Leaflet: information for the user

NORMOTRIDE 6.25 mg tablets EFG

Carvedilol

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

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

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What NORMOTRIDE 6.25 mg tablets are and what they are used for

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

3. How to take NORMOTRIDE 6.25 mg tablets

4. Possible side effects

5. Storage of NORMOTRIDE 6.25 mg tablets

6. Contents of the pack and additional information

Carvedilol belongs to a group of medicines called alpha1- and beta-blockers.

Carvedilol is indicated for the treatment of essential or primary hypertension (high blood pressure), for the prolonged treatment of ischaemic cardiopathy and for congestive heart failure of moderate to severe degree (heart's inability to pump its function).

Do not take NORMOTRIDE 6,25 mg tablets:

• If you are hypersensitive (allergic) to carvedilol or to any of the other components of this medication (including those listed in section 6).
• 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 (medicines that increase the heart's 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 (cardiac failure).
• In case of sinus disease (including sinoatrial block).
• In case of severe hypotension (systolic blood pressure less than 85 mmHg).

Warnings and precautions

Consult your doctor or pharmacist before starting to take NORMOTRIDE 6,25 mg tablets

Be especially careful with NORMOTRIDE 6,25 mg 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, and underlying renal insufficiency), as your doctor will need to monitor your renal function during the dose adjustment phase.

The treatment with NORMOTRIDE 6,25 mg tablets should not be interrupted abruptly, especially in patients with ischemic heart disease. The withdrawal of NORMOTRIDE 6,25 mg tablets should be gradual over a few days, or by reducing the dose by half every three days.

• NORMOTRIDE 6,25 mg tablets should be administered with caution if you suspect you have Prinzmetal's variant angina (angina caused by coronary spasms), 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 to undergo surgery, you must 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 pheochromocytoma (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).
• If you are being treated with calcium channel blockers (such as verapamil or diltiazem) or other antiarrhythmic drugs.
• If you have labile or secondary hypertension.

Consult your doctor even if any of the circumstances mentioned have occurred at any time.

Taking NORMOTRIDE 6,25 mg tablets with other medications:

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

This is extremely important, as taking more than one medication at the same time can either potentiate or weaken its effect. Therefore, do not take NORMOTRIDE 6,25 mg tablets with any other medication unless your doctor has allowed it.

- Carvedilol can potentiate the effect of other antihypertensives (medications to lower blood pressure).

- Along with clonidine (medication to lower blood pressure), it can increase blood pressure and decrease heart rate.

- Calcium channel blockers (verapamil or diltiazem) or other antiarrhythmic drugs, in combination with carvedilol, can increase the risk of cardiac conduction disorders.

- Carvedilol increases the minimum basal serum concentrations of digoxin (medication for treating decreased cardiac function).

- Antidepressants (such as fluoxetine and paroxetine) or the antiarrhythmic quinidine or propafenone can increase carvedilol levels.

- The antibiotic rifampicin can decrease carvedilol serum levels, and cimetidine (medication used for stomach problems) can increase them.

- Along with reserpine (medication for treating hypertension) or IMAO, it can produce severe hypotension and/or bradycardia.

- Carvedilol can increase the mean serum concentration of cyclosporine (medication used to prevent organ rejection in transplants).

- Along with inhaled anesthetics, it is essential to pay close attention to negative inotropic and hypotensive effects.

- It can also potentiate the effect of medications used to reduce blood sugar levels, such as insulin or oral antidiabetic medications. Hypoglycemia symptoms 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, although in patients with heart failure, carvedilol should be taken with food to reduce the incidence of adverse effects.

Pregnancy and lactation:

If you are pregnant or breastfeeding, or if you suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

No sufficient experience with carvedilol has been reported 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 elderly patients:

In the administration of carvedilol to elderly patients, follow the established dosing schedule in section 3, How to take NORMOTRIDE 6,25 mg tablets

Use in children:

The efficacy and safety in children have not been established.

Driving and operating machinery:

The use of this medication does not affect the ability to drive and/or operate machinery

Important information about some of the components of this medication:

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Warning to athletes

It is reported to athletes that this medication contains a component that can produce a positive result in doping control tests.

