Sedam 6

Leaflet attached to the packaging: patient information

Sedam 3, 3 mg, tablets

Sedam 6, 6 mg, tablets

Bromazepam

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine can 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 the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Sedam and what is it used for

Sedam contains the active substance bromazepam - a psychotropic medicine 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.
Indications for the use of Sedam are:
generalized anxiety disorders requiring pharmacological treatment;
autonomic nervous system disorders that 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 using Sedam

When not to use Sedam

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, 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 medicines, drugs, or alcohol in the past or have difficulty stopping their use;
have lung, kidney, or liver disease.

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

Daily use of the medicine for several weeks, even in small doses, can cause psychological and physical dependence.
Repeated use of Sedam over several weeks can lead to a decrease in its effectiveness.
During the use of the medicine, 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 can 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 treatment can cause a transient recurrence of disease symptoms (so-called rebound symptoms) with greater severity 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 medicine should be discontinued gradually, reducing the dose as prescribed by the doctor.
Medicines such as Sedam (benzodiazepines) can cause memory disorders (difficulty remembering new information), especially if the medicine is used in large doses. To reduce the risk of memory disorders, the patient should have several hours of uninterrupted sleep after taking the medicine.
During the use of such medicines as Sedam, restlessness, excitement, irritability, aggression, delusions, outbursts of anger, nightmares, hallucinations, and behavioral disorders may occur. If they occur, the patient should stop using the medicine and consult a doctor.
Sedam 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 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 use.
Sedam and other medicines used at the same time can affect each other's action and the occurrence of side effects.
This applies especially to:
other medicines that act on the central nervous system (e.g., antipsychotic, sedative, and anxiolytic medicines, antidepressants [including fluvoxamine], sleeping pills, anticonvulsants, opioid analgesics*, antihistamines, general anesthetics);
medicines used in fungal infections;
macrolide antibiotics;
protease inhibitors (used, e.g., in HIV treatment);
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, e.g., in asthma treatment);
hormonal contraceptives.
* Concomitant use of Sedam 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. Therefore, concomitant use of these medicines can only be considered when other treatment options are not possible.
If the doctor prescribes Sedam 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 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 the mentioned medicines, the patient should consult their doctor or pharmacist.

Sedam and alcohol

During the use of the medicine, 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 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 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 can persist for 1 to 3 weeks. The use of bromazepam by the mother in high doses can cause respiratory depression and hypothermia in the newborn. Additionally, after a few days after birth, withdrawal symptoms with excessive excitement and tremors can be observed in the newborn.
The medicine can be used during pregnancy only on the explicit recommendation of the doctor, in exceptional, justified cases.
Bromazepam passes into human milk. During the use of this medicine, the patient should not breastfeed.

Driving and using machines

During the use of this medicine, symptoms may occur that unfavorably affect the ability to drive vehicles and operate machines: sedation, memory disorders, concentration disorders, and decreased muscle tension. Therefore, during treatment, especially in the first days, the patient should not drive vehicles or operate machines.

Sedam 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 use Sedam

This medicine 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 medicine are determined by the doctor.
Ambulatory treatment
Treatment starts with a dose of 3 mg of bromazepam (1 Sedam 3 tablet or ½ Sedam 6 tablet) taken one hour before bedtime. If necessary, the doctor may increase the dose to 6 mg of bromazepam (2 Sedam 3 tablets or 1 Sedam 6 tablet).
The effect of the medicine given 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 Sedam 3 tablet or ¼ to ½ Sedam 6 tablet) during the day.
In justified cases, the doctor may increase the dose to 12 mg of bromazepam per day (4 Sedam 3 tablets or 2 Sedam 6 tablets), given in divided doses.
Hospital treatment
In severe cases, the doctor may recommend gradual dose increase 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 or kidney function disorders, the doctor will recommend using a dose that is half of the above-mentioned doses, i.e., 1.5 mg of bromazepam (½ Sedam 3 tablet) 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 effect of the medicine is too strong or too weak, they should consult their doctor.

Using a higher than recommended dose of Sedam

Intentional or accidental overdose of Sedam 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
Severe overdose can rarely cause:
coma (which can last several hours, recur, and worsen, especially in elderly patients)
decreased blood pressure
respiratory depression

Missing a dose of Sedam

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

Stopping the use of Sedam

The patient should not decide to stop using Sedam on their own. Only the doctor can decide to discontinue the medicine.
If the patient plans to stop treatment with Sedam, they should consult their doctor, who will recommend gradual dose reduction.
Sudden cessation of tablet use or 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 medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sedam 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 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 disorders, sexual disorders, dependence on the medicine, abuse of the medicine, withdrawal syndrome
depression
restlessness, excitement, irritability, aggressive behavior, delusions, anger, nightmares, hallucinations, psychosis, abnormal behavior
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 can cause sleep disorders and increase the frequency of dreams. The following symptoms may occur: restlessness, tension, excitement, and fatigue, as well as symptoms such as tremors and sweating, up to somatic and mental symptoms, e.g., seizures, psychosis (delirium).
Withdrawal
Bromazepam can cause dependence, 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, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Sedam

The medicine should be stored in a place that is invisible and inaccessible to children.
Store at a temperature below 25°C.
The medicine should not be used after the expiration date stated on the packaging after the term EXP. The expiration date means the last day of the specified month.
Medicines should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Sedam contains

The active substance of the medicine is bromazepam.
One tablet contains 3 mg (Sedam 3) or 6 mg (Sedam 6) of bromazepam.
The other ingredients are:
Sedam 3: lactose monohydrate, povidone K 30, crospovidone, colloidal silica anhydrous, magnesium stearate.
Sedam 6: lactose monohydrate, povidone K 30, crospovidone, colloidal silica anhydrous, magnesium stearate, green lake (aluminum hydroxide with quinoline yellow and indigo carmine).

What Sedam looks like and what the packaging contains

Sedam 3: white, oblong tablets with 3 notches on both sides, facilitating breaking.
Sedam 6: green, oblong tablets with 3 notches on both sides, facilitating breaking.
Blisters in a cardboard box contain 30 tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben, Germany
To obtain more detailed information, the patient should contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of the last update of the leaflet: