Atenigrone

Package leaflet: Information for the user

Atenigron 100 mg + 25 mg tablets

atenolol + chlorthalidone
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 taking 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 Atenigron is and what it is used for

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

2. What you need to know before taking Atenigron

Do not take Atenigron

• if you are allergic to atenolol or chlorthalidone or to any of the other ingredients of this medicine (listed in section 6);
• if you have heart diseases, for example:
• disorders of the heart's electrical conduction system (second- or third-degree heart block)
• very irregular (sinoatrial node disease) or very slow (bradycardia) heartbeat
• uncontrolled heart failure or cardiogenic shock, which occurs when the heart fails to pump enough blood to meet the body’s needs
• low blood pressure (hypotension)
• if you have severe circulation problems in the limbs (peripheral arterial disease);
• if you have severe liver and/or kidney problems (severe hepatic and/or renal insufficiency);
• if your doctor has diagnosed abnormally high levels of acid in your blood (metabolic acidosis);
• if you have a tumor called phaeochromocytoma that is not being treated;
• if you suffer from an inflammatory joint disease (gout);
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking Atenigron.
Pay special attention and consult your doctor:

• if your heart function is inadequate (heart failure), but is kept under control with appropriate therapy;
• if your heart’s ability to increase the amount of blood pumped to the body is limited (poor cardiac reserve);
• if you suffer from chest pain called Prinzmetal's angina, as this medicine may increase the frequency and duration of angina attacks;
• if you have circulation problems in the limbs, since Atenigron may worsen even mild peripheral vascular disorders;
• if you have a first-degree heart block, a disorder of the heart's conduction system;
• if you have diabetes or are predisposed to diabetes, because atenolol may mask warning signs of low blood sugar (hypoglycemia), such as rapid heartbeat, palpitations, and sweating, while chlorthalidone may cause increased blood sugar levels (hyperglycemia). Close monitoring of blood glucose is recommended at the beginning of treatment, and during prolonged treatment, urine glucose (glucosuria) should be checked regularly;
• if you have thyroid problems (thyrotoxicosis), as atenolol may mask cardiovascular symptoms;
• if you suffer from ischemic heart disease, a heart condition occurring when the heart muscle receives insufficient oxygen. Consult your doctor before stopping treatment with Atenigron;
• if you have previously experienced severe allergic reactions to various allergens (anaphylactic reactions);
• 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 substances (ophthalmic beta-blockers);
• if you are being treated for a tumor called phaeochromocytoma, as your blood pressure will need to be closely monitored during treatment;
• if you are scheduled for anesthesia during surgery. Inform the anesthesiologist that you are taking Atenigron;
• if you are elderly, if you have heart problems (heart failure) and are being treated with digitalis preparations, if you are on a low-potassium diet, or if you have stomach or intestinal disorders, as this may lead to reduced levels of potassium and sodium in the blood (hypokalemia and hyponatremia);
• if you have liver problems (impaired liver function or progressive hepatopathy);
• if you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours or weeks after taking Atenigron. If left untreated, this condition may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.

During treatment with this medicine, have regular blood tests to detect possible changes in electrolyte levels (especially low potassium and sodium levels), and, if necessary, monitor uric acid levels, as increased uricemia may occur. Regular monitoring of glucose levels in urine is also recommended.
This medicine reduces heart rate. If during treatment you develop symptoms of excessive slowing of the heartbeat, consult your doctor, who may reduce the dose.

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

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

• verapamil, diltiazem (used to treat high blood pressure or chest pain), as concomitant use with Atenigron is contraindicated. At least 48 hours must elapse after stopping one of these medicines before starting the other.
• disopyramide, amiodarone, digitalis glycosides (used to treat heart rhythm disorders);
• clonidine (used to treat high blood pressure or prevent migraines). If both medicines are used together, Atenigron must be discontinued several days before stopping clonidine. If Atenigron treatment is to replace clonidine, treatment with Atenigron should begin several days after stopping clonidine.
• heart-stimulating medicines belonging to the sympathomimetic group (e.g. adrenaline);
• medicines used for inflammation and pain relief (e.g. ibuprofen, indomethacin);
• lithium (used to treat psychiatric disorders). Lithium dosage adjustment may be necessary;
• nifedipine (used to treat high blood pressure);
• baclofen (used to treat muscle disorders). Dose adjustments may be necessary.

If you engage in sports: using this medicine without medical need constitutes doping and may lead to a positive anti-doping test.

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 take Atenigron during pregnancy or while breastfeeding.

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

3. How to take Atenigron

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The usual maintenance dose in adults is one tablet daily of atenolol + chlortalidone 50 mg + 12.5 mg. Your doctor may increase the dose to one tablet daily of Atenigron 100 mg + 25 mg if there is an inadequate response to atenolol + chlortalidone 50 mg + 12.5 mg.
When necessary, it may be appropriate to add another antihypertensive, such as a vasodilator.
Use in the elderly
If you are elderly, your doctor may consider it necessary to prescribe a reduced dose of Atenigron.
Use in children and adolescents (under 18 years of age)
ATENIGRON must not be administered to children and adolescents.
Use in patients with kidney problems
If you have 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/overdose of Atenigron, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include slowing of the heartbeat (bradycardia),
lowering of blood pressure (hypotension), inadequate heart function (acute heart failure), and breathing difficulties (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 for the next dose. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Atenigron
Do not stop taking Atenigron without consulting your doctor.
Discontinuation of treatment should be done gradually, especially if you suffer from heart circulation disorders (ischaemic heart disease).
If you have any questions 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 everyone 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 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 transaminase levels)

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

• Skin disease characterized by the appearance of blisters tending 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, headache
• Tingling in the hands and feet (paresthesia)
• Dry eyes, vision disturbances
• Worsening of heart function (heart failure), impairment of heart conduction (precipitation of cardiac block)
• Sudden drop in blood pressure upon standing, possibly leading to loss of consciousness (syncope)
• Worsening of movement difficulties (claudicatio intermittens)
• Circulatory problems in the hands and feet (Raynaud's phenomenon)
• Breathing difficulties (bronchospasm) in people suffering from bronchial asthma or with a history of asthma problems
• Dry mouth
• Liver problems, including disturbances 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 produced by the body against itself

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

• Sudden-onset nearsightedness (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 condition in which the immune system produces antibodies that primarily attack the skin and joints)

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via 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 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.
Store the medicine below 25°C.
The tablets should be kept in the original container to protect them from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Atenigron contains

• The active substances are atenolol and chlorthalidone. Each tablet contains 100 mg of atenolol and 25 mg of chlorthalidone.
• The other components 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 size: 28 tablets.
Marketing Authorization 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)