VALIUM 5mg TABLETS

2. What you need to know before taking Valium

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 long-standing breathing difficulties related or not to sleep.
• If you have a disease called "myasthenia gravis", characterized by muscle weakness and fatigue
• If you have severe respiratory problems (severe respiratory failure).
• If you have severe liver problems (severe hepatic failure).
• If you suffer from drug or alcohol dependence, you should not take Valium, unless your doctor formally indicates it.

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 in patients with depression, alone or associated with anxiety. Your doctor will likely have 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 of or problems with dependence on central nervous system depressants, including alcohol
• If you are taking other medications

Your doctor will decide whether it is convenient for you to take a lower dose of Valium or not to take it at all.

In patients with depression, Valium only acts on the anxious component, so it does not constitute a treatment for depression in itself and may eventually unmask some signs of it.

If you are epileptic and are undergoing long-term treatment with Valium, it is not recommended to use the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of Valium, as convulsions may appear.

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

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

Other medications and Valium

Taking Valium with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This is extremely important because the simultaneous use of more than one medication can increase or decrease its effect. For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and can reinforce the effect of Valium.

Cisapride, 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.

On the other hand, medications such as rifampicin and carbamazepine produce a decrease in 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.

The sedative effect and cardiorespiratory depression can be increased when combining Valium 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 medication unless your doctor has allowed it.

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

Taking Valium with food, drinks, and alcohol

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

You should not take diazepam in combination with grapefruit juice, as it can increase the levels of diazepam in your body.

Food and antacids may decrease the speed, but not the absorption, of diazepam from the tablet; this may lead to milder effects after a single dose, but it 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 uninterrupted use of the medication for a long time. To minimize the risk of dependence, the following precautions should be taken:

• The use of benzodiazepines will only be done under medical prescription (never because they have been effective in other patients), and you should never recommend them to others.
• Do not increase the prescribed doses in any way, nor prolong treatment beyond the recommended time.
• Consult your doctor regularly so that they can decide whether to continue treatment.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

If, for strict medical necessity, you take Valium before or during delivery, the newborn may experience hypothermia (abnormally low body temperature), weakness, hypotension, and respiratory difficulties. There have also been cases of withdrawal syndrome in newborns.

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

Driving and using machines

Do not drive or operate tools or machines 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 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.

3. How to take Valium

Follow your doctor's instructions for administering this medication exactly. If you are 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 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.

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

Adjunctive treatment for muscle spasms:2 to 10 mg, 3 or 4 times a day.

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

Dosage in special populations

Use in children: 2 to 2.5 mg, 1 or 2 times a day, gradually increasing as needed and tolerated; as a general rule, 0.1-0.3 mg/kg per day. Due to the varied response of children to central nervous system medications, treatment should be started with the lowest dose and increased as required. Do not use in children under 6 months of age.

In elderly or debilitated patients: 2 to 2.5 mg, 1 or 2 times a day, gradually increasing as needed and tolerated.

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

If you think 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, or muscle weakness, in children, in debilitated patients, or those with low serum albumin levels, the doctor will prescribe a lower dose.

Guidelines for correct administration

Do not increase the prescribed doses in any way.

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.

The tablets will be taken at the times that are most necessary, usually in the afternoon or evening.

Never change the dose that has been prescribed for you.

Duration of treatment

The duration of treatment should be as short as possible and never more than 2-3 months. Consult your doctor regularly so that they can decide whether to continue treatment.

Do not prolong treatment beyond the recommended time.

To avoid withdrawal symptoms, you should 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 make up for forgotten doses. Instead, continue with the normal dose.

If you interrupt treatment with Valium

When stopping administration, restlessness, anxiety, insomnia, lack of concentration, headache, and hot flashes may appear. It is not recommended to interrupt treatment abruptly, but rather to gradually reduce the dose, according to the doctor's instructions.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you think any of the side effects you are experiencing is serious 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 have been described, such as confusion, decreased alertness, loss of sensation, dizziness, affective disorders, emotional and mood changes, constipation, depression, diplopia (double vision), ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, digestive changes, changes in heart rhythm, headache, hypotension, circulatory changes, changes in libido (sexual appetite), nausea, dry mouth or hypersalivation (exaggerated salivary secretion), incontinence or urinary retention, skin rashes, stuttering, tremors, vertigo, and blurred vision. The most common skin reactions are rash (skin inflammation), urticaria (red patches), and pruritus (itching or uncomfortable skin irritation that causes the desire to scratch the affected area).

Very rarely, increased transaminases and alkaline phosphatase, jaundice (yellowish appearance of the skin and eyes), as well as cardiac arrest, have been reported.

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

Cardiac failure, respiratory depression, including respiratory failure, may occur.

It is known that when benzodiazepines are used, behavioral side effects such as restlessness, disorientation, agitation, irritability, delirium (incoherence of ideas), rage attacks, 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 effects, you should interrupt treatment and contact your doctor immediately.

Furthermore, the use of benzodiazepines can lead to dependence, mainly when the medication is taken uninterrupted for a long time. It is not recommended to interrupt treatment abruptly, but rather to gradually reduce the dose, according to the doctor's instructions.

Anterograde amnesia (difficulty remembering recent events) may occur at normal doses, and the risk increases when the dose is increased. Amnestic effects may be associated with behavioral changes.

If you notice any other reaction not described in this leaflet, consult your doctor or pharmacist.

Reporting side effects

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

5. Storage of Valium

Keep this medication out of sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Valium Composition

• 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).

Product Appearance and Packaging Content

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

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

Marketing Authorization Holder 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

Date of the Last Revision of this Leaflet:May 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/