Sedam 3

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Sedam 3 (Bromazanil 3)

3 mg, tablets
Bromazepamum
Sedam 3 and Bromazanil 3 are different trade names for the same drug.

Before taking the drug, carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Sedam 3 and what is it used for

Sedam 3 contains the active substance bromazepam - a psychotropic drug from the benzodiazepine group. In small doses, it reduces nervous tension, excitement, and anxiety, and has a mild sedative effect. In large doses, it has a calming effect and reduces muscle tension. Bromazepam has an anticonvulsant effect.
The indications for the use of Sedam 3 are:

• generalized anxiety disorders requiring pharmacological treatment;
• autonomic nervous system disorders that occur in the form of skin symptoms, gastrointestinal symptoms, heart symptoms, circulatory symptoms, urogenital symptoms, etc;
• anxiety states in the course of chronic central nervous system diseases;
• post-traumatic stress disorders with anxiety symptoms;
• adjustment disorders (resulting, for example, from difficulties in adapting to new, negative life events).

2. Important information before taking Sedam 3

When not to take Sedam 3

• if the patient is allergic to bromazepam, other benzodiazepines, or any of the other ingredients of the drug (listed in section 6);
• if the patient has severe respiratory failure;
• if the patient has been diagnosed with sleep apnea syndrome;
• if the patient has severe liver failure;
• if the patient has been diagnosed with myasthenia (significant muscle weakness). Page 1 of 7

The drug should not be used in children and adolescents.

Warnings and precautions

Before starting to take Sedam 3, the patient should discuss it with their doctor or pharmacist if they:

• have had depression and/or anxiety in the past;
• have had severe depression to the point of thinking about taking their own life;
• have abused drugs, narcotics, or alcohol in the past or have difficulty stopping their use;
• have lung, kidney, or liver disease.

Taking the drug daily for several weeks, even in small doses, can lead to psychological and physical dependence.
Taking Sedam 3 repeatedly over several weeks can lead to a decrease in its effectiveness.
During treatment, severe allergic reactions (anaphylactic or pseudo-anaphylactic reactions), angioedema (swelling of the skin and underlying tissues), as well as shortness of breath, throat obstruction, or nausea and vomiting may occur.
If such symptoms occur, the patient should immediately consult a doctor, as urgent medical attention may be necessary.
In patients with physical dependence, sudden cessation of treatment can cause withdrawal symptoms, such as headache, diarrhea, muscle pain, severe anxiety, tension, restlessness, disorientation, and irritability. In severe cases, psychiatric disorders (derealization, depersonalization), hypersensitivity to sounds, feeling of numbness and tingling of limbs, hypersensitivity to light, noise, and physical contact, hallucinations, or seizures may occur.
In some patients, stopping treatment can cause a transient recurrence of disease symptoms (so-called rebound symptoms) with greater intensity than before. Mood swings, anxiety, or sleep disturbances and restlessness may also occur. The risk of their occurrence is higher after rapid dose reduction or sudden cessation of treatment. The drug should be discontinued gradually, reducing the dose as prescribed by the doctor.
Drugs like Sedam 3 (benzodiazepines) can cause memory disorders (difficulty remembering new information), especially when taken in large doses. To minimize the risk of memory disorders, the patient should have several hours of uninterrupted sleep after taking the drug.
During treatment with such drugs as Sedam 3, restlessness, excitement, irritability, aggression, delusions, fits of anger, nightmares, hallucinations, psychiatric disorders, or behavioral disorders may occur. If they occur, the patient should stop taking the drug and consult a doctor.
Sedam 3 can reduce muscle tension and cause falls with a risk of bone fractures, especially in older patients.
The treatment duration is limited and determined by the doctor.

