LISINOPRIL/HYDROCHLOROTHIAZIDE CINFA 20 mg/12.5 mg TABLETS

Introduction

Patient Information: Leaflet

lisinopril / hydrochlorothiazide cinfa 20 mg/12.5 mg tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is lisinopril/hydrochlorothiazide cinfa and what is it used for
2. What you need to know before taking lisinopril/hydrochlorothiazide cinfa
3. How to take lisinopril/hydrochlorothiazide cinfa
4. Possible side effects
5. Storage of lisinopril/hydrochlorothiazide cinfa
6. Package contents and additional information

1. What is lisinopril/hydrochlorothiazide cinfa and what is it used for

Lisinopril/hydrochlorothiazide cinfa contains two medications, lisinopril and hydrochlorothiazide. Each of them reduces blood pressure through a different mechanism. Lisinopril belongs to a group of medications called angiotensin-converting enzyme inhibitors, or ACE inhibitors. Lisinopril works by dilating blood vessels, helping to reduce blood pressure and make it easier for the heart to pump blood to the entire body. Hydrochlorothiazide is a diuretic that increases the amount of urine produced by the kidneys.

Lisinopril/hydrochlorothiazide is indicated for the treatment of high blood pressure (hypertension).

2. What you need to know before taking lisinopril/hydrochlorothiazide cinfa

Do not take lisinopril/hydrochlorothiazide cinfa

• If you are allergic to lisinopril, hydrochlorothiazide, or any of the other components of this medication (listed in section 6).
• If you have previously taken any medication from the same group as lisinopril (ACE inhibitors) and have experienced an allergic reaction that caused itching, hives, sudden drop in blood pressure, swelling of hands, feet, or ankles, face, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema).
• If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a 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 high.
• If any member of your family has had a severe allergic reaction (angioedema) to an ACE inhibitor or if you have had a severe allergic reaction (angioedema) for unknown reasons.
• If you have ever had an allergic reaction to diuretics of the hydrochlorothiazide type, which are similar to sulfonamides (a type of antibiotic) or to any other component of this medication.
• If you are pregnant for more than 3 months. It is also best to avoid this medication at the beginning of pregnancy, see the section on "Pregnancy and Breastfeeding").
• If you have kidney function impairment.
• If you have recently undergone a kidney transplant.
• If you have decreased urine production or inability to urinate (anuria).
• If you have liver function impairment.
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

Do not take lisinopril/hydrochlorothiazide if you are in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take lisinopril/hydrochlorothiazide cinfa:

• If you have a narrowing (stenosis) of the aorta (one of the arteries in the heart) or of the mitral valve (one of the valves in the heart).
• If you have a narrowing (stenosis) of the renal artery.
• If you have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy).
• If you have low blood pressure (you may notice it as dizziness, especially when standing up. In these cases, lying down may help).
• If you have heart failure (a problem with the heart pumping enough blood to the body) and normal or low blood pressure.
• If you have kidney problems or if you are on dialysis.
• If you have liver problems.
• If you have diabetes and are being treated with oral antidiabetics or insulin.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as "sartans" - for example, valsartan, telmisartan, irbesartan), particularly if you have diabetic kidney problems.
• aliskiren.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking lisinopril/hydrochlorothiazide cinfa, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals. See also the information under the heading "Do not take lisinopril/hydrochlorothiazide cinfa".

• If you are taking any medication that may increase the risk of angioedema, see "Taking lisinopril/hydrochlorothiazide with other medications".

• Racecadotril, a medication used to treat diarrhea.
• Medications used to prevent organ transplant rejection and cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medication used to treat diabetes.

• If you have gout.
• If you have recently had diarrhea or vomiting.
• If you are on a low-salt diet, taking potassium supplements, or using salt substitutes containing potassium.
• If you are being treated with diuretics (medications used to increase urine production) that spare potassium or medications that can increase potassium levels in the blood, such as heparin.
• If you have high cholesterol levels and are receiving a treatment called "LDL apheresis".
• If you are of African descent, as this medication may be less effective. You are also more likely to develop the side effect "angioedema" (a severe allergic reaction).
• If you have a persistent dry cough.
• If you have persistently low potassium levels in the blood.
• If you have persistently high calcium levels in the blood.
• If you are undergoing tests to detect thyroid or parathyroid disorders.
• You must inform your doctor if you think you are (or plan to become) pregnant. It is not recommended to use lisinopril/hydrochlorothiazide at the beginning of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if used after the third month of pregnancy.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking lisinopril/hydrochlorothiazide cinfa.
• 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 eye pressure, and can occur within a few hours to a week after taking lisinopril/hydrochlorothiazide cinfa.

