Diazepam genoptim

Package leaflet: Information for the user

Diazepam Genoptim, 2 mg, tablets
Diazepam Genoptim, 5 mg, tablets
Diazepamum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult 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, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What is Diazepam Genoptim and what is it used for
2. What you need to know 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 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 by injury, 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), as well as athetosis (continuous, involuntary, slow and unusual movements of fingers and hands) and generalized stiffness syndrome.

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

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, a condition causing muscle weakness and rapid muscle fatigue;
• if the patient has acute respiratory insufficiency (slow and/or shallow breathing);
• if the patient has sleep apnoea (a sleep disorder characterised 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. Initiating treatment of psychosis (mental illness) with benzodiazepines is not recommended. 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 after a few weeks the patient notices that the tablets are no longer as effective as they were shortly after starting treatment. Tolerance to benzodiazepines may have developed;
• if the patient experiences adverse effects or behavioural changes (see section 4).

There is a risk of dependence during treatment with this medicine.
Children and adolescents
Diazepam Genoptim 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.
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 slow down the production 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. Some medicines may affect the way Diazepam Genoptim works. In particular:

• 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 disorders); other medicines causing central nervous system depression (buprenorphine, opioid analgesics, opioids and their derivatives used for cough treatment, baclofen, thalidomide, pizotifen, antihypertensive medicines acting on the central nervous system). Taking these medicines together with diazepam may affect mental state, cause pronounced drowsiness, reduce respiratory rate and lower blood pressure.

• disulfiram (used in the treatment of alcohol dependence). Taking 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 also affect the way phenytoin works;

• theophylline (used in the treatment of asthma and other breathing disorders), as it may reduce the effect of diazepam;

• cimetidine, omeprazole or esomeprazole (medicines that neutralise 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. Breakthrough 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 disorders), as it may slow down the elimination of diazepam from the body and enhance its effect. Valproic acid used together with 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 no other treatment options are available.
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 friends or family members about the risks so they are aware of the symptoms mentioned above. If such symptoms occur, contact your doctor immediately.
Diazepam Genoptim, 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 plans 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 pregnancy or breastfeeding, unless otherwise advised by a doctor. The medicine may affect the child.
Driving and operating machinery
Before driving or operating machinery, consult your doctor, as Diazepam Genoptim may slow reaction times. These effects may be intensified by alcohol consumption or lack of sleep.
Diazepam Genoptim contains monohydrate lactose.
If the patient has been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Diazepam Genoptim

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
This medicine must not be administered to children under 6 years of age unless prescribed by a
physician and under strict supervision of a specialist (paediatrician, neurologist, psychiatrist,
anaesthesiologist, or intensive care specialist), who will determine the dosage.

• 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. Generally, treatment should not last longer than 8 to 12 weeks, including the period of gradual discontinuation.

Use in adults
Recommended dose:

• Anxiety symptoms: 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 during the first 24 hours, then 5 mg, 3 to 4 times per day, as needed.
• Treatment of muscle spasms: 2 mg to 10 mg, 3 to 4 times per day.

Use in children and adolescents

• Treatment of muscle spasms in children over 6 years of age and adolescents
  Recommended dose:
  Children aged 6–12 years: 5 mg, twice daily.
  Children aged 12–18 years: 10 mg, twice daily.
  Long-term use is not recommended.

Due to potential difficulties in swallowing tablets, this medicine is not recommended for children
under 6 years of age. More suitable pharmaceutical forms of this medicine may be available for younger children.
Use in elderly patients
The physician will decide on the dose and frequency of administration of Diazepam Genoptim.
The dose will be lower than that usually recommended for adults. 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 using 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 physician will decide on the dose and frequency of administration of Diazepam Genoptim.
The dose will be lower than that usually recommended for adults.
Use in obese patients
In obese patients, the onset of the drug's effect may be delayed. In addition, the effect of Diazepam Genoptim, including adverse effects, may last longer.
This medicine is best taken in the afternoon or evening.
Tablets may be divided into equal doses.
Taking more than the recommended dose of Diazepam Genoptim

• 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 consult a doctor or pharmacist.
• Symptoms of overdose include: loss of muscle coordination, apnoea (severe breathing difficulties), low blood pressure (hypotension), heart and lung problems (cardiorespiratory depression), and coma (loss of consciousness with inability to awaken).

Missing a 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 it is almost time for the next dose, skip the missed dose and continue with the regular schedule.
Stopping treatment with Diazepam Genoptim

• Do not discontinue 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 (derealisation), feelings of detachment or disconnection from oneself (depersonalisation), 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 doubts regarding 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 experiences them.
Some adverse reactions may be serious and require immediate medical attention:
Allergic reactions
If the patient experiences an allergic reaction, seek immediate medical advice.
Adverse reactions include:

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

Behavioural changes (frequency unknown)
Inform the doctor if the patient experiences any of the following adverse reactions. The doctor may advise discontinuing the medicine:

• psychiatric and paradoxical reactions such as anxiety, irritability, aggression, delirium, thought and perception disturbances inconsistent with reality (hallucinations), rage, nightmares, hallucinations, psychoses, inappropriate behaviour and other undesirable behavioural effects.

If such symptoms occur, diazepam should be discontinued. These are more common 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 may be accompanied by withdrawal symptoms. Possible withdrawal symptoms are described in section 3, "Stopping treatment with Diazepam Genoptim". Cases of benzodiazepine abuse have been reported.
Patients taking sedatives and elderly patients
Patients taking sedatives (including alcohol consumption) and elderly patients taking benzodiazepines have an increased risk of falls and associated fractures.
Other adverse reactions:
At the beginning of treatment with Diazepam Genoptim, the following adverse reactions may occur:

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

During treatment, the following adverse reactions 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 estimated from available data):
Psychiatric and nervous system 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 blood observed in laboratory tests.
• yellowing of the skin or eyes (jaundice).
• blood disorders (dyscrasia and agranulocytosis). Physical 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 difficulties (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 with a sensation of spinning.
• skin reactions. Most common reactions include 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 sedatives and elderly patients" (above).
• muscle weakness.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform the doctor or pharmacist.
Reporting adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform the doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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 authorisation holder.
Reporting adverse reactions helps 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 apply.
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 package and other information

What Diazepam Genoptim contains

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

What Diazepam Genoptim looks like and contents of the pack
Diazepam Genoptim 2 mg tablets: white or almost white, round, flat tablets with a diameter of 8 mm, marked with the number "2" on one side and a division line on the other.
Diazepam Genoptim 5 mg tablets: white or almost white, round, flat tablets with a diameter of 8 mm, marked with the number "5" on one side and a division line on the other.
Diazepam Genoptim is packaged in aluminium/PVC blisters. The blisters, together with the leaflet, are placed in a cardboard box bearing the printed label.
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 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