Dopegyt

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 questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your 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, liver cirrhosis),
• if the patient has previously experienced liver disease induced by methyldopa,
• if the patient is simultaneously 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 the patient has previously had liver disease, abnormal liver function test results or kidney disease, this should be reported to the doctor, as dose reduction may be necessary in such cases.
• If the patient or a close family member has been diagnosed with a specific metabolic disorder (hepatic porphyria), this should be reported to the doctor, as methyldopa should be used with particular caution in such cases.
• During treatment – particularly when doses above 1000 mg are used 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 count and direct Coombs test should be checked before starting treatment and then every 6-12 months during treatment. Symptoms of anaemia may include: pallor of the skin, weakness, jaundice. If such symptoms occur, the medicine should be discontinued immediately and the patient should consult a 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 the doctor and in any case of unexplained fever or jaundice. If fever, jaundice or worsening of liver function test results occur, treatment should be discontinued 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 urine, or unusual or difficult-to-control bleeding occur, the medicine should be discontinued and the patient should consult a doctor. These symptoms usually resolve spontaneously after discontinuation of the medicine.
• Some patients may experience oedema and weight gain. These symptoms usually resolve after administration of diuretic medicines. The patient should consult a doctor if these symptoms worsen despite diuretic treatment or if dyspnoea (difficulty breathing) or easy fatigability 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.
• The doctor should be informed about treatment with Dopegyt before blood transfusion, general anaesthesia and diagnostic tests for a specific type of adrenal gland tumour (pheochromocytoma).
• The patient should consult a doctor in case of vascular brain disorders or presence of involuntary movements, as discontinuation of Dopegyt may be necessary.

Dopegyt and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used or planned to be used.
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 reduce 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 mental disorders (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 lowering blood pressure,
• general anaesthetic agents.

Concomitant use of methyldopa and the following medicines may mutually alter their therapeutic effects, 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,
• anticoagulants (e.g. acenocoumarol); concomitant use of these medicines 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).

Food and alcohol
During treatment with this medicine, consumption of alcoholic beverages should be avoided.
Tablets may be taken either before or after meals.
Pregnancy and breastfeeding
During pregnancy and breastfeeding, or if pregnancy is suspected, or if planning pregnancy, consult a 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 advised by a doctor after careful assessment of benefits and risks.
Driving and operating machinery
This medicine may cause transient sedative symptoms, particularly at the beginning of treatment and during dose escalation. If sedative symptoms occur, activities requiring attention, such as driving or operating machinery, should not be undertaken.
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 divided 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 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 interval between doses 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 nearest hospital emergency department. Bring this leaflet and any remaining tablets to show
the doctor.
Symptoms of overdose: low blood pressure, marked drowsiness, weakness, slow heart rate, dizziness,
constipation, abdominal bloating, flatulence, 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 increase the risk of overdose.
Stopping Dopegyt
Blood pressure usually 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, discontinue taking the medicine Dopegyt immediately
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 dangerous 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 (hives) may also be a sign of an allergic reaction. In such cases, stop taking the medicine 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 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,
• severe 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, may suggest hypersensitivity reactions or heart failure, and can be life-threatening. Serious consequences can be avoided provided you follow your doctor's advice, undergo recommended laboratory tests, and report any of the above symptoms to your doctor immediately.

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

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

• vasculitis (inflammation of blood vessels),
• 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,
• milk discharge from mammary glands outside the 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 disturbance (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,
• 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,
• diarrhoea,
• 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, pharmacist or nurse. 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, phone: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store 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 package 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 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 with tamper-evident seal and a PE
cushion, packed in a cardboard box.

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

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

Marketing Authorisation Number in Slovakia, country of export: 58/0256/70-S
Parallel Import Authorisation Number: 185/23