Senamina

PATIENT INFORMATION LEAFLET

Before taking the medicine, read the leaflet carefully and use the attached

Patient Informator!

Information on the use of the medicine is also available after scanning with a smartphone

the QR code placed on the outer packaging of the medicine and on the
website www.senamina.pl/patient

Leaflet attached to the packaging: information for the user

Senamina, 12.5 mg, coated tablets

Doxylamine hydrogen succinate

You should carefully read the contents of the leaflet 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 directed by your doctor, pharmacist, or nurse.

• 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 pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Senamina and what is it used for

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

• there are difficulties falling asleep,
• there are frequent nighttime awakenings,
• there is early morning awakening related to stress or a change in time zones.

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 it takes to fall asleep exceeds half an hour, the total time spent awake during the night lasts longer than half an hour, such disruption occurs at least three nights a week, and poor sleep quality causes fatigue or reduced psychophysical fitness during the day.
Transient sleep disorders usually last a few days and are associated with the occurrence of certain factors, such as illness, anxiety, noise, inappropriate ambient temperature, or a change in time zone.
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 causing sleep disorders is a necessary condition for lasting sleep quality improvement.
The medicine should 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 should not be taken for more than 7 days without consulting a doctor.If there is no improvement after 7 days or the patient feels worse, they should consult a doctor.

2. Important information before taking Senamina

When not to take Senamina

• 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).
• if the patient has a respiratory disease, such as asthma, bronchitis (persistent cough that produces thick sputum) or pulmonary emphysema (inflammation of the air sacs in the lungs that causes breathing difficulties).
• if the patient has glaucoma (increased eye pressure).
• if the patient has an enlarged prostate (abnormal enlargement of the prostate), urethral stricture (a urinary tract disease) or difficulty urinating.
• if the patient has a stomach or duodenal ulcer or duodenal stenosis (difficulty passing food from the stomach to the intestine).
• if the patient has severe kidney or liver disease.
• if the patient is taking monoamine oxidase inhibitors (medicines used in depression and Parkinson's disease).
• if the patient is taking antiepileptic medicines, antidepressants, certain antibiotics, heart medicines, such as those used to treat arrhythmias, antiviral medicines, antifungal medicines, or certain medicines that affect lipid (fat) levels in the blood.
• if the patient is breastfeeding.

Warnings and precautions

Before starting to take Senamina, you should discuss it with your doctor or pharmacist:

• if the patient has epilepsy (antihistamine medicines can sometimes cause overexcitement and, as a result, lower the seizure threshold).
• if the patient experiences daytime sleepiness, it may be necessary to reduce the dose of the medicine or take the dose earlier to ensure at least an 8-hour interval between taking the medicine and the planned wake-up time.
• you should avoid consuming alcohol during treatment.
• if the patient has a prolonged QT interval (heart rhythm disorder), low potassium levels in the blood, or other electrolyte disturbances, urinary retention, or heart disease.
• if the patient is taking other medicines that can be harmful to the ear, such as carboplatin or cisplatin (medicines used in cancer treatment), chloroquine (a medicine used to treat or prevent malaria), or certain antibiotics (used to treat infections) like erythromycin or aminoglycosides given parenterally, as Senamina may mask the harmful effects of these medicines on hearing.

Patients over 65 years of age are more likely to experience side effects (see section 4). Senamina may exacerbate dehydration and heat stroke caused by reduced sweating, especially during heatwaves. Caution should be exercised, especially in elderly patients.
One should always take the medicine according to the information provided in the patient leaflet or as directed by the doctor or pharmacist. Improper use of the medicine, including taking it for too long or exceeding the recommended doses, may cause side effects. The patient should observe their reaction to the medicine, including possible side effects (see section 4) or symptoms of overdose (see section 3 "Taking a higher dose of Senamina than recommended").
Do not exceed the recommended dose. Do not take Senamina for more than 7 days without consulting a doctor.
Senamina may exacerbate dehydration and heat stroke caused by reduced sweating, especially during heatwaves. Caution should be exercised, especially in elderly patients.

Children and adolescents

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

Senamina and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Do not take Senamina while taking the following medicines:

• epinephrine (used to treat low blood pressure).
• heart medicines, such as those used to treat arrhythmias, certain antibiotics, certain antimalarial medicines, certain antihistamines, or certain medicines used to lower lipid (fat) levels in the blood or certain neuroleptic medicines (used to treat mental disorders).
• antifungal azole derivatives (fluconazole, ketoconazole, itraconazole) or macrolide antibiotics (clarithromycin, erythromycin, telithromycin), as they may enhance the effect of doxylamine.
• certain diuretic medicines (medicines that increase urine production).
• central nervous system depressants (barbiturates, sedatives, tranquilizers, antianxiety medicines, opioid painkillers, antipsychotic medicines, or procarbazine - an anticancer medicine).
• antihypertensive medicines (medicines used to treat high blood pressure) that act on the central nervous system, such as guanabenz, clonidine, or alpha-methyldopa.
• other anticholinergic medicines, such as those used to treat depression (fluoxetine, fluvoxamine, paroxetine) or Parkinson's disease, monoamine oxidase inhibitors (medicines used to treat depression), neuroleptics (medicines used to treat mental disorders), antispasmodic medicines (e.g., atropine), or dyzopiramid (used to treat certain heart diseases).
• medicines with known ototoxic effects, such as carboplatin or cisplatin (medicines used in cancer treatment), chloroquine (a medicine used to treat or prevent malaria), or certain antibiotics (used to treat infections) like erythromycin or aminoglycosides given parenterally, as doxylamine may mask their effects.
• antihistamine medicines used on the skin (such as diphenhydramine in cream, ointment, or spray), antispasmodic medicines (such as atropine or belladonna alkaloids), and scopolamine.
• antiviral medicines (indinavir, ritonavir, telaprevir).
• medicines with a narrow therapeutic index.

