Gutron

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Gutron (Гутрон)

2.5 mg, tablets
Midodrine hydrochloride
Gutron and Гутрон are the same trade names for the same drug written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Gutron and what is it used for
• 2. Important information before taking Gutron
• 3. How to take Gutron
• 4. Possible side effects
• 5. How to store Gutron
• 6. Contents of the packaging and other information

1. What is Gutron and what is it used for

Gutron raises low blood pressure by constricting small veins and arteries and preventing the accumulation of more blood in the lower limbs. Low blood pressure and blood accumulation in the lower limbs can cause dizziness and cerebral hypoperfusion.
Indicated for the treatment of severe orthostatic hypotension (a drop in blood pressure when standing up, leading to dizziness or fainting) caused by disorders of the autonomic nervous system, when there is no possibility of causal treatment.

2. Important information before taking Gutron

When not to take Gutron:

• severe organic heart and circulatory system diseases, arterial hypertension, arrhythmias;
• severe vascular diseases, such as obliterating or spastic diseases (e.g., cerebral vessel occlusion and spasm);
• acute kidney inflammation, severe kidney failure, prostate enlargement with prolonged urine retention, mechanical obstruction of urination, urine retention;
• diabetic proliferative retinopathy (retinal disorders in diabetes);
• phaeochromocytoma (adrenal gland tumor);
• hyperthyroidism;
• glaucoma with a narrow angle of filtration;
• during pregnancy or breastfeeding.

Warnings and precautions

Before starting to take Gutron, you should discuss it with your doctor or pharmacist.
You should be particularly careful when taking Gutron:

• when taking other medicines, especially those containing vasoconstrictor substances (see section "Gutron and other medicines");
• during pregnancy and breastfeeding.

You should inform your doctor about all the above situations. The doctor may recommend additional tests to avoid side effects.
During treatment, you should regularly check your blood pressure in a lying, sitting, and standing position.
At the beginning of treatment, the doctor will assess the risk of developing hypertension in a lying or sitting position.
You should pay attention to symptoms indicating the development of hypertension (palpitations, headache, dizziness, vision disturbances) or slowed heart rate (e.g., slow pulse, increased dizziness, loss of consciousness). In such a case, you should immediately stop the treatment and contact your doctor.
Continuation of midodrine treatment is recommended only if the initial therapy has proven to be effective.
In the event of significant changes/fluctuations in blood pressure, the use of the medicine should be discontinued.

Gutron and other medicines

You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Taking Gutron with certain medicines, such as perfenazine (an antipsychotic medicine, also used in anxiety disorders), amiodarone (a medicine used in arrhythmias), metoclopramide (a medicine against nausea and vomiting), may lead to enhanced effects of these medicines.
Interactions may occur with sympathomimetics (ingredients of, for example, eye or nose drops - phenylephrine, oxymetazoline, pseudoephedrine) and other medicines containing vasoconstrictor substances (e.g., reserpine, guanethidine, antidepressants, antihistamines, thyroid hormones), other medicines used in heart diseases and circulatory system diseases (alpha-adrenergic receptor blockers - e.g., phentolamine, prazosin, dihydroergotamine; beta-adrenergic receptor blockers - e.g., propranolol, metoprolol, atenolol, timolol), digoxin, MAO inhibitors, medicines containing atropine, products containing cortisone (tablets, injections).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
You should not take Gutron during pregnancy or breastfeeding.
If you become pregnant during treatment, you should immediately inform your doctor.

Driving and operating machinery

Warning: this medicine may affect your reaction speed and ability to operate vehicles.
No studies have been conducted on the effect of midodrine on reaction speed and ability to drive vehicles. When driving a vehicle or operating machinery, you should remember that anxiety, agitation, and irritability may sometimes occur.

3. How to take Gutron

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Adults and adolescents (over 12 years old):
Initially 1 to 2 times half a tablet per day. If the effect is not sufficient, the dose can be increased to 2-3 times one tablet per day.
Dosage in patients with hypotension during therapy with psychotropic drugs: 2 times one tablet per day. If the effect is not sufficient, the dose can be increased to 2-3 times two tablets per day.
The maximum daily dose is 30 mg.
Gutron should be taken during the day when the patient is in a standing position and performing daily activities.
The medicine should be taken at intervals of at least 3 to 4 hours.
The first dose should be taken shortly after morning rising, the second at lunchtime, and the third in the late afternoon if necessary.
To minimize the risk of excessive hypertension in a lying position, you should not take Gutron after dinner or later than 4 hours before bedtime.
Children under 12 years old:
No data available.
Elderly patients:
No data available.
Patients with liver or kidney dysfunction:
No data available.
You should not use Gutron in patients with acute kidney inflammation and (or) severe kidney failure (see section "When not to take Gutron").
The duration of treatment is determined by the doctor.
Tablets should be taken orally with a liquid. Gutron can be taken with food.

Taking a higher dose of Gutron than recommended

In case of overdose, the side effects listed in section 4 may occur in an enhanced form, especially: arterial hypertension, gooseflesh, chills, slowed heart rate, and urine retention. You should immediately inform your doctor about such cases.

Missing a dose of Gutron

You should not take a double dose to make up for a missed tablet.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Gutron can cause side effects, although they may not occur in everyone.
During treatment with Gutron, the following side effects may occur:

Very common (more than 1 in 10 patients):

• gooseflesh;
• painful urination.

Common (more than 1 in 100 patients):

• arterial hypertension in a lying position (at doses above 30 mg per day);
• itching, chills, hot flashes, rash;
• nausea, heartburn, oral mucosa inflammation;
• disturbances of sensation (tingling);
• urine retention.

Uncommon (more than 1 in 1000 patients):

• sleep disorders, insomnia;
• slowed heart rate (bradycardia), palpitations;
• sudden urge to urinate;
• headache, anxiety, agitation, irritability.

Rare (more than 1 in 10,000 patients):

• accelerated heart rate (tachycardia), arrhythmias;
• liver dysfunction, increased liver enzyme activity.

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

• anxiety, confusion;
• abdominal pain, vomiting, diarrhea.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Gutron

Store in a temperature below 25°C.
Store in the original packaging to protect from light.
The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Gutron contains

• The active substance of the medicine is midodrine hydrochloride.
• The other ingredients are: magnesium stearate, talc, anhydrous colloidal silica, microcrystalline cellulose, corn starch.

What Gutron looks like and what the packaging contains

Gutron is a white, round tablet with the letters "GU" embossed above and the dose "2.5" below the break line.
The packaging contains 20 tablets in two blisters of PVC/PVDC/Aluminum in a cardboard box.
To obtain more detailed information about the medicine, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:

Takeda Austria GmbH
St. Peter Strasse 25, A-4020 Linz, Austria
Takeda Pharma A/S
Langebjerg 1, DK-4000 Roskilde, Denmark
Takeda GmbH
Plant Oranienburg, Lehnitzstr. 70-98, DE-16515 Oranienburg, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20020886

Parallel import authorization number: 156/24

Date of leaflet approval: 17.04.2024

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