Package leaflet: Information for the user

Diazepam Genoptim, 5 mg, tablets
Diazepamum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Diazepam Genoptim is and what it is used for
What you need to know before taking Diazepam Genoptim
How to take Diazepam Genoptim
Possible side effects
How to store Diazepam Genoptim
Contents of the pack and other information

1. What Diazepam Genoptim is and what it is 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 during alcohol withdrawal.

In adults and children over 6 years of age:

Muscle spasms or pain caused by inflammatory conditions of muscles and joints, or trauma, including spasms associated with conditions such as cerebral palsy (a group of disorders affecting movement, balance, and posture), paraplegia (paralysis of the lower half of the body including both legs), athetosis (continuous, involuntary, slow, and irregular movements of fingers and hands), and generalized stiffness syndrome.

Benzodiazepines are indicated only when the condition is severe, causes disability, or causes extreme distress to the patient.

2. Important information before taking Diazepam Genoptim

When not to use 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, a condition causing muscle weakness and rapid muscle fatigue;
if the patient has acute respiratory depression (slow and/or shallow breathing);
if the patient has sleep apnoea (a sleep disorder characterized by abnormal breathing pauses during sleep);
if the patient has severe hepatic impairment.

Warnings and precautions
Before starting treatment with Diazepam Genoptim, discuss this with your doctor or
pharmacist.

if the patient has liver, heart or kidney disease;
if the patient has a history of alcoholism or drug dependence;
if the patient has muscle weakness;
if the patient has respiratory disorders;
if the patient has psychiatric disorders. Initiation of treatment for psychosis (mental illness) should not begin with benzodiazepines. These medicines should not be used to treat depression or anxiety associated with depression, as symptoms may worsen;
if the patient has epilepsy or a history of seizures.

Talk to your doctor:

if the patient experiences paradoxical reactions or behavioural changes (see section 4: "Behavioural changes").

There is a risk of dependence during treatment with this medicine (see section 4: "Withdrawal symptoms").
Children and adolescents
This medicine must not be given to children under 6 years of age unless prescribed by a
doctor and under strict supervision of a specialist (paediatrician, neurologist, psychiatrist,
anaesthesiologist or intensive care specialist), who will determine the dose. In infants under 6
months of age, the specialist will use Diazepam Genoptim only if no alternative treatments are
available, as the safety and efficacy of the medicine have not been established in this age group.
Children are more sensitive to the effects of benzodiazepines on the central nervous system. In this patient group, the immature metabolic mechanism may impair or inhibit the formation of inactive metabolites.
Diazepam Genoptim and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes over-the-counter medicines and herbal remedies. This is because Diazepam Genoptim may affect the action of certain other medicines. Some medicines may also alter the way Diazepam Genoptim works. In particular, these include:

antidepressants (e.g. fluvoxamine, fluoxetine);
antipsychotics, e.g. clozapine (used in the treatment of mental illnesses);
muscle relaxants (e.g. suxamethonium, tubocurarine);
barbiturates, e.g. phenobarbital (used in the treatment of epilepsy and mental illnesses);
other medicines causing central nervous system depression (buprenorphine, opioid analgesics, opioids and their derivatives used for cough, baclofen, thalidomide, pizotifen, antihypertensive medicines acting on the central nervous system). Taking these medicines with diazepam may affect mental state, cause pronounced drowsiness, reduce respiratory rate and lower blood pressure.
disulfiram (used in the treatment of alcohol dependence). Concomitant use of this medicine with diazepam may cause pronounced drowsiness and may slow down the elimination of diazepam from the body;
antiepileptic medicines e.g. phenytoin and carbamazepine, as they may reduce the effect of diazepam. Diazepam may additionally affect the action of phenytoin;
theophylline (used in the treatment of asthma and other respiratory disorders), as it may reduce the effect of diazepam;
cimetidine, omeprazole or esomeprazole (medicines that neutralize gastric 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 reduced;
atazanavir, ritonavir, delavirdine, efavirenz, indinavir, nelfinavir or saquinavir (antiviral medicines), fluconazole, itraconazole, ketoconazole or voriconazole (antifungal medicines), as they may slow down the elimination of diazepam from the body and increase the risk of adverse effects;
isoniazid (used in the treatment of 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 enhance its effect. Intermenstrual bleeding may occur during concomitant use of diazepam and oral contraceptives; however, contraceptive efficacy is not reduced;
cimetidine (used in the treatment of stomach disorders), as it may slow down the elimination of diazepam from the body;
corticosteroids (medicines used to treat inflammatory conditions in the body), as they may reduce the effect of diazepam;
levodopa (used in the treatment of Parkinson's disease). Diazepam may reduce the effect of levodopa;
valproic acid (used in the treatment of epilepsy and mental illnesses), as it may slow down the elimination of diazepam from the body and enhance its effect. Concomitant use of valproic acid and diazepam increases the risk of psychosis (mental illness);
ketamine (an anaesthetic medicine), as diazepam enhances the effect of ketamine.

