Valium 10 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valium 10 mg tablets

Diazepam

Read the entire 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, 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 any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Valium is and what it is used for

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

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

Doctors prescribe Valium for people experiencing symptoms of anxiety, agitation, and psychological tension caused by psychoneurotic conditions and transient situational disorders. Benzodiazepines are indicated only for the treatment of severe disorders that significantly impair a person's functioning or subject them to considerable stress.

It may also be useful in relieving symptoms of acute agitation, tremor, and hallucinations in patients experiencing alcohol withdrawal syndrome.

Valium helps relieve muscle pain caused by muscle or joint spasms, inflammation, trauma, etc. It may also be used to treat spasms resulting from conditions such as 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), as well as in athetosis (continuous, involuntary, slow, and writhing movements of fingers and hands), and generalized stiffness syndrome.

Valium may be used as an adjunctive treatment (a treatment given after the primary treatment to increase the likelihood of recovery) for seizure disorders (such as epilepsy, convulsions), although it has not been shown to be effective as monotherapy. In such cases, your doctor will periodically evaluate the continued usefulness of the medicine for your condition.

2. What you need to know before taking Valium

Do not take Valium

• If you are allergic to diazepam or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to other medicines in the benzodiazepine group.
• If you have long-standing respiratory difficulties with or without sleep-related symptoms.
• 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 severe liver problems (severe hepatic insufficiency).
• If you suffer from drug or alcohol dependence, you should not take Valium unless your doctor has specifically instructed you to do so.

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. Your doctor will likely have prescribed another medication for these conditions.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 are taking other medicines.

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

In patients with depression, Valium acts only on the anxiety component and therefore does not constitute treatment for depression itself; it may even unmask certain symptoms of depression.

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 due to the increased risk if you are elderly or severely debilitated.

Children

The duration of treatment should be as short as possible.

Elderly patients

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

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

Patients with hepatic impairment

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

Other medicines and Valium

Taking Valium with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is extremely important because taking more than one medicine at the same time may increase or decrease their effects. For example, tranquilizers, 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 taking 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 take Valium with any other medicine unless your doctor has specifically approved it.

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

Taking Valium with food, drinks, and alcohol

Alcoholic beverages increase the sedative effects of Valium; therefore, avoid consuming alcohol during treatment. Consult your doctor if you need further advice.

Diazepam should not be taken with grapefruit juice, as it may increase diazepam levels in your body.

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

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

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 taken on a doctor's prescription (never because they worked for someone else), and you should never recommend them to others.
• Do not increase the dose prescribed by your doctor, or extend the treatment beyond the recommended duration.
• Consult your doctor regularly so they can decide whether treatment should continue.

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 taken before or during delivery 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 take Valium during breastfeeding.

Driving and using machines

Do not drive or operate tools or machinery, as this medicine may cause drowsiness, amnesia, difficulty concentrating, and muscle weakness, which may negatively affect your ability to drive or operate machinery. Your doctor should decide when you can resume these activities. This effect is increased if you have also consumed alcohol.

Valium contains lactose

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

3. How to take Valium

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

Depending on the nature of your illness, your age and weight, your doctor will prescribe the most appropriate dose and will tell you how long you should take Valium. The tablet can be divided into equal doses.

Remember to take your medicine.

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

Adults:

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

Symptomatic relief in acute alcohol withdrawal: 10 mg, 3 or 4 times during the first 24 hours, then reduced to 5 mg 3 or 4 times daily, as needed.

Adjunctive treatment for relief of musculoskeletal spasm: 2 to 10 mg, 3 or 4 times daily.

Adjunctive treatment in anticonvulsant therapy: 2 to 10 mg, 2 or 4 times daily.

Dosing in special populations

Use in children: 2 to 2.5 mg, 1 or 2 times daily, gradually increased according to need and tolerance; as a general rule, 0.1–0.3 mg/kg daily. Due to the variable response of children to drugs acting on the CNS, treatment should be initiated with the lowest dose and increased as required. Not to be used in children under 6 months of age.

In elderly patients or in the presence of debilitating diseases: 2 to 2.5 mg, 1 or 2 times daily, then gradually increased as needed and tolerated.

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

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

In elderly patients or those with liver or kidney disorders, muscular weakness, children, debilitated patients, or those with low serum albumin levels, your doctor will prescribe a lower dose.

Instructions for correct administration

Do not increase the doses prescribed by your doctor under any circumstances.

Each individual dose must not exceed the limits indicated, nor must the total daily dose, unless your doctor prescribes a higher dose.

Valium tablets should be taken without chewing, with a little water or a non-alcoholic drink.

The tablet can be divided into equal doses.

Tablets should be taken at the times when they are most needed, usually in the afternoon or evening.

Never change your prescribed dose on your own.

Duration of treatment

Treatment duration should be as short as possible and never longer than 2–3 months. Consult your doctor regularly so they can decide whether treatment should continue.

Do not prolong treatment beyond the recommended time.

To avoid withdrawal symptoms, Valium should not be stopped 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562.04.20, indicating the medicine and the amount ingested.

If you forget to take Valium

Do not take a double dose to make up for missed doses. Instead, continue with your normal dose.

If you stop taking Valium

When stopping treatment, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flushes may occur. Abrupt discontinuation of the medication is generally not recommended; instead, the dose should be gradually reduced according to your doctor's instructions.

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 everyone experiences 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 frequent 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, numbness, dizziness, affective disorders, emotional and mood disturbances, constipation, depression, diplopia (double vision), ataxia (inability to coordinate voluntary muscle movements), difficulty articulating speech, 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 common 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, elevated transaminases and alkaline phosphatase levels, 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 and contact your doctor immediately.

In addition, the use of benzodiazepines may lead to dependence, particularly when the medicine is taken continuously over a long period. Abruptly stopping the medication is generally not recommended; always follow your doctor's instructions.

Anterograde amnesia (difficulty remembering recent events) may occur at normal doses, and 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 Medicinal Products: www.notificaRAM.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation 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 is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valium

• The active substance is diazepam. Each tablet contains 10 mg of diazepam.
• The other components are monohydrate lactose, corn starch, magnesium stearate, and indigo carmine (E-132).

Appearance of the product and contents of the pack

The tablets are cylindrical in shape, with the imprint "10 V" on one side and scored on the other, pale blue in colour.

Valium 10 mg tablets are available in packs containing 25 tablets.

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

Manufacturer:

Roche Farma, S.A.

C/ Eratóstenes, 19

Getafe

28906 Madrid

Spain

RECIPHARM LEGANÉS S.L.U.

Calle Severo Ochoa 13,

Leganés, 28914 Madrid

Spain

Date of the most recent review of this leaflet: May 2021

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