Lisinopril and hydrochlorothiazide Mylan Generics: detailed information

Patient Information Leaflet

Lisinopril Hydrochlorothiazide Mylan Generics 20 mg/12.5 mg tablets

lisinopril and hydrochlorothiazide
Generic Medicine
Please read all of this leaflet carefully before taking this medicine
because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lisinopril Hydrochlorothiazide Mylan Generics is and what it is used for

Lisinopril Hydrochlorothiazide Mylan Generics is used to treat high blood pressure. It contains the active substances lisinopril, which belongs to a group of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors) that works by dilating blood vessels, and hydrochlorothiazide, which belongs to a group of medicines known as thiazide diuretics that helps your body get rid of water and salts such as sodium in the urine. Lisinopril and hydrochlorothiazide work together to lower your blood pressure. Lisinopril Hydrochlorothiazide Mylan Generics has been prescribed for you because your high blood pressure was not adequately controlled using lisinopril or hydrochlorothiazide alone.

2. What you need to know before taking Lisinopril Hydrochlorothiazide Mylan Generics

Do not take Lisinopril Hydrochlorothiazide Mylan Generics

if you are allergic to lisinopril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
if you are allergic to other ACE inhibitors or to other sulfonamides (medicines chemically similar to hydrochlorothiazide, such as certain antibiotics). If you are unsure whether this applies to you, ask your doctor.
if you have previously experienced itching, hives, sudden drop in blood pressure, sudden swelling of the face, lips, tongue, or hands and feet, or difficulty breathing, particularly if this occurred after treatment with ACE inhibitors.
if you or a family member has ever had an allergic reaction called angioedema for any reason.
if you have severe kidney disease.
if you have stopped producing urine.
if you are more than 3 months pregnant (Lisinopril Hydrochlorothiazide Mylan Generics should be avoided during the first months of pregnancy – see section Pregnancy).
if you have severe liver problems.
if you are diabetic or have impaired kidney function and are taking a blood pressure-lowering medicine called aliskiren.
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, for example in the throat).

Do not take Lisinopril Hydrochlorothiazide Mylan Generics if any of the conditions listed above apply to you. If you are unsure, consult your doctor or pharmacist before taking Lisinopril Hydrochlorothiazide Mylan Generics.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lisinopril Hydrochlorothiazide Mylan Generics:

If you have previously had breathing 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 Lisinopril Hydrochlorothiazide Mylan Generics, contact a doctor immediately.
if you are dehydrated due to treatment with diuretics, dialysis, a low-sodium diet, vomiting, or diarrhea. There is a risk of a significant drop in blood pressure shortly after taking these tablets; you may feel faint or confused. Your doctor will monitor you closely at the beginning of treatment and if your dose is adjusted.
if you think you may be pregnant (or could become pregnant). Lisinopril Hydrochlorothiazide Mylan Generics tablets are not recommended during early pregnancy and must not be taken from the third month of pregnancy onwards, as they may cause serious harm to your baby if taken during this time (see section Pregnancy and Breastfeeding).
if you have previously had skin cancer or are developing 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 cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Lisinopril Hydrochlorothiazide Mylan Generics.
if you have or are at risk of having high potassium levels and are also taking potassium supplements (including salt substitutes), heparin, aldosterone antagonists, trimethoprim, or cotrimoxazole.
if you have narrowing (stenosis) of the aorta (a heart artery), heart valves (mitral valve), or renal artery, or if you have thickening of the heart muscle (known as hypertrophic cardiomyopathy).
if you have blood vessel disorders (collagen vascular disease).
if you have low blood pressure. You may experience dizziness or lightheadedness, especially when standing up.
if you have liver problems.
if you have kidney problems, require dialysis, or have had a kidney transplant.
if your doctor has advised you to monitor your salt intake.
if you have high cholesterol levels and are undergoing a treatment called "LDL apheresis".
if you have ever had a condition called systemic lupus erythematosus (SLE).
if you are taking any of the following medicines used to treat high blood pressure:
- an "angiotensin II receptor antagonist" (ARB) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
- aliskiren.
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 diarrhea).
- medicines called mTOR inhibitors, used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
- vildagliptin (a medicine used to treat diabetes).
Signs of angioedema include swelling of the face, lips, tongue, and/or throat, with difficulty swallowing or breathing.
if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from a few hours to a week after taking Lisinopril Hydrochlorothiazide Mylan Generics. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillins or sulfonamides, you may be at higher risk of developing this.

Your doctor may regularly check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood.
See also the section “Do not take Lisinopril Hydrochlorothiazide Mylan Generics”.
Use in Afro-Caribbean patients: ACE inhibitors may be less effective. The side effect "angioedema" (a severe allergic reaction with swelling of hands, feet, ankles, face, lips, tongue, or throat) may also occur more frequently.
For athletes: Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Lisinopril Hydrochlorothiazide Mylan Generics.

Allergy treatments such as insect stings

Inform your doctor if you are currently undergoing or are about to undergo treatment to reduce the effects of an allergy, such as insect stings (desensitization therapy). Taking Lisinopril Hydrochlorothiazide Mylan Generics during this treatment may cause a severe allergic reaction.

Surgery

If you are scheduled for surgery (including dental procedures), inform your doctor or dentist that you are taking Lisinopril Hydrochlorothiazide Mylan Generics. This is because low blood pressure (hypotension) may occur if certain local or general anesthetics are administered while you are taking lisinopril and hydrochlorothiazide.

While taking Lisinopril Hydrochlorothiazide Mylan Generics

If you experience any of the following symptoms, contact your doctor immediately:

dizziness after your first dose. Some people may experience dizziness, weakness, fatigue, and nausea after their first dose or when the dose is increased. Lie down if you experience a significant drop in blood pressure.
symptoms such as dry mouth, thirst, weakness, lethargy, muscle weakness, pain or cramps, rapid heartbeat, dizziness, nausea, or vomiting, or difficulty urinating – these may indicate an imbalance in body fluids or minerals.
sudden swelling of the lips, face, neck, and possibly hands and feet, skin rash, difficulty swallowing or breathing, and hoarseness – all signs of angioedema. This can occur at any time during treatment. The risk is higher in Afro-Caribbean patients.
high body temperature, sore throat, and mouth ulcers – symptoms of low white blood cell count.
yellowing of the skin or whites of the eyes – possible signs of liver problems.

Your doctor will carefully monitor your condition, prescribing blood tests, checking your kidney function, and monitoring your blood electrolyte levels regularly.

If you are scheduled for surgery or any blood tests:

Inform your doctor, nurse, dentist, or hospital staff that you are taking this medicine if:

you are undergoing tests to check parathyroid function, as this medicine may affect test results.
you are scheduled for surgery or require a general anesthetic.
you participate in competitive sports, because hydrochlorothiazide is a banned substance and may cause a positive anti-doping test.

Other medicines and Lisinopril Hydrochlorothiazide Mylan Generics

Do not take Lisinopril Hydrochlorothiazide Mylan Generics if you have taken or are currently taking sacubitril/valsartan (see section “Do not take Lisinopril Hydrochlorothiazide Mylan Generics”).

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal supplements. This is because Lisinopril Hydrochlorothiazide Mylan Generics may affect how some medicines work, and some medicines may affect Lisinopril Hydrochlorothiazide Mylan Generics. Your doctor may need to adjust your dose and/or take other precautions.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

medicines associated with low potassium levels in the blood (hypokalemia), such as other diuretics (e.g., potassium-sparing diuretics), laxatives, corticosteroids (e.g., prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), or salicylic acid derivatives.
other medicines to control high blood pressure (antihypertensives).
if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also sections “Do not take Lisinopril Hydrochlorothiazide Mylan Generics” and “Warnings and precautions”).
heart medicines (e.g., digoxin) or other medicines to control heart rhythm.
potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots).
medicines known to cause serious types of heart rhythm disorders called torsades de pointes (e.g., certain medicines used to treat heart rhythm disorders or mental illnesses), which are more likely if blood potassium levels are low.
treatment with tissue plasminogen activators (TPA), medicines used to treat blood clots (usually administered in hospital).
medicines containing calcium salts or vitamin D supplements.
non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or indomethacin (used to treat arthritis or muscle pain).
aspirin (acetylsalicylic acid), if taking more than 3 grams per day.
antidepressant medicines (tricyclic and tetracyclic antidepressants).
medicines for mental health conditions such as lithium.
medicines for diabetes (insulin and oral antidiabetics such as sulfonylureas). The dose of your antidiabetic medicine may need to be adjusted during treatment with thiazide diuretics.
medicines used to treat asthma.
medicines for nasal or sinus congestion or other cold remedies (including over-the-counter products).
medicines to suppress the body's immune response (immunosuppressants, such as cyclosporine).
allopurinol (for treating gout).
medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus). See section “Warnings and precautions”.
racecadotril (for treating diarrhea).
vildagliptin (for treating diabetes).
lovastatin (to help reduce cholesterol levels in the blood).
sotalol (a beta-blocker).
medicines for irregular heartbeat (e.g., procainamide).
carbenoxolone (for throat ulcers).
corticosteroids (such as hydrocortisone, used as anti-inflammatory medicines).
corticotropin (a hormone used for rheumatoid arthritis or Crohn’s disease).
medicines used to treat constipation (stimulant laxatives).
injectable amphotericin B (for treating fungal infections).
trimethoprim (an antibiotic).
colestyramine and colestipol (to lower cholesterol, prevent diarrhea, or reduce itching).
muscle relaxants such as tubocurarine.
medicines containing gold, such as sodium aurothiomalate, which may be administered by injection.
amantadine (a medicine used to treat Parkinson’s disease).

Low blood pressure may be worsened by alcohol, barbiturates, or anesthetics. You may experience dizziness when standing up.

Your doctor may need to adjust your dose and/or take other precautions.

Lisinopril Hydrochlorothiazide Mylan Generics and alcohol

You should not drink alcohol while taking this medicine, as it may further impair your ability to drive or operate machinery.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you may be pregnant (or could become pregnant).
Your doctor will likely advise you to stop treatment with Lisinopril Hydrochlorothiazide Mylan Generics before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine.

Lisinopril Hydrochlorothiazide Mylan Generics is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if taken beyond the third month.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Lisinopril Hydrochlorothiazide Mylan Generics is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

This medicine may sometimes cause weakness or dizziness, especially at the beginning of treatment or when the dose is changed. If you experience these symptoms, you must not drive, operate machinery, or use any equipment. Occasionally, dizziness or fatigue may occur while driving or using machinery. Wait to see how the medicine affects you before attempting these activities. These side effects may worsen if alcohol is consumed at the same time.

3. How to take Lisinopril Hydrochlorothiazide Mylan Generics

Take Lisinopril Hydrochlorothiazide Mylan Generics exactly as prescribed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Once you have started taking Lisinopril Hydrochlorothiazide Mylan Generics, your doctor may
perform blood tests. Your doctor may then adjust the dose so that you receive the appropriate
amount of medicine.

The recommended dose is:

Adults (including elderly patients)
The initial dose is one tablet per day. Your doctor will decide which dosage strength to start
treatment with. The maximum daily dose is 2 tablets of 20 mg/12.5 mg once daily.

Patients with kidney problems
If you have kidney problems, your doctor will monitor your kidney function. You may be prescribed
a lower dose than that indicated above. This medicine must not be given to patients with severe
renal impairment (see section 2, Do not take Lisinopril Hydrochlorothiazide Mylan Generics).

Use in children and adolescents (under 18 years of age)
Lisinopril Hydrochlorothiazide Mylan Generics is not recommended for children and adolescents,
as efficacy and safety of the medicine have not been established in this age group.

How to take Lisinopril Hydrochlorothiazide Mylan Generics

Take the tablets with a glass of water.
Try to take the tablets at the same time each day. Most patients prefer to take Lisinopril Hydrochlorothiazide Mylan Generics in the morning, so that the effects of the diuretic (increased urination) occur during the day.
Try to take the tablets at the same time every day. It does not matter whether you take Lisinopril Hydrochlorothiazide Mylan Generics before or after meals.
Continue taking Lisinopril Hydrochlorothiazide Mylan Generics for as long as your doctor tells you to, as this is a long-term treatment. It is important to continue taking Lisinopril Hydrochlorothiazide Mylan Generics every day.

When taking the first dose

Be especially careful when taking the first dose of Lisinopril Hydrochlorothiazide Mylan Generics or when the dose is increased. It may cause a greater drop in blood pressure than subsequent doses.
This could make you feel dizzy or lightheaded. If this happens, lying down may help. If you are concerned, talk to your doctor as soon as possible.

