Lisinopril/hydrochlorothiazide Sandoz Farmaceutica 20/12.5 mg tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica 20 mg/12.5 mg tablets EFG

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 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 you, because it may harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica is and what it is used for

Lisinopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors and lowers blood pressure by widening blood vessels.

Hydrochlorothiazide belongs to a group of medicines called diuretics and lowers blood pressure by increasing urine output.

Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica contains a combination of lisinopril and hydrochlorothiazide and is used to treat high blood pressure when treatment with lisinopril alone is not sufficient.

Your doctor may also prescribe lisinopril/hydrochlorothiazide instead of separate tablets containing the same doses of lisinopril and hydrochlorothiazide. This fixed-dose combination is not appropriate at the start of treatment.

2. What you need to know before taking Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica

DO NOT take Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica:

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, for example ramipril, or to sulfonamide-derived medicines (most antibiotics, e.g., sulfamethoxazole),
if you have ever experienced itching, blistering, sudden drop in blood pressure, sudden swelling of hands, feet, ankles, face, lips, tongue, or throat (angioedema), especially after treatment with medicines of the ACE inhibitor group (angiotensin-converting enzyme inhibitors). Difficulty swallowing or breathing may also occur.
if you have hereditary angioedema (a condition that makes you more prone to the swelling described above). If you are unsure whether this condition applies to you, consult your doctor,
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is high,
if any of your family members have ever had swelling of limbs, face, mouth, throat, or tongue (angioedema),
if you have severe kidney problems,
if you have severe liver problems,
if you have problems producing urine (anuria),
if you are more than 3 months pregnant. (It is also advisable to avoid lisinopril/hydrochlorothiazide in early pregnancy; see Pregnancy section),
if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica:

if you have narrowing of arteries (arteriosclerosis), cerebrovascular disorders such as stroke or transient ischemic attack (TIA, a minor stroke),
if you have heart failure,
if you have low blood pressure, are on a salt-restricted diet, or are taking diuretics,
if you have abnormal levels of water and minerals in your body (fluid/electrolyte imbalance),
if you have heart muscle disease (hypertrophic cardiomyopathy), narrowing of the main artery carrying blood from the heart, the aorta (aortic stenosis), or other forms of a heart condition called outflow tract obstruction,
if you are undergoing LDL apheresis (removal of cholesterol from blood via a machine),
if you are undergoing desensitization treatment for insect stings such as bees or wasps,
if you have diabetes,
if you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking lisinopril/hydrochlorothiazide, seek medical attention immediately,
if you are taking any of the following medicines used to treat high blood pressure (hypertension):
an angiotensin II receptor antagonist (ARA) (also known as "sartans", e.g., valsartan, telmisartan, irbesartan), particularly 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 information under the heading “DO NOT take Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica”),

if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:
sirolimus, temsirolimus, everolimus, and other medicines belonging to the class called mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment),
racecadotril, a medicine used to treat diarrhea,
vildagliptin, a medicine used to treat diabetes,
tissue plasminogen activator (tPA), used to dissolve blood clots formed in blood vessels,
if you are taking other medicines such as salt substitutes or potassium supplements,
if you have gout, high levels of uric acid in the blood, or are being treated with allopurinol or procainamide,
if you are undergoing surgery (including dental surgery) and will receive anesthetics,
if you have recently had prolonged vomiting and/or severe diarrhea,
if you are scheduled for a parathyroid gland function test,
if you have or have had liver or kidney problems, or have narrowing of the arteries to your kidneys (renal artery stenosis), only one functioning kidney, or are on dialysis,
if you have a collagen vascular disease such as systemic lupus erythematosus (SLE) or scleroderma, which may be associated with skin rashes, joint pain, and fever,
if you have had skin cancer or 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 and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica,
if you suffer from allergic conditions or asthma,
if you are taking lithium, used to treat certain psychiatric disorders,
if you think you are (or might become) pregnant. Lisinopril/hydrochlorothiazide 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 during this period (see Pregnancy section),
if you are being treated with other diuretics.

Lisinopril/Hydrochlorothiazide is generally not recommended in the following cases, so you should consult your doctor before taking this medicine:

if you have recently received a kidney transplant,
if you have high levels of potassium in your blood.

See also the section “Other medicines and Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica”.

Consult your doctor if you are an athlete, as this medicine contains a component that may result in a positive analytical finding in doping controls.

Elderly or malnourished patients should take special care when taking lisinopril/hydrochlorothiazide.

Lisinopril/hydrochlorothiazide may be less effective in black patients.

Children

This medicine is not recommended for use in children.

