Bromox

Leaflet attached to the packaging: patient information

Bromox, 3 mg, hard capsules

Bromox, 6 mg, hard capsules

Bromazepam

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Bromox and what is it used for

The active substance of Bromox is bromazepam, which belongs to a group of medicines called benzodiazepines.
Bromox is used to treat:

• anxiety disorders;
• supportive treatment of symptoms of anxiety accompanying mental disorders, such as mood changes or schizophrenia.

Benzodiazepines are used only when the disorder is severe, prevents the patient from functioning or exposes them to strong anxiety.

2. Important information before taking Bromox

When not to take Bromox

• if you are allergic to bromazepam or any of the other ingredients of this medicine (listed in section 6) or other benzodiazepine medicines;
• if you have severe breathing difficulties or lung disease;
• if you have severe muscle weakness;
• if you have severe liver function disorders;
• if you have a disease called "sleep apnea syndrome" (pauses in breathing during sleep).

Warnings and precautions

Before starting to take Bromox, discuss it with your doctor or pharmacist.

• if you have any liver, kidney, or lung function disorders;
• if you have muscle weakness;
• if you have any other disease, such as depression;
• if you abuse alcohol or drugs.

Children

Bromox should not be used in children.

Bromox and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
Especially tell your doctor or pharmacist about taking such medicines as:

• medicines used to treat mental disorders (such as diazepam);
• sleeping pills (such as zolpidem);
• antihistamines that cause drowsiness (such as difenhydramina);
• antiepileptic drugs (such as clozapine);
• cimetidine (used to treat stomach disorders and heartburn);
• propranolol (used to treat high blood pressure, tremors, and chest pain);
• fluvoxamine (used to treat obsessive-compulsive disorders and anxiety);
• strong painkillers (such as morphine);
• strong medicines used to treat infections, including HIV virus (e.g. protease inhibitors).

Taking Bromox with opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use should only be considered when other treatment methods are not possible.
If your doctor has prescribed Bromox with opioids, use the smallest effective dose, and the treatment duration should be as short as possible.
Tell your doctor about all opioid medicines you are taking and strictly follow your doctor's instructions. It may be helpful to inform your friends or relatives about the possibility of the above symptoms. If such symptoms occur, contact your doctor.

Bromox with food and drink

Avoid drinking alcohol during treatment. Alcohol can enhance the sedative effect of the medicine, which can cause severe breathing difficulties or heart problems. For more information, contact your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you should take Bromox.
Bromazepam passes into breast milk. Therefore, your doctor will decide whether you should take Bromox during breastfeeding or not.

Driving and using machines

Bromox may affect your ability to drive and use machines, as it can cause drowsiness, reduced alertness, and reduced reaction ability.
These symptoms are more likely to occur at the beginning of treatment or after increasing the dose. Do not drive or operate machines if you experience such symptoms.

Use in elderly patients

Bromox may have a greater effect on elderly patients than on younger patients.
Your doctor may prescribe a lower dose and monitor your response to treatment. Follow your doctor's instructions carefully.

Bromox contains lactose, cochineal red (E 124), and orange yellow (E 110 [only 3 mg capsule]).

Lactose: If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.
Cochineal red (E 124) and orange yellow (E 110 [only 3 mg capsule]): The medicine may cause allergic reactions.

3. How to take Bromox

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will prescribe the correct dose, depending on the type of disease and your age and weight.
Your doctor will recommend the lowest effective dose.
Swallow the capsules whole with a glass of water or a non-alcoholic drink.
The usual dose of Bromox is 1.5 mg to 3 mg, three times a day (4.5 mg - 9 mg per day). In most cases, only a short treatment period with Bromox is necessary.
Usually, the medicine will be used for no longer than 12 weeks.
In elderly patients or patients with liver or kidney function disorders, your doctor may prescribe a lower dose of the medicine.

Use in children

Bromox is not recommended for use in children under 12 years of age.

Taking a higher dose of Bromox than recommended

If you or anyone else has taken a higher dose of Bromox than recommended, contact your doctor immediately. In mild cases, symptoms of benzodiazepine overdose may include drowsiness, lack of coordination, slurred speech, or rapid eye movements. Taking large doses, especially in combination with other substances that act on the central nervous system, can cause ataxia, loss of reflexes, apnea, hypotension, respiratory depression, and, in single cases, coma.

Missing a dose of Bromox

Do not take a double dose to make up for a forgotten dose. Continue treatment with the usual recommended dose.

Stopping treatment with Bromox

Restlessness, anxiety, muscle pain, diarrhea, and headache may occur, especially if you have been taking the medicine for a long time. Generally, it is not recommended to stop treatment abruptly. Gradually reduce the dose of the medicine according to your doctor's instructions.
Never change the prescribed dose yourself. If you feel that the effect of the medicine is too strong or too weak, contact your doctor.
Remember that Bromox is not intended for long-term treatment. After a few weeks of treatment, your doctor will reduce the dose until you stop taking the medicine.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Bromox and contact your doctor immediately if you experience any of the following serious side effects – urgent medical attention may be required:

• Severe allergic reactions. Symptoms may include:
• Sudden swelling of the throat, face, lips, and tongue, which may cause difficulty breathing or swallowing.
• Sudden swelling of the hands, feet, and ankles.
• Rash and itching of the skin.
• Heart disorders, including heart failure (symptoms may include: shortness of breath, swelling of the ankles, cough, fatigue, and rapid heartbeat) and cardiac arrest.
• Breathing difficulties (respiratory depression). Early symptoms include: sudden, loud, heavy, and uneven breathing. The skin may turn blue.
• Feeling of restlessness, aggression, anger, irritability, or excitement.
• Nightmares and seeing or hearing things that do not really exist (hallucinations).
• Psychiatric disorders, such as delusions (believing in things that are not true) or loss of contact with reality.
• Abnormal changes in behavior.

The following side effects may occur at the beginning of treatment with Bromox:

• sedation, drowsiness, and feeling of fatigue
• reduced or absent emotional sensation
• reduced alertness
• feeling of disorientation
• headache
• dizziness
• nausea and vomiting
• muscle weakness
• coordination disorders, including ataxia (feeling of uncertainty while walking)
• vision disorders (double vision)

These symptoms usually disappear after some time. If you are unsure, talk to your doctor.

The following side effects may occur at any time during treatment:

• difficulty remembering new things, possibly accompanied by changed or strange behavior
• depression
• constipation
• skin rashes, itching, and redness
• increased or decreased interest in sex
• difficulty urinating

Injuries:

Patients taking benzodiazepine medicines have an increased risk of falls and fractures.
This risk is higher in elderly patients and patients taking other sedative medicines (including alcohol).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Bromox

Keep the medicine out of the sight and reach of children.
Store the medicine at a temperature below 30°C.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date (EXP)". The expiry date refers to the last day of the month.
Medicines should 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 pack and other information

What Bromox contains

• The active substance of Bromox is bromazepam. Each capsule contains 3 mg or 6 mg of bromazepam.
• The other ingredients of the medicine are: Capsule contents:lactose monohydrate, corn starch, colloidal silica anhydrous, magnesium stearate Capsule shell:gelatin, titanium dioxide (E 171), cochineal red (E 124), orange yellow (E 110) (only 3 mg capsule) and black iron oxide (E 172) (only 6 mg capsule)

What Bromox looks like and contents of the pack

3 mg: Orange-red hard capsule, size 4, containing white or yellowish powder.
6 mg: Grey-pink hard capsule, size 4, containing white or yellowish powder.
Pack sizes: 30 capsules in blister packs.

Marketing authorization holder and manufacturer

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
Laboratorios Normon S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]
Date of last revision of the leaflet:29.08.2022