Sedam 6

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Sedam 6 (Bromazanil 6)

6 mg, tablets

Bromazepam
Sedam 6 and Bromazanil 6 are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you 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 adverse reactions, including any adverse reactions not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

When not to use Sedam 6:

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 to the point of considering suicide;
• have abused drugs, narcotics, or alcohol in the past or have difficulty stopping their use;
• have lung, kidney, or liver disease. Daily use of the drug for several weeks, even in small doses, may lead to psychological and physical dependence.

Repeated use of Sedam 6 for several weeks may lead to a decrease in its effectiveness.
During the use of the drug, 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.
In case of such symptoms, the patient should immediately consult a doctor, as urgent medical attention may be necessary.
In patients with physical dependence, sudden cessation of treatment may 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, cessation of treatment may cause a transient recurrence of disease symptoms (so-called rebound symptoms) with greater severity 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 such as Sedam 6 (benzodiazepines) may cause memory disturbances (difficulty remembering new information), especially if the drug is used in large doses. To minimize the risk of memory disturbances, the patient should have several hours of uninterrupted sleep after taking the drug.
During the use of such drugs as Sedam 6, restlessness, excitement, irritability, aggression, delusions, fits of anger, nightmares, hallucinations, psychiatric disorders, or behavioral disorders may occur. If they occur, the patient should stop using the drug and consult a doctor.
Sedam 6 may reduce muscle tension and cause falls with a risk of bone fractures, especially in older patients.
The treatment duration is limited and is determined by the doctor.

Sedam 6 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 6 and other drugs used at the same time may interact with each other and affect the occurrence of side effects.
This applies especially to:

• other drugs acting on the central nervous system (e.g., antipsychotics, sedatives, and anxiolytics, antidepressants [including fluvoxamine], hypnotics, 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 6 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 6 together with opioids, they should limit the dose and duration of concomitant use.
The patient should inform their doctor about all the opioid drugs they are using 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 their occurrence, the patient should contact their doctor.
In case of doubts about what the listed drugs are, the patient should consult their doctor or pharmacist.

Sedam 6 and alcohol

During the use of the drug, 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 using 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. The use of 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. The use of 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 of 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.
Bromazepam passes into human milk. During the use of this drug, the patient should not breastfeed.

Driving and operating machinery

During the use of this drug, 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 certain sugars, they should consult their doctor before taking the drug.

3. How to use Sedam 6

This drug should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Sedam 3 (3 mg) and Sedam 6 (6 mg) are available on the market.
The dose and duration of the drug are determined by the doctor.
Ambulatory 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 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 (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), administered 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 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 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 effect of the drug 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 is rarely life-threatening, unless the drug has been taken together with substances that depress the activity of the central nervous system (including alcohol).

In case of an overdose of Sedam 6, the patient should immediately contact their doctor or the nearest

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

• drowsiness
• coordination disorders
• speech disorders
• nystagmus Severe overdose may rarely cause:
• coma (which may 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 the use of Sedam 6

The patient should not decide on their own to stop using Sedam 6. Only the doctor can decide to discontinue the drug.
If the patient intends to stop treatment with Sedam 6, they must consult their doctor, who will recommend gradually reducing the dose.
Sudden cessation of treatment or rapid dose reduction may 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 may cause withdrawal symptoms, such as headache, muscle pain, severe anxiety, tension, restlessness, confusion, 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 any drug, Sedam 6 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 disturbances, libido disorders, drug dependence, drug abuse, withdrawal syndrome
• depression
• restlessness, excitement, irritability, aggressive behavior, delusions, fits of anger, nightmares, hallucinations, psychiatric disorders, or behavioral disorders
• 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 may cause sleep disturbances and increase the frequency of nightmares. The following symptoms may occur: anxiety, tension, excitement, and a feeling of fatigue, as well as symptoms such as tremors and sweating, up to somatic and mental symptoms, e.g., seizures, psychosis (delirium).
Addiction
Bromazepam may cause addiction, even when used 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 any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. 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 drug.

5. How to store Sedam 6

• The drug should be stored in a place invisible and inaccessible to children.
• Do not store at a temperature 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. Translation of some information on the immediate packaging: Ch.-B./verwendbar bis: siehe Prägung- batch number/expiration date: see embossing.
• 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.

6. Contents of the packaging and other information

What Sedam 6 contains

The active substance of the drug is bromazepam.
One tablet of Sedam 6 contains 6 mg of bromazepam.
The other ingredients are: lactose monohydrate, povidone K 30, crospovidone, colloidal silica, magnesium stearate, green lake (aluminum hydroxide with quinoline yellow and indigo carmine).

What Sedam 6 looks like and what the packaging contains

Green, elongated tablets 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
Haupt Pharma AG, Moosrosenstr. 7/13, 12347 Berlin, Germany

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Authorization number in Germany, the country of export:4725.00.00
Parallel import authorization number:48/18
Date of leaflet approval: 26.09.2022
[Information about the trademark]