Lisinopril/hydrochlorothiazide CINFA 20 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

lisinopril / hydrochlorothiazide cinfa 20 mg/12.5 mg tablets EFG

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

• Keep this leaflet as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What lisinopril/hydrochlorothiazide cinfa is and what it is 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. How to store lisinopril/hydrochlorothiazide cinfa
6. Contents of the pack and other information

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

Lisinopril/hydrochlorothiazide cinfa contains two medicines: lisinopril and hydrochlorothiazide. Each of these reduces blood pressure through a different mechanism. Lisinopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. Lisinopril works by dilating blood vessels, helping to lower blood pressure and making it easier for the heart to pump blood throughout the 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 ingredients of this medicine (listed in section 6).
• If you have previously received any medicine from the same class of drugs as lisinopril (ACE inhibitors) and experienced an allergic reaction causing 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 medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, for example in 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-type reaction to diuretics of the hydrochlorothiazide type, which are medicines similar to sulfonamides (a type of antibiotic), or to any other component of this medicine.
• If you are more than 3 months pregnant. It is also advisable to avoid this medicine during early pregnancy; see section "Pregnancy and breastfeeding".
• If you have impaired kidney function.
• If you have recently undergone a kidney transplant.
• If you have reduced urine output or inability to urinate (anuria).
• If you have impaired liver function.
• If you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing 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 medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking lisinopril/hydrochlorothiazide cinfa:

• If you have narrowing (stenosis) of the aorta (one of the arteries in the heart) or of the mitral valve (one of the heart valves).
• If you have narrowing (stenosis) of the renal artery.
• If you have thickening of the heart muscle (known as hypertrophic cardiomyopathy).
• If you have low blood pressure (you may feel dizzy, especially when standing up. In such cases, lying down may help).
• If you have heart failure (heart unable to pump 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 antidiabetic medicines or insulin.
• 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.
• If you have previously experienced respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking lisinopril/hydrochlorothiazide cinfa, seek medical attention immediately.

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 cinfa”.

• If you are taking any medicine that may increase the risk of angioedema; see “Taking lisinopril/hydrochlorothiazide with other medicines”.

• Racecadotril, a medicine used to treat diarrhea.

• Medicines used to prevent rejection of transplanted organs and for cancer (e.g., temsirolimus, sirolimus, everolimus).

• Vildagliptin, a medicine 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 potassium-sparing diuretics or medicines that may increase blood potassium levels, such as heparin.

• If you have high cholesterol and are receiving a treatment called "LDL apheresis".

• If you are of Black race, as this medicine may be less effective. You are also more likely to develop the adverse effect "angioedema" (a serious allergic reaction).

• If you have a persistent dry cough.

• If you have persistently low blood potassium levels.

• If you have persistently high blood calcium levels.

• 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. Use of lisinopril/hydrochlorothiazide is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby (see section on pregnancy).

• 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 cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking lisinopril/hydrochlorothiazide cinfa.

• If you experience vision loss or eye pain, which 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 you are unsure whether you are in any of the situations described above, consult your doctor or pharmacist before taking this medicine.

Stop taking lisinopril/hydrochlorothiazide and seek immediate medical help:

• 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 may cause difficulty swallowing.
• If you develop intense itching of the skin (with hives).

Treatment of allergies such as insect stings

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

Surgery

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

Take special care with the initial dose of this medicine, as it may cause a more pronounced drop in blood pressure than usually seen with continued treatment. This effect may manifest as dizziness or vertigo; in such cases, lying down may help. However, if you are concerned, consult your doctor.

Taking lisinopril/hydrochlorothiazide cinfa with other medicines

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

This is because this medicine may affect how some medicines work, and some medicines may affect this medicine.

