Sulpiride Kern Pharma 50 mg capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sulpiride Kern Pharma 50 mg capsules EFG

Sulpiride

Read the entire leaflet carefully before you start taking this medicine

• 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

1. What Sulpiride Kern Pharma 50 mg capsules is and what it is used for

Sulpiride Kern Pharma belongs to the group of antipsychotic medicines, also known as neuroleptics.

Sulpiride Kern Pharma is indicated in:

Adults: Various psychiatric disorders (neuroses, depressions, neurotic somatizations). Functional psychological disorders. Psychosomatic syndromes. Senile dementia. Gastrointestinal somatizations. Vertigo.

2. Before taking Sulpiride Kern Pharma 50 mg capsules

Do not take Sulpirida Kern Pharma

• If you are allergic (hypersensitive) to sulpiride or to any of the other components of Sulpirida Kern Pharma.
• In case of concomitant prolactin-dependent tumors (hormone that stimulates milk secretion), for example pituitary prolactinomas and breast cancer.
• In case of phaeochromocytoma (a tumor of the adrenal gland).
• In combination with levodopa (see “Use with other medicines”).
• In patients with slow heart rate, heart rhythm disorders, or any other clinically significant heart disease.

Take special care with Sulpirida Kern Pharma

• If administered to patients with a clinical condition that may predispose to heart rhythm disorders, as sulpiride may increase the risk of serious cardiac arrhythmias.
• If you are at risk of suffering a stroke.
• If the medicine is given to elderly patients, as there is a risk of sedation, reduced blood pressure upon standing, or the development of dyskinesia (involuntary, uncontrollable repetitive movements).
• If the medicine is given to children, as sulpiride has not been thoroughly studied in this patient group. Its use in children is not recommended.
• If you have renal impairment (kidney function disorder), as the dose must be reduced.
• If you have or have had epilepsy, as the class of drugs to which Sulpirida Kern Pharma belongs may increase the risk of epileptic seizures and convulsions.
• If you have Parkinson's disease, as Sulpirida Kern Pharma is contraindicated except in exceptional cases in patients taking anti-Parkinson medication.
• If you develop unexplained fever and muscle rigidity, as this may indicate neuroleptic malignant syndrome—a potentially life-threatening condition characterized by high body temperature, muscle rigidity, and nervous system dysfunction (autonomic dysfunction). If unexplained high body temperature occurs, treatment with sulpiride must be discontinued (see “Possible side effects”).
• If you have diabetes mellitus or risk factors for developing diabetes.
• In elderly patients with psychosis associated with dementia who are being treated with antipsychotics (increased risk of death).
• In patients with risk factors for thromboembolism (see “Possible side effects”).

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

Sulpirida Kern Pharma and other medicines

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

Specifically, inform your doctor if you are currently taking any of the following medicines:

• Levodopa (a medicine used to treat Parkinson’s disease).
• Antiarrhythmic agents such as quinidine, disopyramide, amiodarone, and sotalol.
• Other medicines such as cisapride, thioridazine, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine, sparfloxacin, methadone, pimozide, haloperidol, and sultopride.
• Medicines that cause slowing of the heart rate, such as diltiazem and verapamil, clonidine, guanfacine, and cardiac glycosides.
• Medicines that cause a reduction in potassium and magnesium levels.
• 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 ulcers).
• Antacids.
• Medicines used to lower blood pressure.

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

Taking Sulpirida Kern Pharma with food and drinks

Since alcohol enhances the sedative effect of sulpiride, consumption of alcoholic beverages or other medicines containing alcohol is not recommended while taking this medicine.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

The use of sulpiride during pregnancy is not recommended.

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

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 impair your ability to drive or operate machinery. Therefore, special caution is advised.

Important information about some of the components of Sulpirida Kern Pharma

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

3. How to take Sulpirida Kern Pharma 50 mg capsules

Follow exactly the administration instructions for Sulpirida Kern Pharma provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

Remember to take your medication.

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

If you feel that 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 varies depending on your condition. In general, the usual recommended dose is:

Adults:

The recommended dose is 3 to 6 capsules per day. In cases of vertigo, the dose may be increased up to 9 capsules per day.

Divide the daily dose into three doses taken throughout the day, preferably before meals. Sulpirida should be taken at least two hours before antacids and sucralfate.

Renal impairment:

Your doctor will adjust your dose.

Elderly patients:

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

If you take more Sulpirida Kern Pharma than you should

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

In case of overdose, muscle spasms of the face, neck, and tongue may occur. Some patients may develop parkinsonian symptoms (tremor, rigidity) with 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 monitoring until the patient recovers.

In the event of severe extrapyramidal symptoms (tremor, increased muscle tone, decreased 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 ingested.

If you forget to take Sulpirida 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Sulpiride Kern Pharma may produce adverse effects, although not everyone experiences them.

Adverse reactions associated with Sulpiride include:

Disorders of the heart:

• Drop in blood pressure upon standing.
• QT interval prolongation (heart conduction problems) and ventricular arrhythmias (changes in heart rhythm), such as torsade de pointes, ventricular tachycardia (rapid succession of heartbeats originating in the ventricles), which may lead to cardiac arrest or sudden death.

Hormonal disorders:

• Increase in normal prolactin levels.

General disorders and administration site conditions:

• Neuroleptic malignant syndrome (see “Take special care with Sulpiride Kern Pharma”), a complication characterized by high body temperature and muscle rigidity, which may even result in death.
• Weight gain.

Liver disorders:

• Increased liver enzymes.

Nervous system disorders:

• Sedation or drowsiness.
• Extrapyramidal symptoms and related disorders:
• Parkinsonism and related symptoms: tremor, 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 contracture (trismus)).
• Inability to sit still or remain seated (akathisia).

These symptoms are generally reversible if antiparkinsonian medication is administered.

• Tardive dyskinesia (characterized by rhythmic, 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 “Take special care with Sulpiride Kern Pharma”).

Reproductive system and breast disorders:

Disorders related to increased normal levels of prolactin:

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

Skin and subcutaneous tissue disorders

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

Vascular disorders

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

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 not listed in this leaflet. You can also report them directly through 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 Sulpiride Kern Pharma 50 mg capsules

Do not store above 30°C.

Do not use Sulpiride Kern Pharma after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Keep out of the reach and sight of children.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Information for the user

Composition of Sulpiride Kern Pharma 50 mg capsules

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

Appearance of the medicine and contents of the pack

Sulpiride Kern Pharma are white-colored capsules. They are supplied 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 reviewed in September 2012.

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/