Sedam 3 and other drugs

The patient should tell their doctor about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take.
Sedam 3 and other drugs taken at the same time can affect each other's action and the occurrence of side effects.
This applies especially to:

• other drugs acting on the central nervous system (e.g., antipsychotic, sedative, and anxiolytic drugs, antidepressants (including fluvoxamine), sleeping pills, anticonvulsants, opioid analgesics*, antihistamines, general anesthetics);
• drugs used in fungal infections;
• macrolide antibiotics;
• protease inhibitors (used, for example, in the treatment of HIV infection);
• muscle relaxants;
• cimetidine or omeprazole (drugs that reduce stomach acid secretion);
• cisapride (a drug used in the treatment of gastroesophageal reflux disease);
• drugs that lower blood pressure;
• beta-adrenergic blockers (drugs used in hypertension and heart disease, including propranolol);
• digitalis glycosides (drugs used in heart disease);
• methylxanthines (drugs used, among others, in the treatment of asthma);
• hormonal contraceptives.

*
Concomitant use of Sedam 3 and opioids (strong painkillers, drugs used in substitution therapy for addiction, and some cough medicines) increases the risk of excessive sedation, breathing difficulties (respiratory failure), coma, and can be life-threatening. Due to this, concomitant use of these drugs can only be considered when other treatment methods are not possible.
If, however, the doctor prescribes Sedam 3 with opioids, they should limit the dose and duration of concomitant use.
The patient should inform their doctor about all opioid drugs they are taking and strictly follow the dosage instructions. It may be helpful to inform friends or family about the risk so that they are aware of the mentioned symptoms. If these symptoms occur, the patient should contact their doctor.
In case of doubt about what these drugs are, the patient should consult their doctor or pharmacist.

Sedam 3 and alcohol

During treatment, the patient should not drink alcohol, as it can lead to excessive sedation and severe respiratory and circulatory complications.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor before taking this drug.
In children of mothers who took bromazepam during pregnancy, an increased risk of cleft palate has been noted, and benzodiazepine drugs used in high doses in the second and/or third trimester of pregnancy have caused decreased fetal movement and changes in fetal heart rhythm. Taking bromazepam in the late stage of pregnancy (even in small doses) has caused the occurrence of a floppy infant syndrome with symptoms such as decreased muscle tone, sucking disorders leading to poor weight gain. These symptoms are transient but may persist for 1 to 3 weeks. Taking bromazepam by the mother in high doses may cause respiratory depression or apnea and hypothermia in the newborn. Additionally, after a few days after birth, withdrawal symptoms with excessive excitement and tremors may be observed in the newborn.
The drug can be used during pregnancy only on the explicit recommendation of a doctor, in exceptional, justified cases.
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Bromazepam passes into human milk. During treatment with this drug, the patient should not breastfeed.

Driving and operating machinery

During treatment, symptoms may occur that unfavorably affect the ability to drive vehicles and operate machinery: sedation, memory disorders, concentration disorders, and reduced muscle tension. Therefore, during treatment, especially in the first few days, the patient should not drive vehicles or operate machinery.

Sedam 3 contains lactose monohydrate

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

3. How to take Sedam 3

This drug should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The dose and duration of the drug are determined by the doctor.
Sedam 3 (3 mg) and Sedam 6 (6 mg) are available on the market.
Outpatient treatment
Treatment starts with a dose of 3 mg of bromazepam (1 tablet of Sedam 3) taken one hour before bedtime. If necessary, the doctor may increase the dose to 6 mg of bromazepam (2 tablets of Sedam 3).
The effect of the drug taken in the evening usually lasts until the next evening, and there is no need to take an additional dose during the day. However, if necessary, the doctor may recommend taking 1.5 mg to 3 mg of bromazepam (½ to 1 tablet of Sedam 3) during the day.
In justified cases, the doctor may increase the dose to 12 mg of bromazepam per day (4 tablets of Sedam 3), given in divided doses.
Hospital treatment
In severe cases, the doctor may recommend gradually increasing the dose to 18 mg of bromazepam per day. At the beginning of treatment, the doctor will monitor whether the patient does not experience symptoms of overdose. This applies especially to elderly patients, weakened patients, patients with organic brain damage, circulatory failure, respiratory failure, and liver function disorders.
Special dosage instructions
For elderly patients, patients with organic brain damage, circulatory failure, respiratory failure, liver function disorders, or kidney disorders, the doctor will recommend a dose that is half of the above-mentioned doses, i.e., 1.5 mg of bromazepam (½ tablet of Sedam 3) per night.
The maximum daily dose for these patients is 6 mg.
Method and duration of administration
Tablets should be swallowed with a sufficient amount of liquid.
The treatment duration is determined by the doctor. Treatment should last as short as possible. The duration of therapy should not be longer than 8 to 12 weeks.
If the patient feels that the drug's effect is too strong or too weak, they should consult their doctor.

