PACKAGE LEAFLET:

Information for the user
Senamina Forte, 25 mg, coated tablets
Doxylamine hydrogen succinate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Senamina Forte is and what it is used for
What you need to know before taking Senamina Forte
How to take Senamina Forte
Possible side effects
How to store Senamina Forte
Contents of the pack and other information

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

Senamina Forte is a medicinal product containing doxylamine hydrogen succinate as the
active substance.
The medicine is indicated for short-term, symptomatic treatment of occasional insomnia
in adults.
Patients with persistent sleep disorders should consult a doctor.
If there is no improvement after 7 days, or if the patient feels worse, medical advice should be sought.

2. Important information before taking Senamina Forte

When not to take Senamina Forte:

If the patient is allergic to the active substance or to any of the other ingredients of the medicine (listed in section 6).
If the patient is allergic to other antihistamine medicines.
If the patient is breastfeeding.
If the patient suffers from respiratory disorders such as asthma, chronic bronchitis (persistent cough accompanied by sputum and mucus), or emphysema (difficulty breathing).
If the patient has glaucoma (increased pressure in the eye).
If the patient has prostate enlargement (benign prostatic hyperplasia), difficulty passing urine from the bladder (urinary tract disorder), or problems urinating.
If the patient has gastric or duodenal ulcer or pyloroduodenal stenosis (difficulty in food passage from the stomach to the intestine).
Severe liver or kidney insufficiency.
If the patient is currently taking monoamine oxidase inhibitors (MAOIs).
If the patient is taking certain medicines, such as antidepressants, certain antibiotics, cardiovascular medicines including those used to treat cardiac arrhythmias, certain antiviral and antifungal medicines, certain lipid-lowering agents, or quinidine (an anticonvulsant medicine).

Warnings and precautions
Before starting doxylamine, discuss this with your doctor or pharmacist:

If the patient suffers from epilepsy.
If daytime drowsiness occurs, it may be necessary to reduce the dose or take the medicine earlier, ensuring at least an 8-hour interval between taking the medicine and waking up.
Do not drink alcohol during treatment.
Patients over 65 years of age may be more susceptible to adverse effects.
Doxylamine may exacerbate symptoms of dehydration and heat stroke due to reduced sweating.
If the patient has long QT syndrome (a heart rhythm disorder).
The medicine should not be used for longer than 7 days without medical supervision. If symptoms persist, consult a doctor.

Senamina Forte and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, including those available without a prescription. In particular, inform the doctor if the patient is taking any of the following medicines:

Epinephrine (a medicine used to treat low blood pressure).
Cardiovascular medicines, including antiarrhythmics, certain antibiotics, certain antimalarials, certain antihistamines, certain lipid-lowering agents (fats in the blood), and certain antipsychotics (used to treat psychiatric disorders).
Medicines that reduce the elimination of other medicines, such as azole derivatives or macrolides, as they may enhance the effects of doxylamine.
Certain diuretics (medicines that increase urine output).
Central nervous system depressants (barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine).
Antihypertensive medicines acting on the central nervous system, such as guanabenz, clonidine, or methyldopa.
Other anticholinergic medicines, including those used to treat depression or Parkinson’s disease, monoamine oxidase inhibitors (used to treat depression), antipsychotics (used to treat psychiatric disorders), antispasmodics (atropine-like agents), or disopyramide (used to treat certain heart conditions).
Other ototoxic medicines, such as carboplatin or cisplatin (used in cancer treatment), chloroquine (used to treat or prevent malaria), and certain antibiotics used to treat infections, such as erythromycin or injectable aminoglycosides. Doxylamine may mask the ototoxic effects of these medicines; therefore, periodic monitoring of hearing function is recommended.

Effect on diagnostic test results
Doxylamine may affect the results of skin allergy tests using allergens.
It is recommended to discontinue doxylamine at least three days before undergoing such tests.

Taking Senamina Forte with food, drink, and alcohol
Avoid drinking alcohol during treatment with doxylamine.

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.
Since doxylamine may cross the placenta, as a precaution, the use of Senamina Forte during pregnancy is not recommended unless the potential benefit to the mother outweighs the potential risk to the developing fetus.
Due to the passage of doxylamine succinate into breast milk and the risk associated with antihistamine use in young children, Senamina Forte is contraindicated during breastfeeding.
There is no data available regarding the effect of Senamina Forte on fertility.

