Package Insert: Information for the User

DUNA 5 mg Hard Capsules

Pinazepam

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

• Keep this package insert as you may need to read 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 of illness 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.

6. Contents of the pack and additional information

Duna are hard capsules containing Pinazepam, which is a benzodiazepine with anxiolytic activity.

Duna is indicated for states of anxiety and tension of origin:

- psychoneurotic (related to a psychiatric disease: psychosis or neurosis),

- depressive,

- involutional (degenerative process associated with senile disease),

- or psychosomatic (physical disorder related to a psychological cause.

Do not take Duna

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6), or to other benzodiazepines.
• if you have long-standing sleep-related or non-sleep-related difficulties.
• if you suffer from muscle problems.
• if you have severe liver problems.
• if you have drug or alcohol dependencies, do not take Duna unless your doctor formally advises you to do so. If you have any doubts, consult your doctor.
• do not administer to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Duna:

• if you have any liver or kidney disorders.
• if you suffer from muscle weakness.

• if you have other diseases.
• if you have allergies.

The use of benzodiazepines (such as Pinazepam) may lead to dependence. This occurs mainly after taking the medication continuously for a long time. To minimize the risk of dependence, the following precautions should be taken:

• Benzodiazepines should only be taken under medical prescription (never because they have worked for other patients) and should 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.

When taking Duna, ensure that you will sleep uninterrupted for 7-8 hours (at bedtime).

Stopping the medication abruptly may be accompanied by various symptoms (see section: If you interrupt treatment with Duna).

Other medications and Duna

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This is extremely important because the simultaneous use of multiple medications may increase or decrease their effect.

Therefore, do not take other medications at the same time as Duna unless your doctor is informed and approves it in advance. For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and may enhance the effect of Duna.

Taking Duna 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.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Before starting treatment, your doctor must know if you are or suspect you are pregnant, or if you wish to become pregnant. The doctor will then decide whether it is advisable for you to take Duna.

If the medication is taken at the end of pregnancy or at high doses during delivery, the newborn may have low body temperature, muscle tone, and moderate respiratory depression.

Children may be born with physical dependence and have withdrawal syndrome when their mothers take this medication for a long time.

Breastfeeding

Benzodiazepines are excreted in breast milk, so you should consult your doctor about the advisability of taking Duna while breastfeeding your child.

Driving and operating machinery

Duna may impair your ability to drive or operate machinery, as it may cause drowsiness, decrease attention, or decrease reaction time. These effects are more likely to occur at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Duna 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.

The recommended dose for adults is 2.5 mg to 10 mg every 12 hours depending on the severity of the disease.

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

If you have any liver or kidney disorder, or suffer from muscle weakness, your doctor will decide whether to prescribe a lower dose of Duna or not to take it at all.

Never change the dose that has been prescribed to you.

If you believe the medication's effect is too strong or too weak, consult your doctor.

Administration Form

Take the entire capsule without breaking it with a sufficient amount of liquid – a glass of water.

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

Treatment Duration

Remember to take your medication. Your doctor will indicate the duration of your treatment with Duna.

Do not stop treatment before.

The maximum duration of therapy is 8-12 weeks.

Do not stop treatment abruptly, but rather gradually reduce the dose following your doctor's instructions. Do not change treatment.

Use in Children and Adolescents

Duna should not be administered to children.

Use in Elderly Patients

Elderly patients may be affected by Duna more than young patients. If you are an elderly patient, your doctor may prescribe a lower dose and monitor your response to treatment. Please carefully follow your doctor's instructions.

If You Take More Duna Than You Should

If you have ingested an overdose of Duna, call your doctor, pharmacist, or the nearest hospital immediately. The symptoms of Duna overdose range from lethargy to coma.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the name of the medication and the amount ingested.

If You Forget to Take Duna

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, continue with the normal dose.

If You Interrupt Treatment with Duna

Do not stop treatment without consulting your doctor.

Abrupt withdrawal of the medication may be accompanied by headache and/or muscle pain, anxiety, tension, restlessness, confusion, and irritability. In severe cases, it may cause personality changes, increased sensitivity to noise, tingling and cramps in the legs and arms, intolerance to light, noise, and physical contact, hallucinations, and seizures.

To avoid withdrawal symptoms, do not stop taking Duna abruptly, especially if you have been taking it for a long time. Gradually reduce the dose.

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

Like all medications, Duna can produce adverse effects, although not all people will experience them.

Most patients tolerate Duna well, but some, especially at the beginning of treatment, may feel a bit tired or drowsy during the day.

Symptoms that may occur at the beginning of treatment and generally disappear as treatment continues: drowsiness, emotional numbing (lack of reaction to emotional stimuli), confusion, fatigue, headache, dizziness, muscle weakness, double vision, and alteration of voluntary movement.

Much less commonly, gastrointestinal alterations, libido changes, and skin reactions may appear.

You may develop anterograde amnesia, meaning you will not remember what happened while you were standing up after taking the medication.

Very rarely, Duna may produce sudden anxiety, hallucinations, excitement, and sleep disorders.

If this happens, consult your doctor immediately.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

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 trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Duna

• The active principle is pinazepam. Each hard capsule contains 5 mg of pinazepam.
• The other components are: lactose monohydrate, magnesium stearate, gelatin, iron oxide red (E-172), erythrosine (E-127), titanium dioxide (E-171) and iron oxide black (E-172).

Appearance of the product and contents of the packaging

Each package contains 20 hard capsules (standard packaging) and 500 hard capsules (clinical packaging).

Holder of the marketing authorization and responsible for manufacturing

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of the last review of this leaflet:November 2020.

Other sources of information

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