Diazepam Durban 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diazepam Durbán 5 mg tablets EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• 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 must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet :

1 What Diazepam Durbán is and what it is used for

2 What you need to know before taking Diazepam Durbán

3 How to take Diazepam Durbán

4 Possible adverse effects

5 How to store Diazepam Durbán

6 Contents of the pack and other information

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

This medicine contains diazepam as the active ingredient, which belongs to a group of medicines called benzodiazepines.

Diazepam is indicated for the treatment of the following conditions:

In adults:

• Anxiety symptoms
• Symptoms occurring during alcohol withdrawal

In adults and children over 6 years of age:

• Muscle spasms or pain caused by inflammation of muscles and joints, trauma, including spasms associated with conditions such as cerebral palsy (a group of disorders affecting the ability to move, maintain balance and posture), 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 generalized stiffness syndrome.

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 medicine (listed in section 6).
• If you have a disease called "myasthenia gravis", which is characterized by muscle weakness and fatigue.
• If you have acute respiratory problems (slow or weak breathing).
• If you suffer from sleep apnoea (a sleep disorder causing abnormal interruptions in breathing during sleep).
• If you have severe liver problems (severe hepatic insufficiency).

Warnings and precautions

Talk to 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 suffer from muscle weakness.
• If you have a history of drug or alcohol dependence.
• If you have mental disorders. Benzodiazepines are not recommended as first-line treatment for psychosis (mental disorders). These medicines 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 no longer having the same effect as when you started treatment. The use of benzodiazepines may lead to tolerance.
• If you experience adverse effects or changes in behaviour (see section 4).

There is a risk of dependence when taking this medicine.

Children and adolescents

Do not give this medicine to children under 6 years of age unless decided by a physician and under strict supervision by a specialist (paediatrician, neurologist, psychiatrist, anaesthetist, or intensivist), who will determine the appropriate dose.

Children are more sensitive to the effects of benzodiazepines on the central nervous system. In this patient group, the incomplete development of metabolic mechanisms in the body may impair or reduce the production of degradation products, resulting in increased activity.

Taking Diazepam Durbán with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. Some medicines may alter how diazepam works.

Especially:

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

Taking the following medicines with diazepam may affect your mental state, cause drowsiness, and reduce your breathing and blood pressure.

• disulfiram (for the treatment of alcohol addiction). Taking it together with diazepam may cause excessive drowsiness and may cause diazepam to be eliminated from the body more slowly than normal;
• antiepileptic medicines, such as phenytoin and carbamazepine, as they may reduce the effect of diazepam. Diazepam may also affect how phenytoin works;
• theophylline (for treating asthma and other respiratory disorders), as it may reduce the effect of diazepam;
• cimetidine, omeprazole or esomeprazole (medicines 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. This may reduce the effect of diazepam;
• atazanavir, ritonavir, delavirdine, efavirenz, indinavir, nelfinavir or saquinavir (antivirals), fluconazole, itraconazole, ketoconazole or voriconazole (antifungal medicines), as they may cause diazepam to be eliminated from the body more slowly than normal, thereby increasing 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 contraceptive protection is not reduced;
• cisapride (used to treat stomach problems), as it may cause diazepam to be eliminated from the body more slowly than normal;
• corticosteroids (medicines used to treat inflammation in the body), as they may reduce 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 anaesthetic), 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 drinks increase the sedative effects of diazepam. Grapefruit juice may enhance the sedative effect of diazepam.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should not take diazepam if you are pregnant, planning to become pregnant, or breastfeeding. This medicine may affect your baby.

Driving and using machines

Consult your doctor before driving or operating machinery, as diazepam may reduce your reaction time. These effects are increased by alcohol consumption and lack of sleep.

Diazepam Durbán contains lactose

This medicine 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 Diazepam Durbán

Follow exactly the dosage instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not administer this medicine to children under 6 years of age unless decided by a physician and under strict supervision of a specialist (paediatrician, neurologist, psychiatrist, anaesthetist, or intensive care specialist), 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 your 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 in a single dose.

Recommended doses:

Anxiety symptoms: 10 mg per day (2.5 mg in the morning, 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, then reduced 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 of age and adolescents. Recommended dose:

Children 6–12 years: 5 mg twice daily
Children 12–18 years: 10 mg twice daily

Chronic (long-term) treatment is not recommended.

Diazepam is not recommended in children under 6 years of age due to possible difficulties in swallowing. There are more suitable pharmaceutical forms available 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 adult dose. Treatment should start with the lowest possible dose (2 to 2.5 mg, once or twice daily), gradually increasing as needed and tolerated.

Use in patients with renal impairment

Dose adjustment is usually not necessary. However, patients with renal impairment should take diazepam with caution. Benzodiazepines with active metabolites, such as diazepam, should be avoided in patients with end-stage renal disease.

Use in patients with hepatic impairment

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

Use in overweight patients

If you are overweight, the medicine may take longer to take effect. In addition, the effects of diazepam may last longer, including possible side effects.

Take this medicine preferably in the afternoon or at night.

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 suspect that a child may have swallowed any, contact the nearest hospital, consult your doctor or pharmacist immediately, or call the Toxicology Information Service Telephone: 91 562 04 20, indicating the medicine and the amount taken.

Symptoms of overdose include inability to coordinate voluntary muscle movements, apnoea (severe breathing difficulty), 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 missed doses. If you forget a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at the regular time.

If you stop taking Diazepam Durbán

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

• You should gradually reduce the number of doses or the dose amount before stopping treatment completely. Your doctor will advise you on how to do this.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Allergic reactions

If you develop an allergic reaction, you must seek immediate medical attention. The side effects include:

• Sudden swelling of the throat, face, and lips, which may cause difficulty breathing and swallowing

• Sudden swelling of the hands, feet, and ankles, skin rash, or itching.

Effects on behaviour

Talk to your doctor if you notice any of the following side effects. Your doctor may decide to discontinue treatment:

• Aggression, irritability, nervousness, agitation, anxiety, delusions, anger.

• Difficulty sleeping, nightmares, and vivid dreams.

For possible withdrawal symptoms, please refer to 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 an increased risk of falls and fractures associated with the use of benzodiazepines in elderly patients.

Other side effects:

At the beginning of diazepam treatment, the following side effects may occur:

• Drowsiness, fatigue, dizziness, and lightheadedness.

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

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

The following side effects may occur during treatment:

Psychiatric and nervous system disorders

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

Liver and blood (very rare)

• Changes in certain liver enzymes that may be detected 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 cessation of heartbeat (cardiac arrest).

• Low blood pressure (hypotension). You may experience dizziness or a feeling of lightheadedness when standing up.

• Circulatory problems (circulatory depression).

Stomach and intestines (occasionally)

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

Lungs and kidneys

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

Eyes, skin, and hair

• Double vision, blurred vision, dizziness, which may present as dizziness or vertigo.
• The most common reactions are skin rash, hives, itching, and erythematous rash.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diazepam Durbán

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Diazepam Durbán

The active substance is diazepam. Each tablet contains 5 mg of diazepam.

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

Appearance of the product and contents of the pack

Diazepam Durbán 5 mg are white or almost white, round, flat tablets, 8 mm in diameter. The tablets are marked with the number "5" on one side and have a score line on the other side.

This medicine is available in packs of 30 and 40 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 most recent revision of this leaflet: January 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/