Carvedilol teva-ratiopharm 25 mg comprimidos efg

Package Insert: Information for the Patient

Carvedilol Teva-ratiopharm 25 mg Tablets EFG

carvedilol

Read this package insert carefully before starting to take the medicine, as it contains important information for you

- Keep this package insert, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed only for you and should not be given 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 package insert. See section 4.

1. What is Carvedilol Teva-ratiopharm and how is it used

2. What you need to know before starting to take Carvedilol Teva-ratiopharm

3. How to take Carvedilol Teva-ratiopharm

4. Possible side effects

5. Storage of Carvedilol Teva-ratiopharm

6. Contents of the package and additional information

Carvedilol Teva-ratiopharm belongs to the group of alpha and beta-blockers. Carvedilol is used in the treatment of high blood pressure and in the treatment of angina pectoris. Carvedilol is also used as a complementary treatment in heart failure.

Do not take Carvedilol Teva-ratiopharm

• if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6),
• if you haveunstable or decompensated heart failureor certain types ofheart conduction disorders(type II and III AV block, unless you have a pacemaker, or the so-called sick sinus syndrome),
• if you have aliver diseasethat causes problems,
• if you have avery slow heart rate (less than 50 beats per minute)orvery low blood pressure,
• if you haveseverely compromised cardiac function(cardiogenic shock),
• if you have asevere disorder of the body's acid-base balance(metabolic acidosis, acidemia),
• if you haveasthmaor otherrespiratory diseaseswith a tendency to throat constriction caused by cramps (e.g. chronic obstructive pulmonary disease),
• if you have severe respiratory problems (acute pulmonary embolism),
• if you have an unusual form of angina pectoris (Prinzmetal's angina),
• if you have heart failure as a result of a respiratory disease (cor pulmonale),
• if you have apheochromocytomaand are not being treated with medication,
• if you are takingMAO inhibitors(e.g. moclobemide) (except MAO-B inhibitors),
• if you are receiving intravenous treatment withverapamil, diltiazemor other medicines used to treat heart rhythm disorders (antiarrhythmics),
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Carvedilol Teva-ratiopharm

• if you haveheart failureaccompanied by

• low blood pressure,
• insufficient blood and oxygen supply to the heart(ischaemic cardiopathy) andhardening of the arteries(atherosclerosis)
• and/orrenal problems,,

Your kidney function should then be monitored. You may need to reduce your dose.

• if you have had aheart attack. This should be treated before taking carvedilol,

• if you have a certain type ofheart conduction disorder(called type I AV block),
• if you havehypertension due to organic causes,

• if you havediabetes. Treatment with Carvedilol Teva-ratiopharm may mask the signs of low blood sugar. Therefore, your blood sugar should be monitored regularly,

• if you haveseverely impaired circulation in the hands and feet,
• simultaneous treatment with medicines used to treat heart failure (digitalis glycosides) or heart rhythm disorders (e.g. verapamil, diltiazem)
• low blood pressure (orthostatic hypotension),
• acute inflammatory cardiopathy,
• stenosis of the heart valves or the outflow tract,
• terminal peripheral artery disease,
• labile or secondary hypertension,
• simultaneous treatment with other blood pressure-lowering medicines (alpha-1 receptor antagonists or alpha-2 receptor agonists),
• if you haveRaynaud's phenomenon(the fingers of the hands or feet become first blue, then pale, and then reddish with pain). Carvedilol Teva-ratiopharm may worsen the symptoms,
• if you havehyperthyroidism, with elevated production of thyroid hormone, Carvedilol Teva-ratiopharm may mask the symptoms,
• if you are using Carvedilol Teva-ratiopharm and are to undergo asurgerywith an anaesthetic. You should consult the responsible anaesthetist well in advance,
• if you have avery slow heart rate (less than 55 beats per minute).
• if you have asevere allergic reaction(e.g. to an insect bite or food) or if you are undergoing or are to undergoallergen desensitization therapybecause Carvedilol Teva-ratiopharm tablets may weaken the effect of medicines used to treat such allergic reactions,
• if you havepsoriasis,
• severe skin reactions (e.g. toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome [SJS]),
• if you usecontact lenses. Carvedilol may reduce tear production.

