Nodisen

Before using Nodisen, read the leaflet carefully

and fill out the Patient Information Form.

The medicine is intended only for adult patients.

Leaflet attached to the packaging: patient information

NODISEN, 50 mg, tablets

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 according to the doctor's or pharmacist's instructions.

• 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 adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. 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 Nodisen and what is it used for
• 2. Important information before using Nodisen
• 3. How to use Nodisen
• 4. Possible side effects
• 5. How to store Nodisen
• 6. Contents of the packaging and other information

1. What is Nodisen and what is it used for

The active substance of Nodisen is diphenhydramine hydrochloride. Diphenhydramine is classified as a sedating antihistamine.
Nodisen is indicated 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.
Transient sleep disturbances usually last a few days and can be caused by various factors, such as stress, fatigue related to a change in time zone, personal problems, or work-related problems. The use of Nodisen will reduce the time to fall asleep and increase the depth and quality of sleep.
Sleep disturbances can have a negative impact on physiological processes and lead to a decrease in psychophysical fitness. Insomnia is said to occur, among other things, when: the time to fall asleep exceeds half an hour, the total time spent awake during the night lasts longer than half an hour, such disturbances occur at least three nights a week, and poor sleep quality causes fatigue or decreased psychophysical fitness during the day.
Taking medication 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 disturbances and their treatment may lead to a risk of health loss. Treating the underlying disease that causes sleep disturbances 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 Nodisen

When not to use Nodisen:

• 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 has a gastric ulcer;
• if the patient has gastric or intestinal obstruction (e.g., due to ulcers);
• if the patient has a chromaffin tumor of the adrenal gland;
• if the patient has a cardiac problem called QT interval prolongation;
• if the patient has cardiovascular disease or their heart has a very slow rhythm;
• if the patient has low electrolyte levels in the blood (e.g., decreased potassium or magnesium levels);
• if the patient is taking medications used to treat heart rhythm disorders or medications that affect heart rhythm (see section: "Nodisen and other medicines");
• if there have been cases of death in the patient's immediate family due to heart problems.

Warnings and precautions

Before starting to use Nodisen, the patient should discuss it with their doctor or pharmacist:

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

The patient should stop using Nodisen if they experience any symptoms or signs of heart rhythm disturbances. In such a case, they should immediately consult their doctor.
If sleep problems persist despite using the medicine, the patient should consult their doctor, as the symptoms may be a sign of another underlying serious disease.
In young adults, patients with mental disorders or episodes related to such disorders have reported cases of dependence or abuse of the medicine.
Any signs of dependence or abuse of the medicine should be reported to the doctor immediately.
Diphenhydramine should be used for the shortest possible period.
Longer use of the medicine may lead to the development of tolerance and/or dependence.
If after 7 days of using the medicine the patient does not feel better or feels worse, they should consult their doctor.

Allergy tests

The patient should stop using the medicine at least 72 hours before undergoing allergy tests.
Diphenhydramine may affect the test results.

Children and adolescents

The medicine is not intended for use in children and adolescents under 18 years of age and should not be used in this group of patients.

Nodisen and other medicines

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

The patient should not take Nodisen if they are taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm.

The patient should not take Nodisen with other medicines containing substances with antihistamine activity, including medicines used on the skin, for coughs, or colds.
The patient should inform their doctor or pharmacist before using Nodisen if they are taking such medicines as:
medicines that cause drowsiness, e.g., certain sedatives, sleep aids, pain relievers, antidepressants, anxiolytics (e.g., sedatives containing opioids, venlafaxine, tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) that the patient has taken in the last 2 weeks);
atropine (used to dilate the pupils);
metoprolol (a medicine used to treat high blood pressure, heart problems, and to prevent migraines).

Nodisen and alcohol

The patient should not consume alcohol while taking Nodisen.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Nodisen should not be used during pregnancy and breastfeeding.

Driving and operating machinery

Nodisen affects the ability to drive and operate machinery. The patient should not drive or operate machinery for at least 8 hours after taking Nodisen.
Nodisen is used to induce drowsiness, which occurs soon after taking a dose. It can also cause dizziness, blurred vision, attention disturbances, and psychomotor disturbances. If such symptoms occur, the patient should not drive or operate machinery.

Nodisen contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to use Nodisen

This medicine should always be taken exactly as described in this patient leaflet or according to the doctor's or pharmacist's instructions. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is for oral use.

Recommended dose for adults

If necessary, 1 tablet 20 minutes before bedtime.
The patient should not exceed the recommended dose and frequency of administration.
The patient should not take an additional tablet if they wake up during the night.
The patient should not take more than 1 tablet in 24 hours.

Duration of treatment

Treatment should be as short as possible. The medicine should not be used for more than 7 days without consulting a doctor. The patient should consult their doctor if after 7 days of using the medicine there is no improvement or they feel worse.

Use in children and adolescents

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

Using a higher dose of Nodisen than recommended

If a higher dose of the medicine than recommended is used, the patient should immediately consult their doctor or the nearest emergency department.
Overdose may cause: dilated pupils, fever, facial flushing, excitement, muscle tremors, involuntary movements, hallucinations (perceiving 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 Nodisen

The patient should not take a double dose to make up for a missed dose.
The patient should take the next dose the next day according to the instructions in the leaflet.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should immediately consult their doctor or pharmacist if they experience any of the following side effects:

Frequency not known(frequency cannot be estimated from the available data):
Allergic reactions(skin rash, itching, hives, difficulty breathing, wheezing, swelling of the lips, tongue, throat, face).

Other side effects:

Common(occurring in less than 1 in 10 people):
fatigue, sedation, drowsiness,
attention disturbances,
balance disturbances, dizziness,
dry mouth.
Frequency not known(frequency cannot be estimated from the available data):

• disorientation*, paradoxical excitement* (e.g., increased energy*, restlessness*, nervousness*),
• seizures, headaches,
• tingling of the skin (feeling of pins and needles), dyskinesia (difficulty moving),
• blurred vision,
• palpitations or rapid heartbeat,
• thickening and accumulation of mucus,
• indigestion, stomach upset,
• nausea, vomiting,
• muscle tremors,
• difficulty urinating, urinary retention.

* Elderly people are more likely to experience the mentioned side effects.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Nodisen

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light and moisture.
There are no special instructions for storing the medicine at a certain temperature.
The medicine should not be used after the expiry date stated on the carton and blister pack after "EXP".
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Nodisen contains

• The active substance is diphenhydramine hydrochloride. Each tablet contains 50 mg of diphenhydramine hydrochloride.
• The other ingredients are: lactose anhydrous, microcrystalline cellulose, maize starch, crospovidone, magnesium stearate.

What Nodisen looks like and what the pack contains

Nodisen is a white to light cream-colored, oblong, biconvex tablet.
The packaging contains 8 tablets in a blister pack OPA/Aluminum/PVC/Aluminum in a cardboard box.

Marketing authorization holder and manufacturer:

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]

Date of last revision of the leaflet: