Leaflet: information for the user

Stesolid 10 mg rectal solution

diazepam

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Stesolid 10 mg and what it is used for

2.What you need to know before using Stesolid 10 mg

3.How to use Stesolid 10 mg

4.Possible side effects

5.Storage of Stesolid 10 mg

6.Contents of the pack and additional information

Diazepam, belongs to a group of medicines called benzodiazepines. It is indicated for the treatment of febrile seizures in children over 1 year (approximately 10 kg) and for epileptic seizures; in states of anxiety, anguish or tension and as a sedative in minor surgery, diagnostic interventions and endoscopic procedures.

No use Stesolid 10 mg

• if you are allergic (hypersensitive) to the active ingredient or to any of the other components of this medication (see section 6).
• if you are allergic (hypersensitive) to any of the medications known as “benzodiazepines”.
• if you have a muscle disease called “myasthenia gravis”.
• if you have respiratory problems such as sleep apnea (brief respiratory pauses during sleep) or severe respiratory failure.
• if you have severe liver disease (severe hepatic insufficiency).
• if you have angle-closure glaucoma (eye disease that causes an increase in pressure within the eyeball).
• if you have a history of dependence on other substances, including alcohol. An exception to this is the treatment of acute withdrawal reactions.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Stesolid

• if you have used the medication continuously for a long period of time as it may cause dependence. It is not recommended for chronic use as an anticonvulsant due to the potential for a certain degree of loss of efficacy after prolonged use.
• if you are epileptic. You should be aware that there have been reports of increased seizures in patients treated with diazepam.
• if you have porphyria, as diazepam may trigger a relapse of the disease.
• if you have any liver or kidney problems. Your doctor will decide whether you should use a lower dose or not take the medication at all.
• if you are an elderly patient. Due to the muscle-relaxing effect, there is a risk of falls and consequently fractures, especially when getting up at night. In these patients, a dose of 5 mg is recommended, as indicated in section 3 of this leaflet.

If, after taking the medication, you experience reactions such as: restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior; inform your doctor immediately. These reactions are more common in children and elderly patients.

After taking this medication, you should ensure that you will be able to sleep uninterrupted for 7-8 hours. Otherwise, although this is rare, you may not remember part of what happened while you were awake.

If you have had problems with drug or alcohol dependence, you should not use this medication unless your doctor tells you to.

Diazepam may alter the values of the following laboratory tests:

• Blood: increase (biological) of cholesterol, estradiol, phenytoin, prolactin, and testosterone. Decrease (biological) of thyroxine.
• Urine: increase (analytical interference) of 5-hydroxyindoleacetic acid. Decrease (analytical interference) of glucose.

Children and Adolescents

Due to the lack of studies on safety and efficacy, it is not recommended to use Stesolid in children under one year (less than 10 kg), unless your doctor tells you otherwise.

Other Medications and Stesolid

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

The administration of Stesolid with other medications that act on the central nervous system, such as those used to treat insomnia, anxiety, depression, severe pain, psychiatric problems, epilepsy, and allergies, may make the medication's effect too strong. If you are taking any medication for the treatment of any of these conditions, you should inform your doctor.

Be aware that these instructions may also apply to medications that you have taken before or may take afterwards.

Inform your doctor if you are taking or have taken any of the following medications:

• amitriptyline, fluoxetine, fluvoxamine, sertraline, lithium, haloperidol (medications used to treat depression and other psychiatric disorders),
• clozapine (medication used to treat schizophrenia)
• amprenavir, atazanavir, ritonavir (medications used to treat HIV/AIDS)
• fluconazole, itraconazole, ketoconazole (medications used to treat fungal infections)
• barbiturates (medications used as sedatives or anesthetics)
• propranolol, metoprolol (medications used to treat high blood pressure)
• buprenorphine, fentanyl (medications used to treat pain)
• central muscle relaxants such as baclofen, chlorphenesin, tizanidine, metocarbamol,
• cimetidine, omeprazole (medications used to prevent or treat stomach ulcers)
• digitalis medications (medications used to treat the heart)
• ethinyl estradiol, mestranol (oral contraceptives)
• phenytoin, phenobarbital, carbamazepine, valproic acid (medications used to treat epilepsy)
• rifampicin, isoniazid (used to treat tuberculosis)
• propofol (anesthetic)
• clarithromycin, erythromycin, roxithromycin (antibiotics)
• disulfiram (medication used to help treat chronic alcoholism)
• levodopa (medication used to treat Parkinson's disease)
• ethanol,
• caffeine, theophylline
• ginkgo, St. John's wort (hypericum perforatum), valerian.

