Moxonidine Mylan Generics

Package leaflet: Information for the user

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

moxonidine
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 taking 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 Moxonidina Mylan Generics is and what it is 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 taking Moxonidina Mylan Generics

Do not take Moxonidina Mylan Generics if:

• you are allergic (hypersensitive) to moxonidine or to any of the other ingredients of this medicine (listed in section 6)
• you have a slow heartbeat (below 50 beats/minute at rest) or suffer from an abnormal heart rhythm or a change in the heart rate speed (called "sick sinus syndrome" or "second- or third-degree AV block")
• 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 "first-degree AV block" 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 your dose
• you are elderly. Your doctor may start you on the lowest dose and increase it gradually.

Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age.
Other medicines and Moxonidina Mylan Generics Mylan 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 conditions (see "If you stop treatment with 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 pills and tranquilizers
• moxonidine is removed from the body by the kidneys through a process called "tubular excretion". Other medicines eliminated by the kidneys in the same way may affect how moxonidine works.

Moxonidina Mylan Generics and alcohol
Do not drink alcohol while taking this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
This medicine must not be used during pregnancy unless clearly necessary. Moxonidine has been shown to pass into breast milk and therefore must not be used during breastfeeding. If treatment with moxonidine is considered absolutely necessary, breastfeeding must be discontinued.
Driving and using machines
Do not drive or operate machinery if you experience dizziness or drowsiness during treatment.
Moxonidina Mylan Generics contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Moxonidina Mylan Generics

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

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

Recommended dose:
Use in adults (including elderly patients)
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 daily 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 (divided into morning and evening doses).

Use in patients with kidney problems
These patients may be more sensitive to the effects of Moxonidina Mylan Generics.
A single dose should not exceed 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 must not be given to children and adolescents under 18 years of age.

If you take more Moxonidina Mylan Generics than you should
Contact your doctor or the nearest Emergency Department immediately. Take the pack and any remaining tablets with you. Symptoms of overdose include headache, drowsiness (somnolence, sedation), drop in blood pressure (hypotension), dizziness, unusual weakness (asthenia), slowed heart rate (bradycardia), dry mouth, feeling unwell (nausea, vomiting), fatigue, and stomach pain (abdominal pain).

If you forget to take Moxonidina Mylan Generics
Take it as soon as you remember, unless it is almost time for your next dose.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Moxonidina Mylan Generics
Do not stop taking Moxonidina Mylan Generics suddenly, as this may cause serious changes in your blood pressure. Discuss with your doctor first. Your doctor will gradually reduce your dose over a period of 2 weeks.
If you are taking Moxonidina Mylan Generics together with beta-blockers (e.g., propranolol), the beta-blocker treatment should be discontinued a few days before stopping Moxonidina Mylan Generics. This is because stopping both treatments at the same time may cause an increase in blood pressure.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any of the following side effects occur, stop taking Moxonidina Mylan Generics and contact your doctor immediately or go to the nearest hospital emergency department.

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

• Difficulty breathing, tightness in the chest, swelling of the face, lips, mouth, throat or tongue, or skin rashes. These may be signs of 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 whites of the eyes.

These side effects are serious and may require urgent medical treatment.

Other side effects, listed in order of decreasing frequency, may include:

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

• dry mouth

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

• headache
• dizziness/vertigo
• back pain
• abnormal thinking
• sleep problems, difficulty sleeping (insomnia), feeling drowsy (somnolence)
• skin rash/itching
• feeling unwell (nausea), stomach discomfort, indigestion, constipation, diarrhoea, feeling unwell (vomiting)
• hot flushes
• weakness (asthenia)

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

• feeling anxious or nervous
• swelling of various body parts (e.g. hands or ankles), fluid retention, leg weakness
• fainting
• drowsiness
• loss of appetite (anorexia)
• neck pain, pain in the parotid gland (gland below the ear)
• low blood pressure, including low blood pressure upon standing
• ringing or noise in the ears
• dry, itchy or burning eyes
• sensation of pins and needles or other abnormal sensations (paraesthesia) in the extremities
• cold or painful fingers or toes and other circulatory problems
• breast enlargement in male patients
• inability to achieve or maintain an erection, loss of sexual desire
• slow heart rate

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 stated on the label or on the carton after the word “EXP.”. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Moxonidina Mylan Generics contains
Each tablet contains 0.2 mg or 0.4 mg of the active substance moxonidine.
The other ingredients 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 contents of the pack
The medicine is presented as 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 containing 10, 28, 28x1, 30, 50, 98 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano - 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 European Economic Area countries under the following names:
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