ANSIUM hard capsules

Introduction

Package Leaflet: Information for the Patient

ANSIUM Hard Capsules

Sulpiride / Diazepam

Read the entire package leaflet carefully before starting to take the medication, as it contains important information for you

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

Contents of the Package Leaflet

1. What is Ansium and what is it used for
2. What you need to know before taking Ansium
3. How to take Ansium
4. Possible side effects
5. Storage of Ansium
6. Package Contents and Additional Information

1. What is Ansium and what is it used for

Ansium contains two active substances, diazepam, which belongs to the group of medications called benzodiazepines, and sulpiride, which belongs to the group of antipsychotic medications, also known as neuroleptics.

Doctors prescribe Ansium for sleep rhythm disorders and for all forms of insomnia or anxiety, especially when there are difficulties falling asleep, either initially or after a premature awakening.

This medication will only be used to treat a severe disorder that limits activity or puts the patient in a stressful situation.

Treatment should be started with the lowest dose. The maximum dose should not be exceeded.

2. What you need to know before taking Ansium

Do not take Ansium

• If you are allergic to diazepam or sulpiride or to any of the other components of this medication listed in section 6.
• If you are allergic to the benzodiazepine group in general.
• If you have breathing difficulties related or unrelated to sleep for a long time.
• If you have muscle problems.
• If you have severe liver problems.
• If you have increased intraocular pressure.
• If you have severe chronic hypercapnia.
• If you have drug or alcohol dependencies, unless your doctor formally indicates it.

If you have any doubts, consult your doctor.

Since it contains sulpiride, do not take Ansium capsules if:

• you have concomitant prolactin-dependent tumors (hormone that stimulates milk secretion), such as prolactinomas of the pituitary gland and breast cancer,
• you have pheochromocytoma (tumor of the adrenal gland),
• you are being treated with levodopa (see "Use of other medications"),
• you have a low heart rate, with cardiac rhythm disturbances or with any other clinically significant heart disease,
• you have acute porphyria, a metabolic disease that prevents the synthesis of certain components of red blood cells.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Ansium:

• If you have any liver or kidney disorder.

• If you have muscle weakness.
• If you have other diseases or if someone in your family has a history of blood clots, these medications may be associated with the formation of clots.
• If you have allergies.
• If you have a history of drug or alcohol abuse.
• If you are taking other medications.
• If you are epileptic and are undergoing long-term treatment with Ansium, it is not recommended to use the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of diazepam, as convulsions may occur.
• If it is administered to patients with a clinical situation that may favor the appearance of cardiac rhythm disorders, since sulpiride can increase the risk of severe cardiac rhythm disturbances.
• If you are at risk of having a stroke.
• If the medication is administered to elderly patients, as there is a risk of sedation, decreased blood pressure when standing up, or the appearance of dyskinesia (abnormal, uncontrollable repetitive movements).
• If the medication is administered to children, as sulpiride has not been thoroughly investigated in this group of patients. Its use is not recommended in children.
• If you have renal insufficiency (kidney function disorder), as the dose must be decreased.
• If you have a history of epilepsy, as it may favor the appearance of epileptic seizures and convulsions.
• If you have Parkinson's disease, as it is contraindicated, except in exceptional cases, in patients taking antiparkinsonian medication.
• If you experience fever of unknown origin and muscle stiffness, as it could be a sign of malignant neuroleptic syndrome, a potentially fatal complication characterized by elevated body temperature, muscle stiffness, and nervous system dysfunction (autonomic dysfunction). In case of undiagnosed elevated body temperature, treatment with sulpiride should be suspended (see "Possible side effects").
• If you have diabetes mellitus or are at risk of developing diabetes.

If you experience infection or fever of unknown origin, inform your doctor, as it could be a sign of blood disorder (see "Possible side effects"). Cases of leukopenia (decrease in the number of white blood cells), neutropenia (decrease in the number of white blood cells called neutrophils), and agranulocytosis (decrease in a type of white blood cells, granulocytes) have been reported with the use of antipsychotics, including Ansium.