Use of Stesolid 10 mg with Food and Beverages

You should not consume alcoholic beverages while taking this medication.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

You should not use this medication during pregnancy unless your doctor finds it absolutely necessary.

This medication is excreted in breast milk, so if necessary, breastfeeding should be discontinued.

Driving and Operating Machinery

Stesolid 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. The concurrent administration with alcoholic beverages may enhance these effects.

Stesolid contains acid benzoic (E-210), sodium benzoate (E-211), benzyl alcohol, propylene glycol (E-1520), and ethanol

This medication contains 2.5 mg of acid benzoic (equivalent to 1 mg/ml) and 122.5 mg of sodium benzoate (equivalent to 49 mg/ml) in each single-dose container. Acid benzoic and sodium benzoate may cause local irritation. Acid benzoic and sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medication contains 37.5 mg of benzyl alcohol in each single-dose container (equivalent to 15 mg/ml). Benzyl alcohol may cause allergic reactions and moderate local irritation.

This medication contains 1000 mg of propylene glycol in each single-dose container (equivalent to 400 mg/ml). Propylene glycol may cause skin irritation. Do not use this medication in newborns under 4 weeks with open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

This medication contains 250 mg of ethanol in each single-dose container (equivalent to 100 mg/ml). It may cause a burning sensation on damaged skin. In newborns (preterm and full-term babies), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin.

Consult your doctor or pharmacist if your child is under 5 years old, if you have any liver or kidney problems, or if you are pregnant or breastfeeding. This is because the excipients may cause adverse effects. Your doctor may need to adjust the dose if you or your child are taking other medications that contain benzyl alcohol, propylene glycol, or ethanol.

Follow exactly the administration instructions for Stesolid 10 mg as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Stesolid 10 mg is administered rectally.

To ensure correct administration of this medication, the following NORMAS PARA LA CORRECTA ADMINISTRACION DE STESOLID will be followed:

The recommended dose is:

Children

• 5 mg for children weighing between 10-15 kg (approximately 1 to 3 years old). In this case, it is recommended to use a single-dose package of the 5 mg presentation (Stesolid 5 mg rectal solution).
• 10 mg for children over 16 kg of weight (approximately 3 years old).

Your child should not receive more than one dose in a single day if under 5 years old.

Stesolid 10 mg is not indicated for children under 1 year old.

Adults

• 10 mg in most cases.

Senior patients and patients with liver insufficiency

The recommended dose for senior patients and patients with liver insufficiency is 5 mg. In this case, it is recommended to use a single-dose package of the 5 mg presentation (Stesolid 5 mg rectal solution).

Patients with renal insufficiency

Although it has not been demonstrated that doses should be reduced if suffering from any renal disease, caution is advised. If this is your case, consult with your doctor before using this medication.

If you estimate that the action of Stesolid is too strong or too weak, inform your doctor or pharmacist.

If you use more Stesolid 10 mg than you should

You may experience symptoms ranging from drowsiness to coma. However, given the administration route, it is unlikely that overdose is possible.

If this occurs, consult your doctor or pharmacist immediately or go to the nearest hospital and bring this leaflet.

In case of overdose or accidental ingestion, contact the Toxicological Information Service, Telephone 91 562 04 20.

If you forgot to use Stesolid 10 mg

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Stesolid 10 mg

Your doctor will indicate the duration of your treatment with Stesolid. Do not suspend treatment before or abruptly, as your problem may recur or you may experience other symptoms.

If you stop using the medication abruptly, you may experience the following symptoms: insomnia, headache or muscle pain, anxiety, tension, restlessness, confusion, and irritability. Treatment should be suspended gradually, following the instructions received from your doctor.

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

Like all medicines, Stesolid 10 mg can cause side effects, although not everyone will experience them.

Normally, with diazepam-containing medications, side effects have been detected at the beginning of treatment, such as drowsiness, apathy, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, lack of coordination, or double vision. These phenomena usually disappear as treatment continues.

Occasionally, other side effects have been reported, such as gastrointestinal disturbances, skin reactions, or changes in sexual desire.

In general, after diazepam administration, the following side effects have been described:

Very common (may affect more than 1 in 10 patients)

Common (may affect between 1 and 10 in 100 patients)

Uncommon (may affect between 1 and 10 in 1,000 patients)

Rare (may affect between 1 and 10 in 10,000 patients)

Very rare (may affect less than 1 in 10,000 patients)

Blood and lymphatic system disorders

Rare: neutropenia (decreased neutrophil count), with prolonged diazepam administration.

Very rare: anemia, pancytopenia (decreased count of all blood elements), decreased platelets.

Immune system disorders

Very rare: allergies

Endocrine disorders

Very rare: Cases of galactorrhea (milk secretion from the nipple) have been described in women with normal prolactin levels in serum and breast enlargement in men taking diazepam regularly.

Benzodiazepines may decrease body temperature, probably in a dose-dependent manner; this effect has been observed in neonates of mothers who took benzodiazepines in the last stages of pregnancy.

Psychiatric disorders

Rare: depression, decreased sexual desire, paradoxical excitement that may lead to: hostility, aggression, and disinhibition, anxiety, hallucinations, insomnia, sleep disturbances. Mild mental alterations: memory loss, slowing of reaction time.

Very rare: difficulty remembering some things.

Nervous system disorders

Very common: drowsiness.

Common: headache, muscle coordination disturbances, dizziness, confusion.

Uncommon: hyperactivity, speech disturbances, tremor.

Rare: convulsions.

Eye disorders

Rare: blurred vision, double vision, involuntary eye movements.

Diazepam has some anticholinergic activity, which could cause pupil dilation and exacerbate narrow-angle glaucoma.

Ear and labyrinth disorders

Uncommon: vertigo.

Cardiac disorders (only described when administered intravenously)

Uncommon: alteration of heart rhythm and inflammation of veins with thrombus formation.

In rapid intravenous administration

Uncommon: thrombus formation in veins, vein inflammation, local irritation, swelling.

Rare: severe blood pressure drop, decreased heart rate, circulatory collapse.

Vascular disorders

Very rare: bullous vasculitis (purple skin eruption due to alteration of small blood vessels).

Respiratory disorders

Common: respiratory depression.

Gastrointestinal disorders

Uncommon: gastrointestinal disturbances, nausea, constipation, salivation disturbances.

Hepatobiliary disorders

Very rare: yellow skin discoloration, elevated liver enzymes.

Skin and subcutaneous tissue disorders

Uncommon: rash and urticaria, sweating, local irritation after rectal administration.

Very rare: described a clinical syndrome that presents with fever, rashes, and blood alterations (Sweet syndrome).

Musculoskeletal disorders

Very rare: in patients with low sodium levels in the blood, muscle pain and weakness may occur, which can be very severe.

Renal and urinary disorders:

Uncommon: urinary retention, incontinence

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Stesolid 10 mg

• The active ingredient is diazepam. Each single-dose vial of 2.5 ml rectal solution contains 10 mg of diazepam.
• The other components (excipients) are:benzoic acid (E-210), sodium benzoate (E-211), propylene glycol (E-1520), ethanol, benzyl alcohol, and purified water.

Appearance of the product and contents of the packaging

Stesolid 10 mg is a transparent, practically colorless solution presented in single-dose vials for rectal administration. Each single-dose vial contains 2.5 ml of rectal solution.

It is presented in cases containing 2 and 5 single-dose vials.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Last review date of this leaflet: October 2024

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