Carvedilol Kern Pharma 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Carvedilol Kern Pharma 25 mg film-coated tablets EFG

Carvedilol

Package leaflet contents:

1. What Carvedilol Kern Pharma 25 mg film-coated tablets are and what they are used for
2. Before taking Carvedilol Kern Pharma 25 mg film-coated tablets
3. How to take Carvedilol Kern Pharma 25 mg film-coated tablets
4. Possible side effects
5. How to store Carvedilol Kern Pharma 25 mg film-coated tablets
6. Further information

1. What Carvedilol Kern Pharma 25 mg film-coated tablets are and what they are used for

Each tablet contains carvedilol as the active substance, which is an agent that blocks both alpha and beta receptors and additionally possesses antioxidant properties. It also has complementary effects including vasodilation, reduction of cardiac output, antihypertensive (lowering of blood pressure), antianginal properties, and favorable effects on blood circulation in the heart.

Carvedilol Kern Pharma 25 mg is indicated for the treatment of essential arterial hypertension (high blood pressure), as well as for the treatment of various cardiac disorders included under ischemic heart disease.

It is also prescribed for the treatment of moderate to severe symptomatic congestive heart failure (the heart's inability to perform its pumping function), whether of ischemic or non-ischemic origin.

2. Before taking Carvedilol Kern Pharma 25 mg film-coated tablets

Do not take Carvedilol Kern Pharma 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 force of heart 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 manifest hepatic dysfunction (liver disorders).
• If you have asthma.
• If you have second- or third-degree atrioventricular (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 blood pressure less than 85 mm Hg).

Take special care with Carvedilol Kern Pharma 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, or underlying renal insufficiency), as your doctor should monitor your kidney function during the dose-adjustment phase.

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

• Carvedilol should be administered with caution if you are suspected of having Prinzmetal's vasospastic angina (angina caused by coronary spasms), as well as if you suffer from 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 undergoing surgery, you must inform your doctor that you are being treated with carvedilol.
• If you have psoriasis (a skin disease that may arise from multiple causes).
• If you have pheochromocytoma (a disorder of the adrenal glands) not adequately controlled by alpha-blockade.
• If you have any 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 above conditions occurred in the past.

Use of other medicines

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

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

Carvedilol may interact with antihypertensives (drugs to lower blood pressure), clonidine (a drug to reduce blood pressure), antiarrhythmics (drugs for treating heart rhythm disorders), digitalis glycosides (drugs 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 (NSAIDs), the antibiotic rifampicin, and cimetidine.

It may also enhance or reduce the effect of medications used to lower blood glucose 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 taking any medicine.

There is insufficient experience with carvedilol in pregnant women; therefore, your doctor will assess the benefit-risk balance 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 using machines

Individual reactions affecting alertness may occur (e.g., the ability of patients to drive vehicles or operate machinery). This is particularly evident when starting or changing treatment, and especially when combined with alcohol.

Important information about some of the components of Carvedilol Kern Pharma 25 mg film-coated tablets

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

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

3. How to take Carvedilol Kern Pharma 25 mg film-coated tablets

Follow exactly the administration instructions for Carvedilol Kern Pharma 25 mg film-coated tablets as given by your doctor. If in doubt, 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).

If you do not have congestive heart failure, it is not necessary to take carvedilol with food.

Essential hypertension:

Starting dose: 12.5 mg once daily.

Maintenance dose: 25 mg once daily.

If necessary, the dose may be increased at intervals of at least two weeks up to a maximum dose of 50 mg once daily (or administered in two divided doses).

This regimen is the same for both adult and elderly patients.

Long-term therapy of ischemic heart disease:

Starting dose: 12.5 mg twice daily.

Maintenance dose: 25 mg twice daily.

If necessary, the dose may be increased at intervals of at least two weeks up to a maximum dose of 50 mg twice daily.

The maximum recommended dose for elderly patients is 25 mg daily, administered in two divided doses.

Symptomatic congestive heart failure:

The dose must be individually determined, and you must be closely monitored by your doctor during dose titration to higher levels.

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.

If you have previously been taking lower doses of carvedilol and your doctor has prescribed continuation of treatment with Carvedilol Kern Pharma 25 mg film-coated tablets, the recommended dose is one tablet (25 mg) twice daily for two weeks.

If you think that the effect of Carvedilol Kern Pharma 25 mg film-coated tablets is too strong or too weak, inform your doctor or pharmacist.

If you take more Carvedilol Kern Pharma 25 mg film-coated tablets than you should

If you have taken more Carvedilol Kern Pharma 25 mg film-coated tablets than you should, 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 the amount ingested).

Remember to take your medicine.

If you forget to take Carvedilol Kern Pharma 25 mg film-coated tablets

Do not take a double dose to make up for missed doses. Instead, continue with your usual dosing schedule and consult your doctor.

If you stop taking Carvedilol Kern Pharma 25 mg film-coated tablets

Your doctor will advise you on how long you should take Carvedilol Kern Pharma 25 mg film-coated tablets. Do not stop treatment earlier than advised, especially if you have ischemic heart disease. Discontinuation of carvedilol should be gradual over several days, or by reducing the dose by half every three days.

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

4. Possible adverse effects

Like all medicines, Carvedilol Kern Pharma 25 mg tablets can cause adverse effects, although not everybody will experience them.

The frequencies of adverse effects listed below are defined as follows:

Very common (affects more than 1 in 10 people)

Common (affects between 1 and 10 in 100 people)

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

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

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

Frequency not known (cannot be estimated from available data)

The adverse effects observed are as follows:

Blood and lymphatic system disorders:

• Rare: mild thrombocytopenia (reduced number of platelets in peripheral blood), leucopenia, increased serum transaminases.

Metabolism and nutrition disorders:

• Common: hypercholesterolemia (increased cholesterol in blood), hyperglycaemia (elevated blood sugar).

Nervous system disorders:

• Common: dizziness, headache, fatigue (especially at the beginning of treatment).
• Uncommon: paraesthesia (tingling, pricking sensations), syncope, sleep disorders, depression.

Eye disorders:

• Rare: visual disturbances, decreased lacrimation, eye irritation.

Cardiac disorders:

• Common: bradycardia (reduced heart rate), orthostatic hypotension (dizziness upon standing).
• Uncommon: peripheral circulatory failure (cold extremities).
• Rare: peripheral oedema.

Respiratory disorders:

• Common: dyspnoea.
• Uncommon: nasal congestion, asthma.

Gastrointestinal disorders:

• Common: nausea, abdominal pain, diarrhoea.
• Uncommon: constipation, vomiting.
• Rare: dry mouth.

Skin disorders:

• Common: skin reactions (allergic rash, urticaria, pruritus).

Musculoskeletal and connective tissue disorders:

• Uncommon: limb pain.

Renal and urinary disorders:

• Uncommon: worsening of renal function.
• Rare: difficulty in urination.

Reproductive system disorders:

• Rare: impotence.

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

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

5. Storage of Carvedilol Kern Pharma 25 mg film-coated tablets

Keep out of the sight and reach of children.

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

Do not use Carvedilol Kern Pharma 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. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional information

Composition of Carvedilol Kern Pharma 25 mg tablets

• The active substance is carvedilol. Each tablet contains 25 mg of carvedilol.
• The other components are:

Tablet core: microcrystalline cellulose (E-460i), lactose monohydrate (100 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 medicinal product and contents of the container

Carvedilol Kern Pharma 25 mg is presented in packs of 28 film-coated, scored tablets for oral administration.

Other presentations:

Carvedilol Kern Pharma 6.25 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 was last reviewed October 2009