Package leaflet: Information for the user

ELEKTRA 20 mg/12.5 mg tablets

Enalapril maleate/Hydrochlorothiazide
Generic medicine
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 further 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 side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

What ELEKTRA is and what it is used for
What you need to know before you take ELEKTRA
How to take ELEKTRA
Possible side effects
How to store ELEKTRA
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 substances: enalapril and hydrochlorothiazide.

Enalapril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). ACE inhibitors work by relaxing blood vessels, thereby 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 produce more urine. They are used to treat high blood pressure (hypertension).

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

2. What you should know before taking Elektra

Do NOT take Elektra
if you are allergic to:
enalapril maleate,
hydrochlorothiazide,
other sulfonamide-derived drugs (chemically related to hydrochlorothiazide),
or any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced angioedema (an allergic reaction with symptoms such as
swelling of the face, tongue or throat, difficulty swallowing, hives and breathing difficulties)
associated with prior treatment with any other ACE inhibitor or for any other partially or fully known reason;
if a close relative has had angioedema (as familial predisposition is possible);
if you suffer from severe kidney problems and/or require dialysis;
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 more than three months pregnant (ELEKTRA is not recommended even in early pregnancy –
see section Pregnancy);
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, e.g. in 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 salt and water, for example if you are taking a medicine that increases urine output (diuretics), are on a low-sodium diet, or have had severe or prolonged diarrhoea or vomiting;
if you have narrowing of the heart valves of your left ventricle or other obstructions to blood flow from the left ventricle;
if you suffer from heart disease with impaired blood flow in the coronary arteries (coronary heart disease);
if you suffer from impaired blood flow to the brain (cerebrovascular disease);
if your kidney function is moderately impaired;
if you have narrowing of the renal arteries;
if you have recently undergone a kidney transplant;
if your liver enzyme levels increase or if you develop jaundice;
if you experience a decrease in white blood cells (leucopenia) or a significant drop in a certain type of white blood cells sensitive to infections and develop severe general symptoms (agranulocytosis);
if you suffer from a connective tissue disease (collagenosis) involving blood vessels;
if you are being treated with medicines that suppress your immune response;
if you are taking allopurinol (a medicine used to treat gout) or procainamide (a medicine used to treat heart rhythm disorders);
if you suffer from diabetes;
if you suffer from gout;
if you have a persistent dry cough;
if you are at risk of increased blood potassium levels;
if, due to your ethnic background, blood pressure reduction is insufficient (especially in patients of African descent);
if you have previously had skin cancer or develop unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV radiation while taking ELEKTRA;
if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, e.g. in the throat) may be increased:

racecadotril, a medicine used to treat diarrhoea,
medicines used to prevent rejection of transplanted organs 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 antagonist” (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the section “Do NOT take ELEKTRA”.
Inform your doctor if you think you are pregnant (or could become pregnant). ELEKTRA is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if used at this stage (see section Pregnancy).
Inform your doctor immediately if any of the following symptoms occur:
swelling of the face, tongue or throat, difficulty swallowing, hives and breathing difficulties,
yellowing of the skin and mucous membranes,
fever, swollen lymph nodes and/or sore throat.
In such cases, stop taking ELEKTRA. Your doctor will take the necessary measures.
Symptoms such as dry mouth, thirst, weakness, lethargy, muscle pain or cramps, rapid heartbeat, dizziness, nausea, vomiting and reduced urine output may indicate a disturbance in salt and water balance. Inform your doctor if you experience any of these.
If you need to undergo desensitisation to insect venom (e.g. from bees or wasps), your doctor must temporarily replace ELEKTRA with a suitable medicine from another drug class. Otherwise, severe hypersensitivity reactions with life-threatening risk (e.g. drop in blood pressure, difficulty breathing, vomiting, allergic skin reactions) may occur. These reactions may also occur after being stung by insects (e.g. bees or wasps).
Symptoms such as facial flushing, malaise and discomfort may occur if you are receiving injectable gold therapy during treatment with ELEKTRA.
If, during treatment, you undergo dialysis using certain types of dialysis membranes (high-flux membranes) or undergo a special technique to remove fats from the blood (low-density lipoprotein (LDL) apheresis with dextran sulfate absorption), severe hypersensitivity reactions up to shock, which may be life-threatening, may occur.
Before undergoing dialysis, haemofiltration or LDL apheresis, your doctor must prescribe a suitable alternative medicine – not an ACE inhibitor – or use a different type of dialysis membrane. Inform your doctor that you are taking ELEKTRA or tell him/her that you are a dialysis patient so that this can be taken into account during treatment.
If you are about to undergo surgery or anaesthesia (even from a dentist!), inform your doctor that you are taking Elektra, as a sudden drop in blood pressure may occur during anaesthesia.
This medicine should be used under regular medical supervision. Therefore, strictly follow all laboratory tests and check-ups as prescribed by your doctor.

