Tepazepan 50 mg/5 mg/5 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tepazepan 50 mg/5 mg/5 mg hard capsules

sulpiride/diazepam/pyridoxine hydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Tepazepan is and what it is used for
2. What you need to know before taking Tepazepan
3. How to take Tepazepan
4. Possible adverse effects
5. How to store Tepazepan
6. Contents of the pack and other information

1. What Tepazepan is and what it is used for

Tepazepan contains the active substances diazepam and sulpiride.

Diazepam belongs to a group of medicines called benzodiazepines.

Sulpiride belongs to a group of antipsychotic medicines, also known as neuroleptics.

In addition, it contains the active substance pyridoxine hydrochloride (vitamin B6), a water-soluble vitamin involved in human metabolic processes.

Tepazepan is indicated for the treatment of depression in patients with anxiety.

This treatment should only be used for the management of a severe disorder that limits the patient's activity or subjects them to significant stress.

2. What you need to know before taking Tepazepan

Do not take Tepazepan

• If you are allergic (hypersensitive) to diazepam (or other benzodiazepines), sulpiride (or other benzamides), pyridoxine hydrochloride (vitamin B6), or to any of the other components of this medicine (listed in section 6).
• If you have been diagnosed with phaeochromocytoma (a tumor of the adrenal gland).
• If you are pregnant (planning or suspect you may be pregnant).
• If you are breastfeeding your child.
• If you have been diagnosed with QT interval prolongation or bradycardia.
• If you are being treated with levodopa or ropinirole (medications used to treat Parkinson's disease) or neuroleptics (medications used to treat mental illness).
• If you have been diagnosed with arrhythmias.
• If you are taking antiarrhythmic medications such as quinidine, disopyramide, amiodarone, or sotalol.
• If you are taking cisapride, thioridazine, erythromycin, vincamine, halofantrine, pentamidine, or sparfloxacin.
• If you are being treated with medications that prolong the QT interval (see section "Other medicines and Tepazepan").
• If you have electrolyte disturbances (potassium, magnesium), anorexia (lack of appetite), vomiting, or diarrhea, or if you are taking medications that may cause such disturbances, such as diuretics, intravenous amphotericin B, glucocorticoids, or tetracosactide.
• If you have myasthenia gravis (severe muscle weakness).
• If you have respiratory insufficiency.
• If you have sleep apnea syndrome.
• If you have severe hepatic insufficiency.
• If you have closed-angle glaucoma (increased intraocular pressure).
• If you have severe chronic hypercapnia (elevated levels of carbon dioxide in the blood).
• If you have muscle disorders.
• If you have prolactin-dependent tumors (hormone stimulating milk secretion), such as pituitary prolactinomas or breast cancer.

Warnings and precautions

Consult your doctor before starting to take this medicine:

• If you have any liver or kidney disorder.
• If you suffer from muscle weakness.
• If you have other diseases or if someone in your family has a history of blood clots, as these medicines may be associated with clot formation.
• If you have allergies.
• If you have a history of drug or alcohol abuse.
• If you are taking other medicines.
• If you have a clinical condition that could favor the onset of cardiac rhythm disorders, as this medicine may increase the risk of serious heart rhythm disturbances.
• If you are at risk of suffering a stroke.
• If you have kidney insufficiency.
• If you have or have had epilepsy, as it may trigger epileptic seizures and convulsions.
• In patients taking antiparkinsonian medication for conditions other than Parkinson's disease.
• If you develop unexplained fever and muscle rigidity, as this could indicate neuroleptic malignant syndrome—a potentially life-threatening complication characterized by high body temperature, muscle rigidity, and nervous system dysfunction (autonomic dysfunction). If high body temperature of undiagnosed origin occurs, treatment with sulpiride should be discontinued (see "Possible side effects").
• If you have diabetes mellitus or risk factors for developing diabetes.
• If you develop an infection or unexplained fever, inform your doctor, as this could indicate blood dyscrasia (blood disorder) (see "Possible side effects"). Cases of leukopenia (reduced white blood cell count), neutropenia (reduced number of white blood cells called neutrophils), and agranulocytosis (reduced number of white blood cells called granulocytes) have been reported with the use of antipsychotics.

Consult your doctor or pharmacist if any of these symptoms occur.

It is not advisable to take this medicine for the treatment of psychosis or anxiety associated with depression. Behavioral disorders may occur, especially in elderly patients; in such cases, treatment should be discontinued.

The use of benzodiazepines may lead to dependence. This mainly occurs after prolonged, uninterrupted use of the medicine. To minimize the risk of dependence, the following precautions should be observed:

• Benzodiazepines should only be taken under medical prescription (never because they worked for someone else) and should never be recommended to others.
• Do not increase the dose prescribed by your doctor or extend treatment beyond the recommended duration.
• Consult your doctor regularly so they can decide whether treatment should continue.

Elderly patients

In elderly patients, your doctor may prescribe a lower dose (e.g., half the usual dose) and monitor your response to treatment. Please follow your doctor's instructions carefully.

If you have liver or kidney disorders or suffer from muscle weakness, your doctor will decide whether a lower dose is appropriate or whether you should not take the medicine at all.

Children

Tepazepan must not be administered to children.

Other medicines and Tepazepan

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Before starting treatment, your doctor must be informed if you are taking other medicines (including those not prescribed). This is extremely important because taking multiple medicines simultaneously may increase or decrease their effects. Therefore, you should not take other medicines together with Tepazepan unless your doctor is aware and has approved it.

Medicines containing cisapride, cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole temporarily increase the sedative effect of Tepazepan, increasing the risk of drowsiness.

In addition, the metabolism of phenytoin may be affected if you are taking Tepazepan. Therefore, if you are taking this medicine, your doctor will adjust the doses accordingly.

Patients with Parkinson's disease being treated with levodopa must not take this medicine.

Certain hepatic enzyme inhibitors may enhance the activity of this medicine.

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

• Antiarrhythmic medicines such as quinidine, disopyramide, amiodarone, and sotalol.
• Medicines that slow heart rate, such as diltiazem, verapamil, clonidine, guanfacine, and digitalis glycosides.
• Medicines that reduce potassium and magnesium levels.
• Other medicines such as cisapride, thioridazine, intravenous erythromycin, vincamine, halofantrine, pentamidine, sparfloxacin, methadone, pimozide, haloperidol, and sultopride.
• Medicines containing pyridoxine with L-Dopa, barbiturates, and phenytoin (antiarrhythmic).
• Lithium and lithium salts (medicines used to treat manic-depressive disorder or bipolar affective disorder).
• Sucralfate (a medicine used to treat and prevent duodenal ulcers).
• Antacids.
• Medicines to lower blood pressure.
• Central nervous system depressants, including narcotics, analgesics, sedating H1 antihistamines, barbiturates, benzodiazepines, and other anxiolytic drugs.

Concomitant use of this medicine with 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 available.

However, if your doctor prescribes this medicine 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 immediately if you experience any of these symptoms.

Taking Tepazepan with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which could affect your ability to drive or operate machinery. If you need further information on this point, consult your doctor.

You must not drink grapefruit juice during treatment with Tepazepan.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Newborns of mothers who have used sulpiride during the third trimester of pregnancy may present the following symptoms: tremors, muscle rigidity and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor immediately.

Breastfeeding

Benzodiazepines are excreted in breast milk; therefore, the use of this medicine during breastfeeding is not recommended. If your doctor considers it necessary for you to take it, you must discontinue breastfeeding.

Driving and using machines

This medicine may impair your ability to drive or operate machinery, as it may cause drowsiness, reduced attention, or slower reaction times. 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.

Tepazepan contains lactose

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

3. How to take Tepazepan

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

This medicine is for oral use.

Swallow the capsules without chewing, together with water or another non-alcoholic drink.

The dose of this medicine must be the one your doctor has prescribed and taken at the times he or she has indicated, according to your individual needs.

Your doctor will determine the duration of your treatment. Do not stop treatment before your doctor instructs you to do so and under the conditions he or she has prescribed.

Remember to take your medicine.

Follow these instructions unless your doctor has given you different advice:

Adults

The recommended starting dose is 1 to 3 capsules per day, unless your doctor advises otherwise.

Elderly patients

The recommended starting dose is 1 capsule per day.

Patients with mild or moderate kidney or liver impairment

The recommended starting dose is 1 capsule per day.

Patients with muscle weakness

The recommended starting dose is 1 capsule per day.

Use in children

Use in children is not recommended.

Duration of treatment

Treatment duration should be as short as possible and never exceed 2–3 months, including the tapering-off period.

Do not extend treatment beyond the recommended time.

To avoid withdrawal symptoms, do not stop taking this medicine abruptly, especially if you have been taking it for a long time.

This medicine should be taken at least two hours before antacids and sucralfate.

It is advisable that your doctor periodically reviews your treatment, especially if you have a history of alcoholism, drug abuse, or serious personality disorders.

If you feel the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Tepazepan than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

In case of overdose, spasms of the facial, neck, and tongue muscles may occur. Some patients may develop parkinsonian symptoms (tremor, rigidity) with life-threatening risk and coma.

In case of overdose, appropriate supportive measures should be initiated, with close monitoring of vital functions and cardiac function until the patient recovers.

In case of severe extrapyramidal symptoms (tremor, increased muscle tone, reduced movement, hypersalivation, etc.), anticholinergic agents should be administered.

If you forget to take Tepazepan

Do not take a double dose to make up for missed doses. If you forget to take a dose, simply take the next one at the scheduled time.

