ELEKTRA 20 mg /12.5 Mg Coated Tablet

Зміст інструкції

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

ELEKTRA 20 mg/12,5 mg tablets

Enalapril maleate/Hydrochlorothiazide
Generic medicine

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 because it may be harmful.
If you get any side effects, even those not listed in this leaflet, speak to your doctor or
pharmacist. See section 4.

Contents of this leaflet:

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

1. What Elektra is and what it is used for

Elektra is used to treat high blood pressure (essential hypertension). This medicine
contains two active ingredients: enalapril andhydrochlorothiazide.

• Enalapril belongs to a group of medicines called angiotensin converting enzyme inhibitors (ACE inhibitors). ACE inhibitors work by relaxing the blood vessels, making it easier for blood to flow through them. ACE inhibitors are used to treat high blood pressure (hypertension).
• Hydrochlorothiazide belongs to a group of medicines called diuretics (medicinal products with a diuretic effect). Diuretics help the kidneys to produce more urine. They are used to treat high blood pressure (hypertension).

ELEKTRA is indicated in patients whose blood pressure is not adequately controlled
with enalapril or hydrochlorothiazide when administered alone. It is therefore advisable to use
other medicines containing only one active ingredient first.

2. What you need to know before taking Elektra

DO NOT take Elektra
if you are allergic to
enalapril maleate,
hydrochlorothiazide,
other sulfonamides (chemically related to hydrochlorothiazide),
or to any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced angioedema (allergic reaction with symptoms such as
swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing) in
connection with a previous treatment with any other ACE inhibitor or for
any other more or less known cause;
if a relative of yours has had angioedema (as there is a possibility of familial predisposition);
if you have severe kidney problems and/or need dialysis;
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;
if you suffer from anuria (a condition in which less than 100 ml of urine is produced in 24 hours);
if you suffer from severe liver problems;
if you are pregnant for more than three months (ELEKTRA is not recommended even at the beginning of pregnancy –
see section Pregnancy);
if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of
long-term (chronic) heart failure in adults, as this increases the risk of
angioedema (rapid swelling under the skin in areas such as the throat).

Warnings and precautions
Talk to your doctor before taking ELEKTRA:
if you are at risk of excessive drop in blood pressure due to depletion of water and salts, for
example if you are taking a medicine that increases urine output (diuretic tablets), or are following a low-sodium diet or after severe or prolonged diarrhea
or vomiting;
in case of narrowing of the heart valves of your left ventricle or if
there are other obstructions to the flow from the left ventricle;
if you suffer from heart disease with disturbances in blood flow to the coronary arteries
(coronary heart disease);
if you suffer from disturbances in blood flow to the brain (cerebrovascular disease);
if your kidney function is moderately impaired;
if you suffer from narrowing of the renal arteries;
if you have recently undergone a kidney transplant;
if liver enzyme levels increase or if you develop jaundice;
if there is a decrease in the number of white blood cells (leukopenia) or a significant decrease in a certain type of white blood cells sensitive to infections and you develop severe general symptoms (agranulocytosis);
if you suffer from a certain connective tissue disease (collagenopathy) involving the
blood vessels;
if you are being treated with medicines that suppress your immune response;
if you are taking allopurinol (medicine for the treatment of gout) or procainamide
(medicine for the treatment of heart rhythm disorders);
if you suffer from diabetes;
if you suffer from gout;
if you suffer from a dry, persistent cough;
if you are at risk of increased blood potassium levels;
if, depending on your ethnic background, the lowering of blood pressure is not sufficiently strong (especially in patients belonging to the
black population);
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 ELEKTRA;
if you are taking any of the following medicines, the risk of angioedema (rapid
swelling under the skin in areas such as the throat) may be increased:

• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent organ rejection and to treat cancer (such as temsirolimus, sirolimus, everolimus),
• vildagliptin, a medicine used to treat diabetes; if you are taking any of the following medicines used to treat high blood pressure:
• an “angiotensin II receptor blocker” (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• 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 stated under "Do not take ELEKTRA”.
Tell your doctor if you think you might be pregnant (or could become pregnant). ELEKTRA is not recommended
at the beginning of pregnancy, and must not be taken if you are pregnant for more than 3 months, as it may
cause serious harm to the baby if used at that stage (see section Pregnancy).
Tell your doctor immediatelyif you experience any of the following symptoms:
swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing
yellowing of the skin and mucous membranes
fever, swollen lymph nodes and/or sore throat.
In these cases, stop taking ELEKTRA. The doctor will take the necessary measures.
Symptoms such as dry mouth, thirst, weakness, lethargy, muscle pain or cramps, rapid pulse, dizziness, nausea, vomiting and decreased urine production may be indicative of
a water-electrolyte imbalance. In this case, inform your doctor.
If you need to undergo desensitization to insect venom (e.g. bees or wasps), the
doctor must temporarily replace ELEKTRA with a suitable medicine belonging to
another class of medicines. Otherwise, hypersensitivity reactions with
risk of death (e.g. low blood pressure, difficulty breathing, vomiting, allergic skin reactions) may occur. These reactions can occur even after being stung by insects
(e.g. bees or wasps).
Symptoms such as facial flushing, feeling unwell and discomfort may develop if you are
being treated with gold by injection during treatment with ELEKTRA.
If, during treatment, you undergo dialysis using a certain type of dialysis membranes
(high-flux membranes) or undergo a special technique to remove fat from
the blood (LDL apheresis with dextran sulfate absorption) it is
possible that severe hypersensitivity reactions up to shock that can endanger your life occur.
Before undergoing dialysis or hemofiltration or LDL apheresis, your doctor must
prescribe you another suitable medicine - which is not an ACE inhibitor - or use a
different type of dialysis membrane. Tell your doctor that you are taking ELEKTRA or inform him
that you are a dialysis patient, so that he can take this into account during treatment.
If you are about to undergo surgery or anesthesia (even from a dentist)
tell your doctor that you are taking Elektra as a sudden drop in
pressure may occur during anesthesia.
The use of this medicine must take place under regular medical supervision. Therefore, strictly follow the tests and laboratory checks as prescribed by your doctor.

Anti-doping tests
Hydrochlorothiazide contained in the medicine may result in positive anti-doping tests.
For athletes: the use of the medicine without therapeutic need constitutes doping
and may still result in positive anti-doping tests.
The use of Elektra is not recommended simultaneously with lithium (medicine for the treatment
of psychiatric diseases).

Other medicines and ELEKTRA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
You must inform your doctor and use extreme caution if you are using any of the following
medicines:
other medicines that lower blood pressure (antihypertensives), including vasodilators,
beta-blockers, renin inhibitors (e.g. aliskiren).
The doctor may need to adjust the dose and/or take other precautions:
If you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also
"Do not take ELEKTRA" and "Warnings and precautions");
diuretics (dehydrating medicines, diuretics), loop and thiazide diuretics;
potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g.
spironolactone, triamterene, amiloride) and other medicines that may increase the
amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating
bacterial infections; cyclosporine, an immunosuppressant used to
prevent organ rejection; and heparin, a medicine used to thin the
blood);
lithium and other medicines for the treatment of mental illnesses (antipsychotic drugs) or for
treating depression (tricyclic antidepressants);
non-steroidal anti-inflammatory drugs (NSAIDs) often used as painkillers or to reduce
inflammation such as acetylsalicylic acid, indomethacin and naproxen;
carbenoxolone (another anti-inflammatory medicine);
medicines for the treatment of gout (e.g. allopurinol, benzbromarone);
immunosuppressants, which reduce the activity of the immune system, such as cyclosporine (for
preventing organ rejection);
amphotericin B (for treating fungal infections);
certain anti-cancer medicines (e.g. cyclophosphamide, fluorouracil, methotrexate);
antidiabetic medicines, including insulin and oral medicines to reduce blood sugar
levels;
calcium and vitamin D;
medicines for the treatment of heart failure (impairment of the heart's ability to
pump a sufficient amount of blood through the body: cardiac glycosides, such as
digoxin) or for treating irregular heartbeat (antiarrhythmics, such as procainamide,
quinidine, amiodarone, sotalol);
corticosteroids or corticotropin (ACTH) for treating inflammation such as rheumatism;
iodinated contrast agents (substances administered to perform some types of radiological examinations;
your doctor will be informed);
medicines that reduce the production of prostaglandins (groups of fatty acids that play
important functions throughout the body);
anesthetics (e.g. barbiturates);
muscle relaxants (medicines administered during surgical operations; your anesthesiologist will be informed);
narcotics and narcotic analgesics (e.g. opioids);
pressor amines (medicines with potent stimulating effects such as adrenaline);
stimulant laxatives (laxatives that act on the intestinal muscles, such as senna);
sympathomimetics (medicines with a stimulating effect used, for example, to treat asthma);
cholestyramine and colestipol, resins (medicines used to lower cholesterol levels in
the blood). Cholestyramine and colestipol resins reduce the intestinal absorption of the
hydrochlorothiazide component of Elektra. Do not take Elektra one hour before and 4-6 hours
after taking these medicines;
drugs commonly used to prevent organ rejection (sirolimus, everolimus and
other drugs belonging to the class of mTOR inhibitors). See section “Warnings and
precautions”.
Alcohol increases the hypotensive effects of ELEKTRA.
Blood tests and other tests
Hydrochlorothiazide (contained in ELEKTRA) may interfere with the bentiroxide test (a test for
establishing the degree of pancreatic function).
Thiazides can cause a decrease in serum PBI (iodine that binds to proteins). Iodine is
important for the correct functioning of the thyroid but no signs of thyroid problems develop.

