Diazepan Prodes 10 mg tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diazepan Prodes 10 mg tablets

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 others, even if they have the same symptoms as you, because it could be harmful to them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Diazepan Prodes 10 mg tablets are and what they are used for
2. What you need to know before taking Diazepan Prodes 10 mg tablets
3. How to take Diazepan Prodes 10 mg tablets
4. Possible side effects
5. How to store Diazepan Prodes 10 mg tablets
6. Contents of the pack and other information

1. What Diazepan Prodes 10 mg tablets are and what they are used for

Diazepam, the active substance of this medicinal product, is a benzodiazepine derivative that has anxiolytic, sedative, muscle relaxant, anticonvulsant (for seizures), and antipsychotic activity.

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 undergoing alcohol withdrawal, as it may be useful for the symptomatic relief of 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 (muscle stiffness) in conditions such as cerebral palsy and paraplegia, as well as in athetosis (involuntary movements) and generalized rigidity syndrome.

Furthermore, diazepam may be used together with other medications in the treatment of seizure disorders, although it has not proven effective as monotherapy. In such cases, the physician must periodically evaluate the continued usefulness of the medication for each individual patient.

2. What you need to know before starting to take Diazepan Prodes 10 mg tablets

This medicine 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 are dependent on other substances, including alcohol, unless otherwise directed by your doctor.
• If you have closed-angle glaucoma (increased pressure in the eye) or suffer from severe chronic hypercapnia (increased carbon dioxide or CO2 levels in the blood).

Take special care with Diazepan Prodes

• If you have myasthenia (muscle weakness and fatigue), as you may experience increased muscle fatigue, or if you have moderate respiratory insufficiency, or kidney or liver impairment. Your doctor will need to 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 by itself and may eventually unmask some 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 medicines), anticonvulsants (for seizures), analgesics (for pain), and anesthetics, as they 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), which increases 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, medicines 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 medicines 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 10 mg tablets, as alcohol enhances the sedative effect.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

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

Driving and using machines

Diazepam may impair your ability to drive or operate machinery, as it may

cause drowsiness, reduce attention, or impair reaction time. 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 of the components of Diazepan Prodes

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

3. How to take Diazepan Prodes 10 mg tablets

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 10 mg tablets 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.

Adults

Anxiety symptoms: 2 to 10 mg, 2 to 4 times daily, depending on the severity of 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 daily, as needed.

In combination with other medications for relief of muscle spasm or musculoskeletal contracture: 2 to 10 mg, 3 or 4 times daily.

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

Special dosing

In children: 2 to 2.5 mg, 1 or 2 times daily, gradually increased according to needs and tolerance; as a general rule, 0.1–0.3 mg/kg per day. 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 or 2 times daily, gradually increasing 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 10 mg tablets is too strong or too weak, inform your doctor or pharmacist.

Your doctor will determine the duration of treatment with Diazepan Prodes 10 mg tablets. Do not stop treatment before your doctor advises you to do so and only under the conditions prescribed by him. 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 is unlikely, so longer-term treatment should be considered solely as maintenance therapy. During prolonged maintenance therapy, regular medication-free intervals should be implemented to assess the need for continuing treatment. However, treatment must 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 sleep, 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 contact your doctor immediately or go to the nearest hospital emergency department. Take this leaflet with you. In most cases, careful monitoring of vital functions or use of the benzodiazepine antagonist ANEXATE® (active substance: Flumazenil) as therapy will be sufficient.

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 forgotten doses. If you miss 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 over a long period. 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. Under no circumstances should you increase the doses prescribed by your doctor, nor extend the treatment beyond the recommended duration.

When stopping Diazepan Prodes 10 mg tablets, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and sweating may occur. In general, it is not advisable to stop the medication abruptly, but rather to gradually reduce the dose, 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 may produce adverse effects, although not everyone experiences them.

The most common are fatigue, drowsiness and muscle weakness; these are usually dose-dependent. Other less frequent effects include anterograde amnesia (loss 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, abnormalities in liver blood tests (such as elevated transaminases and alkaline phosphatase), as well as some cases of jaundice (yellowing of the skin and mucous membranes) have been observed. Paradoxical reactions such as acute excitement, anxiety, sleep disturbances and hallucinations have also been reported. 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 effects 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 listed 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 10 mg tablets

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use Diazepan Prodes 10 mg tablets after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diazepan Prodes 10 mg tablets

• The active substance is diazepam.
• The other components are lactose, corn starch, sodium croscarmellose, povidone (E-1201), colloidal silica, magnesium stearate (E-470b), talc and indigo carmine (E-132).

Appearance of the product and contents of the pack

The blue color of Diazepan Prodes 10 mg tablets is intended to facilitate differentiation between the various doses of Diazepan Prodes tablets. This coloring does not alter, in any way, the therapeutic properties of the product.

Diazepan Prodes 10 mg tablets are packaged in blisters and available in packs of 30 tablets.

Marketing Authorization Holder and Manufacturer

KERN PHARMA, S.L

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

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