CLORTANOL 125 mg Tablet

Зміст інструкції

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

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

1. What is Clortanol and what is it used for

Clortanol contains the 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 increase the amount of urine produced by the kidneys.
Clortanol is indicated for the treatment of high blood pressure (essential arterial 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 Clortanol

Do not take Clortanol

• if you are allergic to atenolol or clortalidone 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 with antibacterial action, used for infections);
• if you suffer from heart diseases, for example:
• second or third degree atrioventricular block (disease of the heart's conduction system)
• very irregular heartbeat (sick sinus syndrome) or very slow heartbeat (bradycardia)
• uncontrolled heart failure or cardiogenic shock (the blood is unable to pump adequate amounts of blood to meet the body's needs)
• low blood pressure (hypotension)
• if you have severe circulatory disorders of the limbs (peripheral arterial circulation);
• if you have severe kidney problems (including severe renal failure);
• if you have severe liver problems;
• if your doctor has diagnosed you with abnormally high levels of acids in the blood (metabolic acidosis);
• if you have 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, pharmacist or nurse before taking Clortanol.
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 period ranging from a few hours to weeks after taking Clortanol. This can lead to permanent vision loss if not treated. If you have previously experienced an allergy to penicillins or sulfonamides, you may be at higher risk of developing it.
Pay particular attention and consult your doctor:

• if the function of your heart 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 disorders of the limbs, as Clortanol may worsen even mild peripheral vascular disorders;
• if you have a disease of the heart's conduction system called first-degree atrioventricular block;
• if you have diabetes or a predisposition to diabetes, because atenolol can change the warning signals of a low blood sugar level (hypoglycemia) such as a fast heartbeat, palpitations and sweating, while clortalidone can cause an increase in blood sugar levels (hyperglycemia). Careful monitoring of blood sugar is recommended in the initial phase of therapy and, in prolonged treatment, the control of glucose levels in the urine should be done at regular intervals;
• if you have thyroid problems (thyrotoxicosis), as atenolol can mask cardiovascular symptoms;
• if you suffer from 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 Clortanol.
• if you have previously had 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 based on similar active ingredients (beta-blocking ophthalmic agents);
• if you are being treated for a tumor called pheochromocytoma, as in this case blood pressure will need to be closely monitored during treatment;
• if you are to undergo anesthesia for surgery. Tell the anesthesiologist that you are taking Clortanol;
• 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 suffer from liver disorders (impaired liver function or progressive liver disease).

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 glucose levels in the urine.
This medicine reduces the frequency of heartbeats. If you develop symptoms of an excessive reduction in heart rate during treatment, see your doctor who will reduce the dosage.

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

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

Other medicines and Clortanol
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 for the treatment of high blood pressure or chest pain), as concomitant use with Clortanol is contraindicated. 48 hours must have elapsed since the suspension of one of these medicines before starting the other therapy.

disopyramide, amiodarone, digitalis glycosides(used for the treatment of heart rhythm disturbances);

clonidine(used for the treatment of high blood pressure or to prevent migraine). If the two medicines are administered simultaneously, Clortanol must be discontinued several days before stopping clonidine therapy. If Clortanol therapy is to replace that with clonidine, it is necessary that the start of treatment occur several days after the interruption of clonidine therapy.
medicines that stimulate the heart belonging to the sympathomimetic group (e.g. adrenaline);
medicines used in case of inflammation and to relieve pain (e.g. ibuprofen, indometacin);

lithium(used for the treatment of mental disorders). It may be necessary to adjust the lithium dosage.

nifedipine(used for the treatment of high blood pressure);

baclofen(used for the treatment of muscle disorders). Dose adjustments 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 take Clortanol during pregnancy or while breastfeeding.

Driving and using machines
It is unlikely that the use of Clortanol will impair the ability to drive vehicles or use machines.
However, this medicine may cause side effects such as dizziness or fatigue. If this happens to you, avoid driving vehicles or using machines.

3. How to take Clortanol

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 1 Clortanol tablet per day.
When necessary, it is appropriate to associate 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 you a reduced dose of Clortanol.

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 Clortanol”).

If you take more Clortanol than you should
In case of accidental ingestion/taking of an excessive dose of Clortanol, immediately inform
your doctor or go to the nearest hospital.
Symptoms of overdose may manifest with slowing of the heartbeat (bradycardia),
decreased blood pressure (hypotension), impaired heart function (acute heart
failure) and difficulty breathing (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 to
take the next dose. Do not take a double dose to make up for forgetting the previous dose.

If you stop taking Clortanol
Do not stop taking Clortanol 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.

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, vision disorders
worsening of heart function (heart failure), blockage of heart function
(precipitation of cardiac block)
sudden drop in blood pressure when standing 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 antibodies that the body produces against itself

Frequency not known(the frequency cannot be estimated based on available data)
constipation;
lupus-like syndrome (a disease in which the immune system produces antibodies that attack
mainly the skin and joints);
Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation
in the vascular layer of the eye (choroidal effusion)).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any 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 Clortanol

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 “Scad”. The expiry
date refers to the last day of that month. The period of validity refers to the product in its
intact packaging, correctly stored .
Store the medicine at a temperature not exceeding 25°C.
Do not dispose of any medicine in 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 Clortanol contains
The active ingredients are atenolol and chlortalidone. Each tablet contains 100 mg of atenolol and 25 mg of
chlortalidone.
The other ingredients are: corn starch, talc, magnesium stearate, microcrystalline cellulose.

Description of the appearance of Clortanol and contents of the pack
Clortanol is available in tablet form.
Pack of 30 tablets

Marketing authorisation holder and manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - Sanremo (IM)