Children and adolescents

There are insufficient data on the efficacy and safety of carvedilol in children and adolescents under 18 years of age. Therefore, carvedilol should not be used in this patient group.

Older patients

Older patients may be more sensitive to carvedilol and should be monitored more closely.

Other medicines and Carvedilol Teva-ratiopharm

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medicine. Other concomitant treatment may affect or be affected by carvedilol.

It isespecially importantthat your doctor knows if you are already being treated with:

• Digoxin or digitoxin(for treating heart failure).
• Insulinororal antidiabetic medicines(medicines that reduce blood sugar) as the reduction in blood sugar may be increased and the symptoms of hypoglycaemia may be masked.
• Rifampicin(antibiotic used in the treatment of tuberculosis).
• Carbamazepine(medicine for treating epilepsy).
• Fluconazole(medicine for treating fungal infections).
• Paroxetine, fluoxetine, bupropion(medicines for treating depression).
• Medicines containingreserpine, guanitidine, methyldopa, guanfacine or monoamine oxidase inhibitors(MAOIs) (medicines for treating depression and Parkinson's disease), as they may lead to a greater reduction in heart rate.
• Ciclosporin or tacrolimus(medicine for inhibiting the immune system, to prevent rejection after organ transplantation, also used for, for example, certain rheumatic or dermatological problems).
• Medicines for treating irregular heartbeats(e.g. verapamil, diltiazem, quinidine, amiodarone).
• Clonidine(medicine for reducing blood pressure).
• Sympathomimetics(medicines that increase the function of the sympathetic nervous system).
• Medicines used to treat respiratory problems (e.g.salbutamol, formoterol).
• Dihydropyridines(medicine for treating high blood pressure and heart diseases).
• Other medicines that lower blood pressure.Carvedilol may potentiate the effect of other blood pressure-lowering medicines taken concomitantly (e.g.alpha-1 receptor antagonists, nitrates) and medicines in which blood pressure reduction occurs as an adverse effect, for examplebarbiturates(in the treatment of epilepsy),phenothiazines(for treating psychosis),tricyclic antidepressants(for treating depression)vasodilators (medicines for dilating blood vessels).
• Neuromuscular blocking agents(medicines that reduce muscle tension).
• Ergotamine(medicine for migraine).
• Anaesthetics(medicines used in anaesthesia)
• Certain analgesic tablets(NSAIDs),oestrogens(hormones) andcorticosteroids(adrenal hormone), as they may reduce blood pressure, reducing the effect of Carvedilol Teva-ratiopharm.
• Cinacalcet(medicine used for treating problems with the parathyroid gland).

Carvedilol Teva-ratiopharm with food, drinks and alcohol

Carvedilol should be avoided when taken at the same time or near grapefruit or grapefruit juice during the initiation of treatment. Grapefruit and grapefruit juice may cause an increase in the amount of carvedilol in the blood and, possibly, unpredictable side effects. During treatment with carvedilol, the consumption of alcohol should be limited, as alcohol may affect the way carvedilol works.

Pregnancy and lactation

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

There is a risk of damage to the foetus. Carvedilol Teva-ratiopharm should only be used during pregnancy if your doctor considers it necessary. Therefore, always consult your doctor before using Carvedilol Teva-ratiopharm during pregnancy.

It is not known whether Carvedilol Teva-ratiopharm passes into human breast milk and therefore should not be used during breastfeeding.

Driving and operating machines

Mild dizziness and fatigue may occur at the beginning of treatment after dose increase, when changing treatment or in combination with alcohol. At therapeutic doses, it is not known whether carvedilol reduces the ability to drive or operate machines. If you feel dizzy or weak when taking the tablets, you should avoid driving or work that requires great attention.

Carvedilol Teva-ratiopharm contains lactose

If your doctor has told you that you are intolerant to certain sugars, consult him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist. If you feel that the effects of Carvedilol Teva-ratiopharm are too strong or too weak, speak with your doctor or pharmacist.

