Target

Package leaflet: Information for the patient

TARGET 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 taking 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 TARGET is and what it is used for

TARGET is used to treat high blood pressure (essential arterial hypertension) when it is not adequately controlled with atenolol or clortalidone alone.
TARGET contains two different medicines: atenolol and clortalidone. These medicines 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.
Clortalidone belongs to a group of medicines called "diuretics". It works by increasing the amount of urine produced by your kidneys.

2. What you should know before taking TARGET

Do not take TARGET

• 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 or planning to become pregnant, or if you are 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 problems;
• 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 problems;
• if your doctor has diagnosed you with abnormally high levels of acid in the blood (metabolic acidosis).

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

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

• if you have thyroid problems (a gland located in the neck area); this 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 circulation problems, even if they are controlled by appropriate treatment;
• 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 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 TARGET;
• if you have first-degree heart block (a disease of the heart's conduction system);
• if you have high levels of uric acid in the blood (hyperuricemia), as this medicine may further increase uric acid levels, potentially triggering gout;
• 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 eye pressure, which may occur within hours or weeks after taking TARGET. If left untreated, this condition may lead to permanent vision loss. If you have previously had an allergic reaction 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 TARGET, 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.

Hyperuricemia (uric acid in the blood)
With long-term use, TARGET may increase blood uric acid levels, which may lead to gout (a condition causing joint pain). Your doctor will advise appropriate treatment.

Anesthesia
If you are admitted to hospital, inform medical staff that you are taking TARGET, and especially inform the anesthesiologist (the doctor responsible for anesthesia) if you are undergoing surgery.

For athletes
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

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

Other medicines and TARGET
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 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 TARGET, or vice versa;
• a medicine for heart failure (digoxin, a medicine used for heart problems);
• nasal decongestants or other medicines (containing, for example, pseudoephedrine) used to treat colds;
• clonidine (a medicine used to treat high blood pressure or prevent migraines). If you are taking both clonidine and TARGET, 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);
• insulin or other oral medicines for diabetes;
• eye drops for glaucoma (ophthalmic beta-blockers).

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

Driving and using machines
It is unlikely that taking TARGET will affect your ability to drive or operate machinery.
However, dizziness and fatigue may occasionally occur; if you experience these symptoms, it is advisable not to perform such activities.

TARGET contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

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

3. How to take TARGET

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.

• Your doctor will tell you the most appropriate dosage for you, how many tablets to take each day and when to take them. The names of the days of the week are printed on the blister pack to help you follow your treatment correctly.
• Swallow one 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 a lower dose of TARGET.
If you have severe kidney problems
If you suffer from severe kidney problems, you must not take TARGET (see section “Do not take
TARGET”).
Use in children and adolescents
TARGET must not be administered to children and adolescents under 18 years of age.
If you take more TARGET than you should
In case of accidental ingestion/overdose of TARGET, contact your doctor immediately or go to the nearest hospital.
You may experience a slowed heartbeat, dizziness caused by low blood pressure, and difficulty breathing. Your heart may also have difficulty supplying blood to the rest of the body (acute heart failure).
If you forget to take TARGET
Do not take a double dose to make up for a missed tablet. If you forget to take a dose, take it as soon as possible. Two doses must not be taken at the same time.
If you stop taking TARGET
Do not stop treatment just because you feel better, unless your doctor tells you to. Stopping treatment should be done gradually.
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 everyone will experience them.
During treatment with TARGET, as with any medicinal product, the following side effects may occur, with the following frequency:

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

• slowed heart rate
• cold fingers and toes
• stomach and intestinal disorders (e.g. nausea, diarrhoea)
• fatigue
• increased levels of uric acid in the blood, decreased levels of potassium in the blood, decreased 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 disorders
• 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 result in 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 things that cannot be explained)
• dizziness, especially when standing, headache, tingling in the hands
• dry eyes, visual disturbances
• breathing difficulties and/or swelling of the ankles if you have heart failure (a heart condition)
• 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 have previously suffered from 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)
• worsening of intermittent claudication, a pain occurring during walking that resolves with rest
• 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)
• intermittent claudication due to poor blood circulation, causing leg pain that worsens during physical exertion. Your doctor may prescribe blood tests to monitor these parameters.

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)

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 primarily 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, please inform your doctor or pharmacist. You may 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 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 stated on the carton after "Exp.". The expiry date refers to the last day of that month.

Do not dispose of medicines 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 TARGET contains
TARGET 100 mg + 25 mg film-coated tablets

• The active substances are: atenolol 100 mg and chlorthalidone 25 mg.
• The other components are: maize starch, microcrystalline cellulose, sorbitol powder, magnesium carbonate, gelatin, talc, magnesium stearate, sodium carboxymethylcellulose, colloidal silicon dioxide, E 104 Quinoline Yellow.

Description of the appearance of TARGET and package contents
TARGET 100 mg + 25 mg film-coated tablets are supplied in a box containing 28 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group S.r.l.
Via Tiburtina, 1143 – 00156 Rome, Italy

Manufacturer
Lab. It. Biochim. Farm.co LISAPHARMA S.p.A.
Via Licinio, 11 – 22036 ERBA (CO), Italy
Fine Foods & Pharmaceuticals N.T.M. S.p.a
Via Grignano, 43
24041 – Brembate (BG), Italy