NORMOTRIDE 6.25 mg TABLETS

2. What you need to know before you take NORMOTRIDE 6.25 mg Tablets

Do not take NORMOTRIDE 6.25 mg Tablets:

• If you are hypersensitive (allergic) to carvedilol or any of the other ingredients of this medicine (listed in section 6).
• If you have decompensated heart failure of class IV (NYHA) that requires the use of intravenous inotropics.
• If you have chronic obstructive pulmonary disease with a bronchospastic component in patients receiving oral or inhaled treatment.
• If you have clinically manifest liver dysfunction.
• If you have asthma.
• If you have second or third degree AV block.
• If you have severe bradycardia (less than 50 beats per minute).
• In case of cardiogenic shock.
• 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.
• 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 NORMOTRIDE 6.25 mg Tablets should not be interrupted abruptly, especially in patients with ischemic heart disease. 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 will be administered with caution if there is suspicion of having Prinzmetal's 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.
• If you are going to undergo surgery, you should inform your doctor that you are being treated with carvedilol.
• If you have psoriasis.
• If you have pheochromocytoma that is not properly controlled by alpha-blockade.
• If you have any thyroid disorder.
• If you have a history of severe hypersensitivity reactions or are undergoing desensitization therapy.
• 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 have occurred to you at any time.

Taking NORMOTRIDE 6.25 mg Tablets with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is extremely important because when taking more than one medicine at the same time, their effect can be enhanced or weakened. Therefore, you should not take NORMOTRIDE 6.25 mg Tablets with any other medicine unless your doctor has allowed it.

• Carvedilol may enhance the effect of other antihypertensives.
• Together with clonidine, it may increase blood pressure and decrease heart rate.
• Calcium antagonists (verapamil or diltiazem) or other antiarrhythmics, in combination with carvedilol, may increase the risk of cardiac conduction disorders.
• Carvedilol increases the basal minimum concentrations of digoxin.
• Antidepressants (such as fluoxetine and paroxetine) or antiarrhythmics quinidine or propafenone may increase carvedilol levels.
• The antibiotic rifampicin may decrease serum carvedilol levels, and cimetidine (a medicine used for stomach problems) may increase them.
• Together with reserpine or IMAO, it may cause severe hypotension and/or bradycardia.
• Carvedilol may increase the mean concentration of cyclosporin.
• Together with inhaled anesthetics, close attention should be paid to negative inotropic and hypotensive effects.
• It may also enhance the effect of medications used to reduce blood sugar levels, such as insulin or oral antidiabetics. The 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, although in patients whose heart does not function well (for example, in case of heart failure), carvedilol should be taken with food to reduce the incidence of adverse effects.

Pregnancy and lactation:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Use in elderly patients:

In the administration of carvedilol to elderly patients, the dosing regimen established in section 3 should be followed.

Use in children:

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

Driving and using machines:

The use of this medicine does not affect the ability to drive or use machines.

Important information about some of the ingredients of this medicine:

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.

Warning to athletes

Athletes are informed that this medicine contains a component that may produce a positive result in doping tests.

3. How to take NORMOTRIDE 6.25 mg Tablets

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

Remember to take your medicine.

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 stop treatment before it is indicated, especially if you have ischemic heart disease. The withdrawal of NORMOTRIDE 6.25 mg should be gradual over 1-2 weeks, for example, by reducing the dose by 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 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 NORMOTRIDE 6.25 mg Tablets with food.

For a more comfortable 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 at intervals of at least two weeks up to a maximum dose of 50 mg once a day (or administered in two doses).

Elderly (> 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 gradually increased at intervals of at least two weeks.

Long-term therapy of ischemic heart disease

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 at intervals of at least two weeks up to a maximum dose of 50 mg twice a day.

Elderly:

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

Symptomatic congestive heart failure

The dose must be determined individually, and you must 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.

As initial treatment, it is recommended to take 3.125 mg twice a day for the first two weeks. If this dose is tolerated, it can be successively increased at 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 the dose of 25 mg twice a day. It is recommended that the dose be increased to the highest level tolerated by the patient.

The recommended maximum dose is 25 mg administered twice a day to patients with a weight below 85 kg and 50 mg twice a day in patients with a weight above 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/cardiology specialist 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 with 3.125 mg twice a day and gradually increased according to the above recommendation.

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

Go immediately to the emergency department.

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

Taking high doses of this medicine may cause severe hypotension, bradycardia, heart failure, shock, and cardiac arrest. Respiratory problems, bronchospasm, vomiting, decreased consciousness, and convulsions may also occur.

If you forget to take NORMOTRIDE 6.25 mg Tablets:

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

4. Possible side effects

Like all medicines, NORMOTRIDE 6.25 mg Tablets can cause side effects, although not everybody gets them.

The side effects that have been observed are the following:

Central nervous system: Occasionally headache, dizziness, and fatigue, isolated cases of depressive state, sleep disorders, and paresthesia (tingling, numbness, pinching).

Cardiovascular system: Occasionally edema, hypotension, postural hypotension, bradycardia, isolated cases of syncope, AV block, 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.

Metabolism: Occasionally hyperglycemia, in patients with pre-existing diabetes mellitus, weight gain, and hypercholesterolemia.

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

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

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

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

Reporting of side effects:

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

https://www.notificaram.es. By reporting side 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 sight and reach of children.

Expiry date

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

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

Return the packaging and any unused medicine to a pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of NORMOTRIDE 6.25 mg Tablets

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

The other ingredients (excipients) are: lactose monohydrate, low-substituted hydroxypropylcellulose, cornstarch, 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.

The 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 last revision of this leaflet: February 2007

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