PATIENT INFORMATION LEAFLET

Bromazepam NORMON 3 mg Hard Capsules EFG

Bromazepam

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 pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

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

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

In most cases, only a short-term treatment with bromazepam NORMON is needed (in general, it should not exceed two weeks).

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

• Do not take bromazepam NORMON

• If you are allergic (hypersensitive) to bromazepam, to any of the other components of bromazepam NORMON, or to the benzodiazepine group in general.
• If you have respiratory difficulties related or unrelated to sleep for a long time, or suffer from muscle problems or severe liver problems.
• If you suffer from drug or alcohol dependence, unless your doctor formally indicates it.

If you have any doubts, consult your doctor.

Bromazepam NORMON should not be administered to children.

• Be especially careful with bromazepam NORMON

• If you have any liver or kidney disorders
• If you suffer from muscle weakness
• If you have other diseases
• If you have allergies
• If you have drug addiction or alcoholism problems

If you are epilepticand are following a long-term treatment with bromazepam NORMON, do not use the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of bromazepam NORMON, as convulsions may occur.

• 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.

This is extremely important because thesimultaneous use of multiple medicationsmay increase or decrease its effect. Therefore, do not take other medications at the same time as bromazepam NORMON, 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 enhance the effect of bromazepam NORMON.

• Taking bromazepam NORMON with food and beverages

Bromazepam NORMON capsules should be taken before or with meals, and should be swallowed whole and not chewed, with a little water or a non-alcoholic beverage.

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation, and this may affect the 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.

Pregnancy

Before starting treatment, your doctor must know if you are or suspect you are pregnant, or if you wish to become pregnant. The doctor will then decide whether you should 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 operating machinery

Bromazepam NORMON may affect your ability to drive or operate machinery, as it may cause drowsiness, decrease attention, or decrease 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 NORMON unless the 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. Especially in anxiety caused by neurosis and reactive anxiety.

• Use in people over 65 years old

People over 65 years old may be affected by bromazepam NORMON more than young patients. If you are over 65 years old, 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 NORMON or not take it at all.

• Bromazepam NORMON contains lactose, Ponceau 4R, and yellow orange S

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

This medication may cause allergic reactions because it contains Ponceau 4R (E-124) and yellow orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions for bromazepam NORMON 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.

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 (9 mg) per day, although your doctor may prescribe higher doses.

In hospitalized patients, a higher dose may be needed, but it must 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 NORMON capsules should be taken before or with meals, and should be swallowed whole and not chewed with a little water or a non-alcoholic beverage.

The total daily dose of bromazepam NORMON should be divided into two or three doses per day.

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

In most cases, only a short treatment with bromazepam NORMON is needed (usually not exceeding two weeks).

To avoid withdrawal symptoms, do 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. 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 another person has ingested 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 compensate for the missed doses, but rather continue with the normal dose.

• If you interrupt treatment with bromazepam NORMON

You may experience anxiety, insomnia, lack of concentration, headache, and hot flashes, especially if you have been taking it for a long time. It is generally not recommended to stop treatment abruptly, but rather to gradually reduce the dose, as instructed by your doctor.

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 NORMON is not indicated for long-term treatment, but rather after a few weeks of treatment, your doctor will gradually reduce the dose 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 NORMON may cause side effects, although not everyone will experience them.

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

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

In rare cases, muscle weakness with balance problems while walking (falls) may occur. If this happens, report it to your doctor and they may decide to change the dosage.

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

Very rarely, bromazepam NORMON may cause headaches, dizziness (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 urinary disturbances. If you notice hallucinations, sleep disorders, agitation, or jaundice (yellowing of the skin and eyes), consult your doctor immediately if you wish them to discontinue treatment.

The use of benzodiazepines may unmask an existing depression.

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

Amnesia (anterograde memory loss) may appear at normal doses, and the risk increases with increased doses. Amnestic effects may be associated with behavioral disturbances.

Respiratory and cardiac disorders (including heart failure and cardiac arrest) may also occur.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, report it to 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 or prolong treatment beyond the recommended time.
• Consult your doctor regularly to decide whether to continue treatment.

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

Cases of abuse with benzodiazepines have been reported.

Keep out of 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 through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of bromazepam NORMON

The active ingredient is bromazepam. Each capsule contains 3 mg of bromazepam.

The other components (excipients) are: lactose monohydrate, cornstarch (gluten-free), colloidal silica, and magnesium stearate. The gelatin capsule is composed of: gelatin, titanium dioxide (E-171), ponceau 4R (E-124), and yellow-orange S (E-110)

Appearance of the product and contents of the package

Bromazepam 3 mg hard capsules are presented in the form of orange/red capsules.

They are presented in packages containing 30 and 500 capsules.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Bromazepam NORMON 1.5 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