Bromazepam Kern Pharma 3 mg capsules EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Bromazepam Kern Pharma 1.5 mg capsules EFG
Bromazepam Kern Pharma 3 mg capsules EFG
Read the entire 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 other people, even if they have the same symptoms, as it may harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Bromazepam Kern Pharma is and what it is used for
- What you need to know before taking Bromazepam Kern Pharma
- How to take Bromazepam Kern Pharma
- Possible side effects
- How to store Bromazepam Kern Pharma
- Contents of the pack and other information
1. What Bromazepam Kern Pharma is and what it is used for
The active substance in Bromazepam Kern Pharma, bromazepam, belongs to a group of medicines called benzodiazepines. When administered at low doses, bromazepam relieves psychological tension, anxiety, and nervousness. At higher doses, it has a sedative and muscle-relaxant effect.
Doctors prescribe Bromazepam for people experiencing symptoms of anxiety, tension, depression, nervousness, agitation, and difficulty sleeping.
Some patients with anxiety or nervousness may also experience problems with heart rhythm, breathing, or digestion. Bromazepam capsules may also help relieve these symptoms.
In most cases, only short-term treatment with Bromazepam is needed, which should not exceed 8 to 12 weeks, including the time required for gradual withdrawal of the medication.
Treatment should be initiated at the lowest dose. The maximum dose must not be exceeded.
2. Before taking Bromazepam Kern Pharma
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 benzodiazepines in general,
- if you have severe respiratory difficulties,
- if you suffer from 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 condition in which your breathing is irregular and even stops briefly during sleep,
- if you are dependent on drugs or alcohol, you should not take Bromazepam unless your doctor specifically instructs you to. If you have any doubts about this, consult your doctor.
Bromazepam Kern Pharma must not be administered to children.
Take special care with Bromazepam Kern Pharma
- if you have liver or kidney disorders,
- if you suffer from muscle weakness,
- if you have respiratory diseases,
- if you suffer from other illnesses,
- if you have allergies,
- if you have drug addiction or alcoholism problems,
- if you have or have had depression and/or have attempted suicide,
- if you are taking other medicines, especially painkillers (analgesics) and/or medicines for mental disorders.
If you are epileptic and are undergoing long-term treatment with Bromazepam, the use of Anexate (flumazenil) to reverse the effect of Bromazepam is not recommended, as seizures may occur.
Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to interrupt or adjust the dosage of one of them.
This is extremely important because taking more than one medicine at the same time may increase or decrease its effect. Therefore, you should not take other medicines simultaneously with Bromazepam unless your doctor is aware and has approved it beforehand.
For example, sedatives, sleep-inducing medicines, and similar drugs act on the brain and nerves and may increase the effect of Bromazepam.
The concomitant use of Bromazepam and opioids (strong analgesics, medications for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may even be fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes this medicine together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Please inform your doctor about all opioid medicines you are taking, and closely follow your doctor's dosing recommendations. It may be helpful to inform friends or family members so they can watch for the symptoms mentioned above. Contact your doctor if you experience such symptoms.
Taking Bromazepam Kern Pharma with food and drinks
During treatment, avoid alcoholic beverages. The effect of alcohol may enhance sedation, which can affect your ability to drive or operate machinery. If you need further information on this point, consult your doctor.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Before starting treatment, your doctor must know whether you are pregnant or suspect you are pregnant, or if you intend to become pregnant. Your doctor will then decide whether it is appropriate for you to take Bromazepam.
If the product is administered during a late stage of pregnancy due to strict medical necessity, effects on the newborn such as hypothermia (abnormally low body temperature), hypotonia (loss of muscle tone), difficulty sucking, and breathing difficulties may be expected. A few days after birth, the newborn should be closely monitored for withdrawal symptoms such as hyperexcitability, agitation, tremors, or loss of muscle tone.
Benzodiazepines are excreted in breast milk; therefore, your doctor will decide whether you should take Bromazepam while breastfeeding.
Driving and using machines
Bromazepam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or decrease reaction capacity. These effects are more likely to occur 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 the doctor decides it is essential.
Studies conducted in over 200 children and adolescents aged 4 to 21 years with various types of anxiety have shown good results, particularly in anxiety caused by neurosis and reactive anxiety.
Use in elderly
Elderly patients 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 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 some of the components of Bromazepam Kern Pharma
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Bromazepam Kern Pharma
Follow exactly the instructions for taking Bromazepam Kern Pharma as given by your doctor. If you have any doubts, consult your doctor or pharmacist.
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, breathing difficulties, or suffer from muscle weakness, your doctor will decide whether you should take a lower dose of Bromazepam or should 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 daily (4.5 mg – 9 mg per day).
In patients who have been hospitalized, a higher dose may be required, but it must always be prescribed by the doctor.
Each individual dose must not exceed the indicated limits, nor should the total daily dose, unless your doctor prescribes a higher dose.
Bromazepam capsules should be taken before or with meals and must be swallowed whole, without chewing, with a little water or a non-alcoholic drink.
Your doctor will advise you on how long your treatment with Bromazepam should last. Do not stop the treatment prematurely.
In most cases, a short-term treatment with Bromazepam is required, which should not exceed 8 to 12 weeks, including the time needed for gradual withdrawal of the medication. To avoid withdrawal symptoms, you must not stop taking Bromazepam abruptly, especially if you have been taking it for a long time.
Use in children
Bromazepam must not be administered to children unless your doctor has carefully assessed the need for treatment.
Use in elderly patients
Elderly patients are more sensitive to Bromazepam than younger patients. If you belong to this patient group, your doctor may prescribe you 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 signs of a benzodiazepine overdose, in mild cases, usually include drowsiness, lethargy, and mental confusion. Ingestion of high doses, especially in combination with other centrally-acting substances, may cause ataxia (inability to coordinate voluntary muscle movements), hypotonia (reduced muscle tone or floppiness), hypotension (low blood pressure), respiratory depression (slow and shallow breathing), occasionally coma, and very rarely death.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 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 make up for missed doses.
If you stop treatment with Bromazepam Kern Pharma
When stopping treatment, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flushes may occur, especially if you have been taking it for a long time. Abrupt discontinuation of the medication is generally not recommended; instead, the dose should be gradually reduced according to your doctor's instructions.
Never change the prescribed dose on your own. If you think the effect of the medicine is too strong or too weak, consult your doctor.
Remember that Bromazepam Kern Pharma is not intended for long-term treatment. After a few weeks of treatment, your doctor will gradually reduce the dose until treatment is stopped.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Bromazepam Kern Pharma may produce adverse effects, although not everyone experiences them.
Most patients tolerate Bromazepam well, but at the beginning of treatment the following adverse effects may occur: confusion, drowsiness, emotional disturbance, 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 adverse effects that may occur during treatment with this medicine, which have been observed with unknown frequency (cannot be estimated from available data), are:
Immune system disorders: hypersensitivity (allergy), anaphylactic shock, angioedema (swelling of the face).
Psychiatric disorders: confusion, disorientation, emotional and mood disturbances, libido disorders (altered sexual desire), physical and psychological dependence on the medicine, medicine abuse, withdrawal symptoms, depression (use of this medicine may unmask a pre-existing depression), restlessness, agitation, hyperactivity, nervousness, anxiety, irritability, aggressiveness, delirium, rage attacks, nightmares, abnormal dreams, hallucinations, psychosis, inappropriate behavior, and memory disturbances.
Nervous system disorders: drowsiness, headache, dizziness, reduced alertness (slowed reflexes), and ataxia (lack of motor coordination).
Eye disorders: diplopia (double vision).
Cardiac disorders: cardiac failure (heart does not pump blood properly), 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.
Injury-related disorders: falls and fractures, with increased risk in elderly patients and in patients taking other sedatives simultaneously (including alcoholic beverages).
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
The use of benzodiazepines may lead to physical dependence, even at therapeutic doses. This occurs mainly after prolonged uninterrupted use of the medicine. To minimize the risk of dependence as much as possible, the following precautions should be observed:
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Benzodiazepines should only be taken under medical prescription (never because they worked in other patients), and should never be recommended to other people.
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Do not increase the doses prescribed by the doctor, or prolong the treatment beyond the recommended duration.
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Consult your doctor regularly so they can decide whether treatment should continue.
Discontinuation of treatment may lead to withdrawal or rebound phenomena (reappearance of symptoms that led to initiating treatment, although more pronounced), and may result in psychological dependence.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 packaging to protect from moisture.
Keep out of the sight and reach of children.
Do not use Bromazepam Kern Pharma after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Additional information
Composition of Bromazepam Kern Pharma
- The active substance is bromazepam.
- The other components are: monohydrate lactose, pregelatinized corn starch, talc, magnesium stearate, indigo carmine (E-132), erythrosine (E-127), titanium dioxide (E-171), red iron oxide, yellow iron oxide, and gelatin.
Appearance of the product and contents of the container
Bromazepam Kern Pharma is presented in boxes containing 30 capsules in blister packs, and in hospital pack of 500 capsules.
Marketing Authorization Holder and Manufacturer
Kern Pharma, S.L.
C/ Venus 72 - Polígono Ind. Colón II
08228 Terrassa (Barcelona)
Spain
This patient information leaflet was approved in March 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es