LIDALTRIN 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lidaltrin 40 mg Film-Coated Tablets

Quinapril

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Lidaltrin is and what it is used for

2. What you need to know before you take Lidaltrin

3. How to take Lidaltrin

4. Possible side effects

5. Storage of Lidaltrin

6. Contents of the pack and other information

1. What Lidaltrin is and what it is used for

Lidaltrin belongs to a family of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors), which are used to treat high blood pressure and heart failure.

Lidaltrin is indicated for the treatment of patients with high blood pressure (hypertension) and for the treatment of patients with a heart condition known as chronic heart failure, in addition to their usual treatment.

2. What you need to know before you take Lidaltrin

Treatment with Lidaltrin requires periodic monitoring by your doctor.

Do not takeLidaltrin

? if you are allergic or have had an allergic reaction to quinapril, or to any other ACE inhibitor, or to any of the other ingredients of this medicine (listed in section 6).

? if you have previously experienced severe allergic reactions such as swelling of the face, lips, tongue, and/or throat with difficulty breathing, swallowing, and speaking (head and neck angioedema) or intestinal inflammation (intestinal angioedema).

? if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

? if you are more than 3 months pregnant (it is also recommended to avoid Lidaltrin during the first months of pregnancy - see section Pregnancy).

? 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 under the skin in an area such as the throat) is high.

? 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 cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lidaltrin.

? if you have liver disease.

? if you are diabetic.

? if you are going to have surgery, inform your doctor that you are taking Lidaltrin.

? do not use salt substitutes that contain potassium without consulting your doctor.

? if you are taking other medicines.

? if you are on a strict low-salt diet.

? if you are taking any of the following medicines used to lower high blood pressure:

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

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

See also the information under the heading "Do not take Lidaltrin".

? inform your doctor if you are pregnant (or think you might be). Lidaltrin is not recommended during the first trimester of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from this time (see section Pregnancy).

? if you have kidney disease, are undergoing dialysis, or have had a kidney transplant. Your doctor may perform various tests to check if your kidneys are working properly.

? if you have a disease that affects the blood vessels (vascular collagenosis) or kidney disease (renal insufficiency), your doctor may perform various tests to check the condition of your immune system.

? if you are taking other medicines to lower your blood pressure, as it may lower your blood pressure too much (hypotension). Other conditions such as vomiting, diarrhea, dehydration, and excessive sweating can also lower blood pressure. Consult your doctor if you experience dizziness and vertigo. If you feel dizzy, lie down until the feeling passes. After lying down, always get up slowly to avoid the feeling of dizziness. If you faint or feel dizzy, inform your doctor.

? as with other ACE inhibitors, when taking Lidaltrin, a dry cough may appear. In this case, consult your doctor. This cough will disappear when you stop treatment.

Children and adolescents

The safety and efficacy of Lidaltrin in children and adolescents (under 18 years) have not been established.

Other medicines and Lidaltrin

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

Your doctor may need to change 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 take Lidaltrin" and "Warnings and precautions").

If you are hospitalized or visit another doctor, dentist, or pharmacist, inform them that you are taking Lidaltrin or any other medicine. Lidaltrin may interact with the following medicines. Do not take these medicines at the same time as Lidaltrin, unless your doctor has prescribed them.

• Lithium (a medicine used to treat depression)
• Tetracyclines (an antibiotic)
• Diuretics (medicines used to increase urine production)
• Potassium supplements, or medicines or salt substitutes that contain potassium
• Medicines for diabetes (insulin or oral hypoglycemics).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).

If you have any doubts about taking other medicines with Lidaltrin, consult your doctor.

Taking Lidaltrin with food, drinks, and alcohol

Lidaltrin can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

• Pregnancy

Your doctor will usually advise you to stop taking Lidaltrin before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Lidaltrin. Lidaltrin is not recommended during the first trimester of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from this time.

• Breastfeeding

Lidaltrin is not recommended during breastfeeding, especially if your baby is newborn or premature. If necessary, your doctor will inform you about the benefits and risks of using Lidaltrin during breastfeeding compared to other treatments.

Driving and using machines

Lidaltrin may cause a sudden drop in blood pressure, leading to dizziness and, in some cases, fainting. This can occur during the first few days of treatment. Therefore, special attention should be paid to tasks such as driving, using hazardous machinery, etc.

Lidaltrin contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Lidaltrin

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Your doctor will decide what dose of this medicine is most suitable for you.

Do not take more tablets than those specified by your doctor. Your doctor may increase or decrease the dose if necessary until they find the dose that you need. Follow your doctor's instructions exactly regarding the dose and method of administration.

