Normopress

Package leaflet: Information for the patient

Normopress 100mg + 2.5mg tablets

atenolol and indapamide
Please read all of this leaflet carefully before you start 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 they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Normopress is and what it is used for

Normopress is a medicine that reduces arterial blood pressure.

2. What you should know before taking Normopress

Do not take Normopress

• if you are allergic to atenolol, indapamide, or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from any of the following conditions:
  • severe hepatic impairment (severe liver dysfunction),
  • severe renal failure (severe kidney dysfunction),
  • refractory hypokalemia or hyponatremia (deficiency of potassium or sodium salts), hypercalcemia, manifest gout,
  • marked bradycardia (severe slowing of the heartbeat),
  • second- or third-degree atrioventricular block (severe cardiac rhythm disorder),
  • sino-atrial disease, sino-atrial block (severe disorders affecting heart rhythm),
  • cardiogenic shock (severe heart condition),
  • arterial hypotension (low blood pressure),
  • metabolic acidosis (a condition causing increased blood acidity),
  • severe peripheral arterial circulation disorders (severe circulatory problems),
  • uncontrolled heart failure (heart failure not adequately managed by appropriate therapy),
  • recent cerebrovascular accidents,
  • untreated phaeochromocytoma (a tumour of the nervous system),
  • Conn's syndrome (a hormonal disorder characterized by high blood pressure).

Warnings and precautions
Talk to your doctor or pharmacist before taking Normopress.
If you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to several weeks after taking Normopress. If not treated, this may lead to permanent vision loss. If you have previously had an allergic reaction to penicillin or sulfonamides, you may have a higher risk of developing this condition.
Exercise particular caution before taking Normopress if you have heart diseases that are not adequately controlled by prescribed therapy. Also consult your doctor if you suffer from severe respiratory disorders (e.g. asthma). Finally, consult your doctor before taking this medicine if you are breastfeeding.
In any case, do not abruptly stop treatment with Normopress without first consulting your doctor, especially if you have conditions that impair heart function.
Atenolol may also increase the risk of severe hypoglycemia when used concomitantly with certain types of antidiabetic medicines called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).

Children
The use of this medicine is not recommended in children (see section “Do not take Normopress”).

Elderly
If you are elderly, it may be necessary to reduce your dose of Normopress, especially if you have kidney problems. Consult your doctor, who will determine an appropriate dose for you.

Other medicines and Normopress
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Normopress together with the following medicines:

• Non-dihydropyridine calcium antagonists (medicines used to treat arrhythmias and high blood pressure), such as verapamil or diltiazem, due to the risk of severe bradycardia (slowed heartbeat), hypotension (low blood pressure), heart failure (reduced cardiac contractility), atrioventricular block (impaired conduction of heart impulses), and cardiac arrest. At least 48 hours must elapse between stopping one of these medicines and starting Normopress.
• Lithium salts (medicines used in the treatment of mental disorders);
• Potassium-wasting diuretics (medicines that increase urine production).

Exercise particular caution and inform your doctor if you are taking:

• Dihydropyridine calcium antagonists (medicines for the treatment of arrhythmias and high blood pressure), such as nifedipine, as they may increase the risk of low blood pressure and may cause heart failure (reduced cardiac contractility) if you have latent heart failure. In addition, blood pressure-lowering medicines such as Normopress may enhance the negative inotropic effect (reduced force of heart contraction) of other antiarrhythmic medicines.
• Digitalis glycosides (medicines for the treatment of heart arrhythmias), as their combination with Normopress may increase atrioventricular conduction time (slowing of the heart's electrical conduction).
• Clonidine (a medicine for high blood pressure), because beta-blockers such as Normopress may worsen the sudden rise in blood pressure that may occur after stopping clonidine. If you are taking both medicines, stop taking Normopress several days before discontinuing clonidine. If Normopress is to replace clonidine therapy, start Normopress several days after stopping clonidine.
• Sympathomimetic medicines (medicines that stimulate the heart rate), such as adrenaline, as they may counteract the effect of Normopress when used simultaneously.
• Prostaglandin synthetase inhibitors (medicines for fever and inflammation), such as ibuprofen or indometacin, as they may reduce the blood pressure-lowering effect of Normopress.
• Oral hypoglycemics (medicines for diabetes), such as sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide);
• Digitalis medicines (medicines for heart failure);
• Corticosteroid medicines (medicines for the treatment of severe inflammation);
• Laxatives (medicines for constipation) used long-term.