If you are unsure if you are in any of the situations described above, consult your doctor or pharmacist before taking this medication.

Stop taking lisinopril/hydrochlorothiazide and seek immediate medical attention:

• If you have difficulty breathing with or without swelling of the face, lips, tongue, and/or throat.
• If you have swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing.
• If you experience intense itching of the skin (with hives).

Treatment of Allergies such as Insect Bites

Inform your doctor if you are receiving or will receive treatment to reduce the effect of an allergy to insect bites (desensitization treatment). If you take lisinopril/hydrochlorothiazide while receiving this treatment, it may cause a severe allergic reaction.

Surgery

If you are going to undergo surgery (including dental surgery), inform your doctor or dentist that you are taking this medication. This is because you may experience low blood pressure (hypotension) if you are given certain local or general anesthetics while taking lisinopril/hydrochlorothiazide.

Be careful with the initial dose of this medication, as it may cause a more pronounced decrease in blood pressure than what is normally achieved with continued treatment. This effect may be noticed as dizziness or a feeling of vertigo, in which case lying down may help. However, if you are concerned, consult your doctor.

Taking lisinopril/hydrochlorothiazide cinfa with other medications

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

This is because this medication may affect how some medications work and some medications may affect this medication.

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 medications:

• Medications that decrease potassium levels in the blood, such as amphotericin (for fungal infections), carbenoxolone (for esophageal disease or oral ulcers), corticosteroids (e.g., prednisone), pituitary hormone (ACTH), or certain laxatives, other diuretics (including potassium-sparing diuretics), and salicylate derivatives.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that can increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to thin blood to prevent clots). Medications that cause arrhythmias.
• Medications for depression and mental disorders, including lithium.
• Anesthetic medications, barbiturates, or alcohol that can enhance the decrease in blood pressure (you may notice it as dizziness, especially when standing up).
• Non-steroidal anti-inflammatory medications (NSAIDs), including aspirin, ibuprofen, and indomethacin, for pain and arthritis treatment.
• Injectable medications for rheumatoid arthritis that contain gold salts (e.g., sodium aurothiomalate).
• Medications to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers (sotalol).
• Other medications for high blood pressure treatment (antihypertensives) including angiotensin II receptor antagonists (ARAs) or aliskiren (see "Do not take lisinopril/hydrochlorothiazide cinfa").
• Nitrate-derived medications (for heart problems).
• Medications for diabetes treatment (such as insulin and oral antidiabetics like sulfonylureas). You may need to adjust your diabetes medication dose while taking thiazide diuretics.
• Medications that increase potassium levels in the blood, such as heparin (to prevent blood clot formation).
• Calcium or vitamin D supplements.
• Medications to lower cholesterol, such as colestipol or cholestyramine or lovastatin.
• Muscle relaxants like tubocurarine.
• Trimethoprim (an antibiotic).
• Allopurinol (for gout).
• Cyclosporine (a medication to prevent organ transplant rejection and other immune system diseases).
• Medications for cancer treatment, such as cyclophosphamide or methotrexate.

The following medications may increase the risk of angioedema (signs of angioedema include swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing):

• Medications to dissolve blood clots (tissue plasminogen activator) that are usually administered in the hospital.
• Medications administered to prevent organ transplant rejection, such as liver or kidney, such as sirolimus or for cancer treatment, such as temsirolimus and everolimus.
• Racecadotril, a medication used to treat diarrhea.
• Vildagliptin, a medication used to treat diabetes.

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 medication.

Pregnancy

You must inform your doctor if you think you are (or plan to become) pregnant. Normally, your doctor will advise you to stop taking lisinopril/hydrochlorothiazide before becoming pregnant or as soon as you find out you are pregnant and recommend taking another medication instead of this one. Lisinopril/hydrochlorothiazide is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if used after the third month of pregnancy.

Lisinopril/hydrochlorothiazide should normally be replaced with a suitable anti-hypertensive treatment before starting pregnancy. The medication should not be used during the 2nd and 3rd trimesters of pregnancy.

Normally, your doctor will advise you to stop taking lisinopril/hydrochlorothiazide as soon as you find out you are pregnant.

