Valium 5 mg/ml solution for injection
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Valium 5mg/ml injection solution
Diazepam
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 other people, even if they have the same symptoms as you, because 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
- What Valium is and what it is used for
- What you need to know before using Valium
- How to use Valium
- Possible side effects
- How to store Valium
- Contents of the pack and other information
1. What Valium is and what it is used for
Valium contains diazepam as the active substance, which belongs to a group of medicines called benzodiazepines.
Diazepam has calming, sedative, muscle-relaxant, and anticonvulsant effects.
Doctors prescribe Valium for patients experiencing moderate to severe agitation, anxiety, or psychological tension. Benzodiazepines are indicated only for the treatment of severe disorders that significantly impair a person's functioning or subject them to considerable stress.
Doctors also prescribe Valium as premedication for 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 relieve agitation, panic, tremors, and hallucinations (delirium tremens).
For the acute treatment of status epilepticus (a single or repeated epileptic seizure lasting long enough to potentially cause neurological damage), severe convulsions, and tetanus (a disease causing muscle spasms). In gynecology, it is used in pre-eclampsia or eclampsia (seizures due to a sudden and unexpected rise in blood pressure before or during pregnancy) as a second-line treatment (if magnesium sulfate is not available or if epileptic seizures persist despite administration of magnesium sulfate). The physician will evaluate the potential risk to the fetus against the therapeutic benefit to the mother.
Valium is also prescribed by doctors for the treatment of muscle spasms due to local injuries (trauma, 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 stiffness syndrome, including tetanus.
2. What you need to know before using Valium
Do not use Valium
- If you are allergic to diazepam or to any of the other components of this medicine (listed in section 6).
- If you are allergic (hypersensitive) to other medicines in the benzodiazepine group.
- If you suffer from long-term respiratory difficulties with or without sleep-related symptoms.
- If you have a condition called “myasthenia gravis”, which is 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, you should not use Valium unless your doctor specifically instructs you to do so.
This medicine is not recommended for the primary treatment of psychotic disorders (severe mental disorders causing abnormal thoughts and perceptions), nor should it be used as the sole treatment in patients with depression, whether alone or associated with anxiety.
If you have any doubts about this, consult your doctor.
Warnings and precautions
Talk to 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 illnesses
- If you have allergies
- If you have a history of, or problems with, drug dependence or central nervous system depressants, including alcohol
- If you suffer from other diseases
Your doctor will decide whether to prescribe a lower dose of Valium or not to use it at all.
In patients with depression, Valium only acts on the anxious component and therefore does not constitute treatment for depression itself; it may even unmask certain symptoms of depression (risk of suicide).
If you have epilepsy and are undergoing long-term treatment with Valium, the use of the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of Valium is not recommended, as seizures may occur.
Your doctor will pay special attention if you are elderly or severely debilitated due to the increased risk associated with these conditions.
Children
The duration of treatment should be as short as possible.
The use of Valium is not permitted in children under 12 years of age, except for the control of status epilepticus. For status epilepticus, Valium 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 appear to be greater in elderly patients than in younger populations.
Other medicines and Valium
Using Valium with other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicine. This is extremely important because taking multiple medicines at the same time may increase or reduce their effects. For example, sedatives, sleep-inducing medicines, and similar drugs act on the brain and nerves and may enhance the effect of Valium.
Cimetidine, ketoconazole, fluconazole, voriconazole, fluvoxamine, fluoxetine, hormonal contraceptives, disulfiram, isoniazid, diltiazem, idelalisib, modafinil, armodafinil, esomeprazole, and omeprazole temporarily increase the sedative effect of Valium, increasing the risk of drowsiness. The same applies to grapefruit juice.
Conversely, medicines such as rifampicin and carbamazepine reduce the effects of Valium.
In addition, the metabolism of phenytoin may be affected if you are being treated with Valium; therefore, if you are taking this medicine, your doctor will adjust the doses accordingly.
