Dopegit

Package Leaflet: Information for the User

Dopegyt, 250 mg, Tablets

Methyldopa

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Dopegyt and what is it 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 is Dopegyt and what is it used for

The active substance of Dopegyt is methyldopa, which is a centrally acting antihypertensive agent.
Dopegyt is used to treat high blood pressure.

2. Important information before taking Dopegyt

When not to take Dopegyt

• if you are allergic to methyldopa or any of the other ingredients of this medicine (listed in section 6),
• if you have active liver disease (e.g. acute hepatitis, liver cirrhosis),
• if you have had liver disease caused by methyldopa in the past,
• if you are taking monoamine oxidase inhibitors (MAOIs) at the same time (e.g. moklobemide for depression or selegiline for Parkinson's disease or Alzheimer's disease),
• if you have depression,
• if you have a phaeochromocytoma (a special type of adrenal gland tumor).

Warnings and precautions

Before starting treatment with Dopegyt, discuss it with your doctor or pharmacist.

• If you have had liver disease in the past, abnormal liver test results, or kidney disease, inform your doctor, as a dose reduction may be necessary.
• If you have been diagnosed with a special metabolic disorder (porphyria) or if someone in your close family has been diagnosed with it, inform your doctor, as methyldopa should be used with caution in such cases.
• During treatment, especially if doses above 1000 mg are used and mainly after 6-12 months of therapy, laboratory abnormalities (positive direct Coombs test) may occur in 10-20% of patients. In less than 5% of such patients, hemolytic anemia (anemia caused by premature destruction of red blood cells) may develop. Therefore, before starting treatment and then every 6-12 months during treatment, blood morphology and direct Coombs test should be checked. Symptoms of anemia may include: pale skin, weakness, jaundice. If such symptoms occur, stop taking this medicine and consult your doctor. If the cause of these symptoms is methyldopa, do not take Dopegyt again.
• As an allergic reaction to methyldopa, liver cell damage may occur, sometimes severe. Therefore, during the first 6-12 weeks of treatment, liver function tests should be performed with the frequency recommended by your doctor and in case of fever of unknown origin or jaundice. If fever, jaundice, or worsening liver test results occur, treatment should be stopped immediately. If the cause of liver damage is methyldopa, do not take Dopegyt again.
• Very rarely, during treatment, hematopoietic disorders (decrease in white blood cell and platelet count) may occur. If oral ulcers, sore throat, small red spots on the body, black stools, or blood in the urine occur, stop taking this medicine and consult your doctor. These symptoms usually resolve on their own after discontinuation of the medicine.
• Some patients may experience swelling and weight gain. These symptoms usually resolve after administration of diuretics. Consult your doctor if these symptoms worsen despite diuretic treatment or if shortness of breath (difficulty breathing) or easy fatigue occurs, as it may be necessary to discontinue the medicine.
• In case of dialysis treatment, an additional dose of the medicine may be necessary after dialysis, as methyldopa is removed from the body during dialysis.
• Inform your doctor about Dopegyt treatment before blood transfusion, general anesthesia, and before diagnostic tests for a special type of adrenal gland tumor (phaeochromocytoma).
• Consult your doctor if you have cerebral vessel damage or disease and involuntary movements, as it may be necessary to discontinue Dopegyt.

Dopegyt and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Dopegyt should not be taken at the same time as MAOIs(e.g. moklobemide for depression or selegiline for Parkinson's disease or Alzheimer's disease).
Some medicines may weakenthe antihypertensive effect of Dopegyt and their concurrent use requires special caution and careful medical monitoring:

• medicines containing adrenaline, ephedrine, pseudoephedrine used to treat colds, coughs, and asthma,
• certain medicines used to treat depression (e.g. imipramine, amitriptyline),
• medicines used to treat certain mental illnesses (e.g. chlorpromazine, trifluoperazine),
• oral iron supplements (iron gluconate and iron sulfate 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 increasethe antihypertensive effect of Dopegyt:

• other antihypertensive medicines,
• general anesthetics.

Concomitant use of methyldopa and the following medicines may changetheir therapeutic effect and therefore their concomitant use requires special caution:

• lithium (used to treat psychiatric disorders),
• levodopa (used to treat Parkinson's disease),
• alcohol and medicines used to treat anxiety, insomnia, or allergies,
• anticoagulant medicines (e.g. acenocoumarol); concomitant use of these medicines with Dopegyt increases the risk of bleeding,
• bromocriptine (reduces prolactin and growth hormone release in the body, used to treat disorders where less of these substances is needed),
• haloperidol (used to treat mental disorders).

Dopegyt with food and alcohol

During treatment with Dopegyt, avoid consuming alcoholic beverages.
Tablets can be taken before or after meals.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if you think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Although no clear teratogenic effect has been reported, fetal damage cannot be excluded.
Therefore, Dopegyt should not be used during pregnancy unless the potential benefits outweigh the potential risks.
Methyldopa passes into breast milk and therefore breastfeeding women should not take this medicine unless advised to do so by their doctor after careful evaluation of the benefits and risks.

Driving and using machines

This medicine may cause transient sedative effects, especially at the beginning of treatment and during dose increase. If sedative effects occur, do not engage in activities that require attention, such as driving or operating machinery.

Dopegyt contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Dopegyt

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Tablets can be taken before or after meals.
The recommended dose is
Adults
The initial recommended dose for the first two days is 250 mg 2-3 times a day. Your doctor may gradually increase or decrease the initial dose - depending on the degree of blood pressure reduction - at intervals of not 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. Your doctor may then decide to add a diuretic or increase the methyldopa dose.
Elderly patients
In elderly patients, treatment should be started with the lowest possible dose, not exceeding 250 mg per day. Your doctor may increase or decrease the dose, depending on the degree of blood pressure reduction, at intervals of not 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 not less than two days until a satisfactory response to treatment is achieved. The maximum dose is 65 mg/kg body weight per day, up to a maximum dose of 3 g per day.
Use in patients with renal impairment
Your doctor will reduce the dose according to the degree of renal impairment. In case of mild renal impairment, it is recommended to prolong the dosing interval 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, talk to your doctor or pharmacist.

Overdose of Dopegyt

If you have taken more than the recommended dose of Dopegyt, contact your doctor or go to the emergency department of your nearest hospital immediately. Bring this leaflet and any remaining tablets with you to show the doctor.
Symptoms of overdose: low blood pressure, excessive 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 forgotten dose. Taking a double dose by the patient will not make up for the missed dose and may put you at risk of overdose.

Stopping treatment with Dopegyt

Usually, blood pressure returns to pre-treatment levels within 48 hours after stopping treatment without 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dopegyt can cause side effects, although not everybody gets them.
At the beginning of treatment and during dose increase, transient sedative effects, transient headache, or weakness may occur.
If you experience any of the following symptoms, stop taking Dopegyt and contact your doctor or go to the emergency department of your nearest hospital:

• swelling of the lips or throat causing difficulty swallowing or breathing,
• anaphylaxis. These are very serious but very rare side effects. If they occur, they may indicate a severe allergic reaction to Dopegyt. Immediate medical attention or hospitalization may be required. Hives may also be a sign of an allergic reaction. In this case, stop taking the medicine and consult your doctor for advice on further treatment. If the hives are severe and occur all over the body, seek medical attention immediately to avoid serious complications.

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

• pale skin, weakness,
• infection symptoms: fever, sore throat, oral ulcers,
• small red spots on the body, black stools, or blood in the urine,
• unusual or prolonged bleeding,
• yellowing of the eyes and skin, dark urine,
• extreme fatigue,
• chest pain (angina pectoris) occurring more frequently and lasting longer than usual,
• shortness of breath (difficulty breathing), swelling of the legs, weight gain,
• blisters on the skin, flaky skin. These symptoms may indicate blood and lymphatic system disorders, may suggest hypersensitivity reactions, or may indicate heart failure and may be serious. Serious consequences can be avoided if the doctor's instructions are followed, prescribed laboratory tests are performed, and medical attention is sought immediately if any of the above symptoms occur.

The following side effects may occur:
Very common (may affect more than 1 in 10 people):

• positive Coombs test (blood test detecting causes of anemia) (see section warnings and precautions).

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

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

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

• vasculitis,
• a disorder that can affect different systems, often characterized by skin inflammation (e.g. butterfly-shaped rash),
• increased prolactin levels in the blood,
• breast enlargement in men,
• milk secretion from the breasts at times other than breastfeeding,
• absence of menstruation,
• facial nerve palsy (weakness or paralysis of the facial muscles),
• psychiatric disorders,
• involuntary movements,
• symptoms of cerebral circulation disorders (difficulty speaking, vision disturbances, weakness of the 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, which may lead to fainting,
• low blood pressure when standing up, causing dizziness, fainting, or fainting spells,
• nasal congestion,
• colitis (inflammation of the large intestine),
• vomiting,
• diarrhea,
• salivary gland inflammation,
• mouth or tongue pain,
• nausea,
• constipation,
• abdominal pain,
• bloating,
• dry mouth,
• abnormal liver function test results,
• eczema or lichen planus,
• mild joint pain with or without swelling,
• muscle pain,
• impotence,
• ejaculation disorders,
• increased urea levels in the blood.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 .
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dopegyt

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original package.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month stated.
Medicines should 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 pack and other information

What Dopegyt contains

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

What Dopegyt looks like and contents of the pack

White or light gray, round, flat tablet with beveled edges and a round engraving DOPEGYT on one side. The tablet is free from physical defects and mechanical impurities.
50 tablets in an orange glass bottle with a polyethylene (LDPE) cap and a guarantee seal and a cardboard box.

Marketing authorization holder:

Egis Pharmaceuticals PLC
1106 Budapest, Keresztúri út 30-38.
Hungary

Manufacturer:

Egis Pharmaceuticals PLC.
Mátyás király u. 65
9900 Körmend
Hungary
To obtain more detailed information, please contact the representative of the Marketing Authorization Holder in Poland.
Name: EGIS Polska Sp. z o.o.
Address: ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet: