Atenolol and chlorthalidone ratiopharm

Package leaflet: Information for the patient

Atenolol Chlorthalidone ratiopharm 50 mg/12.5 mg tablets, 100 mg/25 mg tablets

Generic medicine
Please read all of 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 adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Atenololo clortalidone ratiopharm is and what it is used for

This medicine contains two active substances, called atenolol and clortalidone.
Atenolol belongs to a group of medicines called "beta-blockers" which work by slowing down the heartbeat and reducing the force of the heart's contractions.
Clortalidone belongs to a group of medicines called diuretics, which work by increasing the amount of urine produced by the kidneys.
Together, these two active substances help lower blood pressure.
Atenololo clortalidone ratiopharm is used to treat high blood pressure (hypertension) when blood pressure is not adequately controlled by treatment with the individual active substances (atenolol and clortalidone) alone.
Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Atenololo clortalidone ratiopharm

• Do not take Atenololo clortalidone ratiopharm if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);

• if you are allergic to sulfonamide-derived medicines (some antibiotics);

• if you have a very slow heartbeat (bradycardia);

• if you suffer from a very irregular heartbeat (such as sick sinus syndrome or second- or third-degree atrioventricular block);

• if you have untreated or inadequately controlled heart failure;

• if you have severe kidney impairment;

• if you are suffering from cardiogenic shock. This occurs when the heart does not pump blood adequately;

• if you have very low blood pressure (hypotension);

• if your doctor has diagnosed you with abnormally high levels of acid in your blood (metabolic acidosis);

• if you have a rare condition characterized by brief episodes of narrowing of the arteries, the blood vessels carrying blood from the heart to the rest of the body (Raynaud's syndrome);

• if you suffer from severe peripheral circulatory disorders;

• if you have an untreated tumor called "pheochromocytoma";

• if you are pregnant or breastfeeding;

• if you suffer from gout;

• if you suffer from severe asthma or severe chronic obstructive pulmonary disease;

• if you have been administered verapamil or diltiazem (see section "Other medicines and Atenololo clortalidone ratiopharm").

If any of the above conditions apply to you, do not take Atenololo clortalidone ratiopharm. If you are unsure, consult your doctor or pharmacist before taking this medicine.
Atenololo clortalidone ratiopharm must not be administered to children.

Warnings and precautions
Talk to your doctor or pharmacist before taking Atenololo clortalidone ratiopharm:

• if you have respiratory problems;
• if you are prone to allergic reactions, such as those caused by insect stings;
• if you suffer from a type of chest pain called "Prinzmetal's angina", as this medicine may increase the frequency and duration of angina attacks;
• if you have severe peripheral circulatory disorders;
• if you have a slow heartbeat;
• if you suffer from heart failure that is controlled with appropriate therapy;
• if you have first-degree heart block (a disorder of the heart's conduction system);
• if you have diabetes. Atenololo clortalidone ratiopharm may alter blood sugar levels;
• if you have thyroid problems, such as "thyrotoxicosis". Atenololo clortalidone ratiopharm may mask the symptoms of "thyrotoxicosis";
• if you have previously experienced severe allergic reactions (anaphylactic reactions);
• if you are using eye drops containing similar active substances (beta-blockers);
• if you are scheduled to undergo anesthesia for surgery; In this case, inform your doctor or healthcare provider that you are taking Atenololo clortalidone ratiopharm, as you may experience a drop in blood pressure (hypotension);
• if you have a tumor called "pheochromocytoma" currently under treatment;
• if you have liver problems;
• if you are in a condition associated with low levels of potassium in the blood, such as a low-potassium diet, gastrointestinal disorders, or advanced age;
• if you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur from a few hours to weeks after taking Atenololo clortalidone ratiopharm. If left untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you are at higher risk of developing this condition;
• if you suffer from ischemic heart disease; in this case, treatment with Atenololo clortalidone ratiopharm should not be stopped abruptly.

Laboratory tests
Your doctor may periodically prescribe blood tests to monitor levels of certain substances (such as potassium, sodium, or uric acid), especially if you are elderly, have heart failure, are taking certain medications (digitalis), or have gastrointestinal disorders.

Other medicines and Atenololo clortalidone ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take this medicine and inform your doctor or pharmacist if:

• you have been administered verapamil or diltiazem by intravenous injection within the last 48 hours. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Inform your doctor or pharmacist if you are taking any of the following medicines:

• clonidine – a medicine for high blood pressure or migraine. Ask your doctor for advice on how to take these two medicines;
• nifedipine – a medicine for high blood pressure or chest pain (see also "Do not take Atenololo clortalidone ratiopharm", above);
• disopyramide, amiodarone, and other medicines for irregular heartbeat;
• digoxin – a medicine used for heart disorders;
• adrenaline and noradrenaline – medicines that stimulate the heart;
• ibuprofen, indomethacin, and certain other medicines used to treat pain and inflammation;
• lithium – used to treat mental health disorders;
• baclofen – used to treat muscle spasms;
• certain eye drops containing similar active substances (beta-blockers).

If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Atenololo clortalidone ratiopharm if you are pregnant or breastfeeding.

Driving and using machines
It is unlikely that Atenololo clortalidone ratiopharm will impair your ability to drive or operate tools or machinery.
If you experience dizziness or drowsiness while being treated with this medicine, do not drive or operate tools or machinery.

Atenololo clortalidone ratiopharm 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 ratiopharm

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

• Your doctor will tell you how many tablets to take each day and when to take them.
• Try to take the tablets at the same time every day.
• Swallow the tablet whole with water.

Adults
The usual dose for an adult is one tablet daily of Atenololo clortalidone ratiopharm 50 mg/12.5 mg tablets or Atenololo clortalidone ratiopharm 100 mg/25 mg tablets.
When treatment with Atenololo clortalidone ratiopharm 50 mg/12.5 mg tablets is not sufficient, your doctor may prescribe Atenololo clortalidone ratiopharm 100 mg/25 mg tablets.

Use in children and adolescents (under 18 years)
Atenololo clortalidone ratiopharm must not be given to children and adolescents.

Patients with kidney problems
Atenololo clortalidone ratiopharm must not be given to patients with severe kidney problems (see also section 2 “Do not take Atenololo clortalidone ratiopharm”).

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

If you are switching from another medicine for high blood pressure to Atenololo clortalidone ratiopharm, your doctor will advise you on the correct way to do this.
If you are taking clonidine, you must stop this treatment and wait several days before switching to Atenololo clortalidone ratiopharm (see section 2, “Other medicines and Atenololo clortalidone ratiopharm”).
Consult your doctor before switching from another medicine for high blood pressure to Atenololo clortalidone ratiopharm.

If you take more Atenololo clortalidone ratiopharm than you should
If you take more Atenololo clortalidone ratiopharm than you should, consult a doctor or go immediately to a hospital.
Take the medicine pack with you so that the doctor knows what you have taken.
You may experience a slow heartbeat, low blood pressure, and breathing difficulties. Your heart may also have difficulty pumping blood to the rest of the body (acute heart failure).

If you forget to take Atenololo clortalidone ratiopharm
If you forget to take a dose, take it as soon as you remember.
However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Atenololo clortalidone ratiopharm
Do not stop taking Atenololo clortalidone ratiopharm without consulting your doctor, especially if you suffer from ischemic heart disease. If treatment with Atenololo clortalidone ratiopharm needs to be stopped or suspended after prolonged use, the dose must always be reduced gradually in a stepwise manner.

If you have any doubts about how to use 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.
If you experience any of the following serious side effects, stop taking Atenolol
clortalidone ratiopharm and consult a doctor immediately or go to hospital straight away.
Rare (may affect up to 1 in 1,000 people)

• abnormal heartbeat, dizziness, tiredness, or fainting. These could be signs of heart block;
• shortness of breath or swelling of the ankles. These could be signs of worsening heart function (heart failure);
• breathing difficulties (bronchospasm), in people who suffer from or have suffered from bronchial asthma;
• severe abdominal and back pain caused by inflammation of the pancreas (pancreatitis);
• low levels of white blood cells (leukopenia).

If you experience any of the above side effects, stop taking Atenololo
clortalidone ratiopharm and consult a doctor immediately or go to hospital straight away.
Other side effects
Common (may affect up to 1 in 10 people)

• poor circulation or feeling cold in the hands and feet;
• slow heartbeat;
• gastrointestinal problems;
• nausea;
• fatigue;
• increased levels of uric acid in the blood;
• low sodium levels in the blood;
• low potassium levels in the blood;
• problems with glucose metabolism.

Uncommon (may affect up to 1 in 100 people)

• sleep disturbances;
• increased levels of enzymes called "transaminases" (detected by blood tests).

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

• worsening of movement difficulties (intermittent claudication) in patients with circulation problems in the hands and feet (Raynaud's phenomenon);
• tingling in the hands and feet;
• drop in blood pressure upon standing, which may cause dizziness, lightheadedness, or fainting;
• headache;
• dizziness;
• confusion;
• mood changes;
• nightmares;
• personality changes (psychotic disorder) or seeing or hearing things that are not there (hallucinations);
• dry mouth;
• hair thinning;
• dry eyes;
• skin rash, including rash similar to psoriasis (formation of thickened areas on the skin), worsening of psoriasis, skin rash;
• vision disturbances;
• increased tendency to bruise or presence of purple spots on the skin;
• inability to achieve an erection (impotence);
• liver problems, including disturbances in bile flow (intrahepatic cholestasis);
• pancreatitis (inflammation of the pancreas);
• blood disorders, such as changes in blood cells (thrombocytopenia and leukopenia). Your doctor may prescribe periodic blood tests to monitor whether Atenololo clortalidone ratiopharm is affecting your blood.

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

• increase in antinuclear antibodies, a type of autoantibody produced by the body against itself.

Frequency not known (cannot be estimated from the available data)

• constipation;

• lupus-like syndrome (a condition in which the immune system produces antibodies that mainly attack the skin and joints);

• sudden onset of reduced 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);

• depression.

Reporting of side effects
If you get any side effects, including ones 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 Atenololo clortalidone ratiopharm

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 packaging after “Exp.”. The expiry date refers to the last day of that month.
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 ratiopharm contains
The active substances are atenolol and chlorthalidone.
Atenololo clortalidone ratiopharm 50 mg/12.5 mg tablets: each tablet contains 50 mg of
atenolol and 12.5 mg of chlorthalidone.
Atenololo clortalidone ratiopharm 100 mg/25 mg tablets: each tablet contains 100 mg of
atenolol and 25 mg of chlorthalidone.
The other components are: maize starch, magnesium carbonate, sodium lauryl sulfate, gelatin, magnesium
stearate.
Description of the appearance of Atenololo clortalidone ratiopharm and contents of the pack
Atenololo clortalidone ratiopharm is available in a box of 28 tablets in opaque PVC and aluminum blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ratiopharm GmbH - Graf-Arco Strasse 3 - Ulm (Germany)
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - Quinto de Stampi, Rozzano - Milan