NORMOPRESS 100 mg /2.5 Mg Coated Tablet

Содержание инструкции

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

Normopress, 100mg + 2,5mg tablets
atenolol and indapamide

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 may 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 Normopress is and what it is used for
• 2. What you need to know before you take 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 is Normopress and what is it used for

Normopress is a medicine that reduces blood pressure.

2. What you need to know before you take 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 diseases:
• severe liver failure (severe liver dysfunction),
• severe kidney failure (severe kidney dysfunction),
• refractory hypokalaemia or hyponatraemia (deficiency of potassium or sodium mineral salts), hypercalcemia, manifest gout
• marked bradycardia (severe slowing of the heartbeat),
• second and third degree atrioventricular block (severe heart rhythm pathology),
• sick sinus syndrome, sino-atrial block (severe pathologies with effects on heart rhythm),
• cardiogenic shock (severe heart disease),
• arterial hypotension (low blood pressure),
• metabolic acidosis (disease that causes increased blood acidity),
• severe disorders of peripheral arterial circulation (severe circulatory disorders),
• uncontrolled heart failure with adequate therapy,
• recent cerebrovascular accidents,
• untreated pheochromocytoma (nervous system tumor),
• Conn's syndrome (hormonal disease characterized by increased pressure).

Warnings and precautions
Consult your doctor or pharmacist before taking Normopress.
If you have decreased vision or eye pain. These may 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 a period ranging from a few hours to a few weeks after taking Normopress. This can lead to permanent vision loss if left untreated. If you have previously experienced an allergy to penicillin or sulfonamides, you may be at a higher risk of developing this condition.
Take particular care before taking Normopress if you suffer from heart disease that is not adequately controlled by therapy prescribed by your doctor. Also consult your doctor if you suffer from severe respiratory diseases (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 or before consulting your doctor, especially if you suffer from diseases that reduce heart function.

Children
Taking 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 suffer from kidney problems. Consult your doctor who will establish 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 for the treatment of arrhythmias and high blood pressure), such as verapamilor diltiazem, due to the possibility of marked bradycardia (slowed heartbeat), hypotension (decreased blood pressure), heart failure (insufficiency of heart contraction force), atrioventricular block (blockage of heart contraction) and cardiac arrest. At least 48 hours must have elapsed since the suspension of one of these medicines before starting the other therapy.
• Lithium salts(medicines used in the treatment of mental illness);
• Potassium-depleting diuretics(medicines that increase urine production). Take particular care 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 it may increase the risk of reduced blood pressure and heart failure (insufficiency of heart contraction force) may occur if you suffer from latent heart failure. In addition, blood pressure medications, such as Normopress, can potentiate the effect of reducing the heart's contractile force of other medicines for the treatment of arrhythmias.
• Cardiac glycoside medicines(medicines for the treatment of heart arrhythmias), as when associated with Normopress, they can cause an increase in the time of conduction of the heart rhythm (atrioventricular).
• Clonidine(medicine for high blood pressure), as beta-blockers such as Normopress can worsen the sudden increase in blood pressure values that can occur after stopping clonidine. If you take both medicines at the same time, stop taking Normopress several days before stopping therapy with clonidine. If therapy with Normopress is to replace that with

clonidine, start treatment with this medicine several days after stopping therapy with clonidine.

• Sympathomimetic medicines(medicines that stimulate the heart rate), such as adrenaline, as they can counteract the effect of Normopress if used simultaneously.
• Prostaglandin synthesis inhibitors(medicines for the treatment of fever and inflammation), such as ibuprofenor indometacin, as they can reduce the blood pressure lowering effects of Normopress.
• Oral hypoglycemic agents(medicines for diabetes);
• Digitalis medicines(medicines for heart failure);
• Corticosteroid medicines(medicines for the treatment of severe inflammation);
• Laxative medicines(medicines for the treatment of constipation) for long-term use. In the event of hospitalization, inform the medical staff of the ongoing treatment with Normopress and, in particular, the anesthesiologist in case of surgery, as this medicine interferes with the action of medicines used in anesthesia.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of Normopress is not recommended during pregnancy as this medicine crosses the filtering barrier between mother and fetus and blood levels (significant levels of medicine) have been found in the umbilical cord. Studies on the use of atenolol in the 1st trimester of pregnancy have not been conducted and therefore the possibility of fetal harm cannot be excluded. Atenolol has been used, under strict medical control, for the treatment of high blood pressure in the 3rd 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 (growth inside the mother's womb).
The use of atenolol, in women who are pregnant or may become pregnant, requires careful evaluation of the benefits induced by therapy compared to the possible risks, particularly in the first six months of pregnancy.
A significant accumulation of atenolol is found in breast milk. Therefore, consult your doctor or pharmacist if you are breastfeeding or plan to do so.

Driving and using machines
This medicine does not interfere with the ability to drive and use machines.

For those who play sports
the use of the medicine without medical necessity constitutes doping and can still determine positivity to anti-doping tests.

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

3. How to take Normopress

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet a day, preferably in the morning.
The effects of treatment with Normopress are usually evident after 1-2 weeks of therapy. In the maintenance
phase, the dose may be reduced to half a tablet at the doctor's discretion.

Use in children and adolescents
Taking this medicine is not recommended in children.

Use in the elderly
It may be necessary to reduce your dose, particularly if you suffer from kidney disease. Consult your
doctor, who will determine the appropriate dose for you.

Use in patients with kidney disease
Consult your doctor or pharmacist if you suffer from kidney disease and/or are undergoing
dialysis (blood filtration using machines). Your doctor will determine a correct dose for you.

If you take more Normopress than you should
Consult your doctor or the nearest hospital if you take more Normopress than you have been
prescribed and if you experience symptoms related to the heart or blood pressure.
Symptoms of overdose may manifest with bradycardia (slowing of the heart rate), marked
hypotension (significant drop in blood pressure), acute heart failure up to cardiogenic shock (cardiac
collapse) and bronchospasm (severe breathing difficulty).
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• bradycardia (slowing of the heart rate),
• worsening of cardiac function in patients with heart failure,
• hypotension (low blood pressure),
• postural hypotension (dizziness, lightheadedness) which may be associated with syncope (temporary loss of consciousness),
• cold extremities. In sensitive patients:
• onset of cardiac block (heart collapse),
• worsening of intermittent claudication (pain in a leg during exertion),
• Raynaud's phenomenon (loss of color in the extremities).
• dizziness,
• headache,
• mood changes,
• nightmares,
• psychosis (alteration of mental balance),
• hallucinations (seeing or hearing things when there is no real external stimulus),
• sleep disorders,
• worsening of nervous syndromes with mental depression, catatonia (alteration of mental state characterized by immobility, impassivity or inaccessibility), confusion and memory impairment.
• dry mouth,
• gastrointestinal disorders,
• increases in transaminase levels (liver enzymes) and liver toxicity, including intrahepatic cholestasis (blockage or reduction of liver function).
• purpura (appearance of localized blood spots on the skin),
• thrombocytopenia (reduced number of platelets, blood clotting elements),
• granulocytopenia (deficiency of granulocytes, white blood cells).
• alopecia (localized hair loss),
• dry eyes,
• psoriatic-type skin reactions (disease that causes plaques, redness and itching on the skin),
• worsening of psoriasis (disease that causes plaques, redness and itching on the skin),
• skin rash (redness of the skin),
• erythematous eruptions (localized redness of the skin).
• paresthesia (alteration of sensitivity of parts of the body).
• impotence.
• bronchospasm (breathing disorder, shortness of breath) in patients with bronchial asthma or with a history of asthmatic problems.
• visual disturbances.
• fatigue,
• increase in antinuclear antibodies (immune defenses); however, the relevance is unclear. Stop treatment with Normopress if the following side effects occur: thrombocytopenia (reduced number of platelets), 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(the frequency cannot be estimated from the available data)
• hypokalemia (excessive reduction of potassium in the body).
• nausea,
• gastrointestinal intolerance (digestive intolerance).
• palpitations,
• orthostatic hypotension (dizziness, lightheadedness).
• allergic reactions including itching, urticaria, erythema, maculopapular rashes.
• asthenia (fatigue),
• headache,
• vertigo,
• drowsiness,
• muscle cramps,
• slight increase in blood urea nitrogen.
• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Normopress

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Normopress contains

• The active ingredients are atenolol and indapamide. Each divisible tablet contains 100 mg of atenolol and 2.5 mg of indapamide.
• The other ingredients are magnesium carbonate, corn starch, sodium lauryl sulfate, gelatin and magnesium stearate.

Description of the appearance of Normopress and contents of the pack
Pack of 30 divisible tablets.

Marketing Authorisation 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)