SENAMINA

Before taking the medicine, carefully read the package leaflet and use the
Patient Information Guide provided!
Information on how to use the medicine is also available by scanning with a smartphone
the QR code on the outer packaging of the medicine and on the website
www.senamina.pl/pacjent

Package leaflet: information for the user

Senamina, 12.5 mg, coated tablets
Doxylamini hydrogenosuccinas
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as advised by
the doctor, pharmacist, or nurse.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Leaflet contents

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

1. What Senamina is and what it is used for

The active substance in Senamina is doxylamine hydrogen succinate. Doxylamine
belongs to a group of antihistamines with sedative and calming effects.
The medicine is used for short-term, symptomatic treatment of occasional insomnia in adults, especially in cases of:

• difficulty falling asleep,
• frequent awakenings during the night,
• 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 other criteria, when:
the time to fall asleep exceeds half an hour, total awakenings during the night last longer than half an hour, such disturbances occur at least three nights per week, and poor sleep quality causes fatigue or reduced psycho-physical performance during the day.
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.
Taking medication is not the primary method of treating sleep disorders and should be limited to short-term use only.
Persistent poor sleep quality may be a symptom of mental or physical disorders requiring different treatment approaches, which should be evaluated by a doctor. Consultation with a doctor is also necessary if symptoms other than insomnia occur. Failure to properly diagnose and treat the underlying cause of sleep disturbances may pose a health risk. Treating the underlying condition causing sleep disturbances is essential for achieving lasting improvement in sleep quality.
This medicine must not be used for the treatment of chronic sleep disorders.
The treatment duration should be as short as possible. Treatment usually lasts from a few 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 you feel worse, you should contact your doctor.

2. Important information before using Senamina

When not to use Senamina

• 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 antihistamine (antiallergic) medicines.
• if the patient has a respiratory disorder, e.g. asthma, bronchitis (persistent cough producing thick saliva (sputum) and mucus) or emphysema (inflammation of the lung alveoli causing breathing difficulties).
• if the patient has glaucoma (increased pressure in the eye).
• if the patient has benign prostatic hyperplasia (abnormal enlargement of the prostate), urinary bladder neck obstruction (a urinary tract disorder) or difficulty passing urine.
• if the patient has peptic ulcer disease of the stomach or duodenum or duodenal stenosis (difficulty in food passage from the stomach to the intestine).
• if the patient has severe kidney or liver disease.
• if the patient is concurrently using monoamine oxidase inhibitors (medicines used in depression and Parkinson's disease).
• if the patient is concurrently using antiepileptic medicines, antidepressants, certain antibiotics, cardiac medicines, e.g. for treating cardiac arrhythmias, antiviral medicines, antifungal medicines, certain lipid-lowering (fat-reducing) medicines.
• if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Senamina, discuss with your doctor or pharmacist:

• if the patient has epilepsy (antihistamines may sometimes cause hyperexcitability and consequently lower the seizure threshold).
• if the patient experiences daytime drowsiness, it may be necessary to reduce the dose or take the dose earlier to ensure at least an 8-hour interval between taking the medicine and planned waking time.
• alcohol consumption should be avoided during treatment.
• if the patient has long QT syndrome (a heart rhythm disorder), low blood potassium levels or other electrolyte imbalances, urinary retention, or heart disease.
• use of other medicines that may be ototoxic (harmful to hearing), such as carboplatin or cisplatin (medicines used in cancer treatment), chloroquine (a medicine used to treat or prevent malaria), and certain antibiotics (used to treat infections), such as erythromycin or parenteral aminoglycosides, because Senamina may mask the ototoxic effects of these medicines.

Patients over 65 years of age are more susceptible to adverse effects (see section 4). Senamina may worsen symptoms of dehydration and heat stroke due to reduced sweating, especially during hot weather. Particular caution is required in elderly patients.

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 take more Senamina than you should").

Do not exceed the recommended dosage. Do not take Senamina for longer than 7 days unless otherwise advised by a doctor.

Senamina may worsen symptoms of dehydration and heat stroke caused by reduced sweating, especially during hot weather. Particular caution is required in elderly patients.

Children and adolescents
Senamina is not recommended for use in children and adolescents under 18 years of age – see also section "Use in children and adolescents".

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

Do not take Senamina while using the following medicines:

• epinephrine (used to treat low blood pressure).
• cardiac medicines, such as those used to treat arrhythmias, certain antibiotics, certain antimalarial medicines, certain antihistamines, certain lipid-lowering (cholesterol-reducing) medicines, or certain neuroleptic medicines (used to treat psychiatric disorders).
• azole antifungals (fluconazole, ketoconazole, itraconazole) or macrolide antibiotics (clarithromycin, erythromycin, telithromycin), as they may enhance the effect of doxylamine.
• certain diuretics (medicines that increase urine excretion).
• central nervous system depressants (barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine – an anticancer medicine).
• antihypertensive medicines (medicines for high blood pressure) acting on the central nervous system, such as guanabenz, clonidine, or methyldopa.
• other anticholinergic medicines, such as those used to treat depression (fluoxetine, fluvoxamine, paroxetine) or Parkinson's disease, monoamine oxidase inhibitors (antidepressants), neuroleptics (medicines used to treat psychiatric disorders), antispasmodics (e.g. atropine), disopyramide (used to treat certain heart conditions).
• medicines known to be ototoxic (harmful to hearing), such as carboplatin or cisplatin (anticancer medicines), chloroquine (used to treat or prevent malaria), certain antibiotics (used to treat infections) such as erythromycin or parenteral aminoglycosides, as doxylamine may mask these effects.
• topical antihistamines (such as diphenhydramine in cream, ointment, or aerosol), antispasmodics (such as atropine, belladonna alkaloids), and scopolamine.
• antiviral medicines (indinavir, ritonavir, telaprevir).
• medicines with a narrow therapeutic index (where there is a small difference between the therapeutic and toxic dose).

Effect on diagnostic test results
Senamina may interfere with skin allergy tests that use allergens. It is recommended to discontinue this medicine at least three days before the test.

Senamina with food, drink and alcohol
Do not drink alcohol while taking Senamina.
Senamina can be taken with or without food.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Senamina should not be used during pregnancy unless otherwise directed by a doctor.
Senamina is contraindicated during breastfeeding.
There are no available data on the effect of Senamina on fertility.

Driving and using machines
Senamina 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 established how Senamina affects the patient, driving and operating machinery should be avoided.

Senamina contains mannitol
May have a laxative effect.

3. How to use Senamina

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Dosage
Adults (over 18 years)
The recommended dose is 12.5 mg to 25 mg (1 or 2 tablets).
If daytime drowsiness occurs, it is recommended to reduce the dose from 25 mg to 12.5 mg or to take the dose earlier, ensuring at least an 8-hour interval between taking the medicine and planned awakening.
The maximum daily dose is 25 mg (2 tablets).
Elderly patients (over 65 years)
In patients over 65 years of age, other medical conditions are more likely, which may require dose reduction. 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 proves ineffective. If adverse effects occur, the dose should be reduced to 12.5 mg per day (1 tablet). Therefore, the effects of treatment should be carefully monitored (see section 4).
Patients with renal or hepatic impairment
Senamina is contraindicated in patients with severe kidney or liver disease.
The use of Senamina is not recommended in patients with moderate kidney or liver disease.
In patients with mild kidney or liver disease, the maximum daily dose should be reduced to one 12.5 mg tablet.
Use in children and adolescents
Senamina is not indicated for use in children under 18 years of age and should not be used in this patient group.
Method of administration
Oral administration.
Tablets should be taken 30 minutes before bedtime with an adequate amount of liquid (preferably water). An interval of at least 8 hours should be ensured between taking the medicine and planned awakening due to the possibility of persistent drowsiness.
Senamina medicinal product may be taken with or without food.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not allow for dividing the tablet into equal doses.
Duration of treatment
Treatment duration should be as short as possible. Treatment usually lasts from a few days to one week.
Senamina should not be used for longer than 7 days without consulting a doctor.
Taking more Senamina than recommended
If more than the recommended dose is taken, contact a doctor immediately.
The doctor will decide whether and what measures should be taken.
Symptoms of overdose include drowsiness, depression or stimulation of the central nervous system, anticholinergic effects (pupil dilation, fever, dry mouth, decreased intestinal motility), changes in heart rate, elevated blood pressure, nausea, vomiting, agitation, ataxia, dizziness, irritability, sedation, confusion, 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 include 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.
Missing a dose of Senamina
Do not take a double dose to make up for a missed dose.
Take the medicine at the usual time on the following day.
Stopping Senamina
If you have any further doubts regarding 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 to Senamina are usually mild and transient, occurring more frequently during the
first days of treatment.
Adverse reactions are listed below according to their frequency of occurrence:

Very common (affects more than 1 in 10 people):

• drowsiness.

Common (affects less than 1 in 10 people):

• dry mouth, constipation, upper abdominal pain,
• blurred vision,
• urinary retention,
• increased bronchial mucus secretion,
• dizziness, headache,
• fatigue, insomnia, nervousness.

Uncommon (affects less than 1 in 100 people):

• weakness, peripheral oedema (e.g. swelling of hands and feet),
• nausea, vomiting, diarrhoea, dyspepsia,
• rash,
• tinnitus,
• orthostatic hypotension (drop in blood pressure upon changing body position),
• diplopia (double vision),
• feeling of relaxation,
• nightmares,
• dyspnoea (breathing difficulties).

Rare (affects less than 1 in 1,000 people):

• restlessness (especially in elderly patients),
• tremor, convulsions,
• decreased number of red blood cells, white blood cells or platelets.

Other adverse reactions usually associated with antihistamine drugs, 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 in ECG (heart disease), loss of appetite, increased appetite, muscle pain, coordination disorders, extrapyramidal disorders (movement disorders), paresthesia (sensory disturbances), psychomotor disturbances (sensory or motor coordination), depression, decreased bronchial mucus secretion, alopecia, allergic dermatitis, excessive sweating, photosensitivity, hypotension (low blood pressure).
The severity and frequency of adverse reactions can be controlled by reducing the daily dose.
Adults over the age of 65 are more susceptible to adverse reactions, as they may suffer from other medical conditions or be taking other medications concurrently. These individuals are also at higher risk of falls.

Reporting of adverse reactions
If any adverse symptoms 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 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Senamina

There are no special requirements for storing this medicinal product.
The medicine should be stored in a place that is out of sight and out of reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging.
The expiry date (EXP) 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Senamina contains
The active substance is doxylamine hydrogen succinate.
Each coated tablet contains 12.5 mg of doxylamine hydrogen succinate.
Other components of the medicine are: mannitol; microcrystalline cellulose (PH-101);
sodium carboxymethyl starch (type A); colloidal anhydrous silica; magnesium stearate.
Coating OPADRY 02B24028 composition: hypromellose 5mPas; titanium dioxide (E171); macrogol 400; erythrosine, lake (E127); iron oxide red (E172); indigo carmine, lake (E132).

What Senamina looks like and contents of the pack
Senamina is a pink, oval, biconvex coated tablet with a dividing score line.
Senamina tablets are packed in aluminium/aluminium or PVC/PE/PVDC/aluminium blisters, placed together with the patient leaflet in a cardboard box.
Pack sizes: 7, 10, 14 or 20 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturers
Industria Química y Farmacéutica VIR, S.A.
C/ Laguna, 66-68-70 Pol. Industrial Urtinsa II
28923 – Alcorcón (Madrid)
Spain

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

Pharmex Advanced Laboratories S.L
Calle A-431 Km. 19, Almodovar del Río
14720 – Cordoba
Spain

Other sources of information
Detailed and up-to-date information about this product, along with educational materials for patients, is available by scanning the QR code on the outer packaging of the medicine with a smartphone, and on the website: www.senamina.pl/pacjent