ATENOLOLO 100 mg/25 mg Таблетки

Содержание инструкции

1. Atenololo e Clortalidone Mylan Generics 100 mg/25 mg tablets
   1. What is Atenololo and Clortalidone Mylan Generics and what is it used for
   2. What you need to know before taking Atenolol and Clortalidone Mylan Generics
   3. How to take Atenololo and Clortalidone Mylan Generics
   4. Possible side effects
   5. How to store Atenololo and Clortalidone Mylan Generics
   6. Contents of the pack and other information

Atenololo e Clortalidone Mylan Generics 100 mg/25 mg tablets

atenololo/clortalidone

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Atenololo and Clortalidone Mylan Generics and what is it used for

This medicine contains two active ingredients, atenolol and clortalidone. Atenolol belongs to a
group of medicines called beta-blockers, which work by slowing down the heartbeat and making the
heart beat with less force. Clortalidone belongs to a group of medicines called diuretics
which work by increasing the amount of urine produced by the kidneys. These two active ingredients work together
to lower blood pressure.
Atenololo e Clortalidone Mylan Generics is indicated for the treatment of high blood pressure
(essential hypertension) when blood pressure is not adequately controlled by therapy with the
individual active ingredients (atenolol and clortalidone).

2. What you need to know before taking Atenolol and Clortalidone Mylan Generics

Do not take Atenolol and Clortalidone Mylan Generics

• if you are allergic to atenolol or clortalidone (or to medicines derived from sulfonamides) or to any of the other ingredients of this medicine (listed in section 6);
• if you have a very irregular heartbeat (sick sinus syndrome) or if you suffer from certain heart conduction diseases (second or third degree atrioventricular block);
• if you have a very slow heartbeat (bradycardia);
• if your heart function is insufficient and is not controlled by adequate therapy (uncontrolled heart failure);
• if you have a severe heart problem, known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
• if you have low blood pressure (hypotension);
• if you suffer from a rare disease characterized by brief episodes of narrowing of the arteries, the blood vessels that carry blood from the heart to the rest of the body (Raynaud's syndrome);
• if you have severe circulatory problems in the limbs (peripheral arterial circulation);
• if you have severe kidney problems (severe renal failure);
• if your doctor has told you that the acidity level of your blood is higher than normal (metabolic acidosis);
• if you suffer from severe asthma and severe chronic obstructive pulmonary diseases;
• if you have a high level of uric acid in your blood (symptomatic hyperuricemia);
• if you have a tumor of the adrenal gland, called “pheochromocytoma” that has not been treated;
• if you have severe liver and kidney problems (hepatopathies and nephropathies);
• if you suffer from an inflammatory type of joint disease (manifest gout);
• if you are pregnant and if you are breastfeeding;
• if you are taking medicines such as verapamil (used to treat high blood pressure) or diltiazem (used to treat high blood pressure, chest pain known as angina pectoris and other heart disorders);
• if you are being treated with verapamil or diltiazem intravenously.

Warnings and precautions
Talk to your doctor or pharmacist before taking Atenolol and Clortalidone Mylan Generics.
If you have a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a few hours to a few weeks after taking Atenolol and Clortalidone Mylan Generics. This can lead to permanent vision loss if left untreated. This risk may be increased if you are allergic to penicillin or sulfonamides.
Take special care and consult your doctor:

• if your heart function is insufficient (heart failure), but is kept under control by adequate therapy;
• if your heart's ability to increase the amount of blood pumped to the body is poor (poor cardiac reserve);
• if you suffer from chest pain called Prinzmetal's angina, as this medicine may increase the number and duration of angina attacks;
• if you have circulatory problems in the limbs;
• if you have heart problems (first-degree atrioventricular block, a disease of the heart's conduction system);
• if you have ischemic heart disease, a heart disease that occurs when there is insufficient oxygenation of the heart muscle. Talk to your doctor before stopping treatment with Atenolol and Clortalidone Mylan Generics;
• if you have had severe allergic reactions (anaphylactic reactions) in the past;
• if you suffer from respiratory diseases. If your symptoms worsen, stop treatment and inform your doctor;
• if you are to receive a type of medicine called anesthetics (medicines administered, for example, during surgery);
• if you are using eye drops based on similar active ingredients (beta-blockers);
• if you are to undergo anesthesia in case of surgery. Inform the anesthesiologist that you are taking Atenolol and Clortalidone Mylan Generics;
• if you are being treated for a type of tumor called pheochromocytoma; in this case, blood pressure will need to be closely monitored during treatment;
• if you have problems with your thyroid gland (thyrotoxicosis), because atenolol may mask its cardiovascular symptoms;
• if you have diabetes or a predisposition to diabetes, because atenolol may alter the signals of a low blood sugar level (hypoglycemia) such as a fast heartbeat, palpitations and sweating, while clortalidone may cause an increase in blood sugar levels (hyperglycemia). If you have diabetes, your blood sugar level (glycemia) should be carefully monitored in the early stages of therapy and at regular intervals during prolonged treatment;
• if you suffer from kidney problems, such as renal insufficiency;
• if you suffer from liver disorders (impaired liver function or progressive liver disease);
• if you are elderly, if you suffer from heart problems (heart failure) and are being treated with medicines belonging to the group of digitalis glycosides, if you follow a low-potassium diet or if you suffer from stomach and intestinal disorders, because a decrease in potassium and sodium levels in the blood (hypokalemia and hyponatremia) may occur.

During treatment with this medicine, periodically perform blood tests to be able to identify any changes in salt levels (especially low levels of potassium and sodium) and, if necessary, to check uric acid levels, as an increase in uricemia may occur. It is also recommended to periodically check the sugar level in your urine.
During treatment with this medicine, a reduction in heart rate is normal, however, if it is excessive, consult your doctor who will reduce the dosage.
If you are an athlete: the use of this medicine without a therapeutic need constitutes doping and may in any case lead to positive doping tests.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

Children and adolescents
Atenolol and Clortalidone Mylan Generics should not be given to children and adolescents.

Other medicines and Atenolol and Clortalidone Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take this medicine if you have been given calcium channel blockers (e.g. verapamil or diltiazem) by intravenous injection in the last 48 hours.
Take special care and talk to your doctor if you are taking:

• medicines used to treat heart rhythm disturbances (disopyramide, amiodarone, digitalis glycosides);
• clonidine, a medicine used to treat high blood pressure. If the two drugs are taken simultaneously, this medicine must be discontinued several days before stopping clonidine therapy. If therapy with Atenolol and Clortalidone Mylan Generics is to replace that with clonidine, the start of treatment must take place several days after stopping therapy with clonidine;
• medicines used to treat high blood pressure (belonging to the group of sympathetic ganglion blockers or other beta-blockers);
• medicines used to treat depression (called monoamine oxidase inhibitors (MAOIs));
• medicines used to treat high blood pressure belonging to the dihydropyridine group (e.g. nifedipine);
• medicines that stimulate the heart belonging to the sympathomimetic group (e.g. adrenaline);
• medicines used to treat mental disorders such as tricyclic antidepressants, barbiturates and phenothiazines, as they may cause a decrease in blood pressure;
• medicines used in case of inflammation and to relieve pain (e.g. ibuprofen, indometacin);
• baclofen, a medicine used to treat muscle disorders. Dose adjustment may be necessary; lithium, a medicine used to treat mental disorders. Dose adjustment of lithium may be necessary; anesthetics (medicines administered, for example, during surgery); medicines for controlling diabetes (oral hypoglycemic agents such as sulfonylureas) as dose adjustment may be necessary.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not use this medicine if you are pregnant and if you are breastfeeding.

Driving and using machines
The use of this medicine may affect your ability to drive and operate machinery because it may cause side effects such as fatigue and dizziness. If this happens to you, avoid driving or using machines.

3. How to take Atenololo and Clortalidone Mylan Generics

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
Do not break the tablets, take them with a little water and preferably always at the same time.
The recommended dose in adults is one tablet a day. If this dose is not effective, it is
necessary to associate another medicine, such as a vasodilator, to lower your blood pressure.
If you are already being treated with other antihypertensive medicines, you may switch directly to using this
medicine, with the exception of preparations based on clonidine (see paragraph “Other medicines and Atenololo
and Clortalidone Mylan Generics”).

