SEDAM 3 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Sedam 3, 3 mg, tablets
3. Sedam 6, 6 mg, tablets
   1. It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Sedam and what is it used for
5. Important information before using Sedam
   1. When not to use Sedam
   2. Warnings and precautions
   3. Sedam and other medicines
   4. Sedam and alcohol
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
   7. Sedam contains lactose monohydrate
6. How to use Sedam
   1. Using a higher dose of Sedam than recommended
   2. In case of overdose, the patient should immediately contact their doctor or the nearest
   3. Missing a dose of Sedam
   4. Stopping Sedam treatment
7. Possible side effects
   1. Reporting side effects
8. How to store Sedam
9. Contents of the packaging and other information
   1. What Sedam contains
   2. What Sedam looks like and what the packaging contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last update of the leaflet:

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 patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. 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 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 anticonvulsant properties.

Indications for the use of Sedam include:

generalized anxiety disorders requiring pharmacological treatment;

autonomic nervous system disorders that occur in the form of skin symptoms, gastrointestinal symptoms, heart symptoms, circulatory 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.

Daily use of the medicine for several weeks, even in small doses, may cause psychological and physical dependence.

Repeated use of Sedam over several weeks may lead to a decrease in its effectiveness.

During treatment with Sedam, 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, psychiatric 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 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 medicine should be discontinued gradually, reducing the dose in the manner prescribed by the doctor.

Medicines like Sedam (benzodiazepines) may 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 treatment with such medicines as Sedam, 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 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 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 and other medicines used at the same time may 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 pills, anticonvulsants, opioid analgesics*, antihistamines, 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 in the treatment of esophageal 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 others, in the treatment of asthma);

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.

Due to this, concomitant use of these medicines can only be considered when other treatment methods 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 what these medicines are, the patient should consult their doctor or pharmacist.

Sedam and alcohol

The patient should not drink alcohol while taking the medicine, as it may 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 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 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 reduced 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, a few days after birth, withdrawal symptoms with excessive excitement and tremors may be observed in the newborn.

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

Bromazepam passes into breast milk.

While taking this medicine, the patient should not breastfeed.

Driving and operating machinery

During treatment with this medicine, 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 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 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

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 (½ Sedam 3 tablet) per night.

The maximum daily dose in these patients is 6 mg.

Method and duration of administration

The tablets should be swallowed, washed down 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 than recommended

Intentional or accidental overdose of Sedam rarely poses a threat to life, 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 may rarely cause:

coma (which may 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 Sedam treatment

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

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 intake or 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, 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 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, the frequency of which is not known:

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, psychiatric 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 dreams.

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 mental symptoms, e.g., seizures, psychosis (delirium).

Withdrawal

Bromazepam may cause dependence, 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 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 invisible and inaccessible to children.

Store in a temperature below 25°C.

The medicine should not be used after the expiry date stated on the packaging after the term "EXP".

The expiry date refers to the last day of the specified month.

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.

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.

Sedam 6: green, oblong tablets with 3 notches on both sides.

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 last update of the leaflet: