BROMAZEPAM KERN PHARMA 3 mg CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bromazepam Kern Pharma 1.5 mg hard capsules EFG

Bromazepam Kern Pharma 3 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Bromazepam Kern Pharma and what is it used for
2. What you need to know before you take Bromazepam Kern Pharma
3. How to take Bromazepam Kern Pharma
4. Possible side effects
5. Storage of Bromazepam Kern Pharma
6. Contents of the pack and other information

1. What is Bromazepam Kern Pharma and what is it used for

The active substance in Bromazepam Kern Pharma, bromazepam, belongs to a group of medicines called benzodiazepines. Bromazepam, when administered at low doses, relieves mental tension, anxiety, and nervousness. At higher doses, it has a sedative and muscle relaxant effect.

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

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

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

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

2. Before taking Bromazepam Kern Pharma

Do not take Bromazepam Kern Pharma

• if you are allergic (hypersensitive) to bromazepam or any of the other ingredients of Bromazepam (listed in section 6)
• if you are allergic (hypersensitive) to the group of benzodiazepines in general
• if you have severe breathing difficulties
• if you have severe liver problems
• If you have a disease called "myasthenia gravis", which is characterized by muscle weakness and fatigue
• If you have sleep apnea, a disease in which your breathing is irregular and even interrupted for short periods while you are sleeping
• if you are dependent on drugs or alcohol, you should not take Bromazepam unless your doctor has formally indicated it. If you have any doubts about this, consult your doctor

Bromazepam Kern Pharma should not be given to children.

Be careful with Bromazepam Kern Pharma

• if you have any liver or kidney disorder
• if you have muscle weakness
• if you have any respiratory disease
• if you have other diseases
• if you have allergies
• if you have problems with drug addiction or alcoholism
• if you have had depression and/or have attempted suicide
• if you are taking other medicines, especially painkillers (analgesics) and/or medicines for mental illnesses

If you are epileptic and are undergoing long-term treatment with Bromazepam, it is not recommended to use Anexate (flumazenil) to reverse the effect of Bromazepam, as convulsions may occur.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, 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 because the simultaneous use of more than one medicine can increase or decrease its effect. Therefore, you should not take other medicines at the same time as Bromazepam unless your doctor is informed and approves it beforehand.

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

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

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

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

Taking Bromazepam Kern Pharma with food and drinks

During treatment, avoid alcoholic beverages. The effect of alcohol can enhance sedation and this can 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 medicine.

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

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

Benzodiazepines are excreted in breast milk, so your doctor will decide whether you should take Bromazepam while breastfeeding your child.

Driving and using machines

Bromazepam can affect your ability to drive or operate machinery, as it can cause drowsiness, reduce your attention, or reduce your reaction time. The appearance of these effects is more likely at the start 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 the doctor decides it is essential.

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

Use in the elderly

The elderly may be more affected by Bromazepam than younger 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 disorder 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 some of the ingredients of Bromazepam Kern Pharma

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

3. How to take Bromazepam Kern Pharma

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

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

Remember to take your medicine.

If you have any liver or kidney disorder, if you have 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 ones.

The usual doses are as follows:

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

In the case of patients who have been hospitalized, a higher dose may be needed, but it should always be prescribed by the 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 and not chewed with a little water or a non-alcoholic drink.

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

In most cases, short-term treatment with Bromazepam is needed, which should not exceed 8 to 12 weeks, including the time needed for gradual withdrawal from the medication. To avoid withdrawal symptoms, you should 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 their doctor having made a careful assessment of the need for treatment.

Use in elderly patients

Elderly patients are more sensitive to Bromazepam than younger patients. If you belong to this group of patients, 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. Ingestion of high doses, especially in combination with other central-acting substances, can cause ataxia (inability to coordinate voluntary muscle movements), hypotonia (decreased muscle tone 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 medicine and the amount ingested.

If you forget to take Bromazepam Kern Pharma

Do not take a double dose to make up for forgotten doses.

If you stop taking Bromazepam Kern Pharma

When stopping treatment, restlessness, anxiety, insomnia, lack of concentration, headache, and hot flashes may appear, especially if you have been taking it for a long time. It is not recommended to interrupt treatment abruptly, but rather to gradually reduce the dose, according to the doctor's instructions.

Never change the dose that has been prescribed for you. If you think the effect of the medicine is too strong or too weak, consult your doctor.

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

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

4. Possible side effects

Like all medicines, Bromazepam Kern Pharma can cause side effects, although not everybody gets them.

Most patients tolerate Bromazepam well, but at the beginning of treatment, 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 disappear with continued treatment.

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

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

Psychiatric disorders: confusion, disorientation, emotional changes and mood swings, libido disorders (alteration of sexual desire), physical and psychological dependence on the medicine, abuse of the medicine, withdrawal symptoms, depression (the use of this medicine may cause a pre-existing depression to appear), restlessness, agitation, hyperactivity, nervousness, anxiety, irritability, aggressiveness, delirium, fits of rage, nightmares, abnormal dreams, hallucinations, psychosis, inappropriate behavior, and memory changes.

Nervous system disorders: drowsiness, headache, dizziness, reduced alertness (slowness in 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: skin rash, pruritus (itching), and urticaria.

Musculoskeletal disorders: muscle weakness.

Renal and urinary disorders: urinary retention.

General disorders: fatigue.

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

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

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

• The use of benzodiazepines will only be done under medical prescription (never because they have worked for other patients) and will never be recommended to other people.

• Do not increase the prescribed doses in any way, nor prolong treatment for longer than recommended.

• Consult your doctor regularly so that he can decide whether treatment should be continued.

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bromazepam Kern Pharma

Do not store above 30°C. Keep in the original package to protect from moisture.

Keep out of the sight and reach of children.

Do not use Bromazepam Kern Pharma after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This way, you will help protect the environment.

6. Additional information

Composition of Bromazepam Kern Pharma

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

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

C/ Venus 72 -Polígono Ind. Colón II

08228 Terrassa (Barcelona)

Spain

This leaflet was approved in March 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es