Concomitant use of Diazepam Genoptim and opioids (strong painkillers, medicines used in substitution therapy for addiction, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered when alternative treatment options are not possible. If your doctor has prescribed Diazepam Genoptim together with opioid medicines, your doctor should reduce the dose and recommend the shortest possible treatment duration.
Inform your doctor about all opioid medicines you are taking and strictly follow dosing instructions. It may be helpful to inform family members or close friends about this risk so they are aware of the symptoms listed above. If such symptoms occur, contact your doctor immediately.
Diazepam Genoptim with food, drink and alcohol
During treatment with diazepam, alcohol must not be consumed. Alcohol may enhance the sedative effect of Diazepam Genoptim.
Grapefruit juice may enhance the effect of diazepam.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before taking this medicine.
Diazepam Genoptim must not be used during pregnancy, if the patient is planning a pregnancy or is breastfeeding, unless otherwise advised by a doctor. The medicine may affect the unborn or breastfed child.
Driving and operating machinery
Before driving or operating machinery, consult your doctor, as Diazepam Genoptim may impair reaction times. These effects are intensified by alcohol consumption and lack of sleep.
Diazepam Genoptim contains monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient 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 in doubt, consult
your doctor or pharmacist.
This medicine should not be given to children under 6 years of age unless prescribed by a
doctor and under strict supervision by a specialist (paediatrician, neurologist, psychiatrist,
anaesthesiologist or intensive care specialist) who will determine the dose. In children under 6
months of age, the specialist will use Diazepam Genoptim only if no other medicines are available,
as the safety and efficacy of the medicine have not been evaluated in this age group.

Your doctor will start with a low dose and gradually increase it until the appropriate dose is reached.
The dose will depend on the patient's condition and response to treatment.
The duration of treatment should be as short as possible. In general, treatment should not last longer than 8 to 12 weeks, including the time needed for gradual withdrawal of the medicine.

Your doctor may prescribe another medicinal product containing the same active substance in a lower
dose due to unavailability of Diazepam Genoptim in strengths other than 5 mg.
Use in adults
Recommended dose:

Anxiety symptoms: 10 mg per day (2.5 mg in the morning, 2.5 mg at midday, and 5 mg in the evening).
Alcohol withdrawal syndrome: 10 mg, 3 to 4 times during the first 24 hours, followed by 5 mg 3 to 4 times daily, as needed.
Treatment of muscle spasms: 2 mg to 10 mg, 3 to 4 times per day.

Use in children

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

Long-term use is not recommended.
Due to potential swallowing difficulties with tablets, use of this medicine is not recommended in children
under 6 years of age. More suitable pharmaceutical forms of this medicine may be available for younger children.
Use in elderly patients
The doctor will decide on the dose and frequency of administration of Diazepam Genoptim.
The dose will be lower than the usual adult dose. Treatment should start with the lowest possible
dose (2 to 2.5 mg once or twice daily) and be gradually increased if necessary and well tolerated.
Use in patients with renal impairment
Dose adjustment is usually not necessary. However, patients with renal impairment should
exercise caution when taking diazepam.
Administration of benzodiazepines whose active metabolites include 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 administration of Diazepam Genoptim.
The dose will be lower than the usual recommended dose for adults.
Use in obese patients
In obese patients, the onset of action of the medicine may be delayed. In addition, the effects of
Diazepam Genoptim, including adverse effects, may last longer.
This medicine is best taken in the afternoon or evening.
The tablet may be divided into equal doses.
Taking more Diazepam Genoptim than recommended

If a patient takes too many tablets (more than prescribed) or if there is suspicion that a child has swallowed tablets, contact the nearest hospital emergency department immediately or seek advice from a doctor or pharmacist.
Symptoms of overdose include: loss of muscle coordination, respiratory arrest (severe breathing difficulties), low blood pressure (hypotension), heart and lung problems (cardiorespiratory depression), and coma (loss of consciousness with inability to awaken).

