Diazepam Genoptim

Leaflet accompanying the packaging: information for the user

Diazepam Genoptim, 2 mg, tablets

Diazepam Genoptim, 5 mg, tablets

Diazepam

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 packaging 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 the patient is allergic to diazepam or any of the other ingredients of this medicine (listed in section 6);
• if the patient has myasthenia gravis causing muscle weakness and rapid fatigue;
• if the patient has acute respiratory disorders (slow and/or shallow breathing);
• if the patient has sleep apnea (a sleep disorder characterized by abnormal pauses in breathing during sleep);
• if the patient has severe liver dysfunction.

Warnings and precautions

Before starting to take Diazepam Genoptim, the patient should discuss it with their doctor or pharmacist.

• if the patient has liver, heart, or kidney disease;
• if the patient has a history of alcoholism or drug addiction;
• if the patient has muscle weakness;
• if the patient has respiratory disorders;
• if the patient has mental 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 it may worsen symptoms;
• if the patient has a history of epilepsy or seizures.

Talk to your doctor:

• if after a few weeks the patient notices that the tablets are not working as well as they did when they first started taking them. Tolerance to benzodiazepines may have developed;
• if the patient experiences side effects or changes in behavior (see section 4).

There is a risk of dependence when taking this medicine.

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.

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

Diazepam Genoptim 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. Some medicines may also change the way Diazepam Genoptim works. In particular, these will be:

• 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 anesthetics, 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 the patient's mental state, cause excessive drowsiness, and decrease breathing rate and blood pressure.
• disulfiram(used to treat alcohol addiction). 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 way phenytoin works;
• 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 when taking diazepam with 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 taken with diazepam increases the risk of psychoses (mental illnesses);
• ketamine(an anesthetic), as diazepam increases the effect of ketamine.

Taking Diazepam Genoptim and opioids (strong painkillers, substitution therapy for addiction, and some cough medicines) at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, taking these medicines together can only be considered if other treatment methods are not possible.
If the doctor has prescribed Diazepam Genoptim with opioid medicines, the doctor should reduce the dose and recommend the shortest possible treatment time.
The patient should inform their doctor about all opioid medicines they are taking and strictly follow the dosage instructions. It may be helpful to inform friends or family members about the risk, so they are aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.

Diazepam Genoptim with food, drink, and alcohol

While taking diazepam, the patient must not drink alcohol. Alcohol may increase the sedative effect of Diazepam Genoptim.
Grapefruit juice may increase the effect of diazepam.

Pregnancy, breastfeeding, and fertility

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 taking this medicine.
Diazepam Genoptim should not be taken during pregnancy, if the patient plans to become pregnant, or if they are breastfeeding, unless the doctor recommends otherwise. The medicine may affect the baby.

Driving and using machines

Before driving or operating machinery, the patient should consult their doctor, as Diazepam Genoptim may slow down reactions. These effects are increased by alcohol consumption and lack of sleep.

Diazepam Genoptim contains lactose monohydrate

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

3. How to take Diazepam Genoptim

This medicine should always be taken according to the doctor's instructions. If the patient has any doubts, they should consult their 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.

• The doctor will prescribe a small dose and then gradually increase it until the appropriate dose is reached.
• The dose will depend on the patient's condition and their 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.

Use in adults

Recommended dose:

• Anxiety disorder symptoms: 10 mg per day (2.5 mg in the morning and 2.5 mg at noon and 5 mg in the evening).
• Alcoholic 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 spasm treatment: 2 mg to 10 mg, 3 to 4 times a day.

Use in children and adolescents

• Muscle spasm treatment in children over 6 years of age and adolescents. Recommended dose: Children aged 6-12 years: 5 mg, 2 times a day. Children aged 12-18 years: 10 mg, 2 times a day. Long-term use is not recommended.

Due to potential swallowing problems with tablets, it is not recommended to use the medicine in children under 6 years of age. For younger children, more suitable pharmaceutical forms of this medicine may be available.

Use in the elderly

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

Use in patients with renal impairment

Dose modification is usually not 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 failure.

Use in patients with hepatic impairment

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

Use in obese patients

In obese patients, the time to onset of action 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.

