LISINOPRIL/HYDROCHLOROTHIAZIDE SANDOZ FARMACEUTICA 20/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical 20 mg/12.5 mg Tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, as 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 others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical and what is it used for.
2. What you need to know before you start taking Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical.
3. How to take Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical.
4. Possible side effects.
5. Storage of Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical.
6. Contents of the pack and further information.

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

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

Hydrochlorothiazidebelongs to a group of medicines called diuretics and lowers blood pressure by increasing urine production.

Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical 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 of the same doses of lisinopril and hydrochlorothiazide. This fixed-dose combination is not suitable for initial treatment.

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

Do not take Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical:

• 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 (e.g. ramipril) or to sulphonamide-derived medicines (most antibiotics, e.g. sulfamethoxazole),
• if you have ever had itching, blisters, a sudden drop in blood pressure, sudden swelling of your hands, feet, ankles, face, lips, tongue or throat (angioedema), especially after treatment with ACE inhibitor medicines. You may also experience difficulty swallowing or breathing.
• if you have hereditary angioedema (a condition that makes you more prone to the above-mentioned swelling). If you are not sure whether this condition applies to you, consult your doctor,
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased,
• if any of your family members have ever had swelling of the 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 recommended to avoid lisinopril/hydrochlorothiazide at the start of pregnancy, see section Pregnancy),
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical:

• if you have narrowing of the arteries (arteriosclerosis), cerebrovascular problems such as a stroke or a transient ischaemic attack (TIA, a small stroke),
• if you have heart failure,
• if you have low blood pressure, are on a low-salt 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 (cardiomyopathy), narrowing of the main artery that carries blood from the heart (aortic stenosis), or other forms of a heart problem called outflow tract obstruction,
• if you are undergoing LDL apheresis (removal of cholesterol from the blood through a machine),
• if you are undergoing desensitization treatment to insect bites (e.g. bee or wasp stings),
• if you have diabetes,
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or difficulty breathing after taking lisinopril/hydrochlorothiazide, see your doctor immediately,
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARB) (also known as "sartans", e.g. valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the information under the heading “Do not take Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical”)

• if you are taking any of the following medicines, the risk of angioedema may increase (rapid swelling under the skin in an area such as the throat):
• sirolimus, temsirolimus, everolimus, and other medicines belonging to the class called mTOR inhibitors (used to prevent rejection in organ transplantation and for cancer),
• 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, have high levels of uric acid in your blood, or are being treated with allopurinol or procainamide,
• if you are going to undergo surgery (including dental surgery) and will receive anaesthetics,
• if you have recently had prolonged vomiting and/or severe diarrhea,
• if you are going to have a test to check your parathyroid gland function,
• if you have or have had liver or kidney problems, or have narrowing of the arteries in your kidneys (renal artery stenosis), or have only one functioning kidney, or are on dialysis treatment,
• 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 if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical,
• if you have allergic problems 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 at the start of 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 section Pregnancy),
• if you are taking other diuretics.

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

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

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

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

Elderly or malnourished patients should be careful 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 Pharmaceutical:

Consult 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 to an increase in dose with dizziness, weakness, fainting, and nausea,
• sudden swelling of lips and throat, 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 temperatures, sore throat or mouth ulcers (these can be symptoms of infection caused by a low white blood cell count),
• yellowing of the skin and whites of the eyes (jaundice) which can be a symptom of liver disease,
• persistent dry cough for a long time. Cough has been reported with the use of ACE inhibitors but may also be a symptom of another respiratory tract infection,
• mild myopia or glaucoma. Talk to your doctor or pharmacist if you experience a decrease in vision or eye pain. They could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within hours to a week after taking lisinopril/hydrochlorothiazide. If left untreated, it could lead to permanent vision loss. If you have previously been allergic to penicillins or sulphonamides, you may be at higher risk of developing them.

Other medicines and Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

This applies especially if you are also taking:

