Gutron

Leaflet attached to the packaging: patient information

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

Gutron, 2.5 mg,tablets
Midodrine hydrochloride

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given 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 inform 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 a larger amount of 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:

• if the patient is allergic to midodrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has:
• severe organic heart and circulatory system diseases, arterial hypertension, heart rhythm disorders;
• severe vascular diseases (e.g., cerebral artery occlusion and spasm);
• acute kidney inflammation, severe kidney failure, prostate enlargement with prolonged urine retention, mechanical obstruction of urination, urine retention;
• proliferative diabetic retinopathy (retinal disorders in diabetes);
• phaeochromocytoma (a tumor of the adrenal gland);
• hyperthyroidism;
• glaucoma with a narrow angle of filtration;
• during pregnancy or breastfeeding.

Warnings and precautions

Before starting to take Gutron, the doctor or pharmacist should be consulted.
Particular caution should be exercised when taking Gutron:

• if the patient suffers from other diseases (especially right ventricular hypertrophy due to lung disease, increased intraocular pressure, liver and kidney function disorders);
• in case of allergies;
• when taking other medicines, especially those containing vasoconstrictor substances (see section "Gutron and other medicines");
• during pregnancy and breastfeeding.

All of the above situations should be reported to the doctor. The doctor may recommend additional tests to avoid side effects.
During treatment, blood pressure should be regularly monitored in the lying, sitting, and standing positions.
At the beginning of treatment, the doctor will assess the risk of developing hypertension in the lying or sitting position.
Attention should be paid 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 cases, treatment should be stopped immediately and the doctor consulted.
Continuation of midodrine treatment is recommended only if the initial therapy has been effective.
In the event of significant changes/fluctuations in blood pressure, the use of Gutron should be discontinued.

Gutron and other medicines

The doctor should be informed about all medicines currently or recently taken by the patient, as well as those planned to be taken.
Concomitant use of Gutron with certain medicines, such as perphenazine (an antipsychotic medicine also used in anxiety disorders), amiodarone (a medicine used in heart rhythm disorders), metoclopramide (a medicine used against nausea and vomiting), may lead to enhanced effects of these medicines.
Interactions may occur with sympathomimetics (ingredients of, e.g., 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 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 the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.
Gutron should not be taken during pregnancy or breastfeeding.
If the patient becomes pregnant during treatment, she should immediately inform her doctor.

Driving and operating machinery

Warning: this medicine may affect reaction speed and the ability to operate vehicles.
No studies have been conducted on the effect of midodrine on reaction speed and the ability to drive vehicles. When driving a vehicle or operating machinery, it should be remembered that anxiety, restlessness, 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, the doctor or pharmacist should be consulted.
Adults and adolescents (over 12 years of age):
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 the lying position, Gutron should not be taken after dinner or later than 4 hours before bedtime.
Children under 12 years of age
No data available.
Elderly patients
No data available.
Patients with liver or kidney function disorders
No data available.
Gutron should not be used in patients with acute kidney inflammation and/or severe kidney failure (see section "When not to take Gutron").
The duration of treatment is decided 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, side effects listed in section 4 may occur in an enhanced form, especially: arterial hypertension, gooseflesh, chills, slowed heart rate, and urine retention. The doctor should be informed immediately about such cases.

Missing a dose of Gutron

A double dose should not be taken to make up for a missed tablet.
In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Gutron can cause side effects, although they may not occur in every patient.
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 the lying position (at doses above 30 mg per day);
• itching, chills, hot flashes, rash;
• nausea, heartburn, inflammation of the oral mucosa;
• disorders 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, restlessness, irritability.

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

• accelerated heart rate (tachycardia), heart rhythm disorders;
• liver function disorders, increased liver enzyme activity.

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

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

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Gutron

Store at a temperature below 25°C. Store in the original packaging to protect from light.
The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Gutron contains

• The active substance of Gutron 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 PVC/PVDC/Al blisters.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in Hungary, the country of export:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:

Takeda GmbH
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 Hungary, the country of export:OGYI-T-4239/02

Parallel import authorization number: 157/24

Date of leaflet approval: 17.04.2024

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