Diazepan Prodes 2 mg/ml oral solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diazepan Prodes 2 mg/ml oral solution

Diazepam

Read the entire 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

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

Diazepam, the active substance of this medicine, is a benzodiazepine derivative that has tranquilizing, sedative, muscle relaxant, anticonvulsant (for seizures), and antipsychotic properties.

Doctors prescribe this medicine for individuals suffering from anxiety, agitation, and psychological tension due to psychoneurotic conditions and transient situational disorders. It is also prescribed for patients experiencing alcohol withdrawal, as it may be helpful in relieving acute agitation, tremors, and hallucinations.

Additionally, it is used in combination with other medications to relieve musculoskeletal pain caused by spasms (muscle cramps) or local pathology (muscle or joint inflammation, trauma, etc.). It may also be used to treat spasticity (stiffness) in conditions such as cerebral palsy and paraplegia, as well as in athetosis (involuntary movements) and generalized stiffness syndrome.

Diazepam may also be used together with other medications in the treatment of seizure disorders, as it has not proven effective when used alone. In these cases, the doctor must periodically evaluate the usefulness of the medication for each individual patient.

2. What you need to know before taking Diazepan Prodes 2 mg/ml oral solution

This medicine is for oral use.

Do not take Diazepan Prodes

• If you are allergic (hypersensitive) to diazepam or to any of the other components of Diazepan Prodes.
• If you are dependent on other substances, including alcohol, unless otherwise directed by your doctor.
• If you have closed-angle glaucoma (increased pressure in the eye) and suffer from severe chronic hypercapnia (increased carbon dioxide or CO2 in the blood).

Take special care with Diazepan Prodes

• If you suffer from myasthenia (muscle weakness and fatigue), as you may experience increased muscle fatigue, or if you have moderate respiratory insufficiency, as well as kidney or liver impairment. Your doctor will need to adjust your dose.
• If you suffer from depression, you should be aware that diazepam only acts on the anxious component and therefore does not constitute a treatment for depression by itself. It may eventually unmask certain signs of depression.

Use of other medicines

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.

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

You should also not take Diazepan Prodes together with cisapride (a medicine used for gastrointestinal disorders), as it causes a temporary increase in the sedative effect of diazepam, as does cimetidine (a medicine for gastric acidity), thereby increasing the risk of drowsiness.

If you take Diazepan Prodes together with phenytoin (a medicine for epilepsy), your doctor should monitor blood levels of phenytoin, as they may undergo unpredictable changes, leading to signs of toxicity, reduced activity, or no change at all.

Concomitant use of Diazepam and opioids (strong analgesics, medications for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may even be fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

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

Please inform your doctor about all opioid medications you are taking, and closely follow your doctor's dosing recommendations. It may be helpful to inform friends or family members so they can watch for the symptoms mentioned above. Contact your doctor if you experience such symptoms.

Taking Diazepan Prodes with food and drinks

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 medicine.

If you are or suspect you are pregnant, or wish to become pregnant, inform your doctor before starting treatment, and he or she will decide whether or not you should take Diazepan Prodes 2 mg/ml oral solution.

Diazepam is excreted in breast milk; therefore, its use is not recommended during breastfeeding. If your doctor considers that you need to take it, you should discontinue natural breastfeeding.

Driving and using machines

Diazepam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or decrease reaction capacity. These effects are 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 components of Diazepan Prodes

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

This medicine contains 50% ethanol, corresponding to 0.4 g per ml, which is equivalent to 8.8 ml of beer or 3.3 ml of wine.

This medicine is harmful for people suffering from alcoholism.

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

The amount of alcohol in this medicine may alter the effects of other medicines.

The amount of alcohol in this medicine may reduce your ability to drive or operate machinery.

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

Follow exactly the administration instructions for Diazepan Prodes as 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 the one prescribed by your doctor according to your individual needs.

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

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

Adults

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

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

In combination with other medications for relief of muscular spasm or musculoskeletal contracture: 2 to 10 mg (1 to 5 ml, approximately), 3 or 4 times daily.

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

Special dosing

In children: 2 to 2.5 mg (1 to 1.25 ml, approximately), 1 or 2 times daily, gradually increased according to needs and tolerance; as a general rule, 0.1–0.3 mg/kg daily. Due to the variable response of children to medications acting on the Central Nervous System, treatment should be initiated with the lowest dose and increased as required. 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 to 1.25 ml, approximately), 1 or 2 times daily, then gradually increased as needed and tolerated.

Particular attention should be paid to individualizing the dose in patients with kidney or liver disease.

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

Your doctor will determine the duration of treatment with Diazepan Prodes 2 mg/ml oral solution. Do not stop treatment before your doctor instructs you to do so, and only under the conditions prescribed by your doctor. The duration of treatment should be as short as possible. In general, total treatment duration should not exceed 8–12 weeks, including gradual withdrawal.

After six weeks of treatment, further improvement should not be expected, so longer-term treatment should be considered exclusively as maintenance therapy. During prolonged maintenance therapy, regular medication-free intervals should be established to assess the need for continuing therapy. However, treatment should not be stopped abruptly, but the dose should 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, contact the Toxicology Information Service at telephone 91 562 04 20, or immediately contact your doctor or go to the nearest hospital emergency department. Take this leaflet with you. In most cases, careful monitoring of vital functions or the use of the benzodiazepine antagonist ANEXATE® (active substance: Flumazenil) as therapy will suffice.

If the patient has ingested a very high amount, coma, loss of reflexes, cardiorespiratory depression, and apnea (a disorder with brief involuntary interruptions in 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 missed doses. If you forget to take a dose, wait until the next scheduled dose.

If you stop taking Diazepan Prodes

The use of benzodiazepines may lead to dependence. This occurs mainly if the medicine is used continuously for a long time. To minimize this risk as much as possible, you should consult your doctor regularly so that he or she can decide whether you should continue treatment.

You must not increase the doses prescribed by your doctor, nor extend the treatment beyond the recommended duration.

When stopping Diazepan Prodes 2 mg/ml oral solution, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and sweating may occur. It is generally not advisable to stop the medication abruptly; instead, the dose should be gradually reduced, always in accordance with your doctor's instructions.

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

4. Possible adverse effects

Like all medicines, Diazepan Prodes can cause adverse effects, although not everyone will experience them.

The most common are fatigue, drowsiness, and muscle weakness; these are usually dose-dependent. Other less frequent effects include anterograde amnesia (lack of recent memory), confusion, constipation, depression, diplopia (double vision), difficulty articulating speech, headache, hypotension (low blood pressure), incontinence, libido disorders (lack of sexual appetite), nausea, dry mouth or excessive salivation, skin rashes, tremor, urinary retention, dizziness, and blurred vision. Very rarely, changes in liver blood tests (elevations in transaminases and alkaline phosphatase) as well as some cases of jaundice (yellowing of the skin and mucous membranes) have been observed. Paradoxical reactions have been reported, such as acute excitation, anxiety, sleep disturbances, and hallucinations. If any of these effects occur, treatment should be discontinued.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform 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 mentioned in this leaflet. You may also report them directly through 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. Storage of 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

After opening, the contents of the bottle must be used within 6 months.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diazepam 2 mg/ml oral drops solution

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

Appearance of the product and contents of the container

• DIAZEPAN PRODES 2 mg/ml oral solution is supplied as:
• a 30 ml amber glass bottle containing the solution with a child-resistant cap with an integrated dropper. The outer part is made of polypropylene (PP), while both the dropper 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 accurate dosing.

Marketing Authorization Holder and Manufacturer Responsible

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: September 2020.