Dopegit

HOJA DE INSTRUCCIONES DEL PAQUETE: INFORMACIÓN PARA EL USUARIO

Atención! Conservar la hoja de instrucciones, la información en el embalaje primario en idioma extranjero

Dopegyt

250 mg, tabletas

Metildopa

Es importante leer atentamente el contenido de la hoja de instrucciones antes de tomar el medicamento, ya que contiene información importante para el paciente.

• Debe conservar esta hoja de instrucciones para poder volver a leerla si es necesario.
• En caso de dudas, debe consultar a un médico, farmacéutico o enfermera.
• Este medicamento ha sido recetado específicamente para usted. No debe dárselo a otros. El medicamento puede ser perjudicial para otra persona, incluso si los síntomas de su enfermedad son los mismos.
• Si el paciente experimenta algún efecto adverso, incluyendo cualquier efecto adverso no mencionado en esta hoja de instrucciones, debe informar a su médico o farmacéutico. Véase el punto 4.

Índice de la hoja de instrucciones:

• 1. Qué es Dopegyt y para qué se utiliza
• 2. Información importante antes de tomar Dopegyt
• 3. Cómo tomar Dopegyt
• 4. Posibles efectos adversos
• 5. Cómo conservar Dopegyt
• 6. Contenido del paquete y otra información

1. Qué es Dopegyt y para qué se utiliza

El principio activo de Dopegyt es metildopa, que es un medicamento que actúa en el centro para reducir la presión arterial. Dopegyt se utiliza para tratar la hipertensión arterial.

2. Información importante antes de tomar Dopegyt

Cuándo no tomar Dopegyt

• si el paciente es alérgico a la metildopa o a cualquier otro componente de este medicamento (enumerado en el punto 6),
• si el paciente tiene enfermedad hepática activa (por ejemplo, hepatitis aguda, cirrosis hepática),
• si el paciente ha tenido enfermedad hepática inducida por metildopa en el pasado,
• si el paciente está tomando inhibidores de la MAO (por ejemplo, moklobemida) para tratar la depresión, la enfermedad de Parkinson o la enfermedad de Alzheimer,
• si el paciente tiene depresión,
• si el paciente tiene un tumor de feocromocitoma (un tipo especial de tumor suprarrenal).

Precauciones y advertencias

Antes de comenzar a tomar Dopegyt, debe consultar a un médico o farmacéutico.

• Si el paciente tiene enfermedad hepática en el pasado, resultados anormales de pruebas hepáticas o enfermedad renal, debe informar a su médico, ya que puede ser necesario reducir la dosis.
• Si el paciente tiene una enfermedad metabólica especial (porfiria hepática) en sí mismo o en un familiar cercano, debe informar a su médico, ya que la metildopa requiere precaución especial en este caso.
• durante el tratamiento, especialmente si se toman dosis superiores a 1000 mg y sobre todo después de 6-12 meses de terapia, pueden aparecer anormalidades en las pruebas de laboratorio (resultado positivo de la prueba de Coombs directa) en un 10-20% de los pacientes. En menos del 5% de estos pacientes, puede desarrollarse anemia hemolítica (anemia causada por la destrucción prematura de glóbulos rojos). Por lo tanto, antes de comenzar el tratamiento y luego cada 6-12 meses durante el tratamiento, debe realizarse un análisis de sangre y una prueba de Coombs directa. Los síntomas de anemia pueden ser: palidez de la piel, debilidad, ictericia. Si aparecen estos síntomas, debe dejar de tomar este medicamento y consultar a un médico. Si la causa de estos síntomas es la metildopa, nunca debe volver a tomar Dopegyt.
• Como reacción de hipersensibilidad a la metildopa, puede ocurrir daño hepático, incluso grave. Por lo tanto, durante las primeras 6-12 semanas de tratamiento, debe realizarse un análisis de función hepática con la frecuencia recomendada por el médico y en caso de fiebre de origen desconocido o ictericia. Si aparecen fiebre, ictericia o empeoramiento de los resultados de las pruebas hepáticas, debe dejar de tomar el medicamento de inmediato. Si la causa del daño hepático es la metildopa, nunca debe volver a tomar Dopegyt.
• Very rarely, during treatment, may appear hematopoietic disorders (decrease in white blood cells and platelets). If there are mouth ulcers, sore throat, small red spots on the body, black stools, blood in the urine, unusual or difficult to control bleeding, you should stop taking this medicine and consult a doctor. These symptoms usually disappear on their own after stopping the medicine.
• Some patients may experience swelling and weight gain. These symptoms usually disappear after taking diuretics. You should consult a doctor if these symptoms worsen despite diuretic treatment or if shortness of breath (difficulty breathing) or easy fatigue occurs, as it may be necessary to stop the medicine.
• In case of dialysis treatment, it may be necessary to administer an additional dose of the medicine after dialysis, since metildopa is removed from the body during dialysis.
• You should inform your doctor about Dopegyt treatment before blood transfusion, general anesthesia, and before diagnostic tests for a special type of adrenal gland tumor (pheochromocytoma).
• You should consult a doctor if you have cerebral vessel damage or disease and involuntary movements, as it may be necessary to stop Dopegyt.

Dopegyt y otros medicamentos

Debe informar a su médico o farmacéutico sobre todos los medicamentos que esté tomando actualmente o recientemente, así como sobre los medicamentos que planea tomar.
No debe tomar Dopegyt al mismo tiempo que inhibidores de la MAO(por ejemplo, moklobemida para tratar la depresión o selegilina para tratar la enfermedad de Parkinson o la enfermedad de Alzheimer).
Algunos medicamentos pueden reducirel efecto hipotensor de Dopegyt y su uso concomitante requiere precaución especial y control médico cuidadoso:

• medicamentos que contienen adrenalina, efedrina, pseudoefedrina para tratar resfriados, tos y asma,
• algunos medicamentos para tratar la depresión (por ejemplo, imipramina, amitriptilina),
• medicamentos para tratar algunas enfermedades psiquiátricas (por ejemplo, clorpromazina, trifluoperazina),
• suplementos orales de hierro (gluconato ferroso y sulfato ferroso reducen la absorción de metildopa),
• medicamentos para aliviar la fiebre y el dolor (por ejemplo, piroxicam, diclofenaco, naproxeno),
• estrógenos (preparados que contienen hormonas femeninas).

La administración concomitante de Dopegyt y los siguientes medicamentos puede aumentarel efecto de reducción de la presión arterial:

• otros medicamentos para reducir la presión arterial,
• preparados para anestesia general.

La administración concomitante de metildopa y los siguientes medicamentos puede alterarsu efecto terapéutico y, por lo tanto, su uso concomitante requiere precaución especial:

• litio (utilizado para tratar enfermedades psiquiátricas),
• levodopa (utilizada para tratar la enfermedad de Parkinson),
• alcohol y medicamentos para tratar la ansiedad, la insomnio o la alergia,
• medicamentos anticoagulantes (por ejemplo, acenocoumarol); la administración concomitante de estos medicamentos aumenta el riesgo de sangrado,
• bromocriptina (reduce la liberación de prolactina y hormona de crecimiento en el cuerpo, utilizada para tratar enfermedades en las que se requiere una menor cantidad de estas sustancias),
• haloperidol (utilizado para tratar trastornos psiquiátricos).

Dopegyt con alimentos y alcohol

During the treatment, you should avoid consuming alcoholic beverages. The tablets can be taken before or after meals.

Embarazo y lactancia

During pregnancy and breastfeeding, or if you suspect that you are pregnant, or if you plan to become pregnant, you should consult a doctor before taking this medicine.
Although no teratogenic effect has been reported, it cannot be ruled out that the fetus may be harmed.
Therefore, Dopegyt should not be taken during pregnancy, unless the expected benefits outweigh the potential risk.
Metildopa passes into breast milk, and therefore, breastfeeding women should not take this medicine unless their doctor recommends it after carefully evaluating the benefits and risks.

Conducción de vehículos y uso de máquinas

This medicine may cause transient sedative effects, especially at the beginning of treatment and during dose increases. If sedative effects occur, you should not perform activities that require attention, such as driving or operating machines.

Dopegyt contiene sodio

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. Cómo tomar Dopegyt

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.
The tablets can be taken before or after meals.
The recommended dose is

Adults
The recommended initial dose for the first two days is 250 mg 2-3 times a day.
The doctor may gradually increase or decrease the initial dose - depending on the degree of blood pressure reduction - at intervals of not less than two days. Initially, it is recommended to increase the evening dose.
The recommended maintenance dose is 500-2000 mg per day, divided into 2-4 doses. The maximum daily dose is 3 g.
After 2 or 3 months of treatment, tolerance to the medicine may develop. The doctor may then decide to add a diuretic or increase the dose of metildopa.
Patientes mayores
Treatment should be started with the lowest possible dose, not exceeding 250 mg per day. The doctor may increase or decrease the dose, depending on the degree of blood pressure reduction, at intervals of not less than two days, up to a maximum dose of 2000 mg, which should not be exceeded.
Uso en niños y adolescentes
The recommended initial dose for children and adolescents is 10 mg/kg body weight per day, given in 2-4 divided doses.
If necessary, the doctor may gradually increase the daily dose at intervals of not less than two days until the desired response to treatment is achieved. The maximum dose is 65 mg/kg body weight per day, up to a maximum dose of 3 g per day.
Uso en pacientes con trastornos renales
The doctor will reduce the dose according to the degree of renal impairment. In case of mild renal impairment, it is recommended to extend the interval between doses to 8 hours, in moderate renal impairment to 8-12 hours, and in severe renal impairment to 12-14 hours.
Since metildopa is removed from the body during dialysis, a supplementary dose of 250 mg is recommended after dialysis treatment.
If you feel that the effect of Dopegyt is too strong or too weak, you should talk to your doctor or pharmacist.

Uso de una dosis mayor que la recomendada de Dopegyt

In case of taking a higher dose than recommended of Dopegyt, you should contact a doctor or go to the emergency room of the nearest hospital immediately. You should bring this leaflet and the remaining tablets to show them to the doctor.
Symptoms of overdose: low blood pressure, significant drowsiness, weakness, slow heart rate, dizziness, constipation, abdominal bloating, gas, diarrhea, nausea, vomiting.

Omision de la dosis de Dopegyt

You should not take a double dose to make up for a missed dose. Taking a double dose by the patient will not make up for the missed dose and may put you at risk of overdose.

Interrupción del tratamiento con Dopegyt

Usually, blood pressure returns to pre-treatment levels within 48 hours of stopping treatment without rebound effect, but treatment should not be stopped prematurely, as blood pressure may rise.
If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Posibles efectos adversos

Like all medicines, this medicine can cause side effects, although not everybody gets them.
At the beginning of treatment and during dose increases, transient sedative effects, transient headache, or weakness may occur.
If you experience any of the following symptoms, you should stop taking Dopegyt and contact a doctor or go to the emergency room of the nearest hospital:

• swelling of the lips or throat causing difficulty swallowing or breathing,
• anaphylaxis. These are very serious but very rare side effects. If they occur, they may indicate a severe allergic reaction to Dopegyt. Immediate medical attention or hospitalization may be necessary. Hives may also be a sign of an allergic reaction. You should stop taking the medicine and consult a doctor for advice on further treatment. If the hives are very severe and occur all over the body, you should go to the doctor immediately to avoid serious complications.

If you experience any of the following symptoms, you should contact a doctor immediately:

• pale skin, weakness,
• infection symptoms: fever, sore throat, mouth ulcers,
• small red spots on the body, black stools, or blood in the urine,
• unusual or prolonged bleeding,
• yellowing of the eyes and skin, dark urine,
• extreme fatigue,
• chest pain (angina pectoris) that occurs more frequently and lasts longer than usual,
• shortness of breath (difficulty breathing), swelling of the legs, weight gain,
• blisters on the skin, peeling skin. These symptoms may indicate blood disorders and lymphatic system disorders, may suggest hypersensitivity reactions or heart failure, and may be serious. Serious consequences can be avoided if you follow your doctor's instructions, undergo the prescribed laboratory tests, and immediately consult a doctor if you experience any of these symptoms.

The following side effects may occur:
Very common (may affect more than 1 in 10 people):

• positive Coombs test (blood test that detects the causes of anemia) (see section warnings and precautions).

Very rare (may affect up to 1 in 10,000 people):

• myocarditis,
• pericarditis (inflammation of the tissue surrounding the heart),
• parkinsonism (tremors, short, rapid steps, muscle weakness),
• pancreatitis,
• hepatitis (inflammation of the liver),
• chest pain (angina pectoris) that occurs more frequently and lasts longer than usual (worsening of angina pectoris),
• slow heart rate,
• heart failure,
• swelling,
• weight gain.

Frequency not known (frequency cannot be estimated from the available data):

• vasculitis,
• a disorder that can affect various systems, often characterized by skin inflammation (e.g., butterfly-shaped rash),
• increased prolactin levels in the blood,
• breast enlargement in men,
• milk leakage from the breasts at a time other than breastfeeding,
• absence of menstruation,
• facial nerve palsy (weakness or paralysis of the facial muscles),
• psychiatric disorders,
• involuntary movements,
• symptoms of cerebral circulation disorders (difficulty speaking, vision disorders, weakness of the arms and legs, especially on one side of the body),
• psychiatric disorders, such as nightmares,
• usually transient mild psychosis and depression,
• dizziness,
• numbness or tingling,
• decreased libido,
• low blood pressure and slow heart rate, which can lead to fainting,
• drop in blood pressure when standing up, causing dizziness, drowsiness, or fainting,
• nasal congestion,
• colitis,
• vomiting,
• diarrhea,
• parotitis (inflammation of the salivary glands),
• pain or black tongue,
• nausea,
• constipation,
• abdominal pain,
• bloating,
• dry mouth,
• abnormal liver function test results,
• eczema or lichen,
• mild joint pain with or without swelling,
• muscle pain,
• impotence,
• ejaculation disorders,
• increased urea levels in the blood.

Notificación de efectos adversos

If you experience any side effects, including any side effects not mentioned in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Agency for the Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. Cómo conservar Dopegyt

The medicine should be stored in a place that is out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contenido del paquete y otra información

Qué contiene Dopegyt

The active substance of Dopegyt is metildopa. Each tablet contains 250 mg of metildopa.
The other ingredients are: ethylcellulose N-100, magnesium stearate, cornstarch, stearic acid, sodium carboxymethylcellulose (type A), talc.

Cómo se presenta Dopegyt y contenido del paquete

White or grayish-white, round, flat tablet with beveled edges and a round engraving DOPEGYT on one side. The tablet is free from physical defects and mechanical impurities.
50 tablets in a brown glass bottle with an LDPE cap and a guarantee seal and a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Titular de la autorización de comercialización en Lituania, país de exportación:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest
Hungary

Fabricante:

Egis Pharmaceuticals PLC
Mátyás király út 65.
H-9900 Körmend
Hungary

Importador paralelo:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Reempaquetado por:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Número de autorización de comercialización en Lituania, país de exportación: LT/1/95/0888/001
Número de autorización de importación paralela: 214/24

Fecha de aprobación de la hoja de instrucciones: 27.05.2024

[Information about the trademark]