If you are admitted to hospital, inform the medical staff, and especially the anaesthetist in case of surgery, that you are being treated with Normopress, as this medicine may interfere with the action of medicines used during anaesthesia.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of Normopress during pregnancy is not recommended, as this medicine crosses the placental barrier and significant blood levels of the medicine have been detected in the umbilical cord. Studies on the use of atenolol during the first trimester of pregnancy have not been conducted, and therefore a risk of fetal harm cannot be excluded. Atenolol has been used, under strict medical supervision, for the treatment of high blood pressure during the third trimester (the last three months). The use of atenolol in pregnant women for the treatment of mild to moderate hypertension has been associated with intrauterine growth retardation (slowed fetal growth).
The use of atenolol in women who are pregnant or who may become pregnant requires careful assessment of the benefits of therapy versus the potential risks, especially during the first six months of pregnancy.
Significant levels of atenolol are excreted in breast milk. Therefore, consult your doctor or pharmacist if you are breastfeeding or plan to breastfeed.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

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

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

3. How to take Normopress

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet per day, preferably in the morning.
The effects of Normopress treatment usually become evident after 1–2 weeks of therapy. During the maintenance
phase, the dose may be reduced to half a tablet, at the doctor's discretion.
Use in children and adolescents
This medicine is not recommended for use in children.
Use in the elderly
A dose reduction may be necessary, especially if you have kidney disease. Please consult your
doctor, who will determine the appropriate dose for you.
Use in patients with kidney disease
Consult your doctor or pharmacist if you have kidney disease and/or are undergoing dialysis
(blood filtration using machines). Your doctor will determine the correct dose for you.
If you take more Normopress than you should
Contact your doctor or go to the nearest hospital if you take more Normopress than prescribed and experience
symptoms related to the heart or blood pressure.
Symptoms of overdose may include bradycardia (slowed heart rate), marked hypotension (severe drop in blood pressure), acute heart failure up to cardiogenic shock (cardiac collapse), and bronchospasm (severe breathing difficulty).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Not known (frequency cannot be estimated from the available data)

• Bradycardia (reduced heart rate),
• Worsening of cardiac function in patients with heart failure,
• Hypotension (low blood pressure),
• Postural hypotension (dizziness, vertigo), which may be associated with syncope (temporary loss of consciousness),
• Cold extremities. In sensitive patients:
• Onset of cardiac arrest (heart collapse),
• Worsening of intermittent claudication (pain in one leg during exertion),
• Raynaud's phenomenon (loss of skin coloration in extremities),
• Dizziness,
• Headache,
• Mood changes,
• Nightmares,
• Psychosis (mental imbalance),
• Hallucinations (seeing or hearing things in the absence of a real external stimulus),
• Sleep disorders,
• Worsening of neurological syndromes with mental depression, catatonia (mental state alteration characterized by immobility, lack of expression or unresponsiveness), confusion, and memory disturbances.
• Dry mouth,
• Gastrointestinal disturbances,
• Increased transaminase levels (liver enzymes) and hepatic toxicity (liver damage), including intrahepatic cholestasis (blockage or reduction of liver function).
• Purpura (appearance of localized blood spots on the skin),
• Thrombocytopenia (reduced platelet count, blood clotting elements),
• Granulocytopenia (deficiency of granulocytes, white blood cells).
• Alopecia (localized hair loss),
• Dry eyes,
• Psoriasiform skin reactions (a condition causing plaques, redness, and itching of the skin),
• Worsening of psoriasis (a condition causing plaques, redness, and itching of the skin),
• Skin rash (redness of the skin),
• Erythematous eruptions (localized redness of the skin).
• Paresthesia (altered sensation in parts of the body).
• Impotence.
• Bronchospasm (breathing difficulty, shortness of breath) in patients with bronchial asthma or a history of asthma-related problems.
• Visual disturbances.
• Fatigue,
• Increase in antinuclear antibodies (immune defenses); however, the clinical relevance is unclear.

Discontinue treatment with Normopress if any of the following adverse effects occur:
thrombocytopenia (reduced platelet count), purpura (appearance of localized blood spots on the skin), granulocytopenia (deficiency of granulocytes, white blood cells), erythematous eruptions require discontinuation of treatment.

At the recommended dose, the undesirable side effects of indapamide are mild and generally transient. They include:
Not known (frequency cannot be estimated from the available data)

• Nausea,
• Gastrointestinal intolerance (digestive intolerance).
• Palpitations,
• Orthostatic hypotension (dizziness, vertigo).
• Allergic reactions including pruritus, urticaria, erythema, maculopapular eruptions.
• Asthenia (fatigue),
• Headache,
• Dizziness,
• Somnolence (drowsiness),
• Muscle cramps,
• Slight increase in blood urea nitrogen.
• Decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)).

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

• Low blood potassium levels

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

• Low blood sodium levels, which may lead to dehydration and reduced blood pressure
• Impotence (inability to achieve or maintain an erection)

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

• Low blood chloride levels
• Low blood magnesium levels

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

5. How to store Normopress

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. 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 Normopress contains

• The active substances are atenolol and indapamide. Each scored tablet contains 100 mg of atenolol and 2.5 mg of indapamide.
• The other components are magnesium carbonate, maize starch, sodium lauryl sulfate, gelatin, and magnesium stearate.

Description of the appearance of Normopress and contents of the pack
Box containing 30 scored tablets.
Marketing Authorization Holder
I.B.N. SAVIO S.r.l. - Via del Mare, 36 Pomezia (RM)
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – Anagni (FR)