Package Leaflet: Information for the Patient

Lisinopril / Hydrochlorothiazide Cinfa 20 mg/12.5 mg Tablets EFG

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Lisinopril/Hydrochlorothiazide Cinfa

4. Possible side effects

5. Storage of Lisinopril/Hydrochlorothiazide Cinfa

6. Contents of the pack and additional information

Lisinopril/hidroclorotiazida cinfa contains two medicines, lisinopril and hidroclorotiazida. Each one reduces blood pressure through a different mechanism. Lisinopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. Lisinopril acts by dilating blood vessels, helping to reduce blood pressure to facilitate the heart's ability to pump blood throughout its entire body. Hidroclorotiazida is a diuretic that increases the amount of urine produced by the kidneys.

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

Do not take lisinopril/hidroclorotiazida cinfa

Do not take lisinopril/hidroclorotiazida 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

Consult your doctor or pharmacist before starting to takelisinopril/hidroclorotiazida cinfa:

• If you have a narrowing (stenosis) of the aorta (one of the arteries that are in the heart) or of the mitral valve (one of the valves that are 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 you).
• If you have heart failure (heart problem 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 drugs or insulin.
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
• a receptor antagonist of angiotensin II (ARA) (also known as “sartanes” – for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.
• aliskirén.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience shortness of breath or severe difficulty breathing after takinglisinopril/hidroclorotiazida 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/hidroclorotiazida cinfa”.

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

• Racecadotrilo, a medicine used to treat diarrhea.
• Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptina, a medicine used to treat diabetes.

• If you have gout.
• If you have recently had diarrhea or vomiting.
• Follow a low-sodium diet, are taking potassium supplements or salt substitutes containing potassium.
• If you are being treated with potassium-sparing diuretics or medicines that may increase potassium in the blood, such as heparin.
• If you have high cholesterol levels and are receiving a treatment called "LDL apheresis”.
• If you are black, as this medicine may be less effective. It is also more likely that you will develop the adverse effect “angioedema” (a severe allergic reaction).
• If you have persistent dry cough that lasts for a long time.
• If you have persistent low potassium levels in the blood.
• If you have persistent high calcium levels in the blood.
• If you are undergoing tests to detect thyroid or parathyroid gland abnormalities.
• You must inform your doctor if you think you are (or plan to become) pregnant. Lisinopril/hidroclorotiazida is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to the baby if used in this stage (see section on pregnancy).
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its 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 exposure and UV rays while taking lisinopril/hidroclorotiazida cinfa.
• If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur within a few hours to a week after taking lisinopril/hidroclorotiazida.

If you are unsurewhether you are in any of the situations described above, consult your doctor or pharmacist beforetaking this medicine.

Stop taking lisinopril/hidroclorotiazida and seek medical attention immediately:

• 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 experience intense itching on the skin (with hives).

Treatment of allergies such as insect bites

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

Surgery

If you are undergoing 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 you are given certain local or general anesthetics while taking lisinopril/hidroclorotiazida.

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

Taking lisinopril/hidroclorotiazida cinfa with other medicines

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

This is because this medicine may affect the way some medicines work and some medicines may have an effect on this medicine.

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

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

• Medicines that cause a decrease in potassium levels in the blood, such as anfotericina (for fungal infections), carbenoxolona (for esophageal disease or oral ulcers), corticosteroids (e.g., prednisona), pituitary hormone (ACTH) or some 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 potassium levels in the blood (e.g., trimetoprima and cotrimoxazol for bacterial infections: ciclosporina, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to prevent blood clotting).Medicines that cause arrhythmias.
• Medicines for depression and mental disorders, including lithium.
• Anesthetics, barbiturates or alcohol that may exacerbate low blood pressure (you may notice it as dizziness, especially when standing up).
• Non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen and indometacina, for pain and arthritis treatment.
• Injectable medicines for rheumatoid arthritis that contain gold salts (e.g., aurotiomalato de sodio).
• Medicines for controlling heart rhythm (antiarrhythmic agents) such as digoxina and beta-blockers (sotalol).
• Other medicines for treating high blood pressure (antihypertensives) including angiotensin II receptor antagonists (ARAs) or aliskirén (see “Do not take lisinopril/hidroclorotiazida cinfa”).
• Nitrate-derived medicines (for heart problems).
• Medicines for diabetes treatment (such as insulin and oral antidiabetic drugs like sulfonylureas). You may need to change your antidiabetic medication dose while taking diuretic tiazides.
• Medicines that cause an increase in potassium levels in the blood, such as heparin (for preventing blood clotting).
• Calcium supplements or vitamin D.
• Medicines for reducing cholesterol, such as colestipol or colestiramina or lovastatina.
• Muscle relaxants such as tubocurarina.
• Trimetoprim (an antibiotic).
• Alopurinol (for gout).
• Ciclosporina (medicine for preventing organ transplant rejection and other immune system disorders).
• Medicines for cancer treatment, such as ciclofosfamida or metotrexato.

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

• Medicines for dissolving blood clots (tissue plasminogen activator) that are normally administered in the hospital.
• Medicines administered to prevent organ transplant rejection, such as hígado or riñón, as for example sirolimus or for cancer treatment, as for example temsirolimus and everolimus.
• Racecaedotrilo, a medicine used to treat diarrhea.
• Vildagliptina, a medicine used to treat diabetes.

Pregnancyand lactation

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

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/hidroclorotiazida before becoming pregnant or as soon as you find out you are pregnant and recommend taking another medicine instead of this medicine. Lisinopril/hidroclorotiazida is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to the baby if used in this stage (see section on pregnancy).

Normally, lisinopril/hidroclorotiazida should be replaced with an appropriate antihypertensive treatment before starting pregnancy. The medicine should not be used during the 2nd and 3rd trimesters of pregnancy.