Follow exactly the administration instructions for NORMOTRIDE 6.25 mg tablets as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

If you are taking other medication, it should be your doctor who establishes the treatment.

Your doctor will indicate the duration of your treatment with NORMOTRIDE 6.25 mg tablets. Do not discontinue treatment before the indicated time, especially if you have ischemic cardiopathy. The withdrawal of NORMOTRIDE 6.25 mg should be gradual over 1-2 weeks, for example, by reducing the dose to half every three days.

The tablets should be taken with sufficient liquid.

If you have congestive heart failure, you should take NORMOTRIDE 6.25 mg tablets with foodto slow down your 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 NORMOTRIDE 6.25 mg tablets with food.

To facilitate the administration of Carvedilol, it is recommended to use its different presentations according to the dose established by your doctor.

Essential hypertension

Adults:

Initial dose 12.5 mg once a day for the first two days.

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).

Seniors (> 65 years):

The recommended initial dose is 12.5 mg of carvedilol once a day, which may also be sufficient to continue treatment. If the response is not adequate, the dose can be increased gradually in intervals of at least two weeks.

Prolonged therapy for ischemic cardiopathy

Adults

Initial dose 12.5 mg twice a day for the first two days.

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.

Seniors

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

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.

As initial treatment, it is recommended during the first two weeks 3.125 mg twice a day. If this dose is tolerated, it can be increased successively in intervals of at least two weeks, up to 6.25 mg of carvedilol twice a day, following up to 12.5 mg of carvedilol twice a day until finally reaching a dose of 25 mg twice a day. It is recommended that the dose be increased to the highest tolerated by the patient.

The maximum recommended dose is 25 mg administered twice a day to patients with a weight less than 85 kg and 50 mg twice a day to patients with a weight greater than 85 kg, provided that the heart failure is not severe. The increase in dose to 50 mg twice a day should be done carefully under strict medical supervision.

If symptoms worsen, consult your doctor.

The patient should be monitored by a doctor/cardiac specialist after starting treatment with carvedilol or increasing the dose.

If carvedilol treatment is interrupted for more than two weeks, it should be restarted with 3.125 mg twice a day and increased gradually according to the previous recommendation.

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, consult the Toxicological Information Service. Phone 91 562 04 20.

The ingestion of high doses of this medication may cause severe decrease in blood pressure, decrease in heart rate, heart failure, shock, and cardiac arrest. Respiratory problems, bronchospasm, vomiting, decreased consciousness, and seizures may also occur.

If you forgot to take NORMOTRIDE 6.25 mg tablets:

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

Like all medicines, NORMOTRIDE 6.25 mg tablets may cause side effects, although not everyone will experience them.

The side effects that have been observed are as follows:

Central nervous system: Occasionally, headache, dizziness, and fatigue, isolated cases of a depressive state, sleep disorders, and paresthesias (tingling, numbness, pins and needles).

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

Respiratory system: Occasionally, nasal congestion, and in patients with a certain predisposition, asthma/dyspnea.

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

Hematology: Occasionally, thrombocytopenia (reduction of platelet count in peripheral blood).

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

In isolated cases, skin allergic reactions, alterations in serum transaminases, and leukopenia, pain in the extremities, and decreased tear production have been reported.

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

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

If you consider that any of the side effects you experience are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects:

If you experience any of the side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:

https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Expiration Date

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.

Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of NORMOTRIDE 6.25 mg tablets

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

The other components (excipients) are: Lactose monohydrate, low-substitution hydroxypropylcellulose, cornstarch, talc, anhydrous colloidal silica, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and contents of the packaging

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

The packaging contains 28 tablets.

Holder of the marketing authorization and manufacturer responsible

Holder:

ARAFARMA GROUP, S.A.

C/ Fray Gabriel de San Antonio, 6-10

Pol. Ind. del Henares

19180 Marchamalo (Guadalajara). Spain

Manufacturer responsible:

ARAFARMA GROUP, S.A.

C/ Fray Gabriel de San Antonio, 6-10

Pol. Ind. del Henares

19180 Marchamalo (Guadalajara). Spain

Last review date of this leaflet: February 2007

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/