Atenolol and chlorthalidone Doc Generici: detailed information

Package leaflet: Information for the patient

ATENOLOLO CLORTALIDONE DOC Generici 50 mg + 12.5 mg tablets

Generic medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ATENOLOLO CLORTALIDONE DOC Generici is and what it is used for

ATENOLOLO CLORTALIDONE DOC Generici is indicated for the treatment of high blood pressure (hypertension) in adults when it cannot be controlled by monotherapy with either atenolol or chlorthalidone alone.

Talk to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking ATENOLOLO CLORTALIDONE DOC Generici

Do not take ATENOLOLO CLORTALIDONE DOC Generici

if you are allergic to atenolol or chlorthalidone, 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 are pregnant, planning to become pregnant, or breastfeeding;
if you have heart diseases, including uncontrolled heart failure (a condition in which the heart cannot pump enough blood to meet the body's needs) or second- or third-degree heart block (a disease affecting the heart's electrical conduction system);
if you have a slow or irregular heartbeat, very low blood pressure, or severe circulatory disorders;
if you have a tumor called "pheochromocytoma" and are not currently receiving treatment (this tumor usually develops near a kidney and may cause high blood pressure);
if you have severe kidney impairment;
if your doctor has diagnosed abnormally high levels of acid in your blood (metabolic acidosis).

If you are in any of the above situations, inform your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking ATENOLOLO CLORTALIDONE DOC Generici:

if you have thyroid problems (a gland located in the neck); this medicine may mask symptoms of thyrotoxicosis, such as rapid heartbeat, tremors, and excessive sweating;
if you have diabetes (a condition characterized by high blood sugar levels);
if you have heart or circulatory problems, even if controlled by appropriate therapy;
if you have respiratory problems or asthma;
if you have a tumor called "pheochromocytoma" and are currently being treated for it;
if you have electrolyte imbalances in the blood (abnormal levels of salts such as sodium and potassium normally dissolved in the blood);
if you have liver problems;
if you suffer from a type of chest pain called "Prinzmetal's angina";
if you have previously experienced allergic reactions (e.g., from insect stings);
if you are due to receive a type of medicine called anesthetics (medicines administered, for example, during surgery);
if you are using ophthalmic beta-blockers (medicines that lower intraocular pressure), as they may enhance the effects of medicines similar to ATENOLOLO CLORTALIDONE DOC Generici;
if you have first-degree heart block (a disorder of the heart's conduction system);
if you experience reduced vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours or weeks after starting ATENOLOLO CLORTALIDONE DOC Generici. 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.

Reduced heart rate (number of heartbeats per minute)
During treatment with ATENOLOLO CLORTALIDONE DOC Generici, you may experience a slower heartbeat (see section "Possible side effects"). This effect is normal, but if it concerns you, consult your doctor.

Diabetes or hypoglycemia (low blood sugar levels)
If you have diabetes and are taking antidiabetic medicines, this medicine may increase your blood sugar levels. This usually causes an increased heart rate.

Uricemia (uric acid in the blood)
With prolonged treatment, ATENOLOLO CLORTALIDONE DOC Generici may increase blood levels of uric acid, which can trigger gout (a condition causing joint pain). Your doctor will advise you on appropriate treatment.

Anesthesia
If you are admitted to hospital, inform medical staff that you are being treated with ATENOLOLO CLORTALIDONE DOC Generici, and especially inform the anesthetist (the doctor administering anesthesia) if you are undergoing surgery.

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

Children and adolescents
ATENOLOLO CLORTALIDONE DOC Generici must not be given to children and adolescents under 18 years of age.

Other medicines and ATENOLOLO CLORTALIDONE DOC Generici
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 any of the following medicines:

medicines for irregular heartbeats (amiodarone, disopyramide, or other antiarrhythmics);
lithium (a medicine used for certain mental disorders);
painkillers such as indomethacin or ibuprofen (medicines used for pain and inflammation);
medicines for high blood pressure or chest pain (especially verapamil, diltiazem, clonidine, or nifedipine). At least 48 hours must pass between stopping verapamil or diltiazem and starting ATENOLOLO CLORTALIDONE DOC Generici, or vice versa;
digoxin (a medicine used to treat heart failure);
nasal decongestants or other medicines (e.g., containing pseudoephedrine) used for colds;
clonidine (a medicine used to treat high blood pressure or prevent migraines). If you are taking clonidine and ATENOLOLO CLORTALIDONE DOC Generici together, do not stop either medicine without first consulting your doctor;
medicines such as adrenaline (a medicine that stimulates the heart);
baclofen (a medicine used to treat muscle spasms).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, do not take ATENOLOLO CLORTALIDONE DOC Generici (see section 2 "Do not take ATENOLOLO CLORTALIDONE DOC Generici").

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery. However, dizziness and fatigue may occasionally occur. If you experience these symptoms, you should avoid such activities.

ATENOLOLO CLORTALIDONE DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take ATENOLOLO CLORTALIDONE DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The tablets should be taken whole with a little water, preferably always at the same time each day.
Use in adults
The recommended dose is 1 tablet daily.
Use in the elderly
If you are elderly, your doctor may decide to prescribe a lower dose of ATENOLOLO CLORTALIDONE
DOC Generici.
If you have severe kidney problems
If you suffer from severe kidney problems, you must not take ATENOLOLO CLORTALIDONE DOC Generici
(see section “Do not take ATENOLOLO CLORTALIDONE DOC Generici”).
Use in children and adolescents
ATENOLOLO CLORTALIDONE DOC Generici must not be given to children and adolescents under 18 years of age.
If you take more ATENOLOLO CLORTALIDONE DOC Generici than you should
In case of accidental ingestion or overdose of ATENOLOLO CLORTALIDONE DOC Generici, contact your doctor immediately or go to the nearest hospital.
You may experience a slowed heartbeat, dizziness due to low blood pressure, and difficulty breathing. Your heart may also have trouble pumping blood to the rest of the body (acute heart failure).
If you forget to take ATENOLOLO CLORTALIDONE DOC Generici
Do not take a double dose to make up for the missed tablet.
If you forget to take a dose, take it as soon as possible. Do not take two doses at the same time.
If you stop taking ATENOLOLO CLORTALIDONE DOC Generici
Do not stop treatment just because you feel better, unless your doctor tells you to do so.
Treatment should be discontinued gradually.
If you have any questions 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 everyone gets them.
During treatment with ATENOLOLO CLORTALIDONE DOC Generici, as with any medicine, the following side effects may occur according to the frequency listed below:

Common (may affect up to 1 in 10 people):

slowed heartbeat;
cold fingers and toes;
stomach and intestinal disturbances (e.g. nausea and diarrhoea);
fatigue;
increased levels of uric acid in the blood, reduced levels of potassium in the blood, reduced levels of sodium in the blood (which may cause weakness, vomiting and cramps), reduced glucose tolerance (a condition that may lead to increased blood sugar levels).

Uncommon (may affect up to 1 in 100 people):

sleep disturbances;
changes in blood tests related to liver function (transaminases).

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

purpura (purple spots on the skin), thrombocytopenia (reduced number of platelets in the blood, which may present as bruising), leucopenia (reduced number of white blood cells in the blood, a type of blood cell);
mood changes, nightmares, confusion, psychosis (mental disorders), and hallucinations (seeing inexplicable things);
dizziness, especially when standing, headache, tingling in the hands;
dry eyes, visual disturbances;
difficulty breathing and/or swelling of the ankles if you have heart failure (heart disease);
heart block (a condition that may cause abnormal heartbeat, dizziness, fatigue or fainting);
sudden drop in blood pressure when standing, possibly leading to loss of consciousness, worsening of circulatory problems, numbness and cramps in the fingers followed by a sensation of heat and pain (Raynaud's phenomenon);
worsening of breathing difficulties if you have asthma or a history of asthmatic conditions;
dry mouth;
jaundice (yellowing of the skin and whites of the eyes), pancreatitis (inflammation of the pancreas, a gland located near the stomach);
hair loss, skin rashes including worsening of psoriasis (chronic skin inflammation);
inability to achieve an erection (impotence).

Very rare (may affect up to 1 in 10,000 people):

changes in laboratory values measuring certain immune responses (positive test for antinuclear antibodies).

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);
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);
depression.

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 CHLORTHALIDONE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in its original packaging, correctly stored.
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 ATENOLOLO CLORTALIDONE DOC Generici contains

The active substances are atenolol and chlorthalidone. Each tablet contains 50 mg of atenolol and 12.5 mg of chlorthalidone.
The other components are corn starch, magnesium carbonate, sodium lauryl sulfate, gelatin, magnesium stearate.

