Prospect: information for the user

Lexatin1.5 mg hard capsules

Bromazepam

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4

1. What is Lexatin and what is it used for

2. What you need to know before starting to take Lexatin

3. How to take Lexatin

4. Possible adverse effects

5. Storage of Lexatin

6. Contents of the package and additional information

The active ingredient of Lexatin, 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 Lexatin 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. Lexatin may also help alleviate these symptoms.

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

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

Do not take Lexatin

• If you are allergic (hypersensitive) to bromazepam or to any of the other components of this medication (listed in section 6).
• If you are allergic (hypersensitive) to the group of 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 disease in which your breathing is irregular, and even stops for short periods while you are sleeping.
• If you suffer from drug or alcohol dependence, do not take Lexatin unless your doctor tells you to. If you have any doubts, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lexatin:

• If you have any liver or kidney disorders,
• If you suffer from muscle weakness,
• If you suffer from any respiratory disease,
• If you have other diseases,
• If you have allergies,
• If you have drug addiction or alcoholism,
• If you haveor have had depression and/or attempted suicide,
• If you are taking other medications, especially pain medications (analgesics), and/or medications for mental illnesses.

If during treatment you experience restlessness, agitation, or other symptoms, you must consult your doctor immediately, who will evaluate whether it is necessary to suspend treatment.

If during treatment you experience memory alterations, you must report it to your doctor. Your doctor will provide you with specific recommendations to reduce this risk.

If you are epilepticand are following a long-term treatment with Lexatin, the use of the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of Lexatin is not recommended, as convulsions may appear.

Children

Lexatin should not be administered to children without a careful evaluation of the need for treatment by your doctor.

Taking Lexatin with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications.

This is extremely important becausethe simultaneous use of more than one medicationmay increase or decrease its effect. Therefore, do not take other medications at the same time as Lexatin, unless your doctor is informed and approves it in advance.

For example, tranquilizers, sleep inducers, medications used to treat mental disorders, anxiolytics/sedatives, some antidepressants (fluvoxamine), opioids, anticonvulsants, and sedative antihistamines, act on the brain and nerves and may increase the effect of Lexatin, including sedation, breathing difficulties.

Some antacids (cimetidine) and some medications for the treatment of high blood pressure (propanolol) may prolong the effect of Lexatin.

Taking Lexatin with food, drinks, and alcohol

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

Foods may decrease the absorption of bromazepam, that is, may decrease the effect of Lexatin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, or if you intend to become pregnant, consult your doctor or pharmacist before using this medication.

If this medication is administered during a late stage of pregnancy, it is predictable that there may be effects on the newborn, such as hypothermia (abnormally low body temperature), hypotonia (loss of muscle tone), difficulty sucking, and breathing difficulties. A few days after birth, the newborn should be closely monitored for symptoms of withdrawal, such as hyperexcitability, agitation, and tremor, or loss of muscle tone.

Due to the fact that Lexatin is excreted in breast milk, breastfeeding is not recommended during treatment. Your doctor will indicate what is best for you.

Driving and operating machinery

Lexatin may alter your ability to drive or operate machinery, as it may cause drowsiness, memory loss, decrease your attention, decrease your reaction time, or cause muscle weakness. 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. Additionally, periods of insufficient sleep and alcohol consumption may increase the deterioration of your alertness.

Lexatin contains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Remember to take your medication.

If you have any liver or kidney disorders, if you suffer from respiratory difficulties or experience muscle weakness, your doctor will decide whether you should take a lower dose of Lexatin or not take it at all.

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

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 must always be prescribed by your 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.

Lexatin 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 amount of Lexatin should be divided into two or three doses per day.

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

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

To avoid withdrawal symptoms, do not stop taking Lexatin abruptly, especially if you have been taking it for a long time.

Use in children

Lexatin should not be administered to children without a careful assessment of the need for treatment by your doctor.

Use in elderly patients

Elderly patients are more sensitive to Lexatin than young 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 Lexatin 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 (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 medication and the amount ingested.

If you forget to take Lexatin

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lexatin

Stopping treatment may cause restlessness, anxiety, insomnia, lack of concentration, headaches, and hot flashes, especially if you have been taking it for a long time. It is not generally 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 Lexatin is not indicated for long-term treatment, but rather your doctor will reduce the dose over a few weeks and then stop treatment.

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

Like all medicines, Lexatin may cause side effects, although not everyone will experience them.

Most patients tolerate Lexatin well, but during the initial treatment phase, 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 as treatment continues.

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

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

Mental health disorders:Confusion, disorientation, emotional and mood alterations, sexual desire disorders (alteration of sexual desire), physical and psychological dependence on the medication, medication abuse, withdrawal symptoms, depression,(the use of this medication may reveal a pre-existing depression)anxiety, agitation, hyperactivity, nervousness, anxiety, irritability, aggression, delirium, anger attacks, nightmares, abnormal dreams, hallucinations, psychosis, inappropriate behavior, and memory alterations.

Nervous system disorders:drowsiness, headache, dizziness, reduced alertness (slowness of 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.

Respiratory disorders:respiratory depression (slow and shallow breathing).

Gastrointestinal disorders:nausea, vomiting, constipation.

Skin and subcutaneous tissue disorders:cutaneous eruption, pruritus (itching) and urticaria.

Musculoskeletal disorders:muscle weakness.

Renal and urinary disorders:urinary retention.

General disorders:fatigue.

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned 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 taking the medication continuously for a long time. To minimize the risk of dependence, the following precautions should be taken:

• The use of benzodiazepines will be made only under medical prescription (never because they have been effective in other patients) and will never be recommended to others.

• Do not increase the prescribed doses, nor prolong the treatment longer than recommended.

• Consult your doctor regularly so that they can decide whether to continue treatment.

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store above 25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lexatin

• The active principle is bromazepam.
• The other components are lactose, cornstarch, talc, magnesium stearate, indigo carmine E-132, erythrosine E-127, titanium dioxide E-171, and gelatin.

Appearance of the product and content of the container

Each capsule contains 1.5 mg of bromazepam.

They are hard capsules of white and red color, with the inscription “LEX-1.5” in the middle of the capsule.

Lexatin 1.5 mg is available in boxes containing blister packs with 30 capsules.

Other presentations:

Lexatin 3 mg is available in boxes containing blister packs with 30 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder:

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Local representative:

Laboratorios Rubió, S.A.

C/ Industria, 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Responsible for manufacturing:

Recipharm Leganés, S.L.U.

Calle Severo Ochoa nº 13,

Leganés

28914 Madrid

Spain

Last review date of this leaflet: November 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.