PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Sedam 6 (Bromazanil 6)
6 mg, tablets
Bromazepamum
Sedam 6 and Bromazanil 6 are different trade names for the same medicinal product.
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What is Sedam 6 and what is it used for
Important information before taking Sedam 6
How to take Sedam 6
Possible side effects
How to store Sedam 6
Contents of the pack and other information

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

Sedam 6 contains the active substance bromazepam – a psychotropic agent belonging to the benzodiazepine derivatives group. In low doses, it reduces nervous tension, agitation, and anxiety, and has a mild hypnotic effect. In higher doses, it exerts a sedative action and reduces muscle tension. Bromazepam has anticonvulsant properties.

The indications for use of Sedam 6 are:

Generalized anxiety disorders requiring pharmacological treatment;
Autonomic nervous system disorders presenting as skin symptoms, gastrointestinal symptoms, cardiac or circulatory symptoms, urogenital symptoms, etc.;
Anxiety states associated with chronic diseases of the central nervous system;
Post-traumatic stress disorders with anxiety symptoms;
Adjustment disorders (e.g., resulting from difficulties 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 medicine (listed in section 6);
if the patient has severe respiratory insufficiency;
if the patient has been diagnosed with sleep apnoea syndrome;
if the patient has severe hepatic insufficiency;
if the patient has been diagnosed with myasthenia (marked muscle weakness).

Sedam 6 must not be used in children and adolescents.
Warnings and precautions
Before starting treatment with Sedam 6, discuss with your doctor or pharmacist if the patient:

has ever had depression and (or) anxiety related to it;
has ever had such severe depression that they thought about taking their own life;
has previously abused medicines, drugs, or alcohol, or has difficulty stopping their use;
has a lung, kidney, or liver disease.

Daily use of the medicine for several weeks, even at low doses, may lead to psychological and physical dependence.
Repeated use of Sedam 6 over several weeks may reduce its effectiveness.
Severe allergic reactions (so-called anaphylactic or pseudoallergic reactions), angioedema (swelling of the skin and underlying tissues), as well as shortness of breath, throat obstruction, or nausea and vomiting may occur during treatment.
If such symptoms occur, seek immediate medical advice, as urgent medical intervention may be required.
In patients with physical dependence, abrupt discontinuation of treatment may cause withdrawal symptoms such as headache, diarrhoea, muscle pain, severe anxiety, tension, restlessness, disorientation, and irritability. In severe cases, psychiatric disturbances (derealisation, depersonalisation), hypersensitivity to sounds, sensations of numbness and tingling in the limbs, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures may occur.
In some patients, stopping treatment may cause a transient return of disease symptoms (so-called rebound symptoms) with greater intensity than before. Mood swings, anxiety, sleep disturbances, and restlessness may also occur. The risk of such symptoms is higher after rapid dose reduction or abrupt discontinuation of treatment. The medicine should be discontinued gradually by tapering the dose as advised by the doctor.
Medicines such as Sedam 6 (benzodiazepines) may cause memory disturbances (difficulty in remembering new information), especially when used at high doses. To reduce the risk of memory disturbances, the patient must have several hours of uninterrupted sleep after taking the medicine.
During treatment with medicines such as Sedam 6, restlessness, agitation, irritability, aggression, delusions, anger attacks, nightmares, hallucinations, psychiatric disturbances, and behavioural disorders may occur. If such symptoms occur, discontinue the medicine and consult a doctor.
Sedam 6 may reduce muscle tone and cause falls with a risk of bone fractures, especially in elderly patients.
The duration of treatment is limited and determined by the doctor.
Sedam 6 and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use.
Sedam 6 and other concomitantly used medicines may interact and affect each other's actions and the occurrence of adverse effects.
This especially applies to:

