Lisinopril/hydrochlorothiazide Teva-Ratiopharm 20/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

1. What Lisinopril/Hydrochlorothiazide Teva-ratiopharm is and what it is used for

Lisinopril/Hydrochlorothiazide Teva-ratiopharm belongs to the group of antihypertensive medicines that contain an ACE inhibitor (angiotensin-converting enzyme inhibitor).

Lisinopril/Hydrochlorothiazide Teva-ratiopharm contains two active substances, lisinopril and hydrochlorothiazide, which lower blood pressure through different mechanisms. Lisinopril prevents the formation of hypertensive agents in the body, while hydrochlorothiazide reduces blood pressure by increasing the elimination of water and salts from the body.

Lisinopril/Hydrochlorothiazide Teva-ratiopharm is indicated for the treatment of hypertension when the desired response has not been achieved with monotherapy alone.

2. What you need to know before taking Lisinopril/Hydrochlorothiazide Teva-ratiopharm

Do not take Lisinopril/Hydrochlorothiazide Teva-ratiopharm

• if you are allergic to lisinopril dihydrate, other ACE inhibitors, hydrochlorothiazide, thiazides, sulfonamide derivatives, or any of the other ingredients of this medicine (listed in section 6.).
• if you have previously been treated with an ACE inhibitor and experienced hypersensitivity reactions at that time, such as swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing, or if you have experienced similar reactions for any other reason,
• if you have had angioedema in your family or have had angioedema under any other circumstances,
• if you are more than three months pregnant (it is best to avoid Lisinopril/Hydrochlorothiazide Teva-ratiopharm in early pregnancy—see section Pregnancy),
• if you have severe kidney or liver problems,
• if your kidneys produce very little urine or you do not urinate at all,
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, such as in the throat) is increased.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lisinopril/Hydrochlorothiazide Teva-ratiopharm

• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Lisinopril/Hydrochlorothiazide Teva-ratiopharm, seek medical attention immediately.
• if you are taking diuretics, your diet is low or very low in salt, or if you are currently suffering from or develop severe diarrhea or vomiting during treatment,
• if you are taking any of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor antagonist (ARA) (also known as sartans—e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes,
  • aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g., potassium) at regular intervals.

• See also the information under the heading “Do not use Lisinopril/Hydrochlorothiazide Teva-ratiopharm”

• if you have coronary artery disease or cerebrovascular disease,

• if you have narrowing of the main artery leaving the left side of the heart (aortic stenosis) or narrowing of a specific heart valve (mitral valve stenosis),

• if you have thickening of the heart muscle,

• if you have low blood pressure. Signs of low blood pressure include dizziness or lightheadedness, especially when standing up,

• if you have renal insufficiency or are undergoing dialysis,

• if you have recently had a kidney transplant,

• if you have bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney,

• if you have diabetes or vascular collagen disease,

• if you have gout,

• if you have recently had diarrhea or vomiting (nausea),

• if your doctor has advised you to monitor the amount of salt in your diet,

• if you are taking potassium tablets or salt substitutes containing potassium,

• if you have hepatic insufficiency or another liver disease,

• if you are undergoing desensitization treatment for insect venom,

• if you have a persistent dry cough,

• if you have high cholesterol and are receiving a treatment called “LDL apheresis”,

• if you are taking lithium (a medicine for depression) at the same time,

• due to your ethnic origin (particularly in Black patients), the effect of lisinopril/hydrochlorothiazide may be reduced. You may also be more prone to allergic reactions (angioedema),

• if you are taking any of the following medicines, the risk of angioedema may increase:

  • racecadotril, a medicine used to treat diarrhea;
  • medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus);
  • vildagliptin, a medicine used to treat diabetes;
  • medicines containing tissue plasminogen activator.

Signs of angioedema include swelling of the face, lips, tongue, and/or throat with difficulty swallowing and breathing.

• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun and UV exposure while taking Lisinopril/Hydrochlorothiazide Teva-ratiopharm.
• if you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to a week after taking Lisinopril/Hydrochlorothiazide Teva-ratiopharm. This may lead to permanent vision loss if untreated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk.

