Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Sedam 3 (Bromazanil 3)
3 mg, tablets
Bromazepamum
Sedam 3 and Bromazanil 3 are different brand names for the same medicinal product.
Please read this leaflet carefully before taking 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, please consult your doctor or pharmacist.
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 of illness 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 3 and what is it used for
What you need to know before taking Sedam 3
How to take Sedam 3
Possible side effects
How to store Sedam 3
Contents of the pack and other information

1. What is Sedam 3 and what is it used for

Sedam 3 contains the active substance bromazepam – a psychotropic agent belonging to the benzodiazepine derivatives group. At low doses, it reduces nervous tension, agitation, and anxiety, and has a mild sedative effect. At higher doses, it acts as a tranquilizer and reduces muscle tension. Bromazepam has anticonvulsant properties.
Indications for the use of Sedam 3 include:

generalized anxiety disorders requiring pharmacological treatment;
autonomic nervous system disorders presenting as skin symptoms, gastrointestinal symptoms, cardiac and circulatory system symptoms, urogenital system 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 3

When not to use Sedam 3

if the patient is allergic to bromazepam, other benzodiazepines, or to 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

Sedam 3 must not be used in children and adolescents.
Warnings and precautions
Before starting treatment with Sedam 3, consult a doctor or pharmacist if the patient:

has ever had depression and (or) anxiety related to it;
has ever had such severe depression that they considered suicide;
has previously abused medicines, drugs, or alcohol, or has difficulty discontinuing their use;
has 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 3 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 dyspnoea, throat obstruction, 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, intense anxiety, tension, motor restlessness, disorientation, and irritability. In severe cases, psychiatric disturbances (derealisation, depersonalisation), hypersensitivity to sound, sensations of numbness and tingling in the limbs, hypersensitivity to light, noise, and physical contact, hallucinations, or epileptic seizures may occur.
In some patients, discontinuation of treatment may cause a transient recurrence 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 these symptoms is higher after rapid dose reduction or abrupt discontinuation of treatment. The medicine should be discontinued gradually, reducing the dose as directed by the doctor.
Medicines such as Sedam 3 (benzodiazepines) may cause memory impairment (difficulty in remembering new information), especially when used at high doses. To reduce the risk of memory impairment, the patient must have several hours of uninterrupted sleep after taking the medicine.
During treatment with medicines such as Sedam 3, motor restlessness, agitation, irritability, aggression, delusions, rage attacks, nightmares, hallucinations, psychiatric disorders, and behavioural disturbances may occur. If such symptoms occur, treatment should be discontinued and medical advice sought.
Sedam 3 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 3 and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use.
Sedam 3 and other concomitantly used medicines may interact and affect each other's actions and the occurrence of adverse effects.
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*, antihistamines, general anaesthetics);
medicines used to treat fungal infections;
macrolide antibiotics;
protease inhibitors (used, for example, 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);
medicines lowering blood pressure;
beta-adrenolytics (medicines used in hypertension and heart diseases, including propranolol);
cardiac glycosides (medicines used in heart diseases);
methylxanthines (medicines used, among others, in the treatment of asthma);
hormonal contraceptives.

* Concurrent use of Sedam 3 and opioids (strong analgesics, medicines used in substitution therapy for addiction, 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 possible.
If the doctor prescribes Sedam 3 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.
If in doubt about which medicines are listed, consult a doctor or pharmacist.
Sedam 3 and alcohol
Do not drink alcohol during treatment, 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 have a child, she should consult a doctor before using this medicine.
In infants of mothers who took bromazepam during pregnancy, an increased risk of cleft palate has been reported. Benzodiazepines used at high doses during the second and (or) third trimester of pregnancy caused reduced active fetal movements and changes in fetal heart rhythm. Use of bromazepam in the late stages of pregnancy (even at low doses) caused floppy infant syndrome with symptoms such as reduced muscle tone, sucking difficulties leading to 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 hypothermia in the newborn. Additionally, withdrawal symptoms with excessive excitability 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 must not be undertaken during treatment with this medicine.
Driving and operating machinery
During treatment with this medicine, symptoms that may adversely affect the ability to drive 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 or operate machinery.
Sedam 3 contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

3. How to use Sedam 3

This medicine should always be used according to the doctor's instructions. If in doubt, consult your
doctor or pharmacist.
The doctor determines the dose and timing of administration.
Available on the market are: Sedam 3 (3 mg) and Sedam 6 (6 mg).
Outpatient treatment
Treatment starts with a dose of 3 mg bromazepam (1 tablet of Sedam 3), taken one hour before
bedtime. If necessary, the doctor may increase the dose to 6 mg bromazepam (2 tablets of Sedam 3).
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 doctor may recommend taking 1.5 mg to
3 mg bromazepam (½ to 1 tablet of Sedam 3) during the day.
In justified cases, the doctor may increase the dose up to 12 mg bromazepam per day (4 tablets of
Sedam 3), administered in divided doses.
Hospital treatment
In severe cases, the doctor may recommend gradually increasing the dose up to 18 mg bromazepam
per day. At the beginning of treatment, the doctor will monitor whether symptoms of overdose occur,
especially in elderly patients, weakened patients, those with organic brain damage, circulatory
failure, respiratory insufficiency, or impaired liver function.
Special dosage instructions
In elderly patients, patients with organic brain damage, circulatory failure, respiratory insufficiency,
or impaired liver or kidney function, the doctor will recommend a dose equal to half of the doses
described above, i.e. 1.5 mg bromazepam (½ tablet of Sedam 3) 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 doctor. Treatment should last as short as possible.
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 doctor.
Use of a higher than recommended dose of Sedam 3
Intentional or accidental overdose of Sedam 3 rarely poses a life-threatening risk unless the medicine
has been taken simultaneously with agents that depress the central nervous system (including
alcohol).
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In case of overdose, contact a doctor or the nearest hospital immediately. Bring the medicine
packaging with you so that medical personnel can accurately determine which medicine was taken.
Symptoms of overdose may include:

drowsiness
coordination disorders
speech disturbances
nystagmus

Significant overdose may rarely cause:

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

Missed dose of Sedam 3
Do not take a double dose to make up for a missed dose.
Discontinuation of Sedam 3
Do not independently decide to stop taking Sedam 3. Only the doctor decides when to discontinue
the medicine.
If the patient intends to stop treatment with Sedam 3, they must consult the doctor, who will
recommend gradually reducing the dose.
Suddenly 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 causes withdrawal
symptoms such as headache, muscle pain, very strong anxiety, tension, motor restlessness,
confusion, and irritability.
If the patient has any doubts, the doctor will provide more detailed information on this subject.
For any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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, sexual dysfunction, 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

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

Dependence
Sudden discontinuation of bromazepam after prolonged use may cause sleep disturbances and increase the frequency of dreams. Symptoms such as anxiety, tension, excitement, and feelings 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).
Abuse and dependence
Bromazepam may lead to dependence, even after daily administration for several weeks. This applies not only to excessive doses but also to therapeutic doses.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse effects allows additional information on the safety of the medicine to be collected.

5. How to store Sedam 3

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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

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

6. Contents of the packaging and other information

What Sedam 3 contains
The active substance is bromazepam.
One tablet of Sedam 3 contains 3 mg of bromazepam.
The other ingredients are:
monohydrate lactose, povidone K 30, crospovidone, colloidal anhydrous silica, magnesium stearate.

What Sedam 3 looks like and contents of the pack
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Sedam 3 is a white, oblong tablet with 3 score lines on both sides to facilitate breaking.
Blister packs in cardboard boxes 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
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

German Marketing Authorisation Number (country of export): 3003276.00.00
Parallel Import Authorisation Number: 237/17
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