Elektra with food, drinks and alcohol
ELEKTRA can be taken with or without food.
Avoid excessive use of table salt (sodium chloride) as the effect of ELEKTRA may decrease.
Consult your doctor before using food supplements or salt substitutes containing potassium.
Alcohol increases the hypotensive effects of ELEKTRA. If you drink alcohol while taking ELEKTRA, a drop in pressure may occur when getting up.

Pregnancy and breastfeeding
Talk to your doctor or pharmacist before taking any medicine.

Pregnancy
Tell your doctor if you think you might be pregnant (or could become pregnant). Your doctor will normally advise you to stop taking ELEKTRA before becoming pregnant or as soon as you find out you are
pregnant and will advise you to take another medicine instead of ELEKTRA. ELEKTRA is not
recommended during pregnancy, and must not be taken if you are pregnant for more than 3 months, as it may
cause serious harm to the baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or regarding the start of breastfeeding.
ELEKTRA is not recommended for mothers who are breastfeeding.

Driving and using machines
Be aware that some possible side effects (see section 4 below) may
impair your ability to drive or operate machinery, especially at the beginning of treatment
or when the dose is increased. Some patients may experience fatigue (tiredness) and
dizziness (feeling dizzy) while taking ELEKTRA. If you notice these symptoms, do not
drive vehicles or operate machinery.

ELEKTRA contains lactose (milk sugar) and sodium
If your doctor has diagnosed you with intolerance to some sugars, contact them before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Elektra

Take this medicine exactly as your doctor has told you. If you have any doubts
consult your doctor or pharmacist.
This medicine can be used as a substitute for treatment with enalapril and hydrochlorothiazide
taken separately.

Dosage
Your doctor will decide how much ELEKTRA you need to take. After starting treatment, the dosage may
be increased or reduced depending on changes in your blood pressure values.
Adults
The usual dose is one tablet a day.
If you have kidney disease, your doctor will carefully monitor the dosage of ELEKTRA. The lowest possible
dose of ELEKTRA will be used and your doctor will monitor your kidney function. Your doctor will not prescribe
ELEKTRA if you suffer from a severe kidney disease (See also paragraph 2 “Do not take Elektra”).
If you are taking another dehydrating medicine (diuretic, medicine that promotes diuresis)
before starting treatment with ELEKTRA, your doctor will ask you to stop taking the
diuretic 2-3 days before starting treatment with ELEKTRA.
Use in children
The safety and efficacy of ELEKTRA have not been established in children. ELEKTRA should not be
given to children.
Elderly patients
The efficacy of treatment with enalapril and hydrochlorothiazide in clinical studies has been shown to be
as good in elderly patients as in younger patients. Elderly patients also tolerate
treatment with ELEKTRA equally well. Kidney function usually decreases with age; in
this case the recommended initial dose is half a tablet once a day.

