Label: information for the user

Valium 10mg/2ml injectable solution

Diazepam

Read the entire label carefully before starting to use the medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you, as it may harm them.
• Ifyou experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What is Valium and how it is used

2.What you need to know before starting touse Valium

3.How to use Valium

4.Possible adverse effects

5.Storage of Valium

6.Contents of the package andadditional information

Valium contains diazepam as its active ingredient, which belongs to a group of medications known as benzodiazepines.

Diazepam has tranquilizing, sedating, muscle-relaxing, and anticonvulsant effects.

Doctors prescribe Valium for individuals experiencing moderate to severe agitation, anxiety, or psychological tension. Benzodiazepines are only indicated for the treatment of intense disorders that limit activity or subject the individual to significant stress.

Doctors also prescribe Valium for preoperative medication to provide basal sedation in patients with anxiety or tension, induction of anesthesia, and sedation prior to diagnostic, surgical, and endoscopic procedures (cardiac catheterization).

For patients with alcohol withdrawal syndrome to alleviate excitement, panic, tremors, and hallucinations (delirium tremens).

For the acute treatment of status epilepticus (a single or repeated seizure that persists long enough to potentially cause neurological damage), severe convulsions, tetanus (a disease causing muscle spasms), in gynecology for preeclampsia or eclampsia (seizures caused by a sudden and unexpected increase in blood pressure prior to delivery or during pregnancy) as a second-line treatment (if magnesium sulfate is not available or seizures continue despite magnesium sulfate administration). The doctor will evaluate the potential risk to the fetus against the therapeutic benefit for the mother.

Valium is also prescribed by doctors for the treatment of muscle spasms due to local trauma (injury, inflammation) and other conditions related to cerebral palsy (a group of disorders affecting a person's ability to move, maintain balance, and posture), paraplegia (paralysis of the lower half of the body, affecting both legs), and generalized rigidity syndrome, including tetanus.

No use Valium

• If you are allergic to diazepam or any of the other components of this medication (listed in section 6).
• If you are allergic (hypersensitive) to other medications in the benzodiazepine group.
• If you have respiratory difficultiesrelated or not to sleepfor a long time.
• If you have a condition called “myasthenia gravis”, characterized by muscle weakness and fatigue.
• If you have severe respiratory problems (Severe respiratory insufficiency).
• If you have severe liver problems (Severe hepatic insufficiency).
• If you suffer from drug or alcohol dependence, do not use Valium unless your doctor has formally indicated it.

This medication is not recommended for the primary treatment of psychotic disorders (serious mental disorders that cause abnormal ideas and perceptions), nor should it be used as the sole treatment for depression, alone or associated with anxiety.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Valium

• If you have any heart, liver, or kidney disease
• If you have respiratory difficulties
• If you suffer from severe muscle weakness
• If you have other diseases
• If you have allergies
• If you have a history or problems of dependence on drugs or central nervous system depressants, including alcohol
• If you have other diseases

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

In patients with depression, Valium only acts on the anxious component, so it is not a treatment for depression itself and may eventually unmask some of its signs (suicide risk).

If you are epilepticand are following a long-term treatment with Valium, do not recommend the use of the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of Valium, as seizures may occur.

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

Children

The duration of treatment should be as short as possible.

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 the younger population.

Other medications and Valium

Use ofValium withother medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 Valium.

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

On the other hand, medications such as rifampicin and carbamazepine reduce the effects of Valium.

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

The sedative effect and cardiopulmonary depression can be increased by combining Valium with other central nervous system depressants, which can cause coma or death.

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

Therefore, do not use Valium with any other medication unless your doctor has allowed it.

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

Use of Valium with food, drinks, and alcohol

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

Do not take 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-type medications can lead to physical and psychological dependence. This occurs mainly after prolonged use of the medication. To minimize the risk of dependence, the following precautions should be taken:

• The use of benzodiazepines should only be under medical prescription (never because they have worked in other patients), and never advise others.
• Once dependence has developed, your doctor will give you instructions to follow and apply the corresponding treatment.
• Follow your doctor's instructions strictly.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

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

If, strictly by medical necessity, Valium is administered before or during delivery, hypothermia (abnormally low body temperature), weakness, hypotension, and respiratory difficulties may occur in the newborn. Additionally, cases of withdrawal syndrome in newborns have been reported.

Benzodiazepines pass into breast milk, so you should consult your doctor about the use or non-use of Valium while breastfeeding.

Driving and operating machinery

Do not drive or operate tools or machinery 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.

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

This medication contains 8.5% ethanol (alcohol); which corresponds to 170.5 mg per dose, equivalent to 4.3 ml of beer or 1.8 ml of wine.

This medication is harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant women, breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

This medication contains 31.4 mg of benzyl alcohol in each 2 ml ampoule, equivalent to 15.7 mg/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 your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been linked to a risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children.

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

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

This medication 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 old).

This medication contains 828 mg of propylene glycol in each 2 ml ampoule, equivalent to 414 mg/ml.

If you are pregnant or breastfeeding, do not take this medication unless your doctor has recommended it. Your doctor may perform additional checks while you are taking this medication.

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

If the child is under 5 years old, consult your doctor or pharmacist, especially if other medications containing propylene glycol or alcohol have been administered.

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

Valium is administered via deep intramuscular injection.

Valium may also be administered intravenously with the following electrolyte infusion solutions: NaCl 0.9%, Dextrosa 5.5%, or Dextrosa 10%. It is essential to avoid the use of PVC bags and infusion equipment when administering the medication (see section 6).

