Sentino forte

Package leaflet: Information for the user

SENTINO Forte, 25 mg, coated tablets
Doxylamine hydrogen succinate
Please read the entire leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Table of contents of the leaflet:

1. What SENTINO Forte is and what it is used for
2. Important information before taking SENTINO Forte
3. How to take SENTINO Forte
4. Possible adverse reactions
5. How to store SENTINO Forte
6. Contents of the pack and other information

1. What SENTINO Forte is and what it is used for

SENTINO Forte is a medicine containing the active substance doxylamine hydrogen succinate.
Doxylamine belongs to a group of antihistamine medicines 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 SENTINO Forte

When not to take SENTINO Forte

• 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 (antiallergic drugs).
• If the patient is breastfeeding.
• If the patient suffers from 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 gastric or duodenal ulceration or pyloroduodenal stenosis (difficulty in food passage from the stomach to the intestine).
• If the patient is taking monoamine oxidase inhibitors.
• If the patient is taking certain medicines, e.g. antidepressants, some antibiotics, cardiac medications such as those used to treat cardiac arrhythmias, some antiviral and antifungal drugs, some lipid-lowering agents, or quinidine (a drug used to treat seizures), which affect liver enzyme activity.
• If the patient has severe impairment of kidney or liver function.

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Warnings and precautions
Before starting treatment with SENTINO Forte, discuss this with your doctor or
pharmacist.

• The patient must inform the doctor before starting treatment if any of the following conditions are present:
• Impaired liver or kidney function – dose reduction is recommended in mild cases; doxylamine is not recommended in moderate impairment;
• Moderate impairment, as this may require dose adjustment;
• Epilepsy (antihistamines may occasionally cause hyperexcitability and thus lower the seizure threshold);
• QT interval prolongation (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 disease and high blood pressure.
• If daytime drowsiness occurs, the patient should consider reducing the dose or taking the dose earlier, ensuring at least an 8-hour interval between taking the medicine and waking up.
• When taking other medicines that may harm hearing, such as carboplatin or cisplatin (used in cancer treatment), chloroquine (used to treat or prevent malaria), or certain injectable antibiotics such as erythromycin or aminoglycosides, SENTINO Forte may mask their ototoxic effects. Therefore, regular hearing tests should be performed.
• SENTINO Forte may worsen symptoms of dehydration and heat stroke due to reduced sweating, especially during hot weather.
• Do not drink alcohol during treatment.
• Patients over 65 years of age may be more susceptible to adverse effects. Therefore, treatment effects should be carefully monitored (see section 4).
• Grapefruit should be avoided during treatment with doxylamine.
• Doxylamine should be avoided if the patient is taking phenytoin, digoxin, warfarin, lithium, aminoglycosides, or vancomycin, as this may lead to acute toxicity.

Do not take SENTINO Forte for longer than 7 days unless otherwise advised by a doctor.
Long-term use of sleep-inducing and/or sedative medicines may lead to loss of effectiveness (tolerance), although this effect has not been observed so far with doxylamine.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.

Children and adolescents
SENTINO Forte is not indicated for use in children under 18 years of age.

SENTINO Forte and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

Do not take SENTINO Forte 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);

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• Medicines such as: drugs used to treat cardiac arrhythmias (amiodarone), certain macrolide antibiotics (clarithromycin, erythromycin, telithromycin), certain lipid-lowering agents (gemfibrozil), certain antidepressants (fluoxetine, fluvoxamine, paroxetine, bupropion, nefazodone), antiviral protease inhibitors (indinavir, ritonavir, telaprevir), and antifungal azole compounds (fluconazole, ketoconazole, itraconazole, voriconazole, terbinafine).

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

• Adrenaline (used to treat low blood pressure);
• Certain antimalarial drugs or certain antihistamines;
• Certain diuretics (medicines that increase urine excretion);
• Alcohol and other central nervous system depressants, such as barbiturates, sleeping pills, sedatives, other medicines used for insomnia or anxiety disorders (alprazolam, diazepam, zolpidem), opioid analgesics (codeine), psychotropic drugs (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 methyldopa;
• Other anticholinergic medicines, such as antipsychotics (used to treat psychiatric disorders), antispasmodic drugs (e.g. atropine, belladonna alkaloids), or disopyramide (used to treat certain heart conditions);
• Topical antihistamines (diphenhydramine in cream, ointment, or aerosol) and scopolamine;
• Medicinal products with a narrow therapeutic index (small difference between therapeutic and toxic dose), such as 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 SENTINO Forte at least three days before undergoing such tests.

