ACESISTEM 20 mg /12.5 Mg Tablets

Зміст інструкції

1. Acesistem 20 mg+12,5 mg tablets
   1. What is Acesistem and what is it used for
   2. What you need to know before taking Acesistem
   3. How to take Acesistem
   4. Possible side effects
   5. How to store Acesistem
   6. Contents of the pack and other information

Acesistem 20 mg+12,5 mg tablets

enalapril maleate/hydrochlorothiazide

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

1. What is Acesistem and what is it used for

Acesistem contains the active ingredients enalapril and hydrochlorothiazide.
Enalapril belongs to the group of medicines called angiotensin converting enzyme inhibitors
(ACE-inhibitors), and it works by dilating blood vessels to make it easier for the heart to perform its function of
pumping blood to all parts of the body.
Hydrochlorothiazide belongs to the group of medicines called diuretics and works by promoting the elimination of
a greater quantity of water and salts through the kidneys, resulting in a decrease in blood
pressure.
Together, enalapril and hydrochlorothiazide help to reduce high blood pressure.
Acesistem is indicated for the treatment of high blood pressure (hypertension) in those patients
whose blood pressure is not adequately controlled with enalapril alone.

2. What you need to know before taking Acesistem

Do not take Acesistem:

• if you are allergic to enalapril, hydrochlorothiazide or any other ingredient of this medicine (listed in section 6);
• if you have had allergic reactions, with swelling of the face, lips, tongue and/or throat, with difficulty swallowing and breathing, after previous treatments with other medicines that inhibit the angiotensin-converting enzyme (ACE inhibitors);
• if you have hereditary or idiopathic angioedema (i.e. without an apparent cause);
• if you are allergic to any sulfonamide-derived medicine (ask your doctor if you are not sure what sulfonamide-derived medicines are);
• if you do not produce urine (anuria);
• if you have severe impairment of kidney function;
• if you are pregnant for more than three months (It is best to avoid ACESISTEM even in the early stages of pregnancy, see sections “Warnings and precautions” and “Pregnancy and breastfeeding”);
• if you have severe impairment of liver function;
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren (see section “Other medicines and ACESISTEM”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Acesistem.
Tell your doctor:

• if you are over 70 years of age;
• if you think you might be pregnant or are planning to become pregnant because they will prescribe you another medicine instead of Acesistem. Acesistem is not recommended in early pregnancy, and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken during this period (see sections “Do not take Acesistem” and “Pregnancy and breastfeeding”);
• if you have or have had vomiting and/or diarrhoea;
• if you are being treated with diuretics (medicines that increase the amount of water and salts eliminated through the kidneys);
• if you are being treated with a particular type of diuretics called potassium-sparing diuretics, if you are using potassium supplements, medicines that increase potassium levels in the blood (e.g. heparin) or salt substitutes containing potassium (see section “Other medicines and Acesistem”);
• if you are following a low-sodium diet;
• if you have or have had liver problems (see section 2 “Do not take Acesistem”);
• if you have kidney failure or are undergoing hemodialysis (see section 2 “Do not take Acesistem”);
• if you have narrowing or blockage of blood vessels that carry blood to the kidneys (bilateral renal artery stenosis or stenosis of the artery of the only functioning kidney);
• if you have kidney problems due to diabetes (diabetic nephropathy);
• if you have recently had a kidney transplant;
• if you urinate frequently;
• if you are using corticosteroids, adrenocorticotropic hormone (hormonal medicines);
• if you have a collagen disease that affects blood vessels (e.g. lupus erythematosus, rheumatoid arthritis), if you are being treated with medicines that suppress the immune response, if you are taking allopurinol or procainamide, or any combination of these conditions;
• if you have or have had an allergic condition, asthma or a condition that causes joint pain, skin redness and fever (systemic lupus erythematosus);
• if you have had allergic reactions that can manifest, for example, with swelling of the face, lips, mouth or throat (angioedema);
• if you have problems with your heart or brain, in particular: o heart failure. o a disease caused by reduced blood flow in the blood vessels of the heart (ischemic cardiovascular disease) o a disease caused by reduced blood circulation in the brain (cerebrovascular disease). o narrowing of the heart valves (aortic stenosis) o a disease that causes thickening of the heart muscle (hypertrophic cardiomyopathy). o acute heart failure.
• if your doctor has told you that the acidity level of your blood is higher than normal (metabolic acidosis);
• if you have diabetes;
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Acesistem.
• if you have blurred vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within hours or weeks of taking Acesistem. If left untreated, this condition can lead to permanent vision loss. If you are allergic to penicillin or sulfonamides, you may have a higher risk of developing a choroidal effusion.
• if you are dehydrated;
• if you are taking any of the following medicines used to treat high blood pressure: o an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes. o Aliskiren. Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also what is reported under “Do not take Acesistem”;
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is greater:

o sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (used
to prevent rejection of transplanted organs);

• if you are going to undergo treatment to reduce the effects of an allergy to bee or wasp stings (desensitization treatment);
• if you are going to undergo treatment to remove cholesterol from the blood by means of machines (low-density lipoprotein-LDL apheresis);
• if you are going to undergo surgery or anesthesia. The anesthesiologist must be informed that you are being treated with Acesistem;
• if you are going to undergo an examination to assess the function of the parathyroid glands (parathyroid function), because the treatment with Acesistem must be stopped before this examination.

