Ansiun hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

ANSIUM Hard capsules

Sulpiride /Diazepam

Read the entire leaflet carefully before starting to take 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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ansium is and what it is used for

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

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

This medicine should only be used for the treatment of severe disorders that impair the patient's activity or subject them to significant stress.

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

2. What you need to know before starting to take Ansium

Do not take Ansium

• If you are allergic to diazepam or sulpiride, or to any of the other components of this medicine listed in section 6.
• If you are allergic to benzodiazepines in general.
• If you suffer from long-term respiratory difficulties, whether related to sleep or not.
• If you have muscle disorders.
• If you have severe liver problems.
• If you have increased intraocular pressure.
• If you suffer from severe chronic hypercapnia.
• If you have drug or alcohol dependence, unless formally instructed otherwise by your doctor.

If you have any doubts, consult your physician.

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

• you have concomitant tumors dependent on prolactin (a hormone that stimulates milk secretion), such as prolactinomas of the pituitary gland or breast cancer,
• you have pheochromocytoma (a tumor of the adrenal gland),
• you are being treated with levodopa (see "Use of other medicines"),
• you have a low heart rate, cardiac arrhythmias, or any other clinically significant heart disease,
• you have acute porphyria, a metabolic disorder that impairs 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 suffer from muscle weakness.

• If you have other diseases or if someone in your family has a history of blood clots, as these medications 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 medications.

• If you are epileptic and are undergoing long-term treatment with Ansium, the use of the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of diazepam is not recommended, as seizures may occur.

• If administered to patients with a clinical condition that could favor the appearance of cardiac rhythm disorders, since sulpiride may increase the risk of serious cardiac rhythm disturbances.

• If you are at risk of suffering a stroke.

• If the medication is administered to elderly patients, as there is a risk of sedation, decreased blood pressure upon standing, or the development of dyskinesia (involuntary, repetitive abnormal movements).

• If the medication is administered to children, as sulpiride has not been thoroughly studied in this patient group. Its use is not recommended in children.

• If you have renal insufficiency (impaired kidney function), as the dose must be reduced.

• If you have or have had epilepsy, as it may promote epileptic seizures and convulsions.

• If you have Parkinson's disease, as it is contraindicated, except in exceptional cases, in patients taking anti-Parkinson medication.

• If you develop fever of unknown origin and muscle rigidity, as this could be 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 must be discontinued (see “Possible adverse effects”).

• If you have diabetes mellitus or have risk factors for developing diabetes.

If you develop an infection or fever of unknown origin, inform your doctor, as this could indicate a blood dyscrasia (blood disorder) (see “Possible adverse effects”). Cases of leucopenia (reduced number of white blood cells), neutropenia (reduced number of white blood cells called neutrophils), and agranulocytosis (reduced number of a type of white blood cells, granulocytes) have been reported with the use of antipsychotics, including Ansium.

• In elderly patients with psychosis associated with dementia who are being treated with antipsychotics (possible increased risk of death).
• In patients with risk factors for thromboembolism (see “Possible adverse effects”).

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

It is not advisable to take this medication for the treatment of psychosis or anxiety associated with depression. Behavioral disturbances may occur, mainly in children and 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 medication. 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 another patient) and should never be recommended to others.
• Do not increase the doses prescribed by your doctor, nor extend treatment beyond the recommended duration.
• Consult your doctor regularly so they can determine whether treatment should continue.

Children

Ansium must 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 (for example, half the average dose) and monitor your response to treatment. Please follow your doctor's instructions carefully.

If you have any liver or kidney disorders, or suffer from muscle weakness, your doctor will decide whether you should take a lower dose of Ansium or should not take it at all.

Taking Ansium with other medicines

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

Before starting treatment, your doctor must be informed if you are taking other medicines (including those not prescribed). This is extremely important because the simultaneous use of more than one medicine may increase or decrease its effect.

Therefore, you must not take other medicines at the same time as Ansium unless your doctor is aware and has previously approved it. For example, tranquilizers, sleep-inducing agents, and similar medicines act on the brain and nerves and may enhance the effect of Ansium.

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

Likewise, the metabolism of phenytoin may be affected if you are taking Ansium; 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-inhibiting medicines may potentiate the activity of this medicine.

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

• Antiarrhythmic agents such as quinidine, disopyramide, amiodarone, and sotalol.
• Other medicines such as cisapride, thioridazine, intravenous erythromycin, vincamine, halofantrine, pentamidine, sparfloxacin, methadone, pimozide, haloperidol, and sultopride.
• Medicines that cause slowing of heart rate such as diltiazem and verapamil, clonidine, guanfacine, and cardiac glycosides.
• Medicines that cause decreased levels of potassium and magnesium.
• Central nervous system depressants including narcotics, analgesics, sedating H1 antihistamines, barbiturates, benzodiazepines, and other anxiolytic drugs.
• Lithium salts (medicines used to treat manic-depressive disorder or bipolar affective disorder).
• Sucralfate (a medicine used to treat and prevent duodenal ulcer).
• Antacids.
• Medicines to lower blood pressure.
• Lithium.

Please note that these instructions may also apply to medicines that have been used previously or may be used in the future.

Taking Ansium with medicines, beverages, and alcohol

During treatment, avoid alcoholic beverages. The effect of 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 consume 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 medicine.

Before starting treatment, your doctor must know whether you are pregnant or suspect you may be, or whether you intend to become pregnant. Your doctor will then decide whether it is appropriate for you to take Ansium.

Newborns of mothers who have used Ansium during 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 shows any of these symptoms, contact your doctor immediately.

Benzodiazepines are excreted in breast milk, so you should consult your doctor about whether it is advisable to take Ansium while breastfeeding.

Driving and using machines

Diazepam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or decrease reaction capacity. 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.

Sulpiride may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce reaction capacity. These effects, as well as the underlying illness itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive or operate machinery, or engage in other activities requiring special alertness, until your doctor has assessed your response to this medicine.

Ansium 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 Ansium

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. Depending on the nature of your illness, your age and weight, your doctor will prescribe the appropriate dose.

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

The usual doses are as follows:

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

Never change the prescribed dose on your own. If you think the effect of the medicine is too strong or too weak, consult your doctor.

No individual dose should exceed the stated limits, nor should the total daily dose, unless your doctor prescribes a higher dose.

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

To avoid withdrawal symptoms, you should 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 in patients with liver or kidney disorders, or with 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.

If you take more Ansium than you should

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

There is no specific antidote for Sulpiride; treatment is purely symptomatic, and hemodialysis is partially effective in removing the drug. In case of overdose, appropriate supportive measures should be initiated, with close monitoring of vital functions and cardiac activity until the patient recovers.

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

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

If you forget to take Ansium

If you forget to take a dose, you should never try to make up for it by taking a double dose next time; instead, you should continue with your normal dose.

If treatment with Ansium is interrupted

When administration is stopped, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flashes may occur. In general, it is not recommended to abruptly discontinue the medication without gradually reducing the dose, according to the physician's instructions.

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

4. Possible adverse effects

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

DIAZEPAM

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

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 have been reported, such as confusion, impaired alertness, numbness, constipation, depression, diplopia (double vision), ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, gastrointestinal disturbances, changes in heart rate, headache, hypotension, circulatory disturbances, increased or decreased libido, nausea, dry mouth or hypersalivation (excessive salivary secretion), urinary incontinence or retention, skin rashes, stammering, tremor, dizziness, and blurred vision. The most frequent skin reactions are rash (skin inflammation), urticaria (reddish hives), and pruritus (tingling or uncomfortable skin irritation causing an urge to scratch the affected area).

Very rarely, increased transaminases and alkaline phosphatase, jaundice (yellowing of the skin and eyes), and cardiac arrest have been reported.

An increased risk of falls and fractures has been observed in elderly patients and in patients taking other sedative medicines simultaneously (including alcoholic beverages). It is known that when benzodiazepines are used, adverse behavioral effects such as restlessness, agitation, irritability, delirium (incoherent thinking), nightmares, hallucinations, psychosis, or inappropriate behavior may occur. These reactions are more common in the elderly and in children. If you experience these effects, you must stop treatment and contact your doctor immediately.

Furthermore, the use of benzodiazepines may lead to dependence, primarily when the medicine is taken continuously over a long period. Abrupt discontinuation of the medication is generally not recommended, always in accordance with your doctor's instructions.

Anterograde amnesia (memory loss) may occur at normal doses; the risk increases with higher doses. Amnesic effects may be associated with behavioral disturbances.

The use of benzodiazepines may unmask an underlying depression.

SULPIRIDE

The following adverse effects may occur due to Sulpiride:

Blood and lymphatic system disorders

• Uncommon (may affect up to 1 in 100 patients): leucopenia (reduction in the number of white blood cells) (see “Warnings and precautions”).

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

Immune system disorders

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

Endocrine disorders

• Common (may affect up to 1 in 10 patients): increased levels of the hormone prolactin.

Psychiatric disorders

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

Nervous system disorders

• Common (may affect up to 1 in 10 patients): sedation or drowsiness, extrapyramidal disorder (these symptoms are usually reversible with antiparkinsonian medication), parkinsonism, tremor, akathisia (inability to sit or remain seated).

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

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

• Frequency not known: seizures, neuroleptic malignant syndrome (see “Warnings and precautions”)—a complication characterized by high body temperature, muscle rigidity, potentially leading to death, reduced or slowed 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).

Cardiac disorders

• Rare (may affect up to 1 in 1000 patients): ventricular arrhythmia (change in heart rhythm), ventricular tachycardia (rapid succession of heartbeats originating in the ventricles), ventricular fibrillation.

• Frequency not known: QT interval prolongation (heart conduction problems), cardiac arrest, torsade de pointes (abnormal 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 upon standing).

• Frequency not known: increased blood pressure, blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, seek immediate medical attention.

Gastrointestinal disorders

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

Hepatobiliary disorders

• Common (may affect up to 1 in 10 patients): increased liver enzymes.

Skin and subcutaneous tissue disorders

• Common (may affect up to 1 in 10 patients): maculopapular rash (appearance of reddish spots and papules on the skin).

Musculoskeletal and connective tissue disorders

• Frequency not known: torticollis, trismus (jaw muscle spasm).

Pregnancy, puerperium and perinatal conditions

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

Reproductive system and breast disorders

• Common (may affect up to 1 in 10 patients): breast pain, lactation (milk secretion from the breasts outside 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

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

A slightly increased number of deaths has been reported in elderly patients with dementia treated with antipsychotics compared to those not receiving such treatment.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ansium

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

Do not store above 30°C.

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Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Ansium

• The active substances are diazepam and sulpiride.
• The other components are pregelatinized corn starch, monohydrate lactose, 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 indigo carmine (E-132).

Appearance of the product and contents of the pack

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

It is marketed in packs 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 most recent review of this leaflet: October 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es