Prazepam EG

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRAZEPAM EG 10 mg tablets, 20 mg tablets, 15 mg/ml oral drops, solution

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Prazepam EG is and what it is used for
2. What you need to know before taking Prazepam EG
3. How to take Prazepam EG
4. Possible side effects
5. How to store Prazepam EG
6. Contents of the pack and other information

1. What Prazepam EG is and what it is used for

The active substance in Prazepam EG is prazepam. Prazepam is a benzodiazepine derivative and is indicated for the treatment of anxiety symptoms.
Benzodiazepines are used to treat severe, disabling symptoms or symptoms causing the patient severe distress.
Prazepam EG is used to treat anxiety and nervous tension requiring sedative treatment.

2. What you should know before taking Prazepam EG

DO NOT take Prazepam EG

• if you are allergic to prazepam or any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced allergic reactions to other benzodiazepines;
• if you suffer from severe myasthenia (muscle weakness);
• if you have serious breathing difficulties;
• in children under 6 years of age; use in children under 6 years is intended only for rare and specific indications, following assessment and under the supervision of a specialist (paediatric neurologist, psychiatrist);
• if you suffer from sleep apnoea syndrome (when you stop breathing for short periods during sleep);
• if you have severe hepatic insufficiency (severe liver disease).

Warnings and precautions
Talk to your doctor or pharmacist before taking Prazepam EG:

• Prazepam EG is recommended only for the treatment of disorders of the nervous system in which anxiety is the main symptom. Therefore, if you suffer from a severe mental illness, prazepam will be administered only as an additional treatment.
• If you are elderly or physically weakened, you may experience mild drowsiness and/or reduced mental alertness during activities, as well as reduced muscle tone.
• If you are elderly or severely debilitated, start treatment with 10 or 15 mg of prazepam (divided throughout the day), increasing the dose later if necessary.
• If you are over 65 years old. Some elderly patients may experience dizziness, drowsiness or muscle weakness after taking Prazepam EG and may be at risk of falls.
• If you have chronic, non-specific respiratory difficulties or dyspnoea (shortness of breath), your doctor will prescribe a lower dose.
• The use of benzodiazepines in children under 6 years of age is intended for rare and specific indications, following assessment and under the supervision of a specialist (paediatric neurologist, psychiatrist) (See “DO NOT take Prazepam EG”). In children aged between 6 and 18 years, a dose reduction based on age and body weight is recommended. Children are more sensitive to the effects of the medicine on the central nervous system. The duration of treatment should be as short as possible.
• Inform your doctor if you have kidney or liver disorders (see section “Do not take Prazepam EG”).
• Benzodiazepines may cause dependence. The risk of dependence increases with dose and duration of treatment, and in patients with a history of alcoholism or drug dependence. In such cases, abrupt discontinuation of treatment may lead to withdrawal symptoms such as: headache, muscle pain, extreme anxiety, tension, confusion and irritability. In severe cases, the following symptoms may occur: derealisation (when things seem strange or unreal), depersonalisation (when one has an altered perception of oneself), hyperacusis (inability to tolerate everyday noises), numbness and tingling in hands and feet (pins and needles), hypersensitivity to light, noise and physical contact, hallucinations (perceiving things that are not real), epileptic seizures. Rebound anxiety:
• Stopping treatment may trigger a short-lived syndrome causing the initial symptoms to reappear in an intensified form. Other reactions may also occur, such as mood changes, anxiety, sleep disturbances, seizures, tremors, muscle and abdominal cramps, vomiting, sweating and agitation. The risk of withdrawal symptoms or rebound phenomena increases significantly when treatment is stopped abruptly; therefore, your doctor will gradually reduce the dose.
• You may experience rebound anxiety when stopping treatment with Prazepam EG.
• You should take Prazepam EG for the shortest possible time, depending on your condition, and for no longer than 8–12 weeks in cases of anxiety, including the period of gradual dose reduction. Your doctor should reassess your condition before you take prazepam for a longer period.
• Benzodiazepines may cause short-term memory loss, which usually occurs within a few hours of taking the medicine. Therefore, to minimise this risk, patients must ensure they sleep uninterrupted for 7 to 8 hours after taking the medicine.
• Extreme caution is required in cases of alcoholism or drug dependence.
• If you are already taking other medicines, please also read the section “Other medicines and Prazepam EG”.

