TENORETIC 100 mg/25 mg TABLETS

Introduction

Patient Information Leaflet

Tenoretic100 mg/25 mg tablets

atenolol/chlorthalidone

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Tenoretic is and what it is used for
2. What you need to know before you take Tenoretic
3. How to take Tenoretic
4. Possible side effects
5. Storing Tenoretic
6. Contents of the pack and further information

1. What Tenoretic is and what it is used for

Tenoretic is indicated for the treatment of high blood pressure.

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

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

2. What you need to know before you take Tenoretic

Do not take Tenoretic

• if you are allergic to atenolol, chlorthalidone, or any of the other ingredients of this medicine (listed in section 6).
• if you have had or have heart problems such as heart failure or heart block.
• if you have ever had very slow or irregular heartbeats, very low blood pressure, or circulatory failure (a heart conduction disorder).
• if you have severe kidney problems.
• if you have been told you have a pheochromocytoma (a tumor in the adrenal glands) that is not being treated with other medicines.
• if you have been fasting.
• 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

• Talk to your doctor, pharmacist, or nurse before starting Tenoretic

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

• If you are using eye drops that contain beta-blockers, you may experience an increased effect of Tenoretic.
• If you are an elderly patient, are on a low-potassium diet, or have gastrointestinal problems, your doctor may need to perform blood tests to check your potassium or sodium levels.
• You may notice that your pulse is slower while taking these tablets. This is normal, but if it worries you, tell your doctor.
• If you are diabetic, Tenoretic may affect your response to insulin or other anti-diabetic treatments. It may also change your normal response to low blood sugar, which usually involves an increase in heart rate.
• Tenoretic may change your body's response to hypoglycemia (low blood sugar), reducing the rapid heartbeat, palpitations, and sweating that occur during hypoglycemia.
• If you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within hours to a week after taking Tenoretic. If left untreated, this can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it.
• If you are hospitalized, inform the healthcare staff and, in particular, the anesthesiologist, that you are being treated with Tenoretic.

Taking Tenoretic with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, as it may be necessary to stop treatment or adjust the dose of one of them. Some medicines can affect the action of others, in particular, tell your doctor if you are using:

• Disopyramide or amiodarone (for irregular heartbeats).
• Other treatments for high blood pressure or angina (in particular, verapamil, diltiazem, nifedipine, clonidine). If you are using clonidine for high blood pressure or to prevent migraines, do not stop treatment with it or with Tenoretic without consulting your doctor first.
• Treatment for heart failure (digoxin).
• Lithium (for certain psychiatric disorders).
• Anti-inflammatory medicines for pain relief (such as indomethacin or ibuprofen).
• Nasal decongestants or other cold products that you may have bought 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

Do not use during pregnancy. See "Do not take Tenoretic".

Breastfeeding:

Do not use during breastfeeding. See "Do not take Tenoretic".

Driving and using machines

It is unlikely that Tenoretic will affect your ability to drive or use machines. However, as with other medicines used to treat high blood pressure, Tenoretic may cause dizziness or drowsiness in some people, especially at the start of treatment, when changing dose, or when consuming alcohol. If you experience dizziness or drowsiness, consult your doctor before performing these activities.

Important information about some of the ingredients of Tenoretic

Athletes: This medicine contains atenolol, which can produce a positive result in doping tests.

Tenoretic contains sodium

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

3. How to take Tenoretic

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Remember to take your medicine.

Your doctor will tell you how long to take Tenoretic.

Adults

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

Children

Do not use in children. See "Do not take Tenoretic".

If you take more Tenoretic than you should

If you have taken more than you should, talk to your doctor, pharmacist, or nurse immediately or go to the emergency department at your nearest hospital. Poison Centre telephone: 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 forgotten doses.

If you stop taking Tenoretic

Do not stop treatment before talking to your doctor. Only stop taking your tablets if your doctor tells you to, and even then, only gradually.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Tenoretic can cause side effects, although not everybody gets them. With Tenoretic, these can be:

Common (affects 1 to 10 users in 100)

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

Uncommon (affects 1 to 10 users in 1,000)

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

Rare (affects 1 to 10 users in 10,000)

• Heart block (which can cause abnormal heartbeats, dizziness, fatigue, or fainting).
• Worsening of your arterial circulation, if you already have some degree of circulatory failure.
• Numbness and spasms in the fingers, followed by heat and pain (Raynaud's phenomenon).
• Shortness of breath and/or swelling 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.
• Tingling sensation in the hands.
• Worsening of breathing difficulties, if you have or have had asthma.
• Vision disorders.
• Thrombocytopenia (increased tendency to bruise).
• Purpura (purple spots on the skin).
• Impotence.
• Jaundice (which can be detected as a yellowish discoloration of the skin and eyes).
• Pancreatitis (inflammation of the pancreas, a large gland located behind the stomach).
• Nightmares.
• Leukopenia (decreased white blood cell count).

Very rare (affects less than 1 user in 10,000)

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

Frequency not known (cannot be estimated from the available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Tenoretic

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

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

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Tenoretic

• The active substances are atenolol and chlorthalidone.
• The other ingredients are: heavy magnesium carbonate, maize starch, sodium lauryl sulfate, gelatin, and magnesium stearate.

Appearance of the product and pack contents

Tenoretic 100 mg/25 mg are white tablets.

This medicinal product is presented in packs containing 56 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturer

AstraZeneca AB

Karlebyhusentrén AstraallénSE-152 57 Södertälje

Sweden

or

Corden Pharma GmbH

Otto-Hahn-Strasse 1

68723 Plankstadt

Germany

Date of last revision of this leaflet: May 2024

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