Diazepam Genoptim

Package Leaflet: Information for the User

Diazepam Genoptim, 5 mg, Tablets

Diazepam

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Diazepam Genoptim and what is it used for

Diazepam Genoptim contains the active substance diazepam, which belongs to a group of medicines called benzodiazepines.
Diazepam Genoptim is indicated for the treatment of the following conditions:
In adults:

• treatment of symptoms of anxiety disorders.
• treatment of symptoms occurring after alcohol withdrawal.

In adults and children over 6 years of age:

• muscle spasms or pain caused by inflammatory muscle and joint conditions, injury, including spasms caused by such conditions as cerebral palsy (a group of disorders affecting movement, balance, and posture) and paraplegia (paralysis of the lower half of the body affecting both legs), as well as athetosis (continuous, involuntary, slow, and abnormal movements of fingers and hands) and stiff person syndrome.

Benzodiazepines are indicated only when the disease is severe, causes disability, or is a cause of extreme discomfort for the patient.

2. Important information before taking Diazepam Genoptim

When not to take Diazepam Genoptim

• if you are allergic to diazepam or any of the other ingredients of this medicine (listed in section 6);
• if you have myasthenia gravis, which causes muscle weakness and rapid fatigue;
• if you have acute respiratory depression (slow and/or shallow breathing);
• if you have sleep apnea (a sleep disorder characterized by abnormal pauses in breathing during sleep);
• if you have severe liver function impairment.

Warnings and precautions

Before starting to take Diazepam Genoptim, discuss it with your doctor or pharmacist.

• if you have liver, heart, or kidney disease;
• if you have a history of alcoholism or drug dependence;
• if you have muscle weakness;
• if you have breathing difficulties;
• if you have psychiatric disorders. It is not recommended to start treatment for psychoses (mental illnesses) with benzodiazepines. These medicines should not be used to treat depression or anxiety associated with depression, as they may worsen symptoms;
• if you have a history of epilepsy or seizures.

You should talk to your doctor:

• if you experience symptoms contrary to those desired or if there are changes in behavior (see section 4: "Behavioral changes").

There is a risk of dependence during treatment with this medicine (see section 4: "Withdrawal symptoms").

Children and adolescents

The medicine should not be given to children under 6 years of age, unless it is done on the basis of a doctor's decision and under the strict supervision of a specialist (pediatrician, neurologist, psychiatrist, anesthesiologist, and intensive care specialist) who will determine the dose. In children under 6

months of age, the specialist will use Diazepam Genoptim only when no other medicines are available, as the safety and efficacy of the medicine have not been assessed in this age group.

Children are more sensitive to the effects of benzodiazepines on the central nervous system. In this group of patients, the not fully developed metabolic mechanism may prevent or inhibit the production of inactive metabolites.

Diazepam Genoptim and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as about medicines you plan to take. This includes medicines that can be obtained without a prescription and herbal medicines. This is because Diazepam Genoptim may affect the action of some other medicines. Some medicines may also change the way Diazepam Genoptim works. In particular, these include:

• antidepressants(e.g., fluvoxamine, fluoxetine);
• antipsychotics, e.g., clozapine (used to treat mental illnesses);
• muscle relaxants(e.g., suxamethonium, tubocurarine);
• barbiturates, e.g., phenobarbital(used to treat epilepsy and mental illnesses);
• other medicines that cause central nervous system depression (buprenorphine, opioid analgesics, opioids, and their derivatives used to treat cough, baclofen, thalidomide, pizotifen, antihypertensive drugs acting on the central nervous system). Taking these medicines with diazepam may affect mental status, cause excessive drowsiness, and decrease respiratory rate and blood pressure.
• disulfiram(used to treat alcohol dependence). Taking this medicine with diazepam may cause excessive drowsiness and may slow down the elimination of diazepam from the body;
• antiepileptic drugs, e.g., phenytoin and carbamazepine, as they may weaken the effect of diazepam. Diazepam may also affect the action of phenytoin;
• theophylline(used to treat asthma and other respiratory disorders), as it may weaken the effect of diazepam;
• cimetidine, omeprazole, or esomeprazole(medicines that neutralize stomach acid), as they may slow down the elimination of diazepam from the body;
• rifampicin(an antibiotic), as it may accelerate the elimination of diazepam from the body. The effect of diazepam may be weakened;
• atazanavir, ritonavir, delavirdine, efavirenz, indinavir, nelfinavir, or saquinavir(antiviral medicines), fluconazole, itraconazole, ketokonazole, or voriconazole(antifungal medicines), as they may slow down the elimination of diazepam from the body and increase the risk of side effects;
• isoniazid(used to treat tuberculosis), as it may slow down the elimination of diazepam from the body;
• oral contraceptives, as they may slow down the elimination of diazepam from the body and increase its effect. Intermenstrual bleeding may occur during treatment with diazepam and oral contraceptives; however, this does not affect the contraceptive efficacy;
• cisapride(used to treat stomach disorders), as it may slow down the elimination of diazepam from the body;
• corticosteroids(medicines used to treat inflammation in the body), as they may weaken the effect of diazepam;
• levodopa(used to treat Parkinson's disease). Diazepam may weaken the effect of levodopa;
• valproic acid(used to treat epilepsy and mental illnesses), as it may slow down the elimination of diazepam from the body and increase its effect. Valproic acid used with diazepam increases the risk of psychoses (mental illnesses);
• ketamine(an anesthetic), as diazepam increases the effect of ketamine.

Concomitant use of Diazepam Genoptim and opioids (strong painkillers, substitution therapy for addiction, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of these medicines can only be considered when other treatment methods are not possible. If, however, the doctor has prescribed Diazepam Genoptim together with opioid medicines, the doctor should reduce the dose and recommend the shortest possible treatment duration. You should inform your doctor about all opioid medicines you are taking and strictly follow the dosage instructions. It may be helpful to inform friends or relatives about the risk, so they are aware of the above symptoms. In case of such symptoms, you should contact your doctor.

Diazepam Genoptim with food, drink, and alcohol

During treatment with diazepam, you must not drink alcohol. Alcohol may enhance the sedative effect of Diazepam Genoptim.
Grapefruit juice may enhance the effect of diazepam.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Diazepam Genoptim should not be used during pregnancy, if you are planning to become pregnant, or if you are breastfeeding, unless your doctor advises you to do so. The medicine may affect the baby.

Driving and using machines

Before driving or using machines, ask your doctor for advice, as Diazepam Genoptim may slow down your reactions. These effects are enhanced by alcohol and lack of sleep.

Diazepam Genoptim contains lactose monohydrate

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Diazepam Genoptim

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The medicine should not be given to children under 6 years of age, unless it is done on the basis of a doctor's decision and under the strict supervision of a specialist (pediatrician, neurologist, psychiatrist, anesthesiologist, and intensive care specialist) who will determine the dose. In children under 6

months of age, the specialist will use Diazepam Genoptim only when no other medicines are available, as the safety and efficacy of the medicine have not been assessed in this age group.

• The doctor will prescribe a small dose, which will then be gradually increased until the appropriate dose is reached.
• The dose will depend on the patient's condition and response to treatment.
• The treatment duration should be as short as possible. In general, treatment should not last longer than 8 to 12 weeks, including the time of gradual withdrawal of the medicine.

The doctor may prescribe another medicinal product containing the same active substance in a lower dose due to the lack of availability of Diazepam Genoptim in a dose other than 5 mg.

Use in adults

Recommended dose:

• Anxiety disorders: 10 mg per day (2.5 mg in the morning and 2.5 mg at noon and 5 mg in the evening).
• Alcohol withdrawal syndrome: 10 mg, 3 to 4 times in the first 24 hours, and then 5 mg 3 to 4 times a day, as needed.
• Muscle spasms: 2 mg to 10 mg, 3 to 4 times a day.

Use in children

• Treatment of muscle spasms in children over 6 years of age. Recommended dose: 2 to 40 mg in divided doses per day.

Long-term use is not recommended.
Due to potential swallowing problems, the medicine is not recommended for use in children under 6 years of age. For younger children, other pharmaceutical forms of this medicine may be available.

