DIAZEPAM BASI 5 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Diazepam Basi 5 mg/ml Solution for Injection EFG

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Diazepam Basi contains the active ingredient diazepam, which belongs to the group of medications called benzodiazepines, with tranquilizing, sedative, muscle relaxant, and anticonvulsant effects.

Diazepam Basi is indicated for:

• the treatment of moderate to severe cases of agitation, anxiety, and psychic tension;
• basal sedation in patients with anxiety or tension; induction of anesthesia and pre-sedation before diagnostic, surgical, and endoscopic procedures (cardiac catheterization);
• relief of excitement, panic, tremors, and hallucinations (delirium tremens) in patients with alcohol withdrawal syndrome;
• acute treatment of status epilepticus, severe convulsions, tetanus, and second-line treatment of pre-eclampsia or eclampsia;
• co-adjuvant treatment of muscle spasms due to local trauma (injury, inflammation); it can also be used to combat spasticity originating from spinal and supraspinal interneuron disorders, such as cerebral palsy and paraplegia, as well as in athetosis and generalized stiffness syndrome.

Diazepam Basi is indicated for adults and children over 6 months of age.

2. What you need to know before taking Diazepam Basi

Do not use Diazepam Basi

• If you are allergic to diazepam, other benzodiazepine medications, or any of the other components of this medication (listed in section 6).
• If you have a disease called "myasthenia gravis", characterized by muscle weakness and fatigue.
• If you have severe respiratory problems (severe respiratory failure).
• If you have breathing difficulties related or not to sleepfor a long time.
• If you have severe liver problems (severe liver failure).

If you have any doubts about this, consult your doctor.

Warnings and precautions

Benzodiazepines are only indicated for the treatment of a serious illness that limits activity or subjects the patient to extreme stress.

Consult your doctor or nurse before starting to use Diazepam Basi:

• If you have a history of drug or alcohol dependence;
• If you are using medications called central nervous system depressants (CNS);
• If you are an elderly patient, are debilitated, or suffer from heart or lung disease. Your doctor will adjust the dose of the medication;
• If you suffer from depression;
• If you have altered kidney or liver function;

Your doctor will decide to use a lower dose of Diazepam Basi or not use it at all.

Concomitant use of alcohol/CNS depressant

The concomitant use of Diazepam Basi with alcohol and/or CNS depressants should be avoided.

An exception to this is the treatment of acute withdrawal symptoms.

This concomitant use has the potential to increase the clinical effects of Diazepam Basi, including intense sedation, which can lead to coma or death, respiratory depression, and/or clinically relevant cardiovascular depression (see section 2. "Other medications and Diazepam Basi").

Dependence

Dependence may occur during treatment with benzodiazepines. The risk increases in patients on prolonged treatment and/or high doses, and is particularly so in patients with a history of alcohol or drug abuse. If physical dependence on benzodiazepines has developed, discontinuation of this medication may cause withdrawal symptoms. These can include headache, diarrhea, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability. In severe cases, the following symptoms have been described: loss of sense of reality, depersonalization, hyperacusis, tingling, and cramps in the limbs, hypersensitivity to light, sounds, and physical contact, hallucinations, or convulsions. After prolonged administration in a vein, your doctor will gradually reduce the dose.

Rebound insomnia and anxiety

A transient syndrome has been described after treatment withdrawal, characterized by the reappearance of symptoms - although more pronounced - that led to the initiation of treatment. It can be accompanied by other reactions such as mood changes, anxiety, or sleep disorders and restlessness. To avoid this, your doctor will gradually reduce the dose.

Amnesia (memory loss)

This medication can cause memory loss, and the risk increases with the dose. These effects can be associated with behavioral changes.

Psychiatric and paradoxical reactions

Paradoxical reactions such as restlessness, agitation, irritability, aggression, anxiety, delirium, fury, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior can occur when using this medication. If these symptoms appear, inform your doctor; the use of the medication should be discontinued. These symptoms are more frequent in children and elderly patients.

Psychotic disorders and depression

This medication is not recommended for the primary treatment of psychotic disorders (severe mental disorders that cause abnormal ideas and perceptions), and should not be used as the sole treatment in patients with depression, alone or associated with anxiety.

In patients with depression, Diazepam Basi only acts on the anxious component, so it does not constitute a treatment for depression in itself and may eventually unmask some signs of it (suicide risk).

Epilepsy

If you are epileptic and are undergoing long-term treatment with Diazepam Basi, it is not recommended to use the benzodiazepine antagonist (flumazenil) to reverse the effect of Diazepam Basi, as convulsions may occur.

Method of administration

The use of bags and perfusion equipment containing PVC should be avoided when administering the medication.

Children

Diazepam Basi should only be used in children when no other therapeutic alternatives are available and with extreme caution.

The duration of treatment in children over 6 months should be as short as possible.

P

If you are an elderly patient, your doctor will administer a lower dose. The pharmacological effects of benzodiazepines in elderly patients seem to be greater than in the younger population.

Your doctor will pay special attention to the high risk associated if you are an elderly patient or are severely debilitated.

Other medications and Diazepam Basi

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This is extremely important, as taking more than one medication at the same time can potentiate or weaken its effect. For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and can reinforce the effect of Diazepam Basi.

The concomitant use of Diazepam Basi and opioids (potent analgesics, substitution therapy medications, and some cough medications) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

If your doctor prescribes Diazepam Basi along with opioids, they will limit the dose and duration of concomitant treatment.

Inform your doctor about all opioid medications you are taking and strictly follow your doctor's recommendations regarding the dose. It may be helpful to inform friends or family members so they can recognize the signs and symptoms mentioned above. If you experience these symptoms, contact your doctor.

Cimetidine, ketoconazole, fluconazole, voriconazole, fluvoxamine, fluoxetine, hormonal contraceptives, disulfiram, isoniazid, diltiazem, idelalisib, modafinil, armodafinil, esomeprazole, and omeprazole temporarily increase the sedative effect of Diazepam Basi, increasing the risk of drowsiness. The same applies to grapefruit juice.

On the other hand, medications such as rifampicin and carbamazepine produce a decrease in the effects of Diazepam Basi.

Similarly, the metabolism of phenytoin may be affected if you are being treated with Diazepam Basi, so if you are using this medication, your doctor will adjust the doses.

The sedative effect and cardiopulmonary depression can be increased when combining Diazepam Basi with other central nervous system depressants (e.g., narcotic analgesics, opioids, and derivatives), which can lead to coma or death.

Diazepam may reduce the effect of levodopa.

Xanthines such as theophylline and caffeine counteract the sedative effects of Diazepam Basi.

Diazepam increases the effect of ketamine.

Therefore, you should not use Diazepam Basi with any other medication unless your doctor has allowed it.

If you need more information, consult your doctor or pharmacist.

Using Diazepam Basi with food, drinks, and alcohol

Alcoholic beverages increase the sedative effects of Diazepam Basi, so you should avoid using alcoholic beverages during treatment. If you need additional information, consult your doctor.

You should not use diazepam in combination with grapefruit juice, as it can increase the levels of diazepam in your body.

Risk of dependence

The use of benzodiazepines and benzodiazepine-like medications can lead to physical and psychological dependence. This occurs mainly after uninterrupted use of the medication for a long time. To minimize the risk of dependence, the following precautions should be taken:

• Benzodiazepines will only be used under medical prescription (never because they have been effective in other patients), and you should never recommend them to others.
• Once dependence has developed, your doctor will give you instructions to follow and apply the corresponding treatment.
• Strictly follow your doctor's instructions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The use of benzodiazepines is not recommended during pregnancy and breastfeeding.

If, for strict medical reasons, Diazepam Basi is administered during the last part of pregnancy or during childbirth, some effects may appear in the newborn, such as decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression.

Children born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, which can trigger a withdrawal syndrome in the postnatal period.

Driving and using machines

Do not drive or operate tools or machines because this medication can cause sedation, amnesia, difficulty concentrating, and muscle weakness, which can negatively affect your ability to drive vehicles or operate machinery. Your doctor will decide when you can resume these activities. This effect is increased if you have also consumed alcohol.

Diazepam Basi contains ethanol, benzyl alcohol, benzoic acid, sodium benzoate, and propylene glycol

This medication contains 170.5 mg of alcohol (ethanol) per dose, which is equivalent to 8.5% (vol.). The amount in a dose of this medication is equivalent to 4.3 ml of beer or 1.8 ml of wine.

The alcohol in this medication can affect children. The effects that may appear are changes in behavior and drowsiness. It can also affect their ability to concentrate and perform physical activities.

The amount of alcohol in this medication can affect your ability to drive and use machines because it can alter your judgment and reaction capacity.

If you have epilepsy or liver problems, consult your doctor or pharmacist before taking this medication.

The amount of alcohol in this medication can alter the effect of other medications. Consult your doctor or pharmacist if you are taking other medications.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication.

If you are addicted to alcohol, consult your doctor or pharmacist before taking this medication.

This medication contains 31.4 mg of benzyl alcohol per 2 ml ampoule, equivalent to 15.7 mg/1 ml.

Benzyl alcohol can cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been linked to the risk of serious adverse effects, including respiratory problems ("gasping syndrome") in children.

Do not administer this medication to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

This medication should not be used for more than one week in children under 3 years of age unless your doctor or pharmacist indicates it.

This medication contains 5 mg of benzoic acid and 95 mg of sodium benzoate per 2 ml ampoule.

Benzoic acid and sodium benzoate can increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medication contains 828 mg of propylene glycol per 2 ml ampoule, equivalent to 414 mg/1 ml. If you are pregnant or breastfeeding, do not take this medication unless your doctor recommends it. Your doctor may perform additional checks while you are taking this medication.

If you have liver or kidney failure, do not take this medication unless your doctor recommends it. Your doctor may perform additional checks while you are taking this medication.

If the child is under 5 years of age, consult your doctor or pharmacist, especially if they have been given other medications that contain propylene glycol or alcohol.

3. How to use Diazepam Basi

Follow your doctor's instructions for administering this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

Diazepam Basi is administered via a deep intramuscular injection.

This medication can also be administered intravenously with the following electrolytic perfusion solutions: NaCl 0.9%, Dextrose 5.5%, or Dextrose 10%. The use of bags and perfusion equipment containing PVC should be avoided when administering the medication(see section 6).

If you think the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

Your doctor will adjust the dose to each patient. The doses will be lower in elderly patients or debilitated patients and in patients with chronic respiratory disorders.

Your doctor will indicate the duration of treatment with this medication, which will be as short as possible.

If you use more Diazepam Basi than you should

Since the administration of this medication will be performed by a doctor or nurse, it is unlikely that you will receive an overdose. An overdose of this medication can cause areflexia, apnea, hypotension, cardiopulmonary depression, and coma. If coma occurs, it usually lasts only a few hours but can be prolonged and cyclical, especially in elderly patients. The respiratory depressant effects are more severe in patients with respiratory disease.

If someone accidentally receives this medication, inform a doctor immediately. In case of overdose, the patient's vital signs will be monitored, and supportive measures will be established according to their condition.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91. 562.04.20, indicating the medication and the amount ingested.

If you stop treatment with Diazepam Basi

After treatment withdrawal, the previous symptoms may reappear transiently (although more pronounced), so it is recommended to gradually reduce the dose until the treatment is definitively discontinued.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

Most patients tolerate Diazepam Basi well, but the most frequent adverse effects, which occur especially at the beginning of treatment, are fatigue, muscle weakness, and drowsiness.

Dependence

Continuous administration of the product (even at therapeutic doses) may lead to the development of physical dependence: stopping treatment may lead to the development of withdrawal or rebound phenomena.

The following adverse effects may occur:

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

- Jaundice (yellowish discoloration of the skin and eyes).

- Elevated transaminase and alkaline phosphatase in blood.

Frequency not known: cannot be estimated from available data

• Anxiety, agitation, irritability, disorientation, aggressiveness, nervousness, hostility, anxiety, delirium (lack of coherence of ideas), fits of rage, nightmares, abnormal dreams, hallucinations, psychosis, hyperactivity, inappropriate behavior, and other adverse behavioral effects, confusion, emotional disorders, and altered mood, depression, changes in libido (sexual impulse).

• Ataxia (inability to coordinate voluntary muscle movements), dysarthria, slurred speech, headaches, tremors, dizziness, decreased alertness. With therapeutic doses, anterograde amnesia (difficulty remembering recent events) may occur, increasing the risk of this effect with higher doses. Amnestic effects may be associated with inappropriate behavior.

• Diplopia (double vision), blurred vision.

- Vertigo.

- Heart failure, including cardiac arrest.

- Hypotension, circulatory depression.

- Respiratory depression, including respiratory failure.

- Nausea, dry mouth, or hypersalivation (exaggerated salivary secretion), constipation, and other gastrointestinal disorders.

- Skin rash (skin inflammation), urticaria (red patches), pruritus (uncomfortable itching or irritation of the skin that gives the urge to scratch the affected area), erythematous rash.

- Incontinence, urinary retention.

- Venous thrombosis, phlebitis, irritation at the injection site, local swelling, or, more rarely, vascular disorders, especially after rapid intravenous administration.

• Local pain.

- Irregular heart rate

• Falls and fractures.

Reporting Adverse Effects

If you experience adverse effects, consult your doctor, even if they are not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Diazepam Basi

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the packaging after EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Do not use Diazepam Basi if it is stored incorrectly, as the content may become cloudy or separate into phases.

After opening:

It has been demonstrated that during use, it presents physical and chemical stability for 24 hours at room temperature. From a microbiological point of view, the medicine should be used immediately. Otherwise, the storage time and conditions prior to use will be the responsibility of the user.

It should not be mixed or diluted with other solutions or medicines.

After dilution:

Chemical and physical stability has been demonstrated during use for up to 12 hours at room temperature. From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, the storage times and conditions will be the responsibility of the user.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Diazepam Basi

• The active ingredient is diazepam. Each 2 ml ampoule contains 10 mg of diazepam.
• The other components (excipients) are ethanol, benzyl alcohol, propylene glycol, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), benzoic acid (E210), sodium benzoate (E211), and water for injectable preparations.

