TARGET 100 mg/25 mg Coated Tablet

Зміст інструкції

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

TARGET 100 mg + 25 mg tablets

Atenolol + clortalidone

Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could 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 TARGET is and what it is used for
• 2. What you need to know before you take TARGET
• 3. How to take TARGET
• 4. Possible side effects
• 5. How to store TARGET
• 6. Contents of the pack and other information

1. What is TARGET and what is it used for

TARGET is used to treat high blood pressure (essential arterial hypertension) when it is not adequately controlled with atenolol or chlortalidone alone.
TARGET contains two different drugs: atenolol and chlortalidone. These drugs work together
to lower your blood pressure:
Atenolol belongs to a group of medicines called “beta blockers”. It works by making your heart beat more slowly and with less force.
Chlortalidone belongs to a group of medicines called “diuretics”. It works by increasing the urine
produced by your kidneys.

2. What you need to know before taking TARGET

Do not take TARGET

• 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 with antibacterial action, used in case of infections);
• if you are pregnant or planning to become pregnant or if you are breastfeeding;
• if you suffer from heart disease, including uncontrolled heart failure with inadequate therapy (the heart is unable to pump enough blood to meet the body's needs) or second and third degree heart block (disease of the heart's conduction system);
• if you suffer from reduced or irregular heartbeat, very low blood pressure, or severe circulatory disorders;
• if you suffer from a tumor called "pheochromocytoma" that is not being treated (this tumor generally develops near a kidney and can cause high blood pressure);
• if you suffer from severe kidney disease;
• if your doctor has diagnosed you with abnormally high levels of acids in your blood (metabolic acidosis);

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

Warnings and precautions
Talk to your doctor or pharmacist before taking TARGET:

• if you suffer from thyroid problems (a gland located in the neck), the medicine may mask the symptoms of hyperthyroidism, such as rapid heartbeat, tremor and excessive sweating;
• if you suffer from diabetes (a disease characterized by an excess of sugars in the blood).;
• if you suffer from heart or blood circulation problems even if controlled by adequate therapy;
• if you suffer from respiratory problems or asthma;
• if you have a tumor called “pheochromocytoma” being treated;
• if you have electrolyte imbalances in your blood (alteration of the concentrations of salts, such as sodium and potassium, normally dissolved in the blood);
• if you suffer from liver problems;
• if you suffer from a type of chest pain called “Prinzmetal's angina”;
• if you have ever had allergic reactions in the past (for example, from insect bites);
• if you are to receive a type of medicines called anesthetics (medicines that are administered, for example, during a surgical operation)
• if you are taking ophthalmic beta-blockers (medicines that lower the pressure inside the eye), as they may increase the effects of medicines similar to TARGET
• if you suffer from first-degree heart block (disease of the heart's conduction system);
• if you have high levels of uric acid in your blood (hyperuricemia) as the medicine can in turn cause an increase in uric acid levels, which can cause gout;
• 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 an increase in pressure in the eye and can occur within hours or weeks of taking TARGET. If left untreated, this condition can lead to permanent vision loss. If you have had an allergic reaction to penicillin or sulfonamides in the past, you may be at higher risk of developing this condition.

Reduced heart rate (number of heartbeats per minute)
During treatment with TARGET you may experience a reduction in heartbeats (see
section “Possible side effects”). This effect is normal, but if it becomes a cause for
concern, consult your doctor.

Diabetes or hypoglycemia (low blood sugar levels)
If you suffer from diabetes and are being treated with antidiabetics (medicines to treat diabetes), this
medicine may increase blood sugar levels. This generally causes an increase
in heartbeats.

Hyperuricemia (uric acid in the blood)
With prolonged treatments TARGET may cause an increase in uric acid levels in the blood,
which can cause gout (a disease that causes joint pain). Your doctor will indicate the
appropriate therapy.

Anesthesia
If you are to be hospitalized, you must inform the medical staff of the ongoing treatment with
TARGET and, in particular, the anesthesiologist (the doctor responsible for the anesthesia) in case of
surgery.

For those who play sports
The use of the drug without a therapeutic need constitutes doping and may still
result in a positive doping test.

Children and adolescents
TARGET must notbe given to children and adolescents under the age of 18 years.

Other medicines and TARGET
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 the following medicines:

• medicines for the treatment of irregular heartbeats (amiodarone, disopyramide or other antiarrhythmics)
• lithium (medicine used for certain mental disorders)
• pain relievers such as indometacin or ibuprofen (medicines used for pain and inflammation)
• medicines for the treatment of high blood pressure or chest pain (in particular verapamil, diltiazem, clonidine, or nifedipine). At least 48 hours must have elapsed since the discontinuation of any previous verapamil or diltiazem therapy before starting treatment with TARGET, or vice versa
• medicine for the treatment of heart failure (digoxin, a medicine used for heart disorders)
• nasal decongestants or other drugs (containing, for example, pseudoephedrine) for the treatment of the cold
• clonidine (medicine for the treatment of high blood pressure or to prevent migraine). If you are taking clonidine and TARGET together, do not stop treatment with clonidine or TARGET without first consulting your doctor
• drugs such as adrenaline (a medicine that stimulates the heart)
• baclofen (medicine used to treat muscle cramps)
• insulin or other medicines taken orally for diabetes
• eye drops for glaucoma (ophthalmic beta-blockers)

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, do not take TARGET (see section 2 “Do not take TARGET”).

Driving and operating machinery
It is unlikely that taking TARGET will affect your ability to drive and operate
machinery.
However, dizziness and fatigue may sometimes occur; if you experience these symptoms, it is
advisable not to engage in these activities.

TARGET contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially ‘sodium-free’.

TARGET contains sorbitol
This medicine contains 15 mg of sorbitol per dose equivalent to 0.2mg/Kg.

3. How to take TARGET

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

• Your doctor will tell you what the most appropriate dosage is for you, how many tablets you should take per day and when to take them. The names of the days of the week are printed on the blister pack containing the tablets to help you follow the therapy correctly.
• Swallow a tablet with a glass of water.

Adults
The recommended dose is one tablet per day.

Elderly
If you are elderly, your doctor may decide to prescribe you a lower dose of TARGET.

If you have severe kidney problems
If you suffer from severe kidney problems, you should not take TARGET (see paragraph “Do not take
TARGET”).

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

If you use more TARGET than you should
In case of accidental ingestion/intake of an excessive dose of TARGET immediately notify your
doctoror go to the nearest hospital.
You may experience a slowing of the heartbeat, dizziness caused by low blood pressure
and difficulty breathing. Your heart may also struggle to supply blood to the rest of the body
(acute heart failure).

If you forget to use TARGET
Do not take a double doseto make up for the missed tablet. If you forget to take a dose, it is advisable to take it as soon as possible. Two doses should not be taken
at the same time.

If you stop treatment with TARGET
Improvement in your health status should not lead to discontinuation of treatment unless
requested by your doctor. Discontinuation of treatment should occur gradually.
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.
During treatment with TARGET, as with any medicine, the following side effects may occur with the
following frequency:

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

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

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 1000 people):

• purpura (purple spots on the skin), thrombocytopenia (reduced number of platelets in the blood, which may manifest with bruising), leucopenia (reduced number of white blood cells in the blood, a type of blood cell);
• changes in mood, nightmares, confusion, psychosis (mental disorders) and hallucinations (seeing inexplicable things);
• dizziness, especially when standing up, 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 can cause an abnormal heartbeat, dizziness, fatigue or fainting);
• sudden drop in blood pressure when standing up with the possibility of loss of consciousness, worsening of circulatory disorders, numbness and cramps in the fingers followed by a sensation of warmth and pain (Raynaud's phenomenon);
• worsening of breathing difficulties if you have asthma or have suffered from asthmatic 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 have an erection (impotence);
• worsening of intermittent claudication, a pain while walking that goes away with rest;
• 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);
• intermittent claudication which is due to poor blood circulation and consists of leg pain that becomes more intense with exercise. Your doctor may prescribe blood tests to monitor these parameters.

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

• alteration of laboratory values for measuring certain immune reactions (positive test for antinuclear antibodies).

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 mainly attack the skin and joints);
• rapid onset of distant 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);
• depression.

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 the web address: 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 TARGET

• This medicine does not require any special storage conditions.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is reported on the pack after “Exp.”. The expiry date refers to the last day of that month.

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 TARGET contains
TARGET 100 mg + 25 mg coated tablets

• The active ingredients are: atenolol 100 mg and chlortalidone 25 mg.
• The other ingredients are: Corn starch, Microgranular cellulose, Sorbitol powder, Magnesium carbonate, Gelatin, Talc, Magnesium stearate, Sodium carboxymethylamide, Colloidal silica, E 104 Quinoline Yellow.

Description of the appearance of TARGET and contents of the pack
TARGET 100 mg + 25 mg coated tablets are presented in a box of 28 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l.
Via Tiburtina, 1143 – 00156 Roma

Manufacturer
Lab. It. Biochim. Farm.co LISAPHARMA S.p.A.
Via Licinio, 11 – 22036 ERBA (CO)
Fine Foods & Pharmaceuticals N.T.M. S.p.a
Via Grignano,43

• 24041 – Brembate (BG)