Atenolol and chlorthalidone Mylan Generics

Package leaflet: Information for the patient

Atenolol and Chlorthalidone Mylan Generics 100 mg/25 mg tablets

atenolol/chlorthalidone
Generic medicinal product
Read this entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

This medicine contains two active substances, atenolol and chlorthalidone. Atenolol belongs to a group of medicines called beta-blockers, which work by slowing down the heartbeat and reducing the force of the heart's contractions. Chlorthalidone belongs to a group of medicines called diuretics, which work by increasing the amount of urine produced by the kidneys. These two active substances work together to lower blood pressure.
Atenolol and 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 substances (atenolol and chlorthalidone).

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

Do not take Atenolol and Chlorthalidone Mylan Generics

• if you are allergic to atenolol or chlorthalidone (or sulfonamide-derived medicines) or to any of the other ingredients of this medicine (listed in section 6);
• if you have a very irregular heartbeat (sinoatrial node disease) or suffer from certain heart conduction disorders (second- or third-degree atrioventricular block);
• if you have a very slow heartbeat (bradycardia);
• if your heart function is inadequate and not controlled by appropriate therapy (uncontrolled heart failure);
• if you have a severe heart condition 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 condition characterized by brief episodes of narrowing of the arteries, the blood vessels carrying blood from the heart to the rest of the body (Raynaud's syndrome);
• if you have severe circulation problems in the limbs (peripheral arterial disease);
• 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 or severe chronic obstructive pulmonary disease;
• if you have a high level of uric acid in your blood (symptomatic hyperuricemia);
• if you have an untreated tumor of the adrenal gland called "pheochromocytoma";
• if you have severe liver and kidney disorders (hepatopathies and nephropathies);
• if you suffer from an inflammatory joint disease (manifest gout);
• if you are pregnant or 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 conditions);
• if you are being treated with intravenous verapamil or diltiazem.

Warnings and precautions
Talk to your doctor or pharmacist before taking Atenolol and Chlorthalidone Mylan Generics.
If you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur from a few hours to several weeks after taking Atenolol and Chlorthalidone Mylan Generics. This may lead to permanent vision loss if untreated. This risk may be increased if you are allergic to penicillin or sulfonamides.
Exercise particular caution and consult your doctor:

• if you have inadequate heart function (heart failure), but it is controlled 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 known as Prinzmetal's angina, as this medicine may increase the frequency and duration of angina attacks;
• if you have circulation problems in the limbs;
• if you have heart disorders (first-degree atrioventricular block, a disease of the heart's conduction system);
• if you suffer from ischemic heart disease, a heart condition that occurs when there is insufficient oxygenation of the heart muscle. Consult your doctor before stopping treatment with Atenolol and Chlorthalidone Mylan Generics;
• if you have previously experienced severe allergic reactions (anaphylactic reactions);
• if you suffer from respiratory diseases. If your symptoms worsen, stop treatment and inform your doctor;
• if you are due to receive medicines called anesthetics (medicines administered, for example, during surgery);
• if you are using eye drops containing similar active substances (beta-blockers);
• if you are scheduled for anesthesia during surgery. Inform the anesthetist that you are taking Atenolol and Chlorthalidone Mylan Generics;
• if you are being treated for a type of tumor called pheochromocytoma; in this case, your blood pressure must be closely monitored during treatment;
• if you have thyroid problems (thyrotoxicosis), as atenolol may mask cardiovascular symptoms;
• if you have diabetes or a predisposition to diabetes, as atenolol may alter the warning signs of low blood sugar (hypoglycemia), such as rapid heartbeat, palpitations, and sweating, while chlorthalidone may cause an increase in blood sugar levels (hyperglycemia). If you have diabetes, your blood sugar levels (glycemia) should be carefully monitored at the beginning of treatment and at regular intervals during prolonged therapy;
• if you have kidney problems, such as renal failure;
• if you have liver disorders (impaired liver function or progressive hepatopathy);
• if you are elderly, if you have heart problems (heart failure) and are being treated with medicines belonging to the group of digitalis glycosides, if you are on a low-potassium diet, or if you suffer from stomach and intestinal disorders, as this may lead to reduced levels of potassium and sodium in the blood (hypokalemia and hyponatremia).

During treatment with this medicine, have periodic blood tests to detect possible changes in electrolyte levels (especially low levels of potassium and sodium), and, if necessary, to monitor uric acid levels, as uricemia may increase. It is recommended to periodically check sugar levels in the urine.
During treatment with this medicine, a reduction in heart rate is normal; however, if it is excessive, consult your doctor, who may reduce the dosage.
If you engage in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".
Children and adolescents
Atenolol and Chlorthalidone Mylan Generics must not be administered to children and adolescents.
Other medicines and Atenolol and Chlorthalidone Mylan Generics
Inform 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 administered calcium channel blockers (e.g., verapamil or diltiazem) intravenously within the last 48 hours.
Exercise particular caution and consult your doctor if you are taking:

• medicines used to treat heart rhythm disorders (disopyramide, amiodarone, digitalis glycosides);
• clonidine, a medicine used to treat high blood pressure. If both medicines are administered simultaneously, this medicine should be discontinued several days before stopping clonidine therapy. If treatment with Atenolol and Chlorthalidone Mylan Generics is to replace clonidine therapy, treatment should start several days after stopping clonidine;
• medicines used to treat high blood pressure (belonging to the group of ganglionic 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 psychiatric disorders such as tricyclic antidepressants, barbiturates, and phenothiazines, as they may cause low blood pressure;
• medicines used for inflammation and pain relief (e.g., ibuprofen, indomethacin);
• baclofen, a medicine used to treat muscle disorders. Dose adjustment may be necessary; lithium, a medicine used to treat psychiatric disorders. Dose adjustment of lithium may be necessary; anesthetics (medicines administered, for example, during surgery); medicines for diabetes control (oral hypoglycemics such as sulfonylureas), as dose adjustments may be necessary.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use this medicine if you are pregnant or breastfeeding.
Driving and using machines
This medicine may affect your ability to drive vehicles or operate machinery, as it may cause side effects such as fatigue and dizziness. If this occurs, avoid driving vehicles or operating machinery.

3. How to take Atenolol and Clortalidone Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Do not break the tablets; swallow them with a glass of water and preferably at the same time each day.
The recommended dose for adults is one tablet daily. If this dose is not effective, it may be necessary to add 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 this
medicine, except for preparations containing clonidine (see section “Other medicines and Atenololo
e Clortalidone Mylan Generics”).
Use in the elderly
If you are elderly, your doctor will adjust your dosage, either by reducing the daily dose or the frequency of administration.
Use in patients with severe renal impairment
If you have severe kidney problems, you must not take Atenolol and Clortalidone Mylan Generics (see
section “Do not take Atenololo and Clortalidone Mylan Generics”).
Use in children and adolescents
Atenolol and Clortalidone Mylan Generics must not be given to children and adolescents under 18 years of age.
If you take more Atenolol and Clortalidone Mylan Generics than you should
Taking too much of this medicine may cause the following symptoms:
slowing of the heartbeat (bradycardia); low blood pressure (hypotension);
impaired heart function (acute heart failure); breathing difficulties (bronchospasm).
If you or someone else has taken an excessive amount of this medicine, contact your doctor or go immediately to the nearest hospital emergency department.
If you forget to take Atenolol and Clortalidone Mylan Generics
If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed tablet.
If you stop taking Atenolol and Clortalidone Mylan Generics
Do not stop taking this medicine if you feel better, unless your doctor advises you to do so. Discontinuation of treatment should be done gradually, especially if you have heart circulation problems (ischaemic heart disease).
If you have any questions about how to use 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);
• cold sensation in hands and feet;
• stomach and intestinal disorders, including nausea;
• fatigue;
• high levels of uric acid in the blood (hyperuricaemia);
• low levels of sodium and potassium in the blood (hyponatraemia 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 characterized by the appearance of blood-tinged blisters (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 hands and feet (paraesthesiae);
• visual disturbances, dry eyes;
• worsening of heart function (heart failure) and heart block;
• sudden drop in blood pressure upon standing, possibly leading to loss of consciousness (syncope);
• worsening of movement difficulty (intermittent claudication);
• circulation problems in hands and feet (Raynaud's phenomenon);
• dry mouth;
• breathing difficulties (bronchospasm), in people suffering from or who have suffered from bronchial 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 produced by the body against itself.

Not known (frequency cannot be estimated from the available data)

• sudden-onset difficulty seeing distant objects (acute myopia), 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);
• constipation;
• lupus-like syndrome (a disease characterized by the production of antibodies by the immune system that primarily attack the skin and joints);
• depression;
• increased sensitivity of the skin to sunlight (photosensitivity and phototoxic reaction).

Allergic reactions (symptoms include itching and hives), loss of appetite, and diarrhoea have also been observed.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Atenolol and Chlorthalidone Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater 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 Atenolol and Clortalidone Mylan Generics contains
The active substances are atenolol and clortalidone. Each tablet contains 100 mg of atenolol and 25 mg of
clortalidone.

• Other components are magnesium carbonate, maize starch, pregelatinized starch, magnesium stearate, sodium lauryl sulfate, gelatin.

Description of the appearance of Atenolol and Clortalidone Mylan Generics and contents of the pack
Pack in blister packs containing 28 tablets.
Marketing Authorization 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)