Dopegyt 250 mg. 30 tablets

What Dopegit is and what it is used for
The active substance in Dopegit is methyldopa, a centrally acting medicine that lowers blood pressure.
Dopegit is used to treat high blood pressure (hypertension).

2. What you need to know before you take Dopegit
Do not take Dopegit:

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 (acute hepatitis, active cirrhosis);
if you have a history of liver disease caused by methyldopa;
if you are taking medicines belonging to the group of so-called monoamine oxidase (MAO) inhibitors - e.g. moclobemide, selegiline;
if you suffer from depression;
if a tumor of the adrenal gland is diagnosed, the so-called pheochromocytoma.
If you are not sure about your condition or the medicines you are taking, talk to your doctor.

Warnings and precautions

Tell your doctor if you have had liver disease in the past or if your liver function tests have been abnormal;
Also inform him if you have kidney disease - in such cases the dose needs to be reduced;
Tell your doctor if you or a close relative suffer from the metabolic disease porphyria, as methyldopa should be used with caution in such cases.
Precautions while taking the tablets:

During treatment, especially if the daily dose is higher than 1000 mg and especially after 6-12 months of treatment - there may be a deviation in one laboratory indicator (namely to positive the Coombs test), which occurs in 10-20% of patients. In less than 5% of these patients may develop the so-called. hemolytic anemia (anemia caused by premature breakdown of red blood cells). Therefore, before starting treatment and every 6-12 months thereafter, a blood cell count and a direct Coombs test should be performed. Signs of anemia may include paleness, weakness, jaundice, and if they do occur, stop taking these tablets immediately and tell your doctor. If these symptoms are the result of taking methyldopa, you should never use this medicine again;
Liver cell damage may occur as a result of a hypersensitivity reaction to methyldopa, with possible severe consequences. Therefore, in the first 6-12 weeks of treatment, liver function tests should be performed as prescribed by your doctor, and also if your body temperature rises for no apparent reason or jaundice occurs. In case of fever, jaundice or worsening of liver test results, treatment should be stopped immediately. If liver damage is due to methyldopa, you should never use this medicine again;
Very rarely, hematopoietic abnormalities may occur during treatment (eg reduced white blood cell and platelet counts). If you notice ulceration of the oral mucosa, redness and sore throat, small bleeding on the skin, black stools, blood in the urine, unusual or uncontrolled bleeding, stop taking this medicine and tell your doctor. The changes described above usually resume upon discontinuation of treatment;
Swelling and weight gain may occur in some patients during treatment with Dopegit. They usually disappear with the use of diuretics (dehydrators). Tell your doctor if the above becomes more pronounced, regardless of diuretic treatment, difficulty breathing or easy tiredness, because treatment may need to be stopped;
As methyldopa is eliminated from the body by hemodialysis, an additional dose may be required after the procedure;
Tell your doctor that you are being treated with Dopegit before any blood transfusions, general anesthesia, pheochromocytoma tests.
Other drugs and Dopegit
Tell your doctor if you are taking, have recently taken or might take any other medicines.
The following may apply to medicines that you have been taking for some time or will take in the future.

This medicinal product should not be used in combination with MAO inhibitors (eg moclobemide given for depression or selegiline for the treatment of Parkinson's or Alzheimer's disease).

Some medicines may reduce the antihypertensive effect of Dopegit, so that their concomitant use requires attention and medical supervision:

drugs that have an effect on the autonomic nervous system, e.g. adrenaline, ephedrine, pseudoephedrine and some medicines for colds, coughs and asthma;
medications used for depression, e.g. imipramine, amitriptyline;
drugs used in mental illness, e.g. chlorpromazine, trifluoperazine;
oral medicines containing iron, e.g. iron gluconate, ferrous sulfate - reduce the absorption of methyldopa;
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Concomitant use of Dopegit with some drugs may increase its antihypertensive effect:

other antihypertensive drugs;
general anesthetics (painkillers).
Methyldopa and the following medicines may alter their healing effects and the side effects may add up, so special caution is required when combining them:

lithium (given for mental illness);
levodopa (prescribed for Parkinson's disease);
sedatives, hypnotics and some anti-allergic drugs;
anticoagulants (medicines that suppress blood clotting, eg acenocoumarol), due to the risk of bleeding;
bromocriptine;
haloperidol.
Dopegit with food and drink
Do not drink any alcoholic beverages while taking this medicine. The tablets can be taken before or after a meal.

Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Dopegit can be taken during pregnancy if needed. However, tell your doctor if you are pregnant. The active substance in Dopegit is excreted in breast milk, therefore breast-feeding women should not take the medicine unless a careful risk / benefit assessment has been made by their doctor.

Driving and using machines
At the beginning of treatment with this medicine it is not recommended to drive or use dangerous machines or to carry out activities with an increased risk of accidents, as your doctor will determine how long this will last. Later, the duration and extent of this ban are determined individually.

3. How to take Dopegit
Always take this medicine exactly as your doctor has told you.
If you are not sure, talk to your doctor or pharmacist.
The tablets can be taken before or after a meal. The treating physician may gradually (at intervals of not less than 2 days) increase the starting dose depending on the degree of reduction in blood pressure. It is recommended to increase the evening dose. The daily dose should be divided into 2 - 4 doses. The starting dose is 250 mg 2-3 times a day for the first 2 days, and the recommended maintenance dose is 500-2000 mg (2-8 tablets) a day, divided into 2-4 doses. The maximum daily dose should not exceed 3000 mg.

In elderly patients, the starting daily dose is as low as possible (2 x 1 tablet). The daily dose should not exceed 2000 mg.

Use in children
In children, a dose is prescribed, depending on the child's weight. The recommended starting dose is 10 mg / kg body weight daily, divided into 2 to 4 doses. The maximum daily dose is 65 mg / kg body weight. The daily dose should not exceed 3000 mg.
Due to the fact that the drug Dopegit has been on the market for more than three decades, clinical studies to determine the minimum age for its use in children have not been conducted.

In patients with renal insufficiency Dopegit is prescribed in a lower dose, depending on the degree of damage.

If you have the impression that the effect of the medicine is very strong or very weak, tell your doctor.

If you take more Dopegit than you should or if someone else accidentally takes Dopegit, contact the nearest emergency department immediately. Take this leaflet and the rest of the tablets to show to your doctor.
Signs of overdose: sudden drop in blood pressure, drowsiness, weakness, decreased heart rate, dizziness, constipation, gas, feeling of bloating, diarrhea, nausea, vomiting.
Treatment: immediately after an overdose - gastric lavage and induced vomiting may reduce the absorption of the drug. Then - infusions of liquids in order to increase its radiation.
Heart rate, blood volume, electrolyte balance, gastrointestinal, renal and brain functions should be monitored. If necessary, sympathomimetics (eg adrenaline) may be given.

If you forget to take Dopegit
Do not take a double dose to make up for a forgotten dose.
Your doctor will determine how long to continue treatment with Dopegit. Strictly follow his instructions.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Sedation (sedation), headache, weakness, which are transient side effects may occur at the beginning of treatment or when the dose is increased.

If any of the following happen, stop taking the medicine and seek medical help immediately:

pallor, weakness;
signs as in infections: fever, sore and red throat, ulceration of the oral mucosa;
small hemorrhages on the skin of the whole body, black stools or blood in the urine;
unusual or prolonged bleeding;
yellowish coloration of the eclairs of the eye
5. How to store Dopegit
Keep out of reach of children.
Store below 25 ° C.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and additional information
What Dopegit contains
The active substance is: 250 mg methyldopa in each tablet.
The other ingredients are: ethylcellulose, magnesium stearate, maize starch, stearic acid, sodium starch glycolate, talc.

What Dopegit looks like and contents of the pack
Description: White or grayish-white, disc-shaped, flat with rounded edges and with the inscription "Dopegyt" on one side.
Contents: 30 or 50 tablets are placed in a brown glass bottle with a polyethylene cap protected against opening and with a polyethylene shock absorber, together with the package leaflet.

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