Label:information for the user

Valium5 mg tablets

Diazepam

Read this label carefully before starting totakethismedicine, 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 medicine has been prescribedonlyfor you,and you must not give it to others even if they have the same symptomsasyou,as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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 people who experience symptoms of anxiety, agitation, and mental tension caused by psychoneurotic states and transient situational disorders. Benzodiazepines are only indicated for the treatment of intense disorders that limit their activity or subject them to significant stress.

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

Valium 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, affecting both legs), as well as in atetosis (slow, involuntary, and extravagant movements of fingers and hands) and in generalized rigidity syndrome.

Valium may be used as an adjunctive treatment (treatment administered after the primary treatment to increase the chances of a cure) for 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 medication for your case.

Do not take 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 breathing difficultiesrelated or unrelated 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 are dependent on drugs or alcohol, do not take Valium, 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 patients with depression, alone or associated 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 Valium

• If you have any heart, liver, or kidney disease
• If you have breathing difficulties
• If you have 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 are taking other medications

Your doctor will decide whether you should take a lower dose of Valium or not take 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 symptoms.

If you are epileptic and are taking long-term treatment with Valium, do not use the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of Valium, as this may cause seizures.

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

Children

The duration of treatment should be as short as possible.

Elderly patients

Elderly patients may need lower doses of Valium than younger patients. The pharmacological effects of benzodiazepines in elderly patients appear to be greater than in the younger population.

If you are an elderly patient, your doctor may prescribe a lower dose and check your response to treatment. Please follow your doctor's instructions carefully.

Patients with liver dysfunction

The sedative effect of diazepam is increased in patients with alcoholic cirrhosis.

Other medications and Valium

Valium with other medications

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. For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and may enhance the effect of Valium.

Cisapride, 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 taking Valium, so if you are taking this medication, your doctor will adjust the doses accordingly.

Combining Valium with other central nervous system depressants may increase the sedative effect and respiratory depression, potentially causing 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 about this, consult your doctor or pharmacist.

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 this may increase the levels of diazepam in your body.

Food and antacids may slow down the absorption of diazepam from the tablet, but will not reduce it; this may lead to milder effects after a single dose, but does not affect treatment with multiple doses.

Prokinetic medications (medications to improve intestinal transit) increase the absorption of diazepam.

Risk of dependence

The use of benzodiazepines and benzodiazepine-like medications can lead to physical and psychological dependence. This occurs mainly after taking the medication continuously for a long time. To minimize the risk of dependence, follow these precautions:

• Take benzodiazepines only under medical prescription (never because they have worked for other patients), and never advise others to take them.
• Do not increase the prescribed doses, nor prolong the treatment longer than recommended.
• Consult your doctor regularly to decide whether to continue treatment.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

If you take Valium before or during delivery, your baby may experience hypothermia (abnormally low body temperature), weakness, hypotension, and breathing difficulties. Additionally, cases of withdrawal syndrome in newborns have been reported.

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

Driving and operating machinery

Do not drive or operate machinery because this medication may cause drowsiness, amnesia, difficulty concentrating, and muscle weakness, which may 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 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 this medication indicated by your doctor. 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 Valium. The tablet can be divided into equal doses.

Remember to take your medication.

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

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 within the first 24 hours, reducing to 5 mg 3 or 4 times a day, as needed.

Co-adjunct for muscle spasm relief:‑skeletal:2 to 10 mg, 3 or 4 times a day.

Co-adjunct in anticonvulsant therapy:2 to 10 mg, 2 or 4 times a day.

Posology in special populations:

Use in children: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 required. Do not use in children under 6 months of age.

In the elderly or in the presence of debilitating diseases:2 to 2.5 mg, 1 or 2 times a day, increasing gradually as needed and tolerated.

The treatment should start with the lowest dose. Do not exceed the maximum dose.

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

In 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.

Valium tablets should be taken without chewing, with a little water or a non-alcoholic beverage. The tablet can be divided into equal doses.

Valium tablets will be taken at the hours that are most necessary, 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 Valium abruptly, especially if you have been taking it for a long time.

If you take more Valium 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 ingested.

If you forget to take Valium:

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

If you interrupt treatment with Valium:

Stopping administration may cause restlessness, anxiety, insomnia, lack of concentration, headache and hot flashes. It is not generally recommended to stop treatment 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 medications, this medication can produce adverse effects, although not all people experience them.

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

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

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

Very rarely, an increase in transaminases and alkaline phosphatase, jaundice (yellowish appearance 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, adverse effects on behavior may occur, such as restlessness, disorientation, agitation, irritability, delirium (incoherence of ideas), outbursts of anger, aggression, nervousness, hostility, anxiety, nightmares, abnormal dreams, hallucinations, psychosis (loss of contact with reality), hyperactivity, or inappropriate behavior. These reactions are more frequent in the elderly and in children. If you experience these 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 discontinue medication, 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 alterations.

If any other reaction not described in this prospectus is observed, consult your doctor or pharmacist.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not appearing in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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.

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

Composition of Valium

• The active ingredient is diazepam. Each tablet contains 5 mg of diazepam.
• The other components are lactose monohydrate, cornstarch, magnesium stearate, and yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

The tablets are cylindrical in shape, with the inscription "5 V" on one face and scored on the other, of pale yellow color.

Valium 5 mg tablets are available in packs of 30 tablets.

Holder of the marketing authorization and manufacturer

Holder:

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturer:

Roche Farma, S.A.

C/ Eratóstenes, 19

Getafe

28906 Madrid

RECIPHARM LEGANÉS S.L.U.

Calle Severo Ochoa 13,

Leganés, 28914 Madrid

Spain

Last review date of this leaflet:May 2021

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