Sedam 6

Package Leaflet: Information for the Patient

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

Sedam 6 (Bromazanil 6)

6 mg, tablets
Bromazepamum
Sedam 6 and Bromazanil 6 are different trade names for the same drug.

Before taking the medicine, the patient should 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 medicine has been prescribed specifically for the patient. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What Sedam 6 is and what it is used for

Sedam 6 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 anticonvulsant properties.

Indications for the use of Sedam 6 are:

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

2. Important information before taking Sedam 6

When not to take Sedam 6

• if the patient is allergic to bromazepam, other benzodiazepines, or any of the other ingredients of the medicine (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).

The medicine should not be used in children and adolescents.

Warnings and precautions

Before starting to take Sedam 6, 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 and thought 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 medicine for several weeks, even in small doses, can lead to psychological and physical dependence.

Repeated use of Sedam 6 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, feelings of numbness and tingling in the 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 medicine should be discontinued gradually, reducing the dose as prescribed by the doctor.

Medicines like Sedam 6 (benzodiazepines) can cause memory disturbances (difficulty remembering new information), especially if the medicine is taken in large doses.

To minimize the risk of memory disturbances, the patient should have several hours of uninterrupted sleep after taking the medicine.

During treatment with such medicines as Sedam 6, restlessness, excitement, irritability, aggression, delusions, outbursts of anger, nightmares, hallucinations, psychiatric disorders, or behavioral disorders may occur.

If they occur, the patient should stop taking the medicine and consult a doctor.

Sedam 6 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 6 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Sedam 6 and other medicines taken at the same time can affect each other's action and the occurrence of side effects.

This applies in particular to:

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

*
Concomitant use of Sedam 6 and opioids (strong painkillers, medicines 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 medicines can only be considered when other treatment methods are not possible.

If the doctor prescribes Sedam 6 together with opioids, they should limit the dose and duration of concomitant use.

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 about the risk so that they are aware of the mentioned symptoms.

In case of these symptoms, the patient should contact their doctor.

In case of doubts about what these medicines are, the patient should consult their doctor or pharmacist.

Sedam 6 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

In children of mothers who took bromazepam during pregnancy, an increased risk of cleft palate has been observed, and benzodiazepines used in high doses in the second and/or third trimester of pregnancy have caused a decrease in fetal movement and changes in fetal heart rhythm.

Taking bromazepam in the last phase 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 in the newborn and a decrease in body temperature.

Additionally, after a few days after birth, withdrawal symptoms can be observed in the newborn, such as excessive excitement and trembling.

The medicine can be used during pregnancy only on the explicit recommendation of a doctor, in exceptional, justified cases.

Bromazepam passes into human milk.

During treatment with this medicine, 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 disturbances, concentration disorders, and decreased muscle tone.

Therefore, during treatment, especially in the first days, the patient should not drive vehicles or operate machinery.

Sedam 6 contains lactose monohydrate

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

3. How to take Sedam 6

This medicine 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 treatment 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 (½ tablet of Sedam 6) taken one hour before bedtime.

If necessary, the doctor may increase the dose to 6 mg of bromazepam (1 tablet of Sedam 6).

The effect of the medicine 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 (¼ to ½ tablet of Sedam 6) during the day.

In justified cases, the doctor may increase the dose to 12 mg of bromazepam per day (2 tablets of Sedam 6), 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 in particular to elderly patients, weakened patients, patients with organic brain damage, circulatory failure, respiratory failure, and liver function disorders.

Special instructions for dosing

In elderly patients, patients with organic brain damage, circulatory failure, respiratory failure, liver function disorders, or kidney disorders, the doctor will recommend using a dose that is half of the above-mentioned doses, i.e., 1.5 mg of bromazepam (¼ tablet of Sedam 6) per night.

The maximum daily dose in 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 treatment duration should not be longer than 8 to 12 weeks.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using a higher dose of Sedam 6 than recommended

Intentional or accidental overdose of Sedam 6 can rarely be life-threatening, unless the medicine has been taken together with substances that suppress the activity of the central nervous system (including alcohol).

In case of overdose, the patient should immediately contact their doctor or the nearest

hospital. The patient should take the medicine packaging with them so that the medical staff can precisely check which medicine has been taken.

Symptoms of 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 6

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

Stopping Sedam 6 treatment

The patient should not decide on their own to stop taking Sedam 6.

Only the doctor can decide to discontinue the medicine.

If the patient plans to stop treatment with Sedam 6, they must consult their doctor, who will recommend gradual dose reduction.

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, their doctor will provide more detailed information on this matter.

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sedam 6 can cause side effects, although not everybody gets them.

The medicine is well-tolerated when used in therapeutic doses.

However, the following side effects may occur, with an unknown frequency:

• 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 disturbances, libido disorders, drug dependence, drug abuse, withdrawal syndrome
• depression
• restlessness, excitement, irritability, aggressive behavior, delusions, anger, nightmares, hallucinations, psychosis, abnormal behavior
• memory disturbances 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 disturbances and increase the frequency of dreams.

The following symptoms may occur: restlessness, tension, excitement, and a feeling of fatigue, as well as symptoms such as trembling and sweating, up to somatic and mental symptoms, e.g., seizures, psychosis (delirium).

Addiction

Bromazepam can cause dependence, even when taken daily for several weeks.

This applies not only to the use of excessive doses but also to the use of therapeutic doses.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they 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

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Sedam 6

• The medicine should be stored in a place invisible and inaccessible to children.
• Do not store above 30°C.
• The medicine should not be used after the expiry date stated on the packaging.
• Medicines should not be disposed of via wastewater or household waste.
• The patient should ask their pharmacist how to dispose of medicines that are no longer used.
• This will help protect the environment.

Translation of some entries on the immediate packaging:

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

6. Contents of the package and other information

What Sedam 6 contains

The active substance of the medicine is bromazepam.

One tablet of Sedam 6 contains 6 mg of bromazepam.

The other ingredients are:

lactose monohydrate, povidone K 30, crospovidone, colloidal silica anhydrous, magnesium stearate, green lake (aluminum hydroxide with quinoline yellow and indigo carmine).

What Sedam 6 looks like and what the package contains

Sedam 6 is a green, oblong 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 the 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

Authorization number in Germany, the country of export: 4725.00.00

Parallel import authorization number: 236/17 Date of leaflet approval: 08.07.2022

[Information about the trademark]