Other medicines and Prazepam EG
Prazepam EG must not be used at the same time as other medicines that may impair brain function, such as:

• Narcotics
• Anaesthetics
• Phenothiazines
• Anticonvulsants
• Sedating antihistamines
• Barbiturates
• Antidepressants
• Antipsychotics (neuroleptic agents)
• Monoamine oxidase inhibitors
• Hypnotics
• Anxiolytics/sedatives
• Analgesics

Concomitant use of Prazepam EG and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Prazepam EG together with opioids, the dose and duration of concomitant therapy must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow the doctor’s recommendations regarding dosage. It may be helpful to inform friends or family members so they are aware of the signs and symptoms listed above. Contact your doctor if these symptoms occur.
Simultaneous intake of benzodiazepines and valproic acid increases the risk of psychosis (loss of contact with reality).
Any combination of benzodiazepines and clozapine must be carefully considered. In such cases, the doctor may decide to reduce the benzodiazepine dose at the start of treatment.
Combination with cimetidine or omeprazole (medicines for the treatment of ulcers) may cause a prolonged effect of Prazepam EG.
Combination with oral contraceptives (the pill) and with supplementary hormone treatments, e.g. hormone replacement therapy, may enhance the effect of Prazepam EG.
The use of narcotic analgesics (e.g. morphine) may cause greater euphoria, thereby increasing psychological dependence (habituation).
Theophylline (a medicine for the treatment of asthma) antagonises the pharmacological effect of benzodiazepines.
Combination of prazepam and buprenorphine is possible only after careful assessment of the risk/benefit ratio. Consult your doctor before taking Prazepam EG.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Prazepam EG with food, drinks and alcohol
Prazepam EG must not be used at the same time as other medicines that may impair brain function, including alcohol.
Do not drink alcoholic beverages during treatment. If alcohol is consumed at the same time, the sedative effect of Prazepam EG may be enhanced, possibly affecting your ability to drive or operate machinery.

Pregnancy and breastfeeding
Do not take Prazepam EG if you are pregnant or think you might be pregnant.
Inform your doctor if you are pregnant or planning to become pregnant. In particular, Prazepam EG must not be taken during the first three months of pregnancy.
Prazepam must not be taken during childbirth.
Inform your doctor if you are breastfeeding. Do not take prazepam if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Depending on your individual sensitivity, the following adverse effects may occur:

• Drowsiness and/or reduced concentration ability
• Amnesia (memory loss)
• Lack of concentration
• Reduced muscle function
• Reduced muscle tone
• Slowed reflexes

These effects may impair your ability to drive or operate machinery. The risk of reduced concentration is higher if you suffer from insomnia. Therefore, be particularly careful when driving or using dangerous tools, especially at the beginning of treatment.

Prazepam EG tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Prazepam EG

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
All formulations of Prazepam EG are intended for oral use. The amount of medicine to take (dosage) will be determined by your doctor. The usual daily dose ranges between 10 and 60 mg of prazepam, depending on the patient's response.

Adults
Your doctor will decide your daily dose. The recommended dose is 10–30 mg per day, depending on your response to the medicine. For severe conditions, higher doses up to 60 mg may be used.

Elderly patients
If you are elderly or severely debilitated, treatment should start with 10 or 15 mg of prazepam (divided throughout the day). The dose may be increased later, if necessary.

Use in children
There are no clinical data on the use of Prazepam EG in children under 6 years of age. The use of Prazepam EG in children under 6 years should only be allowed after evaluation and under the supervision of a specialist (neuropaediatrician, psychiatrist).

