Sentino

Before starting to use this medicine, carefully read the leaflet and the "Patient Information"
leaflet included in the medicine package. To ensure safe use of the medicine, answer all the
questions contained in the information leaflet. This medicine is intended only for adult patients.

Package leaflet: information for the user

SENTINO, 12.5 mg, coated tablets
Doxylamine hydrogen succinate
Please read this 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 directed by the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your doctor or pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

Contents of the leaflet:

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

1. What SENTINO is and what it is used for

SENTINO 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, particularly in cases associated with:

• difficulty falling asleep,
• frequent nocturnal awakenings,
• early morning awakening related to stress or changes in time zones.

Sleep is extremely important. Sleep disturbances may negatively affect physiological processes and lead to reduced psycho-physical performance. Insomnia is diagnosed, among others, when: the time to fall asleep exceeds half an hour, total nocturnal awakenings last longer than half an hour, such disturbances occur at least three nights per week, and poor sleep quality causes fatigue or reduced daytime psycho-physical performance.
Transient sleep disturbances usually last a few days and are associated with certain factors such as illness, anxiety, noise, inappropriate ambient temperature, or time zone changes.
Medication should not be 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 psychological or physical disorders requiring different treatment approaches, which should be evaluated by a physician. Consultation with a doctor is also necessary if symptoms other than insomnia are present. Failure to properly diagnose the underlying cause of sleep disturbances and its treatment may pose a risk to health. Treating the underlying condition causing sleep disturbances is essential for achieving lasting improvement in sleep quality.
This medicine must not be used in the treatment of chronic sleep disorders.
The treatment duration should be as short as possible. Treatment usually lasts from several days to 1 week. This medicine should not be used for longer than 7 days without consulting a doctor.
If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

2. Important information before taking SENTINO

When not to take SENTINO

• 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 (antiallergic medicines).
• If the patient is breastfeeding.
• If the patient has a respiratory disorder such as asthma, chronic bronchitis (persistent cough accompanied by sputum and mucus production), or emphysema (difficulty breathing).
• If the patient has glaucoma (increased pressure in the eye).
• If the patient has benign prostatic hyperplasia (enlargement of the prostate gland), difficulty in passing urine from the bladder (urinary tract disorder), or has problems urinating.
• If the patient has narrowing of the gastrointestinal tract due to peptic ulcer or pylorospasm (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, certain antibiotics, cardiac medicines such as those used to treat heart rhythm disorders, certain antiviral and antifungal medicines, certain lipid-lowering (cholesterol-lowering) medicines, or quinidine (a medicine used to treat seizures), which affect the activity of liver enzymes.
• If the patient has severe impairment of kidney or liver function.

Warnings and precautions
Before starting to take SENTINO, 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 liver or kidney impairment – dose reduction is recommended; moderate liver or kidney impairment – doxylamine should not be used.
• Epilepsy (antihistamines may sometimes 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 diseases and high blood pressure.
• Urinary retention.
• If daytime drowsiness occurs, the patient should consider reducing the dose or taking the dose earlier to ensure at least an 8-hour interval between taking the medicine and waking up.
• If the patient is taking other medicines that may harm 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 injectable aminoglycosides, SENTINO may mask the harmful effects of these medicines. Therefore, regular hearing tests should be performed.
• SENTINO may increase the risk of dehydration and heat stroke due to reduced sweating, especially during hot weather.
• Do not drink alcohol while taking this medicine.
• Patients over 65 years of age may be more susceptible to adverse effects. Therefore, the effects of treatment should be closely monitored (see section 4).
• Grapefruit should be avoided during treatment with doxylamine.
• If the patient is taking medicines such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, or vancomycin, doxylamine should be avoided, as it may lead to acute poisoning.

Do not exceed the recommended dosage. Do not take SENTINO for longer than 7 days unless advised otherwise by a doctor. Long-term use of sleep-inducing and/or sedative medicines may lead to loss of effectiveness (development of tolerance), although such effect has not been observed with doxylamine so far.
Always take the medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist. Improper use of the medicine, including prolonged use or exceeding recommended doses, may cause adverse effects. The patient should monitor their response to the medicine, including possible adverse effects (see section 4) or symptoms of overdose (see section 3 "If you have taken more SENTINO than you should").

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

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

Do not take SENTINO while using 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: medicines used to treat heart rhythm disorders (amiodarone), certain macrolide antibiotics (clarithromycin, erythromycin, telithromycin), certain lipid-lowering (cholesterol-lowering) medicines (gemfibrozil), certain antidepressants (such as fluoxetine, fluvoxamine, paroxetine, bupropion, nefazodone), antiviral protease inhibitors (indinavir, ritonavir, telaprevir), and antifungal azole compounds (fluconazole, ketoconazole, itraconazole, voriconazole, terbinafine).

Patients should avoid taking SENTINO while using the following medicines, as this may increase their effects or cause adverse reactions:

• Adrenaline (used to treat low blood pressure).
• Certain medicines used to treat malaria or certain antihistamines.
• Certain diuretics (medicines that increase urine excretion).
• Alcohol and other medicines that depress the central nervous system, such as barbiturates, sleeping medicines, sedatives, other medicines used for insomnia or anxiety disorders (alprazolam, diazepam, zolpidem), opioid painkillers (codeine), psychotropic medicines (chlorpromazine, risperidone, amitriptyline, trazodone), or procarbazine.
• Antihypertensive medicines (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 mental disorders), medicines used to treat spasms (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), such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, or vancomycin.

