PATIENT INFORMATION LEAFLET

Diazepan Prodes 5 mg Tablets

Diazepam

Read this leaflet carefully before you start taking this medicine.

• 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. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you think you are having a serious side effect or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

The active ingredient, diazepam, is a benzodiazepine derivative that presents tranquilizing, sedative, muscle relaxant, anticonvulsant, and antipsychotic activity.

Doctors prescribe this medication to people suffering from anxiety, agitation, and mental tension due to psychoneurotic states and transient situational disorders. They also prescribe it to patients with alcohol withdrawal, as it can be useful for symptomatic relief of acute agitation, tremors, and hallucinations.

Additionally, it is used in conjunction with other medications for the relief of musculoskeletal pain due to spasms or local pathology (inflammation of muscles or joints, trauma, etc.). It can also be used to treat spasticity (rigidity) in conditions such as cerebral palsy and paraplegia, as well as in ataxia (involuntary movements) and generalized rigidity syndrome.

This medication can also be used in conjunction with other medications for the treatment of convulsive disorders, as it has not been shown to be effective as a single treatment. In these cases, the doctor must periodically evaluate the usefulness of the medication for each patient.

This medication is for oral administration.

Do not take Diazepan Prodes

• If you are allergic (hypersensitive) to diazepam or to any of the other components of Diazepan Prodes.
• If you have a dependence on other substances, including alcohol, unless your doctor tells you to.
• If you have closed-angle glaucoma (increased eye pressure) and have severe chronic hypercapnia (increased carbon dioxide in the blood).

Be especially careful with Diazepan Prodes

• If you have myasthenia (muscle weakness and fatigue), as you may experience increased muscle fatigue, if you have moderate respiratory insufficiency, as well as if you have kidney or liver insufficiency. Your doctor should adjust your dose.

• If you have depression, you should be aware that diazepam only acts on the anxious component, so it does not constitute a treatment for depression and may eventually unmask some of its symptoms.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

You should not take Diazepan Prodes with medications that act on the central nervous system, such as neuroleptics (medications used in psychiatry), tranquilizers, antidepressants, hypnotics (sleep aids), anticonvulsants (for seizures), analgesics (for pain), and anesthetics, as they increase the sedative effect of diazepam.

You should also not take Diazepan Prodes with cisaprida (a medication used for gastrointestinal disorders) as it produces a temporary increase in the sedative effect of diazepam, as well as cimetidina (a medication for acid reflux), which increases the risk of drowsiness.

If you take Diazepan Prodes concomitantly with phenytoin (a medication for epilepsy), your doctor should monitor the blood concentrations of this medication, as they may experience unpredictable variations, leading to signs of toxicity or decreased activity, or no change.

The concomitant use of Diazepam and opioids (strong analgesics, medication for substitution therapy, and some medications for cough) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Diazepam with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Please inform your doctor about all the opioid medications you are taking, and follow your doctor's recommended dose closely. It may be helpful to inform friends or family members to be aware of the mentioned symptoms. Contact your doctor when you experience these symptoms.

Taking Diazepan Prodes with food and drinks

You should avoid consuming alcoholic beverages during treatment with Diazepan Prodes 5 mg tablets, as alcohol potentiates the sedative effect.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are or suspect you are pregnant, or wish to become pregnant, you should inform your doctor before starting treatment, and he will decide whether you should take or not Diazepan Prodes.

Diazepam is excreted in breast milk, so it is not recommended to use it during the lactation period; if your doctor considers that you need to take it, you should substitute breastfeeding.

Driving and operating machinery

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

Important information about some of the components of Diazepan Prodes

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

Follow exactly the administration instructions for Diazepan Prodes indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

The dose of Diazepan Prodes 5 mg tablets should be the one your doctor indicates according to your individual needs.

You should take this medication at the hours your doctor tells you, usually in the afternoon or evening.

Adults

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

Relief of symptoms 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.

Along with other medications for muscle spasm or muscle-skeletal contracture relief: 2 to 10 mg, 3 or 4 times a day.

Along with other medications in anticonvulsant therapy (for seizures): 2 to 10 mg, 2 or 4 times a day.

Special dosages

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 Central Nervous System, treatment should begin with the lowest dose and increase as needed. Do not use in children under 6 months of age.

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

In patients with kidney or liver disease, special attention should be paid to individualizing the dose.

If you estimate that the action of Diazepan Prodes 5 mg tablets is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the duration of treatment with Diazepan Prodes 5 mg tablets. Do not stop treatment before your doctor tells you to and under the conditions they prescribe. The duration of treatment should be as short as possible. In general, the total duration of treatment should not exceed 8-12 weeks, including gradual withdrawal.

After six weeks of treatment, no further improvements can be expected, and prolonged treatments should be considered exclusively as maintenance therapy. During prolonged maintenance therapy, regular intervals without medication should be left to establish the need for continued therapy. However, treatment will not be interrupted abruptly, but the dose will be gradually reduced.

If you take more Diazepan Prodes than you should

You may experience drowsiness and sleepiness, although you can be easily awakened. In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91 562 04 20, or inform your doctor immediately or go to the nearest hospital emergency department. Bring this leaflet with you. In most cases, attentive monitoring of vital functions or the use of the benzodiazepine antagonist ANEXATE®(active ingredient: Flumazenil) as therapy will be sufficient.

If the patient has ingested a very large amount, it may cause coma, loss of reflexes, cardiac and respiratory depression, and apnea (breathing disorder with involuntary interruptions), requiring appropriate measures (ventilation, cardiovascular support) and also flumazenil as specific therapy.

If you forget to take Diazepan Prodes

Do not take a double dose to compensate for the missed dose. If you forget to take a dose, wait for the next one when it is due.

If you interrupt treatment with Diazepan Prodes

The use of benzodiazepines can induce dependence. This occurs mainly if you use the medication continuously for a long time. To prevent this risk as much as possible, consult your doctor regularly so that they can decide if you should continue treatment. Do not increase the prescribed doses or prolong treatment longer than recommended.

When stopping Diazepan Prodes 5 mg tablets, anxiety, insomnia, lack of concentration, headaches, and sweating may appear. It is not recommended to stop treatment abruptly, but to gradually reduce the dose, always in accordance with your doctor's instructions.

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

Like all medications, Diazepan Prodes can produce adverse effects, although not all people will experience them.

The most common are fatigue, drowsiness, and muscle weakness; they are usually dose-dependent. Other less frequent effects are anterograde amnesia (recent memory loss), confusion, constipation, depression, diplopia (double vision), difficulty articulating words, headache, hypotension (low blood pressure), incontinence, libido disorders (loss of sexual appetite), nausea, dry mouth or excessive salivation, skin eruptions, tremor, urinary retention, vertigo, and blurred vision; very rarely, alterations in blood liver tests (such as elevated transaminases and alkaline phosphatase), as well as some cases of jaundice (yellow discoloration of skin and mucous membranes). Paradoxical reactions, such as acute excitement, anxiety, sleep disorders, and hallucinations, have been observed. If these effects occur, treatment should be interrupted.

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 listed 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.

No special storage conditions are required.

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

Do not use Diazepan Prodes 5 mg tablets 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 through drains or in the trash.Ask your pharmacist how to dispose of the packaging and unused medications.This will help protect the environment.

Composition of Diazepan Prodes 5 mg tablets

• The active ingredient is diazepam.
• The other components are lactose, cornstarch, sodium croscarmellose, povidone (E-1201), colloidal silica, magnesium stearate (E-470b), and talc.

Appearance of the product and contents of the packaging

Diazepan Prodes 5 mg tablets are white tablets. They are packaged in blisters and are presented in containers of 30 and 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Last review date of this leaflet:September 2020.

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