Adolescents (aged 12 to 17 years)
The dose will be reduced according to age and body weight. The maximum dose of 1 mg/kg body weight per day must not be exceeded. Your doctor will determine your daily dose.

Treatment duration
Your doctor will inform you how long you should take Prazepam EG. In many cases, benzodiazepines should be used occasionally or temporarily, i.e., for a short period. Sometimes, the medical condition requires longer-term use of Prazepam EG.
Whenever benzodiazepines are used for prolonged periods, your doctor will regularly assess whether continued treatment is necessary.
It is important to exercise caution when discontinuing treatment.

Patients with liver or kidney disease
Consider administering reduced doses in patients with impaired renal or hepatic function.

If you take more Prazepam EG than you should
If you have taken more Prazepam EG than you should have, or if your child has accidentally taken the medicine, contact your doctor or pharmacist or go immediately to the nearest hospital.
Visible signs of overdose include fatigue, sometimes associated with uncoordinated movements and confusion.
As with all cases of overdose, consider the possibility of multiple substances being involved (i.e., other substances taken simultaneously).

If you forget to take Prazepam EG
If you have missed a dose, take the next dose at the scheduled time.
Do not take a double dose of Prazepam EG to make up for a forgotten dose.

If you stop taking Prazepam EG
Do not stop taking Prazepam EG suddenly, especially if you have been taking it for a long time. After abrupt discontinuation of long-term benzodiazepine treatment, symptoms may occur (see “Warnings and precautions”). Always consult your doctor, who will advise you on how to gradually reduce the dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Prazepam EG can cause side effects, although not everybody experiences them.
The reported side effects are summarised in the table below by system and frequency. Frequencies are defined as follows:
Very common: affects more than 1 in 10 people
Common: affects 1 to 10 people in 100
Uncommon: affects 1 to 10 people in 1,000
Rare: affects 1 to 10 people in 10,000
Very rare: affects less than 1 person in 10,000
Not known: frequency cannot be estimated from the available data

The following side effects have been identified during use of benzodiazepines in general. Most of these occur at the beginning of treatment and usually disappear with continued administration.

Blood and lymphatic system disorders:
Rare: blood disorders (agranulocytosis)

Cardiac disorders:
Common: palpitations

Eye disorders:
Common: blurred vision, double vision

Gastrointestinal disorders:
Common: dry mouth, various gastrointestinal disturbances

General disorders and administration site conditions:
Common: fatigue, weakness, altered libido, feeling of drunkenness

Hepatobiliary disorders:
Rare: jaundice

Investigations:
Rare: reduced bile production

Musculoskeletal and connective tissue disorders:
Common: joint pain
Uncommon: swollen feet

Nervous system disorders:
Very common: drowsiness
Common: somnolence, dizziness, episodes of confusion, uncoordinated movements, headache, tremors, difficulty in self-expression
Uncommon: syncope, altered state of consciousness, memory impairment (especially in elderly patients), epileptic seizures, reduced alertness
Not known: falls (particularly in elderly patients)

Psychiatric disorders:
Common: confusion, vivid dreams
Uncommon: agitation, irritability, worsening of insomnia, aggression, worsening of anxiety, confusion
Rare: multiple personality, depression, psychosis, apathy or paradoxical reactions, persecutory mania, paranoia

Renal and urinary disorders:
Uncommon: various genital and urinary disturbances

Reproductive system and breast disorders:
Rare: menstrual, ovulatory and sexual disturbances
Very rare: breast enlargement in men (gynaecomastia)

Respiratory, thoracic and mediastinal disorders:
Not known: respiratory depression in patients affected by non-specific chronic respiratory disease.

Skin and subcutaneous tissue disorders:
Common: episodes of severe sweating, temporary skin rash
Uncommon: pruritus
Very rare: hypersensitivity to external substances, anaphylactic shock

Amnesia:
Loss of memory (anterograde amnesia) may occur even after administration of Prazepam EG at therapeutic doses. The risk increases at higher doses. The effects of memory loss may be associated with inappropriate behaviour (see section "Warnings and precautions").