Appearance of the Product and Package Contents

Diazepam Basi is presented as an injectable solution in 2 ml ampoules. It is available in packs of 5 or 50 ampoules (clinical packaging).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua

Portugal

Tel: + 351 231 920 250

Fax: + 351 231 921 055

E-mail: basi@basi.pt

Manufacturer:

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16

3450-232 Mortágua

Portugal

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local Representative

Laphysan, S.A.U.

Calle Anabel Segura 11,

Complejo Empresarial Albatros, Edificio A, Planta 4, puerta D,

28108 Alcobendas (Madrid) Spain

This medicine is authorized in the member states of the European Economic Area under the following names:

Portugal Diazepam Basi

Spain Diazepam Basi 5 mg/ml injectable solution EFG

Latvia Diazepam Basi 5 mg/ml solution for injection

Lithuania Diazepam Basi 5 mg/ml injectable solution

Estonia Diazepam Basi

Date of the last revision of this prospectus: April 2023

Other Sources of Information

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

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This information is intended only for healthcare professionals:

The dose should be individualized based on the needs of each individual and the smallest effective amount should be administered, especially in children, elderly patients, and debilitated individuals or those with liver disease or low serum albumin levels.

Anxiety of medium/severe degree:The dose for adults is 2 to 10 mg intramuscularly or intravenously, repeated every 3-4 hours if necessary. The recommended dose in elderly patients and patients with renal and/or hepatic insufficiency is the smallest effective amount possible.

Alcoholic withdrawal:10 mg intramuscularly or intravenously. If necessary, 5-10 mg every 3-4 hours (another regimen: 0.1-0.2 mg/kg intravenously every 8 hours, until symptoms cease). Then oral treatment.

As premedication:10-20 mg intramuscularly, one hour before inducing anesthesia. Children: 0.1-0.2 mg/kg intramuscularly.

For anesthetic induction:0.2-0.5 mg/kg intravenously.

Sedation prior to interventions:10-20 mg intravenously (5 mg initially and 2.5 mg every 30 seconds until the eyelids drop to half-pupil). In obese patients, 30 mg intravenously; children: 0.1-0.2 mg/kg intravenously.

Epileptic status:0.15-0.25 mg/kg intravenously, repeated at intervals of 10-15 minutes, if necessary, or in continuous infusion. (Maximum dose: 3 mg/kg in 24 hours).

Tetanus:0.1-0.3 mg/kg body weight should be administered intravenously at intervals of 1-4 hours. Another possibility is continuous infusion or through a gastric tube (3-4 mg/kg body weight in 24 hours).

Preeclampsia and eclampsia:In case of convulsion, or if there is a risk of convulsion, and magnesium sulfate is not available, administer 10-20 mg by intravenous injection. If additional doses are required, they can be administered, both by intravenous injection and by continuous intravenous infusion, up to a maximum of 100 mg in 24 hours. The dose of 100 mg is the total dose that can be administered in 24 hours, and it should not be administered as a single intravenous injection but as a series of slow intravenous injections or as a continuous intravenous infusion. If epileptic seizures continue despite the administration of magnesium sulfate, Diazepam Basi can be administered at a dose of 5-10 mg by intravenous injection.

Muscle spasms:5 to 10 mg intramuscularly or intravenously, repeatable if necessary every 3-4 hours.

Method of Administration

Intravenously, intramuscularly.

Intramuscular injection should be deep.

Intravenous injection should always be administered very slowly (approximately 0.5-1 ml per minute) in large-caliber vessels. Excessively rapid administration can lead to apnea. It is advisable to have a respiratory assistance system available when using the intravenous route. Intra-arterial injection or extravasation should be avoided due to the possibility of vascular alterations.

Diazepam Basi can be administered with the following electrolytic perfusion solutions: NaCl 0.9%, Dextrose 5%, or Dextrose 10%.

It has been demonstrated that during use, it presents physical and chemical stability for 24 hours at room temperature.

From a microbiological point of view, the medicine should be used immediately. Otherwise, the storage time and conditions prior to use will be the responsibility of the user.

It should not be mixed or diluted with other solutions or medicines in the syringe or perfusion bag.

There is evidence that diazepam can be adsorbed by plastic perfusion bags and perfusion equipment containing PVC. This adsorption leads to a decrease in the concentration of diazepam by 50% or more, especially when prepared perfusion bags are stored for 24 hours or more in warm environmental conditions or when long perfusion tubes or low perfusion speeds are used. The use of bags and perfusion equipment containing PVC should be avoided when administering diazepam.Care should be taken when switching between PVC-containing bags and equipment and those that do not contain PVC.

In any case, after the cessation of acute symptoms, if continued treatment is necessary, it will be done orally.