If you stop taking Tepazepan

When stopping this medicine, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and sweating may occur.

Abrupt discontinuation of the medication is not recommended; instead, the dose should be gradually reduced, always following your doctor's instructions.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Diazepam

Common adverse effects (may affect up to 1 in 10 patients):

• Tiredness, muscle weakness.

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Changes in heart rhythm, cardiac arrest.
• Jaundice (yellowing of the skin and eyes).
• Increased transaminases and alkaline phosphatase in blood.

Frequency not known (cannot be estimated from available data):

• Confusion, impaired alertness, headache, dizziness, ataxia (inability to coordinate voluntary muscle movements), difficulty speaking, and memory loss.
• Restlessness, agitation, irritability, disorientation, aggression, nervousness, hostility, anxiety, delirium (incoherent thinking), rage attacks, nightmares, hallucinations, psychosis, hyperactivity, inappropriate behavior, and other behavioral disturbances. Decreased libido, sleep disorders (nightmares), depression, dependence (administration of the medicine (even at therapeutic doses) may lead to physical dependence: discontinuation of treatment may lead to withdrawal or rebound phenomena. Cases of abuse have been reported).
• Blurred vision, double vision (diplopia).
• Dizziness.
• Orthostatic hypotension (drop in blood pressure upon standing) and circulatory disturbances.
• Respiratory depression, respiratory failure.
• Dry mouth, constipation, increased salivation, nausea.
• Rash (skin inflammation), itching, urticaria (red, itchy welts).
• Urinary retention, urinary incontinence.

Sulpiride

Common adverse effects (may affect up to 1 in 10 patients):

• Sedation or drowsiness, dose-related extrapyramidal disorders (abnormal movements) such as restlessness, akathisia (inability to sit or remain seated), tremor, parkinsonism (symptoms similar to Parkinson's disease, usually occurring at the beginning of treatment. These symptoms are generally reversible with antiparkinsonian medication).
• Insomnia (difficulty sleeping).
• Increased levels of the hormone prolactin (hyperprolactinemia).
• Constipation.
• Increased liver enzymes.
• Maculopapular rash (appearance of red spots and papules on the skin).
• Chest pain, milk secretion from the breasts outside pregnancy.
• Weight gain.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Dystonia (muscle spasms), dyskinesia (abnormal, involuntary movements), increased muscle tone.
• Leukopenia (decreased number of white blood cells).
• Orthostatic hypotension (drop in blood pressure upon standing).
• Increased salivation.
• Absence of menstruation in a fertile woman, breast enlargement, abnormal orgasm, impotence.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Oculogyric crisis (involuntary deviation of gaze).
• Ventricular fibrillation, ventricular arrhythmia (change in heart rhythm), ventricular tachycardia (rapid succession of heartbeats originating in the ventricles).

Frequency not known (cannot be estimated from available data):

• Seizures, neuroleptic malignant syndrome (a complication characterized by high body temperature, muscle rigidity, which may even lead to death), decreased or slow involuntary movements (hypokinesia), tardive dyskinesia (characterized by rhythmic, involuntary movements mainly of the tongue and/or face, as reported with all neuroleptics, after administration for more than 3 months. Antiparkinsonian medication is ineffective or may worsen symptoms).
• Confusion.
• QT interval prolongation (heart conduction problems) and heart rhythm disturbances (torsade de pointes), cardiac arrest, sudden death.
• Neutropenia (decreased number of white blood cells called neutrophils), agranulocytosis (decreased number of a type of white blood cells, granulocytes).
• Anaphylactic reactions (severe allergic reaction), urticaria, breathing difficulty (dyspnea), low blood pressure, and anaphylactic shock (a severe allergic reaction that may be life-threatening).
• Increased blood pressure, blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness in the leg). These clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.
• Torticollis, trismus (jaw muscle spasm).
• Withdrawal syndrome in newborns, extrapyramidal symptoms (involuntary movements).
• Breast enlargement in men.
• Increased blood levels of creatine phosphokinase (a marker of muscle damage).

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.

A small increase in the number of deaths has been reported in elderly patients with dementia treated with antipsychotics, compared to those not receiving this treatment.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tepazepan

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Tepazepan

The active substances are sulpiride, diazepam and pyridoxine hydrochloride. Each capsule contains 50 mg of sulpiride, 5 mg of diazepam and 5 mg of pyridoxine hydrochloride.

The other components are: lactose, talc and magnesium stearate.

Components of the capsule shell: indigotine (E-132), titanium dioxide (E-171), gelatin and printing ink (shellac lacquer, soy lecithin, dimethicone and black iron oxide (E-172)).

Appearance of the product and contents of the pack

Tepazepan is presented as blue hard gelatin capsules.

It is available in packs of 30 capsules in blister packs.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of latest revision of this leaflet: February 2025

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