Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Dopegyt, 250 mg, tablets
Methyldopum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Dopegyt is and what it is used for
Important information before taking Dopegyt
How to take Dopegyt
Possible side effects
How to store Dopegyt
Contents of the pack and other information

1. What Dopegyt is and what it is used for

The active substance in Dopegyt is methyldopa, which is a centrally-acting antihypertensive agent.
Dopegyt is used in the treatment of hypertension.

2. Important information before using Dopegyt

When not to use 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, cirrhosis of the liver),
if the patient has a history of methyldopa-induced liver disease,
if the patient is taking medicines called MAO inhibitors used to treat depression (e.g. moklobemide), Parkinson's disease or Alzheimer's disease (e.g. selegiline),
if the patient has depression,
if the patient has a phaeochromocytoma (a specific type of adrenal gland tumour).

Warnings and precautions
Before starting treatment with Dopegyt, discuss this with your doctor or pharmacist.

Inform your doctor if you have had liver disease in the past, abnormal liver function tests, or kidney disease, as dose reduction may be necessary in such cases.
Inform your doctor if you or a close relative has been diagnosed with a specific metabolic disorder (hepatic porphyria), as special caution is required when using methyldopa.
During treatment – particularly at doses above 1000 mg and especially after 6-12 months of therapy – laboratory abnormalities may occur in 10-20% of patients (positive direct Coombs test). Less than 5% of such patients may develop haemolytic anaemia (anaemia caused by premature destruction of red blood cells). Therefore, blood count and direct Coombs test should be checked before starting treatment and then every 6-12 months during treatment. Symptoms of anaemia may include: pale skin, weakness, jaundice. If such symptoms occur, discontinue this medicine immediately and consult your doctor. If methyldopa is the cause of these symptoms, Dopegyt must never be used again.
As a hypersensitivity reaction to methyldopa, liver cell damage may occur, sometimes even severe. Therefore, during the first 6-12 weeks of treatment, liver function tests should be performed at the frequency recommended by your doctor and in every case of unexplained fever or jaundice. If fever, jaundice or worsening of liver function test results occur, treatment must be stopped immediately. If methyldopa is the cause of liver damage, Dopegyt must never be used again.
Very rarely, haematopoietic disorders (reduction in white blood cells and platelets) may occur during treatment. If oral ulcers, sore throat, small red haemorrhagic spots on the body, tarry stools, blood in urine, or unusual or difficult-to-control bleeding occur, stop taking this medicine and consult your doctor. These symptoms usually resolve spontaneously after discontinuation of the medicine.
Some patients may experience oedema and weight gain. These symptoms usually resolve with diuretic treatment. Contact your doctor if these symptoms worsen despite diuretic therapy or if shortness of breath (difficulty breathing) or easy fatigability occur, as discontinuation of Dopegyt may be necessary.
If undergoing dialysis, an additional dose of the medicine may be required after dialysis, as methyldopa is removed from the body during dialysis.
Inform your doctor about treatment with Dopegyt before blood transfusion, general anaesthesia, and diagnostic tests for a specific type of adrenal gland tumour (phaeochromocytoma).
Consult your doctor if you have vascular brain damage or disease, or if involuntary movements occur, as discontinuation of Dopegyt may be necessary.

Dopegyt and other medicines
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 must not be taken together with MAO inhibitors (e.g. moklobemide used to treat depression or selegiline used to treat Parkinson's disease or Alzheimer's disease).
Some medicines may weaken the antihypertensive effect of Dopegyt, and their concomitant use requires special caution and careful medical monitoring:

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

Concomitant use of Dopegyt and the following medicines may enhance the blood pressure-lowering effect of the medicine:

other medicines that lower blood pressure,
general anaesthetic agents.

Concomitant use of methyldopa and the following medicines may mutually alter their therapeutic effects, and therefore their concomitant use requires special caution:

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

Dopegyt with food and alcohol
During treatment, consumption of alcoholic beverages should be avoided.
Tablets can be taken either before or after food.

Pregnancy and breastfeeding
During pregnancy, while breastfeeding, if pregnancy is suspected, or if planning a pregnancy, consult your doctor before using this medicine.
Although no clear teratogenic effects have been reported, fetal damage cannot be excluded.
Therefore, Dopegyt should not be used during pregnancy unless the expected benefits outweigh the potential risks.
Methyldopa passes into human milk, and therefore nursing mothers should not use this medicine unless advised by a doctor after careful assessment of benefits and risks.

Driving and using machines
This medicine may cause transient sedative effects, particularly at the beginning of treatment and during dose escalation. If sedative effects occur, do not engage in activities requiring attention, such as driving vehicles or operating machinery.

Dopegyt contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Dopegyt

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Tablets may 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 daily. Your doctor may
gradually increase or decrease the initial dose—depending on the degree of blood pressure reduction—at intervals of no less than two days. Increasing the evening dose is recommended first.
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. Your doctor may then decide
to add a diuretic or increase the dose of methyldopa.
Elderly patients
In elderly patients, treatment should begin with the lowest possible dose, not exceeding 250 mg per day. Your doctor may gradually increase or decrease the dose, depending on the degree of blood pressure reduction, at intervals of no 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, administered in 2–4 divided doses. If necessary, your doctor may gradually increase the daily dose at intervals of no less than two days until the appropriate response to treatment is achieved. The maximum dose is 65 mg/kg body weight per day, up to a maximum of 3 g per day.
Use in patients with renal impairment
The treating doctor will adjust the dose according to the degree of renal impairment. In mild renal impairment, the dosing interval should be extended to 8 hours; in moderate renal impairment, to 8–12 hours; and in severe renal impairment, to 12–14 hours.
Since methyldopa is removed 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 speak to your doctor or pharmacist.
Taking more Dopegyt than recommended
If you take more Dopegyt than recommended, contact your doctor immediately or go to the nearest hospital emergency department. You should bring this leaflet and any remaining tablets with you to show the doctor.
Symptoms of overdose: low blood pressure, marked drowsiness, weakness, slow heart rate, dizziness, constipation, abdominal bloating, flatulence, diarrhoea, nausea, vomiting.
If you forget to take a dose of Dopegyt
Do not take a double dose to make up for a forgotten dose. Taking a double dose will not compensate for the missed dose and may expose you to the risk of overdose.
Stopping Dopegyt
Usually, blood pressure returns within 48 hours after stopping treatment to the level observed before treatment, without a rebound effect. However, treatment should not be stopped prematurely, as blood pressure may rise.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
At the beginning of treatment and during dose escalation, transient sedative effects,
transient headache or weakness may occur.
If any of the following symptoms occur, stop taking Dopegyt and contact your doctor or go to the emergency department of the nearest hospital:

swelling of the lips or throat causing difficulty in swallowing or breathing,
collapse. These are very serious but very rare adverse reactions. If they occur, they may indicate a significant allergic reaction to Dopegyt. Immediate medical assistance or hospitalization may then be necessary. Urticaria may also be a sign of an allergic reaction. In such a case, discontinue the drug immediately and consult a doctor for advice regarding further treatment. If urticaria is very severe and affects the entire body, seek immediate medical attention to avoid serious complications.
If any of the following symptoms occur, contact your doctor immediately:
pallor, weakness,
signs of infection: fever, sore throat, oral mucosal ulcers,
small red hemorrhagic spots all over the body, tarry stools or blood in the urine,
unusual or prolonged bleeding,
yellowish discoloration of the eyes and skin, dark urine,
extreme fatigue,
chest pain (angina) occurring more frequently and lasting longer than usual,
shortness of breath (difficulty breathing), leg swelling, weight gain,
skin blisters, peeling skin. These symptoms may indicate blood and lymphatic system disorders, may suggest hypersensitivity reactions or heart failure, and may be serious. Serious consequences can be avoided provided the doctor's recommendations are followed, recommended laboratory tests are performed, and medical advice is sought immediately if any of the above symptoms occur.

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

positive Coombs test (a blood test detecting causes of anemia) (see section on warnings and precautions).

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

myocarditis,
inflammation of the tissue surrounding the heart (pericarditis),
parkinsonism (tremor, shuffling gait, muscle weakness),
pancreatitis,
hepatitis (liver inflammation),
chest pain occurring more frequently and lasting longer than usual (worsening angina),
bradycardia (slow heart rate),
heart failure,
edema,
weight gain.

Frequency unknown (frequency cannot be estimated from available data):

vasculitis,
a disorder that may affect various systems, often characterized by skin inflammation (e.g., butterfly-shaped rash),
increased prolactin levels in blood,
breast enlargement in males,
galactorrhea (milk discharge from mammary glands outside the breastfeeding period),
absence of menstruation,
facial nerve palsy (weakness or paralysis of muscles on one side of the face),
psychiatric disorders,
involuntary movements,
symptoms of cerebrovascular disorder (difficulty speaking, visual disturbances, weakness in arms and legs, especially on one side of the body),
psychiatric disorders such as nightmares,
usually transient mild psychoses and depression,
dizziness,
numbness or tingling,
decreased libido,
hypotension and bradycardia, possibly leading to syncope,
orthostatic hypotension causing dizziness, lightheadedness or fainting,
nasal mucosal congestion,
colitis,
vomiting,
diarrhea,
sialadenitis (inflammation of the salivary glands),
black or sore tongue,
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 blood urea nitrogen concentration.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products, Office for 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Dopegyt

Keep the medicine out of the sight and reach of children.
Store below 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 stated month.
Medicines must not be disposed of via wastewater or household waste. 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 is methyldopa. Each tablet contains 250 mg of methyldopa.
The other ingredients are: ethylcellulose, magnesium stearate, maize starch, stearic acid,
sodium carboxymethylstarch (type A), talc.

What Dopegyt looks like and contents of the pack
White or greyish-white, flat, biconvex tablets with bevelled edges, marked with "Dopegyt" on one side.
50 tablets in a brown glass bottle with a PE screw cap with tamper-evident seal and a PE liner,
packaged in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Slovakia, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing Authorisation number in Slovakia, country of export: 58/0256/70-S
Parallel Import Authorisation number: 167/24