DIAZEPAN PRODES 2 mg/ml ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diazepan Prodes 2 mg/ml oral solution

Diazepam

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Diazepan Prodes 2 mg/ml oral solution is and what it is used for
2. Before you take Diazepan Prodes 2 mg/ml oral solution
3. How to take Diazepan Prodes 2 mg/ml oral solution
4. Possible side effects
5. Storing Diazepan Prodes 2 mg/ml oral solution
6. Further information on the package

1. What Diazepan Prodes 2 mg/ml oral solution is and what it is used for

Diazepam, the active substance of this medicinal product, is a benzodiazepine derivative with tranquilizing, sedative, muscle relaxant, anticonvulsant, and antipsychotic activities.

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

Additionally, it is used in combination with other medications for the relief of muscle skeletal pain due to spasms or local pathology. It can also be used to treat spasticity in conditions such as cerebral palsy and paraplegia, as well as in athetosis and generalized stiffness syndrome.

Diazepam can also be used in combination with other medications for the treatment of convulsive disorders, although as a single treatment, it has not been shown to be useful. In these cases, the doctor should periodically evaluate the usefulness of the medication for each patient.

2. Before you take Diazepan Prodes 2 mg/ml oral solution

This medicine is for oral administration.

Do not take Diazepan Prodes

• If you are allergic (hypersensitive) to diazepam or any of the other components of Diazepan Prodes.
• If you have a dependence on other substances, including alcohol, unless your doctor indicates it.
• If you have narrow-angle glaucoma (increased eye pressure) and suffer from severe chronic hypercapnia (increased CO2 in the blood).

Be cautious when taking Diazepan Prodes

• If you have myasthenia (muscle weakness and fatigue), as you may experience increased muscle fatigue. If you have moderate respiratory failure, as well as kidney or liver failure, your doctor should adjust the dose.
• If you have depression, keep in mind that diazepam only acts on the anxious component, so it does not constitute a treatment for depression by itself and may eventually unmask some signs of it.

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.

Do not take Diazepan Prodes with medications that act on the central nervous system, such as neuroleptics, tranquilizers, antidepressants, hypnotics, anticonvulsants, analgesics, and anesthetics, as they increase the sedative effect of diazepam.

Also, do not take Diazepan Prodes with cisapride (a medication used for gastrointestinal disorders), as it produces a transient increase in the sedative effect of diazepam, as well as cimetidine (medications for gastric acidity), which increases the risk of drowsiness.

If you take Diazepan Prodes in combination with phenytoin (a medication for epilepsy), your doctor should monitor the blood concentrations of the latter, as they may undergo unpredictable variations, causing signs of toxicity or decreased activity or no change.

The concomitant use of Diazepam and opioids (strong analgesics, medications for substitution therapy, and some cough medications) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can 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 opioid medications you are taking and follow your doctor's dosage recommendations closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Taking Diazepan Prodes with food and beverages

You should avoid consuming alcoholic beverages during treatment with Diazepan Prodes, as alcohol enhances the sedative effect.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are or think you may be pregnant, or if you plan to become pregnant, you should inform your doctor before starting treatment, and he will decide whether it is convenient for you to take Diazepan Prodes 2 oral solution.

Diazepam is excreted in breast milk, so its use is not recommended during the breastfeeding period. If your doctor considers that you must take it, you should replace breastfeeding.

Driving and using machines

Diazepam can alter your ability to drive or operate machinery, as it can cause drowsiness, decrease your attention, or decrease your reaction capacity. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects.

Important information about some components of Diazepan Prodes

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

This medication contains 50% ethanol, which corresponds to an amount of 0.4 g per ml, equivalent to 8.8 ml of beer or 3.3 ml of wine.

This medication is harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

The amount of alcohol in this medication can alter the effects of other medications.

The amount of alcohol in this medication can decrease the ability to drive or operate machinery.

3. How to take Diazepan Prodes 2 mg/ml oral solution

Follow the administration instructions of 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 2 mg/ml oral solution should be as indicated by your doctor, according to your individual needs.

You should take this medication at the times indicated by your doctor, usually in the afternoon or evening.

Each ml of solution contains 2 mg of diazepam. Each ml is equivalent to approximately 40 drops.