While taking Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica:

Contact your doctor immediately if you develop any of the following symptoms:

if you feel dizzy after your first dose. Some people react to the first dose or dose increase with dizziness, weakness, fainting, and nausea,
sudden swelling of lips and neck, possibly also hands and feet, or wheezing or hoarseness. This condition is called angioedema. It can occur at any time during treatment. ACE inhibitors are more likely to cause angioedema in black patients than in patients of other races,
high fever, sore throat, or mouth ulcers (these may be symptoms of infection due to a reduced number of white blood cells),
yellowing of the skin or whites of the eyes (jaundice), which may be a sign of liver disease,
persistent dry cough over a long period. Cough has been reported with ACE inhibitors but may also be a symptom of another upper respiratory tract disease,
mild myopia or glaucoma. Talk to your doctor or pharmacist if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking lisinopril/hydrochlorothiazide. If untreated, this could lead to permanent vision loss. If you have previously been allergic to penicillins or sulfonamides, you may have a higher risk of developing these symptoms.

Other medicines and Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is particularly important if you are also taking:

potassium supplements (including salt substitutes), potassium-sparing diuretics, or other medicines that increase potassium levels in your body (such as heparin, a medicine used to thin the blood to prevent clots; cotrimoxazole and trimethoprim for bacterial infections; and cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs),
other medicines used to treat high blood pressure. Your doctor may need to adjust your dose and/or take other precautions. If you are taking an angiotensin receptor antagonist (ARA) or aliskiren (see also information under the headings “DO NOT take Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica” and “Warnings and precautions”),
anesthetics, and medicines for mental disorders or depression (e.g., tricyclic antidepressants), medicines for psychosis, medicines for seizures, or sedatives. Low blood pressure may worsen. You may feel dizzy when standing up.
lithium (medicine for depression),
painkillers and anti-inflammatory medicines (used to treat muscle pain or arthritis), such as acetylsalicylic acid, ibuprofen, or indomethacin,
sodium aurothiomalate (gold), an injectable medicine for rheumatoid arthritis,
medicines such as ephedrine, noradrenaline, or adrenaline used to treat hypotensive shock, heart failure, asthma, or allergies,
medicines to lower blood sugar, such as insulin or oral antidiabetics (including vildagliptin). See also section “Warnings and precautions”,
cholestyramine and colestipol resins, active substances to lower blood lipid levels,
corticosteroids, hormonal anti-inflammatory agents,
corticotropin (ACTH), used to check whether your adrenal glands are functioning properly,
diuretics,
muscle relaxants (e.g., tubocurarine chloride, medicines used to relax muscles during surgery),
allopurinol, medicines used to treat gout,
cancer treatments such as cyclophosphamide or methotrexate,
medicines that suppress the immune system, medicines to prevent rejection after organ or bone marrow transplant,
procainamide, a medicine for irregular heartbeats,
cardiac glycosides (e.g., digoxin, medicines to strengthen the heart),
medicines that may cause abnormalities in cardiac conduction as side effects, such as medicines for cardiac arrhythmias, some antipsychotics, and other medicines such as those used to treat bacterial infections,
calcium salts, leading to increased calcium levels in blood,
vitamin D,
amphotericin B, an antifungal medicine,
laxatives, medicines to promote bowel movements,
carbenoxolone, a medicine for gastrointestinal disorders,
medicines often used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section "Warnings and precautions",
medicines called NEP inhibitors such as racecadotril used to treat diarrhea. See section “Warnings and precautions”,
sacubitril/valsartan (used to treat chronic heart failure). See section “Do not take Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica”,
tissue plasminogen activator (tPA), used to dissolve blood clots formed in blood vessels. See section “Warnings and precautions”,
lovastatin, a medicine for high cholesterol,
sotalol (a beta-blocker), as it increases the risk of arrhythmias,
diazoxide (a medicine for blood sugar treatment),
amantadine (a medicine for Parkinson’s disease or severe viral infections).

Taking Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica with alcohol

Low blood pressure may be worsened by alcohol. You may feel dizzy when standing up.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Talk to your doctor if you think you are (or might become) pregnant. Your doctor will advise you to stop taking lisinopril/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Lisinopril/hydrochlorothiazide is not recommended during 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 after the third month of pregnancy.

Breastfeeding

Talk to your doctor if you are breastfeeding or plan to breastfeed. Lisinopril/hydrochlorothiazide is not recommended for breastfeeding mothers. 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 use of machines

You may feel dizzy or tired while taking this medicine. If this occurs, do not drive or operate machinery (see section “Possible side effects”).

Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially sodium-free.

3. How to take Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

The usual dose is one tablet once daily.

The maximum dose is 40 mg of lisinopril and 25 mg of hydrochlorothiazide per day.

Use in children

The safety and efficacy profile has not been established in children.

Elderly

No special dose adjustments are required.

Renal problems

Do not take this medicine if you have severe renal problems.

