ATENIGRON 100 mg/25 mg Tabletki

Treść ulotki

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

Atenigron 100 mg + 25 mg tablets

atenolol + chlortalidone
Read this leaflet carefully before taking this medicine as 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 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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Atenigron and what is it used for

Atenigron contains two active ingredients: atenolol and chlortalidone. Atenolol belongs to a group of
medicines called beta-blockers which work by slowing down the heartbeat. Chlortalidone belongs
to a group of medicines called diuretics which work by increasing the amount of urine produced by the
kidneys.
Atenigron is indicated in the treatment of high blood pressure (essential hypertension) in
patients in whom blood pressure is not adequately controlled by atenolol or chlortalidone monotherapy alone.

2. What you need to know before taking Atenigron

Do not take Atenigron

• if you are allergic to atenolol or chlortalidone or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from heart disease, for example:
• disease of the heart's conduction system (second or third degree heart block)
• very irregular heartbeat (sick sinus syndrome) or very slow heartbeat (bradycardia)
• uncontrolled heart failure or cardiogenic shock which occurs when the heart is unable to pump enough blood to meet the body's needs
• low blood pressure (hypotension)
• if you have severe circulatory disorders of the limbs (peripheral arterial disease);
• if you have severe problems with the liver and/or kidneys (severe hepatic and/or renal failure);
• if your doctor has diagnosed you with abnormally high levels of acids in the blood (metabolic acidosis);
• if you suffer from a tumor called pheochromocytoma that is not being treated;
• if you suffer from an inflammatory type of joint disease (manifest gout);
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Atenigron.

Pay particular attention and consult your doctor:

• if your heart function is insufficient (heart failure), but is kept under control with adequate therapy;
• if your heart's ability to increase the amount of blood it pumps 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 disorders of the limbs, as Atenigron may worsen even mild peripheral vascular disorders;
• if you have a disease of the heart's conduction system called first-degree heart block;
• if you have diabetes or a predisposition to diabetes, because atenolol can change the warning signs of low blood sugar (hypoglycemia) such as a fast heartbeat, palpitations and sweating, while chlortalidone can cause an increase in blood sugar levels (hyperglycemia). Careful monitoring of blood sugar is recommended in the early stages of therapy and, with prolonged treatment, regular monitoring of glucose levels in the urine (glucosuria) should be performed;
• if you have thyroid problems (thyrotoxicosis), as atenolol can mask cardiovascular symptoms;
• if you suffer from ischemic heart disease, a heart condition that occurs when there is insufficient oxygenation of the heart muscle. Talk to your doctor before stopping treatment with Atenigron;
• if you have had severe allergic reactions to various allergens (anaphylactic reactions) in the past;
• if you suffer from respiratory diseases. If your symptoms worsen, stop treatment and inform your doctor;
• if you are using eye drops containing similar active ingredients (beta-blocking ophthalmic agents);
• if you are being treated for a type of tumor called pheochromocytoma, as blood pressure will need to be closely monitored during treatment;
• if you are going to have anesthesia for surgery. Tell the anesthesiologist that you are taking Atenigron;
• if you are elderly, if you suffer from heart problems (heart failure) and are being treated with digitalis preparations, if you follow a low-potassium diet or if you suffer from stomach and intestinal disorders, because a reduction in potassium and sodium levels in the blood (hypokalemia and hyponatremia) may occur;
• if you have liver problems (impaired liver function or progressive liver disease).
• if you have decreased 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 or weeks of taking Atenigron. If left untreated, this condition can lead to permanent vision loss. If you have had an allergy to penicillin or sulfonamides in the past, you may be at higher risk of developing this condition.

During treatment with this medicine, have your blood tested periodically to be able to
detect 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. Regular monitoring of glucose levels in the urine is also recommended.
This medicine reduces the frequency of heartbeats. If you develop symptoms of
excessively slow heart rate during treatment, see your doctor who will reduce the dosage.

Children and adolescents
Atenigron should not be given to children and adolescents under the age of 18 years.

Other medicines and Atenigron
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor if you are taking:

• verapamil, diltiazem(used to treat high blood pressure or chest pain), as taking them at the same time as Atenigron is contraindicated. 48 hours must have passed since stopping one of these medicines before starting the other therapy.
• disopyramide, amiodarone, digitalis glycosides(used to treat heart rhythm disturbances);
• clonidine(used to treat high blood pressure or to prevent migraine). If the two medicines are given at the same time, Atenigron must be stopped several days before stopping clonidine therapy. If Atenigron therapy is to replace clonidine therapy, treatment must begin several days after stopping clonidine therapy.
• medicines that stimulate the heart belonging to the sympathomimetic group (e.g. adrenaline);
• medicines used for inflammation and to relieve pain (e.g. ibuprofen, indometacin);
• lithium(used to treat mental disorders). It may be necessary to adjust the dose of lithium;
• nifedipine(used to treat high blood pressure);
• baclofen(used to treat muscle disorders). Dose adjustments may be necessary.

