Enalapril and hydrochlorothiazide EG: detailed information

Package leaflet: Information for the user

Enalapril Hydrochlorothiazide EG 20 mg/12.5 mg tablets

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 pass it on to other people, even if their symptoms seem identical to yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Enalapril Hydrochlorothiazide EG is and what it is used for
What you need to know before taking Enalapril Hydrochlorothiazide EG
How to take Enalapril Hydrochlorothiazide EG
Possible side effects
How to store Enalapril Hydrochlorothiazide EG
Contents of the pack and other information

1. What Enalapril Hydrochlorothiazide EG is and what it is used for

Your doctor has prescribed Enalapril Hydrochlorothiazide EG for the treatment of hypertension (high blood pressure).
The enalapril component of Enalapril Hydrochlorothiazide EG is a medicine belonging to a group of drugs known as angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by widening blood vessels, making it easier for the heart to pump blood throughout the body. The hydrochlorothiazide component of Enalapril Hydrochlorothiazide EG is a medicine belonging to a group of drugs called diuretics (tablets that increase urine production), and it works by helping the kidneys remove more water and salt. Together, enalapril and hydrochlorothiazide help reduce high blood pressure.

2. What you need to know before taking Enalapril Hydrochlorothiazide EG

DO NOT take Enalapril Hydrochlorothiazide EG
if you are allergic to enalapril maleate, hydrochlorothiazide, or to any of the other ingredients of this
medicinal product (listed in section 6);
if you have previously been treated with a medicine from the same pharmacological group as this
medicinal product (ACE inhibitors) and experienced an allergic reaction involving swelling of the face,
lips, tongue, and/or throat with difficulty swallowing or breathing. You must not take this medicine if
such reactions have occurred without a known cause or if you have been diagnosed with hereditary or
idiopathic angioedema;
if you are allergic to any sulfonamide-derived medicines. Ask your doctor if you are unsure about what
sulfonamide-derived medicines are;
if you are not passing urine;
if you have severe kidney problems;
if you have diabetes or kidney problems and are taking medicines containing aliskiren to lower blood
pressure;
if you are more than three months pregnant (Enalapril Hydrochlorothiazide EG is not recommended even
in early pregnancy – see section Pregnancy);
if you have severe liver problems;
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of chronic
heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example
in the throat).
If you are unsure whether you should start taking this medicine, consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril Hydrochlorothiazide EG.
Inform your doctor about any medical conditions you currently have or have had in the past, and about any
allergies.
Tell your doctor if you have heart disease, blood disorders, liver problems, if you are undergoing dialysis,
if you are being treated with diuretics (tablets that increase urine production), or if you have recently had
excessive vomiting or diarrhoea. Also inform your doctor if you are on a low-sodium diet, taking potassium
supplements, potassium-sparing agents, potassium-containing salt substitutes, or other medicines that may
increase potassium levels in the blood (e.g. heparin [a medicine used to prevent blood clots], products
containing trimethoprim such as co-trimoxazole [medicines used to treat infections]), if you are over 70 years
old, or if you have diabetes or kidney problems (including kidney transplant), as these conditions may lead
to increased potassium levels in the blood, which can be serious. In such cases, your doctor may need to
adjust the dose of Enalapril Hydrochlorothiazide EG or monitor your blood potassium levels. If you have
diabetes and are taking oral antidiabetic medicines or insulin, you should carefully monitor for possible
reductions in blood glucose levels, especially during the first month of treatment with Enalapril
Hydrochlorothiazide EG. Inform your doctor if you have ever had a severe allergic reaction associated with
swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing. It should be noted
that black patients are at higher risk of developing such reactions to ACE inhibitors.
Inform your doctor if you are about to undergo a treatment called LDL apheresis or if you are about to
undergo desensitisation treatment to reduce the effect of an allergy to bee or wasp stings.
Inform your doctor if you suffer from low blood pressure (which may present as fainting or dizziness,
especially when standing up).
Before undergoing surgery or anaesthesia (including dental anaesthesia), inform your doctor or dentist that
you are taking Enalapril Hydrochlorothiazide EG, as a sudden drop in blood pressure may occur in
association with anaesthesia.
Inform your doctor if you have connective tissue vascular disorders (e.g. systemic lupus erythematosus,
rheumatoid arthritis or scleroderma), if you are taking immunosuppressants, allopurinol or procainamide, or
if any combination of these factors applies to you.
Inform your doctor if you are undergoing anti-doping testing, as this medicine may produce a positive result.
You must inform your doctor if you suspect (or are planning) a pregnancy. Use of this medicine is not
advised during early pregnancy and the medicine must not be taken if you are more than three months
pregnant, as it may severely harm your baby (see section Pregnancy).
Inform your doctor if you are taking a medicine containing a neprilysin inhibitor such as sacubitril (available
in fixed-dose combination with valsartan), used in patients with heart failure. You may be at increased risk
of an allergic reaction called angioedema.
If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, for
example 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.
Inform your doctor before taking Enalapril Hydrochlorothiazide EG if you have previously had skin cancer
or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide,
particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer
and lip cancer. Protect your skin from exposure to sunlight and UV rays during treatment with Enalapril
Hydrochlorothiazide EG.
Inform your doctor 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, etc.), especially if you have kidney problems related to diabetes;
aliskiren.
Inform your doctor 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 pressure within the eye, and
may occur within hours or weeks after taking Enalapril Hydrochlorothiazide EG. This may lead to permanent
vision loss if not treated. If you have recently had an allergy to penicillin or sulfonamides, you may be at
high risk of developing this symptom;
if you have previously experienced respiratory or lung problems (including inflammation or fluid in the
lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties
after taking Enalapril Hydrochlorothiazide EG, consult a doctor immediately.
Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your
blood at regular intervals.
See also the information under “Do not take Enalapril Hydrochlorothiazide EG”.