• In elderly patients with psychosis related to dementia who are being treated with antipsychotics (possibility of increased risk of death).
• In patients with risk factors for thromboembolism (see "Possible side effects").

Consult your doctor or pharmacist if you experience such symptoms.

It is not advisable to take this medication for the treatment of psychoses or anxiety associated with depression. Behavioral disorders may appear, mainly in children and the elderly, in which case treatment will be discontinued.

The use of benzodiazepines can lead to dependence. This occurs mainly after uninterrupted use of the medication for a long time. To minimize the risk of dependence, the following precautions should be taken:

• Benzodiazepines should only be taken under medical prescription (never because they have been effective for other patients) and should never be recommended to other people.
• Do not increase the prescribed doses in any way, nor prolong treatment for longer than recommended.
• Regularly consult your doctor to decide whether treatment should be continued.

Children

Ansium should not be administered to children.

Elderly Patients

Elderly patients may be more affected by Ansium than younger patients. If you are elderly, your doctor may prescribe a lower dose (e.g., half the average dose) and monitor your response to treatment. Please follow your doctor's instructions carefully.

If you have any liver or kidney disorder, or if you have muscle weakness, your doctor will decide whether it is convenient for you to take a lower dose of Ansium or not to take it at all.

Taking Ansium with Other Medications

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

Before starting treatment, your doctor should be informed if you are taking other medications (including those that have not been prescribed). This is extremely important because the simultaneous use of more than one medication can increase or decrease its effect.

Therefore, you should not take other medications at the same time as Ansium unless your doctor is informed and approves it beforehand. For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and can enhance the effect of Ansium.

Cisapride, cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole temporarily increase the sedative effect of Ansium, increasing the risk of drowsiness.

Similarly, the metabolism of phenytoin may be affected if you are taking Ansium, so if you are taking this medication, your doctor will adjust the doses accordingly.

Patients with Parkinson's disease treated with levodopa should not take this medication. Certain enzyme-inhibiting medications may enhance the activity of this medication.

Since it contains sulpiride, inform your doctor if you are taking any of the following medications:

• Antiarrhythmic agents such as quinidine, disopyramide, amiodarone, and sotalol.
• Other medications such as cisapride, thioridazine, intravenous erythromycin, vincamine, halofantrine, pentamidine, sparfloxacin, methadone, pimozide, haloperidol, and sultoprida.
• Medications that induce a decrease in heart rate, such as diltiazem and verapamil, clonidine, guanfacine; digitalis.
• Medications that induce a decrease in potassium and magnesium levels.
• CNS depressant medications, including narcotics, analgesics, sedating antihistamines H1, barbiturates, benzodiazepines, and other anxiolytic medications.
• Lithium salts (medications for the treatment of manic-depressive disorder or bipolar affective disorder).
• Sucralfate (medication for the treatment and prevention of duodenal ulcers).
• Antacids.
• Medications for lowering blood pressure.
• Lithium.

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

Taking Ansium with Medications, Beverages, and Alcohol

Avoid alcoholic beverages during treatment. The effect of alcohol can enhance sedation, which can affect your ability to drive or operate machinery. If you need additional information on this point, consult your doctor.

Do not drink grapefruit juice during treatment with Ansium.

Pregnancy and Breastfeeding

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

Before starting treatment, your doctor should know if you are or think you may be pregnant, or if you plan to become pregnant. The doctor will then decide whether it is convenient for you to take Ansium.

Newborns of mothers who have used Ansium in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn experiences any of these symptoms, contact your doctor.

Benzodiazepines are excreted in breast milk, so you should consult your doctor about the convenience of taking Ansium while breastfeeding your child.

Driving and Using Machines

Diazepam can alter your ability to drive or operate machinery, as it can cause drowsiness, decrease your attention, or decrease your reaction time. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Sulpiride can cause symptoms such as drowsiness, dizziness, or vision disturbances, and decrease your reaction time. These effects, as well as the underlying disease, can impair your ability to drive vehicles or operate machinery. Therefore, do not drive or operate machinery, nor engage in other activities that require special attention, until your doctor assesses your response to this medication.

