Diazepam Basi 5 mg/ml solution for injection EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Diazepam Basi 5 mg/ml injection solution EFG

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

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

Package leaflet contents

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

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

Diazepam Basi contains diazepam as the active ingredient, which belongs to a group of medicines called benzodiazepines, with anxiolytic, sedative, muscle relaxant, and anticonvulsant effects.

Diazepam Basi is indicated for:

• the treatment of moderate to severe cases of agitation, anxiety, and psychological tension;
• basal sedation in patients with anxiety or tension; induction to anesthesia and pre-procedural sedation prior to diagnostic, surgical, and endoscopic interventions (cardiac catheterization);
• relief of excitement, panic, tremor, and hallucinations (delirium tremens) in patients with alcohol withdrawal syndrome;
• acute treatment of status epilepticus, severe seizures, tetanus, and as second-line treatment for preeclampsia or eclampsia;
• adjunctive treatment of reflex muscle spasms due to local trauma (injury, inflammation); it may also be used to counteract spasticity resulting from disorders of spinal and supraspinal interneurons, such as cerebral palsy and paraplegia, as well as in athetosis and stiff-person syndrome.

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

2. What you need to know before starting to use Diazepam Basi

Do not use Diazepam Basi

• If you are allergic to diazepam, to other medicines in the benzodiazepine group, or to any of the other components 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 severe respiratory problems (severe respiratory insufficiency).
• If you have long-standing breathing difficulties whether related to sleep or not.
• If you have severe liver problems (severe hepatic insufficiency).

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

Warnings and precautions

Benzodiazepines are indicated only for the treatment of a serious condition that limits your activity or subjects you 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 taking medicines known as central nervous system (CNS) depressants;
• If you are an elderly patient, are debilitated, or suffer from heart or lung disease. Your doctor will adjust the dose of the medicine;
• If you suffer from depression;
• If you have impaired kidney or liver function.

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

Concomitant use of alcohol/CNS depressants

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 may increase the clinical effects of Diazepam Basi, including intense sedation, which may lead to coma or death, and clinically relevant respiratory and/or cardiovascular depression (see section 2, “Other medicines and Diazepam Basi”).

Dependence

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

Rebound insomnia and anxiety

A transient syndrome has been reported following discontinuation of treatment, characterized by the re-emergence of symptoms – although more pronounced – that led to initiating treatment. It may be accompanied by other reactions such as mood changes, anxiety, sleep disturbances, and restlessness. To avoid this, your doctor will gradually reduce the dose.

Amnesia (memory loss)

This medicine may cause memory loss, and the risk increases with higher doses. These effects may be associated with behavioral disturbances.

Paradoxical and psychiatric reactions

Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, anxiety, delirium, rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects may occur while using this medicine. If these symptoms occur, inform your doctor; use of the medicine should be discontinued. These symptoms are more frequent in children and elderly patients.

Psychotic disorders and depression

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

In patients with depression, Diazepam Basi acts only on the anxiety component, and therefore does not constitute treatment for depression itself and may potentially unmask certain signs of depression (suicide risk).

Epilepsy

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

Method of administration

The use of PVC-containing infusion bags and sets should be avoided when administering diazepam.

Children

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

The use of Diazepam Basi is not permitted in children under 12 years of age, except for the management of status epilepticus. For status epilepticus, Diazepam Basi must not be used in neonates.

Elderly Patients

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

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

Other medicines and Diazepam Basi

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is extremely important, as taking more than one medicine at the same time may increase or reduce their effects. For example, tranquilizers, sleep-inducing medicines, and similar drugs act on the brain and nerves and may enhance the effect of Diazepam Basi.

The concomitant use of Diazepam Basi 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 fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

If your doctor nevertheless prescribes Diazepam Basi together with opioids, the dose and duration of concomitant treatment must be limited.

Inform your doctor about all opioid medicines you are taking and strictly follow your doctor's recommendations regarding dosage. 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 immediately.

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, thereby increasing the risk of drowsiness. The same applies to grapefruit juice.

Conversely, medicines such as rifampicin and carbamazepine reduce the effects of Diazepam Basi.

In addition, the metabolism of phenytoin may be affected if you are being treated with Diazepam Basi; therefore, if you are taking this medicine, your doctor will adjust the doses accordingly.

The sedative effect and cardiopulmonary depression may be increased when Diazepam Basi is combined with other central nervous system depressants (e.g., narcotic analgesics, opioids, and their derivatives), potentially leading 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 enhances the effect of ketamine.

Therefore, you should not use Diazepam Basi with any other medicine unless authorized by your doctor.

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

Use of Diazepam Basi with food, beverages, and alcohol

Alcoholic beverages increase the sedative effects of Diazepam Basi; therefore, avoid consuming alcoholic drinks during treatment. If you need further information, consult your doctor.

Diazepam must not be used in combination with grapefruit juice, as it may increase diazepam levels in your body.

Risk of dependence

The use of benzodiazepines and benzodiazepine-like drugs may lead to physical and psychological dependence. This occurs primarily after uninterrupted long-term use of the medication. To minimize the risk of dependence, the following precautions should be observed:

• Benzodiazepines should only be used under medical prescription (never because they have worked in other patients), and should never be recommended to other people.
• Once dependence has developed, your doctor will provide the necessary instructions and apply the appropriate treatment.
• Strictly follow your doctor's instructions.

Pregnancy, lactation 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 medicine.

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

If, due to strict medical necessity, Diazepam Basi is administered during the last part of pregnancy or during childbirth, certain effects may occur in the newborn, such as decreased body temperature (hypothermia), reduced muscle tone (hypotonia), and moderate respiratory depression.

Infants born to mothers who chronically take benzodiazepines during the late stages of pregnancy may develop physical dependence, potentially leading to a withdrawal syndrome in the postnatal period.

Driving and operating machinery

Do not drive or operate tools or machinery, as this medicine may cause sedation, amnesia, difficulty concentrating, and muscle weakness, which could negatively affect your ability to drive vehicles or operate machinery. Your doctor will decide when it is safe to 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

Diazepam Basi contains 15.7 mg of benzyl alcohol and 414 mg of propylene glycol per ml.

Consult your doctor or pharmacist if your child is under 5 years of age, if you have liver or kidney disease, or if you are pregnant or breastfeeding. This is because the excipients may cause adverse effects. Your doctor may need to adjust the dose if you or your child are using other medicines containing benzyl alcohol, propylene glycol, or alcohol.

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

The alcohol contained in this medicine may affect children. Possible effects include changes in behavior and drowsiness. It may also affect your ability to concentrate and perform physical activities.

The amount of alcohol in this medicine may impair your ability to drive or operate machinery, as it may affect your judgment and reaction capacity.

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

The alcohol content in this medicine may alter the effect of other medicines. 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 medicine.

If you have alcohol addiction, consult your doctor or pharmacist before taking this medicine.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with a risk of serious adverse effects, including breathing problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless specifically recommended by your doctor.

This medicine should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.

This medicine contains 5 mg of benzoic acid and 95 mg of sodium benzoate in each 2 ml ampoule.

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

If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring while you are taking this medicine.

If you have hepatic or renal insufficiency, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring while you are taking this medicine.

3. How to use Diazepam Basi

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Diazepam Basi is administered by deep intramuscular injection.

This medicine may also be administered intravenously with the following electrolyte infusion solutions: NaCl 0.9%, Dextrose 5.5%, or Dextrose 10%. The use of infusion bags and sets containing PVC should be avoided when administering this medicine (see section 6).

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

Your doctor will adjust the dose for each patient. Doses will be lower in elderly patients or in debilitated patients, and in patients with chronic respiratory disorders.

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

If the epileptic seizure lasts more than 10–15 minutes, the doctor may decide to administer an additional dose. A maximum of 2 doses may be given.

Your child under 5 years of age should not receive more than two repeated doses in a single day.

Use in children

Diazepam Basi should not be used in children under 12 years of age, except for the control of status epilepticus. For status epilepticus, it should not be used in neonates (see also section 2).

If you use more Diazepam Basi than you should

Since this medicine will be administered by a doctor or nurse, it is unlikely that you will receive an overdose. However, an overdose of this medicine may cause areflexia, apnea, hypotension, cardiorespiratory depression, and coma. If coma occurs, it usually lasts only a few hours but may be prolonged and cyclical, especially in elderly patients. Respiratory depressant effects are more severe in patients with pre-existing respiratory disease.

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

In the event of overdose or accidental ingestion, 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 ingested.

If treatment with Diazepam Basi is interrupted

After discontinuation of treatment, previous symptoms (although more pronounced) may transiently reappear. It is recommended to gradually reduce the dose until definitive discontinuation of treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

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.

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 somnolence.

Dependence

Prolonged use of this product (even at therapeutic doses) may lead to physical dependence: discontinuation of treatment may result in 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 increased alkaline phosphatase in blood.

Frequency not known: cannot be estimated from the available data

• Restlessness, agitation, irritability, disorientation, aggression, nervousness, hostility, anxiety, delirium (incoherent thinking), rage attacks, nightmares, abnormal dreams, hallucinations, psychosis, hyperactivity, inappropriate behavior, and other adverse behavioral effects; confusion, emotional disorders, and altered mood; depression, changes in libido (sexual drive).

• Ataxia (inability to coordinate voluntary muscle movements), dysarthria, slurred speech, headache, tremor, dizziness, decreased level of alertness. Anterograde amnesia (difficulty in remembering recent events) may occur at therapeutic doses, with increased risk at higher doses. Amnestic effects may be associated with inappropriate behaviors.

• Diplopia (double vision), blurred vision.

• vertigo.

• heart failure, including cardiac arrest.

• hypotension, circulatory depression.

- respiratory depression, including respiratory failure.

• nausea, dry mouth or hypersalivation (excessive salivary secretion), constipation, and other gastrointestinal disorders.

