Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging 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 for future reference.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Dopegyt is and what it is used for
What you need to know 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 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 depression,
if the patient has a pheochromocytoma (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 previously had liver disease, 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 a history of a specific metabolic disorder (hepatic porphyria), as special caution is required when using methyldopa in such cases.
During treatment – particularly at doses above 1000 mg and especially 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 morphology 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, stop taking this medicine immediately and consult your doctor. If these symptoms are caused by methyldopa, Dopegyt must never be used again.
Liver cell damage, sometimes severe, may occur as a hypersensitivity reaction to methyldopa. Therefore, during the first 6-12 weeks of treatment, liver function tests should be performed at the frequency recommended by your doctor, and in any case of unexplained fever or jaundice. If fever, jaundice or worsening of liver function test results occur, treatment must be stopped immediately. If liver damage is caused by methyldopa, 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 drug.
Some patients may develop oedema and weight gain. These symptoms usually resolve with diuretic treatment. Contact your doctor if these symptoms worsen despite diuretic treatment, or if shortness of breath (difficulty breathing) or easy fatigue 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 Dopegyt treatment before blood transfusion, general anaesthesia, and diagnostic tests for a specific type of adrenal gland tumour (pheochromocytoma).
Consult your doctor if you have vascular brain damage 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 taken concurrently 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 concurrent use requires special caution and careful medical monitoring:

medicines containing adrenaline, ephedrine, 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).

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

other antihypertensive medicines,
general anaesthetic agents.

Concurrent use of methyldopa and the following medicines may mutually alter their therapeutic effects, and therefore their concurrent 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); concurrent 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 meals.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected, or if planning 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 breast milk; 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 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 doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
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 doctor may
gradually increase or decrease the initial dose—depending on the degree of reduction in arterial
pressure—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. The 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.
The doctor may gradually increase or decrease the dose, depending on the degree of reduction in
arterial pressure, 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 doses. If necessary, the doctor may gradually increase the daily dose at intervals of no less
than two days until an appropriate response to treatment is achieved. The maximum dose is 65 mg/kg
body weight per day, up to a maximum daily dose of 3 g.
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, consult your doctor or pharmacist.
Use of a higher than recommended dose of Dopegyt
If a higher than recommended dose of Dopegyt has been taken, contact a doctor immediately or go
to the emergency department of the nearest hospital. 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, 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
Blood pressure usually returns to the pre-treatment level within 48 hours after stopping the medicine,
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 any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
At the beginning of treatment and during the dose escalation period, transient sedative effects,
transient headache or weakness may occur.
If any of the following symptoms occur, you should 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, you should immediately discontinue the use of the product and consult your doctor for advice regarding further treatment. If urticaria is very severe and occurs all over the body, you should immediately contact your doctor to avoid serious complications.

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

pale skin, weakness,
signs of infection: fever, sore throat, mouth ulcers,
small red haemorrhagic spots all over the body, tarry stools or blood in the urine,
unusual or prolonged bleeding,
yellowing of the eyes and skin, dark urine,
very significant 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, suggest 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 immediately contact your doctor 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 anaemia) (see section 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,
liver inflammation (hepatitis),
chest pain occurring more frequently and lasting longer than usual (worsening of angina),
slow heart rate,
heart failure,
oedema,
weight gain.

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

vasculitis,
a disorder that may affect various systems, often characterised by skin inflammation (e.g. butterfly-shaped rash),
increased prolactin levels in blood,
breast enlargement in men,
milk discharge from mammary glands at times other than breastfeeding,
absence of menstruation,
facial nerve paralysis (weakness or paralysis of muscles on one side of the face),
psychiatric disorders,
involuntary movements,
symptoms of cerebral circulation disorders (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 pulse, possibly leading to fainting,
drop in blood pressure upon standing, causing dizziness, lightheadedness or fainting,
nasal mucosa congestion,
colitis,
vomiting,
diarrhoea,
sialadenitis,
pain or black tongue,
nausea,
constipation,
abdominal pain,
bloating,
dry mouth,
abnormal liver function tests,
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 for Monitoring Adverse Drug Reactions of the 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 allows the collection of further information on the safety of the medicine.

5. How to store Dopegyt

Keep this medicine out of the sight and reach of children.
Store 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 specified 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. Package contents and other information

What Dopegyt contains
The active substance is methyldopa. Each tablet contains 250 mg of methyldopa.
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, flat, biconvex tablets with bevelled edges, marked with "Dopegyt" on one side.
50 tablets in a bottle made of amber glass with a polyethylene screw cap and a cardboard box insert.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Romania, 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 in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Wytwórnia Euceryny Laboratorium Farmaceutyczne 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

Number of marketing authorisation in Romania, country of export: 9698/2017/01
Number of parallel import authorisation: 70/22
[Information regarding the registered trademark]