Sedam 6

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging 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 trade names for 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. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Sedam 6 is and what it is used for
2. What you need to know 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 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 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, 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 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 (marked muscle weakness).

The medicine should not be used in children and adolescents.
Warnings and precautions
Before starting treatment with Sedam 6, discuss with 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 drugs, narcotics, 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, 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 (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 patients, discontinuation of treatment may cause a transient return 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 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), particularly when used at high doses. To minimize 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 6, motor 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.

Sedam 6 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 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 concomitant medicines may interact and affect each other's actions and the occurrence of adverse effects.

This is particularly important for:

• 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 (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);
• antihypertensive medicines;
• 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 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, concurrent use of these medicines should only be considered if other treatment options are not feasible.

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 instructions. It may be helpful to inform friends or family about the risks so they are aware of the mentioned symptoms. If such symptoms occur, contact the doctor immediately.

If in doubt about which medicines are listed above, 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 or 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 at high doses during the second and (or) third trimester of pregnancy caused reduced fetal movements and changes in fetal heart rhythm. Use of bromazepam in the late stages of pregnancy (even at low doses) caused the floppy infant syndrome, characterized 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 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 be avoided 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 occur, which may adversely affect the ability to drive or operate machinery. 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 a doctor before taking this medicine.

3. How to take Sedam 6

This medicine should always be taken exactly as prescribed 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, the 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, 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 (¼ to ½ tablet of Sedam 6) during the day.
In justified cases, the doctor may increase the daily dose up to 12 mg bromazepam (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 symptoms of overdose occur, 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, the 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 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 the doctor.

Taking 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 substances that depress the central nervous system (including alcohol).
In case of overdose, seek immediate medical advice from a doctor or the nearest hospital. Bring 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 worsen, 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.

Stopping Sedam 6 treatment
Do not stop taking Sedam 6 on your own. The decision to discontinue the medicine is made exclusively by the doctor.
If the patient intends to stop treatment with Sedam 6, they must consult their 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 may cause 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 matter.
If you have any further questions about 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 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
• decreased muscle strength
• 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 feeling of fatigue may occur, as well as tremor 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 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 effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Sedam 6

• Keep this medicine out of the 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 embossing.

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

6. Contents of the pack and other information

What Sedam 6 contains
The active substance is bromazepam.
Each 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 (E 104) and indigo carmine (E 132)).

What Sedam 6 looks like and contents of the pack
Green, oblong tablets with 3 score lines facilitating breaking on both sides.
Blister packs in a cardboard box contain 30 tablets.
For more detailed information, please contact the responsible entity or parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany

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

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

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

Marketing Authorisation Number in Germany, the country of export: 7427.00.00
Parallel Import Authorisation Number: 74/22