Use in the elderly

The doctor will decide on the dose and frequency of administration of Diazepam Genoptim. The dose will be lower than that recommended for adults. Treatment should be started with the lowest possible dose (2 to 2.5 mg once or twice a day) and gradually increased if necessary and well tolerated.

Use in patients with renal impairment

Dose adjustment is not usually necessary. However, patients with renal impairment should be cautious when taking diazepam.
Benzodiazepines, whose active metabolites are, for example, diazepam, should be avoided in patients with end-stage renal impairment.

Use in patients with hepatic impairment

The doctor will decide on the dose and frequency of administration of Diazepam Genoptim. The dose will be lower than that recommended for adults.

Use in obese patients

In obese patients, the time to onset of action of the medicine may be longer. Additionally, the effect of Diazepam Genoptim, including side effects, may last longer.
The medicine is best taken in the afternoon or evening.
The tablet can be divided into equal doses.

Overdose of Diazepam Genoptim

• If you have taken too many tablets (more than prescribed) or if you suspect that a child has swallowed some, contact your nearest hospital emergency department or ask your doctor or pharmacist for advice immediately.
• Symptoms of overdose include: loss of muscle coordination, breathing difficulties (respiratory depression), low blood pressure (hypotension), heart and lung problems (cardio-respiratory depression), and coma (loss of consciousness without the possibility of waking up).

Information for healthcare professionals

Monitor the patient's vital signs and provide supportive measures as clinically indicated. In case of respiratory or cardiovascular depression, or if symptoms of central nervous system depression occur, symptomatic treatment should be initiated. Further absorption of the medicinal product can be prevented by administering activated charcoal within 1-2 hours. Unconscious patients who have been given charcoal should have their airways protected. In case of mixed overdose, gastric lavage may be considered, although it is not a routine procedure. In case of severe central nervous system depression, the administration of a benzodiazepine antagonist, flumazenil, should be considered, but only under close monitoring. Flumazenil has a short half-life (about 1 hour) and therefore patients who have been given flumazenil require monitoring after its action has ended. Flumazenil should be used with caution in patients who are also taking medicines that lower the seizure threshold (e.g., tricyclic antidepressants). More information on the proper use of this medicine can be found in the Summary of Product Characteristics of flumazenil.

Missed dose of Diazepam Genoptim

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Stopping treatment with Diazepam Genoptim

• Do not stop taking this medicine without consulting your doctor. Stopping treatment with Diazepam Genoptim abruptly may lead to withdrawal symptoms, including: sleep disturbances, headache, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability, or aggression, mood changes, and hypersensitivity to light, noise, and physical contact. Less common withdrawal symptoms include: visual or auditory hallucinations, loss of reality (depersonalization), feeling of detachment or separation from oneself (derealization), hypersensitivity to noise (hyperacusis), tingling and numbness of hands and feet, and seizures.
• Before completely stopping the medicine, the number or strength of tablets should be gradually reduced. Your doctor will provide you with appropriate instructions.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Some side effects can be serious and may require immediate medical attention:

Allergic reactions
If you experience an allergic reaction, seek medical advice immediately. Side effects include:

• sudden swelling of the throat, face, and lips, which can lead to breathing and swallowing difficulties;
• sudden swelling of hands, feet, ankles, rash, or itching.

Behavioral changes (frequency not known)
Tell your doctorif you experience any of the following side effects. Your doctor may advise you to stop taking the medicine:

• Psychiatric and paradoxical reactions, such as anxiety, irritability, aggression, delirium, disturbances in thinking and perception, rage, nightmares, hallucinations, psychoses, inappropriate behavior, and other undesirable behavioral effects.

These reactions occur more frequently in children and the elderly.
Withdrawal symptoms
Long-term use (even at therapeutic doses) may lead to the development of dependence. When dependence develops, abrupt cessation of treatment will be accompanied by withdrawal symptoms. These symptoms include:

• Difficulty sleeping, headaches.
• Muscle pain, trembling, and feeling of anxiety, drowsiness, and tingling in the limbs.
• Feeling of extreme anxiety, tension, disorientation, irritability, or agitation, and mood changes.
• Hypersensitivity to light, noise, and physical contact.

