DIAZEPAM AUROVITAS SPAIN 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Diazepam Aurovitas Spain 5 mg tablets EFG

Diazepam Aurovitas Spain 10 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Diazepam Aurovitas Spain and what is it used for
2. What you need to know before you take Diazepam Aurovitas Spain
3. How to take Diazepam Aurovitas Spain
4. Possible side effects
5. Storage of Diazepam Aurovitas Spain
6. Contents of the pack and further information

1. What is Diazepam Aurovitas Spain and what is it used for

Diazepam Aurovitas Spain contains the active substance diazepam, which belongs to a group of medicines called benzodiazepines.

Diazepam is indicated for the treatment of the following conditions:

In adults:

• anxiety symptoms
• 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 stiff person syndrome.

Benzodiazepines are only indicated when the disorder is severe, disabling, or subjects the individual to extreme distress.

2. What you need to know before you take Diazepam Aurovitas Spain

Do not take Diazepam Aurovitas Spain

• If you are allergic to diazepam or 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 acute respiratory problems (slow or weak breathing).
• If you suffer from nocturnal 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 Aurovitas Spain:

• If you have any liver, heart, or kidney disease.
• If you have a history of alcohol or drug dependence.
• If you have muscle weakness.
• If you have breathing difficulties.
• 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 you become less sensitive to the therapeutic effects of the medicine. Habituation to the different effects of benzodiazepines may occur.
• If you experience contradictory effects to those desired or changes in behavior (see section 4: "Effects on behavior").

There is a risk of dependence when taking this medicine (see section 4: "Withdrawal symptoms").

Children and adolescents

Do not give this medicine 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.

In children under 6 months, the specialist will only use diazepam if no other medications are available, as it is not known how well diazepam works and how safe it is in these patients.

Children are more sensitive to the effects of benzodiazepines on the central nervous system. In this group of patients, the incomplete metabolism scheme could prevent or reduce the production of inactive metabolites.

Other medicines and Diazepam Aurovitas Spain

Tell your doctor or pharmacist if you are taking or have recently taken or may take other medicines. This also applies to medicines that you can obtain without a prescription and to herbal remedies. This is because diazepam can affect how other medicines work.

Some medicines may alter the way diazepam works. Especially:

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

Taking the following medicines 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 disulfiram with diazepam may cause excessive drowsiness and may cause diazepam to be eliminated from the body more slowly than usual;
• medicines 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(medicines to reduce stomach acid) as they may cause diazepam to be eliminated from the body more slowly than usual;
• rifampicin(an antibiotic) as it may cause diazepam to be eliminated from the body more quickly than usual. It may decrease 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 usual, 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 usual;
• 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 usual;
• corticosteroids(medicines 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. The concomitant use of valproic acid and diazepam increases the risk of psychosis (mental illness);
• ketamine(an anesthetic) as diazepam increases the effect of ketamine.

Taking diazepam at the same time as opioids (potent analgesics, substitution therapy medications, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes diazepam along with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all opioid medications you are taking and follow your doctor's dosing recommendations closely. It may be helpful to inform friends or relatives so they are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

Taking Diazepam Aurovitas Spain with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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, unless your doctor tells you to do so. This medicine 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 Aurovitas Spain contains lactose monohydrate

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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3. How to take Diazepam Aurovitas Spain

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

Do not give this medicine 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. In children under 6 months, the specialist will only use diazepam if no other medications are available, as it is not known how well diazepam works and how safe it is in these patients.

• 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, including the gradual reduction process.

Use in adults

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

Treatment of muscle spasms in children over 6 years

Recommended dose:

Recommended dose: 2 to 40 mg divided into several doses per 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 be started with the lowest possible dose (2 to 2.5 mg, one or two times a day) and then gradually increased, 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 who are overweight

If you are overweight, the medicine may take longer to work. Additionally, the effects of diazepam may take longer to disappear, 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 Aurovitas Spain than you should

• If you have taken too many tablets (more than prescribed) or think that 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 medicine and the amount used.
• The 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).

Information for medical personnel

Monitor the patient's vital signs and initiate supportive measures as required by the patient's clinical condition. Patients may especially need symptomatic treatment for cardiorrespiratory or central nervous system effects. Further absorption should be avoided by an appropriate method, for example, administration of activated charcoal within 1 to 2 hours. If activated charcoal is used, the respiratory tract should be protected in obtunded patients. In case of mixed ingestion, gastric lavage may be considered, but not as a routine measure. If central nervous system depression is severe, the use of flumazenil, a benzodiazepine antagonist, should be considered. This should only be administered under close monitoring. It has a short half-life (about one hour). Therefore, patients who receive flumazenil should be monitored after its effects have disappeared. Caution should be exercised when using flumazenil in the case of medications that reduce the seizure threshold (e.g., tricyclic antidepressants). For more information on the correct use of this medicine, consult the flumazenil summary of product characteristics.

If you forget to take Diazepam Aurovitas Spain

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 it is almost time for your next dose, do not take the missed dose.

If you stop taking Diazepam Aurovitas Spain

• Do not stop taking your medicine without consulting your doctor. If you stop taking diazepam suddenly, you may experience withdrawal symptoms, including: sleep disorders, headache, muscle pain, extreme anxiety, tension, restlessness, 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), feeling disconnected or separated from oneself (depersonalization), feeling sensitive to noise (hyperacusis), tingling, and numbness in arms and legs, and seizures (convulsions).
• Rebound anxiety: a transient syndrome in which the symptoms that led to treatment with a benzodiazepine reappear in an intensified form, which may occur when treatment is discontinued. It may be accompanied by other reactions, such as mood changes, anxiety, or sleep disorders and restlessness.
• You should gradually reduce the number or dose you take before stopping treatment completely. Your doctor will tell you how to do this.

If you have any further questions on 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 all people suffer from them.

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

Allergic reactions

If you develop an allergic reaction, you should seek medical attention immediately. The 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 (frequency not known)

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

• Psychiatric and paradoxical reactions such as restlessness, irritability, aggression, delirium, changes in thinking and perception that conflict with reality (delusions), anger, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects.

Treatment with diazepam should be interrupted if such symptoms occur. They are more likely to occur in children and elderly patients.

Withdrawal symptoms

Chronic use (even at therapeutic doses) can lead to the development of addiction (dependence). Once dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms.

These include:

• Sleep problems, headaches.
• Muscle pain, tremors, and feeling of restlessness, feeling of drowsiness, and tingling in the limbs.
• Feeling very anxious, tense, confused, irritable, or agitated, and mood changes.
• Hypersensitivity to light, noise, and physical contact.

Less frequent withdrawal symptoms include:

• Seeing or hearing things that are not really there (hallucinations).
• Feeling of loss of contact with reality.

Patient taking sedatives and elderly patients

There is a higher risk of falls and associated fractures in patients taking concomitant sedatives (including alcohol) and elderly patients using benzodiazepines.

Other side effects:

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

• Drowsiness, fatigue, dizziness, and lightheadedness.
• Muscle weakness or hypotonia, inability to coordinate voluntary muscle movements (ataxia), and feeling of instability when walking.

If you notice any of these effects, consult your doctor.

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

The following side effects may occur during treatment, whose frequency can be defined as very frequent (may affect more than 1 in 10 people), frequent (may affect up to 1 in 10 people), infrequent (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), and frequency not known (frequency cannot be estimated from available data):

Psychiatric and nervous system disorders (frequency not known)

• Difficulty concentrating, decreased alertness, confusion, and disorientation, restlessness.
• Memory loss (anterograde amnesia), headache, depression. Anterograde amnesia may occur using therapeutic doses, increasing the risk at higher doses. Amnestic effects may be associated with inappropriate behavior.
• Speech disorders (dysarthria), loss of coordination (ataxia), including instability when walking.
• Increased or decreased sexual desire (libido).
• Tremors (tremor), dizziness, emotional poverty.
• Drowsiness. Drowsiness is usually related to the dose. It occurs predominantly at the beginning of therapy but generally disappears with repeated administration.

Liver and blood (frequency not known)

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

Heart, circulation, and blood vessels (frequency not known)

• Irregular heartbeat, heart failure, including cardiac arrest.
• Low blood pressure (hypotension). You may experience dizziness or a feeling of lightheadedness when standing.
• Circulation problems (circulatory depression).

Stomach and intestine (frequency not known)

• Nausea, constipation, and other gastrointestinal disorders, such as stomach pain.
• Dry mouth or increased salivation (hypersalivation).

Lungs and kidneys (frequency not known)

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

Eyes, skin, and hair (frequency not known)

• Double vision, blurred vision, vertigo, whose signs may be dizziness or vertigo.
• Skin reactions. The most common reactions are skin rash, hives, itching, and erythematous rash. Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme) have also been reported.

Injuries and muscles (frequency not known)

• Falls and associated fractures. See "Patients taking sedatives and elderly patients" above in this section.

• Muscle weakness.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Diazepam Aurovitas Spain

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Diazepam Aurovitas Spain

• The active ingredient is diazepam. Each tablet contains 5mg or 10mg of diazepam.
• The other components are lactose monohydrate, pregelatinized cornstarch, and magnesium stearate.

Appearance of the product and package contents

Diazepam Aurovitas Spain 5mg tablets: round, flat, white or almost white tablets, 8mm in diameter, marked with "5" on one face and a break line on the other face.

Diazepam Aurovitas Spain 10mg tablets: round, flat, white or almost white tablets, 8mm in diameter, marked with "10" on one face and a break line on the other face.

Diazepam Aurovitas Spain is packaged in AL/PVC blisters. The blister, along with the prospectus, is packaged in cartons of 10, 20, 25, 28, 30, 40, 50, 56, 60, and 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder and local representative:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

Manufacturer:

SANTA SA

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

Brasov

jud. Brasov, cod 500419

Romania

This medicine is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Belgium - Diazetop

Luxembourg - Diazetop

Spain - Diazepam Aurovitas Spain

United Kingdom (Northern Ireland) – Diazepam GSP

Poland – Diazepam Genoptim

Date of the last revision of this prospectus:October 2024

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