BROMAZEPAM PENSA 3 mg CAPSULES

Introduction

Package Leaflet: Information for the User

Bromazepam Pensa3 mg capsules EFG

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 is Bromazepam Pensa and what is it used for
2. Before taking Bromazepam Pensa
3. How to take Bromazepam Pensa
4. Possible side effects
5. Storage of Bromazepam
6. Further information

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

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

Doctors prescribe Bromazepam Pensa 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 Pensa can also help alleviate these symptoms.

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

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

2. Before taking Bromazepam Pensa

Do not take Bromazepam Pensa

• if you are allergic (hypersensitive) to bromazepam or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic (hypersensitive) to the group of benzodiazepines in general,
• if you have severe breathing difficulties,
• if you have 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 interrupted during short periods while you are sleeping.

• if you suffer from drug or alcohol dependence, you should not take Bromazepam Pensa unless your doctor has formally indicated it. If you have any doubts, consult your doctor,
• if you have hereditary intolerance to galactose (a sugar), Lapp lactase deficiency (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 disorder,
• if you have muscle weakness,
• if you have any respiratory disease
• if you have other diseases,
• if you have allergies,
• if you have problems with drug addiction or alcoholism
• if you have or have had depression and/or have attempted suicide,
• if you are taking other medicines, especially painkillers (analgesics), and/or medicines for treating mental illnesses.

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

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

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

Children

Bromazepam Pensa should not be administered to children without their doctor having made a careful assessment of the need for treatment.

Taking Bromazepam Pensa with other medicines

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

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

For example, tranquilizers, sleep inducers, medicines used to treat mental disorders, anxiolytics/sedatives, some antidepressants, opioids, anticonvulsants, and sedating antihistamines, act on the brain and nerves and can 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 can potentiate sedation and this can affect the 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If, for strict medical necessity, the product is administered during a late stage of pregnancy, it is foreseeable that effects may appear 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.

Since Bromazepam Pensa is excreted in breast milk, breastfeeding is not recommended during treatment. Your doctor will indicate what is most convenient for you.

Driving and using machines

Bromazepam Pensa can alter your ability to drive or operate machinery, as it can 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 start of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects. Also, insufficient sleep and alcohol consumption can 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 them before taking this medicine.

3. How to take Bromazepam Pensa

Follow exactly the administration instructions of this medicine 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 medicine.

If you have any liver or kidney disorder, if you have breathing difficulties or suffer from muscle weakness, your doctor will decide whether it is convenient for you to take a lower dose of Bromazepam Pensa or not to take it at all.

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

The usual 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 patients who have been hospitalized, 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 Pensa should be taken before or with meals and should be swallowed whole and not chewed with a little water or a non-alcoholic drink.

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

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

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

To avoid withdrawal symptoms, you should 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 their doctor having made a careful assessment of the need for treatment.

Use in elderly patients

Elderly patients are more sensitive to Bromazepam Pensa than younger patients. If you belong to this group of patients, your doctor may prescribe a lower dose and check 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 (drowsiness), and mental confusion. The ingestion of high doses, especially in combination with other central-acting substances, can cause ataxia (inability to coordinate voluntary muscle movements), hypotonia (decrease in 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 medicine and the amount ingested.

If you forget to take Bromazepam Pensa

Do not take a double dose to make up for forgotten doses.

If you stop taking Bromazepam Pensa

When stopping the administration, 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 the medication 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 Pensa is not indicated for long-term treatments, but rather after a few weeks of treatment, your doctor will gradually decrease the dose until the 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 Pensa can cause side effects, although not everybody gets them.

Most patients tolerate Bromazepam Pensa well, but at the beginning of 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 with continued treatment.

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

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

Psychiatric disorders:confusion, emotional disorder, libido disorders (alteration of sexual desire), physical and psychological dependence on the medicine, abuse of the medicine, withdrawal symptoms, depression, restlessness, agitation, irritability, aggression, delirium, fits of rage, nightmares, hallucinations, psychosis, inappropriate behavior, and memory disturbances.

Nervous system disorders:drowsiness, headache, dizziness, reduced alertness (slowness in 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:skin rash, pruritus (itching), and urticaria.

Musculoskeletal and connective tissue disorders:muscle weakness.

Renal and urinary disorders:urinary retention

General disorders:fatigue

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

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not listed 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 medicine for a long time. To minimize the risk of dependence, the following precautions should be taken into account:

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

• Do not increase the prescribed doses in any way, nor prolong the treatment for a longer time than recommended.

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

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bromazepam Pensa

Do not store above 30 ºC. Keep in the original package to protect from moisture.

Keep out of the reach and sight of children.

Do not use Bromazepam Pensa after the expiration date stated 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. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Further information

Composition of Bromazepam Pensa

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

Appearance of the product and package contents

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

Other presentations:

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

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Kern Pharma, S.L.

Polígono Ind. Colón II

C/ Venus, 72

08228 Terrassa (Barcelona)

This leaflet was approved in September 2016

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/