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 that reduce blood potassium levels, such as amphotericin (for treatment of fungal infections), carbenoxolone (for esophageal disease or oral ulcers), corticosteroids (e.g., prednisone), pituitary hormone (ACTH), or certain laxatives, other diuretics (medicines used to increase urine output, including potassium-sparing diuretics), and salicylate derivatives.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g., trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). Medicines that may cause arrhythmias.
• Medicines for depression and mental disorders, including lithium.
• Anesthetic medicines, barbiturates, or alcohol, which may worsen the drop in blood pressure (you may feel dizzy, especially when standing up).
• Non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, ibuprofen, and indomethacin, used to treat pain and arthritis.
• Injectable medicines for rheumatoid arthritis containing gold salts (e.g., sodium aurothiomalate).
• Medicines to control heart rhythm (antiarrhythmics) such as digoxin and beta-blockers (e.g., sotalol).
• Other medicines for treating high blood pressure (antihypertensives), including angiotensin II receptor antagonists (ARA) or aliskiren (see “Do not take lisinopril/hydrochlorothiazide cinfa”).
• Nitrate-derived medicines (for heart problems).
• Medicines for treating diabetes, such as insulin and oral antidiabetics like sulfonylureas. The dose of your antidiabetic medicine may need to be adjusted while taking thiazide diuretics.
• Medicines that increase blood potassium levels, such as heparin (to prevent blood clotting).
• Calcium or vitamin D supplements.
• Cholesterol-lowering medicines such as colestipol or cholestyramine or lovastatin.
• Muscle relaxants such as tubocurarine.
• Trimethoprim (an antibiotic).
• Allopurinol (for gout).
• Cyclosporine (a medicine to prevent transplant rejection and treat other immune system diseases).
• Medicines for treating cancer, such as cyclophosphamide or methotrexate.

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

• Medicines to dissolve blood clots (tissue plasminogen activator), usually administered in hospital.
• Medicines used to prevent rejection of transplanted organs such as liver or kidney, e.g., sirolimus, or for cancer treatment, e.g., temsirolimus and everolimus.
• Racecadotril, a medicine used to treat diarrhea.
• Vildagliptin, a medicine 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 medicine.

Pregnancy

Inform your doctor if you think you are (or plan to become) pregnant. Your doctor will usually 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 early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if used after the third month of pregnancy.

Lisinopril/hydrochlorothiazide should normally be replaced with an appropriate antihypertensive treatment before pregnancy begins. The medicine must not be used during the second and third trimesters of pregnancy.

Your doctor will usually advise you to stop taking lisinopril/hydrochlorothiazide as soon as you find out you are pregnant.

If you become pregnant while taking this medicine, inform and see your doctor immediately.

Breastfeeding

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

Driving and using machines

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

Use in athletes:

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

3. How to take lisinopril/hydrochlorothiazide cinfa

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

Taking the medicine

Swallow the tablet with water.

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

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

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

Taking the first dose

Take special care when taking the first dose of this medicine or if your dose is increased. It may cause a greater drop in blood pressure than subsequent doses.

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

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

Adults

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

Use in children and adolescents

The use of lisinopril/hydrochlorothiazide is not recommended in children and adolescents, as 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, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the package leaflet and container of the medicine 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 forgotten doses.

If you stop taking lisinopril/hydrochlorothiazide cinfa

Do not stop treatment before your doctor tells you to do so.

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 experiences them.

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

• Severe allergic reactions (uncommon, may affect up to 1 in 100 patients). Signs may include sudden onset of:

  • Swelling of the face, lips, tongue, or throat. This may make swallowing difficult.
  • Severe or sudden swelling of the hands, feet, or ankles.
  • Difficulty breathing.
  • Severe skin itching (with hives).

• Serious skin disorders, such as an unexpected and sudden rash, skin redness, or skin peeling (very rare, may affect up to 1 in 10,000 patients).

• An infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of localized infection such as sore throat/pharynx/mouth or urinary disorders (very rare, may affect up to 1 in 10,000 patients).

• Sudden pain and redness in the eye, as untreated cases may lead to permanent vision loss.

