GUTRON 2.5 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.
3. Gutron
4. 5 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Gutron and what is it used for
6. Important information before taking Gutron
   1. When not to take Gutron:
   2. Warnings and precautions
   3. Gutron and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and operating machinery
7. How to take Gutron
   1. Taking a higher dose of Gutron than recommended
   2. Missing a dose of Gutron
8. Possible side effects
   1. Very common (more than 1 in 10 patients):
   2. Common (more than 1 in 100 patients):
   3. Uncommon (more than 1 in 1000 patients):
   4. Rare (more than 1 in 10,000 patients):
   5. Frequency not known (cannot be estimated from the available data):
   6. Reporting side effects
9. How to store Gutron
10. Contents of the packaging and other information
    1. What Gutron contains
    2. What Gutron looks like and what the packaging contains
    3. Marketing authorization holder in Romania, the country of export:
    4. Manufacturer:
    5. Parallel importer:
    6. Repackaged by:
    7. Parallel import authorization number: 28/18 Date of approval of the leaflet: 16.01.2023

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Gutron

2.5 mg, tablets

Midodrine hydrochloride

You should 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, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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. It is 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 disorders, hypertension, arrhythmias;
• 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, urinary 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 patient should discuss it with their doctor or pharmacist. 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 dysfunction);
• when taking other medicines, especially those containing vasoconstrictor substances (see section "Gutron and other medicines");
• during pregnancy and breastfeeding.

The doctor should be informed about all the above situations. 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 hypertension in the lying or sitting position. Attention should be paid to symptoms indicating the occurrence of hypertension (palpitations, headache, dizziness, vision disturbances) or slowed heart rate (e.g., slow pulse, increased dizziness, loss of consciousness). In such a case, treatment should be stopped immediately and the doctor should be contacted. Continuing treatment with midodrine is recommended only if the initial therapy has been effective. If there are significant changes/fluctuations in blood pressure, the use of the medicine should be stopped.

Gutron and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Taking Gutron with certain medicines, such as perphenazine (an antipsychotic medicine, also used in anxiety disorders), amiodarone (a medicine used in heart rhythm disorders), or metoclopramide (a medicine used against nausea and vomiting), may enhance their effects. Interactions may occur with sympathomimetics (ingredients in, 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 disorders (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, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Gutron should not be taken during pregnancy or breastfeeding. If the patient becomes pregnant during treatment, they should immediately inform their 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, 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, the patient should consult their 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 1 tablet per day. Dosage in patients with hypotension during therapy with psychotropic drugs: 2 times 1 tablet per day. If the effect is not sufficient, the dose can be increased to 2-3 times 2 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. 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 old: No available data. Elderly patients: No available data. Patients with liver or kidney dysfunction: No available data. 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 determined by the doctor. The 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, especially: hypertension, goosebumps, chills, slowed heart rate, and urinary 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 about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gutron can cause side effects, although not everybody gets them. During treatment with Gutron, the following side effects may occur:

Very common (more than 1 in 10 patients):

• goosebumps;
• painful urination.

Common (more than 1 in 100 patients):

• hypertension in the lying position (at doses above 30 mg per day);
• itching, chills, hot flashes, rash;
• nausea, heartburn, oral mucositis;
• disturbances of sensation (tingling);
• urinary 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 any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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 181 C, 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, more information can be gathered on the safety of the use of the medicine.

5. How to store Gutron

Store in a temperature below 25°C, in the original packaging. The medicine should be stored 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 given month. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer used. 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. Each tablet contains 2.5 mg of midodrine hydrochloride.
• The other ingredients are: magnesium stearate, talc, anhydrous colloidal silica, microcrystalline cellulose PH 101, 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 patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer:

Takeda GmbH, Lehnitzstrasse 70-98, DE-16515 Oranienburg, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Authorization number in Romania, the country of export: 7023/2014/01, 7023/2014/02, 7023/2014/03

Parallel import authorization number: 28/18 Date of approval of the leaflet: 16.01.2023

[Information about the trademark]