PATIENT INFORMATION LEAFLET

Carvedilol Kern Pharma 6.25 mg Film-Coated Tablets

Carvedilol

Each tablet contains carvedilol as the active ingredient, which is an alpha and beta receptor blocker with antioxidant properties. It also has complementary actions of vasodilation, reduction of cardiac output, anti-hypertensive properties (reduction of blood pressure), anti-anginal effects, and favorable effects on blood circulation at the heart level.

Carvedilol Kern Pharma 6,25 mg is indicated for the treatment of symptomatic heart failure of moderate to severe degree, of ischemic or non-ischemic origin.

Do not take Carvedilol Kern Pharma 6,25 mg tablets

• If you are hypersensitive (allergic) to the drug or any of the excipients of this specialty.
• If you have decompensated heart failure of class IV (NYHA) (heart's inability to perform its pumping function with physical activity and in most cases at rest) that requires the use of intravenous inotropes (medicines that increase heart strength).
• If you have chronic obstructive pulmonary disease, with a bronchoconstrictive component (chronic lung disease that produces difficulty breathing) in patients receiving oral or inhaled treatment.
• If you have clinically manifest liver dysfunction (liver alterations).
• If you have asthma.
• If you suffer from second- and third-degree A-V block (cardiac block).
• If you have severe bradycardia (less than 50 heartbeats per minute).
• In case of cardiogenic shock (heart failure).
• In case of sinus disease (including sinoatrial block).
• In case of severe hypotension (systolic pressure less than 85 mmHg).

Be especially careful with Carvedilol Kern Pharma 6,25 mg tablets

• If you have diabetes mellitus (elevated blood sugar).
• If you have congestive heart failure and risk factors (hypotension, ischemic cardiopathy, diffuse vascular disease, and underlying renal insufficiency), as your doctor should monitor your renal function during the dose adjustment phase.

The carvedilol treatment should not be interrupted abruptly, especially in patients with ischemic cardiopathy. The withdrawal of carvedilol should be gradual over a few days, or by reducing the dose by half every three days.

• Carvedilol should be administered with caution if you suspect having Prinzmetal's variant angina (angina caused by coronary spasms), as well as if you have severe peripheral circulation disorders. In rare cases, symptoms have worsened in patients with angina pectoris (chest pain).
• If you are about to undergo surgery, you must inform your doctor that you are being treated with carvedilol.
• If you have psoriasis (skin disease that can be caused by multiple factors).
• If you have phaeochromocytoma (suprarenal capsule alteration) that is not adequately controlled by alpha blockade.
• If you have thyroid disorders.
• If you have a history of severe hypersensitivity reactions (severe allergies) or are undergoing desensitization therapy (treatment for severe allergies).

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

This is extremely important, as taking multiple medications at the same time can potentiate or weaken their effect. Therefore, do not take carvedilol with any other medication unless your doctor has permitted it.

Carvedilol may interact with antihypertensives (medicines to lower blood pressure), clonidine (medicines to lower blood pressure), antiarrhythmics (medicines for the treatment of cardiac rhythm disorders), digitalis (medicines for the treatment of decreased cardiac function), calcium antagonists (verapamil or diltiazem), sedatives or tranquilizers, antidepressants, narcotics, anesthetics, alcohol, migraine and asthma preparations, anti-inflammatory agents, the antibiotic rifampicin, and cimetidine.

It may also potentiate or reduce the effect of medications used to reduce blood sugar levels, such as insulin or oral antidiabetics, so your doctor may modify the antidiabetic dose and/or adjust your diet.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

There is insufficient experience with carvedilol in pregnant women, so your doctor will evaluate the benefit/risk of administering carvedilol or not.

Due to carvedilol excretion in breast milk, its administration is not recommended during lactation.

Use in children

The efficacy and safety in children have not been established.

Driving and operating machinery

Individual reactions may alter alertness (e.g., the patients' ability to drive vehicles or operate machinery). This is mainly manifested when starting or changing treatment, as well as in conjunction with alcohol.

Important information about some of the components of Carvedilol Kern Pharma 6,25 mg tablets

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

It is reported to athletes that this medication contains a component that may result in a positive analytical result in doping control.

Follow exactly the administration instructions for Carvedilol Kern Pharma 6.25 mg tablets as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The tablets should be taken with sufficient liquid, a glass of water.

If you have congestive heart failure, you should take carvedilol with food, to slow down its absorption rate and thus reduce the incidence of orthostatic effects (dizziness when standing up).

The dose should be determined individually and you should be closely monitored by your doctor during the adjustment to higher doses. You must strictly follow your doctor's instructions regarding the administration of this medication.

If you are taking other medication, it should be your doctor who establishes the treatment.

The recommended starting dose for carvedilol treatment is 3.125 mg (1/2 tablet) twice a day for two weeks. If this dose is tolerated, it can be increased later to 6.25 mg (1 tablet) twice a day.

Your doctor may prescribe higher doses of this medication later (at least two weeks after starting treatment).

If you estimate that the action of Carvedilol Kern Pharma 6.25 mg tablets is too strong or too weak, inform your doctor or pharmacist.

If you take more Carvedilol Kern Pharma 6.25 mg tablets than you should

If you have taken more Carvedilol Kern Pharma 6.25 mg tablets than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

Remember to take your medication.

If you forget to take Carvedilol Kern Pharma 6.25 mg tablets

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Carvedilol Kern Pharma 6.25 mg tablets

Your doctor will indicate the duration of your treatment with Carvedilol Kern Pharma 6.25 mg tablets. The withdrawal of carvedilol should be gradual over a few days, or by reducing the dose by half every three days.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Carvedilol Kern Pharma 6.25 mg tablets may cause adverse effects, although not everyone will experience them.

The frequencies of adverse effects have been listed below according to the following definitions:

Very frequent (affects more than 1 in 10 patients)

Frequent (affects between 1 and 10 in 100 patients)

Uncommon (affects between 1 and 10 in 1,000 patients)

Rare (affects between 1 and 10 in 10,000 patients)

Very rare (affects fewer than 1 in 10,000 patients)

Unknown frequency (cannot be estimated from available data)

The adverse effects that have been observed are as follows:

Blood and lymphatic system disorders:

• Frequent: thrombocytopenia.

Metabolism and nutrition disorders:

• Very frequent: hyperglycemia, in patients with pre-existing diabetes mellitus (see Warnings, section 4.4).
• Frequent: hypercholesterolemia.

Nervous system disorders:

• Very frequent: dizziness.

Eye disorders:

• Frequent: visual disturbances.

Cardiac disorders:

• Very frequent: edema.
• Frequent: bradycardia, hypotension, heart failure during dose adjustment phase, syncope, AV block, and postural hypotension.

Gastrointestinal disorders:

• Very frequent: diarrhea.
• Frequent: nausea and vomiting.

Renal and urinary disorders:

• Frequent: renal function abnormalities in patients with diffuse vascular disease or renal function deterioration (see Warnings, section 4.4) and acute renal failure.

The frequency of adverse reactions is not proportional to the dose, except for dizziness, visual disturbances, and bradycardia.

If you consider any of the adverse effects to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of sight and reach of children.

Do not store above 30°C. Store in the original packaging to protect it from moisture.

Do not use Carvedilol Kern Pharma 6,25 mg Tablets after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Carvedilol Kern Pharma 6.25 mg Tablets

• The active ingredient is carvedilol. Each tablet contains 6.25 mg of carvedilol.
• The other components are:

Tablet core: microcrystalline cellulose (E-460i), lactose monohydrate (25 mg), povidone (E-1201), crospovidone, anhydrous colloidal silica, and magnesium stearate (E-470b).

Coating: titanium dioxide (E-171), dextrin, hypromellose (E-464), triethyl citrate, and macrogol 8000.

Appearance of the product and contents of the package

Carvedilol Kern Pharma 6.25 mg is presented in packages of 28 scored, film-coated tablets for oral administration.

Other presentations:

Carvedilol Kern Pharma 25 mg film-coated tablets. Packages containing 28 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for Manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Or

DRAGENOPHARM APOTHEKER PÜSCHL GMBH

Göllstrasse, 1

D-84529 Tittmoning, Germany

Or

Delorbis Pharmaceuticals Ltd.

17, Athinon Street, Ergates Industrial Area,

2643 Ergates, Nicosia, Cyprus

This leaflet has been revised inOctober 2009