Description of the appearance of ATENOLOLO CLORTALIDONE DOC Generici and contents of the
package
Pack containing 28 tablets.
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano
Manufacturer
Francia Farmaceutici S.r.l., Via dei Pestagalli 7, Milano
LACHIFARMA S.r.l. Laboratorio Chimico Farmaceutico Salentino, S.S. 16 Zona industriale, 73010 Zollino (LE)

Patient Information Leaflet

ATENOLOLO CLORTALIDONE DOC Generici 100 mg + 25 mg tablets

Generic medicine
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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ATENOLOLO CLORTALIDONE DOC Generici is and what it is used for

This medicinal product contains two active substances, atenolol and chlorthalidone.
Atenolol belongs to a group of medicines called beta-blockers, which work by slowing down the heart rate and reducing the force of the heartbeat.
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.
ATENOLOLO CLORTALIDONE DOC Generici is indicated for the treatment of high blood pressure (essential hypertension) when blood pressure is not adequately controlled by treatment with the individual active substances (atenolol and chlorthalidone).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking ATENOLOLO CLORTALIDONE DOC Generici

Do not take ATENOLOLO CLORTALIDONE DOC Generici

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 used to treat bacterial infections)
if you are pregnant, planning to become pregnant, or breastfeeding
if you have heart diseases, including uncontrolled heart failure (when the heart cannot pump enough blood to meet the body's needs) or second- or third-degree heart block (a disease of the heart's conduction system)
if you have a slow or irregular heartbeat, very low blood pressure, or severe circulatory disorders
if you have a tumor called "pheochromocytoma" that is not being treated (this tumor usually develops near a kidney and may cause high blood pressure)
if you have severe kidney impairment
if your doctor has diagnosed abnormally high levels of acid in your blood (metabolic acidosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking ATENOLOLO CLORTALIDONE DOC Generici.

if you have thyroid problems (a gland located in the neck), as the medicine may mask symptoms of thyrotoxicosis, such as rapid heartbeat, tremor, and excessive sweating
if you have diabetes (a condition characterized by high blood sugar levels)
if you have heart problems or circulatory disorders, even if controlled by appropriate therapy
if you have respiratory problems or asthma
if you have a tumor called "pheochromocytoma" that is being treated
if you have electrolyte imbalances in the blood (abnormal levels of salts such as sodium and potassium normally dissolved in the blood)
if you have liver problems
if you have a type of chest pain called "Prinzmetal's angina"
if you have previously experienced allergic reactions (e.g., from insect stings)
if you are due to receive medicines called anesthetics (medicines used, for example, during surgery)
if you are using ophthalmic beta-blockers (medicines that lower intraocular pressure), as they may enhance the effects of medicines similar to ATENOLOLO CLORTALIDONE DOC Generici
if you have first-degree heart block (a disorder of the heart's conduction system)
if you experience reduced vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to weeks after starting ATENOLOLO CLORTALIDONE DOC Generici. 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.

Reduced heart rate (number of heartbeats per minute)
During treatment with ATENOLOLO CLORTALIDONE DOC Generici, you may experience a
reduction in heart rate (see section “Possible side effects”). This effect is normal, but
if it becomes concerning to you, consult your doctor.
Diabetes or hypoglycemia (low blood sugar levels)
If you have diabetes and are taking antidiabetic medicines, this medicine may
increase your blood sugar levels. This usually causes an increase in heart rate.
Uricemia (uric acid in the blood)
With prolonged treatment, ATENOLOLO CLORTALIDONE DOC Generici may cause an increase in
blood uric acid levels, which may trigger gout (a disease causing joint pain). Your doctor will advise you on appropriate treatment.
Anesthesia
If you are admitted to hospital, you must inform medical staff that you are taking
ATENOLOLO CLORTALIDONE DOC Generici, and particularly inform the anesthesiologist (the doctor responsible for anesthesia) if undergoing surgery.
For athletes
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
ATENOLOLO CLORTALIDONE DOC Generici must not be given to children and adolescents under 18 years of age.
Other medicines and ATENOLOLO CLORTALIDONE DOC Generici
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 any of the following medicines:

medicines for irregular heartbeats (amiodarone, disopyramide, or other antiarrhythmics)
lithium (a medicine used for certain mental disorders)
painkillers such as indometacin or ibuprofen (medicines used for pain and inflammation)
medicines for high blood pressure or chest pain (especially verapamil, diltiazem, clonidine, or nifedipine). At least 48 hours must pass between stopping verapamil or diltiazem and starting ATENOLOLO CLORTALIDONE DOC Generici, and vice versa
medicines for heart failure (digoxin, a medicine used for heart disorders)
nasal decongestants or other medicines (e.g., containing pseudoephedrine) used to treat colds
clonidine (a medicine for high blood pressure or migraine prevention). If you are taking clonidine and ATENOLOLO CLORTALIDONE DOC Generici together, do not stop either medicine without first consulting your doctor
medicines such as adrenaline (a medicine that stimulates the heart)
baclofen (a medicine used to treat muscle spasms)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, do not take ATENOLOLO CLORTALIDONE DOC Generici (see section 2 “Do not take
ATENOLOLO CLORTALIDONE DOC Generici”).
Driving and using machines
It is unlikely that taking ATENOLOLO CLORTALIDONE DOC Generici will affect your ability to drive or operate machinery.
However, dizziness and fatigue may occasionally occur; if you experience these symptoms, you should avoid such activities.
ATENOLOLO CLORTALIDONE DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take ATENOLOLO CLORTALIDONE DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The tablets should be swallowed whole with a glass of water, preferably always at the same time each day.
Use in Adults
The recommended dose is 1 tablet per day.
Use in the Elderly
If you are elderly, your doctor may decide to prescribe a lower daily dose of ATENOLOLO
CLORTALIDONE DOC Generici.
If you have severe kidney problems
If you suffer from severe kidney problems, you must not take ATENOLOLO CLORTALIDONE
DOC Generici (see section “Do not take ATENOLOLO CLORTALIDONE DOC Generici”).
Use in children and adolescents
ATENOLOLO CLORTALIDONE DOC Generici must not be administered to children and adolescents
under 18 years of age.
If you take more ATENOLOLO CLORTALIDONE DOC Generici than you should
In case of accidental ingestion or overdose of ATENOLOLO CLORTALIDONE
DOC Generici, contact your doctor immediately or go to the nearest hospital.
You may experience a slowed heartbeat, dizziness due to low blood pressure, and
difficulty breathing. Your heart may also struggle to pump blood to the rest of the body (acute heart failure).
If you forget to take ATENOLOLO CLORTALIDONE DOC Generici
Do not take a double dose to make up for the missed tablet.
If you forget to take a dose, take it as soon as possible. Do not take two doses at the same time.
If you stop taking ATENOLOLO CLORTALIDONE DOC Generici
Do not stop treatment even if you feel better, unless otherwise instructed by your doctor.
Treatment should be discontinued gradually.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
During treatment with ATENOLOLO CLORTALIDONE DOC Generici, as with any medicine, the following adverse reactions may occur according to the frequency listed below:

Common (may affect up to 1 in 10 people)

Slow heart rate
Cold fingers and toes
Stomach and intestinal disturbances (e.g. nausea, diarrhoea)
Fatigue
Increased blood uric acid levels, decreased blood potassium levels, decreased blood sodium levels (which may cause weakness, vomiting, and cramps), reduced glucose tolerance (a condition that may lead to increased blood sugar levels)

Uncommon (may affect up to 1 in 100 people)

Sleep disturbances
Changes in blood tests related to liver function (transaminases)
.

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

Purpura (purple skin spots), thrombocytopenia (reduced number of platelets in the blood, which may present as bruising), leucopenia (reduced number of white blood cells in the blood, a type of blood cell)
Mood changes, nightmares, confusion, psychosis (mental disorders), and hallucinations (seeing inexplicable things)
Dizziness, especially when standing, headache, tingling in the hands
Dry eyes, visual disturbances
Breathing difficulties and/or ankle swelling if you have heart failure (heart disease)
Heart block (a condition that may cause abnormal heartbeat, dizziness, fatigue, or fainting)
Sudden drop in blood pressure upon standing, possibly leading to loss of consciousness, worsening of circulatory problems, numbness and cramps in the fingers followed by a sensation of heat and pain (Raynaud's phenomenon)
Worsening of breathing difficulties if you have asthma or a history of asthma-related problems
Dry mouth
Jaundice (yellowing of the skin and whites of the eyes), pancreatitis (inflammation of the pancreas, a gland located near the stomach)
Hair loss
Skin rashes, including worsening of psoriasis (chronic skin inflammation)
Inability to achieve an erection (impotence)

Very rare (may affect up to 1 in 10,000 people)

Changes in laboratory values used to measure certain immune responses (positive antinuclear antibody test)

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

Constipation
Lupus-like syndrome (a disease in which the immune system produces antibodies that primarily attack the skin and joints)
Sudden-onset reduction in distance vision (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)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store ATENOLOLO CLORTALIDONE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging, when stored correctly.
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 ATENOLOLO CLORTALIDONE DOC Generici contains

The active substances are atenolol and clortalidone. Each tablet contains 100 mg of atenolol and 25 mg of clortalidone.
The other components are maize starch, magnesium carbonate, sodium lauryl sulfate, gelatin, magnesium stearate.

Description of the appearance of ATENOLOLO CLORTALIDONE DOC Generici and package contents
Pack containing 28 tablets.
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan
Manufacturer
Francia Farmaceutici S.r.l., Via dei Pestagalli 7, Milan
LACHIFARMA S.r.l. Laboratorio Chimico Farmaceutico Salentino, S.S. 16 Zona industriale, 73010 Zollino (LE)