DIAZEPAM DURBAN 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Diazepam Durbán 10 mg Tablets EFG

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1 What is Diazepam Durbán and what is it used for

1. What you need to know before taking Diazepam Durbán
2. How to take Diazepam Durbán
3. Possible side effects
4. Storage of Diazepam Durbán
5. Package contents and additional information

1. What is Diazepam Durbán and what is it used for

This medication contains the active ingredient diazepam, which belongs to a group of medications called benzodiazepines.

Diazepam is indicated for the treatment of the following conditions:

In adults:

• Symptoms of anxiety
• Symptoms that occur during alcohol withdrawal

In adults and children over 6 years:

• Muscle spasms or pain caused by inflammation of the muscles and joints, trauma, including spasms caused by diseases such as cerebral palsy (a group of disorders that affect movement, balance, and posture) and paraplegia (paralysis of the lower half of the body, affecting both legs), as well as in athetosis (continuous, involuntary, slow, and abnormal movements of fingers and hands) and in the syndrome of generalized stiffness.

2. What you need to know before taking Diazepam Durbán

Do not take Diazepam Durbán

• If you are allergic to diazepam or any of the other components of this medication (listed in section 6).
• If you have a disease called "myasthenia gravis", which is characterized by muscle weakness and fatigue.
• If you have respiratory problems (slow or weak breathing).
• If you have sleep apnea (a sleep disorder that causes abnormal interruptions in breathing during sleep)
• If you have severe liver problems (severe hepatic insufficiency).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diazepam Durbán.

• If you have any liver, heart, or kidney disease
• If you have breathing difficulties
• If you have muscle weakness
• If you have a history of drug or alcohol dependence
• If you have mental disorders. Benzodiazepines are not recommended as a first-line treatment for psychosis (mental disorders). These medications should not be used to treat depression or anxiety associated with depression, as symptoms may worsen.
• If you have epilepsy or a history of seizures.

Tell your doctor:

• If after several weeks you notice that the tablets are not having the same effect as when you started treatment. The use of benzodiazepines can lead to tolerance.
• If you experience side effects or changes in behavior (see section 4).

There is a risk of dependence when taking this medication.

Children and adolescents

Do not give this medication to children under 6 years old unless it is done after a medical decision and under strict supervision of a specialist (pediatrician, neurologist, psychiatrist, anesthesiologist, and intensivist) who will determine the appropriate dose.

Children are more sensitive to the effects of benzodiazepines on the central nervous system. In this group of patients, the incomplete development of the transformation mechanism in the body could prevent or reduce the production of degradation products, resulting in increased activity.

Taking Diazepam Durbán with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. Some medications can alter the way diazepam works.

Especially:

• antidepressants (such as fluvoxamine, fluoxetine);
• antipsychotics such as clozapine (to treat mental problems);
• muscle relaxants (such as suxamethonium, tubocurarine);
• barbiturates such as phenobarbital (to treat epilepsy and mental disorders);
• other central nervous system depressants (buprenorphine, narcotic analgesics, opiates, and derivatives used to treat cough, baclofen, thalidomide, pizotifen, central-acting antihypertensives).

Taking these medications with diazepam may affect your mental state, make you feel drowsy, and decrease your breathing and blood pressure.

