ATENOLOL ALTER 50 mg TABLETS

2. What you need to know before you take Atenolol Alter

Do not take Atenolol Alter

• if you are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6).
• if you have or have had heart problems such as uncontrolled heart failure or blockage (disorder of heart conduction).
• if you have ever had very slow or irregular heartbeats, very low blood pressure, or circulatory failure.
• if you have ever been told that you have a pheochromocytoma (a tumor in the adrenal glands).
• if you have been fasting.
• if you have been told that you have metabolic acidosis (a metabolic disorder that causes excessive blood acidity).
• atenolol should not be given to children.
• this medicine is for your use only and should not be given to anyone else.

Warnings and Precautions

Talk to your doctor before you start taking this medicine.

• if you have health problems such as asthma or breathing difficulties, diabetes, circulatory disorders, heart, kidney, or thyroid problems.
• if you have ever been told that you have a special type of chest pain (angina) called Prinzmetal's angina.
• if you are pregnant, think you may be pregnant, or are breastfeeding (see Pregnancy and Breastfeeding).
• if you have ever had an allergic reaction to anything, for example, an insect bite.
• You may notice that your pulse is slower while taking these tablets. This is normal, but if you are concerned, tell your doctor.
• If you are diabetic, this medicine may change your normal response to low blood sugar, which usually involves an increased heart rate.
• In case of hospitalization, inform the healthcare staff and, in particular, the anesthesiologist, that you are being treated with this medicine.
• Stop taking your tablets only if your doctor tells you to, and in that case, do so gradually.

Children and Adolescents

This medicine should not be used in children (see Do not take Atenolol Alter).

Taking Atenolol Alter with other medicines

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

• Disopyramide or amiodarone (for irregular heartbeats).
• Other treatments for high blood pressure or angina (in particular, verapamil, diltiazem, nifedipine, clonidine).
• If you are taking clonidine for high blood pressure or to prevent migraines, do not stop treatment with it or atenolol without consulting your doctor first.
• Treatment for heart failure (digoxin).
• Anti-inflammatory medicines for pain treatment (such as indomethacin or ibuprofen).
• Nasal decongestants or other cold products that you may have bought yourself at a pharmacy.

Pregnancy and Breastfeeding

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

Pregnancy

There is not enough data on the safety of atenolol during the first trimester of pregnancy. Your doctor will decide if treatment during the second and third trimester is beneficial for you.

Breastfeeding

Tell your doctor if you are being treated with atenolol at the time of delivery or during breastfeeding, as your baby may be at risk of low blood sugar and slower heartbeats.

Women who are breastfeeding should consult their doctor before taking this medicine, as atenolol passes into breast milk.

Driving and Using Machines

Be aware of your response to the medication because in some cases, dizziness and fatigue have been reported at usual doses. If this happens, do not drive or operate hazardous machinery.

Use in Athletes

This medicine contains atenolol, which may produce a positive result in doping tests.

Atenolol Alter contains Wheat Starch

This medicine contains very low levels of gluten from wheat starch. It is considered "gluten-free" and is very unlikely to cause problems if you have celiac disease.

Each tablet does not contain more than 5 micrograms of gluten.

If you have a wheat allergy (different from celiac disease), you should not take this medicine.

3. How to take Atenolol Alter

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

Remember to take your medicine.

Your doctor will indicate the duration of your treatment. Do not stop treatment before your doctor tells you to.

Usual dose for adults

Your doctor will decide the dose of this medicine that you should take each day depending on your situation. The table below shows the usual total daily dose for an adult. The dose is taken, usually, once a day.

Swallow the tablet whole with the help of water. The score line is only for breaking the tablet if you find it difficult to swallow it whole.

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, do so gradually.

If you take more Atenolol Alter than you should

If you take more than the normal dose, contact your doctor or go to the nearest hospital.

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 medicine and the amount taken.

If you forget to take Atenolol Alter

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects that have been seen with this medicine are:

Common (may affect up to 1 in 10 people)

• Slower heartbeats.
• Cold fingers and toes.
• Nausea.
• Diarrhea.
• Fatigue.

Uncommon (may affect up to 1 in 100 people)

• Sleep disorders.

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

• Heart block (which can cause an abnormal heartbeat, dizziness, fatigue, or fainting).
• Worsening of breathing difficulties, if you have or have had asthma.
• Shortness of breath and/or swelling of the ankles, if you also have heart failure.
• Worsening of your circulation, if you already have some degree of circulatory failure.
• Numbness and spasms in the fingers, followed by heat and pain (Raynaud's phenomenon).
• Mood changes.
• Nightmares.
• Confusion.
• Psychosis or hallucinations (mental disorders).
• Headache.
• Dizziness, especially when standing up.
• Feeling of tingling in the hands.
• Impotence.
• Dry mouth.
• Dry eyes.
• Vision disorders.
• Hair loss.
• Skin rash, including worsening of psoriasis.
• Thrombocytopenia (greater tendency to bruise).
• Purpura (purple spots on the skin).
• Jaundice (which can be detected as a yellowish color of your skin and eyes).

Very Rare (may affect up to 1 in 10,000 people)

• Very rarely, changes in some blood cells or components may occur. Your doctor may want to perform a blood test to check if atenolol has had any effect on your blood.

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

• Lupus-like syndrome (a disease in which the immune system produces antibodies that mainly attack the skin and joints)

Do not be alarmed by this list of side effects, you may not get any of them.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atenolol Alter

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

Do not store above 30°C. Store in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the packaging. 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 other information

Composition of Atenolol Alter

• The active ingredient is atenolol. Each tablet contains 50 mg of atenolol.
• The other ingredients are: pregelatinized corn starch, crospovidone, light magnesium carbonate, wheat starch, calcium carmellose, microcrystalline cellulose, dibasic calcium phosphate dihydrate, talc, stearate G, stearic acid, heavy magnesium carbonate.

Appearance of the product and pack contents

White, lenticular tablets with a score line on one face.

Available in packs of 30 or 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Date of last revision of this leaflet:April 2020

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/