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

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

Lactation

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

Driving and using machines

Lisinopril/hidroclorotiazida is unlikely to affect your ability to drive or use machines. However, like other medicines used to treat high blood pressure, lisinopril/hidroclorotiazida may cause dizziness or drowsiness in some people, especially at the beginning of treatment, when changing doses or if consuming alcohol. If you experience dizziness or drowsiness, consult your doctor before engaging in these activities.Wait to see how the medicine affects you before attempting these activities.

Use in athletes:

This medicine contains hidroclorotiazida, which may produce a positive result in doping control tests.

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

Medication intake

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 estimate that the effect of this medication is too strong or too weak, consult your doctor or pharmacist.

First dose intake

Be especially careful when taking the first dose of this medication or if your doctor increases your dose. It may cause a further decrease in blood pressure than what will occur with subsequent doses.

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

If this concerns you, 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 up to two tablets once a day. The maximum dose is 40 mg of lisinopril /25 mg of hidroclorotiazida.

Use in children and adolescents

Lisinopril/hidroclorotiazida is not recommended for use in children and adolescents as the information on safety and efficacy in this age group is limited.

If you take more lisinopril/hidroclorotiazida cinfa than you should

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

If you forget to take lisinopril/hidroclorotiazida 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 compensate for the missed doses.

If you interrupt treatment with lisinopril/hidroclorotiazida cinfa

Do not stop treatment before your doctor tells you to.

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

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

If you experience any of the following reactions,stop taking lisinopril/hydrochlorothiazide and seek medical attention immediately.

• Severe allergic reactions (rare, may affect up to 1 in 100 patients). The signs may include sudden onset of:
• • Swelling of the face, lips, tongue, or throat. This may make it difficult to swallow.
  • 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).
• Infection with symptoms such as fever and severe deterioration of your general condition, or fever with local infection symptoms such as throat, pharynx, or mouth irritation, or urinary tract disorders (very rare, may affect 1 in 10,000 patients).
• Acute eye pain with redness, as if not treated, it could lead to permanent vision loss.

Other possible side 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.
• Renal disorders (detected through blood tests).
• Fainting.

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

• Mood changes.
• Changes in color of the fingers and toes (pale blue followed by redness) or numbness or tingling in the fingers or toes.
• Dizziness.
• Somnolence.
• Difficulty sleeping.
• Seeing or hearing hallucinations.
• Rhinorrhea.
• Nausea.
• Stomach pain and indigestion.
• Changes in blood tests to determine the correct functioning of your liver and kidneys.
• Rash and itching.
• Impotence.
• Sensation of fatigue or weakness (lack of strength).
• Significant decrease in blood pressure that may occur in people with the following conditions: coronary disease, aortic stenosis (a heart artery), renal arteries, or heart valves; a thickening of the heart muscle. If this happens, you may feel dizziness or dizziness, especially if you stand up quickly.
• Myocardial infarction.
• Cerebrovascular accident.
• Tachycardia.

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

• Changes in some blood cells or other blood components. 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.
• Hives.
• Dry mouth.
• Hair loss.
• Psoriasis (a skin disorder).
• Development of breasts in men.
• Acute renal failure.
• Change in the smell of things
• Decrease in sodium levels in the blood (hyponatremia) (the symptoms may be fatigue, headache, nausea, and vomiting).

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

• Low blood glucose levels (hypoglycemia). The signs may include hunger or weakness, sweating, and rapid heartbeat.
• Sinusitis (sensation of pain and pressure behind the cheeks and eyes).
• Chills
• Pulmonary 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 white of the eyes (jaundice).
• Hepatitis. This may cause loss of appetite, yellowing of the skin and eyes, and dark urine.
• Liver insufficiency.
• Sweating.
• Severe skin disorders. The symptoms include redness, blistering, and peeling.
• Hives
• Decrease in urine output or inability to urinate.

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

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

Other side 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

• Depression of the bone marrow.
• Reduction in thenumber of platelets (thrombocytopenia).
• Reduction in the number of white blood cells (leucopenia).
• Decrease in the number of granulocytes (agranulocytosis).
• Anemia due to the destruction of red blood cells (hemolytic anemia).

Metabolic and nutritional disorders

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

Psychiatric disorders

• Restlessness.
• Depression.
• Sleep disturbances.

Nervous system disorders

• Loss of appetite.
• Sensation of tingling in the hands and feet.
• Sensation of dizziness.

Eye disorders

• Changes in vision that make you see objects as yellow.
• Severe eye pain accompanied by redness and sudden blurred vision.
• Alteration of vision.
• Decrease in vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

Ear disorders

• Dizziness.

Cardiac disorders

• Postural hypotension.

Vascular disorders

• Inflammation of the blood vessels.

Respiratory system disorders

• Sensation of shortness of breath.
• Pulmonary inflammation.

Digestive system disorders

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

Liver disorders

• Yellowing of the skin (jaundice).

Skin and subcutaneous tissue disorders

• Sunlight sensitivity reaction.
• Rash.
• Urticaria.
• Rash with hives.
• In some patients with lupus, it may reactivate or worsen their symptoms.

Musculoskeletal disorders

• Muscle spasms.
• Muscle weakness.

Renal and urinary disorders

• Renal function alteration.
• Renal inflammation.

General disorders

• Fever.
• Weakness.

Respiratory system disorders

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

Reporting of side effects

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

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

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

This medication does not require special storage conditions.

Store in the original packaging toprotect itfrom light.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointof the pharmacy.

If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Lisinopril/hydrochlorothiazide cinfa composition

Appearance of the product and content of the packaging

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra) - Spain.

Last review date of this leaflet: June 2020

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your 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