Dopegyt

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Dopegyt,
250 mg, tablets
Methyldopum
Please read this leaflet carefully before use,
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 share it with others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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, cirrhosis of the liver),
• if the patient has previously experienced liver disease induced by methyldopa,
• if the patient is currently taking medicines called MAO inhibitors used to treat 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.
• If you or a close relative has been diagnosed with a particular metabolic disorder (hepatic porphyria), inform your doctor, as methyldopa should be used with special caution in such cases.
• During treatment – particularly when doses above 1000 mg are used and especially after 6–12 months of therapy – laboratory abnormalities (a 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, before starting treatment and subsequently every 6–12 months during treatment, blood counts and a direct Coombs test should be performed. 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.
• 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 whenever fever of unknown origin or jaundice occurs. 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 (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 the 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 experience oedema and weight gain. These symptoms usually resolve after administration of diuretic medicines. Consult your doctor if these symptoms worsen despite diuretic treatment, or if dyspnoea (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 that you are being treated with Dopegyt before blood transfusion, general anaesthesia, and diagnostic tests for a specific type of adrenal 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 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 to treat depression or selegiline used to treat Parkinson's disease or Alzheimer's disease).
Some medicines may reduce 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 for depression (e.g. imipramine, amitriptyline),
• medicines used to treat 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,
• 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 may be taken either before or after meals.
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 harm 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 effects, particularly at the beginning of treatment and during dose escalation. If sedative effects occur, activities requiring attention, such as driving or operating machinery, should not be undertaken.
Dopegyt contains sodium
This 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 exactly as directed by your doctor or pharmacist. If in doubt,
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 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 be started 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, 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, 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 prescribing doctor will adjust the dose according to the degree of renal impairment. In mild renal
impairment, the dosing interval should be prolonged 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, talk 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
emergency department of your 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 heartbeat, dizziness,
constipation, abdominal bloating, flatulence, diarrhea, nausea, vomiting.
If you miss 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 increase the risk of overdose.
Stopping Dopegyt
Usually, blood pressure returns within 48 hours after stopping treatment to the level before treatment,
without a rebound effect. However, do not stop treatment 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 effects

Like all medicines, this medicine can cause adverse effects, although not everybody 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 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 a 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:

• pallor, weakness,
• signs of infection: fever, sore throat, oral 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,
• 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, 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 effects 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 with short, accelerated steps, muscle weakness),
• pancreatitis,
• hepatitis (liver inflammation),
• chest pain occurring more frequently and lasting longer than usual (worsening of angina),
• bradycardia (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 males,
• galactorrhea (milk discharge from mammary glands outside the breastfeeding period),
• 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,
• low blood pressure and slow heart rate, possibly leading to fainting,
• postural hypotension causing dizziness, lightheadedness or fainting,
• nasal mucosal congestion,
• colitis,
• vomiting,
• diarrhoea,
• sialadenitis (inflammation of the salivary glands),
• 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 levels.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of 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 effects helps to provide more information on the safety of the medicine.

5. How to store Dopegyt

Keep the 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 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 N-100, magnesium stearate, corn 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 "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 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing authorisation number in Romania, country of export: 9698/2017/01
Parallel import authorisation number: 364/22