MOXON 0.2 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Moxon 0.2 mg Film-Coated Tablets

Moxonidine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Moxon is and what it is used for
2. What you need to know before you take Moxon
3. How to take Moxon
4. Possible side effects
5. Storage of Moxon
6. Contents of the pack and other information

1. What Moxon is and what it is used for

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

Moxon is indicated for the treatment of high blood pressure.

2. What you need to know before you take Moxon

Do not take Moxon

• If you are allergic to the active substance or any of the other ingredients of this medicine.
• 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 taking Moxon:

• If you have a heart problem called first degree AV block
• If you have 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 need to stop taking both medicines, stop the beta-blocker first and then stop Moxon a few days later.
• Do not stop taking Moxon abruptly, but 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 side 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.

Using Moxon with other medicines

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

Some medicines may interact with Moxon, and in these cases, it may be necessary to change the dose or stop treatment with one of the medicines.

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

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

Taking Moxon with food, drinks, and alcohol

Moxon can be taken with or without food.

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

Pregnancy and breastfeeding

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

Ask your doctor or pharmacist for advice before taking any medicine.

Moxon should not be taken during pregnancy unless 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.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Moxon

Take Moxon exactly as your doctor or pharmacist has told you. If you are not sure, ask 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 given 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 impairment, 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 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 (tel: 91 562 04 20) if you have taken more tablets than your doctor prescribed.

If you forget to take Moxon

If you forget to take a dose, take it as soon as you remember. However, if it is less than 4 hours before the next dose, wait until the next dose and take it at the usual time. Do not take a double dose.

If you stop taking Moxon

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Moxon and go to your doctor immediately if you notice any of the following serious side effects:

• 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 sick (nausea), diarrhea, vomiting, indigestion (dyspepsia)

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

• Neck pain
• Feeling nervous
• Fainting (syncope)
• Swelling (edema)
• Ringing or buzzing in the ears (tinnitus)
• Slow heart rate (bradycardia)

• Low blood pressure, including when standing up or after sitting or lying down for a while

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 Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Moxon

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

Do not store above 25°C.

Do not use Moxon after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Additional Information

Composition of Moxon 0.2 mg film-coated tablets

• The active substance is moxonidine. Each tablet contains 0.2 mg of moxonidine.
• The other ingredients 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 and packaging

Moxon 0.2 mg is presented as film-coated tablets. Each pack contains 30 or 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicine from 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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/