Carvedilol Kern Pharma 6.25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Carvedilol Kern Pharma 6.25 mg film-coated tablets EFG

Carvedilol

Package leaflet contents:

1. What Carvedilol Kern Pharma 6.25 mg film-coated tablets are and what they are used for
2. Before you take Carvedilol Kern Pharma 6.25 mg film-coated tablets
3. How to take Carvedilol Kern Pharma 6.25 mg film-coated tablets
4. Possible side effects
5. How to store Carvedilol Kern Pharma 6.25 mg film-coated tablets
6. Further information

1. What Carvedilol Kern Pharma 6.25 mg film-coated tablets are and what they are used for

Each tablet contains carvedilol as the active substance, which is an alpha and beta receptor-blocking agent that also exhibits antioxidant properties. In addition, it has complementary effects of vasodilation, reduction of cardiac output, antihypertensive properties (lowering of blood pressure), antianginal effects, and also favorable effects on blood circulation at the level of the heart.

Carvedilol Kern Pharma 6.25 mg is indicated for the treatment of symptomatic congestive heart failure (the heart's inability to perform its pumping function), whether of ischemic or non-ischemic origin, of moderate to severe severity.

2. Before taking Carvedilol Kern Pharma 6.25 mg film-coated tablets

Do not take Carvedilol Kern Pharma 6.25 mg film-coated tablets

• If you are hypersensitive (allergic) to the drug or to any of the excipients of this medicinal product.
• If you have decompensated heart failure of class IV (NYHA) (inability of the heart to perform its pumping function during physical activity and, in most cases, even at rest) requiring intravenous inotropic agents (medications that increase the strength of the heart's contractions).
• If you have chronic obstructive pulmonary disease with a bronchospastic component (chronic lung disease causing breathing difficulties) in patients receiving oral or inhaled treatment.
• If you have clinically evident hepatic dysfunction (liver abnormalities).
• If you have asthma.
• If you have second- or third-degree atrioventricular (AV) block (cardiac conduction 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 blood pressure less than 85 mm Hg).

Take special care with Carvedilol Kern Pharma 6.25 mg film-coated tablets

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

Treatment with carvedilol must not be stopped abruptly, especially in patients with ischemic heart disease. Discontinuation of carvedilol should be gradual over several days, or by reducing the dose by half every three days.

• Carvedilol should be administered with caution if there is suspicion of Prinzmetal's vasospastic angina (angina caused by coronary spasms), as well as if you have severe peripheral circulatory disorders. Rarely, worsening of symptoms has been observed in patients with angina pectoris (chest pain due to heart disease).
• If you are scheduled for surgery, you must inform your doctor that you are being treated with carvedilol.
• If you have psoriasis (a skin condition that can arise from multiple causes).
• If you have pheochromocytoma (a disorder of the adrenal glands) 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 such severe allergies).

Consult your doctor, even if any of the above circumstances have occurred in the past.

Use of other medicines

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

This is extremely important, as taking multiple medications simultaneously may enhance or weaken their effects. Therefore, you must not take carvedilol with any other medicine unless specifically authorized by your doctor.

Carvedilol may interact with antihypertensives (medicines to lower blood pressure), clonidine (a medicine to lower blood pressure), antiarrhythmics (medicines for treating heart rhythm disorders), digitalis (medicines for treating reduced heart function), calcium antagonists (verapamil or diltiazem), hypnotics or tranquilizers, antidepressants, narcotics, anesthetics, alcohol, migraine and asthma medications, nonsteroidal anti-inflammatory drugs, the antibiotic rifampicin, and cimetidine.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

There is insufficient experience with carvedilol in pregnant women; therefore, your doctor will assess the benefit-risk ratio of administering carvedilol.

Since carvedilol is excreted in breast milk, its use during breastfeeding is not recommended.

Use in children

The efficacy and safety of carvedilol in children have not been established.

Driving and use of machines

Individual reactions affecting alertness may occur (e.g., the ability of patients to drive vehicles or operate machinery). This is mainly observed at the beginning of treatment or when changing therapy, as well as when combined with alcohol.

Important information about some of the components of Carvedilol Kern Pharma 6.25 mg film-coated tablets

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Athletes are advised that this medicine contains a component that may lead to a positive analytical finding in doping controls.

3. How to take Carvedilol 6.25 mg film-coated tablets

Follow exactly the dosage instructions for Carvedilol Kern Pharma 6.25 mg tablets provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

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

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

The dose must be individually determined, and you must be closely monitored by your doctor during dose escalation. You must strictly follow your doctor's instructions regarding how to take this medicine.

If you are taking other medications, your doctor must determine your treatment regimen.

The recommended starting dose of carvedilol is 3.125 mg (1/2 tablet) twice daily for two weeks. If this dose is well tolerated, it may subsequently be increased to 6.25 mg (1 tablet) twice daily.

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

If you think that the effect 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 prescribed, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20 (indicating the medication and 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 make up for missed doses.

If you stop taking Carvedilol Kern Pharma 6.25 mg tablets

Your doctor will advise you on the duration of your treatment with Carvedilol Kern Pharma 6.25 mg tablets. Discontinuation of carvedilol should be gradual over several days, or by reducing the dose by half every three days.

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

4. Possible adverse effects

Like all medicines, Carvedilol Kern Pharma 6.25 mg tablets can produce adverse effects, although not everyone experiences them.

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

Very common (affects more than 1 in 10 patients)

Common (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)

Frequency not known (cannot be estimated from available data)

The adverse effects observed are as follows:

Disorders of the blood and lymphatic system:

• Common: thrombocytopenia.

Metabolism and nutrition disorders:

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

Nervous system disorders:

• Very common: dizziness.

Eye disorders:

• Common: visual disturbances.

Cardiac disorders:

• Very common: edema.
• Common: bradycardia, hypotension, heart failure during the dose-adjustment phase, syncope, AV block, and postural hypotension.

Gastrointestinal disorders:

• Very common: diarrhea.
• Common: nausea and vomiting.

Renal and urinary disorders:

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

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

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

5. Storage of Carvedilol Kern Pharma 6.25 mg film-coated tablets

Keep out of the sight and reach of children.

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

Do not use Carvedilol Kern Pharma 6.25 mg film-coated tablets after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Additional information

Composition of Carvedilol Kern Pharma 6.25 mg tablets

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

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

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

Appearance of the product and contents of the pack

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

Other presentations:

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

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

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, Lefkosia, Cyprus

This leaflet has been reviewed in October 2009