Package Insert: Information for the User

Lexatin 3 mg Hard Capsules

Bromazepam

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for 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 package insert. 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 pack and additional information

The active ingredient of Lexatin, bromazepam, belongs to a group of medications called benzodiazepines. Bromazepam, administered at low doses, alleviates 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 who have difficulty sleeping.

Some patients with anxiety or nervousness may also experience problems with their heart rate, breathing, or digestion. 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 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 have severe liver problems.
• If you have a condition called "myasthenia gravis", characterized by muscle weakness and fatigue.
• If you have sleep apnea, a condition in which your breathing is irregular, and even stops for short periods while you are sleeping.
• If you are dependent on drugs or alcohol, 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 have muscle weakness,

• If you have any respiratory diseases,

?If you have other diseases,

?If you have allergies,

?If you have drug addiction or alcoholism,

• If you have depression and/or have attempted suicide,
• If you are taking other medications, especially pain medications (analgesics), and/or medications for mental health conditions.

If you experience restlessness, agitation, or other symptoms during treatment, you should consult your doctor immediately, who will assess whether it is necessary to discontinue treatment.

If you experience memory disturbances during treatment, you should inform your doctor. Your doctor will provide specific recommendations to reduce this risk.

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

Children

Lexatin should not be administered to children without a careful assessment 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 multiple medicationsmay 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 sedating 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 operate machinery. If you need additional information on this point, consult your doctor.

Foods may decrease the absorption of bromazepam, i.e., may decrease the effect of Lexatin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be 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 tremors, 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 most convenient for you.

Driving and operating machinery

Lexatin may affect your ability to drive or operate machinery, as it may cause drowsiness, memory loss, decreased attention, decreased reaction time, or 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 again 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 medication.

If you have any liver or kidney disorder, if you suffer from respiratory difficulties or muscle weakness, your doctor will decide whether to prescribe a lower dose of Lexatin or not to 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 (9 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 must not exceed the indicated limits, and the total daily dose must not either, unless your doctor prescribes a higher dose.

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

The total daily amount of Lexatin must 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 must not exceed 8 to 12 weeks, including the time necessary 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 must not be administered to children without a careful assessment of the need for treatment by your doctor.

Use in elderly patients

Elderly patients have more sensitivity 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. The ingestion of high doses, especially in combination with other central-acting substances, may cause ataxia (inability to coordinate voluntary muscle movements), hypotonia (muscle tone decrease 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 forgot to take Lexatin

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

If you interrupt treatment with Lexatin

Stopping administration may cause restlessness, anxiety, insomnia, lack of concentration, headache and hot flashes, especially if you have been taking it for a long time. It is not recommended to stop treatment abruptly, but rather to gradually reduce the dose, according to your doctor's instructions.

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 after a few weeks of treatment, your doctor will gradually reduce the dose until treatment is stopped.

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

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

Most patients tolerate Lexatin well, but during the initial treatment, 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, disorders of libido (alteration of sexual desire), physical and psychological dependence on the medication, abuse of the medication, withdrawal symptoms, depression,(the use of this medication may reveal a depression that already existed)anxiety, agitation, hyperactivity, nervousness, anxiety, irritability, aggressiveness, delirium, outbursts of anger, 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 (heart attack).

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 prospectus, inform 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 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 (reappearance of symptoms - although more pronounced - that led to the initiation of treatment), and may develop a psychological dependence.

Communication of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, 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 contents of the packaging

Each capsule contains 3 mg of bromazepam.

They are hard, salmon and red capsules with the inscription “LEX-3” in the middle of the capsule.

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

Other presentations:

Lexatin 1.5 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 prospectus: 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/.