Lidaltrin 20 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Lidaltrin 20 mg film-coated tablets

Quinapril

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of the 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 adverse effects

5.- Storage of Lidaltrin

6.- Package contents and additional information

1. What Lidaltrin is and what it is used for

Lidaltrin belongs to the family of medicines known as angiotensin-converting enzyme (ACE) inhibitors, a group of antihypertensive drugs 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, as part of their standard therapy.

2. What you need to know before taking Lidaltrin

Treatment with Lidaltrin requires periodic monitoring by your doctor.

Do not take Lidaltrin

? if you are allergic or have had an allergic reaction to quinapril, to any other ACE inhibitor medicine, 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, or speaking (head and neck angioedema), or swelling in the intestinal tract (intestinal angioedema).

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

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

? if you are currently taking or have recently taken 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 areas such as the throat) is high.

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 containing 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 treat high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as “sartans” – for example, valsartan, telmisartan, irbesartan), particularly 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 suspect you may be pregnant). Lidaltrin is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause severe harm to your baby when used from this point onward (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 your kidney function.

? if you have a disease affecting blood vessels (vascular collagenosis) or kidney disease (renal failure), your doctor may perform various tests to assess your immune system.

? if you are taking other medicines to lower your blood pressure, as your blood pressure could drop too much (hypotension). Other conditions such as vomiting, diarrhoea, dehydration, and excessive sweating may also lower blood pressure. Consult your doctor if you experience dizziness or vertigo. If dizziness occurs, lie down until the sensation passes. When getting up after lying down, always do so slowly to avoid dizziness. If you faint or feel dizzy, inform your doctor.

? like with other ACE inhibitors, dry cough may occur while taking Lidaltrin. In this case, consult your doctor. This cough will disappear when treatment is stopped.

Children and adolescents

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

Other medicines and Lidaltrin

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

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 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 listed medicines. Do not take these medicines at the same time as Lidaltrin unless prescribed by your doctor.

• lithium (a medicine used to treat depression)
• tetracyclines (antibiotic)
• diuretics (medicines to increase urine output)
• potassium supplements, or medicines or salt substitutes containing potassium
• medicines for diabetes (insulin or oral hypoglycaemics)
• 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).

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

Taking Lidaltrin with food, drinks, and alcohol

Lidaltrin may 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 medicine.

• Pregnancy

Your doctor will generally advise you to stop taking Lidaltrin before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Lidaltrin. Lidaltrin is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause severe harm to your baby when used from this point.

• Breastfeeding

The use of Lidaltrin during breastfeeding is not recommended, especially if your baby is a 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 may occur during the first few days of treatment. Therefore, special caution is required when performing tasks such as driving or operating dangerous machinery.

Lidaltrin contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Lidaltrin

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, 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 specified by your doctor. Your doctor may increase or decrease the dose if necessary until the appropriate dose for you is established. Always follow your doctor's instructions regarding dose and method of administration.

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

Swallow the tablets with a sufficient amount of liquid (for example, a glass of water).

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

Remember to take your medicine.

Your doctor will inform you of the duration of your treatment with Lidaltrin. Do not stop treatment prematurely, as this could be harmful to your health.

If you feel that the effect of this medicine is too strong or too weak, do not adjust the dose yourself; inform your doctor or pharmacist.

If you take more Lidaltrin than you should

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

It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

The most likely symptom expected after an overdose of Lidaltrin would be a drop in blood pressure. Symptomatic treatment will be provided to counteract the effects of this medicine.

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

If you forget to take Lidaltrin

Do not take a double dose to make up for missed doses; continue 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 adverse effects

Like all medicines, Lidaltrin may cause adverse effects, although not everyone experiences them. Inform your doctor if you notice any of the following adverse effects.

The possible adverse effects during treatment with Lidaltrin are listed below.

• Frequent (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 falling asleep (insomnia)
  • low blood pressure (hypotension)
  • tingling (paresthesia)
  • decreased sodium concentrations in blood

• Uncommon (may affect up to 1 in 100 people):

  • allergic reaction (anaphylactoid reaction)
  • abnormally increased reactivity to sunlight (photosensitivity)
  • palpitations
  • dilation of blood vessels (vasodilation)
  • tightness of chest (angina pectoris)
  • increased heart rate (tachycardia)
  • decrease in blood pressure upon standing (postural hypotension)
  • fainting (syncope)
  • flatulence
  • dryness of mouth or throat
  • inflammation of the pancreas (pancreatitis)
  • decrease in platelet levels (thrombocytopenia)
  • depression
  • nervousness
  • drowsiness

• dizziness

• hair loss (alopecia)

• skin disorders (exfoliative dermatitis, pemphigus, pruritus, and rash)

• increased sweating

• urinary tract infections

• impotence

• decreased visual acuity (amblyopia)

• excessive accumulation of fluid 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 1,000 people):

  • severe allergic reaction with swelling of the face, lips, tongue and/or throat, causing difficulty breathing, swallowing, or speaking (angioedema of head and neck)
  • swelling in the intestinal tract (intestinal angioedema)
  • respiratory condition (eosinophilic pneumonitis)
  • liver disorders (hepatitis, liver failure).

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

  • dark urine, nausea, vomiting, muscle cramps, confusion, and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
  • Psoriasis or worsening of existing psoriasis (a skin disease characterized by red patches covered with silvery scales).

• Laboratory findings:

  • changes in blood cell values (agranulocytosis, neutropenia)
  • increased potassium in blood (hyperkalemia)
  • abnormalities in various laboratory tests

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es

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

5. Storage of Lidaltrin

Keep this medicine out of 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 20 mg of quinapril (as hydrochloride).

The other components (excipients) are monohydrate lactose, 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 contents of the pack

Lidaltrin 20 mg film-coated tablets are yellow, biconvex, round, with a score line on both sides and marked "20" on one side. Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

LACER, S.A. - Boters, 5
08290 Cerdanyola del Vallès
Barcelona – Spain

Date of the most recent revision of this leaflet: March 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/