Normotride 6.25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

NORMOTRIDE 6.25 mg tablets EFG

Carvedilol

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet; you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What NORMOTRIDE 6.25 mg tablets are and what they are used for
2. What you need to know before taking NORMOTRIDE 6.25 mg tablets
3. How to take NORMOTRIDE 6.25 mg tablets
4. Possible side effects
5. How to store NORMOTRIDE 6.25 mg tablets
6. Contents of the pack and other information

1. What NORMOTRIDE 6.25 mg tablets is and what it is used for

Carvedilol belongs to a group of medicines called alpha-1 and beta-blockers.

Carvedilol is indicated for the treatment of essential or primary arterial hypertension (high blood pressure), for the long-term treatment of ischemic heart disease, and for moderate to severe congestive heart failure (the heart's inability to perform its pumping function properly).

2. What you need to know before taking NORMOTRIDE 6.25 mg tablets

Do not take NORMOTRIDE 6.25 mg tablets:

• If you are hypersensitive (allergic) to carvedilol or to any of the other components of this medicine (listed in section 6).
• If you have decompensated heart failure of NYHA class IV (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 heart's pumping strength).
• 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 A-V block (heart 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).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take NORMOTRIDE 6.25 mg tablets.

Take special care with NORMOTRIDE 6.25 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 should monitor your kidney function during the dose-adjustment phase.

Treatment with NORMOTRIDE 6.25 mg tablets must not be stopped abruptly, especially in patients with ischemic heart disease. Discontinuation of NORMOTRIDE 6.25 mg tablets should be gradual over several days, or by halving the dose every three days.

• NORMOTRIDE 6.25 mg tablets 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. In rare cases, worsening of symptoms has been observed in patients with angina pectoris (chest pain).
• If you are going to undergo surgery, you must inform your doctor that you are being treated with carvedilol.
• If you have psoriasis (a skin disease that can be caused by multiple factors).
• 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 these severe allergies).
• If you are being treated with calcium antagonists (such as verapamil or diltiazem) or other antiarrhythmic drugs.
• If you have labile or secondary hypertension.

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

Taking NORMOTRIDE 6.25 mg tablets with other medicines:

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

This is extremely important, as taking multiple medicines at the same time may enhance or weaken their effects. Therefore, you must not take NORMOTRIDE 6.25 mg tablets with any other medicine unless your doctor has approved it.

• Carvedilol may enhance the effect of other antihypertensives (medicines used to lower blood pressure).
• In combination with clonidine (a medicine used to lower blood pressure), it may increase blood pressure and decrease heart rate.
• Calcium antagonists (verapamil or diltiazem) or other antiarrhythmics (medicines used to treat heart rhythm disorders), when used with carvedilol, may increase the risk of cardiac conduction disturbances.
• Carvedilol increases the minimum baseline concentrations of digoxin (a medicine used to treat reduced heart function).
• Antidepressants (such as fluoxetine and paroxetine) or antiarrhythmics like quinidine or propafenone may increase carvedilol levels.
• The antibiotic rifampicin may decrease serum levels of carvedilol, while cimetidine (a medicine used for stomach problems) may increase them.
• In combination with reserpine (a medicine used to treat hypertension) or MAO inhibitors (MAOIs), it may cause severe hypotension and/or bradycardia (reduced heart rate).
• Carvedilol may increase the average concentration of cyclosporine (a medicine used to prevent organ transplant rejection).
• When used with inhaled anesthetics, extreme caution is required due to potential negative inotropic and hypotensive effects.
• It may also enhance the effect of medicines used to lower blood sugar, such as insulin or oral antidiabetics. Symptoms of hypoglycemia may be masked. Regular blood glucose monitoring is recommended.

Taking NORMOTRIDE 6.25 mg tablets with food:

It is not necessary to take the dose with meals. However, in patients with impaired heart function (e.g., in heart failure), carvedilol should be taken with food to reduce the incidence of adverse effects.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this 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 elderly patients:

When administering carvedilol to elderly patients, follow the dosing regimen specified in section 3, How to take NORMOTRIDE 6.25 mg tablets.

Use in children:

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

Driving and using machines:

This medicine does not affect the ability to drive and/or operate machinery.

Important information about some of the ingredients of this medicine:

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.

Warning for athletes:

Athletes should be informed that this medicine contains a component that may result in a positive doping test.

3. How to take NORMOTRIDE 6.25 mg tablets

Follow exactly the instructions for administration of NORMOTRIDE 6.25 mg tablets provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

If you are taking any other medication, your doctor must determine the appropriate treatment.

Your doctor will indicate the duration of your treatment with NORMOTRIDE 6.25 mg tablets. Do not stop the treatment earlier than advised, especially if you suffer from ischemic heart disease. Discontinuation of NORMOTRIDE 6.25 mg should be gradual over 1–2 weeks, for example by halving the dose every three days.

The tablets should be taken with sufficient liquid.