- skin rash (inflammation of the skin), urticaria (reddish bumps), pruritus (tingling or uncomfortable skin irritation causing an 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 of adverse effects

If you experience any adverse effects, consult your doctor, even if they are effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diazepam Basi

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

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

Do not store above 25 °C.

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

After opening:

Physical and chemical stability has been demonstrated for 24 hours at room temperature during use. From a microbiological standpoint, the medicine should be used immediately. Otherwise, the storage duration and conditions prior to use are the responsibility of the user.

This medicine must not be mixed or diluted with other solutions or medicines.

After dilution:

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

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Diazepam Basi

• The active substance 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 injections.

Appearance of the product and contents of the container

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

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: [email protected]

Manufacturer:

Laboratórios Basi - Indústria Farmacêutica, S.A.

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

3450-232 Mortágua

Portugal

Further information on this medicine is available from the local representative of the Marketing Authorization Holder:

Local Representative

Laphysan, S.A.U.

Calle Anabel Segura 11,

Complejo Empresarial Albatros, Building A, 4th Floor, Door D,

28108 Alcobendas (Madrid), Spain

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

Portugal Diazepam Basi

Spain Diazepam Basi 5 mg/ml solution for injection EFG

Latvia Diazepam Basi 5 mg/ml škidums injekcijam

Lithuania Diazepam Basi 5 mg/ml injekcinis tirpalas

Estonia Diazepam Basi

Date of the most recent revision of this leaflet: November 2025

Other sources of information

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

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This information is intended for healthcare professionals only:

The dose should be individualized according to each patient's needs, and the lowest effective dose possible should be used, especially in children, elderly patients, debilitated individuals, and those with hepatic impairment or low serum albumin levels.

Moderate to severe anxiety states: The adult dose is 2 to 10 mg administered intramuscularly or intravenously, repeated every 3–4 hours if necessary. For elderly patients and those with renal and/or hepatic impairment, the lowest effective dose possible is recommended.

Alcohol withdrawal: 10 mg administered intramuscularly or intravenously. If necessary, 5–10 mg may be given every 3–4 hours. (Alternative regimen: 0.1–0.2 mg/kg intravenously, repeated every 8 hours until symptoms cease.) Follow with oral treatment.

Premedication: 10–20 mg intramuscularly, one hour before induction of anesthesia. Children: 0.1–0.2 mg/kg intramuscularly.

Anesthetic induction: 0.2–0.5 mg/kg intravenously.

Sedation prior to procedures: 10–20 mg intravenously (start with 5 mg, then 2.5 mg every 30 seconds until eyelids droop to mid-pupil level). In obese patients: 30 mg intravenously; children: 0.1–0.2 mg/kg intravenously.

Status epilepticus: 0.15–0.25 mg/kg intravenously, repeated every 10–15 minutes if necessary, or administered by continuous infusion. (Maximum dose: 3 mg/kg within 24 hours.)

Should not be used in neonates.

Tetanus: Administer 0.1–0.3 mg/kg body weight intravenously at intervals of 1–4 hours. Alternatively, continuous infusion or administration via gastric tube (3–4 mg/kg body weight over 24 hours).

Preeclampsia and eclampsia: In case of seizures or imminent risk when magnesium sulfate is unavailable, administer 10–20 mg by intravenous injection. If additional doses are required, they may be given either by intravenous injection or continuous intravenous infusion, up to a maximum of 100 mg within 24 hours. The 100 mg dose represents the total amount that may be administered within 24 hours and must not be given as a single intravenous bolus, but rather as a series of slow intravenous injections or as continuous intravenous infusion. If seizures persist despite administration of magnesium sulfate, Diazepam Basi may be administered at a dose of 5–10 mg by intravenous injection.

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

Administration method

Intravenous or intramuscular route.

Intramuscular injection should be deep.

Intravenous injection must always be administered very slowly (approximately 0.5–1 mL per minute) into large-caliber veins. Excessively rapid administration may lead to apnea. When using the intravenous route, it is advisable to have respiratory support equipment available. Intrarterial injection and extravasation must be strictly avoided due to the risk of vascular damage.

Diazepam Basi may be administered with the following electrolyte infusion solutions: 0.9% Sodium Chloride, 5% Dextrose, or 10% Dextrose.

It has been demonstrated that the product maintains physical and chemical stability for 24 hours at room temperature.

From a microbiological standpoint, the medication should be used immediately. If not, the storage duration and conditions prior to use are the responsibility of the user.

Diazepam Basi must not be mixed or diluted with other solutions or medications in the same syringe or infusion bag.

Evidence exists that diazepam may be adsorbed by plastic infusion bags and infusion sets containing PVC. This adsorption may reduce diazepam concentration by 50% or more, particularly when prepared infusion bags are stored for 24 hours or longer under warm ambient conditions, or when long infusion tubing or low infusion rates are used. The use of infusion bags and sets containing PVC must be avoided when administering diazepam. Care must be taken when switching between infusion systems containing PVC and those that do not.

In any case, once acute symptoms have resolved, if continued treatment is indicated, it should be administered orally.