Anti-doping tests
The hydrochlorothiazide contained in this medicine may lead to positive results in anti-doping tests.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test regardless.

Concomitant use of Elektra with lithium (a medicine used to treat psychiatric conditions) is not recommended.

Other medicines and ELEKTRA
Inform 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 taking any of the following medicines:
other medicines that lower blood pressure (antihypertensives), including vasodilators, beta-blockers, renin inhibitors (e.g. aliskiren).
Your doctor may consider it necessary to adjust the dose and/or take other precautions:
if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also section “Do NOT take ELEKTRA” and “Warnings and precautions”);
diuretics (dehydrating medicines, diuretics), loop diuretics and thiazide diuretics;
potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride) and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clot formation);
lithium and other medicines used to treat psychiatric disorders (antipsychotics) or 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 used to treat gout (e.g. allopurinol, benzbromarone);
immunosuppressants, which reduce the activity of the immune system, such as cyclosporine (to prevent rejection of a transplanted organ);
amphotericin B (to treat fungal infections);
certain anticancer medicines (e.g. cyclophosphamide, fluorouracil, methotrexate);
antidiabetic medicines, including insulin and oral medicines to lower blood sugar levels;
calcium and vitamin D;
medicines to treat heart failure (impaired ability of the heart to pump sufficient blood through the body: cardiac glycosides such as digoxin) or to treat irregular heartbeat (antiarrhythmics such as procainamide, quinidine, amiodarone, sotalol);
corticosteroids or corticotropin (ACTH) to treat inflammation such as rheumatism;
iodinated contrast agents (substances administered for certain types of radiological examinations; your doctor will be informed);
medicines that reduce prostaglandin production (a group of fatty acids that play important roles throughout the body);
anaesthetics (e.g. barbiturates);
muscle relaxants (medicines administered during surgical procedures; your anaesthetist will be informed);
narcotics and narcotic analgesics (e.g. opioids);
vasopressor amines (medicines with strong stimulating effects such as adrenaline);
stimulant laxatives (laxatives acting on intestinal muscles, such as senna);
sympathomimetics (stimulant medicines used, for example, to treat asthma);
cholestyramine and colestipol resins (medicines used to lower blood cholesterol levels). Cholestyramine and colestipol resins reduce the intestinal absorption of the hydrochlorothiazide component of Elektra. Do not take Elektra within one hour before or 4–6 hours after taking these medicines;
medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other mTOR inhibitors). See section “Warnings and precautions”.

Alcohol enhances the hypotensive effects of ELEKTRA.

Blood tests and other tests
Hydrochlorothiazide (contained in ELEKTRA) may interfere with the bentiromide test (a test to assess pancreatic function).
Thiazides may cause a decrease in serum PBI (protein-bound iodine). Iodine is important for proper thyroid function, but no signs of thyroid problems develop.

ELEKTRA with food, drinks and alcohol
ELEKTRA may be taken with or without food.
Avoid excessive use of table salt (sodium chloride), as the effect of ELEKTRA may be reduced.
Consult your doctor before using potassium-containing dietary supplements or salt substitutes.
Alcohol enhances the hypotensive effects of ELEKTRA. If you consume alcohol during treatment with ELEKTRA, you may experience a drop in blood pressure upon standing.