Driving and operating machinery
Doxylamine may affect the ability to drive and operate machinery.
Driving vehicles or operating machinery is not recommended during treatment, especially during the first few days of therapy, until the patient knows how the medicine affects them.

Senamina Forte contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Senamina Forte

Always take this medicine exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Adults (aged over 18 years)
The recommended daily dose is 1 tablet (25 mg).
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 waking up.
The maximum daily dose should not exceed 1 tablet (25 mg).
Use in elderly patients
Patients aged over 65 years are more susceptible to other diseases 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 (1 tablet) if the initial dose proves ineffective in relieving insomnia. If
adverse effects occur, the dose should be reduced to 12.5 mg per day.
Use in patients with hepatic or renal impairment
Patients with these conditions require individual dose adjustment by a doctor, depending on the
severity of impairment.
Use in children and adolescents
Doxylamine is not recommended for use in children and adolescents under 18 years of age. The
medicine should not be used in this patient group.
Route and method of administration
Oral administration.
Tablets should be taken 30 minutes before going to rest, with an adequate amount of fluid (preferably
water).
Doxylamine may be taken before or after meals.
The tablet may be divided into equal doses.
Treatment duration
Treatment duration should be as short as possible. Treatment usually lasts from a few days to one
week. Do not take the medicine for longer than 7 days without prior consultation with your doctor.
Taking more Senamina Forte than recommended
Symptoms of overdose include drowsiness, central nervous system depression or excitation,
anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal motility), hot flushes,
changes in heart rate, hypertension, nausea, vomiting, agitation, unsteady gait, dizziness, irritability,
sedation, confusion, and hallucinations. Patients may experience delirium, psychotic disturbances,
hypotension, seizures, dyspnea, loss of consciousness, coma, and death. A serious complication may
be rhabdomyolysis (muscle damage), leading to renal failure.
There is no specific antidote in case of antihistamine overdose; therefore, treatment is symptomatic and
supportive. The physician will decide whether to induce vomiting, perform gastric lavage, or prescribe
medications to raise blood pressure, if necessary.
Missed dose of Senamina Forte
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time on the following day.
Stopping Senamina Forte
If you have any further questions about 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 experiences them.
Adverse reactions caused by doxylamine are usually mild and transient.
They occur more frequently during the first few days of treatment.
Common (in 1 patient out of 10): drowsiness and symptoms such as dry mouth, constipation, epigastric pain, blurred vision, urinary retention, increased bronchial secretion, dizziness, headache, fatigue, insomnia, and nervousness.
Uncommon (in 1 patient out of 100): asthenia (weakness), peripheral edema (of hands and feet), nausea, vomiting, diarrhea, rash, tinnitus, orthostatic hypotension (decrease in blood pressure following a change in body position), double vision, dyspepsia (gastric disturbances), feeling of relaxation, nightmares, and dyspnea (difficulty breathing).
Rare (in 1 patient out of 1,000): excitation (especially in children and elderly patients), tremor, convulsions, blood disorders such as hemolytic anemia, thrombocytopenia, leukopenia, or agranulocytosis (reduction in the number of certain types of blood cells: platelets or white blood cells).
Other adverse reactions of unknown frequency: malaise
Reporting of adverse reactions
If any adverse reactions occur, inform your doctor or pharmacist.
This includes any potential adverse reactions not listed in the leaflet. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw
tel. (22) 49 21 301
fax (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Senamina Forte

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the container. The expiry date (EXP) refers to the last day of the stated month.
No special storage instructions are required for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
Store in the original packaging.

6. Contents of the pack and other information

What Senamina Forte contains
The active substance is 25 mg of doxylamine hydrogen succinate.
Other components of the medicine are:
Excipients:
Mannitol
Microcrystalline cellulose (PH-101)
Sodium carboxymethyl starch (type A)
Colloidal anhydrous silica
Magnesium stearate
Coating OPADRY Y-1-7000:
Hypromellose 5mPas
Titanium dioxide (E 171)
Polyethylene glycol 400
Indigo carmine, aluminium lake (E 132)

What Senamina Forte looks like and contents of the pack
Senamina Forte is in the form of blue, oval, biconvex coated tablets with a central dividing score line.
Aluminium/Aluminium or PVC/PE/PVDC/Aluminium blister packs in a cardboard box.
Pack sizes: 7, 10, 14 or 20 coated tablets.

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

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

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Pharmex Advanced Laboratories S.L
Calle A-431 Km. 19, Almodovar del Río
14720 – Cordoba
Spain