Senolek

Before using SENOLEK medicine, please read the leaflet carefully and complete the
Patient Information Brochure.
This medicine is intended only for adult patients.

Package leaflet: information for the patient

SENOLEK, 50 mg, soft capsules
Diphenhydramini hydrochloridum
Please read this leaflet carefully before taking 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 the doctor or pharmacist.

• Keep this leaflet, so you can read it again if needed.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, you should contact your doctor.

Table of contents of the leaflet

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

1. What SENOLEK is and what it is used for

The active substance in SENOLEK is diphenhydramine hydrochloride. Diphenhydramine belongs to a group of antihistamine medicines with sedative and calming effects.
SENOLEK is intended for short-term use in occasional insomnia in adults.
Occasional insomnia may occur especially when there are difficulties falling asleep, frequent awakenings during the night, or early morning awakening, associated with stress or changes in time zones.
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 wakefulness during the night lasts longer than half an hour, such disturbances occur at least three nights per week, and poor sleep quality causes fatigue or reduced daytime psycho-physical performance.
Transient sleep disturbances may be caused by various factors such as: stress, illness, anxiety, personal or professional problems, or fatigue related to changes in time zones. The diphenhydramine contained in SENOLEK reduces the time required to fall asleep and increases the depth and improves the quality of sleep.
Medication should not be 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 are present. Failure to properly diagnose and treat the underlying causes 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 should not be used for the treatment of chronic sleep disorders.
The treatment period should be as short as possible. 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 your condition worsens, you should contact your 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 peptic ulcer (damage to the stomach or duodenal mucosa);
• if the patient has gastric or intestinal obstruction (e.g. caused by a peptic ulcer);
• if the patient has a tumour of the adrenal gland (known as phaeochromocytoma);
• if the patient has heart problems known as QT prolongation;
• if the patient has cardiovascular disease or a slow heart rate (bradycardia);
• if the patient has low levels of salts in the blood (e.g. reduced potassium or magnesium levels);
• if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section "SENOLek with other medicines");
• if sudden cardiac death due to heart disease has occurred in the patient's immediate family.

Warnings and precautions
Before taking SENOLEK, consult a doctor or pharmacist if:

• the patient suffers from myasthenia gravis (characterised by excessive muscle weakness);
• the patient has epilepsy or convulsive disorders;
• the patient has narrow-angle glaucoma (increased pressure in the eye);
• the patient has an enlarged prostate or difficulty urinating (urinary retention);
• the patient has asthma, bronchitis, or chronic obstructive pulmonary disease (COPD);
• the patient has moderate or severe liver or kidney impairment;
• the patient is elderly (over 65 years of age) and/or has cognitive disorders (disorientation), as the risk of adverse effects is higher.

Stop taking SENOLEK immediately if any symptoms or signs of heart rhythm disturbances occur. In such a case, contact a doctor immediately.
If insomnia persists, contact a doctor, as insomnia may be a symptom of another serious underlying condition.
Diphenhydramine should be used for the shortest possible duration. The effectiveness of SENOLEK may decrease with prolonged continuous use. Prolonged use may lead to the development of tolerance and/or dependence.
Cases of abuse and dependence on diphenhydramine have been reported in young adults and/or patients with psychiatric disorders and/or a history of drug abuse.
Any signs of dependence or abuse should be reported to a doctor immediately.
If after 7 days of treatment the patient does not feel better or feels worse, contact a doctor.
Allergy testing: discontinue use of the medicine at least 72 hours before undergoing allergy tests. Diphenhydramine may interfere with test results.

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

SENOLek with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
The medicine may enhance the effects of certain drugs.
Do not take SENOLEK if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm.
Do not take SENOLEK together with other medicines containing antihistamine substances, including topical products, cough and cold remedies.
In particular, inform the doctor if the patient is taking any of the following medicines:

• sedatives, hypnotics, and anxiolytics, as diphenhydramine may enhance their effects;
• monoamine oxidase inhibitors (MAOIs) taken within the last 2 weeks (used to treat depression), as they prolong and intensify 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 pupil of the eye);
• metoprolol (a medicine used to treat hypertension, heart problems, and for migraine prophylaxis).

SENOLek and alcohol
Alcohol must not be consumed during treatment with this medicine.

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 a doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy or breastfeeding.
There are no available data on the effect of diphenhydramine on fertility.

Driving and operating machinery
SENOLek is a sedative medicine that causes drowsiness and sedation shortly after administration. The medicine affects the ability to drive and operate machinery. It may cause dizziness, blurred vision, attention disturbances, and psychomotor impairment. If these symptoms occur, the patient must not drive or operate machinery. Do not drive motor vehicles or operate mechanical equipment for at least 8 hours after the last dose of the medicine.

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

3. How to use SENOLEK

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is taken orally.
The recommended dose for adults is: if necessary, 1 capsule 20 minutes before bedtime.
Do not exceed the recommended dose or dosing frequency.
Do not exceed the maximum daily dose of the medicine: 1 capsule per day.
Do not take an additional capsule if the patient wakes up during the night.

Duration of treatment
Treatment should be as short as possible. Do not use the medicine for longer than 7 days without consulting a doctor. If there is no improvement after 7 days, or if the patient feels worse, contact a doctor.

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

Taking more SENOLEK than recommended
If more medicine has been taken than recommended, contact a doctor or the nearest emergency department immediately.
Overdose may cause: dilated pupils, fever, facial flushing, agitation, muscle tremors, involuntary movements, hallucinations (perceiving non-existent objects or people), and changes in ECG recording. Significant overdose may lead to rhabdomyolysis (muscle breakdown), seizures, delirium, toxic psychosis, cardiac disturbances, coma, and cardiovascular collapse.

Missed dose of SENOLEK
Do not take a double dose to make up for a missed dose.
Take the next dose as instructed in the leaflet.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The medicine must be discontinued and medical advice must be sought immediately or the patient should go to
the emergency department of the nearest hospital if the patient experiences hypersensitivity reactions with
symptoms such as:

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

Other adverse reactions
Common (occur in 1 to 10 people in 100):

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

Frequency unknown (cannot be estimated from available data):

• gastrointestinal disorders, including nausea, vomiting;
• disorientation, paradoxical excitation (e.g. increased energy, motor restlessness, nervousness);
• seizures, headache;
• paresthesia (tingling, numbness or altered skin temperature sensation);
• dyskinesia (involuntary, uncoordinated movements of limbs or entire body, twisting and rigidity, involuntary lip movements, protrusion and retraction of the tongue);
• blurred vision;
• tachycardia (rapid heartbeat), palpitations (irregular, fast heartbeat);
• thickening of bronchial secretions;
• muscle tremor;
• difficulty in urination, urinary retention.

Elderly patients (over 65 years of age) are more susceptible to disorientation and paradoxical
excitation.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 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 the medicine SENOLEK

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What SENOLEK contains

• The active substance is diphenhydramine hydrochloride. Each capsule contains 50 mg of diphenhydramine hydrochloride.
• Other components (excipients) are: macrogol 400, purified water, gelatine, sorbitol liquid, 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, hermetically filled with liquid, with a smooth and glossy surface.
One pack contains 8 or 16 soft capsules in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel.: 22 742 00 22
e-mail: [email protected]