Effect on diagnostic tests

Senamina may interfere with skin allergy tests that use allergens. It is recommended to stop taking this medicine at least 3 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Senamina should not be used in pregnant women unless the doctor recommends otherwise.
Senamina is contraindicated during breastfeeding.
There is no available data on the effect of Senamina on fertility.

Driving and using machines

Senamina has a significant impact on the ability to drive and use machines, as it causes drowsiness. During the first few days of treatment, until it is determined how the medicine affects the patient, you should not drive or operate machines.

Senamina contains mannitol

It may have a laxative effect.

3. How to take Senamina

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
Adults (over 18 years)
The recommended dose is 12.5 mg to 25 mg (1 or 2 tablets).
If you experience daytime sleepiness, it is recommended to reduce the dose from 25 mg to 12.5 mg or take the dose earlier to ensure at least an 8-hour interval between taking the medicine and the planned wake-up time.
The maximum daily dose is 25 mg (2 tablets).
Elderly patients (over 65 years)
In patients over 65 years of age, it is more likely that other diseases may occur that require a dose reduction. The recommended initial dose is 12.5 mg (1 tablet), given 30 minutes before bedtime. The dose can be increased to 25 mg (2 tablets) if the initial dose proves ineffective. If side effects occur, the dose should be reduced to 12.5 mg per day (1 tablet). For this reason, you should pay attention to the effects of treatment (see section 4).
Patients with kidney or liver impairment
Senamina is contraindicated in patients with severe kidney or liver disease.
It is not recommended to take Senamina in patients with moderate kidney or liver disease.
In patients with mild kidney or liver disease, it is recommended to reduce the maximum daily dose 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 a sufficient amount of liquid (preferably water). You should ensure at least an 8-hour interval between taking the medicine and the planned wake-up time, due to the possibility of persistent drowsiness.
Senamina can be taken before or after a meal.
The score line is only to facilitate breaking the tablet to make it easier to swallow and does not allow the tablet to be divided into equal doses.
Duration of treatment
The treatment period should be as short as possible. Treatment usually lasts from a few days to one week.
Senamina should not be taken for more than 7 days without consulting a doctor.

Taking a higher dose of Senamina than recommended

In case of taking a higher dose of Senamina than recommended, you should immediately contact your doctor.
The doctor will decide whether and what measures should be taken.
Symptoms of overdose include drowsiness, depression, or central nervous system stimulation, anticholinergic symptoms (dilated pupils, fever, dry mouth, decreased intestinal motility), changes in heart rate, increased blood pressure, nausea, vomiting, excitement, abnormal gait, dizziness, irritability, sedation, 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 severe 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 used. The doctor will decide whether to induce vomiting, perform gastric lavage, or prescribe medicines to increase 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 normal time the next day.

Stopping treatment with Senamina

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Senamina can cause side effects, although not everybody gets them.
Senamina's side effects are usually mild and temporary, occurring more frequently in the first days of treatment.
Side effects are listed according to their frequency:

• drowsiness.

Frequent (less than 1 in 10 patients):

• dry mouth, constipation, upper abdominal pain,
• blurred vision,
• urinary retention,
• increased mucus production in the bronchi,
• dizziness, headache,
• fatigue, insomnia, nervousness.

Uncommon (less than 1 in 100 patients):

• weakness, peripheral edema (e.g., swelling of the hands and feet),
• nausea, vomiting, diarrhea, indigestion,
• rash,
• tinnitus,
• orthostatic hypotension (decreased blood pressure when changing body position),
• double vision,
• feeling of relaxation,
• nightmares,
• dyspnea (difficulty breathing).

Rare (less than 1 in 1000 patients):

• excitement (especially in elderly patients),
• tremors, seizures,
• decreased red blood cell count, white blood cell count, or platelet count.

Other side effects usually caused by antihistamine medicines that have not been observed with doxylamine include: heart rhythm disorders (changes in heart rate), palpitations, bile reflux, liver function disorders (cholestatic jaundice), prolonged QT interval in the ECG (heart disease), loss of appetite, increased appetite, muscle pain, coordination disorders, extrapyramidal disorders (movement disorders), paresthesia (sensory disturbances), psychomotor disorders (sensory or motor coordination), depression, decreased mucus production in the bronchi, hair loss, allergic skin inflammation, excessive sweating, hypersensitivity to light, hypotension (low blood pressure).
The intensity and frequency of side effects can be controlled by reducing the daily dose.
Adults over 65 years of age are more likely to experience side effects, as they may have other diseases or be taking other medicines. These patients are also more likely to experience falls.

Reporting side effects

If you experience any side effects, including any possible 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
phone: +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 Senamina

There are no special recommendations for storing the medicinal product.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging.
The expiry date (EXP) means the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Senamina contains

The active substance of Senamina is doxylamine hydrogen succinate.
Each coated tablet contains 12.5 mg of doxylamine hydrogen succinate.
The other ingredients of the medicine are: mannitol; microcrystalline cellulose (PH-101);
sodium carboxymethyl cellulose (type A); colloidal anhydrous silica; magnesium stearate.
Coating OPADRY 02B24028 with the 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 score line.
Senamina tablets are packaged in aluminum/aluminum or PVC/PE/PVDC/aluminum blisters, along 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 authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer

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
Date of last revision of the leaflet:08.2024

Other sources of information

Detailed and updated information about this product, along with patient educational materials, is available after scanning the QR code on the outer packaging of the medicine and on the website www.senamina.pl/patient.