Diazepam Aurovitas 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diazepam Aurovitas 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, 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 you should not give it to others, 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 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 by 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 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 apnea (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 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 behavior (see section 4).

There is a risk of dependence with 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 may 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 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 (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 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.

Opioids

Concomitant use of diazepam and opioids (strong painkillers, 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 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 these 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, breastfeeding, and fertility

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

Driving and using machines

Talk to your doctor before driving or operating machinery, as diazepam may slow your reactions. 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 your doctor before taking this medicine.

3. How to take Diazepam Aurovitas

Follow exactly the instructions for use provided by your doctor. If in 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 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 daily as needed. In severe cases, your 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 daily, divided into 2 to 4 doses.
  • Muscle spasms in cerebral spasticity: up to a maximum of 60 mg daily, divided into 3 to 4 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 swallowing difficulties. 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 the strict medical supervision of 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 according to need and tolerance.

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 take 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, including possible adverse effects, may take longer to wear off.

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 suspect that a child may have swallowed some, contact the nearest hospital immediately, consult your doctor or pharmacist, 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, apnoea (severe breathing difficulty), low blood pressure (hypotension), heart and lung problems (cardiorespiratory failure), and coma (unconsciousness).

Duration of treatment

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 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, skip the missed dose and take the next dose at the usual time.

If you stop taking Diazepam Aurovitas

• Do not stop taking this 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 aggression, 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 perception of reality (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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse 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 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 behaviour (frequency not known)

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

• Aggressiveness, irritability, nervousness, agitation, anxiety, delirium, anger
• Sleep disturbances, 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 associated with the use of benzodiazepines in elderly patients.

Other adverse effects:

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

Psychiatric and nervous system disorders

• Difficulty concentrating, reduced alertness, confusion and 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 perform 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 up
• 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 spinning sensation
• The most common reactions are skin rash, hives, itching, and erythematous rash

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, consult 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

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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, 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

• The active substance is diazepam.

Each tablet contains 10 mg of diazepam.

• The other components are monohydrate lactose, corn starch, pregelatinized corn starch, magnesium stearate, FD&C Blue No.1 (Brilliant Blue FCF aluminum lake) (E133).

Appearance of the product and contents of the pack

Tablet

Diazepam Aurovitas 10 mg tablets:

pale blue, flat-faced, bevel-edged, circular tablets, approximately 8.8 mm in diameter, uncoated, marked with "D" and "10" separated by a break line on one side and smooth on the other side. The tablet can be divided into equal doses.

Diazepam Aurovitas tablets are available in blisters.

Pack sizes:

Blisters: 10, 20, 30, 40 and 60 tablets.

HDPE bottle: 1000 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 :

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 European Economic Area (EEA) member states under the following names:

Belgium: Diazepam AB 10 mg tabletten/comprimés/Tabletten

Spain: Diazepam Aurovitas 10 mg tablets EFG

Netherlands: Diazepam Auro 10mg, 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/