DIAZEPAM QUALIGEN 5 mg TABLETS

2. What you need to know before taking Diazepam Qualigen

Do not take Diazepam Qualigen

• If you are allergic to diazepam or 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 breathing difficulties related or not to sleepfor a long time.
• If you have a disease called "myasthenia gravis", which is characterized by muscle weakness and fatigue.
• If you have severe respiratory problems (severe respiratory failure).
• If you have severe liver problems (severe liver failure).
• If you are drug or alcohol dependent, you should not take Diazepam Qualigen, unless your doctor formally indicates it.

This medicine 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 only treatment in patients with depression, alone or associated with anxiety. Your doctor will probably have prescribed another medicine for these cases.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diazepam Qualigen.

• 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 drug or central nervous system depressant dependence, including alcohol
• If you are taking other medicines

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

In patients with depression, Diazepam Qualigen only acts on anxious behavior, so it does not constitute a treatment for depression itself and may eventually unmask some signs of it.

If you are epileptic and are undergoing long-term treatment with Diazepam Qualigen, it is not recommended to use the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of Diazepam Qualigen, 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 Diazepam Qualigen than younger patients. The pharmacological effects of benzodiazepines in elderly patients seem 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 medicines and Diazepam Qualigen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is extremely important because the simultaneous use of more than one medicine can increase or decrease its effect.

For example, tranquilizers, sleep inducers, and similar medicines act on the brain and nerves and can reinforce the effect of Diazepam Qualigen.

Cisapride, cimetidine, ketoconazole, fluconazole, voriconazole, fluvoxamine, fluoxetine, hormonal contraceptives, disulfiram, isoniazid, diltiazem, idelalisib, modafinil, armodafinil, esomeprazole, and omeprazole temporarily increase the sedative effect of Diazepam Qualigen, increasing the risk of drowsiness. The same applies to grapefruit juice.

On the other hand, medicines such as rifampicin and carbamazepine produce a decrease in the effects of Diazepam Qualigen.

Also, the metabolism of phenytoin may be affected if you are taking Diazepam Qualigen, so if you are taking this medicine, your doctor will adjust the doses of the same.

The sedative effect and cardiorepiratory depression can be increased when combining Diazepam Qualigen with other central nervous system depressants, which can cause coma or death.

Xanthines such as theophylline and caffeine counteract the sedative effects of Diazepam Qualigen.

Therefore, you should not use Diazepam Qualigen with any other medicine, unless your doctor has allowed it.

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

Taking Diazepam Qualigen with food, drinks, and alcohol

Alcoholic beverages increase the sedative effects of Diazepam Qualigen, so you should avoid using 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 can decrease the speed, but not the absorption, of diazepam from the tablet; this can lead to 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 can lead to physical and psychological dependence. This occurs mainly after uninterrupted use of the medicine 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 never advise them to other people.

• Do not increase the prescribed doses in any way, nor prolong the treatment for longer than recommended.

• Consult your doctor regularly so that he can decide if you should continue treatment.

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, for strict medical necessity, you take Diazepam Qualigen before or during delivery, hypothermia (abnormally low body temperature), weakness, hypotension, and breathing difficulties may occur in the newborn. Additionally, cases of withdrawal syndrome have been reported in newborns.

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

Driving and using machines

Do not drive or operate tools or machines because this medicine 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.

Diazepam Qualigen contains lactose

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

3. How to take Diazepam Qualigen

Follow the instructions for administration of this medicine 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.

Remember to take your medicine.

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 variety of response of children to medicines that act on the central nervous system, 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. Do not exceed the maximum dose.

If you think the effect of diazepam is too strong or too weak, tell your doctor or pharmacist.

In elderly patients who have 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.

Rules for correct administration

Do not increase the doses prescribed by the doctor 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.

Diazepam Qualigen tablets should be taken without chewing, with a little water or a non-alcoholic drink. 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 he can decide if treatment should be continued.

Do not prolong treatment for longer than recommended.

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

If you take more Diazepam Qualigen 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 medicine and the amount ingested.

If you forget to take Diazepam Qualigen

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

If you interrupt treatment with Diazepam Qualigen

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

Most patients tolerate Diazepam Qualigen 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 sensitivity, 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 hives), 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 who are also taking other sedative medicines (including alcoholic beverages).

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), fits of rage, 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 stop treatment and contact your doctor immediately.

Furthermore, the use of benzodiazepines can lead to dependence, mainly when the medicine 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 appear 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 package 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 listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diazepam Qualigen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

6. Packaging Content and Additional Information

Composition of Diazepam Qualigen

• The active ingredient is diazepam. Each tablet contains 5 mg of diazepam.

• The other components are lactose monohydrate, cornstarch, and magnesium stearate (E-572).

Product Appearance and Packaging Content

Diazepam Qualigen 5 mg tablets: round, flat, beveled, and scored tablets, white or almost white in color, with the inscription E on one side.

Diazepam Qualigen 5 mg tablets are available in packs of 30 and 40 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona) - Spain

Date of the Last Revision of this Leaflet:February 2024

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