MOXONIDINA 0.2 MG Film-coated tablets

Зміст інструкції

1. Moxonidina Mylan Generics 0.2 mg film-coated tablets, 0.4 mg film-coated tablets
   1. What is Moxonidina Mylan Generics and what is it used for
   2. What you need to know before you take Moxonidina Mylan Generics
   3. How to take Moxonidina Mylan Generics
   4. Possible side effects
   5. How to store Moxonidina Mylan Generics
   6. Package contents and other information

Moxonidina Mylan Generics 0.2 mg film-coated tablets, 0.4 mg film-coated tablets

moxonidina

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Moxonidina Mylan Generics and what is it used for

Moxonidina Mylan Generics belongs to a group of medicines called antihypertensives, which
reduce blood pressure.
Moxonidina Mylan Generics is used to treat high blood pressure (hypertension).

2. What you need to know before you take Moxonidina Mylan Generics

Do not take Moxonidina Mylan Generics if:

• you are allergic (hypersensitive) to moxonidine or any of the other ingredients of this medicine (listed in section 6)
• you have a slowed heartbeat (below 50 beats/minute at rest) or suffer from an abnormal heart rhythm or a change in heart rate (called "sick sinus syndrome" or "AV block of 2nd or 3rd degree")
• you have heart failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking moxonidine if:

• you have a type of irregular heartbeat called “AV block of 1st degree” or if you are at high risk of developing AV block
• you have severe coronary artery disease or chest pain (unstable angina pectoris)
• you have kidney problems. Your doctor may need to adjust the dose
• you are elderly. Your doctor may start you on the lowest dose and gradually increase it.

Children and adolescents
This medicine should not be given to children and adolescents under the age of
18 years.

Other medicines and Moxonidina Mylan GenericsMylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, especially any of the following:

• beta-blockers such as propranolol or atenolol, used to treat heart problems (see "If you stop taking Moxonidina Mylan Generics" in section 3)
• other medicines used to lower blood pressure such as furosemide (a diuretic), captopril (an ACE inhibitor) or tolazoline (an alpha-blocker)
• medicines used to treat anxiety such as benzodiazepines (e.g. diazepam, lorazepam) and depression, for example amitriptyline
• sleeping tablets and sedatives
• moxonidine is removed from the body through the kidneys through a process called "tubular excretion". Other medicines, eliminated by the kidneys in the same way, can affect how moxonidine works.

Moxonidina Mylan Generics with alcohol
Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you might be pregnant ,
ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be given during pregnancy unless clearly
necessary. Moxonidine has been shown to pass into breast milk and therefore should not be
used during breastfeeding. If therapy with moxonidine is considered absolutely
necessary, breastfeeding must be stopped.

Driving and using machines
Donot drive or use machines if you experience dizziness or drowsiness during treatment.

Moxonidina Mylan Generics contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.

3. How to take Moxonidina Mylan Generics

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.

• Swallow the tablet with a glass of water
• Take before, during or after meals.

The recommended dose is:

Use in adults (including the elderly)
The recommended starting dose is one 0.2 mg tablet taken in the morning. After 3 weeks
your doctor may increase the dose to 0.4 mg of moxonidine (taken as a single dose in the morning or
as 0.2 mg in the morning and 0.2 mg in the evening). If necessary, after another 3 weeks, the dose may
be increased to the maximum dose of 0.6 mg (in divided doses in the morning and evening).

Use in patients with kidney problems
They may be more sensitive to the effects of Moxonidina Mylan Generics.
A single dose should not be greater than 0.2 mg and the maximum daily dose is 0.4 mg
of Moxonidina Mylan Generics. If you have severe kidney problems, the maximum daily dose is
0.3 mg of Moxonidina Mylan Generics.

Use in children and adolescents
Moxonidina Mylan Generics should not be administered to children and adolescents under
18 years of age.

If you take more Moxonidina Mylan Generics than you should
Contact immediatelyyour doctor or the nearest Emergency Room. Take the package
and the remaining tablets with you. Symptoms of overdose include headache, feeling sleepy
(drowsiness, sedation), decreased blood pressure (hypotension), feeling dizzy,
unusual weakness (asthenia), slowed heartbeat (bradycardia), dry mouth, feeling
sick (vomiting), feeling tired and stomach pains (abdominal pain).

