Diazepam Aurovitas 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diazepam Aurovitas 5 mg tablets EFG

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

• Keep this leaflet, as 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 should 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Diazepam Aurovitas is and what it is 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 conditions:

In adults:

• anxiety symptoms
• symptoms associated with alcohol withdrawal syndrome

In adults and children over 6 years of age:

• Muscle spasms or pain caused by inflammation of muscles and joints, or trauma, including spasms caused by 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 generalized stiffness syndrome.

2. What you need to know before taking 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 sleep apnoea (a sleep disorder causing abnormal interruptions in breathing during sleep).
• If you have severe liver problems (severe hepatic insufficiency).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take diazepam if:

You have:

• any liver, heart, or kidney disease.

• a history of alcohol or drug dependence.

• muscle weakness.

• breathing difficulties.

• 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.

• epilepsy or a history of seizures.

• If after several weeks you notice that the tablets are no longer producing the same effect as when you started treatment. The use of benzodiazepines may lead to tolerance.

• If you experience adverse effects or changes in behaviour (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 of age unless specifically decided by a physician and under strict supervision by a specialist (paediatrician, neurologist, psychiatrist, anaesthetist, or intensivist), who will determine the appropriate dose.

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

Other medicines and Diazepam Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• Antidepressants (e.g. fluvoxamine, fluoxetine);
• Antipsychotics such as clozapine (used to treat mental disorders);
• Muscle relaxants (e.g. suxamethonium, tubocurarine);
• Barbiturates such as phenobarbital (used to treat epilepsy and mental disorders);
• Other central nervous system depressants (buprenorphine, narcotic analgesics, opioids and derivatives used for cough, baclofen, thalidomide, pizotifen, centrally acting antihypertensives).

Taking the following medicines together with diazepam may affect your mental state, make you feel sleepy, and reduce your breathing and blood pressure.

• Disulfiram (used to treat 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 (used to treat asthma and other respiratory disorders), as it may reduce the effect of diazepam;
• Cimetidine, omeprazole or esomeprazole (medicines used 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 therefore 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.

Opioids

Concomitant use of diazepam and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, 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 should be limited by your doctor.

Inform your doctor about all opioid medicines you are taking and closely follow your doctor's dosing recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Taking Diazepam Aurovitas 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 enhance the effect of diazepam.

Pregnancy, breast-feeding, and fertility

If you are pregnant, 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. This medicine may affect your baby.

Driving and using machines

Talk to 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 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

Follow exactly the instructions for using this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage

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

Use in adults

Recommended doses for:

• Anxiety symptoms:
  • 2 mg to 5 mg of diazepam, 2 to 3 times daily

The dose may be increased up to a maximum of 30 mg daily, 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 needed, 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 daily as needed. In severe cases, the doctor may use other dosing regimens and treatment may need to be conducted 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 daily, divided into 3 to 4 divided doses.

Use in children and adolescents

Children over 6 years of age and adolescents (over 20 kg)

The child's doctor will decide how much diazepam should be taken 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 of age

This medicine is not recommended for children under 6 years of age due to possible difficulties in swallowing. More suitable pharmaceutical forms may be available for younger children. Do not administer this medicine to children under 6 years of age unless after consultation and under strict medical supervision by a specialist (paediatrician, neurologist, psychiatrist, anaesthetist, or intensive care physician), 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 adult dose. Treatment should be initiated 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

Dosage adjustment is usually not necessary. However, patients with renal failure 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. Patients with severe hepatic impairment must 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 take effect. In addition, the effects of diazepam may last longer, including possible adverse effects.

Method of administration

The tablet may 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 that 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 taken.
• Symptoms of overdose include inability to coordinate voluntary muscle movements (ataxia), apnoea (severe breathing difficulty), low blood pressure (hypotension), heart and lung problems (cardiorespiratory failure), and coma (unconsciousness).

Duration of treatment

Treatment duration 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 it is almost time for your next dose, skip the missed dose and take your next dose at the usual time.

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 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) and loss of reality perception (derealization).
• 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 side effects

Like all medicines, this medicine can 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 must seek immediate medical attention. The adverse 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 behaviour (frequency not known)

Consult your doctor if you notice any of the following side effects:

• Aggressiveness, irritability, nervousness, agitation, anxiety, delusions, anger
• Sleep problems, nightmares, and vivid dreams. Your doctor may ask you to stop treatment.

For information on possible withdrawal symptoms, see “If you stop taking Diazepam Aurovitas” in Section 3.

These effects are more common in children and elderly patients.

Elderly patients

There is an increased risk of falls and fractures in patients taking benzodiazepines.

Other side effects:

At the beginning of treatment with diazepam, the 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 suggest 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, disorientation, restlessness
• Memory loss
• Headache
• Depression
• Speech disorders
• Loss of coordination, including unsteadiness when walking
• Changes in sex drive (libido)

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

Liver and blood

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

Heart, circulation, and blood vessels

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

Uncommon (may affect up to 1 in 100 people)

Stomach and intestines

• 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
• Vertigo, which may present as dizziness or a sensation of spinning
• The most common reactions are skin rash, hives, itching, and erythematous rash

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human 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 stated on the packaging after EXP. 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 unused medicines and their containers at a SIGRE point at your pharmacy. If you are unsure how to dispose of medicines and containers you no longer need, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diazepam Aurovitas

• The active substance is diazepam.

Each tablet contains 5 mg of diazepam.

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

Appearance of the product and contents of the pack

Tablet

Diazepam Aurovitas 5 mg tablets:

pale yellow, bevel-edged, round, flat-faced, uncoated tablets of approximately 8.8 mm, marked with "D" and "5" separated by a break line on one side and smooth on the other. The tablet can be divided into equal doses.

Diazepam Aurovitas tablets are available in blisters.

Pack sizes:

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

HDPE bottle: 1000 tablets

Only some pack 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium: Diazepam AB 5 mg tabletten/comprimés/Tabletten

Spain: Diazepam Aurovitas 5 mg tablets EFG

Netherlands: Diazepam Auro 5mg, tabletten

Portugal: Diazepam Generis Phar

Date of the most recent revision of this leaflet: May 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/