SEDAM 3

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Sedam 3 (Bromazanil 3)
3 mg, tablets
Bromazepamum
Sedam 3 and Bromazanil 3 are different trade names for the same medicinal product.
Please read the following leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• 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. It may harm them even if their symptoms are identical.
• 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:

1. What Sedam 3 is and what it is used for
2. What you need to know before taking Sedam 3
3. How to take Sedam 3
4. Possible side effects
5. How to store Sedam 3
6. Contents of the pack and other information

1. What Sedam 3 is and what it is 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 hypnotic effect. At higher doses, it produces sedation and reduces muscle tension. Bromazepam has anticonvulsant properties.

Sedam 3 is indicated for:

• Generalized anxiety disorders requiring pharmacological treatment;
• Autonomic nervous system disorders presenting as skin symptoms, gastrointestinal symptoms, cardiovascular 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 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 (marked muscle weakness).

The medicine should 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 thought about taking their own life;
• has previously abused medicines, drugs or alcohol, or finds it difficult to stop using them;
• 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 3 over several weeks may result in reduced effectiveness.
During treatment, severe allergic reactions (so-called anaphylactic or pseudoanaphylactic reactions), angioedema (swelling of the skin and underlying tissues), as well as shortness of breath, throat obstruction, nausea and vomiting may occur.
If such symptoms occur, medical advice should be sought immediately, as urgent medical assistance 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 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, discontinuation of treatment may cause a transient 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 occurring 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 3 (benzodiazepines) may cause memory disturbances (difficulty in remembering new information), particularly 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 3, motor restlessness, excitement, irritability, aggression, delusions, anger attacks, nightmares, hallucinations, psychiatric disorders and behavioural disturbances may occur. If these occur, treatment should be discontinued and medical advice sought.
Sedam 3 may reduce muscle tone and cause falls with risk of bone fractures, especially in elderly patients.
The duration of treatment is limited and should be 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 with each other, affecting their 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 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.

* Concomitant use of Sedam 3 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, concomitant 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 recommendations. Informing friends or family about the risks may be helpful, so they are aware of the symptoms mentioned. 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, breastfeeding, suspects she may be pregnant, or is planning 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 observed. 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 last from 1 to 3 weeks. High-dose maternal use of bromazepam may cause respiratory depression or absence of breathing and reduced body temperature in the newborn. Furthermore, 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, in exceptional and particularly justified cases.
Bromazepam passes into breast milk. Breastfeeding should not be performed during treatment with this medicine.
Driving and operating machinery
During treatment with this medicine, symptoms may occur that negatively affect the ability to drive vehicles or operate machinery: sedation, memory disturbances, concentration difficulties and reduced muscle tone. Therefore, during treatment, especially in the first days, driving vehicles or operating machinery should be avoided.
Sedam 3 contains monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medicine.

3. How to use Sedam 3

Sedam is available in the following doses: 3 mg, 6 mg.
This medicine should always be used according to the doctor's instructions. If in doubt, consult a
doctor or pharmacist.
The dose and timing of administration are determined by the doctor.

Outpatient treatment
Treatment starts with a dose of 3 mg bromazepam (1 tablet of Sedam 3 or ½ tablet of Sedam 6), taken one hour before bedtime. If necessary, the doctor may increase the dose to 6 mg bromazepam (2 tablets of Sedam 3 or 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 doctor may recommend taking 1.5 mg to 3 mg bromazepam during the day (from ½ to 1 tablet of Sedam 3 or from ¼ to ½ tablet of Sedam 6).
In justified cases, the doctor may increase the dose up to 12 mg bromazepam per day (4 tablets of Sedam 3 or 2 tablets of Sedam 6), 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 the patient shows symptoms of overdose. This especially applies to elderly patients, weakened patients, those with organic brain damage, circulatory failure, respiratory failure, and impaired liver function.

Special dosing instructions
For elderly patients, patients with organic brain damage, circulatory failure, respiratory failure, 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 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 a 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 central nervous system depressants (including alcohol).
In case of overdose, contact a doctor or the nearest hospital immediately. The medicine packaging should be brought along so that medical personnel can accurately determine 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 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 a doctor decides when to discontinue the medicine.
If the patient intends to stop treatment with Sedam 3, they must consult a 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, severe anxiety, tension, motor restlessness, confusion, and irritability.
If the patient has any doubts, the doctor will provide more detailed information on this subject.
In case of any further doubts 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 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
• drowsiness, 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 increase the frequency of dreams. Symptoms such as restlessness, 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 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows the collection of additional information on the safety of the medicine.

5. How to store Sedam 3

• Keep the medicine out of sight and reach of children.
• Do not store above 30°C.
• Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
• Translation of the labels on the immediate packaging: 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. This will help protect the environment.

6. Contents of the packaging and other information

What Sedam 3 contains
The active substance is bromazepam.
Each tablet 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
White, elongated tablets with 3 score lines on both sides to facilitate breaking.
Blister packs in a cardboard box contain 30 tablets.

For more detailed information, please contact the responsible party 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 by:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58
87-100 Toruń
Poland

German Marketing Authorisation Number (country of export): 3003276.00.00
Parallel Import Licence Number: 303/19