• • disulfiram (for the treatment of alcohol addiction). Taking it with diazepam may cause excessive drowsiness and may cause diazepam to be eliminated from the body more slowly than normal;
  • medications for epilepsy, such as phenytoin and carbamazepine, as they may reduce the effect of diazepam. Diazepam may also affect the functioning of phenytoin;
• theophylline (to treat asthma and other respiratory disorders), as it may decrease the effect of diazepam;
• • cimetidine, omeprazole, or esomeprazole (medications to reduce stomach acid) as they may cause diazepam to be eliminated from the body more slowly than normal;
  • rifampicin (an antibiotic) as it may cause diazepam to be eliminated from the body more quickly than normal. It may decrease the effect of diazepam.
  • atazanavir, ritonavir, delavirdine, efavirenz, indinavir, nelfinavir, or saquinavir (antivirals), fluconazole, itraconazole, ketoconazole, or voriconazole (antifungal medications) as they may cause diazepam to be eliminated from the body more slowly than normal, and thus increase the risk of side effects;
  • isoniazid (used to treat tuberculosis), as it may cause diazepam to be eliminated from the body more slowly than normal;
  • oral contraceptives, as they may delay the elimination of diazepam from the body and increase its effect. Bleeding may occur when taking diazepam and oral contraceptives, but it does not decrease contraceptive protection;
  • cisapride (used to treat stomach problems), as it may cause diazepam to be eliminated from the body more slowly than normal;
  • corticosteroids (medications used to treat inflammation in the body), as they may decrease the effect of diazepam;
  • levodopa (used to treat Parkinson's disease). Diazepam may reduce the effect of levodopa;
  • valproic acid (used to treat epilepsy and mental disorders), as it may delay the elimination of diazepam from the body and increase its effect. Taking valproic acid and diazepam together increases the risk of psychosis (mental illness);
  • ketamine (an anesthetic) as diazepam increases the effect of ketamine.

Taking Diazepam Durbán with food, drinks, and alcohol

Do not drink alcoholic beverages during treatment with diazepam. Alcoholic beverages increase the sedative effects of diazepam. Grapefruit juice may increase the sedative effect of diazepam.

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 medication. You should not take diazepam if you are pregnant, planning to become pregnant, or breastfeeding. This medication may affect your baby.

Driving and using machines

Consult your doctor before driving or using machines, as diazepam may decrease your reactions. These effects are increased with the use of alcohol and lack of sleep.

Diazepam Durbán contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Diazepam Durbán

Follow the administration instructions of the medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Do not give this medication to children under 6 years old unless it is done after a medical decision and under strict supervision of a specialist (pediatrician, neurologist, psychiatrist, anesthesiologist, and intensivist) who will determine the appropriate dose.

• Your doctor will prescribe a low dose and gradually increase it until the appropriate dose is reached.
• The dose will depend on your condition and response to treatment.
• The duration of treatment should be as short as possible. In general, treatment should not exceed 8 to 12 weeks.

Use in adults

The recommended dose is 2 to 20 mg per day. Never take more than 10 mg at a time.

Recommended doses:

Anxiety symptoms: 10 mg per day (2.5 mg in the morning and 2.5 mg in the afternoon and 5 mg at night).

Symptomatic relief in acute alcohol withdrawal: 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg 3 or 4 times a day, as needed.

Treatment of muscle spasms: 2 mg to 10 mg, 3 or 4 times a day.

Use in children and adolescents

Treatment of muscle spasms in children over 6 years and adolescents. Recommended dose:

Children 6-12 years: 5 mg, 2 times a day Children 12-18 years: 10 mg, 2 times a day

Chronic treatment (prolonged) is not recommended.

Diazepam is not recommended in children under 6 years due to possible difficulties in swallowing. There are more suitable pharmaceutical forms for young children.

Use in elderly patients

Your doctor will decide how much diazepam you should take and how often. The dose will be lower than the normal dose used for adults. Treatment should start with the lowest possible dose (2 to 2.5 mg, one or two times a day) and then gradually increase, as needed and tolerated.

Use in patients with renal failure

Normally, no dose adjustment is necessary. However, patients with renal failure should be cautious when taking diazepam. Benzodiazepines with active metabolites, such as diazepam, should be avoided in patients with end-stage renal disease.

Use in patients with hepatic failure

Your doctor will decide how much diazepam you should take and how often. The dose will be lower than the normal dose used for adults.

Use in patients with overweight

If you are overweight, the medication may take longer to work. Additionally, the effects of diazepam may take longer to disappear, including possible side effects.

Take this medication preferably in the afternoon or evening.

The tablet can be divided into two equal parts.

If you take more Diazepam Durbán than you should

If you have taken too many tablets (more than prescribed) or think a child may have swallowed some, contact the nearest hospital or consult your doctor or pharmacist immediately or call the Toxicology Information Service Phone: 91 562 04 20 indicating the medication and the amount used.

