Prospecto: information for the user

Coropres 25mg tablets

Carvedilol

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4

1. What Coropres 25 mg tablets are and for what they are used

2. What you need to know before starting to take Coropres 25 mg tablets

3. How to take Coropres 25 mg tablets

4. Possible adverse effects

5. Storage of Coropres 25 mg tablets

6. Contents of the package and additional information

Coropres contains carvedilol as the active ingredient. It belongs to a group of medicines known asalpha and beta receptor blockers. Coropres has antioxidant, antihypertensive (blood pressure reduction), vasodilatory, and antianginal properties. It also reduces cardiac output, and has favorable effects on blood circulation at the heart level.

Coropres is indicated for the treatment of:

• Ischemic cardiopathy (little blood and oxygen reaches the heart).

Do not take Coropres 25 mg tablets if you have:

• Allergy to carvedilol or any of the excipients (listed in section 6).
• Uncompensated heart failure of class IV (heart's inability to pump blood during physical activity and at rest).
• Chronic obstructive pulmonary disease (COPD) with obstructed bronchi (difficulty breathing).
• Impaired liver function.
• Asthma.
• Heart disease consisting of second- and third-degree atrioventricular (A-V) block (unless a permanent pacemaker has been implanted).
• Slow heart rate (less than 50 beats per minute).
• Heart failure (or shock, a state in which the heart has been so damaged that it is unable to supply enough blood to the body's organs).
• Heart disease consisting of sino-auricular node block.
• Very low blood pressure (systolic pressure of less than 85 mmHg).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Coropres 25 mg tablets.

Inform your doctor if you have any of the following diseases:

• Any lung disease.
• Diabetes.
• Any heart disease.
• You are taking other heart medications, especially if you are taking any of the following medications, inform your doctor: digoxin (increases the force of the heart's beat), diuretics (increases urine production), beta-blockers (anti-hypertensive medication), calcium channel blockers (anti-hypertensive medication), and anti-arrhythmics (act on the heart's rhythm).
• You have any thyroid problems.
• You are allergic and receiving allergy treatment.
• You have circulation problems or Raynaud's phenomenon.
• You are scheduled for surgery, inform your doctor that you are being treated with carvedilol.
• You have a disease called pheochromocytoma.
• You have psoriasis (skin disease).
• You have Prinzmetal's angina (chest pain that begins during rest without obvious causes).
• You are undergoing anesthesia. Inform your responsible anesthesiologist.
• You wear contact lenses. Coropres may reduce tear production.
• You have severe cutaneous adverse reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome).

As with all beta-blocker medications, do not stop treatment abruptly. The dose should be gradually reduced according to your doctor's instructions.

Use in athletes

This medication contains carvedilol, which may produce a positive result in doping control tests.

Children and adolescents

Coropres is not recommended for use in children and adolescents under 18 years due to insufficient safety and efficacy data.

Taking Coropres 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 very important, as taking multiple medications at the same time may increase or decrease their effect.

Do not take Coropres with any other medication unless your doctor has allowed it.

These instructions may also apply to medications that have been used before or may be used later.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

- Fluoxetine and paroxetine (depression medications).

- Ciclosporin and tacrolimus (medications used to prevent transplant rejection).

- Digoxin, verapamil, diltiazem, and anti-arrhythmic medications (medications used to treat heart problems and hypertension).

- Amiodarone (medication used to treat certain heart problems).

- Certain analgesics such as Aspirin and Ibuprofen (NSAIDs).

- Other medications for hypertension, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.

- Medications for diabetes (including insulin and oral antidiabetic medications).

- Clonidine (medication used to control hypertension or migraine).

- Rifampicin (medication used to treat infections).

- Cimetidine (medication used to treat gastrointestinal problems).

- Inducers or inhibitors of hepatic metabolism (medications that modify the elimination of other medications from the body).

- Monoamine oxidase inhibitors (medications used to treat depression).

- Beta-agonist bronchodilators (medications used to improve respiratory function, such as in asthma).

- Adrenaline/epinephrine (used to treat severe allergic reactions).

Taking Coropres 25 mg tablets with food, drinks, and alcohol

Avoid taking Coropres simultaneously or immediately after taking grapefruit or grapefruit juice. Grapefruit or grapefruit juice may cause an increase in carvedilol levels in the blood and lead to unpredictable adverse effects. Also, avoid excessive and simultaneous or occasional consumption of alcohol, as alcohol may affect the effect of Coropres.

Your doctor or pharmacist will inform you about the foods with which you should take the medication.

Pregnancy and breastfeeding

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

Coropres is not recommended during pregnancy and breastfeeding.

Coropres may cause fetal death in the womb, as well as premature birth. Additionally, adverse effects may occur in the fetus and newborn. After birth, the newborn has a higher risk of heart and lung problems.

Coropres passes into breast milk, so it is not recommended to use it during breastfeeding.

Driving and operating machinery

In some cases, Coropres may impair your ability to drive or operate machinery, especially when starting or changing treatment and when taken with alcohol.

Coropres 25 mg tablets contain saccharose and lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Essential Hypertension

Adults:

Oral route. The recommended starting dose is 12.5 mg once a day for the first two days. Subsequently, the recommended dose is 25 mg once a day. If necessary, your doctor may increase the dose you receive (at intervals of at least two weeks) to 50 mg once a day or in two doses of 25 mg each.

Older Adults:

Oral route. The recommended starting dose is 12.5 mg once a day, which has provided satisfactory control in some patients. If the response is not adequate, your doctor will adjust the dose (at intervals of at least two weeks).

Ischemic Cardiopathy

Adults:

Oral route. The recommended starting dose is 12.5 mg twice a day (total 25 mg per day) for the first two days. Subsequently, the recommended dose is 25 mg twice a day (total 50 mg per day). If necessary, your doctor may increase the dose you receive (at intervals of at least two weeks) to 50 mg twice a day (total 100 mg per day).

Older Adults:

Oral route. The maximum recommended dose for older adults is 50 mg administered in divided doses (twice a day).

Treatment of Symptomatic Congestive Heart Failure

Adults and Older Adults:

Oral route. Your doctor will tell you individually the dose you should take, closely monitoring you during the adjustment to higher doses.

In the case of using medications for heart diseases (digitalis) or blood pressure control (diuretics and/or ACE inhibitors) and before starting treatment with Coropres, your doctor will adjust the amount of these types of medications you should take.

In any case, the recommended starting dose for Coropres treatment in symptomatic congestive heart failure is 3.125 mg twice a day (total 6.25 mg per day) for two weeks. If you tolerate this dose well, it can be increased later (at intervals of at least two weeks) to 6.25 mg twice a day (total 12.5 mg per day). Your doctor may prescribe higher doses of Coropres later (after at least two weeks).

If you weigh less than85 kgthe maximum recommended dose is 25 mg twice a day (total 50 mg per day). If your weight is greater than85 kgthe maximum recommended dose is 50 mg twice a day (100 mg per day).

Your doctor will indicate the duration of your treatment with Coropres 25 mg tablets.

As a general rule, regardless of your disease, the withdrawal of Coropres 25 mg tablets should be done gradually over a few days, or reduce the dose by half every three days.

Use in Children and Adolescents

Coropres is not recommended for use in children and adolescents under 18 years due to the lack of sufficient data on safety and efficacy.

Guidelines for Correct Administration

Take the tablets with a sufficient amount of liquid, a glass of water.

If you have congestive heart failure (your heart has lost a little of its ability to pump blood and may cause difficulty breathing, weakness, and fluid accumulation), you should take Coropres while eating, to avoid the feeling of dizziness when getting up.

Remember to take your medication.

If You Take More Coropres Than You Should

If you take more Coropres than you should, contact your doctor immediately or go to the nearest hospital. Bring the medication with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, Telephone 91 562.04.20.

If You Forget to Take Coropres

Do not take a double dose to compensate for the missed doses.

If You Interrupt Treatment with Coropres

Treatment with Coropres should not be interrupted abruptly, especially if you have ischemic cardiopathy, a disease that causes the heart not to pump blood well. Your doctor will gradually reduce the dose over a few days until you stop taking Coropres completely.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects are classified as: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people) and unknown frequency (cannot be estimated from available data).

Infections and infestations

Common: Bronchitis, pneumonia, upper respiratory tract infections, urinary tract infections.

Nervous system disorders

Very common: Headache, dizziness, and weakness, which are usually mild and occur mainly at the beginning of treatment.

Common: Lightheadedness, fainting, especially at the beginning of treatment.

Uncommon: Paresthesias (tingling sensation).

Mental disorders

Common: Depressed mood, depression.

Uncommon: Sleep disorders.

Unknown frequency: Hallucinations.

Cardiac disorders

Very common: Increased heart failure (the heart has lost some of its ability to pump blood).

Common: Bradycardia (decreased heart rate), fluid overload, increased blood volume in the body.

Uncommon: Atrioventricular (AV) block (heart problems), and angina pectoris (chest pain).

Unknown frequency: Sinus arrest (a condition that makes heartbeats very slow or stop), especially in elderly patients or patients with other heart rhythm problems.

Vascular disorders

Very common: Hypotension (low blood pressure).

Common: Postural hypotension (dizziness when standing up or changing body position), peripheral circulation disorders (cold hands and feet), increased symptoms in patients with intermittent claudication (increased pain in the legs when walking) or Raynaud's phenomenon (decreased blood flow to the fingers, hands, ears, and nose), hypertension.

Respiratory, thoracic and mediastinal disorders

Common: Asthma and breathing difficulties in predisposed patients, accumulation of fluid in the lungs.

Rare: Nasal congestion.

Gastrointestinal disorders

Common: Gastrointestinal disturbances with symptoms such as nausea, diarrhea, abdominal pain, indigestion, vomiting.

Uncommon: Constipation.

Rare: Dry mouth.

Skin and subcutaneous tissue disorders

Uncommon: Skin reactions (e.g. allergic exanthema, dermatitis, urticaria, pruritus, psoriasis, lichen planus-like skin lesions).

Unknown frequency: Hair loss, severe cutaneous adverse reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome), excessive sweating (hyperhidrosis).

Haematological and lymphatic system disorders

Common: Decreased red blood cell count in the blood (anemia).

Rare: Decreased platelet count in the blood (thrombocytopenia).

Very rare: Decreased white blood cell count in the blood (leucopenia).

Hepatobiliary disorders

Very rare: Alterations in serum transaminases (changes in the amount of certain liver enzymes in the blood).

Ocular disorders

Common: Decreased tear production (dry eye), eye irritation, visual disturbances.

Renal and urinary disorders

Common: Acute renal failure (kidney not functioning well) and kidney function disorders in patients with diffuse vascular disease and/or altered kidney function.

Rare: Urination problems.

Unknown frequency: Urinary incontinence in women (disappears when stopping medication).

Immune system disorders

Very rare: Allergic reactions.

Musculoskeletal and connective tissue disorders

Common: Pain in the limbs.

Reproductive and breast disorders

Uncommon: Impotence.

Metabolism and nutrition disorders

Common: Worsening of blood sugar control in patients with diabetes (hyperglycemia, hypoglycemia), weight gain, increased blood cholesterol.

Unknown frequency: It may manifest latent diabetes, or an existing diabetes may worsen.

General disorders and administration site conditions

Very common: Fatigue.

Common: Pain, edema (fluid retention, swelling of the legs, ankles, and feet).

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines 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 sight and reach of children.

Store in the original packaging to protect it from light and moisture.

This medication does not require any special storage temperature.

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. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Coropres 25 mg tablets

• The active ingredient is carvedilol.
• The other components are lactose, sucrose, povidone, crospovidone, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and content of the packaging

Coropres 25 mg tablets are round, scored, white to pale yellow-beige in color, with the BM engraving on one face and D5 on the other.

Coropres 25 mg is presented in packs of 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Local representative

Laboratorios Rubió, S.A.

C/ Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Last review date of this leaflet: October 2023

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