CARVEDILOL KERN PHARMA 25 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Carvedilol Kern Pharma 25 mg film-coated tablets EFG

Carvedilol

Contents of the package leaflet:

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. Storage of Carvedilol Kern Pharma 25 mg film-coated tablets
6. Additional 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 alpha and beta receptor blocker with additional antioxidant properties. It also has complementary actions of vasodilation, reduction of cardiac output, antihypertensive properties (reduction of blood pressure), anti-anginal 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) and for the treatment of various cardiac disorders included in ischemic heart disease.

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

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

Do not take Carvedilol Kern Pharma 25 mg tablets

• If you are hypersensitive (allergic) to the drug or to any of the excipients of this specialty.
• 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 at rest) that requires the use of intravenous inotropics (medicines that increase heart strength).
• If you have chronic obstructive pulmonary disease with a bronchospastic component (chronic lung disease that causes difficulty breathing) in patients who are receiving oral or inhaled treatment.
• If you have clinically manifest hepatic dysfunction (liver disorders).
• If you have asthma.
• If you have a second or 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 sinoauricular block).
• In case of severe hypotension (systolic blood pressure less than 85 mmHg).

Be careful with Carvedilol Kern Pharma 25 mg tablets

• If you have diabetes mellitus (high 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 will need to monitor your renal function during the dose adjustment phase.

Treatment with carvedilol should not be interrupted abruptly, especially in patients with ischemic heart disease. Withdrawal of carvedilol should be gradual over a few days, or by reducing the dose by half every three days.

• Carvedilol will be administered with caution if there is suspicion of having Prinzmetal's vasospastic angina, as well as if you have severe peripheral circulation disorders. In rare cases, worsening of symptoms has been seen in patients with angina pectoris (chest pain).
• If you are going to undergo surgery, you should inform your doctor that you are being treated with carvedilol.
• If you have psoriasis (skin disease that can be caused by multiple causes).
• If you have pheochromocytoma (adrenal gland disorder) that is not properly controlled by alpha blockade.
• If you have any thyroid disorder.
• If you have a history of severe hypersensitivity reactions (severe allergies) or are undergoing desensitization therapy (treatment for these severe allergies).

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

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 more than one medicine at the same time can potentiate or weaken its effect. Therefore, you should not take carvedilol with any other medicine, unless your doctor has allowed it.

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

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

Pregnancy and lactation

Consult your doctor or pharmacist before taking a medicine.

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

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

Use in children

Efficacy and safety in children have not been established.

Driving and using machines

There may be individual reactions that alter the state of alertness (e.g., the patient's ability to drive vehicles or operate machinery). This is mainly evident when starting or changing treatment, as well as in conjunction with alcohol.

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

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

Athletes are informed that this medicine contains a component that may result in a positive analytical result in doping control.

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

Follow the administration instructions of Carvedilol Kern Pharma 25 mg tablets indicated by your doctor. Consult your doctor or pharmacist if you have 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 at 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 adult and elderly patients.

Prolonged therapy for ischemic heart disease:

Initial dose 12.5 mg twice a day

Maintenance dose 25 mg twice a day.

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

The maximum recommended dose for elderly patients 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 dose adjustment phase.

You must strictly follow your doctor's instructions regarding the administration of this medicine.

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 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 think the effect of Carvedilol Kern Pharma 25 mg tablets is too strong or too weak, tell 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 Toxicology Information Service, phone: 91 562 04 20 (indicating the medicine and the amount ingested).

Remember to take your medicine.

If you forget to take Carvedilol Kern Pharma 25 mg tablets

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

If you stop taking Carvedilol Kern Pharma 25 mg tablets

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

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

4. Possible side effects

Like all medicines, Carvedilol Kern Pharma 25 mg tablets can cause side effects, although not everybody gets them.

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

Very common (affect more than 1 in 10 patients)

Common (affect between 1 and 10 in 100 patients)

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

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

Very rare (affect less than 1 in 10,000 patients)

Frequency not known (cannot be estimated from the available data)

The side effects that have been observed are the following:

Blood and lymphatic system disorders:

• Rare: mild thrombocytopenia (reduction of platelet count 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 start of treatment).
• Uncommon: paresthesia (tingling, pins and needles), syncope, sleep disorders, depression.

Eyedisorders:

• Rare: vision disorders, decreased lacrimation, eye irritation.

Cardiac disorders:

• Common: bradycardia (reduced heart rate), orthostatic hypotension (dizziness when standing up).
• Uncommon: peripheral circulation failure (cold extremities).
• Rare: peripheral edema.

Respiratory 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 in urination.

Reproductive system and breast disorders:

• Rare: impotence.

The frequency of adverse experiences is not dose-related, except for dizziness, vision disorders, and bradycardia.

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

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

Keep out of sight and reach of children.

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

Do not use Carvedilol Kern Pharma 25 mg tablets after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. 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:

Core of the tablet: 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 product and package contents

Carvedilol Kern Pharma 25 mg is presented in packages of 28 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

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 revised in October 2009