Children and adolescents
The safety and efficacy in children have not been established.

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

Other medicines and Enalapril Hydrochlorothiazide EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust your dose and/or take other precautions:
Enalapril Hydrochlorothiazide EG can generally be taken together with other medicines. However, for your
doctor to prescribe the correct dose of Enalapril Hydrochlorothiazide EG, it is particularly important that you
inform them if you are taking any of the following medicines:

an angiotensin II receptor blocker or aliskiren (see also information in sections “Do not take Enalapril Hydrochlorothiazide EG” and “Warnings and precautions”);
other antihypertensives (medicines to lower blood pressure);
diuretics (medicines that increase urine production);
potassium supplements (including potassium-containing salt substitutes), potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride), and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of a transplanted organ; and heparin, a medicine used to thin the blood and prevent clot formation);
lithium (a medicine used to treat manic depression or bipolar disorder);
tricyclic antidepressants (for treating depression);
antipsychotics (medicines for treating schizophrenia);
sympathomimetics (medicines used in the treatment of certain heart and blood vessel diseases and some cold remedies);
antidiabetics (medicines for treating diabetes);
NSAIDs (medicines used to treat pain and arthritis, including gold therapy);
an mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent the body’s immune system from rejecting a transplanted organ). See also information in section “Warnings and precautions”;
a medicine containing a neprilysin inhibitor such as sacubitril (available as a fixed-dose combination medicine with valsartan) and racecadotril. The risk of angioedema (swelling of the face, lips, tongue, or throat associated with difficulty breathing or swallowing) may increase. See also information in sections “Do not take Enalapril Hydrochlorothiazide EG” and “Warnings and precautions”;
cytostatics (medicines for treating cancer).

Enalapril Hydrochlorothiazide EG with food and drinks
Most people take Enalapril Hydrochlorothiazide EG with a glass of water.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your
doctor before taking this medicine. Your doctor will usually advise you to stop treatment with Enalapril
Hydrochlorothiazide EG before you become pregnant or as soon as pregnancy is confirmed, and will prescribe
an alternative medicine. This medicine is not recommended during pregnancy and must not be taken if you
are more than three months pregnant, as it may severely harm your baby if taken after the third month of
pregnancy.

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

Driving and using machines
Individual responses to the medicine may vary. Some side effects reported with this medicine may affect the
ability of some patients to drive or operate machinery (see possible side effects).

Enalapril Hydrochlorothiazide EG contains lactose (milk sugar) and sodium
If your doctor has diagnosed you with an intolerance to certain 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 Enalapril Idroclorotiazide EG

Your doctor will decide the appropriate dose, depending on your condition and whether you are taking other medicines.
The recommended dose is one tablet once daily. Most people take this medicine with a glass of water.
Patients with a history of kidney problems may require a lower dose of this medicine.
Any previous treatment with diuretics should be discontinued 2–3 days before starting treatment with this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. It is very important that you continue taking this medicine for the entire duration prescribed by your doctor. Do not take more tablets than prescribed.
If you take more Enalapril Idroclorotiazide EG than you should
In case of overdose, contact your doctor immediately and seek urgent medical attention. The most likely symptoms include dizziness or lightheadedness due to a sudden or excessive drop in blood pressure, excessive thirst, cough, confusion, rapid breathing, anxiety, reduced urine output, or an abnormally fast or slow heartbeat.
If you forget to take Enalapril Idroclorotiazide EG
You should take this medicine as prescribed. Do not take a double dose to make up for a missed tablet. Simply continue your treatment as per the usual dosing schedule.
If you stop taking Enalapril Idroclorotiazide EG
Do not stop taking this medicine unless instructed by 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 everybody will experience them.
Stop taking Enalapril Hydrochlorothiazide EG and contact your doctor immediately if any of the following occur:

if you develop swelling of the face, lips, tongue and/or throat, possibly causing difficulty in breathing or swallowing (common: may affect up to 1 in 10 people);
if you experience swelling of the hands, feet or ankles (common: may affect up to 1 in 10 people);
if you develop hives (uncommon: may affect up to 1 in 100 people);
severe hypersensitivity reactions with high fever, skin rash in the form of target lesions (erythema multiforme), Stevens-Johnson syndrome and toxic epidermal necrolysis (serious skin conditions characterized by redness, peeling and blistering of the skin), severe skin rash with loss of skin and hair (exfoliative dermatitis), cutaneous lupus erythematosus (an autoimmune disease), redness with peeling of the skin (erythroderma), small fluid-filled blisters on the skin (pemphigus), purple or red spots on the skin (purpura) (rare: may affect up to 1 in 1,000 people);
inflammation of the liver (hepatitis), liver failure which may be fatal, yellowing of the eyes or skin (jaundice) (rare: may affect up to 1 in 1,000 people).

The initial dose may cause a greater drop in blood pressure than with continued treatment. This condition may present as fainting or dizziness, and lying down may be helpful. Consult your doctor if you are affected by this condition.

Other side effects:
Very common (may affect more than 1 in 10 people):
blurred vision;
dizziness;
cough;
nausea;
weakness.

Common (may affect up to 1 in 10 people):
low potassium levels in the blood, increased cholesterol or fat levels in the blood, high uric acid levels in the blood;
headache, depression, fainting (syncope), altered taste sensation;
mild mental confusion due to low blood pressure (including a drop in blood pressure upon standing quickly), angina or chest pain, irregular heart rhythm, rapid heartbeat;
shortness of breath;
diarrhea, abdominal pain;
rash;
muscle cramps**;
chest pain, fatigue;
high potassium levels in the blood, increased creatinine levels in the blood.

Uncommon (may affect up to 1 in 100 people):
anaemia (both aplastic and haemolytic);
low blood sugar levels (hypoglycaemia), low magnesium levels (hypomagnesaemia), a disease characterized by joint pain and swelling due to uric acid crystals (gout)*;
confusion, drowsiness, insomnia, nervousness, unexplained tingling (paraesthesia), sensation of dizziness (vertigo), decreased libido*;
ringing in the ears;
flushing, rapid or irregular heartbeat (palpitations), heart attack, stroke possibly due to excessively low blood pressure in high-risk patients (patients with impaired blood flow to the heart and/or brain);
runny nose, sore throat and hoarseness, tightness in the chest associated with asthma (difficulty breathing and laboured breathing);
slowed movement of food through the intestine (ileus), inflammation of the pancreas (pancreatitis), vomiting, indigestion (dyspepsia), constipation, loss of appetite (anorexia), stomach pain and/or irritation and/or peptic ulcer, dry mouth, excessive gas in the stomach or intestine*;
increased sweating (diaphoresis), itching (pruritus), hives, hair loss (alopecia);
joint pain*;
kidney problems (renal dysfunction), kidney failure, presence of protein in the urine (proteinuria);
impotence;
feeling unwell (malaise), fever;
high levels of urea in the blood, low sodium levels in the blood.

Rare (may affect up to 1 in 1,000 people):
changes in blood test values such as reduced numbers of white and red blood cells, reduced haemoglobin, reduced platelets in the blood, swelling of glands in the neck, armpits or groin;
increased blood sugar levels;
abnormal dreams, sleep disturbances, muscle weakness sometimes due to low potassium levels (paresis);
poor blood flow to limbs (Raynaud's phenomenon);
inflammation of the nose, accumulation of fluid or other substances in the lungs (as seen on X-ray), breathing difficulties, respiratory distress (including pneumonia and pulmonary oedema, allergic alveolitis/eosinophilic pneumonia);
mouth ulcers (stomatitis/aphthous ulceration), swollen tongue (glossitis);
gallbladder problems;
reduced urine production (oliguria), kidney disease (interstitial nephritis);
breast enlargement in men (gynaecomastia);
high concentrations of liver enzymes or bilirubin.

Very rare (may affect up to 1 in 10,000 people):
high calcium levels in the blood (hypercalcaemia);
intestinal swelling (intestinal angioedema);
acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated from available data):
skin and lip cancer (non-melanoma skin cancer);
excessive production of antidiuretic hormone, causing fluid retention, leading to weakness, tiredness or confusion;
decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion), acute angle-closure glaucoma) or temporary myopia (acute myopia);
inflammation of blood vessels (serositis/vasculitis);
a symptomatic complex has been reported which may include some or all of the following symptoms: fever, muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity or other dermatological manifestations may also occur.

* Observed only with hydrochlorothiazide doses of 12.5 mg and 25 mg.
** The frequency of muscle cramps as common refers to hydrochlorothiazide doses of 12.5 mg and 25 mg, while the frequency of the event is uncommon when related to hydrochlorothiazide doses of 6 mg.

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 Enalapril Idroclorotiazide EG

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 carton 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 any medicine 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 Enalapril Hydrochlorothiazide EG 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;
maize starch;
pregelatinized starch;
talc;
sodium bicarbonate;
magnesium stearate.

Description of the appearance of Enalapril Hydrochlorothiazide EG 20 mg/12.5 mg tablets and pack contents
White, round, flat tablets with bevelled edges and a score line on one side.
Enalapril Hydrochlorothiazide EG is available in blisters (aluminum/laminated OPA/PVC) containing 10, 14, 20,
28, 30, 50, 56, 60, 90, 98, 100, 120, 200 and 250 tablets.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria: Co-Renistad 20/12.5 mg
Belgium: Co-enalapril EG 20 mg/12.5 mg
Denmark: Enacecor
Italy: Enalapril Hydrochlorothiazide EG 20 mg/12.5 mg Tablets
Luxembourg: Co-enalapril EG 20 mg/12.5 mg
Netherlands: Enalaprilmaleaat/Hydrochloorthiazide CF 20/12.5 mg
Sweden: Enalapril comp Stada