Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Dopegyt
250 mg, tablets
Methyldopum
Please read carefully the entire leaflet 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 doubts, 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 someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your 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, 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 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.

If you have previously had liver disease, abnormal liver function tests or kidney disease, inform your doctor, as dose reduction may be necessary in such cases.
If you or a close relative has been diagnosed with a specific metabolic disorder (hepatic porphyria), inform your doctor, as methyldopa should be used with special caution 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 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 (decreased number of 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 therapy. Consult your doctor if these symptoms worsen despite diuretic treatment or if shortness of breath (difficulty breathing) or easy fatigue occurs, as discontinuation of Dopegyt may then 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 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, have recently taken, or plan to take.
Dopegyt must not be used simultaneously 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, pseudoephedrine used in the treatment of colds, cough and asthma,
some 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 medicines lowering blood pressure,
general anaesthetics.

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,
anticoagulants (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 meals.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected, or when 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, 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 attention, such as driving vehicles or operating machinery.
Dopegyt contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Dopegyt

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
The tablets may be taken before or after meals.
Recommended dose:
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 extent of blood pressure reduction—
with intervals of no less than two days. Initially, it is recommended to increase the evening dose 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 be initiated at 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, with 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, your 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 impaired kidney function
Your 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, you should contact your doctor immediately or go to
the nearest hospital emergency department. Take 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, diarrhoea, nausea, vomiting.
Missing a 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 you to the risk of overdose.
Stopping Dopegyt
Usually, blood pressure returns within 48 hours after stopping the medicine to the level observed
before treatment, without a "rebound" reaction. However, treatment should not be stopped prematurely,
as blood pressure may rise.
If you have any further doubts 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, discontinue 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 dangerous but very rare adverse effects. 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 medication immediately and consult your doctor for advice regarding further treatment. If urticaria is severe and widespread, 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 the urine,
unusual or prolonged bleeding,
yellowing of the eyes and skin, dark urine,
severe 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, hypersensitivity reactions or heart failure, and may be serious. Serious consequences can be avoided provided the doctor's instructions 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 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 angina),
bradycardia (slow heart rate),
heart failure,
edema,
weight gain.

Frequency unknown (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,
galactorrhea (milk discharge from mammary glands outside of breastfeeding),
amenorrhea (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,
hypotension and bradycardia, possibly leading to fainting,
orthostatic hypotension (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),
tongue 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, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions, 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dopegyt

Keep this medicine out of 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 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 packaging 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, corn starch, stearic acid, sodium carboxymethyl starch (type A), talc.

What Dopegyt looks like and contents of the pack
Round, flat tablets with bevelled edges, white or greyish-white, embossed with the word "DOPEGYT" on one side.
50 tablets in a brown glass bottle with a PE screw cap and desiccant, packed in a cardboard box.

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

Responsible party 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorization number in Romania, country of export: 9698/2017/01
Parallel import authorization number: 91/21