DIAZEPAM AUROVITAS 2.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Diazepam Aurovitas 2.5 mg Tablets

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

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

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

Diazepam is indicated for the treatment of the following disorders:

In adults:

• anxiety symptoms
• symptoms associated with alcohol withdrawal syndrome

In adults and children over 6 years:

• Muscle spasms or pain caused by inflammation of the muscles and joints, or 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.

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

Do not take Diazepam Aurovitas

• 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:

If you have:

• any liver, heart, or kidney disease.
• problems with alcohol or drug dependence.
• muscle weakness.
• breathing difficulties.
• 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.
• epilepsy or a history of seizures.

• If after several weeks you notice that the tablets are not having the same effect as when you started treatment. The use of benzodiazepines can lead to tolerance.
• If you experience side effects or changes in behavior (see section 4).

There is a risk of dependence when taking this medicine.

Children and adolescents

Do not give this medicine to children under 6 years old unless it is done after medical decision 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 metabolism scheme could prevent or reduce the production of inactive metabolites.

Other medicines and Diazepam Aurovitas

Tell your doctor or pharmacist if you are taking or have recently taken or may take other medicines, such as antidepressants (e.g., fluvoxamine, fluoxetine);

• antipsychotics such 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 these 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 it 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 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 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 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 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 normal;
• 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.

Opioids

The concomitant use of diazepam and opioids (potent analgesics, substitution therapy medications, and some cough medications) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, 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.

Tell your doctor about all opioid medications you are taking and closely follow your doctor's dosing recommendations. 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 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take diazepam if you are pregnant, planning to become pregnant, or are breastfeeding. This medicine may affect your baby.

Driving and using machines

Consult your doctor before driving or using machines, as diazepam may impair your reactions. These effects are increased by the use of alcohol and lack of sleep.

Diazepam Aurovitas contains lactose monohydrate

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

3. How to take Diazepam Aurovitas

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

Posology

Your doctor will decide the appropriate dose and for how long you should take the tablets. The usual duration of treatment does not exceed 4 weeks. If necessary, the doctor may increase the duration of treatment.

Use in adults

Recommended doses for:

• Anxiety symptoms:
• • 2 mg to 5 mg of diazepam 2 to 3 times a day

The dose may be increased up to a maximum of 30 mg per day divided into 2 to 4 doses.

• Alcohol withdrawal syndrome
• • 5 mg to 20 mg of diazepam, which may be repeated once after 2 to 4 hours if necessary, or
  • 10 mg of diazepam three or four times on the first day

After the first day, the dose is usually reduced to 5 mg of diazepam three or four times a day as needed. In severe cases, the doctor may use other dosing regimens, and treatment may need to be carried out in a hospital setting.

• Muscle spasms:
• • Up to 15 mg of diazepam per day divided into 2 to 4 doses
  • Muscle spasms in cerebral spasticity up to a maximum of 60 mg per day divided into 3 to 4 doses

Use in children and adolescents

Children over 6 years and adolescents (over 20 kg)

The child's doctor will decide how much diazepam they should take and how often. The usual dose is 0.1-0.3 mg/kg body weight per day divided into 2 to 4 doses.

Children under 6 years

This medicine is not recommended for children under 6 years due to possible difficulties in swallowing. More suitable pharmaceutical forms may be available for younger children. Do not give this medicine to children under 6 years unless it is done after medical consultation and under strict supervision of a specialist (pediatrician, neurologist, psychiatrist, anesthesiologist, or intensivist) who will determine the dose.

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, once or twice a day) and then gradually increased as needed and tolerated.

Use in patients with renal insufficiency

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 insufficiency

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. Patients with severe hepatic insufficiency should not use this medicine (see section 2 "Do not take Diazepam Aurovitas").

Use in overweight patients

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.

Method of administration

The tablet can be divided into two equal parts.

If you take more Diazepam Aurovitas 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, consult your doctor or pharmacist immediately, or call the Toxicology Information Service Telephone: 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).

Duration of treatment

The duration of treatment should be as short as possible. In general, treatment should not exceed 8 to 12 weeks.

If you forget to take Diazepam Aurovitas

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 you are about to take the next dose, do not take the forgotten dose.

If you stop taking Diazepam Aurovitas

• 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 hallucinations and loss of perception of reality (derealization).
• 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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Allergic reactions

If you develop an allergic reaction, 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)

Consult your doctorif you notice any of the following side effects.

• aggressiveness, irritability, nervousness, agitation, anxiety, delirium, anger
• Sleep problems, nightmares, and vivid dreams

It is possible that your doctor will ask you to stop treatment.

To know the possible symptoms of withdrawal, see "If you stop taking Diazepam Aurovitas" in Section 3.

These effects are more frequent in children and the elderly.

Elderly patients

There is a higher risk of falls and fractures associated with the use of benzodiazepines.

Other side effects:

At the start of treatment with diazepamthe 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 propose 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, decreased alertness, confusion, and disorientation, restlessness.
• Memory loss.
• Headache.
• Depression.
• Speech disorders.
• Loss of coordination, including instability when walking.
• Changes in sexual desire (libido).

Very rare(may affect up to 1 in 10,000 people)

Liver and blood

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

Heart, circulation, and blood vessels

• Heart problems such as slow heart rate (bradycardia), heart failure, and cardiac arrest.
• Low blood pressure (hypotension). You may experience dizziness or lightheadedness when standing.
• Circulation problems (circulatory depression).

Uncommon(may affect up to 1 in 100 people)

Stomach and intestine

• Nausea.
• Constipation.
• Stomach pain.
• Dry mouth or 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.
• Dizziness, whose signs may be dizziness or a feeling of spinning.
• The most common reactions are skin rash, hives, itching, and erythematous rash.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diazepam Aurovitas

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 carton after CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Diazepam Aurovitas

• The active ingredient is diazepam.

Each tablet contains 2.5 mg of diazepam.

• The other ingredients are lactose monohydrate, corn starch, pregelatinized corn starch, magnesium stearate, red iron oxide (E172).

Appearance of the Product and Package Contents

Tablet

Diazepam Aurovitas 2.5 mg tablets:

Tablets with a beveled edge, light pink in color, circular, with a flat face, approximately 8.8 mm in size, uncoated, engraved with "D" and "2.5" separated by a score line on one side and smooth on the other. The tablet can be divided into equal doses.

Diazepam Aurovitas tablets are available in blister packs.

Package Sizes:

Blister Packs:10, 20, 30, 40, and 60 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Diazepam Aurovitas 2.5 mg tablets

Portugal: Diazepam Generis Phar

Date of the Last Revision of this Leaflet:May 2024

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