Senamina Forte

LEAFLET INCLUDED IN THE PACKAGE:

Information for the user

Senamina Forte, 25 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.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Senamina Forte is a medicinal product containing doxylamine 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, they should consult a doctor.

2. Important information before taking Senamina Forte

When not to take Senamina Forte:

• If the patient is allergic to the active substance or any other component of the medicine (listed in section 6).
• If the patient is allergic to other antihistamine medicines.
• If the patient is breastfeeding.
• If the patient has respiratory diseases 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 (enlargement of the prostate gland), difficulty urinating, or urinary tract disease.
• If the patient has stomach ulcers or narrowing of the stomach or duodenum (difficulty passing food from the stomach to the intestine).
• Severe liver or kidney failure.
• If the patient is taking monoamine oxidase inhibitors.
• If the patient is taking certain medicines, such as antidepressants, some antibiotics, heart medicines, some antiviral or antifungal medicines, some cholesterol-lowering medicines, or quinidine (an antiepileptic medicine).

Warnings and precautions

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

• If the patient has epilepsy.
• In case of daytime drowsiness, it may be necessary to reduce the dose or take the medicine earlier to ensure at least an 8-hour interval between taking the medicine and waking up.
• Alcohol should not be consumed during treatment.
• Patient over 65 years of age may be more susceptible to side effects.
• Doxylamine may exacerbate dehydration and heat stroke due to reduced sweat production.
• If the patient has a prolonged QT interval (heart rhythm disorder).
• The medicine should not be taken for more than 7 days without medical supervision. If symptoms persist, you should consult a doctor.

Senamina Forte and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those available without a prescription. You should especially inform your doctor about taking the following medicines:

• Epinephrine (a medicine used to treat low blood pressure).
• Heart medicines, such as anti-arrhythmic medicines, some antibiotics, some antimalarial medicines, some antihistamines, some cholesterol-lowering medicines, and some antipsychotic medicines.
• Medicines that reduce the elimination of other medicines, such as azole derivatives or macrolides, as they may enhance the effect of doxylamine.
• Certain diuretics (medicines that increase urine production).
• Medicines that depress the central nervous system (barbiturates, sedatives, anxiolytics, opioid analgesics, antipsychotic medicines, or procarbazine).
• Antihypertensive medicines (blood pressure-lowering medicines) that act on the central nervous system, such as guanabenz, clonidine, or alpha-methyldopa.
• Other anticholinergic medicines, including those used to treat depression or Parkinson's disease, monoamine oxidase inhibitors (used to treat depression), antipsychotic medicines (used to treat mental disorders), antispasmodic medicines (atropine), or disopyramide (used to treat certain heart conditions).
• Other medicines that are toxic to the ear, such as carboplatin or cisplatin (used to treat cancer), chloroquine (used to treat or prevent malaria), or certain antibiotics (used to treat infections), such as erythromycin or aminoglycosides in injectable form. Doxylamine may mask the toxic effects of these medicines, so it is recommended to periodically monitor the condition of the ear.

Effect on diagnostic tests

Doxylamine may affect the results of allergic skin tests using allergens.
It is recommended to discontinue doxylamine at least 3 days before undergoing such tests.

Taking Senamina Forte with food, drink, and alcohol

During treatment with doxylamine, you should avoid consuming alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Since doxylamine can cross the placenta, as a precautionary measure, it is not recommended to take Senamina Forte during pregnancy, unless the potential benefit to the mother outweighs the potential risk to the fetus.
Due to the passage of doxylamine into breast milk and the risk associated with the use of antihistamines in small children, Senamina Forte is contraindicated during breastfeeding.
There is no data on the effect of Senamina Forte on fertility.

Driving and using machines

Doxylamine affects the ability to drive and use machines.
It is not recommended to drive or operate machinery during treatment, at least for the first few days, to determine how the medicine affects the body.

Senamina Forte contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Senamina Forte

The medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
Adults (over 18 years of age)
The recommended daily dose is 1 tablet (25 mg).
In case of daytime drowsiness, 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 waking up.
The maximum daily dose should not exceed 1 tablet (25 mg).
Use in the elderly
Patient over 65 years of age are more susceptible to other diseases 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 (1 tablet) if the initial dose is ineffective in relieving insomnia. If side effects occur, the dose should be reduced to 12.5 mg per day.
Use in patients with liver or kidney failure
Patients with these conditions require individual dose adjustment by the doctor, depending on the degree of failure.
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 bedtime, with a sufficient amount of liquid (preferably water).
Doxylamine can be taken before or after a meal.
The tablet can be divided into equal doses.
Duration of treatment
The duration of treatment 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 prior consultation with a doctor.

Taking a higher dose of Senamina Forte than recommended

Symptoms of overdose include drowsiness, depression or stimulation of the central nervous system, anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal motility), heat stroke, changes in heart rate, hypertension, nausea, vomiting, stimulation, unsteady gait, dizziness, irritability, sedation, confusion, and hallucinations. Patients may experience delirium, psychotic disorders, hypotension, seizures, respiratory failure, loss of consciousness, coma, and death. A serious complication can be rhabdomyolysis (muscle damage), followed by kidney failure.
Since there is no specific antidote in case of overdose of antihistamines, treatment is symptomatic and supportive. The doctor decides on possible induction of vomiting, gastric lavage, or administration of blood pressure-raising medicines if necessary.

Missing a dose of Senamina Forte

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

Stopping treatment with Senamina Forte

If you have any further doubts about taking 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.
The side effects caused by doxylamine are usually mild and transient.
They occur more frequently during the first few days of treatment.
Common (in 1 in 10 patients):drowsiness and symptoms such as dry mouth, constipation, abdominal pain, blurred vision, urinary retention, increased bronchial secretion, dizziness, headache, fatigue, insomnia, and nervousness.
Uncommon (in 1 in 100 patients):asthenia (fatigue), peripheral edema (hands and feet), nausea, vomiting, diarrhea, rash, tinnitus, orthostatic hypotension (decrease in blood pressure when changing body position), double vision, dyspepsia (stomach disorders), feeling of relaxation, nightmares, and dyspnea (difficulty breathing).
Rare (in 1 in 1,000 patients):stimulation (especially in children and the elderly), tremors, seizures, blood disorders, such as hemolytic anemia, thrombocytopenia, leukopenia, or agranulocytosis (decrease in the number of certain types of blood cells: platelets or white blood cells).
Other side effects with unknown frequency:malaise

Reporting side effects

If you experience any side effects, you should tell your doctor or pharmacist.
This includes any possible side effects not listed in the leaflet. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Senamina Forte

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the container. The expiry date (EXP) is the last day of the month stated.
There are no special precautions for storage of the medicinal product.
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.
Store in the original package.

6. Contents of the package and other information

What Senamina Forte contains

The active substance of the medicine is 25 mg of doxylamine succinate.
The other ingredients of the medicine are:
Excipients:
Mannitol
Microcrystalline cellulose (PH-101)
Sodium carboxymethylcellulose (type A)
Colloidal anhydrous silica
Magnesium stearate
Coating OPADRY Y-1-7000:
Hypromellose 5mPas
Titanium dioxide (E 171)
Macrogol 400
Indigo carmine, lake (E 132)

What Senamina Forte looks like and contents of the package

Senamina Forte is a blue, oval, biconvex, coated tablet with a dividing line.
Aluminum/Aluminum or PVC/PE/PVDC/Aluminum blister pack in a cardboard box.
The package contains 7, 10, 14, or 20 coated tablets.

Marketing authorization 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

Date of last revision of the leaflet: