SULPIRIDE KERN PHARMA 50 mg CAPSULES

Introduction

Package Leaflet: Information for the User

Sulpirida Kern Pharma50 mg hard capsules EFG

Sulpirida

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Sulpirida Kern Pharma 50 mg hard capsules are and what they are used for
2. Before you take Sulpirida Kern Pharma 50 mg hard capsules
3. How to take Sulpirida Kern Pharma 50 mg hard capsules
4. Possible side effects
5. Storing Sulpirida Kern Pharma 50 mg hard capsules
6. Further information

1. What Sulpirida Kern Pharma 50 mg hard capsules are and what they are used for

Sulpirida Kern Pharma belongs to a group of medicines called antipsychotics, also known as neuroleptics.

Sulpirida Kern Pharma is indicated for:

Adults: Various psychopathological conditions (neurosis, depression, neurotic somatization). Functional psychological disorders. Psychosomatic syndromes. Senile dementia. Gastrointestinal somatization. Vertigo.

2. Before you take Sulpirida Kern Pharma 50 mg hard capsules

Do not take Sulpirida Kern Pharma

• If you are allergic (hypersensitive) to sulpiride or any of the other ingredients of Sulpirida Kern Pharma.
• In case of concomitant prolactin-dependent tumors (hormone that stimulates milk secretion), such as prolactinomas of the pituitary gland and breast cancer.
• In case of pheochromocytoma (tumor of the adrenal gland).
• In combination with levodopa (see "Using other medicines").
• In patients with low heart rate, with rhythm disorders or with any other clinically significant heart disease.

Be careful with Sulpirida Kern Pharma

• If administered to patients with a clinical situation that may favor the appearance of rhythm disorders, since sulpiride can increase the risk of serious rhythm disorders.
• If you are at risk of having a stroke.
• If the medicine is given to the elderly, as there is a risk of sedation, decreased blood pressure when standing up, or the appearance of dyskinesia (abnormal, uncontrollable, repetitive movements).
• If the medicine is given to children, as sulpiride has not been thoroughly investigated in this group of patients. Its use is not recommended in children.
• If you have kidney failure (alteration of kidney function), as the dose must be reduced.
• If you have or have had epilepsy, as the group of drugs to which Sulpirida Kern Pharma belongs may favor the appearance of epileptic seizures and convulsions.
• If you have Parkinson's disease, as Sulpirida Kern Pharma 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 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 discontinued (see "Possible side effects").
• If you have diabetes mellitus or are at risk of developing diabetes.
• 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 such symptoms appear.

Sulpirida Kern Pharma and other medicines

In order to avoid possible interactions with other medicines, inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those obtained without a prescription.

In particular, inform your doctor if you are currently taking any of the following medications:

• Levodopa (medication for the treatment of Parkinson's disease).
• Anti-arrhythmic agents such as quinidine, disopyramide, amiodarone, and sotalol.
• Other medications such as cisapride, thioridazine, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine, sparfloxacin, methadone, pimozide, haloperidol, and sultopride.
• Medications that induce a slowing of the heart rate, such as diltiazem and verapamil, clonidine, guanfacine; digitalis.
• Medications that induce a decrease in potassium and magnesium levels.
• Central nervous system depressants, 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 to lower blood pressure.

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

Taking Sulpirida Kern Pharma with food and drinks

Since alcohol enhances the sedative effect of sulpiride, it is not recommended to consume alcoholic beverages or other medications that contain alcohol while taking this medication.

Do not drink grapefruit juice during treatment with Sulpirida Kern Pharma.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

The use of sulpiride is not recommended during pregnancy.

Newborns of mothers who have used sulpiride 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.

Since sulpiride passes into breast milk, breastfeeding is not recommended during treatment with Sulpirida Kern Pharma.

Driving and using machines

Sulpirida Kern Pharma may cause sedation and, consequently, may affect the ability to drive vehicles or operate machines, so special caution is recommended.

Important information about some of the ingredients of Sulpirida Kern Pharma

This medication 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 Sulpirida Kern Pharma 50 mg hard capsules

Follow the administration instructions of Sulpirida Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

The duration of this treatment is limited. Your doctor will indicate the duration of treatment as well as how to increase the dose. Do not stop treatment abruptly, as symptoms of your illness may reappear.

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

The route of administration is oral.

The dose to be administered is different depending on the disease you are suffering from. In general, the established normal dose is:

Adults:

The recommended dose is 3 to 6 capsules per day. In cases of vertigo, it can be increased to 9 capsules per day.

Distribute the doses in three intakes throughout the day, and administer preferably before meals. Sulpirida should be taken at least two hours before antacids and sucralfate.

Kidney failure:

Your doctor will adjust the dose.

Elderly:

Your doctor will adjust the dose. These patients may need a lower initial dose and a more gradual dose adjustment.

If you take more Sulpirida Kern Pharma than you should

If you have taken Sulpirida Kern Pharma more than you should, consult your doctor or pharmacist immediately.

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

There is no specific antidote for sulpiride, treatment is only symptomatic, and 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, slowed movement, increased salivation, 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 ingested.

If you forget to take Kern Pharma

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

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

4. Possible side effects

Like all medicines, Sulpirida Kern Pharma can cause side effects, although not everyone gets them.

The adverse reactions associated with Sulpirida are:

Heart disorders:

• Decreased blood pressure when standing up.
• Prolongation of the QT interval (heart conduction problems) and ventricular arrhythmias (change in heart rhythm) such as torsade de pointes, ventricular tachycardia (rapid succession of heartbeats whose cause resides in the ventricles) that can produce cardiac arrest, sudden death.

Hormonal disorders:

• Increase in normal prolactin levels.

General disorders and administration site conditions:

• The malignant neuroleptic syndrome (see "Be careful with Sulpirida Kern Pharma"), is a complication characterized by elevated body temperature, muscle stiffness, and even death.
• Weight gain.

Liver disorders:

• Increased liver enzymes.

Nervous system disorders:

• Sedation or drowsiness.
• Extrapyramidal symptoms and related disorders:
• Parkinsonism and related symptoms: tremors, increased muscle tone, slowed movement, increased salivation.
• Abnormal and involuntary movements (acute dyskinesia) and muscle contractions (dystonia: spasmodic torticollis, involuntary deviation of gaze (oculogyric crisis), jaw contraction (trismus)).
• Impossible for the person to sit or remain seated (akathisia).

These symptoms are generally reversible if antiparkinsonian medication is administered.

• Late dyskinesia (characterized by rhythmic and involuntary movements mainly of the tongue and/or face), as occurs with all neuroleptics, after administration for more than 3 months. Antiparkinsonian medication is ineffective or may worsen symptoms.
• Seizures (see "Be careful with Sulpirida Kern Pharma").

Reproductive system and breast disorders:

Disorders related to increased normal prolactin levels:

• Abnormal milk secretion from the breasts outside of pregnancy.
• Absence of menstruation in a fertile woman.
• Increased breast size in men.
• Breast enlargement.
• Breast pain.
• Orgasmic dysfunction.
• Impotence.

Skin and subcutaneous tissue disorders

• Maculopapular rash (rash with red spots and papules).

Vascular disorders

• Venous thromboembolism (process characterized by blood clotting in the veins), including pulmonary embolism, sometimes fatal, and deep vein thrombosis.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storing Sulpirida Kern Pharma 50 mg hard capsules

Do not store above 30°C.

Do not use Sulpirida Kern Pharma after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Keep out of the reach and sight of children.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Further information

Composition of Sulpirida Kern Pharma 50 mg hard capsules

• The active ingredient is sulpiride. Each capsule contains 50 mg of sulpiride.
• The other ingredients are: lactose monohydrate, anhydrous colloidal silica, methylcellulose, talc, magnesium stearate (E-470b), titanium dioxide (E-171), and gelatin.

Appearance of the product and packaging contents

Sulpirida Kern Pharma are white capsules. They are presented in PVC/Alu blisters, in packs of 28 and 30 capsules.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This leaflet was last revised in September 2012.

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