Method of administration
The tablet can be divided into equal doses.

If you take more Elektra than you should
Contact your doctor or go to the nearest Emergency Room. Remember to bring the package with you,
severe hypotension (low blood pressure) and mental torpor (low level
of consciousness, without being completely unconscious) and other serious disorders may occur (See also
paragraph 4 “Possible side effects”).

If you forget to take Elektra
If you forget to take a tablet, take the next one at the scheduled time and continue the
treatment as before. Do not take a double dose (or a higher dose) to make up for the
forgotten dose(s). Ask your pharmacist for more information or advice.

If you stop taking Elektra
Do not stop taking ELEKTRA without first consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking ELEKTRA and consult your doctor immediately if you experience symptoms of angioedema during therapy, such as:
swelling of the face, tongue or throat
difficulty swallowing
urticaria and difficulty breathing
ELEKTRA may cause a decrease in the number of white blood cells (agranulocytosis) or other
blood cells that help defend the body against bacteria (neutropenia). This may
decrease your resistance to infections. Contact your doctor immediately
if you develop an infection with symptoms such as fever and a severe worsening of your
general condition, or fever with symptoms of a local infection such as sore
throat/pharyngitis/ulcerations in the oral cavity or urinary tract problems. A blood test may
be useful to check for a possible decrease in white blood cells (agranulocytosis). It is important
to inform your doctor about the treatment with ELEKTRA.
ELEKTRA contains two active ingredients: enalapril and hydrochlorothiazide. Therefore, ELEKTRA may cause
side effects mainly associated with the active ingredient enalapril or more associated with the active
ingredient hydrochlorothiazide.

Very common (may affect more than 1 in 10 people):
dizziness;
blurred vision;
cough;
feeling unwell;
general weakness.

Common (may affect up to 1 in 10 people):
blood changes: an increase/decrease in potassium
levels (hyperkalemia/hypokalemia) or creatinine, increased levels of cholesterol and triglycerides (fatty
acids), an increase in uric acid levels in the blood;
fainting (syncope), fatigue, depression;
headache;
altered sense of taste;
low blood pressure (hypotension) including postural hypotension, which occurs when a person gets up
and manifests with symptoms such as dizziness or fainting (orthostatic hypotension);
irregular or fast heartbeat (tachycardia);
chest pain due to lack of blood and therefore oxygen supply to the heart muscle (angina pectoris);
shortness of breath;
diarrhea;
abdominal pain;
skin rash;
hypersensitivity (allergic) reactions and angioedema;
muscle cramps;
chest pain.

Uncommon (may affect up to 1 in 100 people):
blood changes: decrease in the number of red blood cells (aplastic and hemolytic anemia),
low levels of sodium (hyponatremia) or sugar (hypoglycemia) and magnesium
(hypomagnesemia), increased levels of urea;
joint swelling (gout);
confusion, drowsiness, difficulty falling asleep (insomnia), nervousness;
pins and needles sensation (paresthesia);
sense of spinning (vertigo);
decreased libido;
ringing in the ears (tinnitus);
facial flushing/hot flashes
awareness of heartbeat (palpitations);
heart attack (myocardial infarction) and/or stroke (cerebrovascular accident), possibly
secondary to a drastic drop in blood pressure;
runny nose (rhinorrhea);
sore throat and hoarseness;
asthma/bronchospasm (chest tightness that makes breathing difficult and noisy);
reduced bowel movements (ileus);
inflammation of the pancreas (pancreatitis);
vomiting and/or acidic indigestion (dyspepsia);
constipation;
loss of appetite (anorexia);
stomach irritation and/or gastric ulcer;
dry mouth;
gas emission (flatulence);
abnormal sweating (diaphoresis);
itching (pruritus) or urticaria;
hair loss (alopecia);
joint pain;
impaired kidney function or kidney failure;
protein in the urine (proteinuria);
impotence;
feeling unwell;
fever;
muscle spasms.