Taking a higher dose of Sedam 3 than recommended

Intentional or accidental overdose of Sedam 3 is rarely life-threatening, unless the drug has been taken with substances that suppress the activity of the central nervous system (including alcohol).
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In case of an overdose, the patient should immediately contact their doctor or the nearest

hospital. The patient should take the drug packaging with them so that the medical staff can precisely check which drug was taken.
Symptoms of an overdose may include:

• drowsiness
• coordination disorders
• speech disorders
• nystagmus

Significant overdose can rarely cause:

• coma (which can last several hours, recur, and worsen, especially in older people)
• decreased blood pressure
• respiratory depression

Missing a dose of Sedam 3

The patient should not take a double dose to make up for a missed dose.

Stopping Sedam 3 treatment

The patient should not decide on their own to stop taking Sedam 3. Only the doctor can decide to discontinue the drug.
If the patient intends to stop treatment with Sedam 3, they must consult their doctor, who will recommend a gradual reduction in dose.
Sudden cessation of treatment or rapid dose reduction can cause so-called rebound effects, which will temporarily increase anxiety or restlessness or make it difficult to fall asleep.
In patients with physical dependence, sudden cessation of treatment can cause withdrawal symptoms, such as headache, muscle pain, severe anxiety, tension, restlessness, disorientation, and irritability.
If the patient has doubts, the doctor will provide more detailed information on this matter.
In case of any further doubts related to the use of this drug, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, Sedam 3 can cause side effects, although they do not occur in everyone.
The drug is well-tolerated when used in therapeutic doses.
However, the following side effects may occur, the frequency of which is unknown:

• heart failure (including cardiac arrest)
• double vision
• nausea, vomiting, constipation
• fatigue
• hypersensitivity, anaphylactic shock, angioedema (swelling of the skin and underlying tissues)
• falls, fractures
• confusion, emotional disorders, sexual disorders, drug dependence, drug abuse, withdrawal syndrome
• depression
• restlessness, excitement, irritability, aggressive behavior, delusions, fits of anger, nightmares, hallucinations, psychiatric disorders, behavioral disorders
• memory disorders and loss
• urinary retention
• muscle weakness
• drowsiness, headache, dizziness, decreased alertness, movement disorders
• respiratory depression
• rash, itching, urticaria

Dependence
Sudden discontinuation of bromazepam after long-term use can cause sleep disorders and increase the frequency of nightmares. The following symptoms may occur: restlessness, tension, excitement, and a feeling of fatigue, as well as symptoms such as tremors and sweating, up to somatic and psychiatric symptoms, e.g., seizures, psychosis (delirium).
Addiction
Bromazepam can cause addiction, even when taken daily for several weeks. This applies not only to the use of too high doses but also to the use of therapeutic doses.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Reporting side effects can help collect more information on the safety of the drug.

5. How to store Sedam 3

• The drug should be stored in a place invisible and inaccessible to children.
• Do not store above 30°C.
• The drug should not be used after the expiration date stated on the packaging. The expiration date indicates the last day of the given month.
• Drugs should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

Translation of some entries on the immediate packaging:

Ch.-B./verwendbar bis: see embossing – Batch number/Expiration date: see embossing (on the edge of the blister).

6. Contents of the package and other information

What Sedam 3 contains

The active substance of the drug is bromazepam.
One tablet of Sedam 3 contains 3 mg of bromazepam.
The other ingredients are:
lactose monohydrate, povidone K 30, crospovidone, colloidal silica anhydrous, magnesium stearate.

What Sedam 3 looks like and what the package contains

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Sedam 3 is a white, elongated tablet with 3 notches on both sides, facilitating breaking.
Blisters in a cardboard box contain 30 tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Hexal AG
Industriestraße 25
83607 Holzkirchen
Germany

Manufacturer:

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German authorization number: 3003276.00.00

Parallel import authorization number: 237/17 Date of leaflet approval: 08.07.2022

[Information about the trademark]
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