Sedam 6

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language.

Sedam 6 (Bromazepam 6 - 1 A Pharma)

6 mg, tablets
Bromazepamum
Sedam 6 and Bromazepam 6 - 1 A Pharma 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 disease are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Sedam 6 and what is it 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 is Sedam 6 and what is it 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, circulatory, genitourinary, 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

• 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).

The drug 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.

Daily use of the drug for several weeks, even in small doses, may cause psychological and physical dependence.
Repeated use of Sedam 6 over several weeks may reduce 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 people 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, psychological disorders (derealization, depersonalization) may occur, increased sensitivity to sounds, feeling of numbness and tingling of limbs, increased sensitivity to light, noise, and physical contact, hallucinations, or seizures.
In some patients, stopping the treatment may cause a transient recurrence of disease symptoms (so-called rebound symptoms) with greater intensity than before. Mood swings, anxiety, or sleep disorders 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 6 (benzodiazepines) may cause memory disorders (difficulty remembering new information), especially if the drug is used in large doses. To reduce the risk of memory disorders, 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, psychological 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 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 affect each other's action and the occurrence of side effects.
This applies in particular to:

• other drugs acting on the central nervous system (e.g., antipsychotics, sedatives, and anxiolytics, 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 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 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 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 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 poses a risk of 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 reduced 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 reduced 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 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.
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 disorders, concentration disorders, and reduced 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 been diagnosed with intolerance to some sugars, they should consult their doctor before taking the drug.

3. How to use Sedam 6

Sedam 3 (3 mg) and Sedam 6 (6 mg) are available on the market.
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.
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 administered 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 gradual dose escalation 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 dosage instructions
For patients who are elderly, have organic brain damage, circulatory failure, respiratory failure, liver or kidney function disorders, the doctor will recommend 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. The treatment should last as short as possible. The therapy duration 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.

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 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 packaging of the drug with them so that the medical staff can precisely check which drug was taken.
Symptoms of overdose may include:

• drowsiness
• coordination disorders
• speech disorders
• nystagmus.

Significant 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 the treatment with Sedam 6, they must consult their doctor, who will recommend a gradual dose reduction. Sudden cessation of the drug or dose reduction may cause 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, 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 any drug, Sedam 6 may 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, psychological disorders, behavioral disorders
• memory disorders and loss of memory
• 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 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 psychological symptoms, e.g., seizures, psychosis (delirium).
Addiction
Bromazepam may cause addiction, even when the drug is taken daily for several weeks. This applies not only to the use of too high doses but also to the use of the drug in 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, 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 gather more information 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 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.

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 anhydrous, magnesium stearate, green lake (aluminum hydroxide with quinoline yellow (E 104) and indigo carmine (E 132)).

What Sedam 6 looks like and what the packaging contains

Sedam 6 is a green, elongated tablet with 3 notches on both sides, facilitating breaking.
Blister packs 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:

1 A Pharma GmbH, Industriestraße 18, 83607 Holzkirchen, Germany

Manufacturer:

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-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 export permit number: 7427.00.00

Parallel import permit number: 396/19

Date of leaflet approval: 14.10.2024

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