Patient Information Leaflet

Tenoretic100 mg/25 mg Tablets

atenolol/clortalidona

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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must 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, pharmacist or nurse, even if they are not listed in this leaflet.

Tenoretic is indicated for the treatment of high blood pressure.

Tenoretic contains two active ingredients. Atenolol is a beta-blocker and has effects on your heart and circulation. Clortalidona is a diuretic that increases the amount of urine produced by the kidneys. Each one reduces blood pressure through a different mechanism.

Your doctor may prescribe Tenoretic if your blood pressure is not adequately controlled with atenolol or clortalidona separately.

Do not take Tenoretic

• If you are allergic to atenolol, clortalidona or any of the other components of this medication (listed in section 6).
• If you have or have had heart problems such as heart failure or blockage.
• If you have ever experienced very slow or irregular heartbeats, very low blood pressure or circulatory failure (cardiac conduction disorder).
• If you have severe kidney problems.
• If you have been told you have phaeochromocytoma (a tumor in the adrenal glands) that is not being treated with other medications.
• If you have fasted.
• If you have been told you have metabolic acidosis (a metabolic disorder that causes excessive blood acidity).
• If you are pregnant, think you may be pregnant or are breastfeeding. See “Pregnancy and breastfeeding”.

Warnings and precautions

• Consult your doctor, pharmacist or nurse before starting to take Tenoretic

• If you have any health problems such as asthma or breathing difficulties, diabetes, circulatory disorders, gout, heart problems, kidney problems, liver or thyroid problems.
• If you have ever been told you have a specific type of chest pain (angina) called Prinzmetal's angina.
• If you have ever had an allergic reaction to something, for example, an insect bite.

• If you are using eye drops that contain beta-blockers, you may notice a greater effect from Tenoretic.
• If you are an elderly patient, follow a low-potassium diet or have gastrointestinal problems, your doctor may need to perform blood tests to monitor your potassium or sodium levels in the blood.
• You may notice that your pulse is slower while taking these tablets. This is normal, but if this concerns you, inform your doctor.
• If you are diabetic, Tenoretic may alter your response to insulin or other antidiabetic treatments. It may also modify your normal response to low blood glucose, which usually involves an increase in heart rate.
• Tenoretic may modify the body's response to hypoglycemia (low blood glucose levels), reducing the tachycardia, palpitations and sweating that occur during hypoglycemia.
• If you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking Tenoretic.If left untreated, this can cause permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it.
• In the event of hospital admission, inform the healthcare staff and, in particular, the anesthetist that you are being treated with Tenoretic.

Taking Tenoretic with other medications

Inform your doctor or pharmacist that you are taking, have taken recently or may need to take any other medication, including those purchased without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one of them. Some medications may affect the action of others, particularly:

• Disopyramide or amiodarone (for irregular heartbeats).
• Other treatments for hypertension or angina (particularly, see verapamil, diltiazem, nifedipine, clonidine). If you are taking clonidine for hypertension or to prevent migraines, do not interrupt treatment with this or Tenoretic without consulting your doctor first.
• Treatment for heart failure (digoxin).
• Lithium (for certain psychiatric disorders).
• Anti-inflammatory medications for pain relief (such as indometacin or ibuprofen).
• Decongestants or other products for colds that you may have purchased yourself at a pharmacy.
• Baclofen (used as a muscle relaxant).
• Adrenaline.

Pregnancy, breastfeeding and fertility

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

Pregnancy:

Do not use during pregnancy. See “Do not take Tenoretic”.

Breastfeeding:

Do not use during breastfeeding. See “Do not take Tenoretic”.

Driving and operating machinery

It is unlikely that Tenoretic will affect your ability to drive machines. However, like other medications used to treat high blood pressure, Tenoretic may cause dizziness or drowsiness in some people, especially at the start of treatment, when changing doses or if alcohol is consumed. If you experience dizziness or drowsiness, consult your doctor before engaging in these activities.

Important information about some of the components of Tenoretic

Use in athletes:This medication contains atenolol, which may produce a positive result in doping control tests.

Tenoretic contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with Tenoretic.

Use in adults

• The recommended dose is one daily tablet.
• Swallow the tablet whole with water.
• Try to take your tablet at the same time every day.
• Do not stop taking your tablets even if you feel well, unless your doctor tells you to do so; in this case, you should do so gradually.

Use in children

This should not be used in children. See “Do not take Tenoretic”.

If you take more Tenoretic than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Tenoretic

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Tenoretic

Do not stop treatment before your doctor tells you to.Only stop taking your tablets if your doctor tells you to and, in that case, do so only gradually.

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

Like all medications, Tenoretic can produce side effects, although not everyone will experience them. With Tenoretic, these may be:

Frequent (affects between 1 and 10 of every 100 patients)

• Cold hands and feet.
• Slower heartbeats.
• Diarrhea.
• Nausea.
• Fatigue.
• Low sodium levels in the blood, which causes weakness, vomiting, and cramps.
• Hyperuricemia (excess uric acid in the blood).
• Hypokalemia (decrease in potassium levels in the blood).
• Alteration of glucose tolerance.

Infrequent (affects between 1 and 10 of every 1,000 patients)

• Sleep disorders.
• Increased transaminases (a type of liver enzyme).

Rare (affects between 1 and 10 of every 10,000 patients)

• Cardiac block (which can cause abnormal heartbeats, dizziness, fatigue, or fainting).
• Worsening of arterial circulation, if you already have some degree of circulatory insufficiency.
• Numbness and spasms in the fingers of the hands, followed by heat and pain (Raynaud's phenomenon).
• Lack of breathing and/or inflammation of the ankles, if you also have heart failure.
• Dizziness, especially when standing up.
• Headache.
• Confusion.
• Psychosis or hallucinations (mental disorders).
• Mood changes.
• Dry mouth.
• Hair loss.
• Dry eyes.
• Skin rash, including worsening of psoriasis.
• Sensation of tingling in the hands.
• Worsening of respiratory difficulties, if you have or have had asthma.
• Vision disorders.
• Thrombocytopenia (easier bleeding tendency).
• Purpura (purple spots on the skin).
• Impotence.
• Icterus (which can be detected as yellow discoloration of the skin and eyes).
• Pancreatitis (inflammation of the pancreas, a large gland located behind the stomach).
• Nightmares.
• Leucopenia (decrease in the number of white blood cells in the blood).

Very rare (affects fewer than 1 in 10,000 patients)

• Very rarely, changes may occur in some blood components, for example, antinuclear antibodies (ANA).

Frequency unknown (cannot be estimated from available data)

• Constipation.
• Syndrome similar to lupus (a disease in which the immune system produces antibodies that attack mainly the skin and joints).
• Decreased vision or eye pain due to high pressure [possible signs of accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].
• Depression.

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 that does not appear in this prospectus.

You can also report them directly through the Spanish System for the 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 medication.

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

Store below 25°C, in the original packaging to protect it from light and moisture.

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

Medications should not be disposed of through drains or 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 Tenoretic

• The active principles are atenolol and clortalidone.
• The other components are: heavy magnesium carbonate, cornstarch, sodium lauryl sulfate, gelatin, and magnesium stearate.

Appearance of the product and content of the packaging

Tenoretic 100 mg/25 mg are white tablets.

This medication is presented in packaging containing 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5th floor

DK-2300 København S

Denmark

Responsible for manufacturing

AstraZeneca AB

Karlebyhusentrén AstraallénSE-152 57Södertälje

Sweden

or

Corden Pharma GmbH

Otto-Hahn-Strasse 1

68723 Plankstadt

Germany

Last review date of this leaflet: May 2024

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