Ansium Contains Lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Ansium

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. Depending on the nature of your disease, your age, and weight, your doctor will prescribe the appropriate dose.

Swallow the Ansium capsules without chewing, with water or another non-alcoholic beverage.

The usual doses are as follows:

1 capsule (50 mg of sulpiride + 5 mg of diazepam) to 4 capsules (200 mg of sulpiride + 20 mg of diazepam) per day.

Never change the dose prescribed by your doctor yourself. If you think the effect of the medication is too strong or too weak, consult your doctor.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

For the treatment of anxiety, the duration of treatment will be 8 to 12 weeks, including the gradual withdrawal period. For the treatment of insomnia, the duration of treatment will be a few days to two weeks, with a maximum duration of four weeks, including gradual withdrawal.

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

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

In elderly patients or those with liver or kidney disorders, or muscle weakness, the doctor will prescribe a lower initial dose and a more gradual dose adjustment. In cases of severe renal insufficiency, treatment will be discontinued.

Ansium Overdose

In case of overdose, sulpiride can cause spasms of the muscles of the face, neck, and tongue. Some patients may develop parkinsonian manifestations (tremors, rigidity) with vital risk and coma.

There is no specific antidote for sulpiride, and treatment is only symptomatic. Hemodialysis is partially effective in eliminating the drug. In case of overdose, appropriate supportive measures should be initiated, recommending close monitoring of vital functions and cardiac function until the patient recovers.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Ansium Missed Dose

If you forget to take a dose, you should never try to correct it by taking a double dose the next time, but instead, continue with the normal dose.

Ansium Withdrawal

When stopping the administration, restlessness, anxiety, insomnia, lack of concentration, headache, and hot flashes may appear. It is not recommended to interrupt the medication abruptly without gradually reducing the dose, according to the doctor's instructions.

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

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

DIAZEPAM

In addition to the beneficial effects of Ansium, undesirable effects may occur, even when the medication is used properly.

Most patients tolerate Ansium well, but some, especially at the beginning of treatment, may feel somewhat tired or drowsy during the day.

Occasionally, other adverse effects of the type of confusion, impaired alertness, loss of sensitivity, constipation, depression, diplopia (double vision), ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, digestive alterations, alteration of heart rhythm, headache, hypotension, circulatory disorders, increased or decreased libido, nausea, dry mouth or hypersalivation (exaggerated salivary secretion), incontinence or urinary retention, skin rashes, stuttering, tremors, dizziness, and blurred vision have been described. The most frequent skin reactions are rash (skin inflammation), urticaria (red patches), and pruritus (uncomfortable itching or irritation of the skin that causes the desire to scratch the affected area.

Very rarely, an increase in transaminases and alkaline phosphatase, jaundice (yellowish appearance of the skin and eyes), as well as cardiac arrest, have been reported.

An increased risk of falls and fractures has been observed in elderly patients and in patients taking other sedative medications (including alcoholic beverages) at the same time. It is known that when benzodiazepines are used, adverse effects on behavior such as restlessness, agitation, irritability, delirium (incoherence of ideas), nightmares, hallucinations, psychosis, or inappropriate behavior may occur. These reactions are more frequent in the elderly and in children. If you experience these effects, you should discontinue treatment and contact your doctor immediately.

On the other hand, the use of benzodiazepines can lead to dependence, mainly when the medication is taken continuously for a long time. It is not recommended, in general, to abruptly interrupt the medication, always following the doctor's instructions.

Anterograde amnesia (loss of memory) may appear at normal doses, and the risk increases when the dose is increased. Amnestic effects may be associated with behavioral alterations.

The use of benzodiazepines can unmask existing depression.

SULPIRIDA

The following adverse effects due to Sulpirida may occur:

Blood and lymphatic system disorders

• Uncommon (may affect up to 1 in 100 patients): leukopenia (decrease in the number of white blood cells) (see "Warnings and precautions").