If you forget to take Moxonidina Mylan Generics
Take it as soon as you remember unless it is almost time for the next dose.

Do nottake a double dose to make up for a missed dose.

If you stop taking Moxonidina Mylan Generics
Do notsuddenly stop taking Moxonidina Mylan Generics as this may
cause serious changes in your blood pressure. Talk to your doctor first. The
doctor will slowly reduce your dose over 2 weeks.
If you are taking Moxonidina Mylan Generics and beta-blockers (e.g., propranolol)
at the same time, treatment with the beta-blocker should be stopped a few days
before treatment with Moxonidina Mylan Generics is stopped. This is because
stopping both treatments at the same time can cause an increase in
blood pressure.
If you have any doubts 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.
If any of the following side effects occur, stop taking Moxonidina Mylan
Generics and immediately inform your doctoror go to the emergency room of the nearest
hospital.

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

• Difficulty breathing, feeling of tightness in the chest, swelling of the face, lips, mouth, throat or tongue or skin rashes. This may be an allergic reaction to the medicine.

Very rare(may affect up to 1 in 10,000 people):

• Liver problems, dark urine, pale stools, yellowing of the skin or the whites of the eyes.

These side effects are serious. You may need urgent medical attention.
In decreasing order of frequency, other side effects may include:

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

• dry mouth

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

• headache
• feeling dizzy/vertigo
• back pain
• abnormal thinking
• problems with sleeping, difficulty sleeping (insomnia), feeling sleepy (somnolence),
• skin rashes/itching
• feeling unwell (nausea), stomach discomfort, indigestion, constipation, diarrhoea, feeling sick (vomiting)
• hot flushes.
• weakness (asthenia)

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

• feeling anxious or nervous
• swelling of different parts of the body (e.g. of hands or ankles), fluid retention, weakness in the legs
• fainting
• drowsiness
• loss of appetite (anorexia)
• neck pain, pain in the parotid gland (gland under the ear)
• low blood pressure, including low blood pressure when standing up
• ringing or noise in the ears
• dry eyes, with itching or burning
• pins and needles or abnormal sensations (paresthesia) in the extremities
• cold or painful hands or feet and other circulatory problems
• breast enlargement in male patients
• inability to get or maintain an erection, loss of sexual desire
• slow heartbeat

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Moxonidina Mylan Generics

Keep this medicine out of the sight and reach of children .
Do not use this medicine after the expiry date which is stated on the label or the packaging
after the word “EXP.”. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Moxonidina Mylan Generics contains
Each tablet contains 0.2 mg or 0.4 mg of the active ingredient moxonidine.
The other excipients are lactose monohydrate, crospovidone (Type A), povidone K-25, magnesium
stearate. The coating contains hypromellose, titanium dioxide (E171), macrogol 400 and iron
oxide red (E172).

What Moxonidina Mylan Generics looks like and package contents
The medicine is presented in round tablets. The 0.2 mg tablets are light pink and
the 0.4 mg tablets are dark pink.
Moxonidina Mylan Generics is available in blister packs of 10, 28, 28x1, 30, 50, 98 and
100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan - Italy

Manufacturer responsible for batch release:
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Chanelle Medical
IDA Industrial Estate Loughrea Co Galway
Ireland
Mylan Hungary Ltd, H-2900 Komarom, Mylan utca 1, Hungary

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria - Moxonidin “Arcana” Filmtabletten
Belgium - Moxonidine Mylan
Bulgaria – Моксониджен
Czech Republic - Moxonidin Mylan
Finland - Moxonidin Mylan
Germany - Moxodura Filmtabletten
Greece - Moxonidine/Generics
Hungary - Moxonidin Mylan
Italy - Moxonidina Mylan Generics
Luxembourg - Moxonidine Mylan
The Netherlands - Moxonidin Mylan
Romania – Moxonidină Mylan
Slovak Republic - Moxonidin Mylan
The United Kingdom – Moxonidine Film-coated tablets