Patient leaflet - Enalapril and Hydrochlorothiazide 20 mg / 12.5 mg tablets

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

Enalapril and Hydrochlorothiazide contain combination of enalapril maleate and hydrochlorothiazide:

enalapril belongs to a group of medicines called angiotensin converting
enzyme inhibitors (ACE inhibitors), which work by widening your blood vessels.
hydrochlorothiazide belongs to a group of medicines known as water
tablets (diuretics), which increase the volume of urine you produce.

The eﬀect of these medicines is to lower your blood pressure. Enalapril and

Hydrochlorothiazide is used to treat high blood pressure (hypertension). Taking both medicines that Enalapril and Hydrochlorothiazide contain can increase their eﬀect compared to taking just one.

2. What you need to know before you take Enalapril and Hydrochlorothiazide

Do not take Enalapril and Hydrochlorothiazide:

if you are allergic to enalapril maleate, hydrochlorothiazide, or any of the
other ingredients of this medicine (listed in section 6).
if you have previously been treated with a medication in the same group of
drugs as this medicine (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue and/or throat with diﬃculty in swallowing or breathing. You should not take this medicine if you have had these types of reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema.
if you are allergic to any sulfonamide-derived drugs. (Ask your doctor if you
are not sure what sulfonamide-derived drugs are.)
if you are not passing urine.
if you have diabetes or impaired kidney function and you are treated with a
blood pressure lowering medicine containing aliskiren.
if you are more than 3 months pregnant. (It is also better to avoid Enalapril
and Hydrochlorothiazide in early pregnancy – see pregnancy section). · if you have a condition known as renal artery stenosis (narrowing of the
arteries that supply the blood to your kidneys).
if you have severe kidney or liver problems.
if you are being treated with sacubitril/valsartan, a medicine for heart
failure.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warning and precautions

Talk to your doctor or pharmacist before taking Enalapril and Hydrochlorothiazide:

if you experienced breathing or lung problems (including inﬂammation or
ﬂuid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or diﬃculty breathing after taking Enalapril and Hydrochlorothiazide, seek medical attention immediately · if you have blood disorders or liver problems
- if you are on a salt restricted diet, or have suﬀered from excessive vomiting
  or diarrhoea recently
- if you have a heart condition called 'aortic stenosis', 'hypertrophic
  cardiomyopathy' or 'outﬂow obstruction'
- if you have collagen vascular disease, are taking immunosuppressant
  therapy (used for the treatment of autoimmune disorders such as rheumatoid arthritis or following transplant surgery)
- if you are taking allopurinol, (used for the treatment of gout), or
  procainamide, (used to treat abnormal heart rhythms).If you develop an infection (symptoms may be high temperature or fever), you should let your doctor know immediately. Your doctor may take a blood sample from time to time to check your white blood cell count.
- if you have a history of 'angioedema' while taking other medicines. The signs
  may have been itching, nettle rash, wheezing or swelling of your hands, throat, mouth or eyelids.
- if you have diabetes and are taking antidiabetic medicines, including insulin
  to control your diabetes (you should monitor your blood for low blood glucose levels, especially during the ﬁrst month of treatment) · if you are taking potassium supplements, potassium containing salt
  substitutes, or other drugs that may increase potassium in your blood (e.g., heparin [a medicine used to prevent blood clots], trimethoprim-containing products such as cotrimoxazole [medicines used to treat infections]) · if you are taking lithium, used for the treatment of some psychiatric
  illnesses.
- if you have been told by your doctor that you have an intolerance to some
  sugars.
- if you think you are (or might become) pregnant. This medicine is not
  recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section)
- if you have had skin cancer or if you develop an unexpected skin lesion
  during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking this Enalapril and Hydrochlorothiazide. · tell your doctor if you are taking 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), a medicine containing a neprilysin inhibitor such as sacubitril (available as ﬁxed-dose combination with valsartan), used in patients with heart failure and racecadotril, used in patients with acute diarrhoea, or vildagliptin, a medicine used to treat diabetes. You may be at increased risk for an allergic
  reaction called angioedema.
  - tell your doctor if you are taking either of the following medicines used to
    treat high blood pressure:
    - An angiotensin II receptor blocker (ARB) (also known as sartans – for example valsartan, telmisartan, irbesartan etc), in particular if you have diabetes-related kidney problems
    - Aliskiren
  - tell your doctor if you experience a decrease in vision or eye pain. These
    could be symptoms of ﬂuid accumulation in the vascular layer of the eye (choroidal eﬀusion) or an increase of pressure in your eye and can happen within hours to weeks of taking Enalapril and Hydrochlorothiazide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

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 information under the heading “Do not take Enalapril and Hydrochlorothiazide .”