If you have congestive heart failure, you must take NORMOTRIDE 6.25 mg tablets with food to slow the rate of absorption 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 NORMOTRIDE 6.25 mg tablets with food.

For more convenient administration of Carvedilol, it is recommended to use its different formulations according to the dose prescribed by your doctor.

Essential hypertension

Adults:

Starting dose: 12.5 mg once daily for the first two days.

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 divided into two doses).

Elderly patients (> 65 years):

The recommended initial dose is 12.5 mg of carvedilol once daily, which may also be sufficient for ongoing treatment. If the response is inadequate, the dose may be gradually increased at intervals of at least two weeks.

Long-term therapy of ischemic heart disease

Adults:

Starting dose: 12.5 mg twice daily for the first two days.

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.

Elderly patients:

The maximum recommended dose for elderly patients is 25 mg twice daily.

Symptomatic congestive heart failure

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.

As initial treatment, 3.125 mg twice daily is recommended for the first two weeks. If this dose is tolerated, it may be successively increased at intervals of at least two weeks to 6.25 mg of carvedilol twice daily, then to 12.5 mg twice daily, and finally up to the target dose of 25 mg twice daily. It is recommended that the dose be increased to the highest level tolerated by the patient.

The maximum recommended dose is 25 mg twice daily in patients weighing less than 85 kg and 50 mg twice daily in patients weighing more than 85 kg, provided that heart failure is not severe. Dose increases up to 50 mg twice daily must be carefully performed under strict medical supervision.

If worsening of symptoms occurs, consult your doctor.

The patient must be monitored by a physician/cardiologist after starting treatment with carvedilol or when increasing the dose.

If treatment with carvedilol is interrupted for more than two weeks, it should be restarted at 3.125 mg twice daily and gradually increased according to the above recommendations.

If you take more NORMOTRIDE 6.25 mg tablets than you should:

Go immediately to an emergency service.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

Ingestion of high doses of this medicine may cause severe drop in blood pressure, reduced heart rate, heart failure, shock, and cardiac arrest. Respiratory problems, bronchospasm, vomiting, decreased consciousness, and seizures may also occur.

If you forget to take NORMOTRIDE 6.25 mg tablets:

Do not take the missed dose and do not double the next dose. Instead, continue with your usual dosing schedule and consult your doctor.

4. Possible adverse effects

Like all medicines, NORMOTRIDE 6.25 mg tablets can have adverse effects, although not everyone will experience them.

The adverse effects observed are as follows:

CNS (Central Nervous System): Occasionally headache, dizziness, and fatigue; isolated cases of depressive state, sleep disorders, and paresthesias (tingling, numbness, pricking sensations).

Cardiovascular system: Occasionally edema, hypotension (reduction in blood pressure), postural hypotension (dizziness upon standing), bradycardia (decreased heart rate); isolated cases of syncope, A-V block (cardiac rhythm disturbances), and heart failure during the dose-escalation phase; disturbances in peripheral circulation (cold extremities); exacerbation of symptoms in patients with intermittent claudication or Raynaud's disease.

Respiratory system: Occasionally nasal congestion; in patients predisposed to such effects, asthma/dyspnea.

Gastrointestinal system: Occasionally nausea, abdominal pain, diarrhea; very rarely constipation and vomiting.

Hematology: Occasionally thrombocytopenia (reduction in the number of platelets in peripheral blood).

Metabolism: Occasionally hyperglycemia (elevated blood sugar), in patients with pre-existing diabetes mellitus, weight gain, and hypercholesterolemia (increased blood cholesterol).

In isolated cases, allergic skin reactions, alterations in serum transaminases, leukopenia, limb pain, and decreased lacrimation have been reported.

Isolated cases of visual disturbances, acute renal failure, and renal function abnormalities have also been reported in patients with diffuse vascular disease or impaired renal function, as well as dry mouth, urinary disorders, and sexual impotence.

The frequency of adverse effects 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 effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines:

https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of NORMOTRIDE 6.25 mg tablets

Keep this medicine out of the reach and sight of children.

Expiry

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste.

Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of NORMOTRIDE 6.25 mg tablets

The active substance is carvedilol. Each tablet contains 6.25 mg of carvedilol.

The other components (excipients) are: monohydrate lactose, low-substituted hydroxypropylcellulose, corn starch, talc, anhydrous colloidal silica, microcrystalline cellulose and magnesium stearate.

Appearance of the product and contents of the pack

NORMOTRIDE 6.25 mg tablets are round, biconvex, white or almost white, and scored on one side.

Packs contain 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

ARAFARMA GROUP, S.A.
C/ Fray Gabriel de San Antonio, 6-10
Pol. Ind. del Henares
19180 Marchamalo (Guadalajara), Spain

Manufacturer:

ARAFARMA GROUP, S.A.
C/ Fray Gabriel de San Antonio, 6-10
Pol. Ind. del Henares
19180 Marchamalo (Guadalajara), Spain

Date of the most recent revision of this leaflet: February 2007

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/