Sentino

Before starting to use this medicine, read the leaflet carefully and familiarize yourself

with the "Patient Information" attached to the packaging of the medicine. To use the medicine safely,
you must answer all the questions contained in the information leaflet. The medicine is intended
only for adult patients.

Leaflet attached to the packaging: information for the user

SENTINO, 12.5 mg, coated tablets

Doxylamine hydrogen succinate

You should carefully read the contents of the leaflet before taking the medicine, as it contains

important information for the patient.

This medicine should always be taken exactly as described in this patient information leaflet or
according to the doctor's or pharmacist's instructions.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a doctor or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they
  should tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is SENTINO and what is it 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 packaging and other information

1. What is SENTINO and what is it used for

SENTINO 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, especially when
associated with:

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

Sleep is extremely important. Sleep disorders can have a negative impact on physiological processes
and lead to a decrease in psychophysical fitness. Insomnia is talked about, among other things, when:
the time to fall asleep exceeds half an hour, the total time spent awake at night lasts longer than half
an hour, such a disorder occurs at least three nights a week, and poor sleep quality causes fatigue
or decreased psychophysical fitness during the day. Transient sleep disorders usually last a few days
and are related to the occurrence of certain factors, such as disease states, anxiety, noise, inappropriate
environmental temperature, or time zone changes. Page 1 8
Taking medicines is not 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 mental and physical disorders
that require other treatment methods, which should be assessed by a doctor. Consulting a doctor is
also necessary in case of symptoms other than insomnia. Failure to properly diagnose the cause of
sleep disorders and their treatment may lead to health risks. Treating the underlying disease that causes
sleep disorders is a necessary condition for lasting improvement in sleep quality.

The medicine must not be used to treat chronic sleep disorders.

The treatment period should be as short as possible. Treatment usually lasts from a few days to one
week. The medicine must not be used for more than 7 days without consulting a doctor.
If after 7 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking SENTINO

When not to take SENTINO

• 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 (anti-allergic medicines).
• If the patient is breastfeeding.
• If the patient has a respiratory disease, such as asthma, chronic bronchitis (persistent cough with
  sputum and mucus production), or chronic obstructive pulmonary disease (difficulty breathing).
• If the patient has glaucoma (increased eye pressure).
• If the patient has prostate enlargement (excessive prostate growth), difficulty urinating, or urinary
  retention.
• If the patient has narrowing of the gastrointestinal tract due to stomach ulcers or pyloric stenosis
  (difficulty passing food from the stomach to the intestine).
• If the patient is taking monoamine oxidase inhibitors.
• If the patient is taking certain medicines, such as antidepressants, certain antibiotics, heart medicines,
  such as those used to treat arrhythmias, certain antiviral or antifungal medicines, or certain medicines
  that affect liver enzyme function.
• If the patient has severe kidney or liver dysfunction.

Warnings and precautions
Before starting to take SENTINO, you should discuss it with your doctor or pharmacist.
The patient must inform their doctor before starting to take the medicine if they have:

• mild liver or kidney dysfunction - a dose reduction is recommended; moderate liver or kidney
  dysfunction - doxylamine is not recommended;
• epilepsy (antihistamine medicines can sometimes cause overstimulation and, as a result, lower the
  seizure threshold);

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• prolonged QT interval (a heart disease that leads to sudden changes in heart rate in response to
  exercise or stress);
• low potassium levels in the blood or other electrolyte disturbances;
• heart disease and high blood pressure.
• urinary retention;
• In case of drowsiness during the day, the patient is advised to reduce the dose or take the dose earlier
  to ensure at least an 8-hour interval between taking the medicine and waking up.
• In case of 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 aminoglycosides, SENTINO may mask the harmful
  effects of these medicines. Therefore, regular hearing tests should be performed.
• SENTINO may exacerbate dehydration and heat stroke due to reduced sweating, especially during
  heatwaves.
• Do not drink alcohol during treatment.
• Patient over 65 years of age may be more prone to side effects. Therefore, attention should be paid
  to the effects of treatment (see section 4).
• During treatment with doxylamine, you should avoid consuming grapefruits.
• If the patient is taking medicines such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, or
  vancomycin, they should avoid taking doxylamine, as it may cause acute poisoning.

Effect on laboratory tests
Doxylamine may affect the results of allergic skin 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 during treatment with SENTINO. It is not recommended to drink grapefruit juice
while taking SENTINO. See section 3. How to take SENTINO.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they
should consult their doctor or pharmacist before taking this medicine. Due to the lack of sufficient data
on the use of doxylamine in pregnant women, SENTINO should not be used in pregnant women. Because
of the risk associated with the use of antihistamines in small children, SENTINO should not be used in
breastfeeding women. There is no available data on the effect of SENTINO on fertility.

Driving and using machines

SENTINO has a significant impact on the ability to drive and operate machines, as it causes drowsiness.
During the first few days of treatment, until it is determined how the medicine affects the patient, they
should not drive or operate machines. SENTINO contains E 124, E 110, glucose, and sodium.
The medicine contains E 124 and E 110, which may cause allergic reactions.
The medicine contains glucose (as a component of maltodextrin). If the patient has previously been
diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
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The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine
is considered "sodium-free".