If you become pregnant during treatment with this medication, inform and consult your doctor as soon as possible.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Hydrochlorothiazide (one of the components of the medication) is excreted in small amounts in breast milk and, at high doses, may inhibit milk production. It is not recommended to use this medication in breastfeeding mothers, and your doctor may choose another treatment for you if you wish to start breastfeeding, especially if your baby is newborn or premature.

Driving and Using Machines

It is unlikely that lisinopril/hydrochlorothiazide will affect your ability to drive or use machines. However, like other medications used to treat blood pressure, lisinopril/hydrochlorothiazide may cause dizziness or drowsiness in some people, especially at the start of treatment, when changing doses, or if you consume alcohol. If you experience dizziness or drowsiness, consult your doctor before performing these activities. You should wait to see how the medication affects you before attempting these activities.

Use in Athletes:

This medication contains hydrochlorothiazide, which may produce a positive result in doping tests.

3. How to Take lisinopril/hydrochlorothiazide cinfa

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Taking the Medication

Swallow the tablet with water.

Try to take your tablets at the same time every day, preferably in the morning. It does not matter if you take this medication before or after meals.

Do not stop taking your tablets if you feel well, unless your doctor tells you to.

If you think the effect of this medication is too strong or too weak, consult your doctor or pharmacist.

First Dose

Be careful when taking the first dose of this medication or if your dose is increased. It may cause a more pronounced decrease in blood pressure than what is normally achieved with continued treatment.

This effect may make you feel dizzy or lightheaded. If this happens, lying down may help.

If you are concerned, consult your doctor as soon as possible.

Adults

The recommended dose is one tablet once a day. If necessary, your doctor may increase your dose to two tablets once a day. The maximum dose is 40 mg of lisinopril/25 mg of hydrochlorothiazide.

Use in Children and Adolescents

The use of lisinopril/hydrochlorothiazide is not recommended in children and adolescents, as the information on safety and efficacy in this age group is limited.

If you take more lisinopril/hydrochlorothiazide cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the leaflet and the medication packaging to the healthcare professional.

If you forget to take lisinopril/hydrochlorothiazide cinfa

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Do not take a double dose to make up for missed doses.

If you stop taking lisinopril/hydrochlorothiazide cinfa

Do not stop treatment before your doctor tells you to.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following reactions, stop taking lisinopril/hydrochlorothiazide and consult your doctor immediately.

• Severe allergic reactions (uncommon, may affect up to 1 in 100 patients). The signs may include the sudden appearance of:
• • Swelling of the face, lips, tongue, or throat. This can make swallowing difficult.
  • Severe or sudden swelling of the hands, feet, or ankles.
  • Difficulty breathing.
  • Severe skin itching (with hives).

• Severe skin disorders, such as an unexpected and sudden rash, redness, or peeling of the skin (very rare, may affect 1 in 10,000 patients).
• A infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as throat/pharynx/mouth irritation or urinary disorders (very rare, may affect 1 in 10,000 patients).
• Acute pain with redness in the eye, as if left untreated, it could lead to permanent vision loss.

Other possible adverse effects due to lisinopril:

Frequent (may affect up to 1 in 10 patients):

• Dizziness, especially when standing up quickly.
• Headache.
• Persistent dry cough.
• Fatigue.
• Diarrhea.
• Nausea.
• Kidney disorders (detected by blood tests).
• Fainting.

Uncommon (may affect up to 1 in 100 patients):

• Mood changes.
• Change in color of the fingers of the hands and feet (pale blue followed by redness) or numbness or tingling in the fingers of the hands or feet.
• Feeling of dizziness.
• Drowsiness.
• Difficulty sleeping.
• Seeing and/or hearing hallucinations.
• Rhinitis.
• Nausea.
• Stomach pain and indigestion.
• Changes in blood tests to determine the proper functioning of your liver and kidneys.
• Skin rash and itching.
• Inability to have an erection (impotence).
• Feeling of fatigue or weakness (lack of strength).
• A significant decrease in blood pressure that can occur in people in the following situations: coronary artery disease, narrowing of the aorta (a heart artery), renal arteries, or heart valves; thickening of the heart muscle. If this happens to you, you may feel dizzy or lightheaded, especially if you stand up quickly.
• Myocardial infarction.
• Stroke.
• Fast heartbeat.