Tell your doctor during treatment with Acesistem:

• if you have diabetes and notice episodes of hypoglycemia.
• if you develop allergic reactions that can manifest, for example, with swelling of the face, lips, mouth or throat. Black race patients have a higher risk of developing these reactions.
• have a dry, persistent cough as it may be due to one of the active ingredients contained in Acesistem.
• if you have symptoms of altered salt levels, e.g. dry mouth, thirst, weakness and muscle pain, muscle cramps, fatigue, restlessness, low blood pressure, increased heart rate, reduced urine output and stomach or intestinal disorders such as nausea and vomiting.
• if you have any signs of infection.

If you are a black race patient, it is important to know that medicines like Acesistem can
be less effective in lowering blood pressure.

Children and adolescents
Acesistem should not be given to children and adolescents.

Other medicines and Acesistem
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking or are going to take the following medicines:

• other medicines to lower blood pressure because they can further reduce blood pressure
• diuretics (medicines that increase the amount of water and salts eliminated through the kidneys) e.g. furosemide
• nitroglycerin, other nitrates and medicines that act by dilating blood vessels (vasodilators)
• medicines used to treat heart rhythm disturbances, for example: o quinidine o procainamide o amiodarone o sotalol
• medicines against depression (antidepressants)
• medicines used in severe mental disorders (antipsychotics)
• medicines used for anesthesia
• barbiturates (medicine for epilepsy)
• medicines for diabetes e.g. insulin and other oral medicines
• medicines that retain potassium or that can increase potassium levels: o potassium supplements o salt substitutes containing potassium o medicines to lower blood pressure called potassium-sparing diuretics e.g. amiloride, eplerenone, triamterene, spironolactone o heparin o cotrimoxazole also known as trimethoprim/sulfamethoxazole)
• lithium (medicine for mood disorders)
• non-steroidal anti-inflammatory drugs e.g. acetylsalicylic acid
• cholestyramine and colestipol (medicines to reduce cholesterol in the blood)
• corticosteroids, adrenocorticotropic hormone (hormonal medicines)
• noradrenaline
• medicines that relax muscles e.g. tubocurarine
• medicines against tumors e.g. cyclophosphamide, methotrexate
• medicines that act on the heart (digitalis glycosides e.g. digitalis)
• laxatives
• carbenoxolone (medicine for ulcers)
• sodium aurothiomalate, used in gold therapy and administered by injection
• opioid analgesics (medicines used to reduce pain)
• medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

Your doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also what is reported under “Do not take Acesistem” and “Warnings and precautions”).

Acesistem with food, drinks and alcohol
Do not drink alcohol during treatment with Acesistem, as a sharp drop in
blood pressure may occur, especially when getting up (orthostatic hypotension).
Most people take Acesistem with a glass of water.

Pregnancy and breastfeeding
If you are pregnant, suspect you might be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Acesistem is not recommended in early pregnancy, and should not be taken if you are pregnant for
more than three months, as it can cause serious harm to the baby if taken during this
period. Tell your doctor if you think you might be pregnant or are planning to become pregnant because
they will prescribe you another medicine instead of Acesistem.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Acesistem is not
recommended during breastfeeding, unless your doctor considers it strictly necessary.
If you wish to breastfeed, your doctor may prescribe you another treatment instead of
Acesistem.

Driving and using machines
Acesistem can cause dizziness and fatigue, be particularly careful if you are driving vehicles or
using machines.

Acesistem contains lactose (a sugar from milk)
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.
Acesistem contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still
result in a positive doping test.

3. How to take Acesistem

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The doctor will establish the appropriate dose of Acesistem, based on your condition and any other medicines you
are taking. It is very important that you continue to take Acesistem for the entire time that your doctor has
told you, because this will keep your blood pressure under control. Do not take more
tablets than those prescribed by your doctor.
The recommended initial dose of treatment is half a tablet a day.
The usual dose is 1 tablet a day, if necessary your doctor may then tell you to increase the dose to
2 tablets a day, in a single administration.
Most people take this medicine with a glass of water.
If you are being treated with a diuretic, your doctor will tell you to stop it a few days before starting
treatment with Acesistem. If this is not possible, your doctor will assess whether to start therapy with
Acesistem with lower doses.

Use in patients with kidney problems
The use of Acesistem is not recommended for patients with kidney problems (renal insufficiency).

If you take more Acesistem than you should
In case of accidental ingestion of an excessive dose of Acesistem, immediately inform your
doctor or go to the nearest hospital.
If you (or someone else) have taken an excessive dose of this medicine, the following symptoms may occur:

• excessive lowering of blood pressure (marked hypotension, associated with blockade of the renin-angiotensin system);
• dizziness;
• serious circulation problems (circulatory shock);
• alteration of blood salt levels (electrolyte disturbances such as hypokalaemia, hypochloraemia, hyponatraemia);
• serious kidney problems (renal insufficiency);
• increased breathing rate (hyperventilation);
• increase or decrease in heartbeats (tachycardia, bradycardia);
• increased awareness of heartbeats (palpitations);
• vertigo;
• anxiety;
• cough;
• loss of fluids (dehydration), due to excessive elimination of urine (diuresis).