If you take more Lisinopril Hydrochlorothiazide Mylan Generics than you should
Contact your doctor immediately or go to the nearest emergency room. Bring this leaflet, the
container, and any remaining tablets with you so that the doctor knows what you have taken.
Symptoms of overdose may include severe lowering of blood pressure, abnormal levels of electrolytes in the body, dehydration due to excessive urine production, rapid breathing, shock, fast or irregular heartbeat, slow heartbeat, dizziness, reduced level of consciousness (which may lead to coma), difficulty moving, seizures, anxiety, cough, and kidney failure.

If you forget to take Lisinopril Hydrochlorothiazide Mylan Generics
Take your next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Lisinopril Hydrochlorothiazide Mylan Generics
Do not stop taking this medicine suddenly, as Lisinopril Hydrochlorothiazide Mylan Generics may
cause serious fluctuations in your blood pressure. If you decide to stop treatment, discuss it with your
doctor or pharmacist.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Lisinopril Hydrochlorothiazide Mylan Generics contains two medicines: lisinopril and hydrochlorothiazide.
The following side effects have been observed with these individual medicines. This means they could also occur with Lisinopril Hydrochlorothiazide Mylan Generics.
Your doctor may take blood samples from time to time to check whether Lisinopril and Hydrochlorothiazide have had any effect on your blood.

Possible side effects of lisinopril

Severe allergic reactions (rare, may affect up to 1 in 1,000 people)
If you experience a severe allergic reaction, stop taking Lisinopril Hydrochlorothiazide Mylan Generics and contact a doctor immediately.
Symptoms may include sudden onset of:

swelling of the face, lips, tongue, or throat. This may make swallowing difficult
severe or sudden swelling of hands, feet, and ankles
difficulty breathing
severe itching of the skin (with raised lumps)

Severe liver problems (very rare, may affect up to 1 in 10,000 people)
Symptoms may include:

yellowing of the skin or eyes, dark-colored urine, or loss of appetite. If this occurs, see a doctor immediately.

Other side effects include:
Common (may affect up to 1 in 10 people)

dizziness, which usually resolves by reducing the dose
mental confusion when standing up quickly, low blood pressure (hypotension)
headache
dry, persistent cough; consult your doctor who may decide to change your treatment
fatigue
nausea
diarrhea
kidney function problems
fainting

Uncommon (may affect up to 1 in 100 people)

fast or accelerated heartbeat, or pounding heart (palpitations)
heart attack or stroke
painful, cold, and bluish fingers and toes due to blood circulation problems
a pins-and-needles sensation in the limbs, weakness, or fatigue
malaise
indigestion, abdominal pain
altered taste
mood changes
sleep problems
skin rash, itchy skin
impotence
runny and itchy nose
feeling of weakness
feeling of fatigue
increased levels of liver enzymes and bilirubin in the blood
increased levels of urea in the blood (and/or blood urea nitrogen).

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

mental confusion
hair loss (alopecia)
psoriasis, a skin condition characterized by scaly red patches
breast enlargement (in men)
changes in sense of smell
dry mouth
blood infections
kidney failure
syndrome of inappropriate antidiuretic hormone secretion (SIADH)
skin rash with dark red, raised, itchy bumps (urticaria)
changes in certain blood cells that may be observed in blood tests
low levels of sodium (salt) in the blood, which may cause weakness, confusion, muscle pain, and stiffness.

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

acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion)
bone marrow depression or reduced number of blood cells and/or platelets in the blood. You may notice fatigue, an infection (which may be severe), fever, feeling short of breath, or increased tendency to bruise or bleed
swollen glands (lymph nodes)
increased immune response (autoimmune disease)
sudden sensation of wheezing or breathlessness (bronchospasm)
lung inflammation (which may make you feel breathless)
sinusitis (a feeling of pain and fullness behind the cheeks and eyes)
eosinophilic pneumonia. Signs include a combination of the following:
- sinusitis
- feeling like you have the flu
- increasing breathlessness
- pain in the stomach or intestinal area
- skin rash
- tingling or numbness in the arms or legs
inflammation of the pancreas. This causes moderate to severe stomach pain. Swelling of the intestinal lining. This may cause sudden stomach pain, diarrhea, or nausea (vomiting)
severe skin disorder or skin rash. Symptoms include redness, blistering, and peeling of the skin that may develop rapidly and may include blisters in the mouth and nose
reduced urination compared to normal or absence of urination
sweating
low blood sugar levels, which may cause sweating, excessive hunger, trembling, and rapid heartbeat.

Not known (frequency cannot be estimated from available data)

skin redness
seeing, hearing, or sensing things that are not real (hallucinations)
feeling depressed.

Other side effects reported with hydrochlorothiazide alone include:

loss of appetite
changes in vision, such as blurred vision, yellowing of color vision, myopia
fever
glucose in urine
restlessness
constipation
stomach upset
high levels of calcium in the blood, low levels of chloride, sodium, potassium, or magnesium in the blood
you may notice muscle weakness, thirst, tingling, cramps, or feeling unwell
increased levels of cholesterol or triglycerides (blood fats)
increased levels of uric acid (which may be associated with gout)
cancer of the skin and lips (non-melanoma skin cancer)
inflammation of a salivary gland
reduced number of blood cells and/or platelets in the blood. You may notice fatigue, infection (which may be severe), fever, feeling short of breath, or increased tendency to bruise or bleed
increased levels of sugar (glucose) in the blood (hyperglycemia)
depression
difficulty sleeping
tingling sensations like pins and needles
feeling of dizziness
temporary vision problems
severe eye pain with redness and sudden blurred vision. If you suddenly develop a painful red eye, inform your doctor immediately; treatment may be needed to prevent permanent vision loss
decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
sensation of spinning (vertigo)
feeling faint (especially when standing up)
damage to blood vessels causing red or purple spots on the skin
breathing difficulties. You may feel short of breath if your lungs become inflamed or fill with fluid
diarrhea
inflammation of the pancreas. This causes moderate to severe stomach pain
yellowing of the skin or whites of the eyes (jaundice)
skin problems including rashes caused by sensitivity to sunlight, skin rashes, a severe rash that develops rapidly with blistering or peeling of the skin, and possibly blisters in the mouth, activation or worsening of existing lupus conditions, or unusual skin reactions
allergic reactions
muscle cramps and muscle weakness
kidney problems that may be serious (detected by blood tests)
weakness.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Reporting of side effects

If you experience any side effect, 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 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 Lisinopril Hydrochlorothiazide Mylan Generics

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. Contents of the pack and other information

What Lisinopril Hydrochlorothiazide Mylan Generics contains

The active substances are:
each Lisinopril Hydrochlorothiazide Mylan Generics 20 mg/12.5 mg tablet contains 20 mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide.

The other components are calcium hydrogen phosphate dihydrate, mannitol, maize starch, pregelatinized starch, and magnesium stearate. The 20 mg/12.5 mg tablets also contain iron oxide (E 172).

Description of the appearance of Lisinopril Hydrochlorothiazide Mylan Generics and contents of the pack

Lisinopril Hydrochlorothiazide Mylan Generics 20 mg/12.5 mg tablets are round, pink-coloured tablets, marked "LHZ" on one side and "32.5" on the other side.

Lisinopril Hydrochlorothiazide Mylan Generics is available in blisters containing 10, 14, 28, 30, 50, 56, and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturers
Neuraxpharm Pharmaceuticals, S.L., Avda. Barcelona 69, 08970 Sant Joan Despi, Barcelona, Spain
Generics (UK) Ltd, Station Close, Potters Bar, Herts EN6 1TL, United Kingdom
McDermott Laboratories Ltd t/a Gerard Laboratories Ltd, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan B.V., Krijgsman 20, 1186 DM Amstelveen, Netherlands
Mylan Hungary Kft, Mylan utca 1, 2900 Komarom, Hungary

This medicine is authorized in the European Economic Area countries under the following names:
Belgium - Co-Lisinopril Viatris 20 mg/12.5 mg tabletten
Denmark - LISINOHYD MITE, tablets 10mg/12.5mg & LISINOHYD, tablets 20mg/12.5mg
Italy – Lisinopril Hydrochlorothiazide Mylan Generics 20mg/12.5mg Tablets
Luxembourg - Co-Lisinopril Viatris 20 mg/12.5 mg comprimés
Portugal - Lisinopril + hidroclorotiazida Mylan Genericos 20 mg + 12.5 mg
Netherlands - Lisinopril/Hydrochloorthiazide Viatris 20/12.5 mg