Bromazepam Pensa 3 mg capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bromazepam Pensa 3 mg capsules EFG

Read the entire 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What Bromazepam Pensa is and what it is used for
2. Before you take Bromazepam Pensa
3. How to take Bromazepam Pensa
4. Possible side effects
5. How to store Bromazepam Pensa
6. Further information

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

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

Doctors prescribe Bromazepam Pensa for individuals experiencing symptoms of anxiety, tension, depression, nervousness, agitation, and difficulty sleeping.

Some patients with anxiety or nervousness may also experience problems with heart rhythm, breathing, or digestion. Bromazepam Pensa may also help relieve 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 required for gradual withdrawal of the medication.

Treatment should be initiated with the lowest possible dose. The maximum dose must not be exceeded.

2. Before taking Bromazepam Pensa

Do not take Bromazepam Pensa

• if you are allergic (hypersensitive) to bromazepam or to any of the other ingredients of this medicine (listed in section 6),

• if you are allergic (hypersensitive) to benzodiazepines in general,

• if you have severe respiratory 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 condition in which your breathing is irregular and even stops briefly during sleep.

• if you have drug or alcohol dependence, you should not take Bromazepam Pensa unless your doctor has specifically instructed you to do so. If you have any doubts about this, consult your doctor,

• if you have hereditary galactose intolerance, Lapp lactase deficiency (a deficiency observed in certain populations of Lapland), or glucose-galactose malabsorption (types of sugar absorption problems).

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 suffer from 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 medicines to treat pain (analgesics), and/or medicines to treat mental illnesses.

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 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, the use of the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of Bromazepam Pensa is not recommended, as seizures may occur.

Children

Bromazepam Pensa must not be administered to children without careful assessment by their doctor of the need for treatment.

Taking Bromazepam Pensa with other medicines

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

This is extremely important because taking more than one medicine at the same time may increase or decrease their effects. Therefore, you should not take other medicines together with Bromazepam Pensa unless your doctor has been informed and has approved it beforehand.

For example, tranquilizers, sleep-inducing agents, medicines used to treat psychiatric disorders, anxiolytics/sedatives, certain antidepressants, opioids, anticonvulsants, and sedating antihistamines act on the brain and nervous system and may enhance the effect of Bromazepam Pensa, including sedation and breathing difficulties.

Taking Bromazepam Pensa with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

If this product is administered during the late stages of pregnancy due to strict medical necessity, effects in the newborn may be expected, such as hypothermia (abnormally low body temperature), hypotonia (loss of muscle tone), difficulty sucking, and respiratory difficulties. For several days after birth, the newborn should be closely monitored for withdrawal symptoms such as hyperexcitability, agitation, tremor, or loss of muscle tone.

Since Bromazepam Pensa is excreted in breast milk, breastfeeding is not recommended during treatment. Your doctor will advise you on the most appropriate course of action.

Driving and use of machines

Bromazepam Pensa may impair your ability to drive or operate machinery, as it may cause drowsiness, memory loss, reduced attention, slowed reaction times, or muscle weakness. These effects are 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. In addition, insufficient sleep and alcohol consumption may further impair your level of alertness.

Bromazepam Pensa contains lactose

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

3. How to take Bromazepam Pensa

Follow exactly the instructions for using this medicine as given by your doctor. If in 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, breathing difficulties, or suffer from muscle weakness, your doctor will decide whether you should take a lower dose of Bromazepam Pensa or should not take it at all.

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

The usual doses are as follows:

Most patients do not require 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 must always be prescribed by the doctor.

Each individual dose must not exceed the limits indicated, nor must the total daily dose, unless your doctor prescribes a higher dose.

Bromazepam Pensa capsules should be taken before or with meals and must be swallowed whole, without chewing, 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 tell you how long your treatment with Bromazepam Pensa should last. 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 required for gradual withdrawal of the medication.

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

Use in children

Bromazepam Pensa must not be given to children unless your doctor has carefully assessed the need for treatment.

Use in elderly patients

Elderly patients are more sensitive to Bromazepam Pensa than younger patients. If you belong to this patient group, 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 symptoms of benzodiazepine overdose, in mild cases, usually consist of drowsiness, lethargy (drowsiness), and mental confusion. Ingestion of high doses, especially in combination with other centrally-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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 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 missed doses.

If you stop treatment with Bromazepam Pensa

When stopping administration, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flushes may occur, especially if you have been taking it for a long time. Abrupt discontinuation of the medication is generally not recommended; instead, the dose should be gradually reduced according to your doctor's instructions.

Never change the prescribed dose yourself. If you think that the effect of the medicine is too strong or too weak, consult your doctor.

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

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

4. Possible adverse effects

Like all medicines, Bromazepam Pensa may produce adverse effects, although not everyone experiences them.

Most patients tolerate Bromazepam Pensa well, but at the beginning of treatment the following adverse effects may occur: confusion, drowsiness, emotional disturbance, headache, dizziness, reduced level of alertness, ataxia (lack of coordination), diplopia (double vision), nausea, vomiting, muscle weakness, and fatigue. These symptoms usually disappear with continued treatment.

Adverse effects that may occur during treatment with this medicine, observed with unknown frequency (cannot be estimated from available data), are:

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

Psychiatric disorders: confusion, emotional disturbance, libido disorders (altered sexual desire), physical and psychological dependence on the medicine, medicine abuse, withdrawal symptoms, depression, restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and memory disturbances.

Nervous system disorders: drowsiness, headache, dizziness, reduced level of alertness (slowed reflexes), and ataxia (lack of motor coordination).

Eye disorders: diplopia (double vision).

Cardiac disorders: cardiac failure (heart unable to pump blood properly), 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.

Injury-related events: falls and fractures, with increased risk in elderly patients and in patients taking other sedatives simultaneously (including alcoholic beverages).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse 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 mainly occurs after prolonged, uninterrupted use of the medicine. To minimize the risk of dependence, the following precautions should be observed:

• Benzodiazepines should be taken only under medical prescription (never because they worked in other patients), and should never be recommended to other people.

• Do not increase the dose prescribed by the doctor, nor extend the treatment beyond the recommended duration.

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

Discontinuation of treatment may lead to withdrawal phenomena or rebound effects (reappearance of symptoms – although more pronounced – that led to initiating treatment), and may result in psychological dependence.

Reporting of adverse effects:

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

5. Storage of Bromazepam Pensa

Do not store above 30 °C. Keep in the original container to protect from moisture.

Keep out of the reach and sight of children.

Do not use Bromazepam Pensa after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional information

Composition of Bromazepam Pensa

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

Appearance of the product and contents of the package

Bromazepam Pensa is available in boxes containing 30 capsules in blister packs and in clinical packages of 500 tablets.

Other presentations:

Bromazepam Pensa 1.5 mg capsules, available in boxes containing 30 capsules in blister packs and in clinical packages 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 up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/