GUTRON 2.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Gutron, 2.5 mg, Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
3. What is Gutron and What is it Used For
4. Important Information Before Taking Gutron
   1. When Not to Take Gutron:
   2. Warnings and Precautions
   3. Gutron and Other Medications
   4. Pregnancy and Breastfeeding
   5. Driving and Operating Machines
5. How to Take Gutron
   1. Overdose of Gutron
   2. Missed Dose of Gutron
6. 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 Determined from Available Data):
   6. Reporting Side Effects
7. How to Store Gutron
8. Contents of the Package and Other Information
   1. What Gutron Contains
   2. What Gutron Looks Like and Contents of the Package
   3. Marketing Authorization Holder
   4. Manufacturer

Package Leaflet: Information for the Patient

Gutron, 2.5 mg, Tablets

Midodrine Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 Package and Other Information

1. What is Gutron and What is it Used For

Gutron increases 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:

• if you are allergic to midodrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have:
• severe organic heart and circulatory system diseases, hypertension, arrhythmias;
• severe vascular diseases, such as zarostic 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;
• 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, discuss it with your doctor or pharmacist. Be particularly cautious when taking Gutron:

• if you have other diseases (especially right ventricular hypertrophy due to lung disease, increased intraocular pressure, liver and kidney dysfunction);
• in case of allergies;
• when taking other medications, especially those containing vasoconstrictor substances (see section "Gutron and Other Medications");
• during pregnancy and breastfeeding.

Tell your doctor about all the above situations. Your doctor may recommend additional tests to avoid side effects. During treatment, regularly monitor blood pressure in the lying, sitting, and standing positions. At the beginning of treatment, your doctor will assess the risk of developing hypertension in the lying or sitting position. 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 cases, stop treatment immediately and contact your doctor. Continuing midodrine treatment is recommended only if initial therapy has been effective. If significant changes/fluctuations in blood pressure occur, discontinue the medication.

Gutron and Other Medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take. Concurrent use of Gutron with certain medications, such as perphenazine (an antipsychotic medication also used for anxiety disorders), amiodarone (a medication used for arrhythmias), metoclopramide (a medication for nausea and vomiting), may enhance their effects. Interactions may occur with sympathomimetics (ingredients in eye or nose drops, such as phenylephrine, oxymetazoline, pseudoephedrine) and other medications containing vasoconstrictor substances (e.g., reserpine, guanethidine, antidepressants, antiallergic medications, thyroid hormones), other medications used for heart and circulatory system diseases (alpha-adrenergic receptor blockers, such as phentolamine, prazosin, dihydroergotamine; beta-adrenergic receptor blockers, such as propranolol, metoprolol, atenolol, timolol), digoxin, MAO inhibitors, medications 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, consult your doctor before taking this medication. Do not take Gutron during pregnancy or breastfeeding. If you become pregnant during treatment, inform your doctor immediately.

Driving and Operating Machines

Note: This medication may affect 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 or operating machines, remember that anxiety, agitation, and irritability may occur.

3. How to Take Gutron

Always take this medication exactly as your doctor has told you. If you are not sure, ask your 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 medications: 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 standing and performing daily activities. The medication 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 increase in blood pressure when lying down, do not take Gutron 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. Do 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 your doctor. Tablets should be taken orally with a liquid. Gutron can be taken with food.

Overdose of Gutron

In case of overdose, side effects listed in section 4 may occur, especially: hypertension, piloerection, chills, slowed heart rate, and urine retention. Inform your doctor immediately about these cases.

Missed Dose of Gutron

Do not take a double dose to make up for a missed tablet. If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, 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):

• piloerection;
• painful urination.

Common (More Than 1 in 100 Patients):

• 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 Determined from Available Data):

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

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Gutron

Do not store above 25°C. Keep the medication out of the sight and reach of children. Do not use this medication after the expiration date stated on the carton and blister after the abbreviation EXP. The expiration date refers to the last day of the month stated. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Gutron Contains

• The active substance is midodrine hydrochloride.
• The other ingredients are: magnesium stearate, talc, anhydrous colloidal silica, microcrystalline cellulose, cornstarch.

What Gutron Looks Like and Contents of the Package

Gutron is a white, round tablet with the letters "GU" embossed above and the dose "2.5" below the break line. The package contains 20 tablets in two blisters made of PVC/PVDC/Aluminum.

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer

Takeda GmbH, Manufacturing site Oranienburg, Lehnitzstrasse 70-98, 16515 Oranienburg, Germany For further information, please contact: Komtur Polska Sp. z o.o., [email protected] Date of Last Revision of the Leaflet:07/2024