If you have a kidney disorder, your doctor will prescribe a lower dose and monitor your kidney function.

Prior treatment with diuretics

If you are switching from a diuretic to lisinopril/hydrochlorothiazide, your doctor should instruct you to stop taking the diuretic 2 or 3 days before starting this medicine.

How to take the tablet

Take the tablet or half tablet with plenty of water. Try to take your medicine at the same time every day.

Tablet splitting

Place the tablet on a hard surface with the score line facing upwards. Press your finger in the middle of the tablet and the tablet will split into two parts.

If you take more Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica than you should

If you (or someone) take many tablets at once or you think a child has swallowed any tablets, consult your doctor immediately.

Overdose may cause low blood pressure, dizziness, circulatory shock, disturbances in electrolyte balance, kidney failure, hyperventilation (rapid breathing, feeling unwell), excessively fast or slow heartbeat, palpitations (awareness of abnormally rapid or irregular heartbeat), anxiety, and cough. Take this leaflet and any remaining tablets to the hospital or doctor so they can see what has been taken.

If you have taken more Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica

Do not take a double dose to make up for forgotten doses. Take your next dose at the scheduled time.

If you stop taking Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica

Treatment of hypertension is long-term, and stopping treatment should be discussed with your doctor. Stopping or discontinuing treatment may cause your blood pressure to increase.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, stop taking this medicine immediately and consult your doctor or go to the nearest hospital emergency department.

Severe allergic reaction called angioedema (rash, itching, swelling of the limbs, face, lips, mouth or throat which may cause difficulty breathing or swallowing).

This is a rare and serious adverse effect (may affect up to 1 in 1,000 people). It may require urgent medical attention or hospitalization.

A severe allergic reaction called anaphylactoid reaction causing difficulty breathing or dizziness. The frequency of this adverse effect is not known.
Serious skin disorders with severe rash or itching, skin peeling or blisters, redness of the skin all over the body, eye, mouth or genital pain, fever (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, pemphigus). These side effects are serious and very rare (may affect up to 1 in 10,000 people).
Heart attack or stroke (mini-stroke) (mainly in patients with low blood pressure). This is a serious and uncommon adverse effect (may affect up to 1 in 100 people).
Difficulty breathing, wheezing (bronchospasm). This is a serious and very rare adverse effect (may affect up to 1 in 10,000 people).
Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion). This is a very rare adverse effect (may affect up to 1 in 10,000 people).
Jaundice (yellowing of the skin and whites of the eyes).

This is a potentially serious but very rare adverse effect (may affect up to 1 in 10,000 people), indicating liver inflammation which may progress to liver failure. It may require urgent medical attention or hospitalization.

Inflammation of the pancreas causing severe abdominal and back pain (pancreatitis). This is a serious and very rare adverse effect (may affect up to 1 in 10,000 people).
Weakness and fatigue, loss of appetite, dizziness, vomiting, tremors, reduced or no urination (decreased urine output), possibly accompanied by high temperature (fever), side pain, swelling of legs, ankles, feet, face and hands, or blood in the urine. These are serious adverse effects due to kidney problems such as uraemia (high levels of urea in blood), sudden kidney failure (adverse effects rare, may affect up to 1 in 1,000 people), or inflammation of the kidneys (interstitial nephritis), an adverse effect with frequency not known.
Sudden onset of myopia. This is a serious adverse effect with frequency not known.
Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma). These are serious adverse effects with frequency not known.
Allergic conditions causing joint pain, skin rashes and fever (systemic lupus erythematosus). The frequency of this serious adverse reaction is unknown.
Cough, shortness of breath and elevated temperature (fever) due to lung inflammation (pneumonitis). This is a serious and very rare adverse effect (may affect up to 1 in 10,000 people).
Difficulty breathing. You may feel short of breath if your lungs become inflamed or fill with fluid (pneumonitis, pulmonary oedema). These are serious adverse reactions with frequency not known.

Lisinopril/hydrochlorothiazide commonly (may affect up to 1 in 10 people) causes a drop in blood pressure which may be associated with mild headache and weakness. In some patients, this may occur after the first dose or when the dose is increased. If you experience these symptoms, consult your doctor immediately.

Lisinopril/hydrochlorothiazide may very rarely (may affect up to 1 in 10,000 people) reduce the number of white or red blood cells or platelets and may decrease your resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, pale skin, fatigue, shortness of breath, or fever with local signs of infection such as sore throat/pharyngitis/oral ulcers, dark urine, spontaneous bleeding or bruising, or urinary problems, consult your doctor immediately. A blood sample will be taken to check for possible reduction in white blood cells (agranulocytosis). It is important to inform your doctor about your medication.

