Carvedilol Mylan Generics

Package leaflet: Information for the patient

Carvedilolo Mylan Generics 3.125 mg, 6.25 mg, 12.5 mg and 25 mg film-coated tablets

Generic medicine
(carvedilol)
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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Carvedilolo Mylan Generics contains as its active substance carvedilol, which is a beta-blocker and
vasodilator. Carvedilol widens blood vessels, lowers blood pressure, and reduces the workload of the
heart in pumping blood throughout the body.
Carvedilolo Mylan Generics is indicated for the treatment of hypertension and angina (chest pain).
Carvedilolo Mylan Generics may also be used, in combination with other medicinal products, as an adjunct in the treatment of moderate to severe heart failure.

2. What you need to know before taking Carvedilolo Mylan Generics

Do not take Carvedilolo Mylan Generics:

• if you are allergic to carvedilolo or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from asthma or respiratory disorders due to other lung problems
• if you suffer from unstable heart failure or heart conduction disorders (so-called AV block type II or III, except if you have a pacemaker, or so-called sino-atrial node disease)
• if you have a severe heart condition called cardiogenic shock
• if you have a very slow heart rate (less than 50 beats per minute) or very low blood pressure
• if you have liver disease

Warnings and precautions
Talk to your doctor or pharmacist before taking Carvedilolo Mylan Generics:

• if you suffer from heart failure and:
• low blood pressure
• fluid retention (swelling)
• inadequate blood supply to the heart (ischaemic heart disease)
• and/or kidney problems. Your doctor will perform tests to monitor your kidney function. It may be necessary to reduce your dose.
• If you have a heart conduction problem known as first-degree atrioventricular (AV) block
• If you have diabetes. Treatment with Carvedilolo Mylan Generics may mask symptoms of low blood sugar levels such as feeling unwell, sweating, and weakness. Monitor your blood sugar levels regularly.
• If you have breathing problems, such as shortness of breath or wheezing, and you are not taking specific medicines for this condition. Carvedilolo Mylan Generics may worsen these breathing difficulties.
• If you wear contact lenses, as Carvedilolo Mylan Generics may cause dry eyes.
• If you suffer from Raynaud's syndrome (cold hands and feet) or other peripheral vascular diseases, for example, circulation problems in the legs causing cramp-like pain when walking, as Carvedilolo Mylan Generics may worsen these symptoms.
• If you have hyperthyroidism, as Carvedilolo Mylan Generics may mask its symptoms.
• If you have ever had a severe allergic reaction (e.g. following an insect sting or food) or if you are currently undergoing allergen desensitisation therapy.
• If you have psoriasis.
• If you have a serious acid-base imbalance disorder, a condition called metabolic acidosis, which causes dehydration, rapid breathing, drowsiness, and confusion.
• If you have a very slow heart rate (especially if below 55 beats per minute)
• If you have adrenal gland overactivity (pheochromocytoma)
• If you suffer from a particular type of angina called Prinzmetal's variant angina, caused by spasms of the coronary arteries
• If you suffer from labile or secondary hypertension (blood pressure fluctuates rapidly or high blood pressure is caused by another medical condition)
• If you suffer from orthostatic hypotension, a sudden drop in blood pressure when standing up.
• If you have an acute inflammatory heart disease.
• If you suffer from obstruction of heart valves.

Other medicines and Carvedilolo Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal remedies, especially any of the following:

• other medicines for the heart or for treating blood pressure, including alpha-adrenergic receptor antagonists (e.g. doxazosine), calcium antagonists (e.g. verapamil, diltiazem), medicines for irregular heartbeat (e.g. quinidine, flecainide, amiodarone), nitrates (e.g. isosorbide mononitrate), digoxin, reserpine
• other medicines that may cause low blood pressure as a side effect; since carvedilolo may worsen this effect, e.g. barbiturates (for epilepsy)
• carbamazepine, for the treatment of epilepsy
• cinacalcet, for the treatment of high calcium levels in the blood
• bupropion, for the treatment of nicotine dependence
• fluconazole, for the treatment of fungal infections
• clonidine, for high blood pressure or migraine; if treatment is to be discontinued, treatment with Carvedilolo Mylan Generics should be stopped a few days before gradually reducing the dose of clonidine
• antibiotics such as rifampicin, erythromycin
• cimetidine, for the treatment of gastric ulcers, heartburn
• ciclosporin, an immunosuppressant used in organ transplants
• antidepressants (for the treatment of depression) such as monoamine oxidase inhibitors (MAOIs, e.g. phenelzine), paroxetine, fluoxetine, amitriptyline
• all types of antidiabetic medicines, including insulin, as carvedilolo may enhance the effect of these medicines and also mask symptoms of hypoglycaemia (feeling unwell, weakness, sweating)
• medicines known as sympathomimetics, e.g. pseudoephedrine (for colds), adrenaline (epinephrine), isoprenaline (cardiac stimulant), noradrenaline (norepinephrine)
• neuromuscular blocking agents (to reduce muscle tension)
• medicines for respiratory disorders, e.g. salbutamol, formoterol
• ergotamine, for migraine
• certain types of painkillers (NSAIDs), e.g. ibuprofen
• estrogens (hormones)
• corticosteroids, e.g. prednisolone.

