Package leaflet: Information for the patient

Warning! Keep this leaflet. The 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 entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Sedam 6 is and what it is 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 Sedam 6 is and what it is 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 sedative effect. In higher doses, it acts as a tranquilizer and reduces muscle tension. Bromazepam also has anticonvulsant properties.

Indications for the use of Sedam 6 include:

generalized anxiety disorders requiring pharmacological treatment;
autonomic nervous system disorders presenting with skin symptoms, gastrointestinal symptoms, cardiac and circulatory system 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. 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 gravis (severe muscle weakness). Page 1 of 7

The medicine should not be used in children and adolescents.
Warnings and precautions
Before starting treatment with Sedam 6, consult 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 suicide;
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 pseudoanaphylactic reactions), angioedema (swelling of the skin and underlying tissues), breathing difficulties, throat obstruction, nausea, or vomiting may occur during treatment.
If such symptoms occur, seek immediate medical advice, as urgent medical intervention may be necessary.
In patients with physical dependence, abrupt discontinuation of treatment may cause withdrawal symptoms such as headache, diarrhoea, muscle pain, severe anxiety, tension, psychomotor agitation, disorientation, and irritability. In severe cases, psychiatric disturbances (derealisation, depersonalisation), hypersensitivity to sound, numbness and tingling in the limbs, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures may occur.
In some individuals, stopping treatment may lead to a temporary recurrence of symptoms (so-called rebound symptoms) with greater intensity than before. Mood swings, anxiety, sleep disturbances, and restlessness may also occur. The risk of these symptoms is higher after rapid dose reduction or abrupt discontinuation of treatment. The medicine should be discontinued gradually, reducing 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 should ensure 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 any of these occur, treatment should be discontinued and medical advice sought.
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 should be 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 influence each other's effects and the occurrence of adverse reactions.
This particularly applies to:

other medicines acting on the central nervous system (e.g. antipsychotics, sedatives and anxiolytics, antidepressants (including fluvoxamine), hypnotics, anticonvulsants, opioid analgesics, antihistamine medicines, general anaesthetics);
antifungal medicines;
macrolide antibiotics;
protease inhibitors (e.g. used in the treatment of HIV infection);
muscle relaxants;
cimetidine or omeprazole (medicines reducing gastric acid secretion);
cisapride (a medicine used in the treatment of gastro-oesophageal reflux disease);
antihypertensive medicines;
beta-blockers (medicines used in hypertension and heart diseases, including propranolol);
digitalis glycosides (medicines used in heart diseases);
methylxanthines (medicines used, among others, in asthma treatment);
hormonal contraceptives.

* Concomitant use of Sedam 6 and opioids (strong analgesics, medicines used in substitution treatment of addiction, and some cough medicines) increases the risk of excessive sedation, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered if other treatment options are not possible.
If the doctor prescribes Sedam 6 together with opioids, the dose and duration of concomitant 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 or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her 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 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, characterised by reduced muscle tone and sucking difficulties leading to poor weight gain. These symptoms are transient but may last from 1 to 3 weeks. High-dose maternal use of bromazepam may cause respiratory depression or absence of breathing and hypothermia in the newborn. Additionally, withdrawal symptoms with excessive agitation and tremors may be observed in the newborn several days after birth.
The medicine may be used during pregnancy only on a doctor's explicit recommendation and only in exceptional, particularly justified cases.
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Bromazepam passes into human milk. Breastfeeding should not be performed during treatment with this medicine.
Driving and operating machinery
During treatment with this medicine, symptoms that may adversely affect the ability to drive vehicles or operate machinery may occur: sedation, memory disturbances, concentration difficulties, and reduced muscle tone. Therefore, during treatment, especially in the first days, patients should not drive vehicles or operate machinery.
Sedam 6 contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

3. How to use Sedam 6

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
The dose and duration of treatment are determined by the physician.
Available on the market are: Sedam 3 (3 mg), Sedam 6 (6 mg).

Outpatient treatment
Treatment starts 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 daytime dose of 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, especially in elderly, debilitated patients, those with organic brain damage, circulatory failure, respiratory insufficiency, or impaired liver function.

Special dosage instructions
In elderly patients, those with organic brain damage, circulatory failure, respiratory insufficiency, or 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 liquid.
The duration of treatment is determined by the physician. Treatment should be as short as possible. Therapy should not last 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 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 together with agents that depress the central nervous system (including alcohol).
In case of overdose, seek immediate medical help from a doctor or the nearest hospital. Bring the medicine packaging with you so that medical personnel can accurately identify which medicine was 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 patients)
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. Only the physician decides when to discontinue the medicine.
If the patient intends to stop 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, resulting in temporary worsening of anxiety or restlessness, or difficulty falling asleep.
In patients with physical dependence, abrupt discontinuation 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 subject.
For any further questions regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The medicine is well tolerated when used at therapeutic doses.
However, the following adverse 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, disturbances of libido, drug dependence, drug abuse, withdrawal syndrome
depression
motor restlessness, agitation, irritability, aggressive behaviour, hallucinations, anger, nightmares, illusions, psychosis, unusual behaviour
memory disturbances and memory loss
urinary retention

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muscle weakness
somnolence, headache, dizziness, reduced alertness, movement disorders
respiratory depression
rash, itching, urticaria

Dependence
Sudden discontinuation of bromazepam after prolonged use may lead to sleep disturbances and increased frequency of dreams. Symptoms such as anxiety, tension, excitement, and feeling of fatigue may occur, as well as physical symptoms such as tremor and profuse sweating, up to somatic and psychiatric symptoms, e.g. seizures, psychosis (delirium).

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

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 effects helps to provide more information on the safety of the medicine.

5. How to store Sedam 6

Keep this medicine out of 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

Translation of some inscriptions on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – Batch number/Expiry date: see embossing (on the edge of the blister).

6. Contents of the packaging and other information

What Sedam 6 contains
The active substance is bromazepam.
One tablet of Sedam 6 contains 6 mg of bromazepam.
The other ingredients are:
monohydrate lactose, povidone K 30, crospovidone, colloidal anhydrous silica,
magnesium stearate, green lake (aluminium hydroxide with quinoline yellow and indigo carmine).
What Sedam 6 looks like and contents of the packaging
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Sedam 6 is green, elongated tablets with 3 notches on both sides facilitating breaking.
Blisters in cardboard packaging contain 30 tablets.
For more detailed information, please contact the responsible party or 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Number of marketing authorisation in Germany, the country of export: 4725.00.00
Parallel import authorisation number: 236/17
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