The sedative effect and cardiorespiratory depression may be increased when Valium is combined with other central nervous system depressants, potentially leading to coma or death.
Xanthines such as theophylline and caffeine counteract the sedative effects of Valium.
Therefore, you should not use Valium with any other medicine unless your doctor has specifically 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; therefore, avoid consuming alcohol during treatment. If you need further information, consult your doctor.
Diazepam should not be taken 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 mainly after prolonged, uninterrupted use of the medicine. To minimize the risk of dependence, the following precautions should be observed:
- Benzodiazepines should only be used under medical prescription (never because they worked for someone else), and you should never recommend them to others.
- Once dependence has developed, your doctor will provide instructions and apply the appropriate treatment.
- Strictly follow your doctor's instructions.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
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.
If Valium is administered before or during childbirth due to strict medical necessity, the newborn may experience hypothermia (abnormally low body temperature), weakness, hypotension, and respiratory difficulties. Cases of withdrawal syndrome in newborns have also been reported.
Benzodiazepines pass into breast milk; therefore, you should consult your doctor about whether or not to use Valium during breastfeeding.
Driving and operating machinery
Do not drive or operate tools or machinery, as this medicine may cause sedation, amnesia, difficulty concentrating, and muscle weakness, all of which may negatively affect your ability to drive vehicles or operate machinery. Your doctor will determine 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 medicine contains 8.5% ethanol (alcohol), corresponding to 170.5 mg per dose, equivalent to 4.3 ml of beer or 1.8 ml of wine.
This medicine may be harmful to people suffering from alcoholism.
The alcohol content should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
This medicine contains 31.4 mg of benzyl alcohol in each 2 ml ampoule, equivalent to 15.7 mg/1 ml.
Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may 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 may accumulate in your body and cause adverse effects (metabolic acidosis).
Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems ("gasping syndrome") in children.
Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has specifically recommended it.
This medicine should not be used for more 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).
This medicine contains 828 mg of propylene glycol in each 2 ml ampoule, equivalent to 414 mg/1 ml.
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.
If the child is under 5 years of age, consult your doctor or pharmacist, especially if other medicines containing propylene glycol or alcohol have been administered.
Valium contains benzyl alcohol and propylene glycol. Valium contains 31.4 mg of benzyl alcohol and 828 mg of propylene glycol per ml.
Seek advice from your doctor or pharmacist if your child is under 5 years of age, if you have any liver or kidney disease, or if you are pregnant or breastfeeding. This is because 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.
3. How to use Valium
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Valium is administered by deep intramuscular injection.
Valium may also be administered intravenously with the following electrolyte infusion solutions: 0.9% NaCl, 5.5% Dextrose, or 10% Dextrose. The use of PVC-containing infusion bags and administration sets should be avoided when administering this medicine (see section 6).
If you feel that the effect of Valium is too strong or too weak, inform your doctor or pharmacist.
Your doctor will adjust the dose for each individual patient. Dosages will be lower in elderly or debilitated patients and in patients with chronic respiratory disorders.
Your doctor will determine 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, contact 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 you stop treatment with Valium
After discontinuation of treatment, previous symptoms may transiently reappear (although more pronounced). It is recommended to gradually reduce the dose until definitive discontinuation of treatment.
Status epilepticus If an epileptic seizure lasts more than 10–15 minutes, the doctor may decide to administer an additional dose. A maximum of 2 doses may be administered. Your child should not receive more than two repeated doses in a single day if under 5 years of age.
Use in children Valium 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 have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody 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 Valium well, but the most common adverse effects, especially at the beginning of treatment, are fatigue, muscle weakness and drowsiness.
Occasionally, other adverse effects have been reported, such as confusion, reduced alertness, loss of sensation, dizziness, affective disorders, emotional and mood disturbances, constipation, depression, diplopia (double vision), ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, gastrointestinal disturbances, changes in heart rhythm, headache, hypotension, circulatory disturbances, changes in libido (sexual desire), nausea, dry mouth or hypersalivation (excessive salivary secretion), urinary incontinence or urinary retention, skin rashes, stammering, tremor, vertigo and blurred vision. The most frequent skin reactions are rash (skin inflammation), urticaria (reddish welts) and pruritus (tingling or uncomfortable skin irritation causing an urge to scratch the affected area).
Very rarely, increased levels of transaminases and alkaline phosphatase, jaundice (yellowing 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 sedative medicines simultaneously (including alcoholic beverages).
Heart failure and respiratory depression, including respiratory failure, may occur.
It is known that when benzodiazepines are used, adverse effects on behaviour may occur, such as restlessness, disorientation, agitation, irritability, delirium (incoherent thinking), rage attacks, aggressiveness, nervousness, hostility, anxiety, nightmares, abnormal dreams, hallucinations, psychosis (loss of contact with reality), hyperactivity or inappropriate behaviour. These reactions are more frequent in elderly patients and in children. If you experience any of these effects, you must stop treatment immediately and contact your doctor without delay.
In addition, the use of benzodiazepines may lead to dependence, particularly when the medicine is taken continuously over a long period. It is generally not recommended to stop treatment abruptly, always following your doctor's instructions.
Anterograde amnesia (difficulty in remembering recent events) may occur at normal doses; the risk increases with higher doses. Amnesic effects may be associated with behavioural disturbances.
If you notice any other reaction not described in this leaflet, consult 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 Valium
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 refers to the last day of the month indicated.
Store in the outer packaging.
Do not store at temperatures above 30°C.
Do not use Valium if it has been stored incorrectly, as the solution may become cloudy or separate into phases.
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. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
Physical and chemical stability has been demonstrated for 24 hours at room temperature after use.
From a microbiological standpoint, the medicine should be used immediately. Otherwise, the duration of storage and the conditions prior to use are the responsibility of the user.
This medicine must not be mixed or diluted with other solutions or medicines in the syringe or infusion bottle.
6. Contents of the pack and other information
Composition of Valium
- The active substance 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 water for injection.
Presentation of the product and contents of the pack
Valium is available as an injectable solution in 2 ml ampoules. It is available in packs of 5 or 50 ampoules (clinical pack).
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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
Date of the most recent revision of this leaflet: September 2025
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/
This information is intended for healthcare professionals only:
Dosage 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, or 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 after 3–4 hours. (Alternative regimen: 0.1–0.2 mg/kg intravenously, repeated every 8 hours until symptoms cease.) Follow with oral treatment.
As premedication: 10–20 mg intramuscularly, one hour before induction of anesthesia. In children: 0.1–0.2 mg/kg intramuscularly.
For 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; in children: 0.1–0.2 mg/kg intravenously.
In status epilepticus: 0.15–0.25 mg/kg intravenously, repeated at intervals of 10–15 minutes if necessary, or administered by continuous infusion. (Maximum dose: 3 mg/kg within 24 hours).
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 in 24 hours).
Pre-eclampsia and eclampsia: In case of seizures, or if there is a risk of seizures occurring and magnesium sulfate is not available, 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 in 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 a continuous intravenous infusion. If epileptic seizures persist despite administration of magnesium sulfate, Valium may be administered at 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.
Method of administration
Intramuscular injection must be administered deeply.
Intravenous injection must always be given 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 or extravasation must be strictly avoided due to the risk of vascular damage.
Valium may be administered with the following electrolyte infusion solutions: 0.9% NaCl, 5.5% Dextrose, or 10% Dextrose.
Physical and chemical stability has been demonstrated for 24 hours at room temperature.
From a microbiological standpoint, the product should be used immediately. If not, the storage duration and conditions prior to use are the user's responsibility.
Valium must not be mixed or diluted with other solutions or medications in the same syringe or infusion bottle.
Evidence indicates 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 environmental 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 should be taken when switching between infusion systems containing PVC and those that do not.
In any case, after resolution of acute symptoms, if continuation of treatment is indicated, it should be switched to oral administration.