Package leaflet: Information for the patient

Bromox, 3 mg, hard capsules
Bromox, 6 mg, hard capsules
Bromazepamum
Please read this leaflet carefully before using this medicine because it contains important information for you.

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 share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What is Bromox and what is it used for?
Important information before taking Bromox
How to take Bromox
Possible side effects
How to store Bromox
Contents of the package and other information

1. What is Bromox and what is it used for?

The active substance in Bromox is bromazepam, which belongs to a group of medicines called benzodiazepines.
Bromox is used for the treatment of:

anxiety states;
as adjunctive treatment of anxiety symptoms associated with psychiatric disorders such as mood disorders or schizophrenia.

Benzodiazepines are used only when the disorder is severe, impairs the patient's functioning, or exposes the patient to intense anxiety.

2. Important information before using Bromox

When not to use Bromox

if the patient is allergic to bromazepam or to any of the other ingredients of this medicine (listed in section 6), or to other medicines from the benzodiazepine group;
if the patient has severe breathing problems or lung disease;
if the patient has severe muscle disorders;
if the patient has severe liver function impairment;
if the patient suffers from a condition called "sleep apnoea syndrome" (interruptions in breathing during sleep).

Warnings and precautions
Before starting to take Bromox, discuss this with your doctor or pharmacist.

if the patient has any liver, kidney or lung function disorders;
if the patient has muscle weakness;
if the patient has any other illness, e.g. depression;
if the patient abuses alcohol or medicines.

Children
Bromox must not be used in children.
Bromox and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

medicines used to treat mental disorders (such as diazepam);
sleeping medicines (such as zolpidem);
antihistamines causing drowsiness (such as diphenhydramine);
antiepileptic medicines (such as clozapine);
cimetidine (used to treat stomach disorders and heartburn);
propranolol (used to treat high blood pressure, tremor, 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 infection (e.g. protease inhibitors).

Concomitant use of Bromox with opioids (strong painkillers, medicines used in substitution treatment, and some antitussive medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.
If your doctor has prescribed Bromox together with opioids, use the lowest effective dose and keep the duration of treatment as short as possible.
Inform your doctor about all opioid medicines the patient is taking and strictly follow the doctor's instructions. It may be helpful to inform friends or relatives about the possibility of the above-mentioned symptoms occurring in the patient. If such symptoms occur, contact your doctor immediately.
Bromox with food and drink
Avoid drinking alcohol during treatment. Alcohol may intensify the sedative effect of the medicine, which could lead to severe breathing problems or heart complications. For further information on this topic, consult your doctor.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The doctor will decide whether the patient should take Bromox.
Bromazepam passes into breast milk. Therefore, the doctor will decide whether the patient should take Bromox during breastfeeding or discontinue its use during this period.
Driving and operating machinery
Bromox may affect the ability to drive and operate machinery, as it may cause drowsiness, reduced alertness, and impaired reaction ability.
These effects are more likely at the beginning of treatment or after an increase in dose. Do not drive or operate machinery if such symptoms occur.
Use in elderly patients
Bromox may have a greater effect in elderly patients than in younger patients. The doctor may prescribe a lower dose and monitor the patient's response to treatment. Follow the doctor's instructions exactly.
Bromox contains lactose, cochineal red (E 124), and orange yellow (E 110 [only in 3 mg capsules]).
Lactose: If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Cochineal red (E 124) and orange yellow (E 110 [only in 3 mg capsules]): This medicine may cause allergic reactions.

3. How to use Bromox

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The doctor will prescribe the appropriate dose depending on the type of illness and the patient's age and body weight.
The doctor will recommend the lowest effective dose.
Bromox capsules should be swallowed whole, without chewing, with a sufficient amount of water or
a non-alcoholic drink.
The usual dose of Bromox is 1.5 mg to 3 mg, three times daily (4.5 mg – 9 mg per day). In most cases,
treatment with Bromox is required only for a short duration.
Typically, the medicine should not be used for longer than 12 weeks.
In elderly patients or patients with impaired liver or kidney function, the doctor will recommend
a lower dose of the medicine.
Use in children
The use of Bromox is not recommended in children under 12 years of age.
Taking more Bromox than recommended
If a patient or anyone else takes more Bromox than recommended, contact a doctor immediately.
In mild cases, symptoms of benzodiazepine overdose usually include drowsiness, lack of coordination,
slurred speech, or rapid eye movements. Taking large doses, especially in combination with other
substances acting on the central nervous system, may cause ataxia, loss of reflexes, apnea,
arterial hypotension, respiratory depression, and, in rare cases, coma.
Missed dose of Bromox
Do not take a double dose to make up for a missed dose. Continue treatment with the usual recommended dose.
Stopping Bromox
Anxiety, tension, muscle pain, diarrhea, and headache may occur, especially if the patient has been taking
the medicine for a long time. Generally, abrupt discontinuation of treatment is not recommended.
The dose should be gradually reduced according to the doctor's instructions.
Never change the prescribed dose independently. If you feel the medicine's effect is too strong or too weak,
consult your doctor.
Keep in mind that Bromox is not intended for long-term treatment. After several weeks of treatment,
the doctor will gradually reduce the dose until the medicine is discontinued.
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 will experience them.
You should stop taking Bromox and contact your doctor immediately if any of the following serious adverse reactions occur –
urgent medical attention may be required:

Severe allergic reactions. Symptoms may include:
Sudden swelling of the throat, face, lips and mouth, which may cause difficulty breathing or swallowing.
Sudden swelling of hands, feet and ankles.
Skin rash and itching.
Heart disorders, including heart failure (symptoms may include: shortness of breath, swelling of the ankles, cough, fatigue and rapid heartbeat) and cardiac arrest.
Breathing disorders (respiratory depression). Early symptoms include: sudden loud, laboured and irregular breathing. The skin may turn blue.
Feelings of anxiety, aggression, anger, irritability or agitation.
Nightmares and seeing or possibly hearing things that are not real (hallucinations).
Psychiatric disorders such as delusions (believing in things that are not true) or loss of contact with reality.
Unnatural changes in behaviour.

The following adverse reactions may occur at the beginning of treatment with Bromox:

Calmness, drowsiness and feeling tired
Reduced sensation or lack of emotional feeling
Reduced alertness
Feeling disoriented
Headache
Dizziness
Nausea and vomiting
Muscle weakness
Coordination disorders, including ataxia (feeling unsteady while walking)
Visual disturbances (double vision)

These symptoms usually resolve after some time. If in doubt, talk to your doctor.
The following adverse reactions may occur at any time during treatment:

Difficulty remembering new things, along with possible changes in behaviour or unusual behaviour
Depression
Constipation
Skin rashes, itching and redness of the skin
Increased or decreased interest in sex
Difficulty passing urine

Injuries:
Patients taking medicines from the benzodiazepine group are at risk of falls and bone fractures.
This risk is higher in elderly patients and in patients taking other sedative medicines (including alcohol).
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Bromox

Keep this medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Bromox contains

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

What Bromox looks like and contents of the pack
3 mg: Orange-red, hard capsule of size 4, containing white or yellowish powder.
6 mg: Grey-pink, hard capsule of size 4, containing white or yellowish powder.

Pack sizes
30 capsules in blister packs.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation 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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]