Dopegyt

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Dopegyt is and what it is 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 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, liver cirrhosis),
• if the patient has a history of methyldopa-induced liver disease,
• if the patient is concurrently taking medicines called MAO inhibitors used in the treatment of depression (e.g. moclobemide), Parkinson's disease or Alzheimer's disease (e.g. selegiline),
• if the patient has been diagnosed with depression,
• if the patient has a chromaffin tumour (a specific type of adrenal gland tumour).

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

• If you have a history of liver disease, abnormal liver function tests, or kidney disease, inform your doctor, as a dose reduction may be necessary in such cases.
• If you or a close family member has been diagnosed with a specific metabolic disorder (hepatic porphyria), inform your doctor, as methyldopa should be used with particular caution in such cases.
• During treatment – especially when doses above 1000 mg are used and particularly after 6–12 months of therapy – laboratory abnormalities (positive direct Coombs test) may occur in 10–20% of patients. Less than 5% of these 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 the 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 the doctor and in every case of unexplained fever or jaundice. If fever, jaundice or worsening of liver function test results occur, treatment must be discontinued 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, discontinue 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. Consult your 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 patients 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 (chromaffin tumour).
• Consult your doctor if you have vascular brain disorders or involuntary movements, 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 used together with MAO inhibitors (e.g. moclobemide used in the treatment of depression or selegiline used in the treatment of 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 in the treatment of colds, cough, and asthma,
• certain medicines used in depression (e.g. imipramine, amitriptyline),
• medicines used in the treatment of certain psychiatric disorders (e.g. chlorpromazine, trifluoperazine),
• oral iron supplements (ferrous gluconate and ferrous sulphate reduce methyldopa absorption),
• 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 antihypertensive medicines,
• general anaesthetic agents.

Concomitant use of methyldopa and the following medicines may mutually alter their therapeutic effects, and therefore 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 the treatment of conditions 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 may be taken either before or after meals.

Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected, or if pregnancy is planned, 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 breastfeeding women should not use this medicine unless recommended by a doctor after careful assessment of benefits and risks.

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

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

3. How to use Dopegyt

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
The tablets may be taken before or after meals.
Recommended dosage:
Adults
The recommended initial dose for the first two days is 250 mg 2-3 times daily.
The physician may gradually increase or decrease the initial dose—depending on the degree of
blood pressure reduction—at intervals of no 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 physician may then
decide whether it is necessary 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. The physician 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, given
in 2–4 divided doses. If necessary, the physician may gradually increase the daily dose at intervals
of no less than two days until the appropriate therapeutic response 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 physician will adjust the dose according to the degree of renal impairment. In cases of
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 supplemental dose of 250 mg is recommended after
dialysis treatment.
If you feel that the effect of Dopegyt is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Dopegyt
If a higher than recommended dose of Dopegyt is taken, contact a doctor immediately or go to the
emergency room of the nearest hospital. Bring this leaflet and any remaining tablets to show the
doctor.
Symptoms of overdose: low blood pressure, marked drowsiness, weakness, slow pulse, dizziness,
constipation, abdominal bloating, gas, diarrhea, nausea, vomiting.
Missed dose of Dopegyt
Do not take a double dose to make up for a missed dose. Taking a double dose will not compensate
for the missed dose and may expose the patient to the risk of overdose.
Stopping Dopegyt treatment
Usually, blood pressure returns within 48 hours after stopping treatment to the level observed before
treatment began, 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 experiences 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 room 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 case, discontinue the medicine immediately and consult your doctor for advice regarding further treatment. If urticaria is severe and occurs all over the body, seek immediate medical attention to avoid serious complications.

If any of the following symptoms occur, contact your doctor immediately:

• pale skin, weakness,
• signs of infection: fever, sore throat, mouth ulcers,
• small red hemorrhagic spots all over the body, tarry stools or blood in urine,
• unusual or prolonged bleeding,
• yellowing 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,
• blisters on the skin, peeling skin.

These symptoms may indicate blood and lymphatic system disorders, hypersensitivity reactions or heart failure, and may be serious. Serious consequences can be avoided provided you follow your doctor's advice, undergo recommended laboratory tests, and contact your doctor 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 Warnings and precautions).

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

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

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

• vasculitis (inflammation of blood vessels),
• 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,
• milk discharge from mammary glands outside of breastfeeding period,
• absence of menstruation,
• facial nerve paralysis (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 psychosis and depression,
• dizziness,
• numbness or tingling,
• decreased libido,
• low blood pressure and slow heart rate, possibly leading to fainting,
• drop in blood pressure upon standing, causing dizziness, lightheadedness or fainting,
• nasal mucosal congestion,
• colitis (inflammation of the large intestine),
• vomiting,
• diarrhea,
• sialadenitis (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 joint swelling,
• muscle pain,
• impotence,
• ejaculation disorders,
• increased blood urea nitrogen concentration.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 this medicine.

5. How to store Dopegyt

Keep this medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

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

What Dopegyt looks like and contents of the pack
White or greyish-white, round, flat tablet with bevelled edges and an engraved circular mark reading DOPEGYT on one side. The tablet is free from physical defects and mechanical contamination.
50 tablets in a brown glass bottle with an LDPE screw cap, a tamper-evident seal, and a shock absorber, packed in a cardboard box.

For further detailed information, please contact the responsible party or the parallel importer.

Responsible party in Lithuania, country of export:
Egis Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest
Hungary

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

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation number in Lithuania, country of export: LT/1/95/0888/001
Parallel import authorisation number: 214/24