Surgery
Carvedilolo Mylan Generics may interact with anaesthetics during surgery. If you are scheduled for any surgical procedure, including dental surgery, inform your doctor or dentist that you are taking Carvedilolo Mylan Generics.
Ask your doctor for advice before taking any medicine.

Carvedilolo Mylan Generics and alcohol
Alcohol may intensify the effects of Carvedilolo Mylan Generics, causing side effects such as dizziness.

Pregnancy and breastfeeding
Beta-blockers may affect fetal growth. Carvedilolo should be used during pregnancy only if the expected benefit to the mother outweighs the potential risks to the newborn.
Mothers taking carvedilolo should not breastfeed, as carvedilolo may be excreted in breast milk.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Carvedilolo Mylan Generics usually does not affect the ability to drive or operate machinery. However, some people may experience side effects such as dizziness or reduced alertness, especially at the beginning of treatment or when the dose is changed. If you experience any such side effects, do not drive or operate machinery and inform your doctor.

Carvedilolo Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, such as lactose, contact your doctor before taking this medicine.

For athletes: using this medicine without a medical need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to take Carvedilolo Mylan Generics

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.

• The tablets should be taken with at least ½ glass of water.
• You may take the tablets during or apart from meals; however, patients with heart failure should take the tablets with food to reduce the risk of dizziness when standing up suddenly.
• If you feel that the effects of carvedilol are too strong or too weak, discuss this with your doctor.

Carvedilolo Mylan Generics film-coated tablets are available in different strengths. Your doctor will
determine the most appropriate dose for your treatment. The 6.25 mg, 12.5 mg, and 25 mg tablets may be
divided into two equal doses.

Adults (including elderly)
For the treatment of hypertension
The recommended starting dose is 12.5 mg once daily for the first two days, then 25 mg once daily. If
necessary, the dose may be increased up to a maximum of 50 mg daily, given either as a single dose or
divided into two doses.
If you are elderly, your doctor may increase your dose more slowly.

Angina
The recommended starting dose is 12.5 mg twice daily for the first two days, then 25 mg twice daily. If
necessary, your doctor may slowly increase the dose up to a maximum of 100 mg daily. The maximum
recommended dose for elderly patients is 25 mg twice daily.

Heart failure
The recommended starting dose is 3.125 mg twice daily for two weeks. Your doctor may decide to gradually
increase the dose at two-week intervals until the optimal dose for you is reached. The maximum
recommended dose ranges between 25 mg and 50 mg twice daily, depending on your body weight. The
maximum recommended dose in severe heart failure is 25 mg twice daily.
If treatment with carvedilol is interrupted for more than 2 weeks, you should restart at a dose of 3.125 mg
twice daily and gradually increase the dose according to the recommendations above.

If you have liver problems, your doctor will prescribe lower doses than those indicated above.

Use in children and adolescents
Carvedilolo Mylan Generics must not be administered to children or adolescents under 18 years of age.

If you take more Carvedilolo Mylan Generics than you should
If you take more Carvedilolo Mylan Generics than you should, contact your doctor or the nearest hospital
emergency department immediately. Symptoms of overdose may include feeling faint due to very low
blood pressure, slow heartbeat, and in some cases irregular heartbeat, breathing difficulties, feeling unwell,
loss of consciousness, and seizures.

If you forget to take Carvedilolo Mylan Generics
If you forget to take a dose of Carvedilolo 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 the forgotten dose.

If you stop taking Carvedilolo Mylan Generics
If you stop treatment with Carvedilolo Mylan Generics suddenly, unwanted effects may occur. If
necessary, your doctor will gradually reduce your dose.

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 everybody gets them.
If you think you are experiencing any of the following side effects, contact your doctor or go
immediately to the nearest hospital emergency department:
Very common (may affect more than 1 in 10 people):

• Heart problems. Symptoms include chest pain, tiredness, shortness of breath, and swelling of the arms and legs (heart failure or angina).

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

• Severe breathing difficulties, even when resting (pneumonia)
• Severe kidney problems which may lead to reduced urination, feeling drowsy or unwell, breathlessness, weakness, or loss of appetite.

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

• Irregular or missed heartbeats

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

• Allergic reactions (hypersensitivity). Signs may include difficulty breathing or swallowing due to sudden swelling of the throat or face, or swelling of the hands, feet, and ankles.
• Severe skin reactions, including blisters, red or purple spots, or peeling of the skin. The mouth, eyes, nose, and genitals may also be affected (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Other possible side effects:
Very common (may affect more than 1 in 10 people):

• Dizziness.
• Headache.
• Feeling weak and tired.
• Low blood pressure. Symptoms include dizziness or feeling lightheaded.
• Swelling and pain in the genital area.