A dry cough has been detected frequently (may affect up to 1 in 10 people) with lisinopril/hydrochlorothiazide and other ACE inhibitors, which may persist for a long time. However, it may also be a symptom of another upper respiratory tract disease. Consult your doctor if you experience this symptom.

The following adverse effects have also been reported:

Common (may affect up to 1 in 10 people)

dizziness, headache, sudden loss of consciousness,
low blood pressure associated with changes in posture (such as dizziness or weakness when standing up after lying down),
diarrhoea, nausea,
kidney problems.

Uncommon (may affect up to 1 in 100 people)

mood changes,
tingling or numbness (paraesthesia), sensation of spinning, taste disturbances, difficulty breathing,
palpitations (awareness of rapid or strong heartbeat),
excessively fast heartbeat (tachycardia),
Raynaud's syndrome, a blood vessel disorder causing tingling, paleness, followed by blueness and then redness in fingers and toes,
inflammation of the nasal lining causing rhinitis,
nausea, abdominal pain and indigestion,
increased levels of liver enzymes and waste products,
rash or itching,
inability to achieve or maintain an erection (impotence),
general fatigue, weakness,
increased blood urea levels,
high blood potassium levels, which may cause abnormal heart rhythm and increased blood creatinine levels.

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

decreased haemoglobin and number of red blood cells (haematocrit),
mental confusion,
changes in the sense of smell,
dry mouth,
itching, hair loss, red/silvery skin patches (psoriasis),
breast enlargement in men (gynaecomastia),
low blood sodium levels, which may cause fatigue, confusion, muscle cramps, seizures or coma, also leading to dehydration and low blood pressure causing dizziness upon standing,
syndrome of inappropriate antidiuretic hormone secretion (SIADH). Symptoms include weight gain, nausea, vomiting, muscle cramps, confusion and seizures.

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

lymph node disease, autoimmune disorder in which the body attacks itself,
hypoglycaemia (low blood sugar levels) (see "Warnings and precautions"),
inflammation of the sinuses,
swelling of the intestinal lining (intestinal angioedema). This may cause sudden stomach pain, diarrhoea or nausea (vomiting),
excessive sweating (diaphoresis),
accumulation of mature or abnormal-looking lymphocytes in the dermis (cutaneous pseudolymphoma). A complex adverse reaction has been reported which may include one or all of the following: high temperature, inflammation of blood vessels, muscle and joint pain and swelling, blood abnormalities detected by blood tests, rash, photosensitivity, and other skin effects**,
reduced or no urination (low urine output).

Frequency not known (cannot be estimated from available data)

skin and lip cancer (non-melanoma skin cancer),
inflammation of the salivary glands,
loss of appetite, weight loss,
increased blood sugar (glucose) levels (hyperglycaemia),
sugar in the urine,
increased blood uric acid levels,
elevated or high blood fat levels (including cholesterol),
low blood potassium levels, which may cause muscle weakness, cramps or abnormal heart rhythm,
joint pain or swelling (gout),
decreased blood magnesium and chloride levels,
stomach irritation,
constipation,
restlessness,
seeing, feeling or hearing things that are not real (hallucinations),
vision disorders (yellow vision, blurred vision),
damage to blood vessels causing red or purple spots on the skin,
inflammatory condition of blood vessels causing red or purplish spots on the skin,
skin sensitivity to light, skin disorders with red patches on the nose and cheeks (lupus erythematosus), which may worsen in patients who already have it,
muscle cramps, muscle weakness,
fever,
depression,
hot flushes.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

5. Storage of Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica

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 CAD/EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica

The active substances are lisinopril and hydrochlorothiazide. Each tablet contains 20 mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide.
The other components are: calcium hydrogen phosphate dihydrate, croscarmellose sodium, manitol, corn starch, magnesium stearate and red iron oxide (E172).

Appearance of the product and contents of the pack

Pink, round, biconvex tablet, scored on one side.

The tablets are packaged in PVC/aluminum blisters inside a cardboard box.

Lisinopril/Hydrochlorothiazide Sandoz Farmacéutica is available in packs of 14, 28, 30, 50, 56, 98, 100 and 400 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

ROWA Pharmaceuticals Limited

Newtown, Bantry, Co. Cork

Ireland

This medicinal product is authorized in the European Economic Area member states under the following names:

Belgium: Co-Lisinopril Sandoz 20 mg/12.5 mg tabletten

Ireland: Lispril-Hydrochlorothiazide 20 mg/12.5 mg tablets

Italy: LISINOPRIL IDROCLOROTIAZIDE SANDOZ

Portugal: Lisinopril + Hidroclorotiazida Sandoz 20 mg + 12.5 mg comprimidos

Date of the most recent review of this leaflet: February 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):

http://www.aemps.gob.es/