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

Pregnancy
Inform your doctor if you think you are 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 recommend an alternative medicine. ELEKTRA is not recommended during pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if used after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or plan to start breastfeeding.
ELEKTRA is not recommended for breastfeeding mothers.

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 (a sensation of spinning) during treatment with ELEKTRA. If you experience these symptoms, do not drive or operate machinery.

ELEKTRA contains lactose (milk sugar) and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, consult him 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 directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This medicine may be used as a substitute for separate treatment with enalapril and hydrochlorothiazide.

Dosage
Your doctor will decide how much ELEKTRA you should take. After starting treatment, the dosage may be increased or decreased depending on changes in your blood pressure values.

Adults
The usual dose is one tablet daily.

If you have kidney disease, your doctor will carefully monitor your ELEKTRA dosage. 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 have severe kidney disease (see section 2 “Do NOT take Elektra”).

If you are taking another dehydrating medicine (diuretic, a medicine that increases urine production) before starting ELEKTRA treatment, your doctor may ask you to stop taking the diuretic 2–3 days before starting ELEKTRA.

Use in children
The safety and efficacy of ELEKTRA have not been established in children. ELEKTRA must not be given to children.

Elderly patients
The effectiveness of enalapril and hydrochlorothiazide treatment has been shown to be as good in elderly patients as in younger ones. Elderly patients also tolerate ELEKTRA treatment equally well. Kidney function usually decreases with age; in such cases, the recommended starting dose is half a tablet once daily.

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

If you take more Elektra than you should
Contact your doctor or go to the nearest Emergency Department immediately. Remember to bring the package, this leaflet, and any remaining tablets with you. If you take more tablets than you should, severe hypotension (low blood pressure) and mental stupor (reduced level of consciousness, without being completely unconscious) may occur, as well as other serious problems (see section 4 “Possible side effects”).

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

If you stop taking Elektra
Do not stop taking ELEKTRA without first consulting your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking ELEKTRA and contact your doctor immediately if, during treatment, you experience symptoms of angioedema, such as:

swelling of the face, tongue or throat
difficulty swallowing
hives and breathing difficulties

ELEKTRA may cause a reduction in the number of white blood cells (agranulocytosis) or other blood cells that help the body defend against bacteria (neutropenia). This may reduce your resistance to infections. Contact your doctor immediately if you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever accompanied by signs of local infection such as sore throat/pharyngitis/oral ulcers or urinary tract problems. A blood test may be useful to check for a possible reduction in white blood cells (agranulocytosis). It is important to inform your doctor that you are being treated with ELEKTRA.

ELEKTRA contains two active substances: enalapril and hydrochlorothiazide. Therefore, ELEKTRA may cause side effects mainly associated with the active substance enalapril or more commonly associated with the active substance hydrochlorothiazide.

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

dizziness
blurred vision
cough
malaise
general weakness

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

blood changes: increased/decreased potassium levels (hyperkalaemia/hypokalaemia) or creatinine, increased cholesterol and triglyceride (fatty acids) levels, increased blood uric acid levels
fainting (syncope), fatigue, depression
headache
altered taste sensation
low blood pressure (hypotension), including a drop in blood pressure upon standing, causing symptoms such as dizziness or fainting (orthostatic hypotension)
irregular or rapid heartbeat (tachycardia)
chest pain due to insufficient blood and oxygen supply to the heart muscle (angina pectoris)
shortness of breath
diarrhoea
abdominal pain
skin rash
hypersensitivity (allergic) reactions and angioedema
muscle cramps
chest pain