Effect on laboratory tests
Doxylamine may affect the results of skin allergy tests. Patients are advised to stop taking SENTINO at least three days before undergoing such tests.

SENTINO with food, drink, and alcohol
Do not drink alcohol while taking SENTINO. Grapefruit juice is not recommended during treatment with SENTINO.
See section 3. How to take SENTINO.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There is insufficient data on the use of doxylamine in pregnant women; therefore, SENTINO should not be used during pregnancy.
Due to the risk associated with the use of antihistamines in young children, SENTINO must not be used in breastfeeding women.
There are no available data on the effect of SENTINO on fertility.

Driving and using machines
SENTINO has a marked effect on the ability to drive and use machines, as it causes drowsiness. During the first few days of treatment, until the patient knows how the medicine affects them, driving and operating machinery should be avoided.

SENTINO contains carmine, cochineal carmine (E 124), sunset yellow, cochineal lake (E 110), glucose, and sodium.
The medicine contains carmine, cochineal carmine (E 124), and sunset yellow, cochineal lake (E 110). It may cause allergic reactions.
The medicine contains glucose (as a component of maltodextrin). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take SENTINO

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

Adults (aged over 18 years)
The recommended initial dose is 12.5 mg (1 tablet), taken 30 minutes before bedtime. The dose may be increased to 25 mg (2 tablets) if the initial dose does not provide sufficient relief of insomnia symptoms.

Before taking doxylamine, ensure that there is a sufficiently long period of time available for sleep (8 hours) to avoid next-day drowsiness. If daytime drowsiness occurs, it is recommended to take the dose earlier to ensure at least an 8-hour interval between taking the medicine and waking up, or, in case of taking a 25 mg dose, to reduce the dose next time to 12.5 mg (1 tablet).

Do not take more than 2 tablets (25 mg) per day.

Patients with persistent sleep problems should consult a doctor.

The score line on the tablet is intended only to facilitate breaking the tablet if the patient has difficulty swallowing it whole.

The maximum daily dose should not exceed 25 mg (2 tablets).

SENTINO should not be used for longer than 7 days without consulting a doctor.

Use in elderly patients
In adults aged over 65 years, other medical conditions are more likely, which may require dose adjustment. 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 (2 tablets) if the initial dose proves ineffective. If adverse effects occur, the dose should be reduced to 12.5 mg (1 tablet) per day. Therefore, the effects of treatment should be closely monitored (see section 4).

Use in patients with hepatic or renal impairment
In patients with moderate impairment of liver and/or kidney function, consult a doctor before taking this medicine, who will decide on appropriate treatment. In patients with mild renal or hepatic impairment, the recommended daily dose should be reduced to 12.5 mg.

Use in children and adolescents
SENTINO 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 going to bed, with a sufficient amount of liquid (preferably water).

SENTINO may be taken with or after food.

Duration of treatment
Treatment should be as short as possible. Treatment typically lasts from a few days to one week.

SENTINO should not be used for longer than 7 days without consulting a doctor.

Taking more SENTINO than recommended
If you take more SENTINO than recommended, contact your 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, unsteady gait, 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.

Severe complications may include rhabdomyolysis (muscle breakdown), leading 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.

If you forget to take SENTINO
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
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 generally 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 mucus secretion in the bronchi, dizziness, lightheadedness, headache, upper abdominal pain, fatigue, insomnia, nervousness.
Uncommon adverse effects (occurring in less than 1 in 100 people): weakness (feeling of fatigue), peripheral edema (hands and feet), nausea, vomiting, diarrhea, 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 dyspnea (shortness of breath).
Rare adverse effects (occurring in less than 1 in 1,000 people): agitation (especially in elderly people), tremor, seizures, or hematological disorders such as hemolytic anemia, thrombocytopenia, leukopenia, or agranulocytosis (reduction in certain types of blood cells).
Adverse effects with unknown frequency (frequency cannot be determined from available data): malaise (general feeling of being unwell).
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 individuals are also at higher risk of falls.
Reporting adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine SENTINO

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after
"Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of in wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the pack and other information

What SENTINO contains
The active substance is doxylamine hydrogen succinate. Each tablet contains 12.5 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 57U35237 Red): hypromellose (15 mPas),
polydextrose, talc, titanium dioxide (E 171), maltodextrin, medium-chain triglycerides, carmine red,
lake (E 124), orange yellow, lake (E 110), quinoline yellow, lake (E 104).
What SENTINO looks like and contents of the pack
Red, round, film-coated tablet with a break line on one side.
The break line on the tablet is intended only to facilitate breaking the tablet if the patient has
difficulty swallowing it whole.
Pack sizes available:
Aluminium/PVC/PCTFE blister packs in cardboard cartons.
Pack sizes: 7 tablets, 14 tablets, 20 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:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa, Poland
Tel. +48 (22) 543 60 00
Additional materials are available by scanning the QR code on the packaging with a smartphone, and on
the website: {address}