Information for medical personnel
Monitor the patient's vital signs and implement supportive measures as required by the patient's clinical condition. If necessary, symptomatic treatment should be administered in case of respiratory-circulatory failure or central nervous system (CNS) symptoms. Further absorption of the medicinal product can be prevented by administering activated charcoal within 1–2 hours. Airway patency must be ensured in unconscious patients who have received activated charcoal. Gastric lavage may be considered in cases of mixed poisoning, although this is not a routine procedure. In cases of severe CNS depression, consider administering the benzodiazepine antagonist flumazenil, but only under closely monitored conditions. Flumazenil has a short half-life (approximately 1 hour), and therefore patients who have received flumazenil require monitoring after its effects wear off. Flumazenil should be used with great caution when other drugs that lower the seizure threshold (e.g. tricyclic antidepressants) are administered concomitantly. Further information on the proper use of this medicine can be found in the Summary of Product Characteristics for flumazenil.
Missed dose of Diazepam Genoptim
Do not take a double dose to make up for a missed dose. If a dose is missed, take it as soon as possible. However, if the next dose is due soon, skip the missed dose.
Stopping treatment with Diazepam Genoptim

Do not stop taking this medicine without consulting your doctor. Abrupt discontinuation of Diazepam Genoptim 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 sense of reality (derealization), feelings of detachment or separation from oneself (depersonalization), sensitivity to noise (hyperacusis), tingling and numbness in hands and feet, and seizures.
Before completely stopping the medicine, the number or strength of tablets should be gradually reduced. Your doctor will provide appropriate instructions.

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

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be severe and require immediate medical attention:
Allergic reactions
If the patient experiences an allergic reaction, seek medical advice immediately.
Adverse effects include:

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

Behavioural changes (frequency unknown)
Tell the doctor if the patient experiences any of the following adverse effects. The doctor may recommend discontinuing the medication:

Psychiatric and paradoxical reactions such as anxiety, irritability, aggression, delirium, disturbances in thinking and perception contrary to reality (hallucinations), rage, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects.

If such symptoms occur, diazepam should be discontinued. These occur more frequently in children and elderly patients.
Withdrawal symptoms
Long-term use (even at therapeutic doses) may lead to dependence. When dependence develops, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms. These symptoms include:

Sleep disturbances, headaches;
Muscle pain, tremor and restlessness, drowsiness and tingling sensations in the limbs;
Intense 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 really there (hallucinations);
Feeling of losing touch with reality.

Cases of benzodiazepine abuse have been reported.
Patients taking sedatives and elderly patients
Patients who are simultaneously taking sedative medicines (including alcohol) and elderly patients taking benzodiazepines have an increased risk of falls and associated fractures.
Other adverse effects:
At the beginning of treatment with Diazepam Genoptim, the following adverse effects may occur:

drowsiness, feeling of fatigue, dizziness and lightheadedness;
muscle weakness or hypotonia, loss of muscle coordination (ataxia) and feeling of unsteadiness while walking. If any of the above symptoms occur, consult a doctor. The doctor may suggest a lower dose of Diazepam Genoptim, then gradually increase it.

During treatment, the following adverse effects may occur, with frequencies 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 (frequency cannot be determined from available data):
Nervous system and psychiatric disorders (frequency not known)

Difficulty concentrating, reduced alertness, confusion and disorientation, anxiety;
Memory loss (anterograde amnesia), headache, depression.

Anterograde amnesia may occur with therapeutic doses, and the risk increases with higher doses. Memory effects may be associated with inappropriate behaviour.

Slurred speech (dysarthria), loss of coordination (ataxia), including unsteadiness while walking;
Changes in sexual drive (libido);
Tremor, dizziness, emotional blunting;
Drowsiness. Drowsiness is usually dose-related. It occurs mainly at the beginning of treatment but usually diminishes with repeated dosing.

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 composition disorders (dyscrasia and agranulocytosis). Objective symptoms may include: fatigue, tendency to bruise easily, shortness of breath and nosebleeds. The doctor may recommend regular blood tests.

Heart, circulation and blood vessels (frequency not known)

Irregular heartbeat, heart failure, including cardiac arrest;
Low blood pressure (hypotension). Dizziness or lightheadedness when standing;
Circulatory problems (circulatory depression).

Stomach and intestines (frequency not known)

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

Lungs and kidneys (frequency not known)

Breathing problems (respiratory depression), including respiratory arrest;
Inability to pass urine (urinary retention), loss of bladder control (urinary incontinence).

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

Double vision, blurred vision, dizziness manifesting as a sensation of spinning;
Skin reactions. The most common reactions are skin rash, urticaria, itching and erythematous rash. Cases of severe skin reactions have also been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).

Injuries and muscles (frequency not known)

Falls and associated fractures. See "Patients taking sedative medicines and elderly patients" (above);
Muscle weakness.

If any adverse effect worsens or if any adverse effects not listed in this leaflet occur, inform the doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform the doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Diazepam Genoptim

Keep this medicine 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 stated month.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 gelatinized, 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,
marked with the number “5” on one side and a division line on the other.
Diazepam Genoptim is packed in aluminium/PVC blisters. The blisters, together with the leaflet,
are placed in a cardboard carton with printed labelling.
The pack contains 10, 20, 25, 28, 30, 40, 50, 56, 60 or 100 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Tel. 607 696 231
e-mail: [email protected]

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

This medicinal product is authorised in the European Economic Area countries 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

Diazepam genoptim