Senolek

Before using the SENOLEK medicine, read the leaflet carefully and fill out

Patient Information.

The medicine is intended only for adult patients.

Leaflet attached to the packaging: information for the patient

SENOLEK, 50 mg, soft capsules

Diphenhydramine hydrochloride

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 this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 SENOLEK and what is it used for
• 2. Important information before using SENOLEK
• 3. How to use SENOLEK
• 4. Possible side effects
• 5. How to store SENOLEK
• 6. Contents of the pack and other information

1. What is SENOLEK and what is it used for

The active substance of the medicine is diphenhydramine hydrochloride. Diphenhydramine belongs to a group of antihistamine medicines that cause drowsiness and have a sedative effect.
SENOLEK is intended for short-term use in occasional insomnia in adults.
Occasional insomnia may occur, especially when there are difficulties falling asleep, frequent nighttime awakenings, early morning awakenings, related to stress or a change in time zones.
Sleep disorders can have a negative impact on physiological processes and lead to a decrease in psychophysical fitness. We talk about insomnia, among other things, when: the time it takes to fall asleep exceeds half an hour, the total time spent awake at night lasts longer than half an hour, such disruption occurs at least three nights a week, and poor sleep quality causes fatigue or decreased psychophysical fitness during the day.
Transient sleep disorders can be caused by various factors, such as: stress, illness, anxiety, personal or professional problems, fatigue related to a change in time zone. Diphenhydramine contained in SENOLEK causes a shortening of the time it takes to fall asleep and increases the depth and improves the quality of sleep.
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 other symptoms, apart from insomnia. Failure to properly diagnose the causes of sleep disorders and their treatment may lead to health risks. Treating the underlying disease that causes sleep disorders is a necessary condition for a lasting improvement in sleep quality.

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

The treatment period should be as short as possible. The medicine should 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 a doctor.

2. Important information before using SENOLEK

When not to take SENOLEK:

• if the patient is allergic to diphenhydramine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a stomach ulcer (damage to the stomach lining or the initial section of the intestine);
• if the patient has gastric and intestinal obstruction (caused by an ulcer, for example);
• if the patient has an adrenal gland tumor (known as a pheochromocytoma);
• if the patient has heart problems called QT interval prolongation;
• if the patient has cardiovascular disease or low blood pressure;
• if the patient has low salt levels in the blood (e.g., decreased potassium or magnesium levels);
• if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see "SENOLEK and other medicines");
• if there has been a sudden death in the patient's immediate family due to heart disease.

Warnings and precautions

Before starting to use SENOLEK, you should discuss it with your doctor or pharmacist:

• if the patient has myasthenia (excessive muscle weakness);
• if the patient has epilepsy or seizure disorders;
• if the patient has glaucoma with a narrow angle of filtration (increased pressure in the eye);
• if the patient has an enlarged prostate or difficulty urinating (urinary retention);
• if the patient has asthma, bronchitis, or chronic obstructive pulmonary disease (COPD);
• if the patient has moderate or severe liver or kidney function disorders;
• if the patient is elderly (over 65 years old) and (or) has impaired consciousness (disorientation), as there is a greater likelihood of side effects.

You should stop using SENOLEK if you experience any symptoms or signs of heart rhythm disorders. In such a case, you should contact your doctor immediately.
In the case of persistent insomnia, you should contact your doctor, as the symptoms of insomnia may be a sign of another underlying serious disease.
Diphenhydramine should be used for the shortest possible period. The effectiveness of SENOLEK may be lower if it is used continuously. Taking the medicine may lead to the development of tolerance and (or) dependence.
There have been reports of abuse and dependence on diphenhydramine in young adults and (or) patients with mental disorders and (or) those who have previously had substance abuse disorders.
Any signs of dependence or abuse of the medicine should be reported to the doctor immediately.
If after 7 days of using the medicine the patient does not feel better or feels worse, they should contact their doctor.
Allergy tests: you should stop using the medicine at least 72 hours before undergoing allergy tests. Diphenhydramine may affect the test results.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

SENOLEK and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The medicine may enhance the effects of certain medicines.

You should not take SENOLEK if you are taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm.

You should not take SENOLEK with other medicines containing antihistamine substances, including medicines used on the skin, for coughs, or colds.
In particular, you should inform your doctor if you are taking any of the following medicines:

• sedatives, hypnotics, and anxiolytics, as diphenhydramine may enhance their effects;
• monoamine oxidase inhibitors (MAOIs) that you have taken in the last 2 weeks (used to treat depression), as they may prolong and enhance the effects of diphenhydramine;
• tricyclic antidepressants (used to treat depression, such as amitriptyline, doxepin), as diphenhydramine may enhance their effects;
• venlafaxine (a medicine used to treat depression);
• atropine (a medicine used to dilate the pupils of the eyes);
• metoprolol (a medicine used to treat high blood pressure, heart problems, and to prevent migraines).