Children and adolescents

Do not give Lisinopril/Hydrochlorothiazide Teva-ratiopharm to children under 18 years of age. There is limited information on the safety and efficacy of Lisinopril/Hydrochlorothiazide in children.

Elderly

In patients over 65 years of age, blood pressure and certain laboratory values—serum electrolytes, creatinine, blood glucose, and blood count—should be monitored, especially at the beginning of treatment. Dosage should be carefully adjusted in elderly patients.

Kidney

If you have renal insufficiency, it is important not to take potassium supplements or potassium-sparing diuretics during treatment with lisinopril/hydrochlorothiazide, as this may excessively increase potassium levels in your body.

Surgery

Inform your doctor that you are taking Lisinopril/Hydrochlorothiazide Teva-ratiopharm if you need surgery (including dental surgery) during treatment, as some anesthetic agents used during surgery may cause excessive lowering of blood pressure when combined with Lisinopril/Hydrochlorothiazide Teva-ratiopharm.

Pregnancy

Inform your doctor if you think you are (or might be) pregnant. Use of lisinopril/hydrochlorothiazide is not recommended in early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if taken during this period (see section Pregnancy).

While taking Lisinopril/Hydrochlorothiazide Teva-ratiopharm

If you develop any of the following symptoms, inform your doctor immediately:

• if you feel dizzy after the first dose. Some people react to Lisinopril/Hydrochlorothiazide Teva-ratiopharm with the first dose or when the dose is increased, experiencing dizziness, weakness, fainting, or vomiting,
• sudden swelling of the lips and face, neck, and possibly also hands and feet, or wheezing or hoarseness. This condition is called angioedema. It can occur at any time during treatment. ACE inhibitors have a higher incidence of angioedema in Black patients compared to White patients,
• high fever, sore throat, or mouth ulcers (these may be symptoms of an infection caused by a reduction in white blood cells),
• yellowing of the skin or whites of the eyes (jaundice), which may be signs of liver disease.

At the beginning of treatment and/or during the dose adjustment period, more frequent medical check-ups may be necessary. Do not skip these visits even if you feel well. Your doctor will determine the frequency of medical examinations.

Taking Lisinopril/Hydrochlorothiazide with other medicines

The concomitant use of other medicines may affect the efficacy and safety of this medicine. Conversely, Lisinopril/Hydrochlorothiazide Teva-ratiopharm may affect the safety and efficacy of other medicines. Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, herbal products, and natural remedies. Remember to tell your doctor that you are taking Lisinopril/Hydrochlorothiazide Teva-ratiopharm if another medicine is prescribed during or shortly after treatment.

It is especially important to inform your doctor if you are taking:

• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots),
• other antihypertensive agents.

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

• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not use Lisinopril/Hydrochlorothiazide Teva-ratiopharm” and “Warnings and precautions”).

• other diuretics,

• allopurinol (for gout), procainamide (antiarrhythmic), oral cortisone, cytostatic agents (anticancer medicines), or medicines affecting the body's immune system (such as cyclosporine),

• lithium (used in bipolar affective disorder),

• antipsychotic medicines or central nervous system stimulants,

• non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid,

• certain anesthetics,

• vitamin D preparations,

• insulin or oral antidiabetics,

• lovastatin, cholestyramine, or colestipol (for lowering cholesterol),

• digoxin (for heart conditions),

• medicines to control heart rhythm (antiarrhythmics),

• sotalol (antiarrhythmic),

• amphotericin B (antifungal medicine),

• carbenoxolone (for ulcers),

• a certain pituitary gland hormone (ACTH),

• laxatives (medicines that help bowel movements),

• racecadotril (used to treat diarrhea),

• sacubitril/valsartan (used to treat high blood pressure),

• vildagliptin (used to treat diabetes),

• certain medicines used to treat asthma,

• medicines to treat nasal or sinus congestion or other cold remedies (including those available without prescription),

• tubocurarine (muscle relaxant),

• gold,

• diazoxide (used, for example, to treat hypoglycemia),

• amantadine (used to treat Parkinson’s disease or serious viral infections),

• barbiturates (a type of sedative also used to treat epilepsy),

• alcohol,

• adrenergic amines such as noradrenaline (substances that increase blood pressure),

