Dogmatil Fuerte 200 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dogmatil Fuerte 200 mg tablets

Sulpiride

Read the entire leaflet carefully before you start taking 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.

Leaflet contents:

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

1. What Dogmatil Fuerte is and what it is used for

Dogmatil Fuerte belongs to the group of antipsychotic medicines, also known as neuroleptics.

Dogmatil Fuerte is indicated for:

• Treatment of depressive disorders with psychotic symptoms in combination with antidepressants, when treatment with antidepressant medicines alone has not been effective, and for the treatment of other severe forms of depression resistant to antidepressants.

• Treatment of vertigo in cases where there is no response to usual antivertigo treatment.

• Treatment of acute and chronic psychoses.

2. What you need to know before taking Dogmatil Fuerte

Do not take Dogmatil Fuerte

• if you are allergic to sulpiride or any of the other ingredients of this medicine (listed in section 6),

• if you have multiple prolactin-dependent tumours (concomitant tumours), for example pituitary prolactinomas and breast cancer,

• if you have phaeochromocytoma (a tumour of the adrenal gland),

• if you are being treated with levodopa or antiparkinsonian medicines (including ropinirol) (see “Use of Dogmatil Fuerte with other medicines”),

• if you have a metabolic disorder called acute porphyria,

• in patients with slow heart rate (bradycardia), cardiac rhythm disturbances, or any other clinically significant heart disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dogmatil Fuerte:

• If it is administered to patients with a clinical condition that may favour the occurrence of heart rhythm disorders, as sulpiride may increase the risk of serious cardiac rhythm disturbances.

• If you have risk factors for 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 (repetitive involuntary and uncontrollable movements).

• If you have renal impairment (altered kidney function), the dose should be reduced.

• If you have or have had epilepsy, since the group of medicines to which Dogmatil Fuerte belongs may increase the risk of epileptic seizures and convulsions.

• If you have Parkinson's disease, as Dogmatil Fuerte is contraindicated except in exceptional cases in patients taking antiparkinsonian medication.

• Medicines of this type (antipsychotics) may cause a combination of fever, muscle rigidity, and autonomic symptoms such as sweating or rapid breathing (called "neuroleptic malignant syndrome"). If this occurs, treatment must be stopped and you should contact your doctor immediately.

• If you have diabetes mellitus (high blood sugar (glucose) levels) or risk factors for diabetes.

• If you are an elderly patient with psychosis associated with dementia being treated with antipsychotics (possible increased risk of death).

• If you are a patient with risk factors for thromboembolism (blockage of a blood vessel by a blood clot) (see “Possible side effects”). Cases of venous thromboembolism, sometimes fatal, have been reported with antipsychotic medicines.

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

• In patients with a history of glaucoma, ileus, congenital gastrointestinal stenosis, urinary retention, or prostate hyperplasia, caution should be exercised.

• If you are a patient with high blood pressure, especially in the elderly population, due to the risk of hypertensive crisis (acute rise in blood pressure).

• In patients with personal or family history of breast cancer, sulpiride should be used with caution and patients should be monitored during treatment.

Children and adolescents

Administration of this medicine is not recommended in children, as sulpiride has not been thoroughly studied in this patient group.

Use of Dogmatil Fuerte with other medicines

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

Do not take Dogmatil if you are being treated with:

• Levodopa (a medicine for Parkinson's disease), antiparkinsonian medicines (including ropinirol) (see “Do not take Dogmatil Fuerte”).

Inform your doctor if you are currently being treated with any of the following medicines:

Associations not recommended:

• Medicines containing alcohol.

• Antiarrhythmic agents (medicines that regulate heart rhythm) such as quinidine, disopyramide, amiodarone, and sotalol.

• Cisapride (a medicine for gastrointestinal motility disorders).

• Thioridazine (a medicine for psychiatric disorders).

• Intravenous erythromycin (an antibiotic).

• Intravenous vincamine (a medicine that improves cerebral blood circulation).

• Halofantrine (a medicine for malaria).

• Pentamidine (a medicine for certain infectious diseases).

• Sparfloxacin (an antibiotic).

• Methadone (a medicine for pain relief).

• Pimozide, haloperidol, and sultopride (medicines for psychiatric disorders).

• Bepridil (a medicine for angina pectoris).

• Imipramine-type antidepressants (medicines for treating depression).

• Medicines that cause slowing of the heart rate, such as diltiazem and verapamil, clonidine, guanfacine, and cardiac glycosides.

• Medicines that cause a decrease in potassium levels: hypokalaemic diuretics, stimulant laxatives, intravenous amphotericin B (an antibiotic), glucocorticoids, tetracosactide.

Associations to be considered:

• Central nervous system depressants including narcotics, analgesics, sedative H1 antihistamines, barbiturates, benzodiazepines and other anxiolytic drugs, clonidine and its derivatives.

• Lithium salts (medicines for the treatment of manic-depressive disorder, also known as bipolar affective disorder).

• Sucralfate (a medicine for treating and preventing duodenal ulcer). (See “3. How to take Dogmatil Fuerte”).

• Antacids. (See “3. How to take Dogmatil Fuerte”).

• Medicines for lowering blood pressure.

Taking Dogmatil Fuerte with food, drinks and alcohol

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

You should not drink grapefruit juice during treatment with Dogmatil Fuerte.

Pregnancy, breastfeeding and fertility

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

Pregnancy

Use of Dogmatil during pregnancy is not recommended, and in women of childbearing age who are not using an effective contraceptive method.

If you take Dogmatil during the last three months of pregnancy, your baby may experience restlessness, increased muscle tone, involuntary body tremors, drowsiness, breathing difficulties, or feeding problems. Consult your doctor if your baby shows any of these symptoms.

Breastfeeding

You must not breastfeed while being treated with Dogmatil. Consult your doctor about the best way to feed your baby if you are taking Dogmatil.

Driving and using machines

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

Even when used according to recommendations, this medicine may cause sedation, which may affect your ability to drive and use machines.

Dogmatil Fuerte contains lactose

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

3. How to take Dogmatil Fuerte

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

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

The route of administration is oral. Swallow the tablet with a little water.

The recommended dose varies depending on the condition you have:

• Depression and vertigo: the recommended dose is 150–300 mg/day.

• Acute and chronic psychoses: 200–1600 mg/day of sulpiride (1–8 tablets/day).

In these cases, treatment should be initiated with Dogmatil 50 mg/ml injectable solution, administered intramuscularly, during the first two weeks.

The daily dose should be divided into three doses taken throughout the day, preferably before meals.

Sulpiride must be taken at least two hours before antacids and sucralfate.

• Patients with renal impairment (impaired kidney function): your doctor will adjust the dose.
• Elderly patients: your doctor will adjust the dose. These patients may require a lower initial dose and a more gradual dose adjustment.

If you take more Dogmatil Fuerte than you should

If you have taken more Dogmatil Fuerte than you should, contact your doctor or pharmacist immediately or go to the nearest hospital.

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.

Fatal outcomes have been reported, mainly when combined with other medicines acting on the central nervous system (psychotropic agents).

There is no specific antidote for sulpiride; treatment is symptomatic only, 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 function 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: 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Dogmatil Fuerte

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

4. Possible adverse effects

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

The adverse effects associated with Dogmatil are:

Blood and lymphatic system disorders

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

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

Immune system disorders

Frequency not known: anaphylactic reactions (severe allergic reaction): urticaria, difficulty breathing (dyspnea), decreased blood pressure, and anaphylactic shock (a 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.

Metabolism and nutrition disorders

Frequency not known: decreased sodium levels in the blood (hyponatremia), a condition known as “syndrome of inappropriate antidiuretic hormone secretion (SIADH)”.

Psychiatric disorders

Common (may affect up to 1 in 10 patients): insomnia (difficulty falling or staying asleep).

Frequency not known: confusion.

Nervous system disorders

Common (may affect up to 1 in 10 patients): sedation or somnolence, extrapyramidal disorder (these symptoms are usually reversible if antiparkinsonian medication is administered), parkinsonism, tremor, akathisia (inability of the person 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 1,000 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, which may even lead to death, lack of or reduced voluntary 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 1,000 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: venous thromboembolism (a condition characterized by blood clotting in the veins), pulmonary embolism, deep vein thrombosis, increased blood pressure (see “Warnings and precautions”).

Respiratory, thoracic and mediastinal disorders

Frequency not known: aspiration pneumonia (mainly in association with other central nervous system depressants).

Gastrointestinal disorders

Common (may affect up to 1 in 10 patients): constipation.

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.

Frequency not known: liver damage (hepatocellular, cholestatic or mixed hepatic damage).

Skin and subcutaneous tissue disorders

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

Musculoskeletal and connective tissue disorders

Frequency not known: torticollis, trismus (jaw muscle contracture), muscle breakdown leading to kidney damage (rhabdomyolysis).

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, milk secretion from the breasts outside the pregnancy period.

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.

Frequency not known: fever.

Investigations

Frequency not known: increased blood levels of creatine phosphokinase (a marker of muscle damage).

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dogmatil Fuerte

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Dogmatil Fuerte

• The active substance is sulpiride. Each tablet contains 200 mg of sulpiride.
• The other components are: monohydrate lactose, gluten-free potato starch, methylcellulose, colloidal silica, talc, magnesium stearate.

Appearance of the medicinal product and contents of the pack

Tablets are white to off-white, cross-scored on one side and marked "SPD200" on the other. The tablets may be divided into halves and quarters.

Dogmatil Fuerte 200 mg tablets are supplied in packs of 36 tablets in PVC/Alu blister packs.

Other presentations:

• Dogmatil 50 mg/ml injectable solution: Pack containing 12 ampoules of 2 ml. Clear type I glass ampoules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69,

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Spain

Date of the most recent revision of this leaflet:

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) http://www.aemps.gob.es/