BROMAZEPAM NORMON 1.5 mg HARD CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bromazepam NORMON 1.5 mg hard capsules EFG

Bromazepam

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience 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 BROMAZEPAM NORMON IS AND WHAT IT IS USED FOR
2. BEFORE TAKING BROMAZEPAM NORMON
3. HOW TO TAKE BROMAZEPAM NORMON
4. POSSIBLE SIDE EFFECTS
5. STORAGE OF BROMAZEPAM NORMON
6. ADDITIONAL INFORMATION

1. What is Bromazepam Normon and what is it used for

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

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

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

In most cases, only short-term treatment with bromazepam NORMON is needed (generally not exceeding two weeks).

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

2. Before taking Bromazepam Normon

• Do not take bromazepam NORMON

• if you are allergic (hypersensitive) to bromazepam, to any of the other components of bromazepam NORMON, or to the group of benzodiazepines in general.
• if you have breathing difficulties related or not to sleep for a long time, or if you have muscle problems or severe liver problems.
• if you are dependent on drugs or alcohol, unless your doctor has formally indicated it.

If you have any doubts, consult your doctor.

Bromazepam NORMON should not be administered to children.

• Be careful with bromazepam NORMON

• if you have liver or kidney disorders
• if you have muscle weakness
• if you have other illnesses
• if you have allergies
• if you have problems with drug addiction or alcoholism

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

• Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

This is extremely important because the simultaneous use of more than one medication can increase or decrease its effect. Therefore, you should not take other medications at the same time as bromazepam NORMON, unless your doctor is informed and approves it beforehand.

For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and can reinforce the effect of bromazepam NORMON.

• Taking bromazepam NORMON with food and drinks

The capsules of bromazepam NORMON should be taken before or with meals, and should be swallowed whole and without chewing, with a little water or a non-alcoholic beverage.

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

• Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Pregnancy

Before starting treatment, your doctor should know if you are or suspect you are pregnant or plan to become pregnant. The doctor will then decide whether it is convenient 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 can alter your ability to drive or operate machinery, as it can cause drowsiness, decrease your attention, or decrease your reaction capacity. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects.

• Use in children

Children should not use bromazepam NORMON 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. Especially in anxiety caused by neurosis and reactive anxiety.

• Use in people over 65 years old

People over 65 years old may be more affected by bromazepam NORMON than younger patients. If you are over 65 years old, your doctor may prescribe a lower dose and check 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 it is convenient for you to take a lower dose of bromazepam NORMON or not to take it at all.

• Bromazepam NORMON contains lactose and Ponceau 4R

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

This medication may cause allergic reactions because it contains Ponceau 4R (E-124). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Bromazepam Normon

Follow the instructions for administration of bromazepam NORMON 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 medication.

In elderly patients or those with liver or kidney disorders, or muscle weakness, the doctor will prescribe a lower dose.

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

The normal doses are as follows:

Most patients do not need more than three capsules (4.5 mg) per day, although your doctor may prescribe higher doses.

In the case of hospitalized patients, 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.

The capsules of bromazepam NORMON should be taken before or with meals, and should be swallowed whole and without chewing, with a little water or a non-alcoholic beverage.

Each day, the total amount of bromazepam NORMON should be divided into two or three doses.

Your doctor will indicate 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 should 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 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, hypotonia, hypotension, respiratory depression, occasionally coma, and very rarely death.

If you or someone else has taken an overdose of bromazepam NORMON, call your doctor, pharmacist, or the nearest hospital immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone: 91 562 04 20

• If you forget to take bromazepam NORMON

Do not take a double dose to make up for forgotten doses, but instead, continue with the normal dose.

• If you interrupt treatment with bromazepam NORMON

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 NORMON is not indicated for long-term treatments, but rather after a few weeks of treatment, 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 NORMON can cause side effects, although not everyone gets them.

Most patients tolerate bromazepam NORMON well, but the most common side effects, which occur especially at the start of treatment, are fatigue and drowsiness.

Very rarely, bromazepam NORMON can cause sudden anxiety, hallucinations, excitement, and sleep disorders. If this happens, consult your doctor immediately.

In rare cases, muscle weakness with balance problems when walking (falls) may occur. If this happens, inform your doctor, and they may decide to change the dose.

An increased risk of falls and fractures has been observed in elderly patients.

Very rarely, bromazepam NORMON can cause headache, vertigo (dizziness), deterioration of the state of alertness, low blood pressure (fainting), gastrointestinal disorders, skin reactions, visual disturbances (double vision), ataxia (inability to coordinate voluntary muscle movements), changes in libido (sexual appetite), and bladder disorders. If you notice hallucinations, sleep disorders, agitation, or jaundice (yellowish appearance of the skin and eyes), consult your doctor immediately, as they may want to interrupt treatment.

The use of benzodiazepines can uncover a pre-existing depression.

It is known that when benzodiazepines are used, behavioral side effects such as restlessness, agitation, irritability, aggression, delirium (incoherence of ideas), fits of rage, nightmares, hallucinations, psychosis, or inappropriate behavior can occur. These reactions are more frequent in the elderly and in children. If you experience these effects, you should interrupt treatment and contact your doctor immediately.

Anterograde amnesia (loss of memory) may appear at normal doses, and the risk increases when the dose is increased. The amnestic effects may be associated with behavioral disorders.

Respiratory and cardiac disorders (including cardiac arrest) may also appear.

If you think any of the side effects you are experiencing 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 medication 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 they can decide whether to continue treatment.

Withdrawal from treatment can lead to the development of withdrawal or rebound phenomena, and may lead to psychological dependence.

There have been reports of abuse with benzodiazepines.

5. Storage of Bromazepam Normon

Keep out of the reach and sight of children.

Do not store at a temperature above 30°C.

Do not use bromazepam NORMON 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 via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Additional information

Composition of bromazepam NORMON

The active substance is bromazepam. Each capsule contains 1.5 mg of bromazepam.

The other components (excipients) are: lactose monohydrate, cornstarch (gluten-free), colloidal silicon dioxide, and magnesium stearate. The gelatin capsule is composed of: gelatin, titanium dioxide (E-171), and Ponceau 4R (E-124).

Appearance of the product and packaging content

Bromazepam 1.5 mg hard capsules are presented in the form of white/pink capsules.

They are presented in packages containing 30 and 500 capsules.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Bromazepam NORMON 3 mg hard capsules EFG in packages of 30 and 500 capsules.

Bromazepam NORMON 6 mg hard capsules EFG in a package of 20 capsules.

This leaflet was approved in December 2010