ATENOLOLO 25 mg Coated Tablet

Содержание инструкции

1. Atenololo AHCL 25 mg tablets, 50 mg tablets, 100 mg tablets
   1. What Atenololo AHCL is and what it is used for
   2. What you need to know before taking Atenololo AHCL
   3. How to take Atenololo AHCL
   4. Possible side effects
   5. How to store Atenololo AHCL
   6. Contents of the pack and other information
2. Atenololo AHCL 100 mg tablets (white, round, flat, bevelled tablets,

Atenololo AHCL 25 mg tablets, 50 mg tablets, 100 mg tablets

Generic medicine

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

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Atenololo AHCL is and what it is used for
• 2. What you need to know before you take Atenololo AHCL
• 3. How to take Atenololo AHCL
• 4. Possible side effects
• 5. How to store Atenololo AHCL
• 6. Contents of the pack and other information

1. What Atenololo AHCL is and what it is used for

Atenololo AHCL contains an active ingredient called atenolol, belonging to a group
of medicines called beta-blockers.
Atenololo AHCL is indicated for:

• treating high blood pressure (hypertension);
• treating chest pain caused by “stable chronic angina pectoris”;
• treating some types of irregular heartbeat (arrhythmias);
• preventing another heart attack.

The medicine works by slowing down the heartbeat and reducing the force of cardiac
contractions.

2. What you need to know before taking Atenololo AHCL

Do not take Atenololo AHCL:

• If you are allergic (hypersensitive) to atenolol or any of the other ingredients of this medicine (listed in section 6).
• If you have untreated or uncontrolled heart failure. Symptoms may include shortness of breath and swelling of the ankles.
• If you have a very irregular heartbeat (such as in the case of sinus node syndrome) or a second or third degree heart block (you may have a pacemaker).
• If you have a very slow heartbeat (less than 50 beats per minute before starting treatment).
• If you have very low blood pressure.
• If you have circulation problems.
• If you have cardiogenic shock. This occurs when your heart does not pump enough blood throughout your body. Symptoms may include confusion, sweating, rapid heartbeat, and pale skin.
• If you have a tumor called “pheochromocytoma” that has not been treated. It is usually located near the kidney and can cause high blood pressure.
• If you are taking adrenergic beta-blockers (e.g. floctafenine).
• If your doctor has told you that you have higher than normal levels of acidity in your blood (metabolic acidosis).
• If you suffer from asthma.
• If you are taking other antihypertensive medicines such as beta-blockers, verapamil or diltiazem.

If any of these conditions apply to you, do not take Atenololo AHCL tablets. If you have
doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Before starting treatment with Atenololo AHCL, consult your doctor, pharmacist or nurse if:

• You have breathing problems such as wheezing.
• You have allergic reactions, for example to insect bites.
• You have kidney problems.
• You experience a type of chest pain called “Prinzmetal’s angina”.
• You have circulation problems.
• You have a slow heartbeat (between 50 and 55 beats per minute).
• You have a first-degree heart block (the impulses from the upper part of the heart to the lower chambers are slowed down).
• You suffer from diabetes. Atenololo tablets may alter your sensations in case of low blood sugar levels. The symptoms of low blood sugar levels may be masked by atenolol; you may not notice a faster or stronger heartbeat and sweating caused by low blood sugar levels. Blood sugar levels should be monitored carefully.
• You have a skin condition called psoriasis.
• You have thyroid problems such as “thyrotoxicosis”. Atenololo tablets may mask the symptoms of thyrotoxicosis such as rapid heartbeat, tremor or excessive sweating.
• You have a tumor called “pheochromocytoma” should also be treated with medicines called alpha-blockers in addition to Atenololo AHCL. Blood pressure should be monitored carefully.
• You want to stop taking the tablets. Especially patients who suffer from a significant reduction in oxygen supply to the heart due to impaired blood circulation (ischemic heart disease) cannot suddenly stop taking the tablets. An abrupt discontinuation can also cause blood pressure to rise rapidly.
• You are to undergo surgery. In this case, it is important that the medical staff, especially the anesthesiologist, knows that you are taking atenolol.
• You are elderly. In this case, it may be necessary to adjust the dosage.

For those who play sports: the use of the drug without a therapeutic need constitutes
doping and may still result in a positive doping test.
If any of these conditions apply to you (or if you have doubts), consult your doctor or
pharmacist before taking this medicine.

Other medicines and Atenololo AHCL
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicines.

In particular, tell your doctor if you are taking any of the following medicines: DO
NOT take this medicine and consult your doctor or pharmacist if:

• You are taking floctafenine (for pain and swelling).
• You are taking verapamil, diltiazem and nifedipine (for high blood pressure or chest pain).

Tell your doctor or pharmacist if you are taking any of the medicines listed below:

• Clonidine: for the treatment of high blood pressure or migraine. Do not stop using clonidine unless your doctor has told you to do so. If you need to stop taking clonidine, your doctor will give you detailed instructions on how to proceed.
• Digoxin: for heart problems.
• Lidocaine, procainamide, disopyramide, amiodarone or quinidine: for irregular heartbeat.
• Adrenaline and noradrenaline: medicines that stimulate the heart.
• Ibuprofen or indometacin: for pain and swelling.
• Baclofen: for muscle cramps.
• Insulin or other medicines you take by mouth for diabetes.
• Ampicillin: for bacterial infections.
• Barbiturates: for sleep disorders.
• Sultopride and phenothiazines: for serious mental health problems (psychosis).
• Medicines for depression belonging to the classes of “tricyclic antidepressants” or “MAO inhibitors”.
• Medicines for colds or sinusitis, including over-the-counter medicines.
• Diuretics: medicines that help reduce the amount of water in the body through urine.
• Vasodilators: medicines that widen blood vessels.
• Peripheral muscle relaxants (e.g. suxamethonium halide, tubocurarine): concomitant use of atenolol may increase and extend the muscle relaxing effect of these medicines.

If any of these conditions apply to you, consult your doctor or pharmacist before taking
this medicine.

Surgery and radiological examinations
Tell your doctor or medical staff that you are taking Atenololo AHCL if:

• You are about to undergo surgery. This is because the administration of certain anesthetics during the intake of this medicine can cause low blood pressure (hypotension).
• You are about to undergo a radiological examination involving the use of substances containing iodine (so-called “contrast medium”) to examine a part of your body carefully.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Atenololo AHCL is not recommended during pregnancy or breastfeeding.

Driving and operating machinery
Atenololo AHCL may impair your ability to drive vehicles or operate
machinery due to dizziness and fatigue.
Therefore, it is best to wait and observe the effects of this medicine on you before performing these activities.
If you experience dizziness or fatigue after taking this medicine, you should not drive or
operate machinery.

3. How to take Atenololo AHCL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Your doctor will tell you how many tablets you will need to take each day and when to take them.
Read the label on the pack to remind yourself what your doctor told you.
Try to take the tablets at the same time each day.
Swallow the tablets whole with a glass of water.

Adults
Your doctor will decide how many Atenololo tablets you need to take each day based on your
health conditions.

High blood pressure

• The usual starting dose is 50 mg once a day.
• You may then take a dose between 50 mg and 100 mg once a day.

Chest pain
The usual dose is between 50 mg and 100 mg once a day. If you need to take 100
mg, your doctor may tell you to take this dose in two separate portions: 50 mg in the
morning and 50 mg in the evening.

Irregular heartbeat
The usual dose is between 50 mg and 100 mg once a day.

To prevent another heart attack
The usual dose is 100 mg once a day. Your doctor may tell you to take
this dose in two separate portions: 50 mg in the morning and 50 mg in the evening.

Elderly
If you are an elderly person, your doctor may decide to give you a lower dose, especially if
you have kidney problems.

People with severe kidney problems
If you have severe kidney problems, your doctor may decide to give you a lower dose of Atenololo
AHCL tablets or to have you take the medicine less frequently.

Use in children and adolescents under 18 years of age
Atenololo is not recommended in children and adolescents under 18 years of age.

If you take more Atenololo AHCL than you should
If you take more Atenololo AHCL tablets than you should, consult a doctor or go
directly to hospital.
Bring the package of the medicine with you so that the doctor knows what you have
taken.
You may experience a slowing of the heartbeat, dizziness due to low blood pressure
and difficulty breathing. Your heart may also have problems pumping blood
to the rest of the body (acute heart failure).

If you forget to take Atenololo AHCL
If you forget to take a dose, you can take it as soon as you remember.
However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Atenololo AHCL
Do not stop taking Atenololo AHCL without first consulting your doctor. The
doctor may consider it appropriate to reduce the dose gradually.
If you have any doubts 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.

Stop taking Atenololo AHCL and contact your doctor or hospital immediately if you notice any of the following side effects.
Rare (affects less than 1 in 1,000 people)
Abnormal heartbeat, feeling dizzy, tired or fainting. These can be symptoms of heart block.
Shortness of breath or swollen ankles. These can be symptoms of heart failure or worsening of heart failure.
Breathing problems such as wheezing. These can be a symptom of worsening asthma.

Not known (frequency cannot be estimated):
Swelling of the face or throat, difficulty breathing or dizziness. These can be symptoms of a serious allergic reaction.
Stop taking Atenololo AHCL and contact your doctor or hospital immediately if you notice any of the side effects listed above.

Other side effects include:
Common (affects less than 1 in 10 people)
Cold hands or feet, or problems with circulation in the hands and feet.
Slower heart rate. This is a normal effect, but if it worries you, tell your doctor.
Diarrhoea.
Constipation.
Problems with digestion.
Nausea or vomiting.
Feeling tired.
Sweating.

Uncommon (affects less than 1 in 100 people)
Sleep disturbances.
High levels of an enzyme called “transaminases” (detected by blood tests).

Rare (affects less than 1 in 1,000 people)
Numbness or tingling in the fingers, followed by warmth and pain (“Raynaud’s disease”).
Tingling or “pins and needles” in the hands and feet.
Problems with circulation (intermittent claudication), which may worsen when you start taking this medicine.
Low blood pressure.
Headache.
Feeling dizzy.
Feeling confused, anxious or frightened.
Nightmares.
Change in personality (psychosis) or seeing or sensing things that are not there (hallucinations).
Depression.
Dry mouth.
Hair loss.
Dry eyes.
Skin rash.
Dry, scaly skin (psoriasis) which may worsen when you start taking the medicine.
Problems with vision.
Tendency to bruise easily or develop purple spots on the skin.
For men, inability to get an erection (impotence).
Yellowing of the skin or the whites of the eyes (jaundice).
Problems with the blood such as changes in its cells. Your doctor may take blood samples from time to time to check if Atenololo AHCL is affecting your blood

Not known (frequency cannot be estimated):
Allergic reactions (hypersensitivity) such as itchy rashes.
Atenololo AHCL can mask the symptoms of “hyperthyroidism” and low blood glucose levels in diabetes (see Section 2 “What you need to know before you take Atenololo AHCL”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
www.agenziadelfarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Atenololo AHCL

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is reported on the pack after the word “Scad.”. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage conditions.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Atenololo AHCL contains
The active ingredient is atenolol.
Atenololo AHCL contains 25 mg, 50 mg or 100 mg of atenolol.
The other ingredients are: heavy magnesium carbonate, corn starch, sodium lauryl sulfate,
gelatin, magnesium stearate (E572), microcrystalline cellulose, talc.

Description of the appearance of Atenololo AHCL and contents of the pack
Atenololo AHCL 25 mg tablets (white, round, flat, bevelled tablets,
with “AA” imprinted on one side and with a score line on the other). The tablet can be
divided into two equal doses.
Atenololo AHCL 50 mg tablets (white, round, flat, bevelled tablets,
with “AB” imprinted on one side and with a score line on the other). The tablet can be
divided into two equal doses.

Atenololo AHCL 100 mg tablets (white, round, flat, bevelled tablets,

with “AC” imprinted on one side and a score line on the other). The tablet can be
divided into two equal doses.
Atenololo AHCL 25 mg is packaged in PVC/PVDC/aluminium blisters.
Packs: 14, 20, 28, 30 and 90 tablets.
Atenololo AHCL 50 mg is packaged in PVC/PVDC/aluminium blisters.
Packs: 14, 20, 28, 30, 50, 90 and 100 tablets.
Atenololo AHCL 100 mg is packaged in PVC/PVDC/aluminium blisters.
Packs: 14, 20, 28, 30, 50 and 90 tablets.
Atenololo AHCL 25 mg tablets are available in HDPE tablet containers with
a PP screw cap.
Packs: 100, 500, 1000 and 5000 tablets.
Atenololo AHCL 50 mg and 100 mg tablets are available in HDPE tablet containers with
a PP screw cap.
Packs: 500 tablets.
It is possible that not all packs are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area
under the following designations:
NL : Atenolol Accord 25/50/100 mg Tablets
FR : Atenolol Accord 50/100 mg Tablets
IT : Atenololo AHCL 25/50/100 mg tablets
SE : Atenolol Accord 25/50/100 mg Tablets