LIDALTRIN 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lidaltrin5 mg Film-Coated Tablets

Quinapril

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Lidaltrin is and what it is 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. Contents of the pack and further information

1. What Lidaltrin is and what it is used for

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

Lidaltrin is used to treat patients with high blood pressure (hypertension) and 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 regular monitoring by your doctor.

Do not takeLidaltrin

? if you are allergic or have had an allergic reaction to quinapril, any other ACE inhibitor, or 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 swelling (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 better 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

Talk to 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 it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

? if you have kidney disease, are on 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 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 your 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 feeling dizzy. 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 taking the medicine.

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 that 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; cyclosporin, an immunosuppressant 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, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• Pregnancy

Your doctor will usually advise you to stop taking Lidaltrin before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medicine instead of Lidaltrin. Lidaltrin is not recommended during the first trimester of pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

• 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 for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Do not take more tablets than prescribed 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 taken orally. Your doctor will tell you how many tablets to 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 tell you how long to take Lidaltrin. Do not stop treatment before then, as it may be harmful to your health.

If you feel that 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 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. Telephone 91 562 04 20, stating the medicine and the amount used.

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

The most likely symptom after an overdose of Lidaltrin would be a drop in blood pressure. Symptomatic treatment will be given to compensate 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 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 stop taking Lidaltrin

If you have any further questions 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
  • 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)
  • low blood pressure when standing up (postural hypotension)
  • fainting
  • flatulence
  • dry mouth or throat
  • inflammation of the pancreas (pancreatitis)
  • low platelet count (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)
  • intestinal swelling (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 silver scales).

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this package 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 stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lidaltrin

The active ingredient is quinapril (hydrochloride). Each tablet contains 5 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), yellow iron oxide (E172), titanium dioxide (E171), hypromellose (E464), hydroxypropylcellulose (E463), and macrogol 400.

Appearance of the product and packaging

Lidaltrin 5 mg film-coated tablets are yellow, biconvex, oval, scored, and marked with "5" on both sides. Each pack contains 60 tablets.

Marketing authorization holder and manufacturer

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of last revision of this package 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/