other medicines acting on the central nervous system (e.g. antipsychotics, sedatives and anxiolytics, antidepressants [including fluvoxamine], hypnotics, anticonvulsants, opioid analgesics*, antihistamines, general anaesthetics);
medicines used for fungal infections;
macrolide antibiotics;
protease inhibitors (e.g. used in the treatment of HIV infection);
medicines reducing muscle tone;
cimetidine or omeprazole (medicines reducing gastric acid secretion);
cisapride (a medicine used in the treatment of gastroesophageal reflux disease);
antihypertensive medicines;
beta-adrenolytics (medicines used in hypertension and heart diseases, including propranolol);
cardiac glycosides (medicines used in heart diseases);
methylxanthines (medicines used, among others, in asthma treatment);
hormonal contraceptives.

* Concurrent use of Sedam 6 and opioids (strong analgesics, medicines used in substitution treatment of addictions, and some cough medicines) increases the risk of excessive sedation, breathing difficulties (respiratory depression), coma, and may be life-threatening. Because of this, concurrent use of these medicines should only be considered when other treatment options are not feasible.
If the doctor prescribes Sedam 6 together with opioids, the dose and duration of concurrent use should be limited.
Inform the doctor about all opioid medicines used by the patient and strictly follow dosing instructions. Informing friends or family about the risks may be helpful so they are aware of the mentioned symptoms. If these symptoms occur, contact the doctor immediately.
If in doubt about which medicines are referred to, consult your doctor or pharmacist.
Sedam 6 and alcohol
Do not drink alcohol while taking this medicine, as it may lead to excessive sedation and serious respiratory and circulatory complications.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, she should consult a doctor before using this medicine.
In children of mothers who took bromazepam during pregnancy, an increased risk of cleft palate has been reported. Benzodiazepine medicines used at high doses during the second and (or) third trimester of pregnancy caused reduced active fetal movements and changes in fetal heart rate. Use of bromazepam in the late stages of pregnancy (even at low doses) may lead to the floppy infant syndrome, with symptoms such as reduced muscle tone and sucking difficulties causing poor weight gain. These symptoms are transient but may persist for 1 to 3 weeks. High-dose maternal use of bromazepam may cause respiratory depression or absence of breathing and lowered body temperature in the newborn. Additionally, withdrawal symptoms with excessive agitation and tremors may be observed in the newborn several days after birth.
This medicine may be used during pregnancy only on a doctor's explicit recommendation and only in exceptional, particularly justified cases.
Bromazepam passes into breast milk. Breastfeeding must not be continued during treatment with this medicine.
Driving and operating machinery
During treatment with this medicine, symptoms that may negatively affect the ability to drive and operate machinery may occur: sedation, memory disturbances, concentration difficulties, and reduced muscle tone. Therefore, during treatment, especially in the first few days, driving vehicles or operating machinery should be avoided.
Sedam 6 contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

3. How to use Sedam 6

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician or pharmacist.
The dosage and duration of treatment are determined by the physician.
Sedam 3 (3 mg) and Sedam 6 (6 mg) are available on the market.
Outpatient treatment
Treatment is initiated with a dose of 3 mg bromazepam (½ tablet of Sedam 6), taken one hour before
bedtime. If necessary, the physician may increase the dose to 6 mg bromazepam (1 tablet of Sedam 6).
The effect of the evening dose usually lasts until the next evening, and there is no need to take an
additional dose during the day. However, if necessary, the physician may recommend taking a dose
during the day ranging from 1.5 mg to 3 mg bromazepam (¼ to ½ tablet of Sedam 6).
In justified cases, the physician may increase the dose up to 12 mg bromazepam per day (2 tablets of
Sedam 6), administered in divided doses.
Hospital treatment
In severe cases, the physician may recommend gradually increasing the dose up to 18 mg bromazepam
per day. At the beginning of treatment, the physician will monitor whether symptoms of overdose occur.
This particularly applies to elderly patients, debilitated patients, patients with organic brain damage,
circulatory failure, respiratory insufficiency, and impaired liver function.
Special dosage instructions
In elderly patients, patients with organic brain damage, circulatory failure, respiratory insufficiency,
impaired liver or kidney function, the physician will recommend a dose equal to half of the doses
described above, i.e. 1.5 mg bromazepam (¼ tablet of Sedam 6) at night. The maximum daily dose in
these patients is 6 mg.
Method and timing of administration
Tablets should be swallowed with an adequate amount of fluid.
The duration of treatment is determined by the physician. Treatment should be as short as possible.
The duration of therapy should not exceed 8 to 12 weeks.
If the patient feels that the effect of the medicine is too strong or too weak, consult the physician.
Use of a higher than recommended dose of Sedam 6
Intentional or accidental overdose of Sedam 6 rarely poses a life-threatening risk, unless the medicine
has been taken simultaneously with central nervous system depressants (including alcohol).
In case of overdose, contact a physician or the nearest hospital immediately. Bring the medicine
packaging with you so that medical personnel can accurately determine which medicine has been
taken.
Symptoms of overdose may include:

drowsiness
coordination disturbances
speech disturbances
nystagmus

Significant overdose may rarely cause:

coma (which may last several hours, recur, and deepen, especially in elderly individuals)
decreased arterial blood pressure
respiratory depression

Missed dose of Sedam 6
Do not take a double dose to make up for a missed dose.
Discontinuation of Sedam 6
Do not discontinue Sedam 6 independently. The decision to discontinue treatment is made exclusively
by the physician.
If the patient intends to discontinue treatment with Sedam 6, they must consult the physician, who
will recommend gradually reducing the dose.
Abruptly stopping the tablets or reducing the dose may cause so-called "rebound" effects, leading to
temporary worsening of anxiety or restlessness, or difficulty falling asleep.
In patients with physical dependence, abrupt discontinuation of treatment may cause withdrawal
symptoms such as headache, muscle pain, severe anxiety, tension, motor restlessness, confusion, and
irritability.
If the patient has any doubts, the physician will provide more detailed information on this matter.
In case of any further doubts regarding the use of this medicine, consult the physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The medicine is well tolerated when used at therapeutic doses.
However, the following adverse reactions may occur, although their frequency 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, disturbances in sexual drive, drug dependence, drug abuse, withdrawal syndrome
depression
motor restlessness, agitation, irritability, aggressive behaviour, hallucinations, anger, nightmares, illusions, psychosis, unusual behaviour
disturbances and loss of memory
urinary retention
decreased muscle strength
somnolence, headache, dizziness, reduced alertness, movement disorders
respiratory depression
rash, itching, urticaria

Dependence
Bromazepam may lead to dependence, even after daily administration for several weeks. This applies not only to the use of excessively high doses but also to the administration of therapeutic doses.

Withdrawal symptoms
Abrupt discontinuation of bromazepam after prolonged use may cause sleep disturbances and increase the frequency of dreams. Symptoms such as anxiety, tension, excitement, and feeling of fatigue may occur, as well as tremor and profuse sweating, up to somatic and psychiatric symptoms, e.g. seizures, psychosis (delirium).

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sedam 6

Keep this medicine out of the sight and reach of children. Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Translation of information on the blister: Ch.-B.:/verwendbar bis: siehe Prägung - Batch number and expiry date are imprinted on the edges of the blister.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Sedam 6 contains
The active substance in this medicine is bromazepam.
Each tablet contains 6 mg of bromazepam.
The other ingredients are: monohydrate lactose, povidone K 30, crospovidone, anhydrous colloidal silicon dioxide, magnesium stearate, green lake (aluminium hydroxide with quinoline yellow and indigo carmine).

What Sedam 6 looks like and contents of the pack
Green, oblong tablets with three notches on both sides facilitating division.
Blister packs in cardboard boxes contain 30 tablets.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland

Marketing authorisation number in Germany, the country of export: 4725.00.00
Parallel import licence number: 126/19