GUTRON 2.5 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. Gutron, 2.5 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
4. What is Gutron and what is it used for
5. 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 using machines
6. How to take Gutron
   1. Taking a higher dose of Gutron than recommended
   2. Missing a dose of Gutron
7. 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
8. How to store Gutron
9. 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: 218/22 Date of leaflet approval: 16.05.2022

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

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 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 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 the accumulation of blood 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, arterial hypertension, arrhythmias;
• severe vascular disorders (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, you should discuss it with your doctor or pharmacist. You should be particularly careful when taking Gutron:

• if the patient has other diseases (especially right ventricular hypertrophy due to lung disease, increased intraocular pressure, liver and kidney dysfunction);
• in case of allergies;
• when taking other medicines, especially those containing vasoconstrictor substances (see "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. 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 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 used against nausea and vomiting), may enhance their effects. 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, antiallergic medicines, 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 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 using machines

Warning: this medicine may affect your reaction speed and ability to drive 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 machines, 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 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. The medicine should be taken during the day, when the patient is standing 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 increase in blood pressure when lying down, 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 "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, the side effects listed in section 4 may occur in an enhanced manner, especially: arterial hypertension, goosebumps, 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 about 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 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):

• arterial hypertension when lying down (at doses above 30 mg per day);
• itching, chills, hot flashes, rash;
• nausea, heartburn, oral mucosa inflammation;
• 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, 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 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, you can help provide more information on the safety of this 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 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 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, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Cheplapharm Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer:

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

Parallel importer:

Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Cesky Tesin, Czech Republic

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellonska 76, 03-301 Warsaw, CEFEA Sp. z o.o. Sp. komandytowa, ul. Dzialkowa 56, 02-234 Warsaw, Wytwornia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY, ul. Wladyslaw Zelenski 45, 31-353 Krakow, Medezin Sp. z o.o., ul. Zbaszynska 3, 91-342 Lodz, Romanian marketing authorization number: 7023/2014/02

Parallel import authorization number: 218/22 Date of leaflet approval: 16.05.2022

[Information about the trademark]