SENOLEK with alcohol

You should not consume alcohol while taking the medicine.

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 using this medicine.
You should not use the medicine during pregnancy and breastfeeding.
There is no available data on the effect of diphenhydramine on fertility.

Driving and using machines

SENOLEK is a sedative medicine that soon after taking a dose causes drowsiness and sedation. The medicine affects the ability to drive vehicles and operate machines.
It may cause dizziness, blurred vision, attention disorders, and psychomotor disorders. If you experience these symptoms, you should not drive vehicles or operate machines. You should not drive vehicles or operate mechanical equipment for at least 8 hours after taking the last dose of the medicine.

SENOLEK contains liquid sorbitol, partially dehydrated

The medicine contains 77.5 mg of liquid sorbitol, partially dehydrated, in each capsule.

3. How to use SENOLEK

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
The medicine is taken orally.
The recommended dose for adults is: if necessary, 1 capsule 20 minutes before bedtime.
You should not exceed the recommended dose and frequency of administration.
You should not exceed the maximum daily dose of the medicine: 1 capsule per day.
You should not take an additional capsule if you wake up during the night.
Duration of treatment
Treatment should be as short as possible. The medicine should not be used for a period longer than 7 days without consulting a doctor. If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Use in children and adolescents

The medicine should not be used in children and adolescents under 18 years of age.

Taking a higher dose of SENOLEK than recommended

If you have taken a higher dose of the medicine than recommended, you should immediately contact your doctor or the nearest emergency department.
Overdose may cause: dilated pupils, fever, flushing of the face, excitement, muscle tremors, involuntary movements, hallucinations (perception of non-existent objects or people), and changes in the ECG recording. Significant overdose of the medicine may cause rhabdomyolysis (muscle breakdown), seizures, delirium, toxic psychosis, heart problems, coma, and cardiovascular collapse.

Missing a dose of SENOLEK

You should not take a double dose to make up for a missed dose.
You should take the next dose as directed in the leaflet.
If you have any further doubts about using 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.

You should stop using the medicine and immediately contact your doctor or go to the emergency department of the nearest hospital if you experience an allergic reaction with symptoms such as:

• sudden swelling of the lips, tongue, throat, face, limbs, or joints without itching and pain (so-called angioedema). Swelling in the head and neck area may cause difficulty swallowing and breathing;
• hives (itchy, red bumps on the skin);
• urticaria (light red, itchy blisters on the skin);
• difficulty breathing, wheezing. The frequency of these symptoms is unknown.

Other side effects
Common(occurring in 1 to 10 people in 100):

• fatigue, sedation;
• drowsiness;
• attention disorders;
• difficulty maintaining balance, dizziness;
• dry mouth.

Frequency not known(cannot be estimated from the available data):

• gastrointestinal disorders, including nausea, vomiting;
• disorientation, paradoxical excitement (e.g., increased energy, restlessness, nervousness);
• seizures, headaches;
• paresthesia (tingling, numbness, or changes in skin temperature);
• dyskinesia (uncoordinated and involuntary movements of the limbs or the whole body, bending and stretching, involuntary movements of the lips, tongue protrusion);
• blurred vision;
• tachycardia (rapid heartbeat), palpitations (irregular, rapid heartbeat);
• thickening of bronchial secretions;
• muscle tremors;
• difficulty urinating, urinary retention.

Elderly people (over 65 years old) are more prone to disorientation and paradoxical excitement.

Reporting side effects

If you experience any side effects, including any side effects not listed in this 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:
Aleje 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.
Reporting side effects will allow for more information to be collected on the safety of the medicine.

5. How to store SENOLEK

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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 pack and other information

What SENOLEK contains

• The active substance of the medicine is diphenhydramine hydrochloride. One capsule contains 50 mg of diphenhydramine hydrochloride.
• The other ingredients (excipients) are: macrogol 400, purified water, gelatin, liquid sorbitol, partially dehydrated, patent blue (E 131).

What SENOLEK looks like and contents of the pack

The medicine is in the form of oval, blue, transparent capsules, tightly filled with liquid, with a smooth and shiny surface.
One pack of the medicine contains 8 soft capsules in PVC/PVDC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

phone: 22 742 00 22
e-mail: [email protected]

Date of last update of the leaflet: