Bromazepam Normon 6 mg hard capsules EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Bromazepam NORMON 6 mg hard capsules EFG
Bromazepam
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 and should not be given to others, even if they have the same symptoms, as it may harm them.
- If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- WHAT bromazepam NORMON IS AND WHAT IT IS USED FOR
- BEFORE TAKING bromazepam NORMON
- HOW TO TAKE bromazepam NORMON
- POSSIBLE SIDE EFFECTS
- STORAGE OF bromazepam NORMON
- ADDITIONAL INFORMATION
1. What Bromazepam Normon is and what it is used for
The active substance in Bromazepam Normon, 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 Normon for people who experience symptoms of anxiety, tension, depression, nervousness, agitation, and difficulty sleeping.
Some patients with anxiety or nervousness may also have problems with their heart rhythm, breathing, or digestion. Bromazepam Normon may also help relieve these symptoms.
In most cases, only short-term treatment with Bromazepam Normon is required (generally not exceeding two weeks).
Treatment should be initiated with the lowest dose. The maximum dose must not be exceeded.
2. Before taking Bromazepam Normon
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Do not take bromazepam NORMON
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if you are allergic (hypersensitive) to bromazepam, to any of the other ingredients of bromazepam NORMON, or to benzodiazepines in general.
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if you suffer from respiratory difficulties, whether or not related to sleep, or have muscle disorders or severe liver problems.
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if you have drug or alcohol dependence, unless your doctor has specifically instructed you otherwise.
If you have any doubts about this, consult your doctor.
Bromazepam NORMON must not be administered to children.
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Take special care with bromazepam NORMON
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if you have liver or kidney disorders
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if you suffer from muscle weakness
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if you have other illnesses
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if you have allergies
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if you have drug addiction or alcoholism
If you are epileptic and undergoing long-term treatment with bromazepam NORMON, the use of the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of bromazepam NORMON is not recommended, as seizures may occur.
- Use of other medicines
Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.
This is extremely important because taking more than one medicine at the same time may increase or decrease their effects. Therefore, you should not take other medicines concurrently with bromazepam NORMON unless your doctor is aware and has approved it in advance.
For example, sedatives, sleeping aids, and similar medicines act on the brain and nerves and may enhance the effect of bromazepam NORMON.
- Taking bromazepam NORMON with food and drinks
Bromazepam NORMON capsules should be taken before or with meals, swallowed whole and not chewed, with a little water or a non-alcoholic drink.
During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which could 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 using any medicine.
Pregnancy
Before starting treatment, your doctor must know whether you are pregnant, suspect you may be pregnant, or intend to become pregnant. Your doctor will then decide whether it is appropriate for you to take bromazepam NORMON.
Breastfeeding
Benzodiazepines are excreted in breast milk, so your doctor will decide whether you should take bromazepam NORMON while breastfeeding your child.
- Driving and using machines
Bromazepam NORMON may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or decrease reaction time. These effects are 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 NORMON unless your 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 patients aged 65 years and older
Patients aged 65 years and older may be more affected by bromazepam NORMON than younger patients. If you are over 65, 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 NORMON or not take it at all.
- Bromazepam NORMON contains lactose and Ponceau 4R
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
This medicine may cause allergic reactions because it contains Ponceau 4R (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Bromazepam Normon
Follow exactly the bromazepam NORMON dosing instructions given 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.
In elderly patients or those with liver or kidney disorders, or muscle weakness, your doctor will prescribe a lower dose.
Follow these instructions unless your doctor has given you different advice.
The usual doses are as follows:
Most patients do not need more than two or three capsules per day, although your doctor may prescribe higher doses.
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 limits indicated, nor must the total daily dose, unless your doctor prescribes a higher dose.
Bromazepam NORMON capsules should be taken before or with meals, and must be swallowed whole, without chewing, with a little water or a non-alcoholic drink.
The total daily amount of bromazepam NORMON should be divided into two or three doses.
Your doctor will advise you on the duration of treatment with bromazepam NORMON. Do not stop treatment prematurely.
In most cases, only short-term treatment with bromazepam NORMON is needed (generally not exceeding two weeks).
To avoid withdrawal symptoms, you must not stop taking bromazepam NORMON abruptly, especially if you have been taking it for a long time.
- If you take more bromazepam NORMON than you should
The symptoms of a benzodiazepine overdose, in mild cases, usually consist of drowsiness, lethargy, and mental confusion. Ingestion of high doses, especially in combination with other centrally-acting substances, may cause ataxia, hypotonia, hypotension, respiratory depression, occasionally coma, and very rarely death.
If you or someone else has ingested an overdose of bromazepam NORMON, contact your doctor, pharmacist, or the nearest hospital immediately.
In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone: 91 562 04 20
- If you forget to take bromazepam NORMON
Do not take a double dose to make up for missed doses. Instead, continue with your normal dose.
- If you stop treatment with bromazepam NORMON
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 NORMON is not indicated for long-term treatment. After a few weeks of treatment, your doctor will gradually reduce the dose until treatment is discontinued.
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 NORMON may produce adverse effects, although not everyone experiences them.
Most patients tolerate bromazepam NORMON well, but the most common side effects—especially at the beginning of treatment—are tiredness and drowsiness.
Very rarely, bromazepam NORMON may cause sudden anxiety, hallucinations, excitement, and sleep disturbances. If this occurs, consult your doctor immediately.
Occasionally, muscle weakness with problems in walking balance (falls) may occur. If this happens, inform your doctor, who may decide to adjust the dose.
An increased risk of falls and fractures has been observed in elderly patients.
Very rarely, bromazepam NORMON may cause headache, dizziness, decreased alertness, low blood pressure (fainting), gastrointestinal disturbances, skin reactions, visual disturbances (double vision), ataxia (inability to coordinate voluntary muscle movements), changes in libido (sexual desire), and bladder disturbances. If you experience hallucinations, sleep disturbances, agitation, or jaundice (yellowing of the skin and eyes), consult your doctor immediately and consider discontinuing treatment.
The use of benzodiazepines may unmask a pre-existing depression.
It is known that when benzodiazepines are used, adverse behavioral effects may occur, such as restlessness, agitation, irritability, aggressiveness, delirium (incoherent thinking), rage attacks, nightmares, hallucinations, psychosis, or inappropriate behavior. These reactions are more frequent in elderly patients and in children. If you experience any of these effects, you must stop treatment and contact your doctor immediately.
Anterograde amnesia (loss of memory for events occurring after drug intake) may occur at normal doses, and the risk increases with higher doses. Amnesic effects may be associated with behavioral disturbances.
Respiratory disorders and cardiac disorders (including heart failure and cardiac arrest) may also occur.
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 mainly occurs after prolonged, uninterrupted use of the medicine.
To minimize the risk of dependence, the following precautions should be observed:
- Benzodiazepines should only be taken under medical prescription (never because they worked for another patient), and should never be recommended to other people.
- Do not increase the dose prescribed by your doctor, or extend the treatment beyond the recommended duration.
- Consult your doctor regularly so they can decide whether treatment should continue.
Discontinuation of treatment may lead to withdrawal or rebound phenomena, and psychological dependence may develop.
Cases of benzodiazepine abuse have been reported.
5. Storage of Bromazepam Normon
Keep out of the reach and sight of children.
Do not store above 30°C.
Do not use Bromazepam Normon after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Additional information
Composition of bromazepam NORMON
The active substance is bromazepam. Each capsule contains 6 mg of bromazepam.
The other components (excipients) are: monohydrate lactose, maize starch (gluten-free), colloidal silica, and magnesium stearate. The gelatin capsule consists of: gelatin, titanium dioxide (E-171), ponceau 4R (E-124), and black iron oxide (E-172).
Appearance of the product and contents of the container
Bromazepam 6 mg hard capsules are presented as grey/pink coloured capsules.
It is available in packs containing 20 capsules.
Marketing Authorization Holder and Manufacturer Responsible
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
OTHER PRESENTATIONS
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This patient information leaflet was approved in December 2010