Package leaflet: Information for the user

Clortanol 100 mg + 25 mg tablets

Atenolol-Chlorthalidone
Please read this leaflet carefully before you start 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:

What Clortanol is and what it is used for
What you need to know before taking Clortanol
How to take Clortanol
Possible side effects
How to store Clortanol
Contents of the pack and other information

1. What Clortanol is and what it is used for

Clortanol contains the active substances atenolol and chlortalidone. Atenolol belongs to a group of medicines called "beta-blockers" which work by slowing down the heart rate. Chlortalidone belongs to a group of medicines called diuretics, which increase the amount of urine produced by the kidneys.
Clortanol is indicated for the treatment of high blood pressure (essential arterial hypertension) in patients whose blood pressure is not adequately controlled by monotherapy with either atenolol or chlortalidone alone.

2. What you should know before taking Clortanol

Do not take Clortanol

if you are allergic to atenolol or chlortalidone, or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to sulfonamide derivatives (a class of antibiotics used to treat infections);
if you have heart diseases, for example:
- second- or third-degree atrioventricular block (a disease of the heart's conduction system)
- very irregular heartbeat (sinoatrial node disease) or very slow heartbeat (bradycardia)
- uncontrolled heart failure or cardiogenic shock (the heart is unable 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 kidney problems (including severe renal failure);
if you have severe liver problems;
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 (manifest gout);
if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Clortanol.
If you experience vision disturbances or eye pain, contact your doctor immediately. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from a few hours to several weeks after taking Clortanol. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillins or sulfonamides.
Pay special attention and consult your doctor:

if you have impaired heart function (heart failure), even if it is 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 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, as Clortanol may worsen even mild peripheral vascular disorders;
if you have a heart conduction disorder called first-degree atrioventricular block;
if you have diabetes or are predisposed to diabetes, because atenolol may mask the warning signs of low blood sugar (hypoglycemia), such as rapid heartbeat, palpitations, and sweating, while chlortalidone may cause an increase in blood sugar levels (hyperglycemia). Close monitoring of blood glucose is recommended at the beginning of treatment, and during prolonged treatment, urine glucose levels (glucosuria) should be checked regularly;
if you have a thyroid disorder (thyrotoxicosis), as atenolol may mask cardiovascular symptoms;
if you suffer from ischemic heart disease, a heart condition that occurs when the heart muscle does not receive enough oxygen. Consult your doctor before stopping treatment with Clortanol.
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 must be closely monitored during treatment;
if you are scheduled for anesthesia during surgery. Inform your anesthesiologist that you are taking Clortanol;
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 gastrointestinal 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).

During treatment with this medicine, have regular blood tests to monitor possible changes in electrolyte levels (especially low potassium and sodium levels). It may also be necessary to monitor uric acid levels, as uricemia may increase. Regular monitoring of glucose levels in the 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.
If you are an athlete: using this medicine without a medical need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
Clortanol must not be given to children and adolescents under 18 years of age.
Other medicines and Clortanol
Inform 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 Clortanol is contraindicated. At least 48 hours must pass 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 to be used together, Clortanol must be discontinued several days before stopping clonidine. If Clortanol is to replace clonidine therapy, treatment with Clortanol should start several days after stopping clonidine.
medicines that stimulate the heart 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). Adjustment of lithium dosage may be necessary.
nifedipine (used to treat high blood pressure);
baclofen (used to treat muscle disorders). Dose adjustments may be necessary.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Clortanol during pregnancy or while breastfeeding.
Driving and using machines
It is unlikely that Clortanol 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 Clortanol

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 1 tablet of Clortanol per day.
When necessary, it may be appropriate to combine it with another medicine that lowers blood pressure, such as a
vasodilator.
Use in the elderly
If you are elderly, your doctor may consider it necessary to prescribe a reduced dose of Clortanol.
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 Clortanol").
If you take more Clortanol than you should
In case of accidental ingestion or overdose of Clortanol, 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 difficulty (bronchospasm).
If you forget to take Clortanol
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 dose.
If you stop taking Clortanol
Do not stop taking Clortanol 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 doubts 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.
Common (may affect up to 1 in 10 people)
slowing of the heartbeat (bradycardia)
feeling of coldness in 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 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, headache
tingling in hands and feet (paresthesia)
dry eyes, visual disturbances
worsening of heart function (heart failure), impairment of heart conduction (precipitation of heart block)
sudden drop in blood pressure upon standing, possibly leading to loss of consciousness (syncope)
worsening of difficulty in movement (intermittent claudication)
circulatory problems in hands and feet (Raynaud's phenomenon)
breathing difficulty (bronchospasm) in people suffering from bronchial asthma or who have previously had
asthmatic 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 that the body produces against itself
Frequency not known (frequency cannot be estimated from the available data)
constipation
lupus-like syndrome (a disease in which the immune system produces antibodies that mainly attack the
skin and joints)
Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the
vascular layer of the eye (choroidal effusion))
Reporting of side effects
If you experience any side effects, 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 the following website:
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 Clortanol

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. The shelf life applies to the product in its original, undamaged packaging, correctly stored.
Store the medicine at a temperature not exceeding 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Clortanol contains
The active substances are atenolol and chlorthalidone. Each tablet contains 100 mg of atenolol and 25 mg of
chlorthalidone.
The other components are: maize starch, talc, magnesium stearate, microcrystalline cellulose.
Description of the appearance of Clortanol and contents of the pack
Clortanol is presented as tablets.
Pack size: 30 tablets
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - Sanremo (IM)