Rare (may affect up to 1 in 1,000 people):
decrease in the number of a certain type of white blood cells (neutropenia, leucopenia and agranulocytosis),
amount of hemoglobin, total volume of red blood cells (low hematocrit), platelets (thrombocytopenia) or all different types of blood cells (pancytopenia);
bone marrow suppression (when the bone marrow fails to produce a sufficient
number of cells found in the blood);
swelling of the glands (lymphadenopathy);
diseases due to immunity to part of the body (autoimmune diseases);
increased blood sugar;
abnormal dreams and/or sleep disturbances;
inability to move (paresis);
Raynaud's syndrome (symptoms affecting the hand);
radiological changes in the lungs (pulmonary infiltrates);
allergic (hypersensitivity) reaction in the lungs (allergic alveolitis) or eosinophilic pneumonia
(a lung disease);
rhinitis (inflammation of the nose);
serious lung problems (including inflammation and fluid accumulation in the lungs);
inflammation of the mucous membranes (stomatitis) or ulcerations in the oral cavity;
inflammation of the tongue (glossitis);
impaired liver function; liver damage (hepatic necrosis);
increased liver enzymes (blood test that studies liver function) or
bilirubin levels in the blood;
liver disease (hepatitis; which may be associated with jaundice (yellowing of the skin));
abnormal bile secretion from the liver, including jaundice;
inflammation of the gallbladder (especially in patients with gallstones);
serious skin diseases with blister formation, redness and scaling, including
erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal
necrosis, purpura, cutaneous lupus erythematosus (an autoimmune disease that causes
skin inflammation), pemphigus and erythrodermia (redness of the skin);
decreased urine output (oliguria);
interstitial nephritis (kidney disease);
breast enlargement in men (gynecomastia);
a group of symptoms that include some or all of the following: fever, serositis
(inflammation of the membranes lining the body cavities, such as the chest and
abdomen), vasculitis (inflammation of blood vessels), muscle pain or inflammation of
the muscles, pain or inflammation of the joints, changes in blood tests (positive ANA antibodies, increased erythrocyte sedimentation rate ([ESR]), increased
number of white blood cells (eosinophilia, leucocytosis), skin rash, sensitivity to light
(photosensitivity) and other skin problems.

Very rare (may affect up to 1 in 10,000 people):
swelling of the intestinal mucosa (intestinal angioedema);
increased calcium levels in the blood.

Not known (frequency cannot be estimated from available data):
syndrome of inappropriate secretion of antidiuretic hormone (excessive release of a hormone
that can cause headache, nausea and malaise);
sialoadenitis (inflammation of the salivary glands);
inflammation of blood vessels (necrotizing angiitis, vasculitis, cutaneous vasculitis);
anaphylactic reactions (severe allergic/hypersensitivity reactions);
restlessness, mild mental confusion;
yellow vision;
presence of sugar in the urine (glycosuria);
skin cancer and lip cancer (non-melanoma skin cancer).
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 Elektra

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 and on the blister
after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What contains ELEKTRA 20 mg/12.5 mg tablets
The active ingredients are enalapril and hydrochlorothiazide.
Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
The other ingredients are:
lactose monohydrate
corn starch
pregelatinized starch
talc
sodium bicarbonate
magnesium stearate

Description of the appearance of ELEKTRA 20 mg/12.5 mg tablets and contents of the pack
Round, white, flat tablets with beveled edges and with a notch on one side.
ELEKTRA is available in blisters (Aluminum/OPA/PVC laminates) containing 10, 14, 20, 28, 30, 50, 56,
60, 90, 98, 100, 200 and 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan

Distributor
S.F. Group S.r.l., Via Tiburtina, 1143 – 00156 Rome

Manufacturer
STADA ARZNEIMITTEL AG Stadastrasse 2-18 D-61118 Bad Vilbel (Germany)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark: Lirpalane
Germany: Enaplus AL 20 mg/12.5 mg Tablets
Italy: Elektra 20 mg/12.5 mg Tablets