Symptoms of overdose include inability to coordinate voluntary muscle movements, apnea (severe breathing difficulties), low blood pressure (hypotension), heart and lung problems (cardiorespiratory failure), and coma (unconsciousness).

If you forget to take Diazepam Durbán

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take it as soon as you remember. If you are about to take the next dose, do not take the forgotten dose.

If you stop taking Diazepam Durbán

• Do not stop taking your medication without consulting your doctor. If you stop taking diazepam suddenly, you may experience withdrawal symptoms, including: sleep disorders, headache, muscle pain, tension, confusion, irritability or aggression, mood changes, and hypersensitivity to light, noise, and physical contact. Less common withdrawal symptoms are: seeing or hearing things that do not exist (hallucinations) and loss of perception of reality (derealization).

• You should gradually reduce the number or dose you take before stopping treatment completely. Your doctor will tell you how to do it.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some side effects can be serious and may require immediate medical attention:

Allergic reactions

If you develop an allergic reaction, seek medical attention immediately. Side effects are:

• Sudden swelling of the throat, face, and lips, which can cause difficulty breathing and swallowing
• Sudden swelling of the hands, feet, and ankles, skin rash, or itching.

Effects on behavior

Talk to your doctorif you notice any of the following side effects. Your doctor may request that you stop treatment:

• Aggression, irritability, nervousness, agitation, anxiety, delirium, anger.
• Sleep problems, nightmares, and vivid dreams.

For possible symptoms of withdrawal, please see the section "If you stop taking Diazepam Durbán" in Section 3.

These are more likely to occur in children and elderly patients.

Elderly patients

There is a higher risk of falls and fractures associated with the use of benzodiazepines in elderly patients.

Other side effects:

At the start of treatment with diazepamthe following side effects may occur:

• Drowsiness, fatigue, dizziness, and dizziness.
• Muscle weakness, inability to coordinate voluntary muscle movements (ataxia), and other movement disorders.

Your doctor may propose a lower dose of diazepam and then gradually increase it.

The following side effects may occur during treatment:

Psychiatric and nervous system disorders

• Difficulty concentrating, decreased alertness, confusion, and disorientation, agitation.
• Memory loss, headache, depression.
• Speech disorders, loss of coordination, including instability when walking.
• Changes in sexual desire (libido).

Liver and blood (very rare)

• Changes in certain liver enzymes that can be seen in blood tests.
• Yellowing of the skin or eyes (jaundice).
• Blood disorders. Signs may include fatigue, easy bruising, difficulty breathing, and nosebleeds. Your doctor may perform periodic blood tests.

Heart, circulation, and blood vessels

• Heart problems such as slow heart rate (bradycardia), heart failure, and cardiac arrest.
• Low blood pressure (hypotension). You may experience dizziness or dizziness when standing.
• Circulatory problems (circulatory depression).

Stomach and intestine (occasionally)

• Nausea, constipation, stomach pain.
• Dry mouth and increased salivation.

Lungs and kidneys

• Respiratory depression.
• Inability to urinate (urinary retention), loss of bladder control (urinary incontinence).

Eyes, skin, and hair

• Double vision, blurred vision, vertigo, whose signs may be dizziness or vertigo.
• The most common reactions are skin rash, hives, itching, and erythematous rash.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Diazepam Durbán

Keep this medication out of 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Diazepam Durbán

The active ingredient is diazepam. Each tablet contains 10 mg of diazepam.

The other components are lactose monohydrate, pregelatinized cornstarch, and magnesium stearate.

Appearance of the product and package contents

Diazepam Durbán 10 mg are white or almost white, round, and flat tablets with a diameter of 8 mm. The tablets are engraved with the inscription "10" on one side and with a score line on the other side.

This medication is available in packages of 25 and 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Francisco Durbán S.A.

Polígono Ind. La Redonda, c/ IX, nº 2

04710 El Ejido (Almería)

Spain

Manufacturer:

SANTA SA

Str. Panselelor nr. 25, nr. 27, nr. 29

Brasov, Jud. Brasov, 500419

Romania

Date of the last revision of this package leaflet: February 2023

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