• potassium supplements (including salt substitutes), or potassium-sparing diuretics and other medicines that increase the amount of potassium in your body (such as heparin, a medicine used to thin the blood to prevent clots, cotrimoxazole and trimethoprim, for bacterial infections; and ciclosporin, an immunosuppressant used to prevent organ rejection after transplantation),
• other medicines used to treat high blood pressure. Your doctor may need to change your dose and/or take other precautions. If you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also the information under the headings “Do not take Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical” and “Warnings and precautions”)
• anaesthetics and medicines for mental disorders or depression (e.g. tricyclic antidepressants), medicines for the treatment of psychosis, medicines for the treatment of seizures, or sedatives. Low blood pressure may worsen. You may feel dizzy when standing up.
• lithium (a medicine for depression),
• analgesics 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 shock due to low blood pressure, heart failure, asthma or allergies,
• medicines to lower blood sugar, such as insulin or oral medicines (including vildagliptin). See also section “Warnings and precautions”
• cholestyramine and colestipol resins, active substances to lower blood lipid levels,
• corticosteroids, anti-inflammatory medicines of the hormonal type,
• corticotropin (ACTH), used to check if your adrenal glands are working properly,
• diuretics,
• muscle relaxants (e.g. tubocurarine chloride, medicines to relax muscles used in operations),
• allopurinol, medicines used to treat gout,
• medicines for cancer treatment, such as cyclophosphamide or methotrexate,
• medicines that suppress the immune system, medicines to prevent rejection after organ transplantation or bone marrow transplantation,
• procainamide, a medicine for irregular heartbeats,
• cardiac glycosides (e.g. digoxin, medicines to strengthen the heart),
• medicines that as a side effect cause abnormalities in the conduction of stimuli in the heart, such as medicines for heart rhythm disorders, some medicines for psychosis, and other medicines such as those used to treat bacterial infections,
• calcium salts, increase in calcium levels in the blood,
• vitamin D,
• amphotericin B, a medicine for fungal infections,
• laxatives, medicines to facilitate bowel movements,
• carbenoxolone, a medicine for gastrointestinal diseases,
• medicines commonly used to prevent organ rejection after transplantation (sirolimus, everolimus, and other medicines belonging to the class of 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 long-term heart failure). See section “Do not take Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical”
• tissue plasminogen activator (tPA), used to dissolve blood clots that have 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 high blood sugar),
• amantadine (a medicine for Parkinson's disease or severe viral infections).

Taking Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical and alcohol

Low blood pressure may worsen due to alcohol. You may feel dizzy when standing up.

Pregnancy and breastfeeding

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

Pregnancy

Consult your doctor if you think you are (or might become) pregnant. Your doctor will advise you to stop taking lisinopril/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of lisinopril/hydrochlorothiazide. 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

Consult your doctor if you are breastfeeding or plan to breastfeed. Lisinopril/hydrochlorothiazide is not recommended for breastfeeding mothers, your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

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

Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical contains sodium

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

3. How to Take Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

The normal dose is one tablet once a day.

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.

Advanced Age

No special dose adjustments are required.

Kidney Problems

Do not take this medication if you have severe kidney problems.

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

Previous Treatment with Diuretics

If you switch from a diuretic to lisinopril/hydrochlorothiazide, your doctor should indicate that you stop taking the diuretic 2 or 3 days before starting this medication.

How to Take the Tablet

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

Dividing the Tablet

Place the tablet on a hard surface with the dividing line facing up. Press with your finger in the middle of the tablet and the tablet will divide into two parts.

If You Take More Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical Than You Should

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

Overdose can cause a decrease in blood pressure, dizziness, circulatory shock, changes in salt balance, kidney failure, hyperventilation (rapid breathing, feeling of illness), excessive or slow heart rate, palpitations (feeling of an irregular heartbeat), anxiety, and cough. Bring this leaflet and the remaining tablets to the hospital or doctor so they can know what you have taken.

If you have taken more Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If You Forget to Take Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical

Do not take a double dose to make up for missed doses; take your next dose at the planned time.

If You Interrupt Treatment with Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical

Treatment for hypotension is long-term, and interrupting treatment should be discussed with your doctor. Stopping or abandoning treatment can cause an increase in blood pressure.

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

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people experience them.

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

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

This is a rareand severe adverse effect (may affect up to 1 in 1,000 people). You may need urgent medical attention or hospitalization.

• A severe allergic reaction called anaphylactoid reaction that causes difficulty breathing or dizziness. The frequency of this adverse effect is unknown.
• Severe skin disorders with severe rash or itching, skin peeling, or blisters on the skin, redness of the skin all over the body, eye pain, mouth or genital pain, fever, (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, pemphigus). These adverse effects are severe and very rare (may affect up to 1 in 10,000 people).
• Heart attack or stroke (mainly in patients who suffer from low blood pressure). This is a severe and infrequentadverse effect (may affect up to 1 in 100 people).
• Breathing difficulties, wheezing (bronchospasm). This is a severe and very rareadverse effect (may affect up to 1 in 10,000 people).
• Acute respiratory distress (signs include severe breathing difficulties, fever, weakness, and confusion). This is a very rareadverse effect (may affect up to 1 in 10,000 people),
• Jaundice (yellowing of the skin and whites of the eyes).

This is a potentially severe but very rareadverse effect (may affect up to 1 in 10,000 people) that indicates liver inflammation that can progress to liver failure. You may need urgent medical attention or hospitalization.

• Pancreatitis, which causes severe abdominal and back pain. This is a severe and very rareadverse effect (may affect up to 1 in 10,000 people).
• Weakness and fatigue, loss of appetite, feeling of dizziness, vomiting, tremors, not urinating (decreased urine output) may also appear with high fever, side pain, swelling of the legs, ankles, feet, face, and hands, or blood in the urine. These are severe adverse effects due to kidney problems such as uremia (high levels of urea in the blood), sudden kidney failure, adverse effects that are rare(may affect up to 1 in 1,000 people), or kidney inflammation (interstitial nephritis), an adverse effect of unknown frequency.
• Sudden vision loss. This is a severe adverse effect whose frequency is unknown.
• 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). These are severe adverse effects with unknown frequency.
• Allergic conditions that cause joint pain, skin rash, and fever (systemic lupus erythematosus). The frequency of this severe adverse reaction is unknown.
• Cough, shortness of breath, and elevated temperature (fever) due to lung inflammation (pneumonia). This is a severe and very rareadverse effect (may affect up to 1 in 10,000 people).
• Breathing difficulties. You may feel short of breath if your lungs become inflamed or have fluid inside (pneumonitis, pulmonary edema). These are severe adverse reactions with unknown frequency.

Lisinopril/hydrochlorothiazide frequently(may affect up to 1 in 10 people) produces a decrease in blood pressure that can be associated with a feeling of mild headache and weakness. In some patients, this can 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) cause a reduction in the number of white blood cells or red blood cells or platelets and may decrease your resistance to infections. If you suffer from an infection with symptoms such as fever and severe deterioration of your general condition, pale skin, fatigue, shortness of breath, or fever with local infection symptoms such as sore throat/pharynx/mouth ulcers, dark urine, bleeding, or spontaneous bruising, or urinary problems, consult your doctor immediately. A blood sample will be taken to check for a possible reduction in white blood cells (agranulocytosis). It is essential to inform your doctor about your medication.

A frequent(may affect up to 1 in 10 people) dry cough has been detected, which can persist for a long time with the use of lisinopril/hydrochlorothiazide and other ACE inhibitors, but it can 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 detected:

Frequent(may affect up to 1 in 10 people)

• dizziness, headache, sudden loss of consciousness,
• decrease in blood pressure associated with postural changes (such as feeling dizzy or weak when getting up after lying down),
• diarrhea, feeling of dizziness,
• kidney problems.

Infrequent(may affect up to 1 in 100 people)

• mood changes,
• tingling or numbness (paresthesia), feeling of spinning, taste alterations, breathing difficulties,
• palpitations (feeling of rapid or very strong heartbeat),
• excessively rapid heart rate (tachycardia),
• Raynaud's syndrome, a disorder of the blood vessels that can cause tingling, pale, and then blue and then reddish fingers and toes,
• inflammation of the nasal lining that causes rhinitis,
• feeling of dizziness, abdominal pain, and indigestion,
• increase in the amount of liver enzymes and waste products produced by the liver,
• rash or itching,
• inability to achieve or maintain an erection (impotence)
• fatigue, general weakness,
• increase in the amount of urea in the blood,
• high levels of potassium in the blood, which can cause an abnormal heart rhythm and increased creatinine levels in the blood.

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

• decrease in hemoglobin and red blood cell count (hematocrit),
• mental confusion,
• changes in the smell of things
• dry mouth,
• itching, hair loss, skin spots (psoriasis),
• breast enlargement in men (gynecomastia),
• low sodium levels in the blood, which can cause fatigue and confusion, muscle spasms, convulsions, or coma, also leading to dehydration and low blood pressure that makes you feel dizzy when standing up,
• syndrome of inadequate secretion of antidiuretic hormone (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 disease, in which the body attacks itself,
• hypoglycemia (low blood sugar levels) (see "Warnings and Precautions"),
• inflammation of the nasal sinuses,
• swelling of the intestinal lining (intestinal angioedema). This can cause sudden stomach pain, diarrhea, or feeling of dizziness (vomiting),
• excessive sweating (diaphoresis),
• aggregation of mature or abnormal lymphocytes in the dermis (cutaneous pseudolymphoma). A complex adverse effect has been reported that may include some or all of the following: elevated temperature, blood vessel inflammation, pain, and inflammation of muscles and joints, blood problems found by blood analysis, rash, hypersensitivity to sunlight, and other skin effects**,
• not urinating or urinating less (low urine output).

Unknown Frequency(cannot be estimated from available data)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Like all medications, this medication can produce adverse effects, although not all people experience them.

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5. Conservation of Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical

• The active ingredients 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, sodium croscarmellose, mannitol, cornstarch, magnesium stearate, and red iron oxide (E172).

Appearance of the Product and Package Contents

Pink, round, biconvex, and scored tablet.

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

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

Not all package 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

or

ROWA Pharmaceuticals Limited

Newtown, Bantry, Co. Cork

Ireland

This medication is authorized in the Member States of the European Economic Area with the following names:

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

Ireland: Lispril-Hydrochlorothiazide 20 mg/12.5 mg tablets

Italy: LISINOPRIL IDROCLOROTIAZIDE SANDOZ

Portugal: Lisinopril + Hydrochlorothiazide Sandoz 20 mg + 12.5 mg tablets

Date of the Last Revision of this Leaflet:February 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

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