If you play sports:the use of this medicine without a therapeutic need constitutes doping and may
still result in a positive doping test.

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

Driving and using machines
It is unlikely that taking Atenigron will impair your ability to drive vehicles or operate machinery.
However, this medicine may cause side effects such as dizziness or fatigue. If this
happens to you, avoid driving vehicles or operating machinery.

3. How to take Atenigron

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

The usual maintenance dosein adults is one tablet a day of atenolol + chlortalidone 50 mg
+ 12.5 mg. The doctor may increase the dosage to one tablet a day of Atenigron 100 mg + 25 mg if
you do not respond adequately to atenolol + chlortalidone 50 mg + 12.5 mg.
When necessary, it is appropriate to associate another antihypertensive, such as a vasodilator.

Use in the elderly
If you are elderly, your doctor may consider it necessary to prescribe you a reduced dose of Atenigron.

Use in children and adolescents (under 18 years of age)
ATENIGRON should not be administered to children and adolescents.

Use in patients with kidney problems
If you suffer from severe kidney problems (severe impairment of renal function) do not take this
medicine (see “Do not take Atenigron”).

If you take more Atenigron than you should
In case of accidental ingestion/taking of an excessive dose of Atenigron, inform your
doctor immediately or go to the nearest hospital.
Symptoms of overdose may include slowing of the heartbeat (bradycardia),
decreased blood pressure (hypotension), impaired heart function (acute heart failure) and difficulty breathing (bronchospasm).

If you forget to take Atenigron
If you forget to take a tablet, take it 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 forgetting the previous dose.

If you stop taking Atenigron
Do not stop taking Atenigron without consulting your doctor.
Discontinuation of treatment must occur gradually, especially if you suffer from disorders of
heart blood circulation (ischemic heart disease).
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.
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 hypokalemia)
• reduced glucose tolerance Uncommon (may affect up to 1 in 100 people)
• sleep disorders
• changes in blood tests related to liver function (increased levels of transaminases) Rare (may affect up to 1 in 1,000 people)
• skin disease that manifests with the appearance of blisters that tend to bleed (purpura)
• reduction in the number of platelets and white blood cells (thrombocytopenia and leukopenia)
• mood changes
• nightmares, confusion, mental disorders (psychosis and hallucinations)
• dizziness, headache
• tingling in the hands and feet (paresthesia)
• dry eyes, visual disturbances.
• worsening of heart function (heart failure), blockage of heart function (precipitation of cardiac block)
• sudden drop in blood pressure when getting up, with possible loss of consciousness (syncope)
• worsening of movement difficulty (intermittent claudication)
• circulation problems in the hands and feet (Raynaud's phenomenon)
• difficulty breathing (bronchospasm) in people who suffer from asthma or who have suffered from asthmatic problems
• dry mouth
• liver problems, including alterations in bile flow (intrahepatic cholestasis) and inflammation of the pancreas (pancreatitis)
• hair loss (alopecia)
• skin inflammations (psoriasiform skin reactions), worsening of psoriasis, skin rashes
• difficulty achieving or maintaining an erection (impotence) Very rare (may affect up to 1 in 10,000 people)
• increase in Antinuclear Antibodies (ANA), a type of antibody that the body produces against itself Frequency not known (the frequency cannot be estimated from available data)
• Rapid onset of distance vision reduction (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 in which the immune system produces antibodies that mainly attack the skin and joints)

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: www.aifa.gov.it/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 Atenigron

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”. The expiry
date refers to the last day of that month.
Store the medicine at a temperature below 25°C.
The tablets must be stored in the original container to protect them from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Atenigron contains

• The active ingredients are atenolol and chlortalidone. Each tablet contains 100 mg of atenolol and 25 mg of chlortalidone.
• The other ingredients are: magnesium stearate, corn starch, pregelatinized corn starch, magnesium carbonate, gelatin, sodium lauryl sulfate.

Description of the appearance of Atenigron and contents of the pack
Atenigron is available in tablet form.
Pack of 28 tablets.

Marketing Authorisation Holder
Aesculapius Farmaceutici S.r.l. - Via Cefalonia, 70 - 25124 Brescia

Manufacturer
Fine Foods & Pharmaceuticals NTM S.p.A. - Via Grignano, 43 - 24041 - Brembate (BG)