Prospect: information for the user

Diazepam Durbán 5 mg tablets EFG

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1 What is Diazepam Durbán and how is it used

2. What you need to knowbefore starting to takeDiazepam Durbán

3. How to take Diazepam Durbán

4. Possible adverse effects

5. Storage of Diazepam Durbán

6. Contents of the package and additional informationl

This medication contains diazepam as its active ingredient, 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 muscles and joints, trauma, including spasms caused by conditions such as cerebral palsy (a group of disorders that affect the ability to move, maintain balance, and posture) and paraplegia (paralysis of the lower half of the body, affecting both legs), as well as in athetosis (slow, involuntary, abnormal movements of fingers and hands) and in generalized rigidity syndrome.

Do not take DiazepamDurbán

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

Inform your doctor:

There is a risk of dependence when taking this medication.

Children and adolescents

Do not administer this medication to children under 6 years old unless a medical decision is made and under strict supervision of a specialist (pediatrician, neurologist, psychiatrist, anesthesiologist, or 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 may prevent or reduce the production of degradation products, resulting in increased activity.

Taking Diazepam Durbán with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take another medication. Some medications may alter the way diazepam works.

Especially:

The use of the following medications with diazepam may affect your mental state, make you feel drowsy, and decrease your breathing and blood pressure.

• theophylline (for asthma and other respiratory disorders), as it may reduce the effect of diazepam;

Taking Diazepam Durbán with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment with diazepam. Alcoholic beverages increase the sedative effects of diazepam. The juice of a grapefruit may increase the sedative effect of diazepam.

Pregnancy and breastfeeding

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

Driving and operating machinery

Consult your doctor before driving or operating machinery as diazepam may impair 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.

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

Do not administer this medication to children under 6 years old unless a medical decision is made 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 to reach the appropriate dose.
• The dose will depend on your condition and your response to treatment.
• The treatment duration 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. Do not 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).

Absinthe relief in acute alcohol deprivation:10 mg, 3 or 4 times within 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 old and adolescentsRecommended dose:

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

Chronic treatment (prolonged) is not recommended.

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

Use in elderly people

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, once or twice 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 terminal 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 obesity

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 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 some, contact the nearest hospital or consult your doctor or pharmacist immediately or call the Toxicological Information Service Telephone: 91 562 04 20 indicating the medication and the amount used.

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

If you forgot to take Diazepam Durbán

Do not take a double dose to compensate for the missed 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 missed dose.

If you interrupt treatment with Diazepam Durbán

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

Like all medicines, this medicine may cause side 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 mustseek immediate medical attention.The side effects are:

• 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 behavior

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

For possible withdrawal symptoms, please refer to the section "If you interrupt treatment with Diazepam Durbán" in Section 3.

It is more likely to occur in children and elderly patients.

Elderly patients

There is a higher risk of falls and fractures associated with elderly patients using benzodiazepines.

Other side effects:

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

• Drowsiness, fatigue, dizziness, and disorientation.

• 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

Liver and blood (very rare)

Heart, circulation, and blood vessels

Stomach and intestines (occasionally)

Lungs and kidneys

Eyes, skin, and hair

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Diazepam Durbán

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

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

Appearance of the product and contents of the packaging

Diazepam Durbán 5 mg are white or off-white, round, and flat tablets of 8 mm in diameter. The tablets are engraved with the inscription “5” on one face and with a groove on the other face.

This medication is available in packaging of 30 and 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Francisco Durbán S.A.

Polígono Ind. La Redonda, c/ IX, nº 2

04710 El Ejido (Almería)

Spain

Responsible for manufacturing:

SANTA SA

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

Brasov, Jud. Brasov, 500419

Romania

Last review date of this leaflet: January 2023

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