You should swallow the tablets with at least half a glass of water. You can take the tablets with or without food. Patients with heart failure should, however, take the tablets with food to reduce the risk of dizziness when standing up suddenly.

The tablets can be divided into equal doses.

Carvedilol Teva-ratiopharm tablets are available in the following concentrations: 6.25 mg, and 25 mg

Hypertension

Adults

The usual dose is 1 Carvedilol 12.5 mg tablet (corresponding to 12.5 mg of carvedilol) for the first two days and 2 Carvedilol 12.5 mg tablets (corresponding to 25 mg of carvedilol) once a day thereafter. For this dosing, other carvedilol concentrations are also available.

If necessary, the dose can be increased gradually at intervals of at least two weeks. The maximum recommended daily dose is 50 mg.

Older patients

The recommended dose is 1 Carvedilol 12.5 mg tablet (corresponding to 12.5 mg of carvedilol) once a day.

If necessary, the dose can be increased further gradually at intervals of at least two weeks up to a maximum daily dose of 50 mg.

Angina pectoris

Adults

The usual dose is 1 Carvedilol 12.5 mg tablet (corresponding to 12.5 mg of carvedilol) twice a day for the first two days and 2 Carvedilol 12.5 mg tablets (corresponding to 25 mg of carvedilol) twice a day thereafter. For this dosing, other carvedilol concentrations of Carvedilol Teva-ratiopharm are also available.

If necessary, the dose can be increased gradually at intervals of at least two weeks. The maximum recommended daily dose is 100 mg.

Older patients

The usual dose is 1 Carvedilol 12.5 mg tablet (corresponding to 12.5 mg of carvedilol) twice a day for the first two days and 2 Carvedilol 12.5 mg tablets (corresponding to 25 mg of carvedilol) twice a day thereafter. The maximum recommended daily dose is 50 mg.

Heart failure

The usual initial dose is 3.125 mg of carvedilol twice a day for two weeks. The dose can be increased incrementally, usually at intervals of two weeks.

However, it may be necessary to increase or decrease the dose. Your doctor will advise accordingly.

The maximum recommended dose is 25 mg administered twice a day in patients weighing less than 85 kg, and 50 mg twice a day in patients weighing more than 85 kg, provided that heart failure is not severe. The dose should be increased to 50 mg twice a day carefully with close medical supervision.

If you take more Carvedilol Teva-ratiopharm than you should

If you take more Carvedilol Teva-ratiopharm than you should, or if children have taken the medication by accident, contact your doctor, the hospital, or call emergency services to obtain an assessment of the risk and advice on the action to be taken.

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 medication and the amount ingested.

The symptoms of overdose may include a feeling of faintness due to excessively low blood pressure, low heart rate, and in severe cases, pauses in heartbeats. Respiratory difficulties, narrowed airways, discomfort, decreased level of consciousness, and convulsions may also occur.

If you forget to take Carvedilol Teva-ratiopharm

If you forget a dose (or more doses), take the next dose at the usual time.

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

If you interrupt treatment with Carvedilol Teva-ratiopharm

Do not stop your treatment suddenly or change the dose unless your doctor tells you to. Your treatment should be withdrawn gradually over a period of two weeks. Sudden interruption may worsen your symptoms.

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.

Most side effects are related to the dose and disappear when the dose is reduced or treatment is stopped. Some side effects may occur at the beginning of treatment and resolve spontaneously as treatment continues.

Contact your doctor immediately if you experience any of the following side effects

• Chest pain with simultaneous difficulty breathing, sweating, and nausea (may affect up to 1 in 100 people).
• Severe skin reactions, such as skin rash, redness, blisters on the lips, around the eyes or mouth, scaly skin (symptoms of erythema multiforme), mouth sores, lips, and skin (signs of Stevens-Johnson syndrome), peeling of the top layer of the skin from the lower layers of the skin all over the body (signs of toxic epidermal necrolysis) (very rare frequency).