Adults

Anxiety symptoms: 2 to 10 mg (1 to 5 ml, approximately), 2 to 4 times a day, depending on the severity of the symptoms.

Symptomatic relief in acute alcohol withdrawal: 10 mg (approximately 5 ml), 3 or 4 times during the first 24 hours, reducing to 5 mg (2.5 ml, approximately), 3 or 4 times a day, as needed.

In combination with other medications for the relief of muscle skeletal spasms or contractures: 2 to 10 mg (1 to 5 ml, approximately), 3 or 4 times a day.

In combination with other medications in anticonvulsant therapy: 2 to 10 mg (1 to 5 ml, approximately), 2 or 4 times a day.

Special dosages

In children: 2 to 2.5 mg (1 to 1.25 ml, approximately), 1 or 2 times a day, gradually increasing according to needs and tolerance; as a general rule, 0.1-0.3 mg/kg per day. Due to the variety of response of children to medications 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 the elderly or patients with kidney or liver disease: 2 to 2.5 mg (1 to 1.25 ml, approximately), 1 or 2 times a day, gradually increasing according to needs and tolerance.

In patients with kidney or liver disease, the dose should be individualized with special attention.

If you think the effect of Diazepan Prodes 2 mg/ml oral solution is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the duration of treatment with Diazepan Prodes 2 mg/ml oral solution. Do not stop treatment before your doctor indicates it and under the conditions that he prescribes. 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 improvement can be expected, so prolonged treatment should only be considered as maintenance therapy. During prolonged maintenance therapy, regular intervals without medication should be left to determine the need for continued therapy. However, treatment should not be interrupted abruptly, but the dose should be gradually decreased.

If you take more Diazepan Prodes than you should

You may experience drowsiness and sleep, 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 emergency department of the nearest hospital. Bring this leaflet with you. In most cases, careful 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 high amount, coma, lack of reflexes, cardio-respiratory depression, and apnea (brief involuntary interruptions of breathing) may occur, 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 make up for forgotten doses. If you forget to take a dose, wait for the next one when it is due.

If you stop taking Diazepan Prodes

The use of benzodiazepines can lead to dependence. This occurs mainly if you use the medication continuously for a long time. To minimize this risk, you should consult your doctor regularly so that he can decide whether you should continue treatment.

Do not increase the prescribed doses or prolong treatment beyond the recommended time.

When stopping Diazepan Prodes 2 mg/ml oral solution, you may experience anxiety, insomnia, lack of concentration, headache, and sweating. It is not recommended to interrupt the medication abruptly, but rather to gradually reduce the dose, always following the doctor's instructions.

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

4. Possible side effects

Like all medications, Diazepan Prodes can cause side effects, although not everyone experiences them.

The most common side effects are fatigue, drowsiness, and muscle weakness; these are usually dose-dependent. Less frequent side effects include anterograde amnesia (recent memory loss), confusion, constipation, depression, diplopia (double vision), difficulty articulating words, headache, hypotension (low blood pressure), incontinence, libido disorders (lack of sexual appetite), nausea, dry mouth or excessive salivation, skin rashes, tremors, urinary retention, vertigo, and blurred vision; very rarely, alterations in liver blood tests (elevated transaminases and alkaline phosphatase), as well as some cases of jaundice (yellowing of the 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 discontinued.

If you consider any of the side effects you experience to be serious or if you notice any side effect not mentioned in this leaflet, inform 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 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. Storing Diazepan Prodes 2 mg/ml oral solution

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use Diazepan Prodes 2 mg/ml oral solution after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Once opened, the contents of the bottle should be used within 6 months.

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

6. Package contents and further information

Composition of Diazepan 2 mg/ml oral drops in solution

• The active ingredient is diazepam.
• The other ingredients are sucrose, sodium saccharin, ethanol (400 mg), and purified water.

Appearance of the product and package contents

• DIAZEPAN PRODES 2 mg/ml oral solution is presented in the form of:
• a brown glass bottle containing 30 ml of solution with a child-proof cap with an inserted stopper. The outer part is made of polypropylene (PP), and both the stopper and the inner thread are made of polyethylene. A 3 ml graduated dosing syringe is included, allowing increments of 0.125 ml (0.25 mg) for correct dosing.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this leaflet:September 2020.