Sedam 6

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Sedam 6 (Bromazanil 6)
6 mg, tablets
Bromazepamum
Sedam 6 and Bromazanil 6 are different brand names of the same medicinal product.
Please read this 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Sedam 6 is and what it is used for
2. Important information before taking Sedam 6
3. How to take Sedam 6
4. Possible side effects
5. How to store Sedam 6
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 small doses, it reduces nervous tension, agitation and anxiety, and has a mild hypnotic effect. In higher doses, it acts as a sedative 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 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). The medicine 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) 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 discontinuing their use;
• has a lung, kidney, or liver disease. Daily use of the medicine for several weeks, even in small doses, may lead to psychological and physical dependence.

Repeated use of Sedam 6 over several weeks may reduce its 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, 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, restlessness, disorientation, and irritability. In severe cases, psychiatric disturbances (derealization, depersonalization), 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 individuals, stopping treatment may cause a transient return of the illness 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, reducing the dose as directed by the doctor.
Medicines such as Sedam 6 (benzodiazepines) may cause memory disturbances (difficulty in remembering new information), especially when used in high doses. To minimize the risk of memory disturbances, the patient should ensure uninterrupted sleep for several hours after taking the medicine.
During treatment with medicines such as Sedam 6, restlessness, agitation, irritability, aggression, delusions, anger outbursts, nightmares, hallucinations, psychiatric disturbances, and behavioural disorders may occur. If any of these occur, treatment should be discontinued and medical advice sought immediately.
Sedam 6 may reduce muscle tone and cause falls with risk of bone fractures, particularly 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 used, recently used, or planned to be used.
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*, antihistamines, 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 gastroesophageal reflux disease);

• antihypertensive medicines;

• beta-adrenolytics (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 addictions, 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 no other treatment options are available.
If the doctor prescribes Sedam 6 together with opioids, the dose and duration of concomitant use should be minimized.
Inform the doctor about all opioid medicines used by the patient and strictly follow dosing recommendations. It may be helpful to inform friends or family about the risks 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 a 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, 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 reported. Benzodiazepines used in high doses during the second and (or) third trimester of pregnancy have been associated with reduced fetal movement and changes in fetal heart rhythm. Use of bromazepam in the late stages of pregnancy (even in small doses) may result in floppy infant syndrome, characterized by reduced muscle tone and 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 such as excessive excitability and tremors may be observed in the newborn several days after birth.
The 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 be discontinued during treatment with this medicine.

Driving and operating machinery
During treatment with this medicine, symptoms such as sedation, memory disturbances, concentration difficulties, and reduced muscle tone may impair the ability to drive vehicles or operate machinery. Therefore, during treatment, especially in the first few days, patients should not drive or operate machinery.

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 taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Sedam 3 (3 mg) and Sedam 6 (6 mg) are available on the market.
The dose and duration of treatment are determined by the doctor.

Outpatient treatment
Treatment is initiated with a dose of 3 mg bromazepam (½ tablet of Sedam 6), taken one hour before bedtime. If necessary, your doctor may increase the dose to 6 mg bromazepam (1 tablet of Sedam 6).

The effect of the evening dose usually lasts until the following evening, so there is generally no need to take an additional dose during the day. However, if necessary, your doctor may recommend taking 1.5 mg to 3 mg bromazepam (¼ to ½ tablet of Sedam 6) during the day.

In justified cases, your doctor may increase the dose up to a maximum of 12 mg bromazepam per day (2 tablets of Sedam 6), administered in divided doses.

Hospital treatment
In severe cases, your doctor may recommend gradually increasing the dose up to 18 mg bromazepam per day. At the beginning of treatment, your doctor will monitor you for symptoms of overdose, especially in elderly patients, debilitated patients, patients 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, your doctor 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 whole with an adequate amount of liquid.

The duration of treatment is determined by the doctor. Treatment should be as short as possible. The duration of therapy should not exceed 8 to 12 weeks.

If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Use of a higher than recommended dose of Sedam 6
Intentional or accidental overdose of Sedam 6 is rarely life-threatening, unless the medicine has been taken together with agents that depress the central nervous system (including alcohol).

In case of overdose, seek immediate medical advice from your doctor or the nearest hospital.
Take the medicine packaging with you so that medical personnel can clearly identify 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 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 stop taking Sedam 6 on your own. Only your doctor decides when to discontinue the medicine.

If you intend to stop treatment with Sedam 6, you must consult your doctor, 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 you have any doubts, your doctor can provide you with more detailed information.

If you have any further questions regarding the use of this medicine, consult your doctor 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, 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 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
• decreased muscle strength
• somnolence, headache, dizziness, reduced alertness, movement disorders
• respiratory depression
• rash, itching, urticaria

Tolerance
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 tremor and profuse sweating, up to somatic and psychiatric symptoms, such as seizures and psychosis (delirium).
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 administration at therapeutic doses.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables the collection of further information on the safety of the medicine.

5. How to store Sedam 6

• Keep the medicine out of sight and reach of children.
• Do not store above 30℃.
• 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 some information on the immediate packaging: Ch.-B./verwendbar bis: siehe Prägung - batch number/expiry date: see imprint.
• 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 is bromazepam.
One tablet of Sedam 6 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, elongated tablets with 3 notches on both sides facilitating division.
Blister packs in a cardboard box contain 30 tablets.
For more detailed information, please contact the responsible party or parallel importer.

Responsible party 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
Haupt Pharma AG, Moosrosenstr. 7/13, 12347 Berlin, Germany

Parallel importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing authorisation number in Germany, the country of export: 4725.00.00
Parallel import authorisation number: 48/18