3. How to take SENTINO

This medicine should always be taken exactly as described in this patient information leaflet or
according to the doctor's or pharmacist's instructions. In case of doubt, you should consult your doctor
or pharmacist. Adults (over 18 years of age)
The recommended initial dose is 12.5 mg (1 tablet), taken 30 minutes before bedtime. The dose
can be increased to 25 mg (2 tablets) if the initial dose does not provide sufficient relief from insomnia
symptoms. Before taking doxylamine, you should make sure you have enough time for sleep (8 hours)
to avoid drowsiness the next morning. In case of drowsiness during the day, it is recommended to take
the dose earlier to ensure at least an 8-hour interval between taking the medicine and waking up or
reduce the dose to 12.5 mg (1 tablet) the next time.

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

Patient with persistent sleep problems should consult their doctor.

The dividing line on the tablet is 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).

Do not take SENTINO for more than 7 days without consulting your doctor.

Use in elderly patients
In adults over 65 years of age, it is more likely that other diseases will occur that 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 (2 tablets) if the initial dose is ineffective. In case
of side effects, the dose should be reduced to 12.5 mg (1 tablet) per day. Therefore, attention should
be paid to the effects of treatment (see section 4). Use in patients with liver or kidney dysfunction
In patients with moderate liver or kidney dysfunction, the doctor should be consulted before taking
the medicine, who will decide on the treatment. In patients with mild kidney or liver dysfunction, the
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. The tablets should be taken 30 minutes before bedtime, with a sufficient amount of liquid
(preferably water). SENTINO can be taken with or after food.

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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 used for more than 7 days without consulting a doctor.

Taking a higher dose of SENTINO than recommended

In case of taking a higher dose of SENTINO than recommended, you should immediately inform your
doctor. Symptoms of overdose are: drowsiness, inhibition or stimulation of the central nervous system,
anticholinergic effects (dilated pupils, fever, dry mouth, decreased smooth muscle tone in the intestines),
heat strokes, increased or changed heart rate, increased blood pressure, nausea, vomiting, stimulation,
unsteady gait, dizziness, irritation, calming, disorientation, and hallucinations. Severe poisonings
can cause delirium, psychotic disorders, decreased blood pressure, seizures, decreased respiratory rate,
loss of consciousness, coma, and can be life-threatening. A serious complication is rhabdomyolysis
(muscle breakdown), followed by kidney failure. There is no specific antidote in case of overdose of
antihistamine medicines. If necessary, symptomatic and supportive treatment should be applied. The
doctor will decide whether to induce vomiting, perform gastric lavage, or prescribe medicines that increase
blood pressure.

Missing a dose of SENTINO

Do not take a double dose to make up for a missed dose. You should take the next dose at the usual
time.

Stopping treatment with SENTINO

In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects
caused by 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 bronchi, dizziness, drowsiness, headaches,
abdominal pain, fatigue, insomnia, nervousness. Uncommon side 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 (decrease in blood pressure caused by
changes in body position), diplopia (double vision), dyspepsia (indigestion), feeling of relaxation, nightmares,
and shortness of breath (shortness of breath). Rare side effects (occurring in less than 1 in 1,000 people):
stimulation (especially in elderly patients), tremors, seizures, or hematological disorders, such as hemolytic
anemia, thrombocytopenia, leukopenia, or agranulocytosis (decrease in the number of certain types of blood
cells). Page 6 8
Side effects with unknown frequency (frequency cannot be estimated from available data): general
malaise. The intensity and frequency of side effects can be controlled by reducing the daily dose. Adults
over 65 years of age are more prone to side effects, as they may have other diseases or take other medicines
at the same time. These people are also more prone to falls.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your
doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring
of the 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
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can
help provide more information on the safety of this medicine.

5. How to store SENTINO

The medicine should be stored out of sight and reach of children. There are no special precautions for
storing the medicine. Do not use this medicine after the expiry date stated on the carton and blister pack
after "Expiry Date" or "EXP". The expiry date refers to the last day of the month. Medicines should not be
disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines
no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What SENTINO contains

The active substance of the medicine is doxylamine succinate. Each tablet contains 12.5 mg of doxylamine
succinate. The other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose,
sodium carboxymethylcellulose (type A), colloidal silica anhydrous, magnesium stearate; Coating
(OPADRY II Complete Film Coating System 57U35237 Red): hypromellose (15 mPas), polydextrose,
talc, titanium dioxide (E 171), maltodextrin, medium-chain triglycerides, E 124, E 110, E 104.

What SENTINO looks like and what the pack contains

Red, round, coated tablet with a dividing line on one side. The dividing line on the tablet is only to
facilitate breaking the tablet if the patient has difficulty swallowing it whole. Page 7 8

Pack sizes:

Aluminium/PVC/PCTFE blister pack in a cardboard box. Pack sizes: 7, 14. Not all pack sizes may be
marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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
To obtain more detailed information, you should contact the representative of the marketing authorization
holder: USP Zdrowie Sp. z o.o. ul. Poleczki 35 02-822 Warszawa tel. +48 (22) 543 60 00 Additional
materials are available after scanning the QR code on the packaging and on the website: {address}

Date of last revision of the leaflet:

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