Diazepam Durban 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diazepam Durbán 10 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 must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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 substance, 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 movement, 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 to any of the other ingredients 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 respiratory problems (slow or weak breathing).
• If you have sleep apnea (a sleep disorder causing abnormal pauses 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.

Inform 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 behavior (see section 4).

There is a risk of dependence with this medicine.

Children and adolescents

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

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

Taking Diazepam Durbán with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may alter the way 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 slow down the elimination of diazepam from the body;
  • 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 anesthetic), as diazepam enhances 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 or breastfeeding, think you may be pregnant, or plan 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 them before taking this medicine.

3. How to take Diazepam Durbán

Follow exactly the instructions for use of the medicine 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 (pediatrician, neurologist, psychiatrist, anesthesiologist, or 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 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 per day as needed.

Treatment of muscle spasms: 2 mg to 10 mg, 3 or 4 times per 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 (prolonged) treatment is not recommended.

Diazepam is not recommended in children under 6 years of age due to possible swallowing difficulties. 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 be initiated 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 exercise caution 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 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 think a child may have swallowed any, contact the nearest hospital or 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, apnea (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 to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose.

If you stop taking Diazepam Durbán

• Do not stop taking your 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 or dose taken 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 will experience 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, delirium, anger
• Sleep disturbances, 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 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 periodically perform 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 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 (urinary incontinence)

Eyes, skin, and hair

• Double vision, blurred vision, vertigo, whose signs may include dizziness or spinning sensations
• The most common reactions are skin rash, urticaria, pruritus, and erythematous rash

Reporting of adverse effects

If you experience any 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 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 are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. 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 10 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 10 mg are white or almost white, round, flat tablets, 8 mm in diameter. The tablets are marked with the inscription "10" on one side and have a score line on the other side.

This medicine is available in packs 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 most recent revision of this leaflet: February 2023

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