Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Sedam 6 (Bromazepam 6 - 1 A Pharma)
6 mg, tablets
Bromazepamum
Sedam 6 and Bromazepam 6 - 1 A Pharma are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are similar.
If you experience any adverse reactions, including those 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 drug belonging to the benzodiazepine derivatives group. In small 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 has anticonvulsant properties.

Indications for the use of Sedam 6 include:

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 (severe muscle weakness).

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

has ever had depression and (or) experienced anxiety related to it;
has ever had such severe depression that they considered 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 pseudoallergic reactions), angioedema (swelling of the skin and underlying tissues), as well as shortness of breath, throat obstruction, nausea, and vomiting may occur during treatment.
If such symptoms occur, immediate medical advice should be sought, 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, intense anxiety, tension, motor restlessness, disorientation, and irritability.
In severe cases, psychiatric disturbances (derealization, depersonalization), 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 individuals, 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 such events 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 must ensure several hours of uninterrupted sleep after taking the medicine.
During treatment with medicines such as Sedam 6, motor restlessness, agitation, irritability, aggression, delusions, anger outbursts, nightmares, hallucinations, psychiatric disturbances, and behavioural disorders may occur. If these occur, treatment should be discontinued and medical advice sought.
Sedam 6 may reduce muscle tone and cause falls with a risk of fractures, especially in elderly patients.
The duration of treatment is limited and should be determined by the doctor.
Sedam 6 and other medicines
Inform the 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 to treat fungal infections;
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 gastroesophageal reflux disease);
antihypertensive medicines;
beta-blockers (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.

* 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. Because of this, concomitant use of these medicines should only be considered when 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 recommendations. Informing friends or family members 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 listed, consult a doctor or pharmacist.
Sedam 6 and alcohol
Alcohol must not be consumed during treatment, as it may lead to excessive sedation and serious respiratory and circulatory complications.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, 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 fetal movement and changes in fetal heart rhythm. Use of bromazepam in the late stages of pregnancy (even at low doses) caused the floppy infant syndrome, with symptoms such as reduced muscle tone and sucking difficulties leading to poor weight gain. These symptoms are transient but may persist for 1 to 3 weeks. Maternal use of bromazepam at high doses may cause respiratory depression or apnoea and hypothermia in the newborn. Additionally, withdrawal symptoms with excessive excitability and tremors may be observed in the newborn several days after birth.
This medicine should be used during pregnancy only on a doctor's explicit recommendation and only in exceptional, particularly justified cases.
Bromazepam passes into human milk. Breastfeeding should not be undertaken during treatment with this medicine.
Driving and operating machinery
During treatment with this medicine, symptoms that may impair 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 few days, driving and 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

Available on the market are: Sedam 3 (3 mg) and Sedam 6 (6 mg).
This medicine should always be used as directed by the physician. In case of doubt, consult a
physician or pharmacist.
The physician determines the dosage and duration of administration.

Outpatient treatment
Treatment is initiated at 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 1.5 mg
to 3 mg bromazepam (¼ to ½ tablet of Sedam 6) during the day.
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 the patient shows symptoms
of overdose. 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,
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.
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, 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 simultaneously with agents that depress the central nervous system (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
ingested.
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 independently decide to discontinue Sedam 6. Only the physician decides when to stop the
medicine. 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, resulting in temporary worsening of anxiety
or restlessness, or difficulty falling asleep. In patients with physical dependence, abrupt cessation of
treatment causes 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 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, 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 of libido, 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
muscle weakness
somnolence, 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 feeling of fatigue may occur, as well as tremors and profuse sweating, up to somatic and psychiatric symptoms, e.g. seizures, psychosis (delirium).
Abuse potential
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 at 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 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.

6. Contents of the packaging and other information

What Sedam 6 contains
The active substance in this medicine is bromazepam.
One tablet of Sedam 6 contains 6 mg of bromazepam.
Other ingredients are:
monohydrate lactose, povidone K 30, crospovidone, colloidal anhydrous silica,
magnesium stearate, green lake (aluminium lake of hydroxide with quinoline yellow (E 104) and indigo carmine (E 132)).

What Sedam 6 looks like and contents of the pack
Sedam 6 is green, oblong tablets with three break lines on both sides to facilitate division.
Blister packs in cardboard cartons 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:
1 A Pharma GmbH, Industriestraße 18, 83607 Holzkirchen, Germany

Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

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

German Marketing Authorisation Number (country of export): 7427.00.00
Parallel Import Authorisation Number: 396/19