Use in the elderly
If you are elderly, your doctor will adjust the dosage, decreasing the daily dose or decreasing the frequency
of administrations.

Use in patients with severe renal impairment
If you suffer from severe kidney problems, you should not take Atenololo and Clortalidone Mylan Generics (see
paragraph “Do not take Atenololo and Clortalidone Mylan Generics”).

Use in children and adolescents
Atenololo and Clortalidone Mylan Generics should not be administered to children and adolescents under the age of
18 years.

If you take more Atenololo and Clortalidone Mylan Generics than you should
Following the intake of an excessive dose of this medicine, the following symptoms may occur:
slowing of the heartbeat (bradycardia); decrease in blood pressure (hypotension);
insufficient heart function (acute heart failure); difficulty breathing (bronchospasm).
In case of ingestion/taking an excessive amount of this medicine, seek immediate medical attention or go to the nearest hospital Emergency Room.

If you forget to take Atenololo and Clortalidone Mylan Generics
If you forget to take a tablet, do so as soon as you remember, unless it is almost time to
take the next dose. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Atenololo and Clortalidone Mylan Generics
Do not stop taking this medicine if you notice an improvement in your health condition, unless your
doctor advises you to do so. Discontinuation of treatment must occur gradually, especially
if you suffer from disorders of the blood circulation of the heart (ischemic heart disease).
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• slowing of the heartbeat (bradycardia);
• feeling of coldness in the hands and feet;
• stomach and intestinal disorders, including nausea;
• fatigue;
• high level of uric acid in the blood (hyperuricemia);
• low levels of sodium and potassium in the blood (hyponatremia and hypokalaemia);
• reduced glucose tolerance.

Uncommon(may affect up to 1 in 100 people)

• sleep disorders;
• changes in blood tests related to liver function (transaminases).

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

• skin disease manifested by the appearance of blisters that tend to bleed (purpura);
• reduction in the number of platelets and white blood cells (thrombocytopenia and leucopenia);
• mood changes;
• nightmares, confusion, mental disorders (psychosis and hallucinations);
• dizziness and headache;
• tingling in the hands and feet (paresthesia);
• vision disturbances, dry eyes;
• worsening of heart function (heart failure) and blockage of heart function;
• sudden drop in blood pressure when standing up with possible loss of consciousness (syncope);
• worsening of difficulty moving (intermittent claudication);
• circulation problems in the hands and feet (Raynaud's phenomenon);
• dry mouth;
• difficulty breathing (bronchospasm), in people who suffer from bronchial asthma or who have suffered from asthma;
• liver problems, including alterations in bile flow (intrahepatic cholestasis) and inflammation of the pancreas (pancreatitis);
• hair loss (alopecia);
• skin inflammation, worsening of psoriasis, skin rash;
• difficulty achieving or maintaining an erection (impotence).

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

• increase in antinuclear antibodies, a type of autoantibody that the body produces against itself.

Not known(frequency cannot be estimated from available data)

• rapid-onset distance vision impairment (acute myopia), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
• constipation;
• Lupus-like syndrome (a disease characterized by the production of antibodies by the immune system that primarily attacks the skin and joints);
• depression;
• increased skin sensitivity to sunlight (photosensitivity and phototoxic reaction).

Allergic reactions (symptoms include itching and hives), loss of appetite and
diarrhea have been observed.

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national
reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Atenololo and Clortalidone Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
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 and Clortalidone Mylan Generics contains
The active ingredients are atenolol and clortalidone. Each tablet contains 100 mg of atenolol and 25 mg of
clortalidone.

• The other ingredients are magnesium carbonate, corn starch, pregelatinized starch, magnesium stearate, sodium lauryl sulfate, gelatin.

Description of the appearance of Atenololo and Clortalidone Mylan Generics and pack contents
Blister pack of 28 tablets.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano

Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG)