CARVEDILOL KERN PHARMA 6.25 mg FILM-COATED TABLETS

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

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) (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 receiving oral or inhalation 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 sinoatrial block).
• In case of severe hypotension (systolic blood pressure less than 85 mmHg).

Be careful with Carvedilol Kern Pharma 6.25 mg tablets

• If you have diabetes mellitus (high blood sugar).
• If you have congestive heart failure with risk factors (hypotension, ischemic heart disease, diffuse vascular disease, and underlying renal insufficiency), as your doctor should 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.

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used 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 decreased heart function), calcium antagonists (verapamil or diltiazem), sedatives or tranquilizers, antidepressants, narcotics, anesthetics, alcohol, preparations against migraine and asthma, anti-inflammatory drugs, 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 breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

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

Use in children

The efficacy and safety of carvedilol 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 6.25 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 doping test.

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

Follow the administration instructions of Carvedilol Kern Pharma 6.25 mg tablets 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 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.

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

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

If you think the effect of Carvedilol Kern Pharma 6.25 mg tablets is too strong or too weak, tell 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 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 6.25 mg tablets

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, Carvedilol Kern Pharma 6.25 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:

• 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.

Eyedisorders:

• Common: vision 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 disorders 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, vision disturbances, and bradycardia.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storing Carvedilol Kern Pharma 6.25 mg film-coated tablets

Keep out of sight and reach of children.

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

Do not use Carvedilol Kern Pharma 6.25 mg tablets after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

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

6. Further information

Composition of Carvedilol Kern Pharma 6.25 mg tablets

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

Tablet core: microcrystalline cellulose (E-460i), lactose monohydrate (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 package contents

Carvedilol Kern Pharma 6.25 mg is presented in packages of 28 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

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 inOctober 2009