Package Insert: Information for the User

Bromazepam pensa3 mg capsules EFG

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

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

2. Before taking Bromazepam Pensa

3. How to take Bromazepam Pensa

4. Possible adverse effects

5. Storage of Bromazepam

6. Additional information

The active ingredient of Bromazepam Pensa, 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 Bromazepam Pensa 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 digestive system. Bromazepam Pensa may also help alleviate these symptoms.

In most cases, only a short-term treatment with Bromazepam Pensa 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 Bromazepam Pensa

• 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 suffer from drug or alcohol dependence, do not take Bromazepam Pensa unless your doctor tells you to. If you have any doubts, consult your doctor,
• if you have hereditary intolerance to galactose (a sugar), Lapp lactase deficiency (observed in certain populations of Lapland) or problems with glucose or galactose absorption (types of sugars).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Bromazepam Pensa

• if you have any liver or kidney disorders,
• if you suffer from muscle weakness,
• if you have any respiratory disease
• 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 during treatment you experience restlessness, agitation, or other symptoms, you should consult your doctor immediately, who will assess whether it is necessary to discontinue treatment.

If during treatment you experience memory disturbances, 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 Bromazepam Pensa, the use of the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of Bromazepam Pensa is not recommended, as convulsions may occur.

Children

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

Taking Bromazepam Pensa 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 Bromazepam Pensa unless your doctor is informed and approves it in advance.

For example, tranquilizers, sleep inducers, medications used to treat mental health conditions, anxiolytics/sedatives, some antidepressants, opioids, anticonvulsants, and sedative antihistamines, act on the brain and nerves and may increase the effect of Bromazepam Pensa, including sedation, breathing difficulties.

Taking Bromazepam Pensa with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or 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 tremors, or loss of muscle tone.

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

Driving and operating machinery

Bromazepam Pensamay affect your ability to drive or operate machinery, as it may cause drowsiness, memory loss, decrease your attention, or 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.

Bromazepam Pensa 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.

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 experience muscle weakness, your doctor will decide whether you should take a lower dose of Bromazepam Pensa 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 (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 should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

Bromazepam Pensa capsules should be taken before or with meals and should be swallowed whole without chewing with a little water or a non-alcoholic beverage.

The total daily amount of Bromazepam Pensa should be divided into two or three doses per day.

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

In most cases, only a short-term treatment with Bromazepam Pensa 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 Bromazepam Pensa abruptly, especially if you have been taking it for a long time.

Use in children

Bromazepam Pensa 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 Bromazepam Pensa 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 Bromazepam Pensa 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 (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 Bromazepam Pensa

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

If you interrupt treatment with Bromazepam Pensa

Upon cessation of administration, 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 generally 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 believe the medication's effect is too strong or too weak, consult your doctor.

Remember that Bromazepam Pensa is not indicated for long-term treatment, but rather your doctor will gradually reduce the dose over a few weeks of treatment until treatment is stopped.

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

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

Most patients tolerate Bromazepam Pensa 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, emotional disorder, libido disorders (alteration of sexual desire), physical and psychological dependence on the medication, medication abuse, withdrawal symptoms, depression, restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, 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 (heart not pumping 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:skin rash, 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 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 to decide whether to continue treatment.

Stopping treatment may lead to the development of withdrawal symptoms or rebound phenomena (reappearance of symptoms – although more intense – that led to the initiation of treatment), and may develop 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.

Do not store at a temperature above30 °C. Store in the original packaging to protect it from humidity.

Keep out of the reach and sight of children.

Do not use Bromazepam Pensa 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. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Bromazepam Pensa Composition

• The active ingredient is bromazepam.
• The other components are: lactose monohydrate, pregelatinized cornstarch, talc, magnesium stearate, indigo carmine (E-132), erythrosine (E-127), titanium dioxide (E-171), iron oxide red, iron oxide yellow, and gelatin.

Product Appearance and Packaging Content

Bromazepam Pensa is presented in boxes containing blister packs with 30 capsules and in a clinical pack of 500 tablets.

Other presentations:

Bromazepam Pensa 1.5 mg capsules, which is presented in boxes containing blister packs with 30 capsules and in a clinical pack of 500 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for Manufacturing

Kern Pharma, S.L.

Polígono Ind. Colón II

C/ Venus, 72

08228 Terrassa (Barcelona)

This leaflet was approved in September 2016

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