Taking a higher dose of Diazepam Genoptim than recommended

• If the patient takes too many tablets (more than recommended) or if it is suspected that a child has swallowed tablets, they should immediately contact the nearest hospital emergency department or consult a doctor or pharmacist.
• Symptoms of overdose include: loss of muscle coordination, breathing difficulties (apnea), low blood pressure (hypotension), heart and lung problems (cardio-respiratory depression), and coma (loss of consciousness without the possibility of waking up).

Missing a dose of Diazepam Genoptim

The patient should not take a double dose to make up for a missed dose. If a dose is missed, it should be taken as soon as possible. However, if it is close to the time for the next dose, the missed dose should be skipped.

Stopping Diazepam Genoptim

• The patient should not stop taking this medicine without consulting their doctor. Stopping 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 dose should be gradually reduced. The doctor will provide the patient with appropriate instructions.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Diazepam Genoptim can cause side effects, although not everybody gets them.

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

Allergic reactions
If the patient experiences an allergic reaction, they should immediately consult a doctor. Side effects include:

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

Behavioral changes (frequency unknown)
Tell your doctorif the patient experiences any of the following side effects. The doctor may recommend stopping the medicine:

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

These effects occur more frequently in children and the elderly.
Withdrawal symptoms
Long-term use (even at therapeutic doses) may lead to dependence. When dependence develops, abrupt cessation of treatment will be accompanied by withdrawal symptoms. Possible withdrawal symptoms see "Stopping Diazepam Genoptim" in section 3. Cases of benzodiazepine abuse have been reported.
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 Genoptimthe following side effects may occur:

• drowsiness, fatigue, dizziness, and feeling of disorientation;
• muscle weakness or hypotonia, loss of muscle coordination (ataxia), and feeling of instability while walking. If any of these symptoms occur, the patient should consult their doctor for advice. The 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 occur in more than 1 in 10 people), common (may occur in up to 1 in 10 people), uncommon (may occur in up to 1 in 100 people), rare (may occur in up to 1 in 1,000 people), very rare (may occur in up to 1 in 10,000 people), and frequency not known (frequency cannot be estimated from available data):

Psychiatric and nervous system disorders (frequency unknown)

• Concentration disorders, decreased alertness, confusion, and disorientation, anxiety.
• Memory loss (anterograde amnesia), headache, depression. Anterograde amnesia may occur at therapeutic doses, and the risk increases with 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 unknown)

• Changes in the activity of some liver enzymes in the blood, observed in laboratory tests.
• Jaundice (yellowing of the skin or eyes).
• Blood disorders (blood dyscrasias and agranulocytosis). Objective symptoms may include: fatigue, tendency to bruise, shortness of breath, and nosebleeds. The doctor may order regular blood tests.

Heart, circulation, and blood vessels (frequency unknown)

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

Stomach and intestines (frequency unknown)

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

Lungs and kidneys (frequency unknown)

• Breathing difficulties (respiratory depression), including respiratory arrest.
• Urinary retention (inability to urinate), loss of bladder control (urinary incontinence).

Eyes, ears, skin, and hair (frequency unknown)

• 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. Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme) have also been reported.

Injuries and muscles (frequency unknown)

• 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 worse or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the
Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 help to gather more information on the safety of the medicine.

5. How to store Diazepam Genoptim

The medicine should be stored out of 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 the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Diazepam Genoptim contains

• The active substance is diazepam. Each tablet contains 2 mg or 5 mg of diazepam.
• Other ingredients are: lactose monohydrate, maize starch, and magnesium stearate.

What Diazepam Genoptim looks like and contents of the pack

Diazepam Genoptim, 2 mg, tablets: white or almost white, round, flat tablet with a diameter of 8 mm with the number "2" on one side and a break line on the other.
Diazepam Genoptim, 5 mg, tablets: 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 leaflet, are placed in a cardboard box with printed labeling.
The packaging 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.
Krakowiaków 65
02-255 Warsaw
Phone: 607 696 231
e-mail: [email protected]

Manufacturer

SANTA SA
Panselelor Street 25, 27, 29
Brasov
Brasov County, 500419
Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium – Diazetop
Luxembourg – Diazetop
Spain – Diazepam Aurovitas
United Kingdom – Diazepam GSP
Poland – Diazepam Genoptim

Date of last revision of the leaflet: 04.2023