SENTINO Forte with food, drink and alcohol
Do not drink alcohol while taking SENTINO Forte. See section 3. How to take SENTINO Forte.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
There is insufficient data on the use of doxylamine in pregnant women; therefore, use of SENTINO Forte in pregnant women should be avoided.
Due to the risk associated with antihistamine use in infants, SENTINO Forte must not be used in breastfeeding women.
There is no available data on the effect of SENTINO Forte on fertility.

Driving and using machines
SENTINO Forte has a marked effect on the ability to drive and use machines, as it causes drowsiness. During the first few days of treatment, until it is established how the medicine affects the patient, the patient should not drive or operate machinery.

SENTINO Forte contains lactose monohydrate.
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If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.

3. How to take SENTINO Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults (over 18 years of age)
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 to 12.5 mg (such a dose cannot be obtained using the SENTINO Forte medicinal product with a strength of 25 mg) or to take the dose earlier, ensuring at least an 8-hour interval between taking the medicine and waking up.
The break line on the tablet is intended only for easier swallowing and does not divide the tablet into equal doses. Do not take more than 1 tablet (25 mg) per day. Do not use SENTINO Forte for longer than 7 days unless your doctor advises otherwise.

Use in elderly patients
In adult patients over 65 years of age, other diseases are more likely to be present, 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 per day (such a dose cannot be obtained using the SENTINO Forte medicinal product with a strength of 25 mg). Therefore, the effects of treatment should be closely monitored (see section 4).

Use in patients with liver or kidney disease
In patients with mild impairment of liver or kidney function, the recommended daily dose should be reduced to 12.5 mg (such a dose cannot be obtained using the SENTINO Forte medicinal product with a strength of 25 mg).

Use in children and adolescents
SENTINO Forte is not indicated for use in children under 18 years of age and 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 fluid (preferably water).
SENTINO Forte may be taken with or without food.

Duration of treatment
Treatment should be as short as possible. Treatment usually lasts from a few days to one week.
Do not use this medicine for longer than 7 days unless your doctor recommends prolonged use.

Taking more than the recommended dose of SENTINO Forte
If more than the recommended dose of SENTINO Forte has been taken, contact a doctor immediately.
Symptoms of overdose include: drowsiness, depression or stimulation of the central nervous system, 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, unsteady gait, dizziness, irritability, sedation, disorientation, and hallucinations.
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Severe poisoning may lead to delirium, psychotic disturbances, decreased blood pressure, 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 in case of 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 SENTINO Forte
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 SENTINO Forte
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects caused by doxylamine are usually mild and transient, and occur more frequently during the first few days of treatment.
Very common adverse effects (occurring in more than 1 in 10 people): drowsiness.
Common adverse effects (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 effects (occurring in less than 1 in 100 people): asthenia (feeling of tiredness), peripheral oedema (of 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 effects (occurring in less than 1 in 1,000 people): excitation (especially in elderly people), tremor, convulsions or haematological disorders such as haemolytic anaemia, thrombocytopenia, leukopenia or agranulocytosis (reduction in the number of certain types of blood cells).
Adverse effects with unknown frequency (frequency cannot be estimated from available data): malaise.
The severity and frequency of adverse effects can be controlled by reducing the daily dose.
Adults over the age of 65 are more susceptible to adverse effects, as they may suffer from other diseases or be taking other medicines simultaneously. These people are also more prone to falls.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 effects allows more information on the safety of the medicine to be collected.

5. How to store the medicine SENTINO Forte

Keep the medicine out of the sight and reach of children.
No special storage instructions apply to this medicinal product.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the packaging and other information

What SENTINO Forte contains
The active substance is doxylamine hydrogen succinate. Each tablet contains 25 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;
Coating (OPADRY II Complete Film Coating System 32F280008 White): Hypromellose (15 mPas),
Titanium dioxide (E 171), Polyethylene glycol 4000, Lactose monohydrate.

What SENTINO Forte looks like and contents of the pack
White, round, film-coated tablet with a breakline on one side.
Pack sizes available:
Aluminium/PVC/PCTFE blisters in cardboard packaging.
Pack sizes: 7 tablets, 14 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław, Poland

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

For further information, contact the representative of the Marketing Authorisation Holder:
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USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa, Poland
tel. +48 (22) 543 60 00
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