Lidaltrin is administered orally. Your doctor will indicate how many tablets you should take each day.

Swallow the tablets with a sufficient amount of liquid (e.g., a glass of water).

Follow these instructions unless your doctor has given you different instructions.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Lidaltrin. Do not stop treatment before, as it may be harmful to your health.

If you think the effect of this medicine is too strong or too weak, do not change the dose yourself and inform your doctor or pharmacist.

If you take moreLidaltrinthan you should

If for any reason you have taken more Lidaltrin than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 91 562 04 20 indicating the medicine and the amount used.

It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

The most likely symptom to be expected after an overdose of Lidaltrin would be a drop in blood pressure. Symptomatic treatment will be carried out, compensating for the effects of this medicine.

In severe cases, the necessary measures will be taken. In addition to maintaining blood volume, it may be necessary to administer medicines that adequately restore blood pressure.

If you forget to takeLidaltrin

Do not take a double dose to make up for forgotten doses and continue with the treatment in the usual way.

If you stop taking Lidaltrin

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

4. Possible side effects

Like all medicines, Lidaltrin can cause side effects, although not everybody gets them. Inform your doctor if you notice any of the following side effects.

The following are the possible side effects during treatment with Lidaltrin.

• Common (may affect up to 1 in 10 people):
  • headache
  • dizziness
  • inflammation of the nasal mucosa (rhinitis)
  • cough
  • fatigue
  • nausea and/or vomiting
  • muscle pain (myalgia)
  • diarrhea
  • chest pain
  • abdominal pain
  • disorder of digestive function (dyspepsia)
  • difficulty breathing (dyspnea)
  • back pain
  • inflammation of the pharynx (pharyngitis)
  • difficulty sleeping (insomnia)
  • low blood pressure (hypotension)
  • tingling (paresthesia)
  • low sodium levels in the blood

• Uncommon (may affect up to 1 in 100 people):
  • allergic reaction (anaphylactoid reaction)
  • abnormal increased sensitivity to sunlight (photosensitivity)
  • palpitations
  • dilation of blood vessels (vasodilation)
  • chest pain (angina pectoris)
  • increased heart rate (tachycardia)
  • decrease in blood pressure when standing up (postural hypotension)
  • fainting
  • flatulence
  • dry mouth or throat
  • inflammation of the pancreas (pancreatitis)
  • decrease in platelet levels (thrombocytopenia)
  • depression
  • nervousness
  • drowsiness

? dizziness

• hair loss (alopecia)
• skin diseases (exfoliative dermatitis, pemphigus, pruritus, and rash)
• increased sweating
• urinary tract infections
• impotence
• decreased visual acuity (amblyopia)
• excessive fluid accumulation in the body (edema)
• joint pain (arthralgia)
• anemia characterized by the rapid destruction of red blood cells (hemolytic anemia).

• Rare (may affect up to 1 in 1,000 people):
  • severe allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty breathing, swallowing, and speaking (head and neck angioedema)
  • inflammation in the intestinal tract (intestinal angioedema)
  • respiratory disease (eosinophilic pneumonitis)
  • liver disease (hepatitis, liver failure).

• Frequency not known (cannot be estimated from the available data):
  • Dark urine, nausea, vomiting, muscle cramps, confusion, and convulsions. These may be symptoms of a condition called SIADH (inappropriate secretion of antidiuretic hormone).
  • Psoriasis or worsening of existing psoriasis (a skin disease characterized by red plaques covered with silvery scales).

• Laboratory findings:
  • alterations in blood cell values (agranulocytosis, neutropenia)
  • increased potassium levels in the blood (hyperkalemia)
  • alterations in various laboratory tests

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lidaltrin

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

Do not store above 25°C. Store protected from light and moisture.

Do not use Lidaltrin after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Lidaltrin

The active substance is quinapril (hydrochloride). Each tablet contains 40 mg of quinapril (as hydrochloride).

The other ingredients (excipients) are lactose monohydrate, heavy magnesium carbonate (E504), magnesium stearate (E572), gelatin (E441), crospovidone, candelilla wax (E902), red iron oxide (E172), titanium dioxide (E171), hypromellose (E464), hydroxypropylcellulose (E463), and macrogol 400.

Appearance of the product and contents of the pack

Lidaltrin 40 mg film-coated tablets are reddish-brown, biconvex, oval, with the mark "40" on one face and "PD535" on the other face. Each pack contains 28 tablets.

Marketing authorization holder and manufacturer

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona - Spain

Date of last revision of this leaflet: March 2022

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