Depression:
During treatment with benzodiazepines, latent depression may become apparent.

Psychiatric and paradoxical reactions:
Reactions such as:

• agitation
• irritability
• aggression
• delirium (sudden inability to focus attention)
• rage attacks
• nightmares
• hallucinations (perception of things that are not actually present)
• psychosis (mental disorders)
• inappropriate behaviour and other behavioural problems

are well-known reactions that may occur during treatment with benzodiazepines or benzodiazepine-like medicines. These reactions may also be relatively dangerous and occur more frequently in elderly patients.

Dependence:
The use of benzodiazepines (even at therapeutic doses) may lead to the development of physical dependence. Consequently, discontinuation of treatment may result in withdrawal symptoms or rebound effects (see section "Warnings and precautions"). Psychological dependence may also develop. Cases of benzodiazepine abuse have been reported.
Prolonged use of benzodiazepines may lead to physical and psychological dependence.

Symptoms that may occur following abrupt discontinuation of prolonged benzodiazepine treatment include mood swings, anxiety (extreme) or sleep disturbances, agitation, seizures, tremors, muscle and abdominal cramps, vomiting, sweating, headache, muscle pain, tension, confusion and irritability. In more severe cases, the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling in the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures; the risk of such symptoms occurring with prazepam is relatively low.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prazepam EG

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Oral drops: Prazepam EG 15 mg/ml oral drops, solution should be used within 30 days of first opening.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle after the word EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Prazepam EG Contains

• The active substance is: prazepam. Each tablet contains 10 mg or 20 mg of prazepam. 1 ml of solution contains 15 mg of prazepam (equivalent to 30 drops).
• The other ingredients are:
  Prazepam EG 10 mg tablets:
• Monohydrate lactose
• Microcrystalline cellulose
• Corn starch
• Magnesium stearate
• Indigo carmine lake (E132)

Prazepam EG 20 mg tablets:

• Monohydrate lactose
• Microcrystalline cellulose
• Corn starch
• Magnesium stearate
• Colloidal silica

Prazepam EG 15 mg/ml oral drops, solution:

• Propylene glycol
• Diethylene glycol monoethyl ether
• Sodium saccharin
• Polysorbate 80
• Menthol
• Anethole
• Patent Blue V (E131)

Description of the Appearance of Prazepam EG and Contents of the Pack
Prazepam EG 10 mg tablets are available as blue, scored tablets in aluminum/PVC blister packs containing 20, 30, 40, 50, and 60 tablets. The tablet can be divided into two equal halves.
Prazepam EG 20 mg tablets are available as white, scored tablets in aluminum/PVC blister packs containing 20, 50, and 60 tablets. The tablet can be divided into two equal halves.
Prazepam EG 15 mg/ml oral drops, solution is available in 20 ml bottles with a dropper.
30 drops of solution correspond to 1 ml and therefore to 15 mg of prazepam.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy

Manufacturer
Cosmo S.p.A., Via C. Colombo, 1 - 20045 Lainate (MI) – Italy
Sanico NV, Industrieterrein 4 - Veedijk 59, 2300 Turnhout – Belgium
EG NV/SA, Heizel Esplanade b22 - 1020 Brussels – Belgium
Laboratoires BTT, Zone Industrielle de Kraft - 67150 Erstein – France (only for 10 mg and 20 mg tablets)

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Prazepam EG 10 mg tabletten, 20 mg tabletten, 15 mg/ml druppels voor oraal gebruik
France: Prazepam EG 10 mg comprimé, 15 mg/ml solution buvable en gouttes
Italy: Prazepam EG 10 mg compresse, 20 mg compresse, 15 mg/ml gocce orali, soluzione
Luxembourg: Prazepam EG 10 mg tabletten, 20 mg tabletten, 15 mg/ml druppels voor oraal gebruik