Moxon 0.2 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Moxon 0.2 mg film-coated tablets
Moxonidine
Read the entire package leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the package leaflet
- What Moxon is and what it is used for
- What you need to know before taking Moxon
- How to take Moxon
- Possible adverse effects
- How to store Moxon
- 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 hypertension.
2. What you need to know before starting Moxon
Do not take Moxon
- If you are allergic to the active substance or to any of the other components of the medicine.
- If your heart beats slowly due to a condition 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 condition called first-degree AV block.
- If you have severe coronary artery disease or unstable chest pain (angina).
- If you have kidney problems. Your doctor may need to adjust the dose.
- If Moxon is being administered together with a beta-blocker (used to treat high blood pressure, arrhythmias, and other heart disorders) and treatment with both medicines needs to be discontinued, the beta-blocker should be stopped first, followed by moxonidine a few days later.
- Do not stop treatment with moxonidine abruptly; instead, taper it off gradually over 2 weeks.
- If you are elderly, as your initial dose will be lower and you will need to be monitored more carefully for any adverse effects.
Children and adolescents
Moxon is not recommended for use in children and adolescents under 18 years of age due to lack of data on safety and efficacy.
Use of Moxon with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interact with Moxon; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.
It is especially important that you inform your doctor if you are taking any of the following medicines:
- Other medicines that lower blood pressure. Moxon may enhance the effect of these medicines.
- Medicines for depression, such as imipramine or amitriptyline. Concomitant administration with Moxon is not recommended.
- Tranquilizers, sedatives, sleeping medicines (hypnotics), benzodiazepines (used to treat anxiety). Moxon may increase the sedative effect of these medicines.
- Moxon is eliminated from the body via the kidneys through a process called tubular excretion. Other medicines that are also eliminated by tubular excretion may affect how Moxon works.
Taking Moxon with food, drinks, and alcohol
Moxon may 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 might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Consult your doctor or pharmacist before using any medicine.
Moxon should not be used during pregnancy unless strictly necessary.
Moxon should not be used during breastfeeding.
Driving and use of machines
There is no information available 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 medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Moxon
Follow exactly the instructions for using Moxon provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The usual starting dose of moxonidine is 0.2 mg once daily. The daily dose may be increased up to a maximum of 0.6 mg, divided into two doses. The maximum dose that may be administered to a patient in a single dose is 0.4 mg. Doses should be individually adjusted according to the patient's response.
Patients with impaired renal function
In patients with moderate or severe renal impairment, the initial dose is 0.2 mg daily. If necessary and if well tolerated, the dose may be increased to 0.4 mg daily.
In patients undergoing haemodialysis, the initial dose is 0.2 mg daily. If necessary and if well tolerated, the dose may be increased to 0.3 mg daily.
Use in children and adolescents
Moxon is not recommended for use in children and adolescents under 18 years of age due to the absence of data on safety and efficacy.
If you take more Moxon than you should
Contact your doctor immediately, go to the nearest hospital, or contact the Toxicology Information Service at telephone number 91 562 04 20 if you have taken more tablets than prescribed 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 remaining before the next dose, wait until the next dose and take it at the usual time. Do not double the dose.
If you stop taking Moxon
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Stop taking Moxon and go to the doctor immediately if you notice any of the following adverse effects, as they may require urgent treatment:
- Swelling of the face, lips or mouth (angioedema). This is very rare, affecting up to 1 in every 100 people who take it.
Other adverse effects include:
Very common (may affect more than 1 in every 10 people):
- Dry mouth
Common (may affect up to 1 in every 10 people):
- back pain
- headache
- tiredness (asthenia)
- dizziness, vertigo
- skin rash, itching (pruritus)
- difficulty sleeping (insomnia), feeling drowsy (somnolence)
- feeling sick (nausea), diarrhoea, vomiting, indigestion (dyspepsia)
Uncommon (may affect up to 1 in every 100 people):
- neck pain
- feeling nervous
- fainting (syncope)
- swelling (oedema)
- ringing or noises in the ears (tinnitus)
- slow heartbeat (bradycardia)
- low blood pressure, including when standing up or when standing up after sitting or lying down for a period of time
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 indicated on the packaging after "CAD" or "EXP". The expiry date refers to the last day of the month stated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 components are monohydrate lactose, povidone K25, crospovidone, magnesium stearate, hypromellose 2910, ethylcellulose 30% solution, macrogol 6000, talc, iron oxide red (E 172), and titanium dioxide (E 171).
Appearance of the product and contents of the container
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
For further information about this medicinal product, 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
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/