PATIENT INFORMATION LEAFLET

Bromazepam Kern Pharma 1.5 mg capsules EFG

Bromazepam Kern Pharma 3 mg capsules EFG

Read this leaflet carefully before you start taking this medicine

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you think you are having a severe side effect or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

The active ingredient of Bromazepam Kern Pharma, bromazepam, belongs to a group of medications called benzodiazepines. Bromazepam, administered at low doses, alleviates mental tension, anxiety, and nervousness. At higher doses, it presents a sedative and muscle-relaxing effect.

Doctors prescribe Bromazepam to people who exhibit symptoms of anxiety, tension, depression, nervousness, agitation, and who have difficulty sleeping.

Some patients with anxiety or nervousness may also experience problems with their heart rate, breathing, or digestive system. Bromazepam capsules may also help alleviate these symptoms.

In most cases, only a short-term treatment with Bromazepam is needed, which should not exceed 8 to 12 weeks, including the necessary time for gradual withdrawal of the medication.

Treatment should begin with the lowest dose. The maximum dose should not be exceeded.

Do not take Bromazepam Kern Pharma

• if you are allergic (hypersensitive) to bromazepam or to any of the other components of Bromazepam (listed in section 6)
• if you are allergic (hypersensitive) to the benzodiazepine group in general,
• if you have severe respiratory difficulties,
• if you have severe liver problems,
• If you have a condition called "myasthenia gravis", which is characterized by muscle weakness and fatigue,
• If you have sleep apnea, a condition in which your breathing is irregular, and even stops for short periods while you are sleeping,
• if you suffer from drug or alcohol dependence, do not take Bromazepam unless your doctor instructs you to do so. If you have any doubts, consult your doctor,

Bromazepam Kern Pharma should not be administered to children.

Be especially careful with Bromazepam Kern Pharma

• if you have any liver or kidney disorders,
• if you suffer from muscle weakness,
• if you suffer from any respiratory disease,
• if you have other diseases,
• if you have allergies,
• if you have drug addiction or alcoholism,
• if you have or have had depression and/or attempted suicide,
• if you are taking other medications, especially painkillers and/or medications for mental health disorders.

If you are epilepticand are following a long-term treatment with Bromazepam, it is not recommended to use Anexate (flumazenil) to reverse the effect of Bromazepam, as this may cause seizures.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

This is extremely important becausethe simultaneous use of multiple medicationsmay increase or decrease their effect. Therefore, do not take other medications at the same time as Bromazepam unless your doctor is informed and approves it in advance.

For example, tranquilizers, sleep inducers, and similar medications, act on the brain and nerves and may increase the effect of Bromazepam.

The concomitant use of Bromazepam and opioids (strong painkillers, medication for substitution therapy, and some cough medications) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes this medication together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Please inform your doctor about all the opioid medications you are taking, and follow your doctor's recommended dose closely. It may be helpful to inform friends or family members to be aware of the mentioned symptoms. Contact your doctor when you experience these symptoms.

Taking Bromazepam Kern Pharma with food and drinks

During treatment, avoid alcoholic beverages. The effect of alcohol may enhance sedation and this may affect your ability to drive or operate machinery. If you need additional information on this point, consult your doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Before starting treatment, your doctor must know if you are or suspect you are pregnant or if you want to be. The doctor will then decide whether you should take Bromazepam.

If, for strict medical reasons, the product is administered during a late stage of pregnancy, it is predictable that there may be effects on the newborn such as hypothermia (abnormally low body temperature), hypotonia (loss of muscle tone), difficulty sucking, and breathing difficulties. A few days after birth, the newborn should be closely monitored for symptoms of withdrawal such as hyperexcitability, agitation, and tremors or loss of muscle tone.

Benzodiazepines are excreted through breast milk, so your doctor will decide whether you should take or not Bromazepam while breastfeeding your child.

Driving and operating machinery

Bromazepam may affect your ability to drive or operate machinery, as it may cause drowsiness, decrease your attention, or decrease your reaction time. The appearance of these effects is more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Use in children

Children should not use Bromazepam unless your doctor decides it is essential.

Studies conducted with over 200 children and adolescents, between 4 and 21 years old, with different types of anxiety, have given good results. Essentially in anxiety caused by neurosis and reactive anxiety.

Use in the elderly

The elderly may be affected by Bromazepam more than young patients. If you are elderly, your doctor may prescribe a lower dose and monitor your response to treatment. Please follow your doctor's instructions carefully.

If you have any liver or kidney disorders or suffer from muscle weakness, your doctor will decide whether you should take a lower dose of Bromazepam or not take it at all.

Important information about one of the components of Bromazepam Kern Pharma

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for Bromazepam Kern Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Depending on the nature of your illness, your age, and weight, your doctor will prescribe the appropriate dose.

Remember to take your medication.

If you have any liver or kidney disorders, if you experience breathing difficulties or suffer from muscle weakness, your doctor will decide whether you should take a lower dose of Bromazepam or not take it at all.

Follow these instructions unless your doctor has given you different instructions.

Normal doses are as follows:

The usual dose is 1.5 mg to 3 mg taken three times a day (4.5 mg – 9 mg per day).

In the case of hospitalized patients, a higher dose may be needed, but it must always be prescribed by your doctor.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

Bromazepam capsules should be taken before or with meals and should be swallowed whole without chewing with a little water or a non-alcoholic beverage.

Your doctor will indicate the duration of treatment with Bromazepam. Do not stop treatment prematurely.

Most cases require a short-term treatment with Bromazepam that should not exceed 8 to 12 weeks, including the time needed for gradual withdrawal of the medication. To avoid withdrawal symptoms, do not stop taking Bromazepam abruptly, especially if you have been taking it for a long time.

Use in children

Bromazepam should not be administered to children without a careful assessment of the need for treatment by your doctor.

Use in elderly patients

Elderly patients are more sensitive to Bromazepam than young patients. If you belong to this group, your doctor may prescribe a lower dose and monitor your response to treatment. Please follow your doctor's instructions carefully.

If you take more Bromazepam Kern Pharma than you should

The manifestation of a benzodiazepine overdose, in mild cases, usually consists of drowsiness, lethargy, and mental confusion. The ingestion of high doses, especially in combination with other central-acting substances, can cause ataxia (inability to coordinate voluntary muscle movements), hypotonia (muscle tone decrease or flaccidity), hypotension (low blood pressure), respiratory depression (slow and shallow breathing), occasionally coma, and very rarely death.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Bromazepam Kern Pharma

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Bromazepam Kern Pharma

Stopping administration may cause restlessness, anxiety, insomnia, lack of concentration, headaches, and hot flashes, especially if you have been taking it for a long time. It is not recommended to stop treatment abruptly, but rather to gradually reduce the dose according to your doctor's instructions.

Never change the dose prescribed by your doctor yourself. If you think the medication's effect is too strong or too weak, consult your doctor.

Remember that Bromazepam Kern Pharma is not indicated for long-term treatment, but rather your doctor will gradually reduce the dose over a few weeks until treatment is stopped.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Bromazepam Kern Pharma may cause side effects, although not everyone will experience them.

Most patients tolerate Bromazepam well, but during the initial treatment phase, the following side effects may be observed: confusion, drowsiness, emotional disorder, headache, dizziness, reduced alertness, ataxia (lack of coordination), diplopia (double vision), nausea, vomiting, muscle weakness, and fatigue. These symptoms usually subside as treatment continues.

The side effects that may occur during treatment with this medication, and which have been observed with an unknown frequency (cannot be estimated from available data), are:

Immune system disorders:hypersensitivity (allergy), anaphylactic shock, angioedema (swelling in the face).

Mental health disorders:Confusion, disorientation, emotional and mood alterations, libido disorders (alteration of sexual desire), physical and psychological dependence on the medication, medication abuse, withdrawal symptoms, depression (the use of this medication may reveal existing depression), restlessness, agitation, hyperactivity, nervousness, anxiety, irritability, aggressiveness, delirium, anger attacks, nightmares, abnormal dreams, hallucinations, psychosis, inappropriate behavior, and memory alterations.

Nervous system disorders:drowsiness, headache, dizziness, reduced alertness (slowness of reflexes), and ataxia (lack of coordination of movements).

Eye disorders:diplopia (double vision).

Cardiac disorders:heart failure (the heart does not pump blood well) including cardiac arrest (heart attack).

Respiratory disorders:respiratory depression (slow and shallow breathing).

Gastrointestinal disorders:nausea, vomiting, constipation, and gastrointestinal discomfort.

Skin and subcutaneous tissue disorders:cutaneous eruption, pruritus (itching), and urticaria.

Musculoskeletal disorders:muscle weakness.

Renal and urinary disorders:urinary retention.

General disorders:fatigue.

Physical injuries:falls and fractures, with a higher risk in elderly patients and patients taking other sedatives (including alcoholic beverages) at the same time.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effects not mentioned in this prospectus, inform your doctor or pharmacist.

The use of benzodiazepines can lead to physical dependence, even at therapeutic doses. This occurs mainly after taking the medication continuously for a long time. To minimize the risk of dependence, the following precautions should be taken:

• The use of benzodiazepines should only be under medical prescription (never because they have been effective in other patients) and should never be recommended to others.

• Do not increase the prescribed doses, nor prolong the treatment beyond the recommended time.

• Consult your doctor regularly to decide whether to continue treatment.

Withdrawal from treatment may lead to the development of withdrawal symptoms or rebound phenomena (reappearance of symptoms - although more pronounced - that led to the initiation of treatment), and may develop psychological dependence.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medications for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above 30 °C. Store in the original packaging to protect it from humidity.

Keep out of sight and reach of children.

Do not use Bromazepam Kern Pharma after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Bromazepam Kern Pharma Composition

• The active ingredient is bromazepam.
• The other components are: lactose monohydrate, pregelatinized cornstarch, talc, magnesium stearate, indigo carmine (E-132), erythrosine (E-127), titanium dioxide (E-171), iron oxide red, iron oxide yellow, and gelatin.

Product Appearance and Packaging Contents

Bromazepam Kern Pharma is presented in boxes containing blister packs with 30 capsules and in a clinical pack of 500 capsules.

Marketing Authorization Holder and Responsible Manufacturer

Kern Pharma, S.L.

C/ Venus 72 -Polígono Ind. Colón II

08228 Terrassa (Barcelona)

Spain

This leaflet was approved in March 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es