If you forget to take Acesistem
Do not take a double dose to make up for forgetting the tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you stop taking Acesistem
Do not stop treatment with this medicine unless your doctor tells you to.
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.

Stop treatment with Acesistem and contact your doctor immediately if you develop:

• swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing
• swelling of the hands, feet or ankles
• urticaria (hives)

Very common (may affect more than 1 in 10 people)

• Blurred vision
• Dizziness
• Cough
• Nausea
• Muscle weakness

Common (may affect up to 1 in 10 people)

• Diarrhoea, abdominal pain
• Muscle cramps
• Headache
• Fatigue
• Depression
• Fainting
• Decrease or increase in blood potassium levels
• Increased cholesterol and fats (triglycerides) in the blood
• Increases in uric acid levels in the blood
• Changes in taste
• Reduced blood pressure, especially when getting up
• Heart rhythm disturbances
• Chest pain (angina pectoris)
• Chest discomfort
• Difficulty breathing
• Skin rashes, allergic reactions
• Swelling of the face, tongue, lips and extremities
• Increased creatinine levels in the blood

Uncommon (may affect up to 1 in 100 people)

• Anaemia
• Reduced magnesium levels in the blood
• Hot flushes
• Gout
• Joint pain
• Tinnitus (ringing in the ears)
• Reduced blood sugar levels
• Nervousness, confusion, insomnia, drowsiness
• Altered sensation of the limbs or other parts of the body (paraesthesia)
• Vertigo
• Heart attack, palpitations
• Stroke (TIA, "mini-stroke")
• Sore throat, altered voice (hoarseness), runny nose, asthma
• Inflammation of the pancreas (pancreatitis), vomiting, difficulty digesting, constipation, loss of appetite, irritation of the stomach, dry mouth, stomach lesions (peptic ulcer), excess gas in the stomach or intestines (flatulence)
• Altered intestinal motility (ileus)
• Urticaria, itching, sweating
• Hair loss
• Impaired kidney function, including kidney failure, accumulation in the blood of substances that should be eliminated through the kidneys (uraemia), presence of protein in the urine
• Reduced sodium levels in the blood
• Decreased libido, impotence
• General feeling of being unwell (malaise), fever

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

• Reduced white blood cells
• Reduced number of platelets in the blood
• Reduced number of all blood cells (pancytopenia)
• Bone marrow suppression, i.e. a decrease in the number of blood cells caused by a malfunction of the system that produces blood cells
• Enlarged lymph nodes
• Immune system diseases (autoimmune diseases)
• Decreased levels of cells in the blood (haematocrit) and haemoglobin levels
• Increased blood sugar levels
• Abnormal dreams, sleep disorders
• Partial loss of voluntary muscle movement and sensation
• Poor blood circulation in the extremities (Raynaud's phenomenon)
• Lung problems, including pneumonia, fluid in the lungs (causing difficulty breathing), allergic alveolitis, common cold
• Inflammation of the oral mucosa, mouth ulcers and sores, inflammation of the tongue
• Liver problems including liver failure, inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), inflammation of the gallbladder and death of liver cells which can be potentially fatal
• Increased levels of liver enzymes (sign of liver damage)
• Increased levels of bilirubin
• Severe allergic reactions with high fever, appearance of red patches on the skin (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, purpura), severe rash with loss of skin and hair (exfoliative dermatitis), cutaneous lupus erythematosus, rash with scaling (erythrodermia), appearance of small blisters filled with fluid on the skin (pemphigus)
• Reduced urine output (oliguria)
• Acute kidney inflammation (interstitial nephritis)
• Breast enlargement in males (gynaecomastia)

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

• Increased calcium levels (hypercalcaemia)
• Swelling due to accumulation of fluid in the intestine (intestinal angioedema).

Not known (frequency cannot be estimated from available data)

• Syndrome due to an abnormal secretion of the antidiuretic hormone (SIADH)
• Skin and lip cancer (non-melanoma skin cancer)
• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)

Other possible side effects
A complex of symptoms that may include:
o fever
o inflammation of a particular type of membrane lining some organs (serositis)
o inflammation of blood vessels
o pain in muscles, joints and bones
o elevated ESR (visible in blood tests)
o increased number of specific types of white blood cells in the blood (eosinophilia, leucocytosis)
o reactions at the skin level including reactions of the skin to sunlight

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. 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 Acesistem

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date that is stated on the packaging after “Scad.”. 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 Acesistem contains

• The active ingredients are enalapril maleate and hydrochlorothiazide. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
• The other ingredients are sodium bicarbonate, lactose monohydrate, yellow iron oxide, corn starch, pregelatinized starch, magnesium stearate.

Description of the appearance of Acesistem and contents of the pack
Each pack contains a blister of 14 or 28 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
Alfasigma S.p.A - Via Pontina km 30,400 – 00071 Pomezia (RM)

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