MOXON 0.4 mg FILM-COATED TABLETS

1. What Moxon is and what it is used for

Moxon belongs to the group of medications called imidazoline receptor agonists (medications that lower blood pressure).

Moxon is indicated for the treatment of arterial hypertension.

2. What you need to know before taking Moxon

Do not take Moxon

• If you are allergic to the active ingredient or any of the other components of the medication.
• If your heart beats slowly due to a disease called sick sinus syndrome or second- or third-degree AV block.
• If you have bradycardia.
• If you have heart failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Moxon:

• If you have a heart problem called first-degree AV block
• If you have severe coronary artery disease or unstable angina (chest pain)
• If you have kidney problems. Your doctor may need to adjust the dose.
• If it is administered with a beta-blocker (to treat high blood pressure, arrhythmias, and other heart disorders) and the administration of both medications needs to be discontinued, the beta-blocker should be discontinued first, and a few days later, the moxonidine.
• Do not stop taking Moxon abruptly, but rather gradually over 2 weeks.
• If you are an elderly person, as the initial dose will be lower and you will need to be monitored more closely for any side effects you may experience.

Children and adolescents

Moxon is not recommended for use in children and adolescents under 18 years of age due to the lack of data on safety and efficacy.

Using Moxon with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Certain medications may interact with Moxon, and in these cases, it may be necessary to change the dose or discontinue treatment with one of the medications.

It is especially important to inform your doctor if you are taking one of the following medications:

• other medications that lower blood pressure. Moxon may enhance the effect of these medications
• medications for depression, such as imipramine or amitriptyline. It is not recommended to take them with Moxon.
• tranquilizers, sedatives, sleep medications (hypnotics), benzodiazepines (to treat anxiety). Moxon may increase the sedative effect of these medications.
• Moxon is eliminated from the body through the kidneys by a process called tubular excretion. Other medications that are eliminated through the kidneys by tubular excretion may affect the way Moxon works.

Taking Moxon with food, drinks, and alcohol

Moxon can be taken with or without food.

You should avoid consuming alcohol. Alcohol increases the sedative effect of Moxon.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Consult your doctor or pharmacist before using any medication.

Moxon should not be taken during pregnancy unless it is strictly necessary.

Moxon should not be taken during breastfeeding.

Driving and using machines

There is no information on whether Moxon affects the ability to drive or use machines. Drowsiness and dizziness have been reported. This should be taken into account when performing these activities.

Moxon contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Moxon

Follow the administration instructions for Moxon indicated by your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist again.

The usual starting dose of moxonidine is 0.2 mg per day. The daily dose can be increased up to a maximum of 0.6 mg, divided into two doses. The maximum dose that can be administered to a patient in a single dose is 0.4 mg. The doses should be adjusted individually based on the patient's response.

Patient with renal impairment

In patients with moderate or severe renal insufficiency, the initial dose is 0.2 mg per day. If necessary and if well tolerated, the dose can be increased to 0.4 mg per day.

In patients undergoing hemodialysis, the initial dose is 0.2 mg per day. If necessary and if well tolerated, the dose can be increased to 0.3 mg per day.

Use in children and adolescents

Moxon is not recommended for use in children and adolescents under 18 years of age due to the lack of data on safety and efficacy.

If you take more Moxon than you should

Consult your doctor immediately, go to the nearest hospital, or contact the Toxicology Information Service, phone 91 562 04 20, if you have taken more tablets than your doctor indicated.

If you forget to take Moxon

If you forget to take a dose, take it as soon as you remember. However, if there are less than 4 hours left before the next dose, wait for the next dose and take it at the usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Moxon

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Stop taking Moxon and go to the doctor immediately if you notice any of the side effects described below, as you may need urgent treatment:

• Swelling of the face, lips, or mouth (angioedema). This is very rare, affecting up to 1 in 100 people who take it.

Other side effects include:

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

• Dry mouth

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

• Back pain
• Headache
• Fatigue (asthenia)
• Dizziness, vertigo
• Rash, itching (pruritus)
• Difficulty sleeping (insomnia), feeling drowsy (somnolence)
• Feeling nauseous (nausea), diarrhea, vomiting, indigestion (dyspepsia)

Uncommon (may affect up to 1 in 100 people):

• Neck pain
• Feeling nervous
• Fainting (syncope)
• Swelling (edema)
• Ringing or sounds in the ears (tinnitus)
• Slow heart rate (bradycardia)
• Low blood pressure, including when standing or getting up after sitting or lying down

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Moxon

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

Do not store above 30°C.

Do not use Moxon after the expiration date shown on the packaging after "CAD" or "EXP". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Moxon

• The active ingredient is moxonidine. Each tablet contains 0.4 mg of moxonidine.
• The other components are lactose monohydrate, povidone K25, crospovidone, magnesium stearate, hypromellose 2910, ethylcellulose solution 30%, macrogol 6000, talc, red iron oxide (E 172), and titanium dioxide (E 171).

Appearance of the product and package contents

Moxon 0.4 mg is presented in the form of film-coated tablets. Each package contains 30 or 60 tablets.

Marketing authorization holder and manufacturer

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Mylan Laboratories SAS

Route de Belleville – Lieu dit Maillard

01400 Châtillon sur Chalaronne

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the last revision of this prospectus: January 2019

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