GUTRON 5 mg TABLETS

2. What you need to know before you take Gutron

Do not 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 high blood pressure
• if you have a slow pulse
• if you have difficulty urinating
• if you suffer from any type of heart or vascular disease
• if you have high eye pressure (glaucoma) and vision problems due to diabetes
• if you have hyperactivity of the thyroid gland
• if you have hormonal disorders due to a tumor in the adrenal medulla (pheochromocytoma)
• if you have severe kidney failure
• if you have an enlarged prostate gland

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gutron:

• if you have high blood pressure when lying down, then your blood pressure will be monitored when standing and sitting due to the risk of high blood pressure when lying down, for example at night.

If you have high blood pressure when lying down and it does not vary when reducing the dose, then treatment with Gutron should be discontinued.

This is important when taking Gutron.

Avoid nighttime administration. The risk of increased blood pressure is also reduced if you sleep with your head elevated.

Patients should be monitored due to possible hypertensive side effects.

• if you have a severe alteration of the autonomic nervous system, because Gutron can lead to a greater decrease in blood pressure when standing. If this is the case, treatment with midodrine should be stopped.

if you suffer from alterations in the circulatory system in the arteries.

• if you suffer from prostate alterations because it can cause difficulty urinating.

It is recommended that your kidney function and blood pressure be monitored before starting treatment with Gutron. During treatment with Gutron, your doctor should occasionally monitor your blood pressure to adjust the dose if necessary.

It is important that you immediately report symptoms related to high blood pressure, such as rapid heartbeat, headache, and blurred vision. Your doctor will decide whether to adjust the dose or discontinue treatment with Gutron.

Consult your doctor if any of the above circumstances have ever occurred to you.

Children

Gutron should not be used in children due to the limited information available on the use of midodrine hydrochloride in this population.

Taking Gutron with other medicines

• Midodrine may affect how some medicines work. These include perfenazine (for the treatment of psychosis, manic episodes), amiodarone (for the treatment of irregular heartbeat), metoclopramide (for the treatment of nausea and vomiting). Taking midodrine with these medicines may increase their respective effects.
• Concomitant treatment with sympathomimetics (substances with a stimulating effect on certain parts of the nervous system) and other vasoconstrictors (agents that cause narrowing of blood vessels) such as reserpine, guanethidine, tricyclic antidepressants, antihistamines, thyroid hormones, and MAO inhibitors should be avoided because they can cause an increase in blood pressure.
• As with other medicines of the same class, the effect of midodrine is nullified by medicines such as prazosin and phentolamine (medication for heart disease)
• It is not recommended to use it simultaneously with digitalis preparations (medicines used for heart disease) because it can cause alterations in cardiac function.

Midodrine may increase the hypertensive effect of fluorocortisone acetate (corticosteroid anti-inflammatory).

• If midodrine is combined with other medicines that can directly or indirectly reduce heart rate, monitoring by your doctor is advised.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Gutron is not recommended during pregnancy.

You should not take Gutron during breastfeeding.

Driving and using machines

The effect of Gutron is insignificant; however, in case of dizziness or slight drowsiness, you should be cautious when driving vehicles or operating machinery.

Gutron contains the yellow-orange dye S

It may cause allergic reactions.

3. How to take Gutron

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The initial dose is 2.5 mg three times a day. (Gutron can be divided into equal doses of 2.5 mg). This dose can be increased weekly up to 10 mg three times a day, which is the normal maintenance dose of 30 mg per day.

The total daily recommended dose should be administered in three daily doses.

There is no information available on the use in children, in elderly patients, in patients with renal failure, and in patients with altered liver function.

Take the tablets with a small amount of water. The medicine can be taken with food.

The tablet can be divided into equal doses.

Avoid nighttime administration. The last dose should be taken 4 hours before bedtime. Elevating the head at night reduces the risk of increased blood pressure. More information is available in this leaflet in the section "Warnings and precautions".

Your doctor will indicate the duration of treatment with Gutron. The treatment is usually long-term. If you have any impression that the effect of Gutron is too strong or too weak, talk to your doctor or pharmacist.

If you take more Gutron than you should

If you have taken too much Gutron, contact your doctor or pharmacist.

Overdose can cause:

• high blood pressure
• slow heart rate (bradycardia)
• difficulty urinating
• goosebumps
• feeling of cold

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Gutron

Do not take a double dose of Gutron to make up for the forgotten individual dose due to the risk of high blood pressure when lying down.

Avoid nighttime administration.

If you stop taking Gutron

It will not cause a sudden drop in blood pressure.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

Goosebumps, itching on the head, and pain when urinating.

Common (may affect up to 1 in 10 people):

Numbness and itching, increased blood pressure when lying down, headache, nausea, acidity, inflammation of the mouth mucosa, flushing, skin rash, chills, difficulty urinating.

Uncommon (may affect up to 1 in 100 people)

Sleep disorders, including difficulty sleeping, excitability, agitation, and irritability, slow heartbeats, urgent need to urinate.

Rare (may affect up to 1 in 1,000 people)

Cardiac palpitations, rapid heart rate, altered liver function, including elevated liver enzymes.

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

Anxiety, abdominal pain, vomiting, and diarrhea.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Gutron

Keep this medicine out of the sight and reach of children.

Store at a temperature below 25°C. Store in the original package.

Keep the blister pack in the carton box.

Gutron has a shelf life of 3 years. Do not use Gutron after the expiry date stated on the carton after "CAD". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions on how to dispose of the packaging and any unused medicine, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and further information

What Gutron contains

The active substance is midodrine hydrochloride

The other ingredients in Gutron are magnesium stearate, talc, anhydrous colloidal silica, microcrystalline cellulose, corn starch, E 110 yellow-orange S.

Appearance of the product and pack contents

Tablets

Orange, round, biplanar tablets with a beveled edge, scored on one side "GU" above and "5" below the score line.

Presentation of 20, 30, or 50 tablets.

100-tablet glass bottle.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer:

Takeda GmbH

Plant Oranienburg

Lehnitzstr., 70-98

DE-16514 Oranienburg

Germany

Local representative

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

NetherlandsGutron 5, 5mg tablets

SpainGutron 5mg tablets

Date of last revision of this leaflet: February 2016

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es