PATIENT INFORMATION LEAFLET

Diazepan Prodes 2 mg/ml Oral Solution

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 have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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 psychological 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 demonstrated utility 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 suffer from 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, even 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 cisapride (a medication used for gastrointestinal disorders) as it produces a temporary increase in the sedative effect of diazepam, as well as cimetidine (medications 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 substance abuse, and some medications for cough) increases the risk of drowsiness, breathing 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 dosage closely. It may be helpful to inform friends or family members to be aware of the mentioned symptoms. Contact your doctor when you experience such symptoms.

Taking Diazepan Prodes with food and drinks

You should avoid consuming alcoholic beverages during treatment with Diazepan Prodes, 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 they will decide whether you should take or not Diazepan Prodes 2 oral solution.

Diazepam is eliminated through 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 affect 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 increasing the dose. Do not drive or use machinery 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 them before taking this medication.

This medication contains 50% ethanol, which corresponds to 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 women, breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

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

The amount of alcohol in this medication may decrease your ability to drive or operate machinery.

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 2 mg/ml oral solution should be the one your doctor tells you according to your individual needs.

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

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

Acute alcohol withdrawal relief: 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.

Along with other medications for muscle spasm or muscle-skeletal contracture relief: 2 to 10 mg (1 to 5 ml, approximately), 3 or 4 times a day.

Along with other medications in anticonvulsant therapy (for seizures): 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, 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 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, 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 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 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 should not be stopped abruptly, but rather 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, 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 principle: Flumazenil) as therapy will be sufficient.

If a large amount has been ingested, it may cause coma, lack of reflexes, cardiac and respiratory depression, and apnea (breathing disorder with involuntary interruptions), requiring appropriate measures (ventilation, cardiovascular support) and 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 whether you should continue treatment.

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

When stopping Diazepan Prodes 2 mg/ml oral solution, anxiety, insomnia, lack of concentration, headaches, and sweating may appear. It is not recommended to stop treatment abruptly, but rather to gradually reduce the dose, always following 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 everyone 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, liver blood test alterations (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.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 Medicinal Products 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 out of the sight and reach of children.

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

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition of Diazepan 2 mg/ml oral drops in solution

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

Appearance of the product and contents of the packaging

-DIAZEPAN PRODES 2 mg/ml oral solution is presented in the form of:

- a topaz glass bottle containing 30 ml of solution with a child-proof cap with a stopper mounted. 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 that allows increments of 0.125 ml (0.25 mg) for correct dosing.

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.