Other possible adverse effects due to lisinopril:

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

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

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

• Mood changes.
• Change in color of fingers and toes (pale blue followed by redness) or numbness or tingling in fingers or toes.
• Sensation of dizziness.
• Drowsiness.
• Difficulty sleeping.
• Visual and/or auditory hallucinations.
• Rhinitis.
• Nausea.
• Stomach pain and indigestion.
• Changes in blood tests used to monitor proper liver and kidney function.
• Skin rash and itching.
• Inability to achieve an erection (impotence).
• Feeling of tiredness or weakness (lack of strength).
• A significant drop in blood pressure that may occur in patients with the following conditions: coronary heart disease, narrowing of the aorta (a heart artery), renal arteries or heart valves; thickening of the heart muscle. If this occurs, you may feel dizzy or lightheaded, especially when standing up quickly.
• Myocardial infarction.
• Stroke.
• Rapid heartbeat.

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

• Changes in certain blood cells or other blood components. Your doctor may take blood samples from time to time to check whether lisinopril/hydrochlorothiazide is affecting your blood. Signs may include fatigue, pale skin, sore throat, fever, joint and muscle pain, joint or gland swelling, or sensitivity to sunlight.
• Confusion.
• Hives rash.
• Dry mouth.
• Hair loss.
• Psoriasis (a skin condition).
• Breast development in men.
• Sudden kidney failure.
• Change in the perception of smell.
• Decreased sodium levels in blood (hyponatremia) (symptoms may include fatigue, headache, nausea, and vomiting).

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

• Low blood glucose levels (hypoglycemia). Signs may include feeling hungry or weak, sweating, and rapid heartbeat.
• Sinusitis (feeling of pain and pressure behind the cheeks and eyes).
• Wheezing.
• Lung inflammation. Signs include cough, shortness of breath, and high fever.
• Pancreatitis. This causes moderate to severe stomach pain.
• Intestinal inflammation.
• Yellowing of the skin or whites of the eyes (jaundice).
• Liver inflammation. This may cause loss of appetite, yellowing of the skin and eyes, and dark-colored urine.
• Liver failure.
• Sweating.
• Severe skin disorders. Symptoms include redness, blistering, and peeling.
• Hives.
• Decreased urine output or inability to urinate.

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

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

Other adverse effects due 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.
• Reduction in platelet count (thrombocytopenia).
• Reduction in white blood cell count (leukopenia).
• Decrease in granulocyte count (agranulocytosis).
• Anemia due to destruction of red blood cells (hemolytic anemia).

Metabolism and nutritional disorders

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

Psychiatric disorders

• Restlessness.
• Depression.
• Sleep disturbances.

Nervous system disorders

• Loss of appetite.
• Tingling sensation in hands and feet.
• Dizziness.

Eye disorders

• Visual disturbances causing objects to appear yellowish.
• Severe eye pain accompanied by redness and sudden blurred vision.
• Visual disturbances.
• Decreased vision or eye pain due to elevated 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

• Inflammation of blood vessels.

Respiratory system disorders

• Shortness of breath.
• Pulmonary inflammation.

Gastrointestinal disorders

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

Hepatic disorders

• Yellowish discoloration of the skin (jaundice).

Skin and subcutaneous tissue disorders

• Skin reaction due to sensitivity to sunlight.
• Rash.
• Urticaria.
• Skin rash with hives.
• In some patients with lupus, symptoms may be reactivated or worsened.

Musculoskeletal disorders

• Muscle spasms.
• Muscle weakness.

Renal and urinary disorders

• Impaired kidney function.
• Kidney inflammation.

General disorders

• Fever.
• Weakness.

Respiratory system disorders

Very rare frequency: Acute respiratory difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused 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 cinfa

• The active substances 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, colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and contents of the pack

Lisinopril/hydrochlorothiazide cinfa is presented as white, cylindrical, biconvex, scored tablets marked with the code "LH", in packs containing 28 and 280 tablets (clinical pack).

Only certain pack 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 most recent revision of this leaflet: June 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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

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