Less common withdrawal symptoms include:

• Seeing or hearing things that are not there (hallucinations).
• Loss of reality.

There have been reports of benzodiazepine abuse.
Patients taking sedatives and elderly patients
Patients taking sedatives (including those consuming alcohol) and elderly patients taking benzodiazepines are at increased risk of falls and related fractures.

Other side effects:

At the beginning of treatment with Diazepam Genoptim, the following side effects may occur:

• Drowsiness, feeling of fatigue, dizziness, and feeling of disorientation;
• Muscle weakness or hypotonia, loss of muscle coordination (ataxia), and feeling of instability while walking. If you experience any of these symptoms, consult your doctor. Your doctor may recommend a lower dose of Diazepam Genoptim and then gradually increase it.

During treatment, the following side effects may occur, with frequencies that can be defined as very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people),

rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), and frequency not known (cannot be estimated from the available data):
Psychiatric and nervous system disorders (frequency not known)

• Concentration disorders, decreased alertness, confusion, and disorientation, anxiety.
• Memory impairment (anterograde amnesia), headache, depression.

Anterograde amnesia may occur at therapeutic doses, and the risk increases at higher doses. The effects of amnesia may be associated with inappropriate behavior.

• Slurred speech (dysarthria), loss of coordination (ataxia), including instability while walking.
• Changes in sexual desire (libido).
• Tremors, dizziness, emotional poverty.
• Drowsiness. Drowsiness is usually dose-related. It occurs mainly at the beginning of treatment but usually disappears after repeated administration.

Liver and blood disorders (frequency not known)

• Changes in the activity of certain liver enzymes in the blood, observed in laboratory tests.
• Yellowing of the skin or eyes (jaundice).
• Blood disorders (blood dyscrasias and agranulocytosis). Objective symptoms may include: fatigue, tendency to bruise, shortness of breath, and nosebleeds. Your doctor may recommend regular blood tests.

Heart, circulation, and blood vessels (frequency not known)

• Irregular heart rhythm, heart failure, including cardiac arrest.
• Low blood pressure (hypotension). Dizziness or feeling of disorientation when standing up.
• Circulatory problems (cardiovascular depression).

Gastrointestinal disorders (frequency not known)

• Nausea, constipation, and other gastrointestinal disorders, such as abdominal pain.
• Dry mouth or excessive (increased) salivation.

Lungs and kidneys (frequency not known)

• Breathing difficulties (respiratory depression), including respiratory arrest.
• Urination problems (urinary retention), loss of bladder control (urinary incontinence).

Eyes, ears, skin, and hair (frequency not known)

• Double vision, blurred vision, dizziness, which may be accompanied by a feeling of spinning.
• Skin reactions. The most common reactions are skin rash, hives, itching, and erythematous rash. Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have also been reported.

Injuries and muscles (frequency not known)

• Falls and related fractures. See "Patients taking sedatives and elderly patients" (in the same section above).
• Muscle weakness.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please 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, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diazepam Genoptim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "EXP". The expiry date refers to the last day of that month.
There are no special precautions for storage.
Medicines should 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 Diazepam Genoptim contains

• The active substance is diazepam. Each tablet contains 5 mg of diazepam.
• The other ingredients are: lactose monohydrate, maize starch, and magnesium stearate.

What Diazepam Genoptim looks like and contents of the pack

White or almost white, round, flat tablet with a diameter of 8 mm
with the number "5" on one side and a break line on the other.
Diazepam Genoptim is packaged in aluminum/PVC blisters. The blisters, along with the package leaflet, are placed in a cardboard box with printed labeling.
The pack contains 10, 20, 25, 28, 30, 40, 50, 56, 60, and 100 tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Tel. 607 696 231
e-mail: infodn@synoptispharma.pl

Manufacturer

SANTA SA
Str. Panselelor nr. 25, nr. 27, nr. 29
Brasov
jud. Brasov, cod 500419
Romania

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium – Diazetop
Spain – Diazepam Aurovitas
Luxembourg – Diazetop
Poland – Diazepam Genoptim
United Kingdom (Northern Ireland) – Diazepam GSP

Date of last revision of the leaflet: 10.2024