Package Insert: Information for the User

Moxon 0.2 mg Film-Coated Tablets

Moxonidine

Read this package insert carefully before you start taking the medicine because it contains important information for you

Keep this package insert, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this package insert. See section 4.

Moxonbelongs to a group of medications known as imidazoline receptor agonists (medications that lower blood pressure).

Moxon is indicated for the treatment of high blood pressure.

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 a severe coronary artery disease or unstable angina.
• If you have kidney problems. Your doctor may need to adjust the dose.
• If you are taking a beta-blocker (to treat high blood pressure, arrhythmias, and other heart disorders) and both medications need to be discontinued, the beta-blocker should be stopped first and then Moxonidina after a few days.
• Do not stop taking moxonidina abruptly, but rather gradually over 2 weeks.
• If you are an elderly person, as the initial dose you will be given will be lower and you will need to be closely monitored for any adverse effects.

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.

Use of Moxon with other medications

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

Certain medications may interact with Moxon, in which case it may be necessary to change the dose or discontinue 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 potentiate the effect of these medications.
• Medications for depression, such as imipramine or amitriptyline. Their concurrent administration with Moxon is not recommended.
• Sedatives, tranquilizers, sleep medications (hypnotics), benzodiazepines (for anxiety). Moxon may increase the sedative effect of these medications.
• Moxon is eliminated from the body through the kidneys via a process called tubular excretion. Other medications that are eliminated through the kidneys via 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, or if you think you may be 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 strictly necessary.

Moxon should not be taken during breastfeeding.

Driving and operating machinery

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

Moxon contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for Moxon indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual starting dose of moxonidine is 0.2 mg per day. The daily dose may 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. Doses should be adjusted individually based on the patient's response.

Patients with renal function impairment

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

In patients undergoing hemodialysis, the initial dose is 0.2 mg per day. If necessary and well tolerated, the dose may 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 due to the absence 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 Toxicological Information Service at phone number 91 562 04 20, if you have taken a number of tablets greater than that indicated by your doctor.

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 before the next dose, wait for the next dose and take it at the usual time. Do not double the dose.

If you interrupt treatment with Moxon

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Stop taking Moxon and go quickly to the doctor if you notice any of the adverse effects described below, as it may require urgent treatment:

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

Other adverse effects include:

Very frequent (can affect more than 1 in 10 people):

• Dry mouth

Frequent (can affect up to 1 in 10 people):

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

Less frequent (can affect up to 1 in 100 people):

• Neck pain
• Feeling nervous
• Fainting (syncope)
• Swelling (edema)
• Tinnitus or sounds in the ears
• Slow heart rate (bradycardia)

• Low blood pressure, including when standing up or standing up after being seated or lying down

Reporting Adverse Effects

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

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

Do not store above 25°C.

Do not use Moxon after the expiration date that appears on the packaging after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Moxon Composition0.2 mg film-coated tablets

- The active ingredient is moxonidina. Each tablet contains 0.2 mg of moxonidina.

- The other components are lactose monohydrate, povidone K25, crospovidone, magnesium stearate, Hypromellose 2910, ethylcellulose solution at 30%, Macrogol 6000, talc, iron oxide red (E 172), and titanium dioxide (E 171).

Product appearance and packaging contents

Moxon 0.2 mg is presented in the form of film-coated tablets. Each package contains 30 or 60 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

Mylan Laboratories SAS

Route de Belleville – Lieu dit Maillard

01400 Châtillon sur Chalaronne

France

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This leaflet was approved in August 2011

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/