Luminastil

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

Package leaflet: Information for the patient

Luminastil, 50 mg, tablets
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 a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet

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

1. What Luminastil is and what it is used for

Luminastil is a medicine containing the active substance diphenhydramine hydrochloride.
Diphenhydramine belongs to a group of antihistamine medicines with sedative and calming effects.

Indications
Short-term use in occasional insomnia in adults.
Occasional insomnia may occur especially in connection with difficulty falling asleep, frequent awakenings during the night, or early morning waking related to stress or changes in time zones.
Sleep disturbances may negatively affect physiological processes and lead to reduced psycho-physical performance. Insomnia is considered to be present, among other things, 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 problems, work-related issues, or fatigue due to time zone changes. The diphenhydramine contained in Luminastil shortens the time required to fall asleep and increases the depth and quality of sleep.

The use of medicines is not the primary method for treating sleep disorders and should be limited to short-term use only.
Persistent poor sleep quality may be a symptom of psychological 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.
This medicine should not be used in the treatment of chronic sleep disorders.
The treatment period should be as short as possible. Do not use this medicine for longer than 7 days without consulting a doctor. If there is no improvement after 7 days, or if you feel worse, consult your doctor.

2. Important information before taking Luminastil

When not to take Luminastil

• 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 lining or the initial part of the intestine);
• if the patient has gastric or intestinal obstruction (e.g. caused by peptic ulcer);
• if the patient has an adrenal gland tumour (known as a chromaffin tumour);
• if the patient has heart problems known as QT prolongation;
• if the patient has cardiovascular disease or a slow heart rate;
• if the patient has low levels of electrolytes in the blood (e.g. reduced potassium or magnesium levels);
• if the patient is taking medicines used for heart rhythm disorders or medicines that may affect heart rhythm (see section: "Luminastil with other medicines");
• if sudden cardiac death due to heart disease has occurred in the patient's immediate family.

Warnings and precautions
Before starting treatment with Luminastil, discuss with your doctor or pharmacist:

• if the patient has myasthenia gravis (a disease characterised by excessive muscle weakness);
• if the patient has epilepsy or convulsive disorders;
• if the patient has angle-closure glaucoma (an eye condition associated with increased intraocular pressure);
• if the patient has an enlarged prostate or difficulty passing urine (urinary retention);
• if the patient has asthma, bronchitis or chronic obstructive pulmonary disease (COPD);
• if the patient has moderate or severe liver or kidney impairment;
• if the patient is elderly (over 65 years of age), as they are more likely to experience adverse effects.

Treatment with this medicine should be discontinued if any symptoms or signs of cardiac arrhythmia occur. In such a case, contact your doctor immediately.
If insomnia persists, consult your doctor, as insomnia may be a symptom of a serious underlying condition.
Cases of misuse and dependence on diphenhydramine have been reported in young adults and/or patients with psychiatric disorders and/or those with a history of drug abuse.
Any signs of dependence or drug misuse should be reported to the doctor immediately.
Diphenhydramine should be used for the shortest possible duration.
Luminastil may become less effective if used continuously.
Use of this medicine may lead to the development of tolerance and/or dependence.
If the patient does not feel better or feels worse after 7 days of treatment, medical advice must be sought immediately.

Allergy tests
This medicine may affect the results of allergy tests; do not take the medicine at least 3 days before undergoing such tests.

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

Luminastil with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
This medicine may enhance the effects of certain medicines.
Do not take Luminastil if the patient is taking medicines for heart rhythm disorders or medicines that may affect heart rhythm.
Do not take Luminastil together with other antihistamines, including those applied to the skin or used to treat cough and colds.
The patient should inform the doctor if taking any of the following medicines:

• sedatives, hypnotics, and anxiolytics, as diphenhydramine may enhance their sedative effects;
• monoamine oxidase inhibitors (MAOIs – medicines used to treat depression), as they prolong and intensify the effects of diphenhydramine. Luminastil should be used with caution with MAOIs and for at least 2 weeks after their discontinuation;
• 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 prevention).

Luminastil and alcohol
Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Do not use Luminastil during pregnancy or while breastfeeding.

Driving and operating machinery
Luminastil is a sedative medicine that will cause drowsiness and sedation shortly after taking a dose. Do not drive or operate machinery for at least 8 hours after taking the last dose of Luminastil. This medicine may also cause dizziness, blurred vision, attention disturbances, psychomotor disturbances, and slowed reaction times. If such symptoms occur, do not drive or operate machinery.

This medicine contains monohydrate lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Luminastil

This medicine should always be taken exactly as described in this patient information leaflet or as
advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This is an oral medicine.
Recommended dose
Adults
If needed, 1 tablet 20 minutes before bedtime.
Do not exceed the recommended dose or dosing frequency.
Do not exceed the maximum daily dose of Luminastil: 1 tablet per day.
Do not take an additional tablet after waking up during the night.
Duration of treatment
Treatment should be as short as possible. Do not use this medicine for longer than 7 days without
consulting a doctor. If there is no improvement after 7 days, or if symptoms worsen, consult your doctor.
Use in children and adolescents
Luminastil must not be used in children and adolescents under 18 years of age.
Taking more Luminastil than recommended
If you take more than the recommended dose, seek immediate medical advice from your doctor or
the nearest Emergency Department.
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 Luminastil
Do not take a double dose to make up for a missed dose.
Take the next dose the following day, as instructed in this leaflet.
If you have any further doubts 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 will experience them.
You must stop taking Luminastil and immediately contact a doctor or
go to the Emergency Department of the nearest hospital if the patient experiences any of the
following adverse symptoms:

• Angioedema (severe allergic reaction – sudden swelling of the lips, tongue, throat, face, limbs or joints without itching or pain). Swelling in the head and neck area may cause difficulty swallowing and breathing;
• Rash (itchy, red bumps on the skin);
• Urticaria (pinkish, itchy blisters on the skin);
• Shortness of breath. The frequency of these symptoms is unknown.

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

• Fatigue, sedation;
• Drowsiness;
• Attention disturbances;
• Difficulty maintaining balance, dizziness;
• Dry mouth.

Frequency unknown (cannot be estimated based on 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 (uncoordinated and involuntary movements of limbs or entire body, twisting and rigidity, involuntary lip movements, protruding and retracting of the tongue);
• Blurred vision;
• Tachycardia (rapid heartbeat), palpitations (irregular, fast heartbeat);
• Thickening of bronchial secretions (phlegm);
• Muscle tremor;
• Difficulty urinating, urinary retention.

Elderly individuals (over 65 years of age) are more susceptible to disorientation and paradoxical
excitation.
Reporting adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your 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
Al. 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.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Luminastil

Keep this medicine out of sight and reach of children.
Store below 25°C, in the original packaging.
Do not use this medicine after the expiry date stated on the blister and carton. 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Luminastil contains

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

What Luminastil looks like and contents of the pack
Luminastil is in the form of tablets. The tablets are elongated, oval, convex on both sides, white in colour,
without spots or damage.
The pack contains 10 tablets, packed in blisters made of white, orange or colourless Aluminium/PVDC/PVC foil,
in a cardboard box.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel.: (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów