Leaflet: information for the user

Diazepam Aurovitas Spain 5 mg tablets EFG

Diazepam Aurovitas Spain 10 mg tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to 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 additional informationl

Diazepam Aurovitas Spain contains as active ingredient 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 muscles and joints, trauma, including spasms caused by diseases 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.

Benzodiazepines are only indicated when the disorder is severe, incapacitating or causes extreme anguish.

Do not take Diazepam Aurovitas Spain

• 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 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 respiratory 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.

Inform your doctor:

• If you become less sensitive to the therapeutic effects of the medication. Habituation to the different effects of benzodiazepines may occur.
• If you experience contradictory effects or changes in behavior (see section 4: “Effects on behavior”).

There is a risk of dependence when taking this medication (see section 4: “Withdrawal symptoms”).

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.

In children under 6 months, the specialist will only use diazepam if no other medications are available, as its effectiveness and safety in these patients are unknown.

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

Other medications and Diazepam Aurovitas Spain

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

Some medications may alter the way diazepam works. Especially:

• antidepressants(e.g. fluvoxamine, fluoxetine);
• antipsychoticssuch as clozapine (for mental health problems);
• muscle relaxants(e.g. suxamethonium, tubocurarine);
• barbiturates such asphenobarbital(for epilepsy and mental health disorders);
• other central nervous system depressants (buprenorphine, opioid analgesics, opiatesand derivatives used ??for cough, baclofen, thalidomide, pizotifen, anti-hypertensive drugs with central action).

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

• disulfiram(for alcohol addiction treatment). The combination with diazepam may cause excessive sleepiness and can cause diazepam to be eliminated from the body more slowly than normal;
• antiepileptic medicationssuch as phenytoin and carbamazepine, as they may reduce the effect of diazepam. Diazepam may also affect the functioning of phenytoin;
• theophylline(for 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 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 contraceptivesas they may delay the elimination of diazepam from the body and increase its effect. Taking diazepam and oral contraceptives may cause bleeding, but 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 health disorders) as it may delay the elimination of diazepam from the body and increase its effect. The combination of valproic acid and diazepam increases the risk of psychosis (mental disorders);
• ketamine(an anesthetic) as diazepam may increase the effect of ketamine.

The use of diazepam with opioids (potent analgesics, substitution therapy medications, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

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

Inform your doctor about all opioid medications you are taking and follow your doctor's recommended dosing. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

Taking Diazepam Aurovitas Spain with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you 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, unless your doctor tells you to. This medication may affect your baby.

Driving and operating machinery

Consult your doctor before driving or operating machinery as diazepam may decrease your reactions. These effects are increased with alcohol and lack of sleep.

Diazepam Aurovitas Spain contains lactose monohydrate

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

• 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, 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).

Acute alcohol withdrawal relief:10 mg, 3 or 4 times within the first 24 hours, reducing to 5 mg, 3 or 4 times a day, as needed.

Muscle spasm treatment:2 mg to 10 mg, 3 or 4 times a day.

Use in children

Treatment of muscle spasms in children over 6 years old

Recommended dose:

Recommended dose: 2 to 40 mg divided into different doses per 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 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, 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 Aurovitas Spain 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).

Information for medical personnel

Follow the patient's vital signs and initiate supportive measures as needed based on the patient's clinical condition. Patients may require especially symptomatic treatment for cardiorespiratory effects or central nervous system effects. Avoid further absorption using an appropriate method, for example, administering activated charcoal within 1 to 2 hours. If activated charcoal is used, the respiratory tract should be protected in obtunded patients. In cases of mixed ingestion, gastric lavage may be considered, but not as a routine measure. If the CNS depression is severe, consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under close monitoring. It has a short half-life (around 1 hour). Therefore, patients receiving flumazenil should be monitored after its effects have disappeared. Extreme 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 medication, consult the flumazenil technical sheet.

If you forget to take Diazepam Aurovitas Spain

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

• Do not stop taking your medication without consulting your doctor. If you stop taking diazepam suddenly, you may experience withdrawal symptoms, including: sleep disturbances, headaches, 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 losing perception of reality (derealization), feeling disconnected or separated from oneself (depersonalization), feeling sensitive to noise (hyperacusia), 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 appear when treatment is stopped. It may be accompanied by other reactions, such as mood changes, anxiety, or sleep and restlessness disturbances.
• 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 other questions 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 (unknown frequency)

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

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

Discontinue diazepam treatment if such symptoms occur. It is more likely to occur in children and elderly patients.

Withdrawal symptoms

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

These include:

• Difficulty sleeping, headaches.
• Muscle pain, tremors, and a feeling of restlessness, a feeling of drowsiness, and tingling in the extremities.
• Feeling very anxious, tense, confused, irritable, or agitated and mood changes.
• Increased sensitivity to light, noise, and physical contact.

Less frequent withdrawal symptoms include:

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

Patients taking sedatives and elderly patients

There is a higher risk of falls and fractures associated with patients taking sedatives concomitantly (including alcohol) and 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 or hypotonia, inability to coordinate voluntary muscle movements (ataxia), and feeling of instability when walking.

Consult your doctor if you notice any of these side effects.

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

The following side effects may occur during treatment, whose frequency may 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 unknown frequency (the frequency cannot be estimated from the available data):

Mental health and nervous system disorders (unknown frequency)

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

Liver and blood (unknown frequency)

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

Heart, circulation, and blood vessels (unknown frequency)

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

Stomach and intestines (unknown frequency)

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

Lungs and kidneys (unknown frequency)

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

Eyes, skin, and hair (unknown frequency)

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

Injuries and muscles (unknown frequency)

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

-Muscle weakness.

If you consider that any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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.

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.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medications that you no longer need. By doing so, you will help protect the environment.

Composition of Diazepam Aurovitas Spain

•The active ingredient is diazepam. Each tablet contains 5mg or 10 mg of diazepam.

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

Appearance of the product and contents of the packaging

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

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

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

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization and local representative:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

Responsible for manufacturing:

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

Revision date of this leaflet:October 2024

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