STESOLID 5 mg rectal solution

2. What you need to know before taking Stesolid 5 mg

Do not take Stesolid 5 mg

• if you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to any of the medicines known as "benzodiazepines"
• if you have a muscle disease called "myasthenia gravis".
• if you have respiratory problems such as sleep apnea syndrome (brief pauses in breathing during sleep) or severe respiratory failure.
• if you have severe liver disease (severe hepatic insufficiency).
• if you have closed-angle glaucoma (an eye disease that causes increased pressure inside the eyeball).
• if you have 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 take Stesolid

• if you have used the medicine continuously for a long period, as it may cause dependence. Chronic use as a daily anticonvulsant is not recommended due to the potential for loss of efficacy after continuous use.
• if you are epileptic. You should be aware that some cases of increased convulsions have been reported in epileptic patients treated with diazepam.
• if you have porphyria, as diazepam may cause a relapse of the disease.
• if you have any liver or kidney disorder. Your doctor will decide whether it is convenient for you to use a lower dose or not to take the medicine.
• if you are an elderly patient. Due to the muscle relaxant 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 package leaflet.

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

After taking this medicine, you should ensure that you will be able to sleep uninterrupted for 7-8 hours. Otherwise, although this is rare, it is possible that you will 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 medicine unless your doctor formally indicates it.

Diazepam may alter the values of the following analytical determinations:

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

Children and Adolescents

Due to the lack of studies on safety and efficacy, the use of Stesolid is not recommended in children under 1 year of age (less than 10 kg of weight), unless the doctor indicates otherwise.

Other Medicines and Stesolid

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

The administration of Stesolid together with other medicines that act on the central nervous system, such as those used to treat insomnia, anxiety, depression, severe pain, psychiatric problems, epilepsy, and allergy, as well as some anesthetics, may make the action of the medicine too strong. If you are taking any medicine for the treatment of any of these diseases, you should inform your doctor.

Keep in mind that these instructions may also apply to medicines that have been taken before or may be taken after.

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

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

Using Stesolid 5 mg with Food and Drinks

Do not drink alcoholic beverages while using this medicine.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Do not use this medicine during pregnancy unless your doctor considers it essential.

This medicine is excreted in breast milk, so if necessary, breastfeeding should be suspended.

Driving and Using Machines

Stesolid may affect your ability to drive or operate machinery, as it can cause drowsiness, reduce your attention, or reduce 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. The concomitant administration with alcoholic beverages can enhance these effects.

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

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

This medicine 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 medicine 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 medicine in babies under 4 weeks with open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

This medicine 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 (premature and full-term babies), high concentrations of ethanol can cause severe local reactions and systemic toxicity due to significant absorption through immature skin.

Ask your doctor or pharmacist for advice if your child is under 5 years old, if you have any liver or kidney disease, 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 using other medicines that contain benzyl alcohol, propylene glycol, or alcohol.

3. How to Take Stesolid 5 mg

Follow the administration instructions of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Stesolid 5 mg is administered rectally.

To ensure the correct administration of Stesolid, the following RULES FOR THE CORRECT ADMINISTRATION OF STESOLID will be followed:

The recommended dose is:

Children

• 5 mg for children weighing between 10-15 kg (approximately 1 to 3 years).
• 10 mg for children over 16 kg in weight (approximately 3 years).

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

Stesolid 5 mg is not indicated for children under 1 year of age.

Adults

• 10 mg in most cases.

Elderly Patients and Patients with Hepatic Insufficiency

The recommended dose in elderly patients and patients with hepatic insufficiency is 5 mg.

Patients with Renal Insufficiency

Although it has not been demonstrated that doses need to be reduced if you have any kidney disease, caution is advised. If this is the case, consult your doctor before using this medicine.

If you think the effect of Stesolid is too strong or too weak, inform your doctor or pharmacist.

If you use more Stesolid 5 mg than you should

You may experience symptoms ranging from drowsiness to coma. However, given the route of administration, the possibility of overdose is unlikely.

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

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

If you forget to use Stesolid 5 mg

Do not use a double dose to make up for forgotten doses.

If you stop taking Stesolid 5 mg

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

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Normally, with medicines that contain diazepam, the following side effects have been detected at the start of treatment: drowsiness, apathy, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, lack of coordination, or double vision. These phenomena usually disappear with continued treatment.

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

In general, after the administration of diazepam, 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 (decrease in the number of neutrophils), with prolonged administration of diazepam. Very rare: anemia, pancytopenia (decrease in all blood cell elements), decrease in platelets.

Immune System Disorders

Very rare: allergies

Endocrine Disorders

Very rare: Cases of milk secretion from the nipple have been described in women with normal prolactin serum values and increased breast volume in men who regularly took diazepam.

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 include: hostility, aggression, and disinhibition, anxiety, hallucinations, insomnia, sleep disturbances. Mild mental disorders: memory loss, slowed reaction time.

Very rare: difficulty remembering some things.

Nervous System Disorders

Very common: drowsiness.

Common: headache, lack of muscle coordination, dizziness, confusion.

Uncommon: hyperactivity, speech disorders, tremors.

Rare: rebound convulsions.

Eye Disorders

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

Diazepam has some anticholinergic activity, so it may cause pupil dilation and therefore 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.

Rapid Intravenous Administration

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

Rare: severe hypotension, decreased heart rate, circulatory collapse.

Vascular Disorders

Very rare: bullosus vasculitis (purple-colored skin rash due to small vessel disorder).

Respiratory Disorders

Common: respiratory depression.

Gastrointestinal Disorders

Uncommon: gastrointestinal disorders, nausea, constipation, alterations in salivation.

Hepatobiliary Disorders

Very rare: yellowing of the skin, elevated liver enzymes.

Skin and Subcutaneous Tissue Disorders

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

Very rare: A clinical picture has been described that occurs with fever, rash, and blood alterations (Sweet's syndrome).

Musculoskeletal Disorders

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

Renal and Urinary Disorders

Uncommon: urinary retention, incontinence

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Stesolid 5 mg

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

Do not use this medicine after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Stesolid 5 mg

• The active ingredient is diazepam. Each 2.5 ml single-dose container of rectal solution contains 5 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 Package Contents

Stesolid 5 mg is a practically colorless transparent solution presented in single-dose containers for rectal administration. Each single-dose container contains 2.5 ml of rectal solution.

It is presented in packs containing 2 and 5 single-dose containers.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the Last Revision of this Leaflet: October 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/