LIDALTRIN 20 mg FILM-COATED TABLETS

Introduction

Leaflet:Information for the patient

Lidaltrin 20 mg film-coated tablets

Quinapril

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 doubts, 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 Lidaltrin and what is it used for

2. What you need to know before taking Lidaltrin

3. How to take Lidaltrin

4. Possible side effects

5. Storage of Lidaltrin

6. Package contents and additional information

1. What is Lidaltrin and what is it used for

Lidaltrin belongs to the family of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors), a group of antihypertensive medications that work by dilating blood vessels in the body.

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 taking 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, any other ACE inhibitor medication, or any of the other components of this medication (listed in section 6).

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

? if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

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

? 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 you are taking any of the following medications, the risk of angioedema may increase:

• 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.

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 medications.

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

? if you are taking any of the following medications used to lower high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., valsartan, telmisartan, ibersartan), 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 may be). Lidaltrin is not recommended during the first trimester of pregnancy, and it should not be administered if you are pregnant for more than three months, as it may cause serious harm to your baby when administered from this time on (see Pregnancy section).

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

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

? if you are taking other medications to lower your blood pressure, as it may decrease too much (hypotension). Other processes 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, get up slowly to avoid the feeling of dizziness. If you faint or feel dizzy, inform your doctor.

? as with other ACE inhibitors, taking Lidaltrin may cause a dry cough. 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 medications and Lidaltrin

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

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 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 medication. Lidaltrin may interact with the following medications. Do not take these medications at the same time as Lidaltrin, unless prescribed by your doctor.

• Lithium (medication for depression)
• Tetracyclines (antibiotic)
• Diuretics (medications to increase urine production)
• Potassium supplements, or medications or salt substitutes that contain potassium
• Medications for diabetes (insulin or oral hypoglycemics).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may 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 the blood to prevent clots).

If you have any doubts about taking other medications 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

• Pregnancy

Your doctor will generally recommend that you stop taking Lidaltrin before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Lidaltrin. Lidaltrin is not recommended during the first trimester of pregnancy, and it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from this time on.

• 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 medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Lidaltrin

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide which dose of this medication is most suitable for you.

Do not take more tablets than 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 carefully regarding the dose and method of use.

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 medication.

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

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

If you take more Lidaltrin than you should

If 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 medication and the amount used.

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

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

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

If you forget to take Lidaltrin

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

If you interrupt treatment with Lidaltrin

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

4. Possible side effects

Like all medications, Lidaltrin can cause side effects, although not everyone will experience them. Inform your doctor if you notice any of the following side effects.

The following are 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
  • digestive disorder (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 rapid destruction of red blood cells (hemolytic anemia).

• Rare (may affect up to 1 in 1000 people):
  • severe allergic reaction with inflammation 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 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 (skin disease characterized by red plaques covered with silver scales).

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es

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

5. Storage of Lidaltrin

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

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

Do not use Lidaltrin after the expiration date stated on the package after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Lidaltrin

The active ingredient is quinapril (hydrochloride). Each tablet contains 20 mg of quinapril (as hydrochloride).

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

Appearance of the product and package contents

The film-coated tablets of Lidaltrin 20 mg are yellow, biconvex, round, with a score line on both sides, and have the mark "20" on one side. Each package 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 medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/