risk associated with antihistamine use in infants, Sonoxen must not be used by breastfeeding women.
There is no available data on the effect of Sonoxen on fertility.
Driving and operating machinery
Sonoxen has a major influence on the ability to drive and operate machinery because it causes drowsiness. During the first few days of treatment, until it is established how Sonoxen affects the patient, driving and operating machinery should be avoided.
Sonoxen contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars (e.g. lactose), he or she should consult a doctor before taking this medicine.

3. How to take Sonoxen

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults (aged over 18 years)
The recommended dose is 1 tablet (25 mg) once daily, taken 30 minutes before bedtime.
If daytime drowsiness occurs, it is recommended to reduce the dose from 25 mg to 12.5 mg or to take the dose earlier to ensure at least an 8-hour interval between taking the medicine and waking up.
The score line on the tablet is for aesthetic purposes only and does not divide the tablet into equal doses.
If the recommended dosing regimen cannot be achieved using Sonoxen FORTE 25 mg tablets, other doxylamine preparations with a 12.5 mg dose are available on the market, e.g. Sonoxen 12.5 mg, coated tablets.
Do not take more than 1 tablet (25 mg) per day.

Use in elderly patients
In adults aged over 65 years, other medical conditions are more likely, which 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 may be increased to 25 mg (1 tablet) if the initial dose proves ineffective. If adverse effects occur, the dose should be reduced to 12.5 mg daily. Therefore, the effects of treatment should be closely monitored (see section 4).
The score line on the tablet is for aesthetic purposes only and does not divide the tablet into equal doses.
If the recommended dosing regimen cannot be achieved using Sonoxen FORTE 25 mg tablets, other doxylamine preparations with a 12.5 mg dose are available on the market, e.g. Sonoxen 12.5 mg, coated tablets.

Use in patients with liver or kidney disorders
Doxylamine is contraindicated in patients with severe renal or hepatic impairment, as well as in end-stage renal failure; it should also be avoided in patients with moderate renal or hepatic impairment.
In patients with mild renal or hepatic impairment, the daily dose should be reduced to 12.5 mg.

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

Route and method of administration
Oral administration.
Tablets should be taken 30 minutes before going to bed, with an adequate amount of liquid (preferably water).
Sonoxen may be taken with or without food.

Duration of treatment
Treatment should be as short as possible. Treatment typically lasts from several days to one week.
Do not use this medicine for longer than 7 days unless otherwise directed by a doctor.

Taking more than the recommended dose of Sonoxen
If more than the recommended dose of Sonoxen has been taken, consult a doctor immediately.
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 renal 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 Sonoxen
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time the following day.

Stopping Sonoxen
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 generally mild and transient, and occur more frequently during the first few days of treatment.
Very common adverse reactions (occurring in more than 1 in 10 people): daytime drowsiness.
Common adverse reactions (occurring in less than 1 in 10 people): symptoms such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial mucus secretion, dizziness, lightheadedness, headache, upper abdominal pain, fatigue, insomnia, nervousness.
Uncommon adverse reactions (occurring in less than 1 in 100 people): asthenia (feeling of weakness), peripheral edema (hands and feet), nausea, vomiting, diarrhoea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (low blood pressure caused by changes in body position), diplopia (double vision), dyspepsia (indigestion), feeling of relaxation, nightmares, and dyspnoea (shortness of breath).
Rare adverse reactions (occurring in less than 1 in 1000 people): excitation (especially in elderly patients), tremor, convulsions, or hematological disorders such as: haemolytic anaemia, thrombocytopenia, leukopenia, or agranulocytosis (reduced levels of certain types of blood cells).
Adverse reactions with unknown frequency (cannot be estimated from available data): malaise.
Other adverse reactions usually associated with antihistamine use, 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 on ECG (heart disease), loss of appetite, increased appetite, muscle pain, coordination disorders, extrapyramidal disorders (movement disorders), paresthesia (sensory disturbances), psychomotor disturbances (sensory-motor coordination), depression, decreased mucus secretion in the bronchi, alopecia, allergic dermatitis, excessive sweating, photophobia (light sensitivity), or hypotension (low blood pressure).
The severity and frequency of adverse reactions can be controlled by reducing the daily dose.
Adults aged over 65 are more susceptible to adverse reactions, as they may suffer from other medical conditions or be taking other medicines simultaneously. These individuals are also at higher risk of falls.
Reporting of adverse reactions
If any adverse reactions occur, including any 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions may also be reported to the responsible entity.

5. How to store Sonoxen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP".
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Sonoxen contains

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

Coating excipients:
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, 7.5 mm in diameter, with a score line on one side. The score line is not a break line and serves only a decorative function.
Aluminium/PVC/PCTFE blister pack in a cardboard carton.
The pack contains 7 or 14 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
"Polski Lek – Dystrybucja" Sp. z o.o.
Chopina 10 Street
34-100 Wadowice
Poland
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