If you are about to have any of the following procedures, you should tell your doctor who is treating you that you are taking Enalapril and Hydrochlorothiazide :

any surgery or receive anaesthetics (even at the dentist) · a treatment called LDL apheresis, to remove cholesterol from your blood
using a machine
desensitisation treatment, to reduce the eﬀect of an allergy to bee or wasp
stings.

Routine tests

When you ﬁrst start to take this medicine your doctor will monitor your blood pressure frequently to ensure you have been given the correct dose. In addition, for some patients the doctor may want to do some tests to measure your potassium, sodium, magnesium, creatinine and liver enzyme levels.

Tell your doctor if you have or will take an anti-doping test since this medication can produce a positive result.

Children and adolescents

Enalapril and Hydrochlorothiazide is not recommended for use in children.

Other medicines and Enalapril and Hydrochlorothiazide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. Your doctor may need to change your dose and/or to take other precautions.

In general, Enalapril and Hydrochlorothiazide can be taken with other drugs. For prescribing the correct dose of Enalapril and Hydrochlorothiazide, it is especially important for your doctor to know whether you are taking any of the following medicines:

an angiotensin II-receptor blocker (ARB) or aliskiren (see also information
under the headings “Do not take Enalapril and Hydrochlorothiazide ” and “Warnings and precautions”),
potassium sparing water tablets (diuretics) such as spironolactone,
eplerenone, triamterene or amiloride, potassium supplements, potassium-containing salt substitutes or other drugs that may increase potassium in your blood (e.g., heparin [a medicine used to prevent blood clots], trimethoprim-containing products such as cotrimoxazole [medicines used to treat infections]). Enalapril and Hydrochlorothiazide may increase the levels of potassium in your blood leading to high potassium levels. This causes few signs and is usually seen by a test.
water tablets (diuretics) such as thiazides, furosemide, bumetanide. · other medicines that lower blood pressure, such as nitroglycerin, nitrates,
and vasodilators.
lithium used for the treatment of some psychiatric illnesses. Enalapril and
Hydrochlorothiazide should not be taken with this drug. · barbiturates (sedatives used for sleeplessness or epilepsy), · tricyclic antidepressants such as amitriptyline, used for depression,
antipsychotics such as phenothiazines, used for severe anxiety. · pain killers such as morphine or anaesthetics, because your blood pressure
may become too low.
cholestyramine or colestipol (used to help control cholesterol levels). · medicines used for stiﬀness and inﬂammation associated with painful
conditions, particularly those aﬀecting your muscles, bones and joints:
- including gold therapy which can lead to ﬂushing of your face, feeling sick (nausea), vomiting and low blood pressure, when taken with Enalapril and Hydrochlorothiazide, and
- non-steroidal anti-inﬂammatory drugs (NSAIDs), for example diﬂunisal or diclofenac. They may prevent your blood pressure from being well controlled and may increase the level of potassium in your blood · medicines such as ephedrine, used in some cough and cold remedies, or

noradrenaline and adrenaline used for low blood pressure, shock, cardiac failure, asthma or allergies. If used with Enalapril and Hydrochlorothiazide

these drugs may keep your blood pressure high.

ACTH (to test whether your adrenal glands are working properly) · corticosteroids (used to treat certain conditions such as rheumatism, arthritis, allergic conditions, asthma or certain blood disorders) · allopurinol (used to treat gout),
ciclosporins (immunosuppressive agents used for autoimmune disorders), · medicines for the treatment of cancer.
procainamide, amiodarone or sotalol (used to treat abnormal heart rhythms)
digitalis (used to treat heart rhythm problems)
carbenoxalone (used to treat stomach ulcers)
excessive use of laxatives.
antidiabetic medicines such as insulin. Enalapril and Hydrochlorothiazide may cause your blood sugar levels to drop even further if you take it with antidiabetics
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 under the heading “Warnings and precautions”.
a medicine containing a neprilysin inhibitor such as sacubitril (available as
ﬁxed-dose combination with valsartan) and racecadotril, or a medicine containing vildagliptin. The risk of angioedema (swelling of the face, lips, tongue or throat with diﬃculty in swallowing or breathing) may be increased. See also information under the headings “Do not take Enalapril and Hydrochlorothiazide ” and “Warnings and precautions”.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Enalapril and Hydrochlorothiazide.

