Package Leaflet: Information for the User

Diazepam Vir 2 mg Tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1 What Diazepam Vir is and what it is used for

2. What you need to know before you start taking Diazepam Vir

3. How to take Diazepam Vir

4. Possible side effects

5. Storage of Diazepam Vir

6. Contents of the pack and additional informationl

Diazepam Vir contains as active ingredient diazepam, which belongs to the group of medicines called benzodiazepines.

Diazepam has tranquilizing, sedative, muscle relaxant and anticonvulsant effects.

Doctors prescribe diazepam to people who present symptoms of anxiety, agitation and mental tension produced by psychoneurotic states and transient situational disorders. Benzodiazepines are only indicated for the treatment of an intense disorder, which limits their activity or subjects them to a situation of important stress.

It may also be useful for the relief of symptoms of acute agitation, tremor and hallucinations in patients with alcohol withdrawal syndrome.

Diazepam Vir contributes to the relief of muscle pain caused by spasms or inflammation of muscles or joints, trauma, etc. It can also be used to combat spasms originating from diseases such as cerebral palsy (a group of disorders that affect a person's ability to move, maintain balance and posture) and paraplegia (paralysis of the lower half of the body, which affects both legs), as well as in atetosis (continuous, involuntary, slow and extravagant movements of fingers and hands) and in generalized rigidity syndrome.

Diazepam Vir may be used as an adjunctive treatment (treatment administered after the main treatment to increase the chances of a cure) of convulsive disorders (such as epilepsy, seizures), but it has not been proven useful as a single treatment. In these cases, your doctor will periodically evaluate the usefulness of the medicine for your case.

Do not take Diazepam Vir

• If you are allergic to diazepam or any of the other components of this medication (listed in section 6).
• If you are allergic to other medications in the benzodiazepine group.
• If you have respiratory difficulties (related or unrelated to sleep) for 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 take diazepam unless your doctor has formally instructed you to do so.

This medication is not recommended for the primary treatment of psychotic disorders (severe mental disorders that cause abnormal ideas and perceptions), nor should it be used as the sole treatment for depression, alone or in combination with anxiety. Your doctor has probably prescribed another medication for these cases.

Do not use this medication in children under 6 months of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you have any 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 drug or alcohol dependence problems
• If you are taking other medications

Your doctor will decide whether you should take a lower dose of this medication or not take it at all.

If you are epilepticand are following a long-term treatment with Diazepam Vir, do not use the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of diazepam, as this may cause seizures.

Other medications and Diazepam Vir

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is extremely important because the simultaneous use of multiple medications may increase or decrease their effect.

Therefore, do not take diazepam with other medications unless your doctor is informed and approves it in advance. For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and may enhance the effect of this medication.

Cisapride, cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole temporarily increase the sedative effect of diazepam, increasing the risk of drowsiness.

Similarly, the metabolism of phenytoin may be affected if you are taking diazepam, so if you are taking this medication, your doctor will adjust the doses accordingly.

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

Taking Diazepam Vir with food, drinks, and alcohol

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

Risk of dependence

The use of benzodiazepines may lead to dependence. This occurs mainly after taking the medication continuously for a long time. To minimize the risk of dependence, consider the following precautions:

• The use of benzodiazepines should only be under medical prescription (never because they have worked for other patients), and never advise others to take them.

• Do not increase the prescribed doses or prolong the treatment longer than recommended.

• Consult your doctor regularly to decide whether to continue treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.Your doctor will then decide whether you should take this medication or not.

Benzodiazepines pass into breast milk, so you should consult your doctor about taking diazepam while breastfeeding.

Driving and operating machinery

Diazepam may impair your ability to drive or operate machinery, as it may cause drowsiness, decrease attention, or decrease reaction time. The appearance of these effects is more likely at the beginning of treatment or when increasing the dose. Do not drive or operate machinery if you experience any of these effects.

Use in elderly people

Elderly people may need lower doses of diazepam than younger patients. If you are an elderly person, your doctor may prescribe a lower dose and monitor your response to treatment. Please follow your doctor's instructions carefully.

Diazepam Vir contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of the medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Depending on the nature of your illness, your age and weight, your doctor will prescribe the most suitable dose and indicate the duration of your treatment with Diazepam Vir.

Remember to take your medication.

Follow these instructions unless your doctor has given you different instructions:

Use in adults

Anxiety symptoms:2 to 10 mg, 2 to 4 times a day, depending on the severity of the symptoms.

Acute alcohol withdrawal relief:10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg 3 or 4 times a day, as needed.

Muscle skeletal spasm relief:2 to 10 mg, 3 or 4 times a day.

Adjunct in anticonvulsant therapy:2 to 10 mg, 2 or 4 times a day.

Use in children

From 2 to 2.5 mg, 1 or 2 times a day, increasing gradually as needed and tolerated; as a general rule, 0.1-0.3 mg/kg per day. Due to the variety of responses of children to medications acting on the CNS, treatment should begin with the lowest dose and increase as needed. Do not use in children under 6 months of age.

Use in elderly or in the presence of debilitating diseases

From 2 to 2.5 mg, 1 or 2 times a day, increasing gradually as needed and tolerated.

Treatment should begin with the lowest dose. The maximum dose should not be exceeded.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

In elderly patients with liver or kidney disorders, or muscle weakness, in children, in debilitated patients or with low serum albumin levels, the doctor will prescribe a lower dose.

Guidelines for correct administration

Do not increase the doses prescribed by your doctor at all.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

Tablets should be taken without chewing, with a little water or a non-alcoholic beverage.

Tablets should be taken at the hours when they are most needed, usually in the afternoon or evening. Never change the dose that has been prescribed for you.

Treatment duration

The duration of treatment should be as short as possible and never exceed 2-3 months. Consult your doctor regularly to decide if treatment should continue.

Do not prolong treatment beyond the recommended time.

To avoid withdrawal symptoms, do not stop taking this medication abruptly, especially if you have been taking it for a long time.

If you take more Diazepam Vir than you should

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 used.

If you forgot to take Diazepam Vir

Do not take a double dose to compensate for the missed doses. Instead, continue with the normal dose.

If you interrupt treatment with Diazepam Vir

Upon cessation of administration, restlessness, anxiety, insomnia, lack of concentration, headache and hot flashes may appear. It is not generally recommended to stop medication abruptly, but rather to gradually reduce the dose, according to the doctor's instructions.

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

Like all medicines, this medicine may 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 diazepam well, but the most common side effects, which occur especially at the beginning of treatment, are fatigue and drowsiness.

Occasionally, other side effects such as confusion, decreased alertness, numbness, constipation, depression, double vision, ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, digestive alterations, heart rhythm alterations, headache, hypotension, circulatory alterations, increased or decreased libido (sexual appetite), nausea, dry mouth or hypersalivation (excessive salivation), incontinence or urinary retention, skin eruptions, stuttering, tremors, dizziness, 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.

It is known that when benzodiazepines are used, side effects on behavior such as restlessness, agitation, irritability, delirium (incoherent ideas), outbursts of anger, aggression, nightmares, hallucinations, psychosis (loss of contact with reality), or inappropriate behavior may occur. These reactions are more common 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 abruptly stop medication, always following the doctor's instructions.

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

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: https://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.

This medication does not require special storage conditions.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Diazepam Vir Composition

The active ingredient is diazepam. Each tablet contains 2 mg of diazepam.

The other components are lactose, cornstarch, and magnesium stearate (E470b).

Product appearance and packaging contents

Diazepam Vir 2 mg tablets are round, white or almost white, scored tablets. The tablet can be divided into equal doses.

Diazepam Vir 2 mg tablets are available in packaging of 30 or 100 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

or

SANTA S.A.

60 Str. Carpatilor, objective no. 47,48,58,133

Brasov, Brasov County, 500269

Romania

This leaflet was approved in April 2022

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