• tissue plasminogen activator (a medicine used to dissolve blood clots),

• medicines more commonly used to prevent organ transplant rejection (sirolimus, everolimus, and other medicines belonging to the mTOR inhibitor class). See section “Warnings and precautions”

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might 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 might be) 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 instead of Lisinopril/Hydrochlorothiazide Teva-ratiopharm. Lisinopril/Hydrochlorothiazide Teva-ratiopharm is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Lisinopril/Hydrochlorothiazide Teva-ratiopharm is not recommended for nursing mothers, and your doctor should choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was premature.

Driving and using machines

At the beginning of treatment, when the dose is changed, or in combination with alcohol, Lisinopril/Hydrochlorothiazide Teva-ratiopharm may have mild to moderate effects on your ability to drive or operate machinery requiring special attention. Be aware that dizziness or fatigue may occur while driving or operating machinery.

Athletes

Athletes are advised that this medicine contains an active substance (hydrochlorothiazide) that may result in a positive doping test.

Lisinopril/Hydrochlorothiazide Teva-ratiopharm contains sodium

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

3. How to take Lisinopril/Hydrochlorothiazide Teva-ratiopharm

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

The recommended dose is one or two tablets daily. Your doctor will decide the dose you should take based on your previous treatment with lisinopril and hydrochlorothiazide taken separately.

Renal impairment

The dose depends on the degree of impairment. Follow your doctor's instructions.

Before diuretic treatment

Diuretic treatment should be discontinued for 2 to 3 days before starting treatment with
Lisinopril/Hydrochlorothiazide Teva-ratiopharm. Follow your doctor's instructions.

Changing the dose

Do not change the dose or stop taking the medicine without first consulting your doctor.

If you take more Lisinopril/Hydrochlorothiazide Teva-ratiopharm than you should

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

Contact your doctor or the nearest hospital immediately if you have taken more than the prescribed dose (overdose). An overdose may cause a marked decrease in blood pressure, which may lead to dizziness and mild headache. Symptoms may include difficulty breathing, increased or decreased pulse, palpitations, anxiety, or cough.

If you forget to take Lisinopril/Hydrochlorothiazide Teva-ratiopharm

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

Resume your regular dosing schedule.

If you stop taking Lisinopril/Hydrochlorothiazide Teva-ratiopharm

Do not stop taking the medicine without first consulting your doctor.

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

4. Possible adverse effects

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

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

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

Not known: frequency cannot be estimated from the available data

If you experience any of the following adverse effects, stop taking lisinopril/hydrochlorothiazide and contact a doctor immediately:

• Severe allergic reactions (uncommon), which may include the following symptoms occurring suddenly:
  • Swelling of the face, lips, tongue, or throat. This may cause difficulty swallowing
  • Severe or sudden swelling of hands, feet, and ankles
  • Difficulty breathing
  • Severe skin itching (with blisters)
• Serious skin conditions, such as a sudden and unexpected rash or a burning sensation, redness, or peeling of the skin (very rare)
• An infection with fever and severe deterioration in your general condition, or fever with signs of a localized infection such as sore throat, throat or mouth infection, or urinary problems (very rare)

Lisinopril

Common

Dizziness, headache, syncope, hypotension associated with symptoms (dizziness, weakness, blurred vision), dry cough, vomiting, diarrhea, renal dysfunction.

Uncommon

Mood changes, paresthesia, vertigo, taste disturbances, sleep disorders, depressive symptoms, hallucinations, increased heart rate, palpitations, myocardial infarction or stroke (in high-risk patients possibly secondary to excessive hypotension), skin color changes (pale or blue followed by redness) and/or numbness or tingling in fingers and toes (Raynaud's syndrome), rhinitis, nausea, abdominal pain, indigestion, increased liver enzymes and bilirubin, itching with or without rash, skin rash, impotence, fatigue, asthenia, increased blood urea, increased serum creatinine, hyperkalemia.

Rare

Red blood cell deficiency, decreased hemoglobin, syndrome of inappropriate antidiuretic hormone secretion (SIADH), mental confusion, smell disturbance, dry mouth, urticaria, psoriasis, hair loss, kidney function disorders including renal failure, uremia, breast development in men, hyponatremia.

Very rare

Poor bone marrow production, low platelet count (thrombocytopenia), decreased white blood cell count (neutropenia, leukopenia), reduction in white blood cells (agranulocytosis), making infections more likely, lymph node disorders, autoimmune diseases where the body attacks itself, anemia, hemolytic anemia, bronchospasm, sinusitis, allergic alveolitis/eosinophilic pneumonia, pancreatitis, allergic reaction in the small intestine (intestinal angioedema), liver failure and cholestasis (including jaundice), hepatitis including necrosis, sweating, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, erythroderma, pemphigoid reactions and exfoliative dermatitis, decreased or absent urinary excretion, low blood sugar levels (hypoglycemia).

A complex symptom has been reported that may include one or more of the following: fever, vasculitis, myalgia, arthralgia/arthritis, positive antinuclear antibodies (ANA), elevated erythrocyte sedimentation rate, eosinophilia and leukocytosis, rash, photosensitivity, and other dermatological manifestations may occur.

Not known

Severe allergic reaction (anaphylactic/anaphylactoid reaction), flushing.

Hydrochlorothiazide

Very rare

Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Not known

Inflammation of the salivary glands, skin and lip cancer (non-melanoma skin cancer), leukopenia, neutropenia/agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bone marrow suppression, anorexia, hyperglycemia, glucosuria, hyperuricemia, electrolyte imbalance (including hyponatremia, hypokalemia, hypochloremic alkalosis, and hypomagnesemia), increased cholesterol and triglycerides, gout, restlessness, depression, sleep disturbances, loss of appetite, paresthesia, photosensitivity to light, yellow vision, transient blurred vision, 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), vertigo, postural hypotension, necrotizing angiitis (vasculitis, cutaneous vasculitis), respiratory distress (including pneumonitis and pulmonary edema), gastric irritation, diarrhea, constipation, pancreatitis, jaundice (intrahepatic cholestatic jaundice), photosensitivity reactions, rash, cutaneous lupus erythematosus, systemic lupus erythematosus, skin reactions such as lupus erythematosus, reactivation of cutaneous lupus erythematosus, urticaria, anaphylactic reactions, toxic epidermal necrolysis, muscle spasms, muscle weakness, renal dysfunction, interstitial nephritis, fever, weakness.

Stop using this medicine and consult your doctor immediately if symptoms of angioedema occur, such as swelling of the limbs, face, lips, larynx, or mucous membranes, or if breathing or swallowing becomes difficult during treatment.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lisinopril/Hydrochlorothiazide Teva-ratiopharm

Keep 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 is the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Lisinopril/Hydrochlorothiazide Teva-ratiopharm 20/12.5 mg

The active substances are: Lisinopril (as lisinopril dihydrate) and hydrochlorothiazide.

Each tablet contains 20 mg of lisinopril (as lisinopril dihydrate) and 12.5 mg of hydrochlorothiazide.

The other components are: mannitol, calcium hydrogen phosphate dihydrate, pregelatinized gluten-free corn starch, sodium croscarmellose and magnesium stearate.

Appearance of the medicine and contents of the pack

White, round tablets, scored on one side and marked with "LH" on the other.

Lisinopril/Hydrochlorothiazide Teva-ratiopharm 20/12.5 mg is available in PVC/PVDC/Aluminum blisters and in polypropylene bottles with low-density polyethylene screw caps and desiccant.

Each pack contains 10, 28, 30, 50, 56, 60, 98, 100, 50 x 1 (perforated unit dose blister), 100 x 1 (perforated unit dose blister), and 500 x 1 (perforated unit dose blister) tablets.

Polypropylene bottles: 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 - Madrid, Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren (Germany)

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

Date of the most recent review of this leaflet: July 2023

Other sources of information

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

You can access detailed information about this medicinal product by scanning the QR code included on the outer packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65829/P_65829.html

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