Diazepam Aurovitas Spain 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diazepam Aurovitas Spain 5 mg tablets EFG

Diazepam Aurovitas Spain 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; you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you 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 effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Diazepam Aurovitas Spain contains diazepam as the active substance, which belongs to a group of medicines known as 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 stiff-person syndrome.

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

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

Do not take Diazepam Aurovitas Spain

• 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 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

Consult your doctor or pharmacist before taking Diazepam Aurovitas Spain:

• If you have any liver, heart, or kidney disease.
• If you have a history of alcohol or drug dependence.
• If you experience muscle weakness.
• If you have breathing difficulties.
• 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 you become less responsive to the therapeutic effects of the medicine. Tolerance to the various effects of benzodiazepines may develop.
• If you experience paradoxical reactions (opposite to the desired effects) or changes in behaviour (see section 4: "Effects on behaviour").

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

Children and adolescents

Do not administer 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.

In children under 6 months of age, the specialist will only use diazepam if no other medicines are available, because it is not known how well it works or how safe it is in these patients.

Children are more sensitive to the effects of benzodiazepines on the central nervous system. In this patient group, an incomplete metabolic pathway could prevent or reduce the production of inactive metabolites.

Other medicines and Diazepam Aurovitas Spain

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

Some medicines can alter how diazepam works. Especially:

• antidepressants (e.g. fluvoxamine, fluoxetine);
• antipsychotics such as clozapine (to treat mental disorders);
• 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, centrally acting antihypertensives).

Taking the following medicines together 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 it together with diazepam may cause excessive drowsiness and may cause diazepam to be eliminated from the body more slowly than normal;
• medicines for epilepsy, such as phenytoin and carbamazepine, as they may reduce the effect of diazepam. Diazepam may also affect how phenytoin works;
• theophylline (to treat 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 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 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.

Using diazepam together with opioids (strong analgesics, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all opioid medicines 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 mentioned above. Contact your doctor if you experience such symptoms.

Taking Diazepam Aurovitas Spain with food, drinks and alcohol

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 breast-feeding, unless your doctor tells you to. 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 Aurovitas Spain contains lactose monohydrate

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 Aurovitas Spain

Follow exactly the dosage instructions given by your doctor. 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 intensivist), who will determine the appropriate dose. In children under 6 months of age, the specialist will use diazepam only if no other medicines are available, as it is not known how well diazepam works or 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 your 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 process of gradual dose reduction.

Use in adults

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, reducing to 5 mg, 3 or 4 times daily, as needed.

Treatment of muscle spasms: 2 mg to 10 mg, 3 or 4 times daily.

Use in children

Treatment of muscle spasms in children over 6 years of age

Recommended dose:

Recommended dose: 2 to 40 mg divided into several doses/day.

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 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 normally 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 work. 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 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 Toxicology Information Service at telephone number: 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).

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 require symptomatic treatment for cardiorespiratory or central nervous system effects. Further absorption should be prevented using an appropriate method, for example, administration of activated charcoal within 1 to 2 hours. If activated charcoal is used, the respiratory tract must be protected in drowsy patients. In cases of mixed ingestion, gastric lavage may be considered, but not as a routine measure. If central nervous system depression is severe, consider using flumazenil, a benzodiazepine antagonist. This should only be administered under close monitoring. It has a short half-life (approximately one hour). Therefore, patients receiving flumazenil must be monitored after its effects have worn off. Extreme caution must be exercised when using flumazenil in cases involving drugs that lower the seizure threshold (e.g., tricyclic antidepressants). For further information on the correct use of this medicine, refer to the flumazenil product information.

If you forget to take Diazepam Aurovitas Spain

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 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 disturbances, headache, muscle pain, extreme anxiety, tension, restlessness, 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), loss of perception of reality (derealization), feeling detached or separated from oneself (depersonalization), sensitivity to noise (hyperacusis), tingling and numbness sensations in arms and legs, and seizures (convulsions).
• Rebound anxiety: a transient syndrome in which symptoms that led to benzodiazepine treatment reappear in an intensified form, which may occur upon discontinuation of treatment. It may be accompanied by other reactions such as mood changes, anxiety or sleep disturbances, and restlessness.
• 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 further 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 should 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 behavior (frequency not known)

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

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

Treatment with diazepam should be discontinued if such symptoms occur. These are 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 discontinuation of treatment will be accompanied by withdrawal symptoms.

These include:

• Difficulty sleeping, headaches.
• Muscle pain, tremors, and restlessness, drowsiness and tingling sensations 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 losing touch with reality.

Patients taking sedatives and elderly patients

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

Other side effects:

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

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

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

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

The following side effects may occur during treatment, with frequencies defined as very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (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 even at therapeutic doses, with increased risk at higher doses. Amnesic effects may be associated with inappropriate behavior.
• Speech disorders (dysarthria), loss of coordination (ataxia), including unsteadiness when walking.
• Increased or decreased sexual desire (libido).
• Tremors (tremor), dizziness, emotional blunting.
• Drowsiness. Drowsiness is usually dose-related. It occurs predominantly at the beginning of therapy but usually diminishes with repeated administration.

Liver and blood (frequency not known)

• Changes in certain liver enzymes that may be detected in blood tests.
• Yellowing of the skin or eyes (jaundice).
• Blood disorders (blood dyscrasias 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 lightheadedness upon standing.
• Circulatory 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)

• Breathing 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, which may present as dizziness or spinning sensations.
• Skin reactions. The most common reactions are skin rash, hives, itching, and erythematous rash. Cases of severe skin reactions have also been reported (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Erythema Multiforme).

Injury 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 any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diazepam Aurovitas Spain

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

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

This medicine does not require any special storage conditions.

Medicines must 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 have any doubts, 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 Aurovitas Spain

• The active substance is diazepam. Each tablet contains 5 mg or 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 Aurovitas Spain 5 mg tablets: round, flat, white or almost white tablets, 8 mm in diameter, marked with “5” on one side and a break line on the other side.

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

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

Only certain pack 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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium - Diazetop

Luxembourg - Diazetop

Spain - Diazepam Aurovitas Spain

United Kingdom (Northern Ireland) – Diazepam GSP

Poland – Diazepam Genoptim

Date of the most recent revision of this leaflet: October 2024

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