Package Insert: Information for the User

Sulpiride Kern Pharma50 mg EFG Capsules

Sulpiride

Read this package insert carefully before starting to take the medicine

•Keep this package insert, as you may need to read it again.

•If you have any doubts, consult 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 adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

Sulpirida Kern Pharma belongs to the group of antipsychotic medications, also known as neuroleptics.

Sulpirida Kern Pharma is indicated for:

Adults: Various psychopathological conditions (neurosis, depressions, neurasthenic somatizations). Functional psychological disorders. Psychosomatic syndromes. Senile dementia. Gastrointestinal somatizations. Dizziness.

Do not take Sulpirida Kern Pharma

• If you are allergic (hypersensitive) to sulpiride or any of the other components of Sulpirida Kern Pharma.

• In the case of prolactin-dependent tumors (hormone that stimulates milk secretion), for example, prolactinomas of the pituitary gland and breast cancer.
• In the case of Phaeochromocytoma (adrenal gland tumor).
• In association with levodopa (See "Use of other medications").
• In patients with low heart rate, with heart rhythm disturbances or with any other clinically important heart disease.

Be especially careful with Sulpirida Kern Pharma

• If administered to patients with a clinical condition that may favor the appearance of heart rhythm disorders, as sulpiride may potentiate the risk of severe heart rhythm disorders.
• If you are at risk of suffering a stroke.
• If the medication is administered to the elderly, as there is a risk of sedation, decrease in blood pressure when standing up, or the appearance of dyskinesia (uncontrollable abnormal repetitive movements).
• If the medication is administered to children, as sulpiride has not been thoroughly investigated in this group of patients. It is not recommended for use in children.
• If you have kidney insufficiency (kidney function alteration), as the dose must be reduced.
• If you have or have had epilepsy, as the group of drugs to which sulpiride 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 develop fever of unknown origin and muscle rigidity, as it could be the neuroléptico malignant syndrome, a potentially fatal complication characterized by elevated body temperature, muscle rigidity, and autonomic nervous system dysfunction (autonomic dysfunction). In case of unexplained elevated body temperature, discontinue sulpiride treatment (See "Possible adverse effects").
• If you have diabetes mellitus or have risk factors for developing diabetes.
• In elderly patients with dementia-related psychosis, who are being treated with antipsychotics (possibility of presenting a higher risk of death).
• In patients with risk factors for thromboembolism (See "Possible adverse effects").

Consult your doctor or pharmacist if such symptoms appear.

Use of other medications

To avoid possible interactions with other medications, inform your doctor or pharmacist if you are taking, or have recently taken, another medication, even those acquired without a prescription.

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

• Levodopa (medication for the treatment of Parkinson's disease).

• Antiarrhythmic agents such as quinidine, disopyramide, amiodarone, and sotalol.

• Other medications such as cisapride, thioridazine, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine, enoxacin, methadone, pimozide, haloperidol, and sultopride.
• Medications that slow 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, antihistamines H1 sedatives, barbiturates, benzodiazepines, and other anxiolytic drugs.
• Lithium salts (medications for the treatment of manic-depressive disorder or bipolar affective disorder).
• Sucralfate (medication to treat and prevent duodenal ulcers).
• Antacids.
• Medications to lower blood pressure.

Take note that these instructions may also apply to medications that have been used before or may be used afterwards.

Taking Sulpirida Kern Pharma with food and beverages

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Sulpiride is not recommended during pregnancy.

Newborns of mothers who have used sulpiride in the last trimester of pregnancy may present the following symptoms: tremor, muscle rigidity, and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn presents 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 operating machinery

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

Important information about some of the components of Sulpirida Kern Pharma

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of Sulpirida Kern Pharma indicated by your doctor. Consult with 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 the way to increase the dose. Do not abruptly stop treatment, as symptoms of your disease may reappear.

If you estimate that the action of Sulpirida Kern Pharma is too strong or too weak, inform your doctor or pharmacist.

The administration route is oral.

The dose to be administered is different depending on the disease you suffer from. Generally, the established normal dose is:

Adults:

The recommended dose is 3 to 6 capsules per day. In vertigo, it can be increased up 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 anti-acids and sucralfate.

Renal insufficiency::

Your doctor will adjust the dose.

Seniors:

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 appear. Some patients may develop parkinsonian manifestations (tremor, rigidity) with vital risk and coma.

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

In case of severe extrapyramidal symptoms (tremor, 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Kern Pharma

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Sulpirida Kern Pharma may cause side effects, although not everyone will experience them.

The side effects associated with Sulpirida are:

Cardiac disorders:

• Decreased blood pressure when standing up.
• Prolongation of the QT interval (heart conduction problems) and ventricular arrhythmias such astorsade de pointes, ventricular tachycardia (rapid succession of heartbeats originating in the ventricles) that may cause cardiac arrest, sudden death.

Endocrine disorders:

• Increased normal levels of prolactin.

General disorders and administration site conditions:

• The neuroleptic malignant syndrome (See “Be especially careful with Sulpirida Kern Pharma”), is a complication characterized by elevated body temperature, muscle rigidity, and may even cause death.
• Weight gain.

Hepatic disorders:

• Increased liver enzymes.

Nervous system disorders:

• Drowsiness or somnolence.
• Extrapyramidal symptoms and related disorders:

• Parkinsonism and related symptoms: tremor, increased muscle tone, slowed movement, increased salivation.
• Absent or involuntary movements (acute dystonia) and muscle contractions (dystonia: spasmodic torticollis, involuntary deviation of the gaze (oculogyric crisis), jaw contracture (trismus)).
• Difficulty for the person to sit or remain seated (akathisia).

These symptoms are generally reversible if antiparkinsonian medication is administered.

• Tardive dyskinesia (characterized by involuntary, rhythmic 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 exacerbate symptoms.
• Seizures (See “Be especially careful with Sulpirida Kern Pharma”).

Reproductive and breast disorders:

Disorders related to increased normal levels of prolactin:

• Abnormal milk secretion by the breasts outside of pregnancy.
• Amenorrhea in a fertile woman.
• Enlargement of the breasts in men.
• Enlargement of the breast.
• Chest pain.
• Organic dysfunction.
• Impotence.

Dermatological and subcutaneous tissue disorders

• Maculopapular rash (eruption with red patches and papules).

Vascular disorders

• Thromboembolism (blood clot formation in veins), including pulmonary embolism, sometimes fatal, and deep vein thrombosis.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Do not store above 30°C.

Do not use Sulpirida Kern Pharma after the expiration date that appears on the packaging after “CAD”. 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 through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Sulpiride Kern Pharma 50 mg Capsules Composition

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

Product Appearance and Packaging Contents

Sulpiride Kern Pharma capsules are white in color. They are presented in PVC/Alu blisters, in packs of 30 capsules.

Marketing Authorization Holder and Responsible Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

This leaflet was revised in September 2012.