Dopegit

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Dopegyt, 250 mg, tablets

Methyldopa

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Dopegyt and what is it used for
• 2. Important information before taking Dopegyt
• 3. How to take Dopegyt
• 4. Possible side effects
• 5. How to store Dopegyt
• 6. Contents of the packaging and other information

1. What is Dopegyt and what is it used for

The active substance of Dopegyt is methyldopa, which is a centrally acting antihypertensive agent.
Dopegyt is used to treat high blood pressure.

2. Important information before taking Dopegyt

When not to take Dopegyt

• if the patient is allergic to methyldopa or any of the other ingredients of this medicine (listed in section 6),
• if the patient has active liver disease (e.g., acute hepatitis, liver cirrhosis),
• if the patient has a history of liver disease induced by methyldopa,
• if the patient is taking MAO inhibitors (e.g., moklobemide) used to treat depression, Parkinson's disease, or Alzheimer's disease (e.g., selegiline),
• if the patient has depression,
• if the patient has a pheochromocytoma (a special type of adrenal gland tumor).

Warnings and precautions

Before starting treatment with Dopegyt, you should discuss it with your doctor or pharmacist.

• In case of a history of liver disease, abnormal liver test results, or kidney disease, you should inform your doctor, as a dose reduction may be necessary in such cases.
• In case of a diagnosed special metabolic disorder (porphyria) in yourself or a close relative, you should inform your doctor, as the use of methyldopa requires special caution in such cases.
• During treatment, especially if doses above 1000 mg are used and mainly after 6-12 months of therapy, laboratory abnormalities (positive direct Coombs test result) may occur in 10-20% of patients. In less than 5% of such patients, hemolytic anemia (anemia caused by premature destruction of red blood cells) may develop. Therefore, before starting treatment and then every 6-12 months during treatment, blood morphology and direct Coombs test should be checked. Symptoms of anemia may include: pale skin, weakness, jaundice. If such symptoms occur, you should immediately stop taking this medicine and consult a doctor. If the cause of these symptoms is methyldopa, you should never take Dopegyt again.
• As an allergic reaction to methyldopa, liver cell damage may occur, sometimes severe. Therefore, during the first 6-12 weeks of treatment, liver function tests should be performed with the frequency recommended by the doctor, and in case of fever of unknown origin or jaundice, treatment should be stopped immediately. If the cause of liver damage is methyldopa, you should never take Dopegyt again.
• Very rarely, during treatment, hematopoietic disorders (decrease in white blood cell and platelet count) may occur. If oral ulcers, sore throat, small red spots on the body, black stools, or blood in the urine occur, you should stop taking this medicine and consult a doctor. These symptoms usually resolve on their own after discontinuation of the medicine.
• In some patients, swelling and weight gain may occur. These symptoms usually resolve after administration of 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 discontinuation of the medicine may be necessary.
• In case of dialysis treatment, an additional dose of the medicine may be necessary after dialysis, as methyldopa is removed from the body during dialysis.
• You should inform your doctor about treatment with Dopegyt before blood transfusion, general anesthesia, and before diagnostic tests for a special type of adrenal gland tumor (pheochromocytoma).
• You should consult a doctor in case of cerebral vessel damage or disease and occurrence of involuntary movements, as discontinuation of Dopegyt may be necessary.

Dopegyt and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Dopegyt should not be taken at the same time as MAO inhibitors(e.g., moklobemide used to treat depression or selegiline used to treat Parkinson's disease or Alzheimer's disease).
Some medicines may weakenthe antihypertensive effect of Dopegyt, and their concurrent use requires special caution and careful medical monitoring:

• medicines containing adrenaline, ephedrine, pseudoephedrine used to treat colds, coughs, and asthma,
• certain medicines used to treat depression (e.g., imipramine, amitriptyline),
• medicines used to treat certain mental illnesses (e.g., chlorpromazine, trifluoperazine),
• oral iron supplements (iron gluconate and iron sulfate reduce methyldopa absorption),
• medicines used to relieve fever and pain (e.g., piroxicam, diclofenac, naproxen),
• estrogens (preparations containing female sex hormones).

Concurrent use of Dopegyt and the following medicines may increasethe antihypertensive effect of Dopegyt:

• other antihypertensive medicines,
• general anesthetics.

Concurrent use of methyldopa and the following medicines may changetheir therapeutic effect, and therefore, their concurrent use requires special caution:

• lithium (used to treat psychiatric disorders),
• levodopa (used to treat Parkinson's disease),
• alcohol and medicines used to treat anxiety, insomnia, or allergies,
• anticoagulant medicines (e.g., acenocoumarol); concurrent use of these medicines increases the risk of bleeding,
• bromocriptine (reduces prolactin and growth hormone release in the body, used to treat diseases where reduced levels of these substances are necessary),
• haloperidol (used to treat mental disorders).

Dopegyt with food and alcohol

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

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, you should consult a doctor before taking this medicine.
Although no clear teratogenic effect has been reported, fetal damage cannot be ruled out.
Therefore, Dopegyt should not be taken during pregnancy, unless the expected benefits outweigh the potential risk.
Methyldopa passes into breast milk, and therefore, breastfeeding women should not take this medicine unless advised by a doctor after careful evaluation of the benefits and risks.

Driving and operating machinery

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

Dopegyt contains sodium

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

3. How to take Dopegyt

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Tablets can be taken before or after meals.
The recommended dose is
Adults
The recommended initial dose over 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 methyldopa dose.
Elderly patients
In elderly patients, 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.
Use in children and adolescents
In children and adolescents, the recommended initial dose 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 a satisfactory 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.
Use in patients with renal impairment
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 methyldopa 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.

Using a higher than recommended dose of Dopegyt

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

Missing a dose of 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 them at risk of overdose.

Stopping treatment with Dopegyt

Usually, blood pressure returns to pre-treatment levels within 48 hours after stopping treatment without rebound effect; however, treatment should not be stopped prematurely, as blood pressure may rise.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Dopegyt can cause side effects, although not everybody gets them.
At the beginning of treatment and during dose increase, transient sedative effects, transient headache, or weakness may occur.
In case of 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 then stop using the preparation and consult a doctor for advice on further treatment. If the hives are very severe and occur all over the body, you should immediately consult a doctor to avoid significant complications.

In case of the following symptoms, you should immediately contact a doctor:

• pale skin, weakness,
• infection symptoms: fever, sore throat, oral 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) occurring more frequently and lasting 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 and lymphatic system disorders, may suggest hypersensitivity reactions or heart failure, and may be life-threatening. Serious consequences can be avoided if the doctor's instructions are followed, prescribed laboratory tests are performed, and a doctor is consulted immediately if any of the above symptoms occur.

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

• positive Coombs test (blood test detecting 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 (tremor, gait with short, accelerated steps, muscle weakness),
• pancreatitis,
• hepatitis (liver inflammation),
• chest pain occurring more frequently and lasting 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 secretion 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 disturbances, 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,
• decrease in blood pressure when standing up, causing dizziness, drowsiness, or fainting,
• nasal congestion,
• colitis,
• vomiting,
• diarrhea,
• salivary gland inflammation,
• mouth or tongue pain,
• nausea,
• constipation,
• abdominal pain,
• bloating,
• dry mouth,
• abnormal liver function test results,
• eczema or lichen,
• mild joint pain with or without joint swelling,
• muscle pain,
• impotence,
• ejaculation disorders,
• increased urea levels in the blood.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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. How to store Dopegyt

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

6. Contents of the packaging and other information

What Dopegyt contains

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

What Dopegyt looks like and contents of the packaging

White or off-white, flat, biconvex tablets with beveled edges, with the inscription Dopegyt on one side.
50 tablets in an orange glass bottle with a PE cap and a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

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

Manufacturer:

Egis Pharmaceuticals PLC
Mátyás király u. 65, 9900 Körmend, Hungary

Parallel importer:

Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Český Těšín
Czech Republic

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Euceryna Laboratory Pharmaceutical COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Romanian marketing authorization number: 9698/2017/01

Parallel import authorization number: 70/22 Date of leaflet approval: 02.02.2022

[Information about the registered trademark]