Very common (may affect more than 1 in 10 people)

• Dizziness,
• Headache,
• Heart failure,
• Low blood pressure,
• Weakness.

Common (may affect up to 1 in 10 people)

• Bronchitis, pneumonia, upper respiratory tract infection,
• Urinary tract infections,
• Decreased red blood cell count in the blood,

• Weight gain,
• Elevated cholesterol levels,
• Loss of blood sugar control in people with diabetes,
• Depression, depressive mood,
• Visual disturbances,
• Decreased tear production, eye irritation,
• Low heart rate,
• Edema (inflammation of the body or parts of the body), fluid overload, increased blood volume in the body,
• Dizziness when standing up suddenly,
• Fainting,
• Problems with blood circulation (the signs include cold hands and feet), hardening of the arteries (atherosclerosis), worsening of symptoms in patients with Raynaud's disease (the fingers of the hands and feet first turn blue, then pale, and then red with pain) or claudication (pain in the legs that worsens when walking),
• Asthma and respiratory problems,
• Fluid accumulation in the lungs,
• Diarrhea,
• Discomfort, nausea, vomiting, stomach pain, indigestion,
• Pain (e.g. in arms and legs),

• Acute renal failure and renal function disorders in patients with hardening of the arteries and/or altered renal function,
• Difficulty urinating.

Uncommon (may affect up to 1 in 100 people)

• Sleep disturbance,
• Confusion, hallucinations,
• Nightmares,

• Abnormal sensation,
• Heart conduction system disorders, angina pectoris (including chest pain),
• Determined skin reactions (e.g. allergic dermatitis, urticaria, itching, and inflammation of the skin, increased sweating, psoriatic skin lesions or lichen planus type lesions),
• Constipation,
• Impotence.

Rare (may affect up to 1 in 1,000 people)

• Decreased platelet count (thrombocytopenia),

• Nasal congestion,
• Dry mouth.

Very rare (may affect up to 1 in 10,000 people, including isolated cases)

• Decreased white blood cell count in the blood,
• Psychosis,
• Allergic reactions,
• Abnormal liver function test,
• Involuntary loss of urine in women (urinary incontinence).

Frequency not known (cannot be estimated from available data)

• Hair loss.

The pharmacological class of beta receptor blockers may trigger hidden diabetes.

Bradycardia (lack of impulse from the sinoatrial node, the "pacemaker" of the heart that controls heart contractions and regulates heart rate) in predisposed patients (e.g. elderly patients or patients with pre-existing bradycardia, sinoatrial node dysfunction, or AV block).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano http://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.

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

PVC/PVdC/Aluminum Blister Packs

Store in the original packaging to protect it from light.

This medication does not require special temperature storage conditions.

OPA/Aluminum/PVC/Aluminum Blister Packs

Store in the original packaging to protect it from light.

This medication does not require special temperature storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at 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 Carvedilol Teva-ratiopharm 25 mg tablets

• Theactive ingredientis: Carvedilol

Each tablet contains 25 mg of carvedilol

• Theother componentsare:

- microcrystalline cellulose

- lactose monohydrate

- crospovidone

- povidone

- anhydrous colloidal silica

- magnesium stearate

Appearance of the product and contents of the package

Tablets, white, biconvex, capsule-shaped, engraved with “C” with a notch and “4” on one side and smooth on the other.

The tablets can be divided into equal doses.

Package sizes: 10, 14, 28, 30, 50, 56, 60, 98, 100, and 105 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer:

Merckle GmbH

Ludwig Merckle Strasse 3

89143 Blaubeuren

Germany

Or

Teva Operations Poland Sp. z o.o.

Mogilska 80 Str.

31-546 Krakow

Poland

Or

Teva Pharmaceutical Works Privated Limited

Pallagi út 13

Debrecen H-4042

Hungary

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany, Austria:Carvedilol-ratiopharm 25 mg Tabletten

Finland, Sweden:Carveratio

Spain:Carvedilol Teva-ratiopharm 25 mg tablets EFG

Poland, Portugal:Carvedilol-ratiopharm

Last review date of this leaflet: April 2024

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