Enalapril and Hydrochlorothiazide with food, drink and alcohol

Most people take Enalapril and Hydrochlorothiazide with a drink of water. This medicine can be taken with or without food. However, if you drink alcohol while taking Enalapril and Hydrochlorothiazide it may cause your blood pressure to drop too much and you may experience dizziness, light-headedness or faintness. You should keep your alcohol intake to a minimum.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

8 mm

24 mm

5 mm

480 mm

Enalapril and Hydrochlorothiazide 20mg / 12.5mg Tablets - Leaﬂet

FRONT

XXXXXX

Country: United Kingdom

Text Area: 451 x 145 mm

P:\Generic and Domestic\Generic Open\Ipca UK\Enalapril+HCTZ FRONT

Country: United Kingdom

Text Area: 451 x 145 mm

P:\Generic and Domestic\Generic Open\Ipca UK\Enalapril+HCTZ FRONT

Your doctor will normally advise you to stop taking Enalapril and Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Enalapril and Hydrochlorothiazide .

This medicine is not recommended during pregnancy, and must not be

taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. This medicine is not recommended for mothers who are breast-feeding.

Driving and using machines

Side eﬀects of this medicine include blurred vision, feeling dizzy, feeling drowsy, or confused (see 'Possible side eﬀects'). If this happens do not drive or use any tools or machines.

Enalapril and Hydrochlorothiazide Tablets contain lactose and sodium

Enalapril and Hydrochlorothiazide contains lactose, which is a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

Enalapril and Hydrochlorothiazide contains less than 1mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

3. How to take Enalapril and Hydrochlorothiazide

Taking this medicine

You should take this medicine by mouth.
Always take this medicine exactly as your doctor or pharmacist has told you. · The number of tablets you take each day will depend upon your condition.

Check with your doctor or pharmacist if you are not sure.

REMEMBER, this medicine is for you. Do not share it with anyone else. It may not suit them.

The recommended dose is:

One tablet each day.
Your doctor may increase the dose to two tablets each day. · Do not take more or less than your doctor has prescribed.
If you take more Enalapril and Hydrochlorothiazide than you should
Contact your doctor immediately if you think you have taken more of your tablets than you should. The most common signs and symptoms of an overdose are a fall in blood pressure and stupor (a state of almost complete lack of consciousness). Other symptoms may include dizziness or light-headedness due to a fall in blood pressure, forceful and rapid heartbeat, rapid pulse, anxiety, cough, kidney failure, and rapid breathing.
If you forget to take Enalapril and Hydrochlorothiazide
- If you forget to take a tablet, skip the missed dose.
- Take the next dose as usual.
- Do not take a double dose to make up for a forgotten dose.

If you stop taking Enalapril and Hydrochlorothiazide

Do not stop taking this medicine, unless your doctor tells you to. If you do your blood pressure may increase. If your blood pressure becomes too high, it may aﬀect your heart and kidneys.

If you have any further questions on 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. The following side eﬀects may happen with this medicine:

It is vital to stop taking Enalapril and Hydrochlorothiazide tablets and seek medical attention immediately if you begin to have the following symptom:

Allergic reaction - you may get a rash, short of breath or wheezy and
develop swelling of your hands, mouth, throat, face or eyes. · Severe hypersensitivity reaction with high fever, skin rash that looks like
targets (erythema multiforme); severe skin conditions with reddening, scaling and blistering of the skin (Stevens Johnson syndrome and toxic epidermal necrolysis)
Liver failure or hepatitis. This may cause yellowing of your skin (jaundice)

Stop taking this medicine immediately and see your doctor if you have any of the following side eﬀects

severe dizziness, light-headedness, especially at the start of treatment or
when your dose is increased or when you stand up.
Other possible side eﬀects:
Very common (may aﬀect more than 1 in 10 people)
- blurred vision, cough, feeling sick (nausea), weakness.

Common (may aﬀect up to 1 in 10 people)

low blood pressure (which may make you feel dizzy or light-headed,
especially if you stand up quickly)
headache, depression, fainting (syncope)
chest pain, heart rhythm changes, angina or chest pain, fast heart beat,
shortness of breath.
diarrhoea, pain around your stomach area (abdomen), changes in taste,
ﬂuid retention (oedema), feeling tired.
rash, allergic reactions with swelling of the face, extremities, lips, tongue,
and/or throat has been reported.
increased blood potassium level, increases in serum creatinine (both are
usually detected by a test); low levels of potassium in the blood, increased levels of cholesterol, increased levels of triglycerides, increased levels of uric acid in the blood.
muscle cramps.

Uncommon (may aﬀects up to 1 in 100 people)

decreased number of red blood cells and low haemoglobin (anaemia) a
sense of heightened awareness or a shaky feeling (caused by low blood sugar), confusion, feeling sleepy, diﬃculty sleeping, feeling nervous, tingling or numbness, feeling like you are spinning (vertigo) · fast or uneven heart beats (palpitations), heart attack or stroke (in high risk
patients)runny nose, sore throat and hoarseness, diﬃculty breathing or asthma.
slow movement of food through your intestine (ileus), inﬂammation of the
pancreas (pancreatitis), being sick, indigestion, constipation, not feeling like eating properly (anorexia), stomach irritation, dry mouth, ﬂatulence, gout burning, aching pain with an empty feeling and hunger, particularly when the stomach is empty (caused by a peptic ulcer), increased sweating, itching, hives (urticaria), hair loss, protein in your urine (usually detected by a
test)
impotence, decreased libido, ﬂushing, ringing in your ears, feeling lethargic,
high temperature.
- increases in blood urea and decreases in blood sodium levels (usually
  detected by a test), feeling unwell (malaise)
- low level of magnesium in the blood (hypomagnesaemia) · kidney problems.
- joint pain.

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

strange dreams, sleep problems.
changes in blood test values such as a lower number of white and red blood
cells, lower haemoglobin, lower number of blood platelets, and/or swollen glands in neck, armpit or groin.
autoimmune diseases, low blood ﬂow to your ﬁngers and toes causing
redness and pain (Raynaud's), accumulation of ﬂuid or other substances in the lungs (as seen on X-rays), runny or sore nose.
eosinophilic pneumonia (signs may be cough, high temperature and
diﬃculty breathing)
pain, swelling or ulcers in your mouth, infection or pain and swelling of your
tongue, kidney problems such as lower back pain and reduction in the volume of urine you pass.
inﬂammation of the nose.
diﬃculty breathing, shortness of breath.
gall bladder problems.
severe skin rash with loss of skin and hair (exfoliative dermatitis), cutaneous
lupus erythematosus (an immune disease), red rash with peeling of the skin (erythroderma), small ﬂuid-ﬁlled bumps on the skin (pemphigus), purple or red spots on the skin (purpura)
development of breasts in men.
increased liver enzymes or blood 'bilirubin' (usually detected by a blood
test), increases in blood sugar.
muscle weakness, sometimes due to low potassium (paresis)

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

swelling in your intestine (intestinal angioedema). Signs may include
stomach pain, feeling sick and vomiting, elevated calcium level in blood.
acute respiratory distress (signs include severe shortness of breath, fever,
weakness, and confusion)

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

A complex side eﬀect has also been reported which may include some or all of the following signs:

fever, inﬂammation of your blood vessels, pain and inﬂammation of muscles or joints.
blood disorders aﬀecting the components of your blood (usually detected by a blood test)
rash, hypersensitivity to sunlight and other eﬀects on your skin. · overproduction of antidiuretic hormone, which causes ﬂuid retention, resulting in weakness, tiredness or confusion.
skin and lip cancer (non-melanoma skin cancer)
decrease in vision or pain in your eyes due to high pressure (possible signs of ﬂuid accumulation in the vascular layer of the eye (choroidal eﬀusion)).

Reporting of side eﬀects

If you get any side eﬀects, talk to your doctor or pharmacist. This includes any possible side eﬀects not listed in this leaﬂet. You can also report side eﬀects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side eﬀects you can help provide more information on the safety of this medicine.

5. How to store Enalapril and Hydrochlorothiazide

Keep this medicine out of the sight and reach of children.

Store below 25°C Store in the original pack to protect from moisture. Do not put this medicine into another container as it might get mixed up. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and further information

What Enalapril and Hydrochlorothiazide tablets contain

The active substances are enalapril maleate and hydrochlorothiazide. Each tablet contains 20 mg enalapril maleate and 12.5 mg hydrochlorothiazide. · The other ingredients are lactose (contains 130 mg lactose monohydrate),
Pregelatinised starch, maleic acid, iron oxide yellow (E172), dried maize starch, sodium stearyl fumarate.
What Enalapril and Hydrochlorothiazide tablets look like and the contents of the pack
Enalapril and Hydrochlorothiazide tablets are pale yellow colour, approximately 8.5 mm, circular, biconvex uncoated tablets with breakline on one side and plain on the other side.
28 tablets are supplied in aluminium/aluminum blister pack.
Marketing Authorisation Holder and Manufacturer
Ipca Laboratories UK Ltd.
Unit 97-98, Silverbriar,
Sunderland Enterprise Park East,
Sunderland, SR5 2TQ
United Kingdom
Telephone: +44 (0) 1915166517
Fax: +44 (0) 1915166526
Email: regulatoryfrm.mumbai@ipca.com
This leaﬂet was last revised in 06/2025