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

blood changes: decreased number of red blood cells (aplastic and haemolytic anaemia), low sodium (hyponatraemia), low blood sugar (hypoglycaemia) and low magnesium (hypomagnesaemia), increased urea levels
joint swelling (gout)
confusion, drowsiness, difficulty falling asleep (insomnia), nervousness
sensation of pins and needles (paraesthesia)
sensation of dizziness (vertigo)
reduced sexual desire
ringing in the ears (tinnitus)
facial flushing
awareness of heartbeat (palpitations)
heart attack (myocardial infarction) and/or stroke (cerebrovascular accident), possibly secondary to a sudden drop in blood pressure
runny nose (rhinorrhoea)
sore throat and hoarseness
asthma/bronchospasm (tightness in the chest making breathing difficult and noisy)
reduced intestinal movement (ileus)
inflammation of the pancreas (pancreatitis)
vomiting and/or acid indigestion (dyspepsia)
constipation
loss of appetite (anorexia)
stomach irritation and/or gastric ulcer
dry mouth
gas (flatulence)
abnormal sweating (diaphoresis)
itching (pruritus) or hives
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):

decreased number of certain types of white blood cells (neutropenia, leucopenia, agranulocytosis), reduced haemoglobin levels, low total red blood cell volume (low haematocrit), low platelet count (thrombocytopenia), or reduced levels of all types of blood cells (pancytopenia)
bone marrow depression (when the bone marrow fails to produce enough blood cells)
swollen glands (lymphadenopathy)
autoimmune diseases (diseases caused by immune reaction against parts of the body)
increased blood glucose levels
abnormal dreams and/or sleep disturbances
inability to move (paresis)
Raynaud's syndrome (symptoms affecting the hands)
radiological lung abnormalities (pulmonary infiltrates)
allergic reaction (hypersensitivity) in the lungs (allergic alveolitis) or eosinophilic pneumonia (a lung disease)
rhinitis (inflammation of the nose)
severe lung problems (including lung inflammation and fluid accumulation in the lungs)
inflammation of the mucous membranes (stomatitis) or oral ulcers
inflammation of the tongue (glossitis)
altered liver function; liver damage (hepatic necrosis)
increased liver enzymes (blood test assessing liver function) or increased blood bilirubin levels
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 (particularly in patients with gallstones)
severe skin diseases with blistering, redness and peeling, including erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, purpura, cutaneous lupus erythematosus (an autoimmune disease causing skin inflammation), pemphigus and erythroderma (skin redness)
decreased urine output (oliguria)
interstitial nephritis (kidney disease)
breast enlargement in men (gynaecomastia)
a group of symptoms including some or all of the following: fever, serositis (inflammation of the membranes lining body cavities such as chest and abdomen), vasculitis (inflammation of blood vessels), muscle pain or muscle inflammation, joint pain or joint inflammation, changes in blood tests (ANA-positive antibodies, increased erythrocyte sedimentation rate ([ESR]), increased white blood cell count (eosinophilia, leucocytosis)), skin rash, skin 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 the available data):

syndrome of inappropriate antidiuretic hormone secretion (excessive release of a hormone that may cause headache, nausea and malaise)
sialoadenitis (inflammation of the salivary glands)
inflammation of blood vessels (necrotizing angiitis, vasculitis, cutaneous vasculitis)
anaphylactic reactions (severe allergic reactions/hypersensitivity)
restlessness, mild mental confusion
yellow vision
presence of sugar in the urine (glucosuria)
skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects
If you experience any side effects, including those 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 Elektra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and 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 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 ELEKTRA 20 mg/12.5 mg tablets contain
The active substances are enalapril and hydrochlorothiazide.
Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
The other components are:
monohydrate lactose
corn starch
pregelatinized starch
talc
sodium bicarbonate
magnesium stearate

Description of the appearance of ELEKTRA 20 mg/12.5 mg tablets and package contents
White, round, flat tablets with bevelled edges and a score line on one side.
ELEKTRA is available in blisters (aluminum/OPA/PVC laminated) containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 200 and 250 tablets.
Not all pack sizes may be marketed.

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

Marketing Authorization Holder's Representative
S.F. Group S.r.l., Via Tiburtina, 1143 – 00156 Rome, Italy

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

This medicinal product is authorized in the European Economic Area Member States under the following names:
Denmark: Lirpalane
Germany: Enaplus AL 20 mg/12,5 mg Tabletten
Italy: Elektra 20 mg/12.5 mg Compresse