PATIENT INFORMATION LEAFLET

Carvedilol Kern Pharma 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 25 mg is indicated for the treatment of essential hypertension (high blood pressure) as well as for the treatment of various cardiac alterations included in ischemic cardiopathy.

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

Do not take Carvedilol Kern Pharma 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 (drugs 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 have a second- and third-degree AV 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 mmHg).

Be especially careful with Carvedilol Kern Pharma 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, 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 taking, or have recently taken, 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 (drugs to lower blood pressure), clonidine (drug to lower blood pressure), antiarrhythmics (drugs for the treatment of cardiac rhythm disorders), digitalis (drugs 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 taking a 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 one of the components of Carvedilol Kern Pharma 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 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).

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

Essential Hypertension:

Initial dose 12.5 mg once a day.

Maintenance dose 25 mg once a day.

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

This regimen is the same for adults and the elderly.

Long-term therapy for ischemic cardiopathy:

Initial dose 12.5 mg twice a day

Maintenance dose 25 mg twice a day.

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

The maximum recommended dose for the elderly is 25 mg daily administered in 2 doses.

Symptomatic congestive heart failure:

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.

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

If you estimate that the action of Carvedilol Kern Pharma 25 mg tablets is too strong or too weak, inform your doctor or pharmacist.

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

If you have taken more Carvedilol Kern Pharma 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 forgot to take Carvedilol Kern Pharma 25 mg tablets

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

If you interrupt treatment with Carvedilol Kern Pharma 25 mg tablets

Your doctor will indicate the duration of your treatment with Carvedilol Kern Pharma 25 mg tablets. Do not discontinue treatment before the indicated time, especially if you have ischemic cardiopathy. The withdrawal of carvedilol should be gradual over a few days, or by reducing the dose to half every three days.

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

Like all medications, Carvedilol Kern Pharma 25 mg tablets may cause side effects, although not everyone will experience them.

The frequencies of side effects have been 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 cannot be estimated (cannot be estimated from available data)

The side effects that have been observed are as follows:

Blood and lymphatic system disorders:

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

Metabolism and nutrition disorders:

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

Nervous system disorders:

• Common: dizziness, headache, fatigue (especially at the beginning of treatment).
• Uncommon: paresthesia (tingling, pins and needles), syncope, sleep disorders, depression.

Eye disorders:

• Rare: visual disturbances, decreased tear production, eye irritation.

Cardiac disorders:

• Common: bradycardia (decreased heart rate), orthostatic hypotension (dizziness when standing up).
• Uncommon: peripheral circulatory insufficiency (cold extremities).
• Rare: peripheral edema.

Respiratory, thoracic and mediastinal disorders:

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

Gastrointestinal disorders:

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

Skin and subcutaneous tissue disorders:

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

Musculoskeletal and connective tissue disorders:

• Uncommon: limb pain.

Renal and urinary disorders:

• Uncommon: worsening of renal function.
• Rare: difficulty urinating.

Reproductive system and breast disorders:

• Rare: impotence.

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

If you consider any of the side effects you are experiencing to be severe or if you notice any side 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 25 mg tablets after the expiration date that appears 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 packaging and unused medicines at the SIGRE collection point of 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 25 mg Tablets

• The active ingredient 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, 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 25 mg is presented in packages of 28 scored, film-coated tablets for oral administration.

Other presentations:

Carvedilol Kern Pharma 6.25 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 October 2009