Rare (may affect up to 1 in 1,000 patients):

• Changes in some blood cells or other components of the blood. Your doctor may take samples from time to time to check if lisinopril/hydrochlorothiazide is affecting your blood. The signs may include fatigue, pale skin, throat irritation, fever, joint and muscle pain, inflammation of the joints or glands, or sensitivity to sunlight.
• Confusion.
• Rash with hives.
• Dry mouth.
• Hair loss.
• Psoriasis (a skin problem).
• Development of breast tissue in men.
• Sudden kidney failure.
• Change in the smell of things.
• Decrease in sodium levels in the blood (hyponatremia) (symptoms may be fatigue, headache, nausea, and vomiting).

Very rare (may affect 1 in 10,000 patients):

• Low blood sugar levels (hypoglycemia). The signs may include a feeling of hunger or weakness, sweating, and rapid heartbeat.
• Sinusitis (feeling of pain and pressure behind the cheeks and eyes).
• Shortness of breath.
• Lung inflammation. The signs include cough, shortness of breath, and high fever.
• Pancreatitis. This causes moderate to severe stomach pain.
• Intestinal inflammation.
• Yellowing of the skin or the whites of the eyes (jaundice).
• Liver inflammation. This can cause loss of appetite, yellowing of the skin and eyes, and dark urine.
• Liver failure.
• Sweating.
• Severe skin disorders. The symptoms include redness, blistering, and peeling.
• Hives.
• Decreased urine output or inability to urinate.

Frequency not known(cannot be estimated from the available data):

• Depressive symptoms.
• Flushing (redness).
• Severe allergic reaction.

Other adverse effectsdue to hydrochlorothiazide (frequency not known)

Benign, malignant, and unspecified neoplasms (including cysts and polyps)

• Skin and lip cancer (non-melanoma skin cancer).

Blood and lymphatic system disorders

• Bone marrow depression.
• Reduced platelet count (thrombocytopenia).
• Reduced white blood cell count (leukopenia).
• Decreased granulocyte count (agranulocytosis).
• Anemia due to the destruction of red blood cells (hemolytic anemia).

Metabolic and nutritional disorders

• Anorexia.
• High blood sugar levels (hyperglycemia).
• Presence of glucose in the urine.
• High uric acid levels in the urine.
• Low sodium, potassium, chloride, and magnesium levels in the blood.
• Increased cholesterol and triglyceride levels in the blood.
• Gout.

Psychiatric disorders

• Restlessness.
• Depression.
• Sleep disturbances.

Nervous system disorders

• Lack of appetite.
• Feeling of tingling in hands and feet.
• Feeling of dizziness.

Eye disorders

• Changes in vision that make you see objects yellow.
• Severe eye pain accompanied by redness and sudden blurred vision.
• Visual disturbance.
• 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].

Ear disorders

• Vertigo.

Cardiac disorders

• Postural hypotension.

Vascular disorders

• Vasculitis.

Respiratory disorders

• Shortness of breath.
• Pulmonary inflammation.

Gastrointestinal disorders

• Stomach irritation.
• Diarrhea.
• Constipation.
• Pancreatitis.

Liver disorders

• Yellowing of the skin (jaundice).

Skin and subcutaneous tissue disorders

• Skin reaction caused by sensitivity to sunlight.
• Rash.
• Urticaria.
• Skin rash with hives.
• In some patients with lupus, it can reactivate or worsen their symptoms.

Musculoskeletal disorders

• Muscle spasms.
• Muscle weakness.

Renal and urinary disorders

• Kidney function impairment.
• Kidney inflammation.

General disorders

• Fever.
• Weakness.

Respiratory disorders

Very rare frequency: Acute respiratory distress (symptoms include severe respiratory distress, fever, weakness, and confusion).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. 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 medicine.

5. Storage of lisinopril/hydrochlorothiazide cinfa

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

Do not use this medicine after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Store in the original packaging to protect it from light.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy.

In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of lisinopril/hydrochlorothiazide cinfa

• The active ingredients are lisinopril in the form of lisinopril dihydrate (20 mg) and hydrochlorothiazide (12.5 mg).
• The other components are: mannitol (E-421), calcium hydrogen phosphate dihydrate, corn starch, pregelatinized corn starch, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and package contents

Lisinopril/hydrochlorothiazide cinfa is presented in the form of cylindrical, scored, biconvex tablets of white color, and marked with the code “LH”, in packages containing 28 and 280 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain.

Date of the last revision of this prospectus:June 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76944/P_76944.html

QR code to: https://cima.aemps.es/cima/dochtml/p/76944/P_76944.html