• Frequency not known: neutropenia (decrease in the number of white blood cells called neutrophils) and agranulocytosis (decrease in a type of white blood cells, granulocytes) (see "Warnings and precautions").

Immune system disorders

• Frequency not known: anaphylactic reactions (severe allergic reaction), urticaria, difficulty breathing (dyspnea), decrease in blood pressure, and anaphylactic shock (severe allergic reaction that can be life-threatening).

Endocrine disorders

• Frequent (may affect up to 1 in 10 patients): increase in normal prolactin levels.

Psychiatric disorders

• Frequent (may affect up to 1 in 10 patients): insomnia (difficulty sleeping).

Nervous system disorders

• Frequent (may affect up to 1 in 10 patients): sedation or drowsiness, extrapyramidal disorder (these symptoms are generally reversible if antiparkinsonian medication is administered), parkinsonism, tremors, akathisia (inability to sit or remain seated).

• Uncommon (may affect up to 1 in 100 patients): increased muscle tone, dyskinesia (abnormal and involuntary movements), dystonia (muscle contractions).

• Rare (may affect up to 1 in 1000 patients): oculogyric crisis (involuntary deviation of the gaze).

• Frequency not known: convulsions, malignant neuroleptic syndrome (see "Warnings and precautions"), which is a complication characterized by elevated body temperature, muscle rigidity, and can even lead to death, decreased or slowed involuntary movements (hypokinesia), tardive dyskinesia (characterized by rhythmic and involuntary movements mainly of the tongue and/or face, as has been reported with all neuroleptics, after administration for more than 3 months. Antiparkinsonian medication is ineffective or may worsen symptoms).

Cardiac disorders

• Rare (may affect up to 1 in 1000 patients): ventricular arrhythmia (change in heart rhythm), ventricular tachycardia (rapid succession of heartbeats whose cause resides in the ventricles), ventricular fibrillation.
• Frequency not known: prolongation of the QT interval (heart conduction problems), cardiac arrest, torsades de pointes (alteration of heart rhythm), sudden death (see "Warnings and precautions").

Vascular disorders

• Uncommon (may affect up to 1 in 100 patients): orthostatic hypotension (decrease in blood pressure when standing up).
• Frequency not known: increase in blood pressure, blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to your doctor immediately.

Gastrointestinal disorders

• Uncommon (may affect up to 1 in 100 patients): increased salivation.

Hepatobiliary disorders

• Frequent (may affect up to 1 in 10 patients): increase in liver enzymes.

Skin and subcutaneous tissue disorders

• Frequent (may affect up to 1 in 10 patients): maculopapular rash (appearance of red patches and papules on the skin).

Musculoskeletal and connective tissue disorders

• Frequency not known: torticollis, trismus (contraction of the jaw muscles).

Pregnancy, puerperium, and perinatal disorders

• Frequency not known: extrapyramidal symptoms (involuntary movements), withdrawal syndrome in newborns (see "Pregnancy and lactation").

Reproductive system and breast disorders

• Frequent (may affect up to 1 in 10 patients): chest pain, milk secretion from the breasts outside of pregnancy.
• Uncommon (may affect up to 1 in 100 patients): absence of menstruation in a fertile woman, breast enlargement, abnormal orgasm, impotence.
• Frequency not known: breast enlargement in men.

General disorders and administration site conditions

• Frequent (may affect up to 1 in 10 patients): weight gain.

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

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ansium

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

Nappears in the box after CAD. L

Medications should not be thrown down the drain or into the trash. Deposit the containers and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ansium

• The active ingredients are diazepam and sulpiride.
• The other components are pregelatinized cornstarch, lactose monohydrate, colloidal hydrated silica, talc (E-553b), magnesium stearate (E-572). Gelatin capsule: gelatin, titanium dioxide (E-171), yellow iron oxide (E-172), black iron oxide (E-172), and carmine indigo (E-132).

Appearance of the product and package contents

The hard capsules are opaque, with a white body and blue head.

It is marketed in packages of 30 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the last revision of this prospectus: October 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es