Dizziness, headache, and feelings of weakness and tiredness are usually mild and occur most commonly at the beginning of treatment.
Common (may affect up to 1 in 10 people):

• Airway infections (bronchitis), nose, and throat (upper respiratory tract). Symptoms include wheezing, shortness of breath, chest tightness, and sore throat.
• Problems during urination.
• Low number of red blood cells (anaemia). Symptoms include feeling tired, pale skin, a sensation of rapid heartbeat (palpitations), and shortness of breath.
• Weight gain.
• Increased cholesterol levels (shown by a blood test).
• Loss of blood sugar control in people with diabetes.
• Feeling depressed.
• Vision problems, eye pain, or dry eyes due to reduced tear production.
• Slow heart rate.
• Dizziness or lightheadedness when standing up.
• Fluid retention. Symptoms include general swelling of the body, swelling of body parts such as hands, feet, ankles, and legs, and an increase in blood volume.
• Circulation problems in arms and legs. Symptoms include cold hands and feet, paleness, tingling and pain in fingers, and leg pain that worsens when walking.
• Breathing problems such as cough or wheezing.
• Malaise, nausea, and vomiting.
• Diarrhoea.
• Stomach upset / indigestion.
• Stomach pain.
• Pain, possibly in hands and feet.
• Kidney problems, including changes in how often you urinate.

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

• Sleep disorders.

• Fainting.

• Tingling or numbness in hands or feet.

• Skin problems, including rashes that may cover large parts of the body, nodular erythema (erythema nodosum), itching, and dry skin patches.

• Hair loss.

• Inability to get an erection (erectile dysfunction).

• Constipation.
  Rare (may affect up to 1 in 1,000 people):

• Low number of platelets in the blood. Symptoms include easy bruising and nosebleeds.

• Nasal congestion.

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

• Low number of all types of white blood cells. Symptoms include mouth, gum, throat, and lung infections.
• Dry mouth.
• Liver problems shown in blood tests.
• Some women may experience difficulty controlling the bladder during urination (urinary incontinence). This usually improves when treatment is stopped.

Carvedilol Mylan Generics may also cause the development of diabetes symptoms in people who have a very mild form of diabetes called "latent diabetes".

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Carvedilol 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 packaging. The expiry date refers to the
last day of that month.
Do not store above 30°C.
Store in the original packaging to protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Carvedilolo Mylan Generics contains

• The active substance is carvedilol. Each film-coated tablet contains 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol.
• The other ingredients are microcrystalline cellulose, monohydrate lactose (see section 2, “Carvedilolo Mylan Generics contains lactose”), crospovidone, povidone, anhydrous colloidal silica, magnesium stearate, hypromellose, titanium dioxide (E171), triethyl citrate, polyethylene glycol and polydextrose (E 1200).

Description of the appearance of Carvedilolo Mylan Generics and contents of the pack
Film-coated 3.125 mg tablet: white, oval and smooth on both sides.
Film-coated 6.25 mg tablet: white, oval, marked on both sides, with "6.25" engraved on one side.
Film-coated 12.5 mg tablet: white, oval, marked on both sides, with "12.5" engraved on one side.
Film-coated 25 mg tablet: white, oval, marked on both sides, with "25" printed on one side.
Carvedilolo Mylan Generics film-coated tablets are available in plastic bottles or blisters containing 10, 14, 28, 30, 50, 56, 98, 100 or 250 tablets (only in plastic container).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan SpA
Via Vittor Pisani 20 – 20124 Milano
Italy

Responsible for batch release
Specifar S.A
1, 28 Octovriou Str.
Ag.Varvara
Athens
123 51 Greece
McDermott Laboratories Ltd t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Dragenopharm Apotheker Püschl GmbH
Göllstrasse 1
84529 Tittmoning
Germany
Generics [UK] Limited
Station Close, Potters Bar
Herts EN6 1TL
United Kingdom
Mylan Hungary Kft.
H-2900 Komárom,
Mylan útca.1
Hungary
Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium - Carvedilol Mylan 3.125 mg, 6.25 mg, 12.5 mg, 25 mg, filmomhulde tabletten
Luxembourg - Carvedilol Mylan 3.125 mg, 6.25 mg, 12.5 mg, 25 mg comprimés pelliculés
Sweden - Karvedilol Mylan 3.125 mg, 6.25 mg, 12.5 mg, 25 mg filmdragerad tablett
Italy - Carvedilolo Mylan Generics 3.125 mg, 6.25 mg, 12.5 mg, 25 mg compresse rivestite con film
Netherlands - Carvedilol Mylan 3.125 mg, 6.25 mg, 25 mg filmomhulde tabletten
Portugal - Carvedilol Mylan
Greece - Carvedilol/Generics F.C. Tab, 6.25 mg, 12.5 mg, 25 mg
United Kingdom - Carvedilol 3.125 mg, 6.25 mg, 12.5 mg, 25 mg Film-coated Tablets