If you estimate that the action of Valium 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 patients who are debilitated and in patients with chronic respiratory disorders.

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

If you use more Valium than you should

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

If you interrupt treatment with Valium

After discontinuing treatment, transient symptoms from before treatment may appear (although more pronounced), it is recommended to gradually reduce the dose until definitive discontinuation of treatment.

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

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Most patients tolerate Valium well, but the most common side effects, which occur especially at the beginning of treatment, are fatigue, muscle weakness, and drowsiness.

Occasionally, other side effects of the type of confusion, decreased alertness, loss of sensitivity, dizziness, emotional disturbances, mood changes, constipation, depression, double vision, ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, digestive changes, heart rhythm alterations, headache, hypotension, circulatory changes, changes in libido (sexual desire), nausea, dry mouth or excessive salivation, urinary incontinence or retention, skin eruptions, stuttering, tremors, vertigo, and blurred vision have been described. The most common skin reactions are inflammation (skin inflammation), urticaria (red itchy patches), and pruritus (uncomfortable skin itching that causes the desire to scratch the affected area).

Very rarely, an increase in transaminases and alkaline phosphatase, jaundice (yellowish discoloration of the skin and eyes), and cardiac arrest have been reported.

An increased risk of falls and fractures has been observed in elderly patients and in patients taking other sedatives (including alcoholic beverages) at the same time.

Heart failure, respiratory depression, including respiratory insufficiency, may occur.

It is known that when benzodiazepines are used, side effects on behavior such as restlessness, disorientation, agitation, irritability, delirium (incoherent ideas), outbursts of anger, aggression, nervousness, hostility, anxiety, nightmares, abnormal dreams, hallucinations, psychosis (loss of contact with reality), hyperactivity, or inappropriate behavior may occur. These reactions are more frequent in the elderly and in children. If you experience these side effects, you should discontinue treatment and contact your doctor immediately.

On the other hand, the use of benzodiazepines can lead to dependence, mainly when the medication is taken continuously for a long time. It is generally not recommended to stop the medication abruptly, always following the doctor's instructions.

Amnesia (difficulty remembering recent events) may appear at normal doses, and the risk increases with increased doses. The amnestic effects may be associated with behavioral changes.

If you observe any other reaction not described in this leaflet, consult 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 appearing in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the outer packaging.

Do not store at a temperature above 30°C.

Do not use Valium if it is stored incorrectly, as the content may become turbid or separate into phases.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.This has been demonstrated to present physical and chemical stability for 24 hours at room temperature.

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

It should not be mixed or diluted with other solutions or medications in the syringe or infusion bottle.

Valium Composition

• The active ingredient is diazepam. Each 2 ml ampoule contains 10 mg of diazepam.
• The other components are ethanol, benzyl alcohol, propylene glycol, sodium hydroxide, benzoic acid (E-210), sodium benzoate (E-211), and injection water.

Appearance of the product and contents of the package

Valium is presented as an injectable solution in 2 ml ampoules. It is available in clinical packaging of 5 or 50 ampoules.

Holder of the marketing authorization and responsible manufacturer

Holder::

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturers:

Roche Farma, S.A.

C/ Eratóstenes, 19

Getafe

28906 Madrid

or

CENEXI SAS

Rue Marcel et Jacques Gaucher, 52

Fontenay Sous Bois F-94120 - France

Last review date of this leaflet: May 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

-------------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

The dose should be individualized according to the needs of each individual and the minimum effective dose should be administered, especially in children, elderly patients, and individuals with weakened or hepatic disease or low serum albumin levels.

Moderate to severe anxiety:The adult dose 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 minimum effective dose possible.

Alcohol withdrawal:10 mg intramuscularly or intravenously. If necessary, repeat every 3-4 hours with 5-10 mg (Other dosage: 0.1-0.2 mg/kg intravenously repeated 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.

Pre-sedation for interventions:10-20 mg intravenously (5 mg initially and every 30 seconds 2.5 mg until eyelid drop to half pupil). In obese patients 30 mg intravenously; children: 0.1-0.2 mg/kg intravenously).

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

Tetanus:Administer 0.1-0.3 mg/kg body weight intravenously in intervals of 1-4 hours. Another option is continuous infusion or 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 producing it, 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, this dose should not be administered as a single intravenous injection but as a series of slow intravenous injections or as continuous intravenous infusion. If seizures continue despite administration of magnesium sulfate, Valium can be administered in a dose of 5-10 mg by intravenous injection.

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

Administration form

The intramuscular injection should be made deep.

The intravenous injection should always be applied very slowly (approximately 0.5-1 ml per minute) in large-caliber vessels. A too rapid administration can lead to apnea. It is advisable to use a respiratory assistance system when using the intravenous route. Avoid intraarterial injection or extravasation due to the possibility of vascular alterations.

Valium can be administered with the following electrolyte solutions for infusion: NaCl 0.9%, Dextrose 5.5% 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 medication should be used immediately. If not, the time it is stored and the previous conditions of its use will be the responsibility of the user.

It should not be mixed or diluted with other solutions or medications in the syringe or infusion bottle.

There is evidence that diazepam can be adsorbed by PVC infusion bags and infusion equipment. This adsorption leads to a decrease in diazepam concentration of 50% or more, especially when prepared infusion bags are stored for 24 hours or more in warm environmental conditions or when long infusion tubes or low infusion rates are used.It should be avoided to use PVC bags and infusion equipment when diazepam is to be administered. Care should be taken when changing between PVC bags and infusion equipment and those that do not contain PVC.

Regardless, after the acute symptoms have ceased, if it is necessary to continue treatment, it will be done orally.