Sentino Forte

Package Leaflet: Information for the User

SENTINO Forte, 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.

Table of Contents of the Leaflet:

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

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

SENTINO Forte is a medicine that contains the active substance doxylamine succinate. Doxylamine belongs to a group of sedating antihistamines. The medicine is indicated for short-term, symptomatic treatment of occasional insomnia in adults over 18 years of age.

2. Important information before taking SENTINO Forte

When not to take SENTINO Forte

• 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 antihistamines (anti-allergic medicines).
• If you are breastfeeding.
• If you have respiratory diseases, such as asthma, chronic bronchitis (persistent cough with sputum and mucus 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 stomach or duodenal ulcers, or pyloric stenosis (difficulty passing food from the stomach to the intestine).
• If you are taking monoamine oxidase inhibitors.
• If you are taking certain medicines, such as antidepressants, certain antibiotics, heart medicines, such as those used to treat arrhythmias, certain antiviral or antifungal medicines, or certain cholesterol-lowering medicines, which affect liver enzyme activity.
• If you have severe kidney or liver impairment.

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

• You must inform your doctor before starting treatment if you have:
• liver or kidney impairment - with mild impairment, a dose reduction is recommended; with moderate impairment, doxylamine is not recommended;
• moderate impairment, as this may require dose adjustment;
• epilepsy (antihistamines may sometimes cause excitement, leading to a lowered seizure threshold);\li>
• 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 daytime drowsiness, you should 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 harm your hearing, such as carboplatin or cisplatin (medicines used to treat cancer), chloroquine (a medicine used to treat or prevent malaria), or certain antibiotics (used to treat infections) such as erythromycin or aminoglycosides, SENTINO Forte may mask the harmful effects of these medicines. Therefore, you should have regular hearing tests.
• SENTINO Forte may worsen dehydration and heat stroke due to reduced sweating, especially during heatwaves.
• Do not drink alcohol during treatment.
• Patient over 65 years may be more prone to side effects. Therefore, you should be careful with the treatment effects (see section 4).
• During treatment with doxylamine, you should avoid consuming grapefruit.
• If you are taking medicines such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, or vancomycin, you should avoid taking doxylamine, as it may cause acute poisoning.

Do not take SENTINO Forte for more than 7 days, unless your doctor recommends it. Long-term use of sleeping pills and/or sedatives can lead to loss of efficacy (development of tolerance), although this has not been observed with doxylamine so far.
If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
Children and adolescents
SENTINO Forte is not indicated for use in children under 18 years of age.
SENTINO Forte and other medicines
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might 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, and tranylcypromine, isocarboxazid, linezolid, methylene blue, procarbazine, rasagiline, and selegiline);

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

Patient should avoid taking SENTINO Forte 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, sleeping pills, sedatives, or 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, anticholinergic agents), or disopyramide (used to treat certain heart conditions);
• antihistamines used on the skin (diphenhydramine cream, ointment, spray) and scopolamine;
• medicines with a narrow therapeutic index (i.e., the difference between the therapeutic and toxic dose is small), such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, or vancomycin.

Effect on laboratory tests
Doxylamine may affect the results of skin allergy tests. Patients should stop taking SENTINO Forte at least 3 days before undergoing such tests.

SENTINO Forte with food, drink, and alcohol

Do not drink alcohol during treatment with SENTINO Forte. See section 3. How to take SENTINO Forte.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is limited experience with the use of doxylamine in pregnant women, so SENTINO Forte should be avoided in pregnancy.
Due to the risk associated with the use of antihistamines in small children, SENTINO Forte should not be used during breastfeeding.
There are no data on the effects of SENTINO Forte on fertility.

Driving and using machines

SENTINO Forte has a major influence on the ability to drive and use machines, as it causes drowsiness. During the first few days of treatment, until it is known how the medicine affects you, do not drive or operate machinery.

SENTINO Forte contains lactose monohydrate.

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

3. How to take SENTINO Forte

Always take this medicine exactly as described in this 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 daytime drowsiness, you should reduce the dose to 12.5 mg (this dose cannot be achieved with the 25 mg strength of SENTINO Forte) or take it earlier to ensure at least 8 hours between taking the medicine and waking up.
The score line is only for ease of breaking the tablet to make it easier to swallow and does not divide the tablet into equal doses. Do not take more than 1 tablet (25 mg) per day. Do not take SENTINO Forte for more than 7 days, unless your doctor recommends it.
Use in the elderly
In adults over 65 years, it is more likely that other diseases 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 (this dose cannot be achieved with the 25 mg strength of SENTINO Forte). Therefore, you should be careful with the treatment effects (see section 4).
Use in patients with liver or kidney disease
In patients with mild liver or kidney impairment, the recommended daily dose should be reduced to 12.5 mg (this dose cannot be achieved with the 25 mg strength of SENTINO Forte).
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 use.
Tablets should be taken 30 minutes before bedtime, with a sufficient amount of liquid (preferably water).
SENTINO Forte 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 taken for more than 7 days, unless the doctor recommends it.

Taking a higher dose of SENTINO Forte than recommended

If you have taken more than the recommended dose of SENTINO Forte, contact your doctor immediately.
Symptoms of overdose are: drowsiness, depression or stimulation of the central nervous system, 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, excitement, unsteady gait, dizziness, irritability, sedation, disorientation, and hallucinations.
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Severe poisonings can cause delirium, psychotic disorders, hypotension, 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 used. The doctor will decide whether to induce vomiting, perform gastric lavage, or prescribe medicines to increase blood pressure.

Missing a dose of SENTINO Forte

Do not take a double dose to make up for a forgotten dose.
Take the next dose at the usual time.

Stopping treatment with SENTINO Forte

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of 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 airways, 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 (decrease in blood pressure when changing position), diplopia (double vision), dyspepsia (indigestion), feeling of relaxation, nightmares, and shortness of breath (dyspnea).
Rare side effects (occurring in less than 1 in 1,000 people): excitement (especially in the elderly), 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 (frequency cannot be estimated from the available data): general malaise.
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 diseases or take other medicines. These patients 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.

5. How to store SENTINO Forte

Keep this medicine out of the sight and reach of children.
There are no special precautions for storage.
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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What SENTINO Forte contains

The active substance is doxylamine succinate. Each tablet contains 25 mg of doxylamine succinate.
The other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate;
Coating (OPADRY II Complete Film Coating System 32F280008 White): hypromellose (15 mPas), titanium dioxide (E 171), macrogol 4000, lactose monohydrate.

What SENTINO Forte looks like and contents of the pack

White, round, coated tablet with a score line on one side.

Pack sizes:

Aluminium/PVC/PCTFE blister pack in a cardboard box.
Pack sizes: 7, 14.
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

Manufacturer

Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares (Madrid), Spain
For more 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
tel. +48 (22) 543 60 00

Date of last revision of the leaflet:

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