Prospect: Patient Information

Lidaltrin5 mg Film-Coated Tablets

Quinapril

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.- What is Lidaltrin and what is it used for

2.- What you need to know before starting to take Lidaltrin

3.- How to take Lidaltrin

4.- Possible adverse effects

5.- Storage of Lidaltrin

6.- Contents of the pack and additional information

Lidaltrin belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors, which are anti-hypertensive medicines 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 association with their usual treatment.

The 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 angiotensin-converting enzyme (ACE) inhibitor, or any of the other components of this medication (listed in section 6).

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

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

? if you are more than 3 months pregnant (it is better 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 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 for 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 to be operated on, inform your doctor that you are taking Lidaltrin.

? do not use potassium substitutes without consulting your doctor.

? if you are taking other medications.

? if you are following a strict low-sodium diet.

? if you are taking any of the following blood pressure-lowering medications (hypertension):

- an angiotensin II receptor antagonist (ARA) (also known as “sartanes” - for example, valsartan, telmisartan, ibersartan), particularly if you have kidney problems related to diabetes

- aliskiren

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (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 if you suspect that you may be). Lidaltrin is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from this point onwards (see Pregnancy section).

? if you have kidney disease, are undergoing dialysis sessions, 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 blood vessels (vascular collagenosis) or kidney disease (renal insufficiency), your doctor may perform various tests to check the state of your immune system.

? if you are taking other medications to lower your blood pressure, as this may cause excessive lowering of blood pressure (hypotension). Other processes such as vomiting, diarrhea, dehydration, and excessive sweating may also lower blood pressure. Consult your doctor if you experience dizziness and vertigo. If dizziness occurs, lie down until it passes. After lying down, always get up slowly to avoid dizziness. If you faint or experience dizziness, inform your doctor.

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

Children and adolescents

The safety and efficacy 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 taken recently, or may need to take any other medication.

Your doctor may need to modify 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 they have been 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
• diabetes medications (insulin or oral hypoglycemics).
• potassium supplements (including salt substitutes), diuretics that conserve potassium, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to dilute the blood to prevent clots).

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

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 usually recommend that you stop taking Lidaltrin before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Lidaltrin. Lidaltrin is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from this point onwards.

• Breastfeeding

Lidaltrin is not recommended for use 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 operating machinery

Lidaltrin may cause a sudden drop in blood pressure, causing dizziness and in some cases fainting. This may 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 indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

Your doctor will decide on the most suitable dose of this medication for you.

Do not take more tablets than specified by your doctor. Your doctor may increase or decrease the dose as needed until they find the dose you need. Follow your doctor's instructions faithfully regarding the dose and method of use.

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 instructions.

Remember to take your medication.

Your doctor will tell you the duration of your treatment with Lidaltrin. Do not stop treatment before, 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 moreLidaltrinthan you should

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

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

The most probable symptom that could be expected after an overdose of Lidaltrin would be a drop in blood pressure. Symptomatic treatment will be carried out to compensate 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 your blood pressure adequately.

If you have forgotten to takeLidaltrin

Do not take a double dose to compensate for the missed doses and continue treatment in the usual way.

If you interrupt treatment with Lidaltrin

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

Like all medicines, 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 that may occur during treatment with Lidaltrin.

-Frequent(may affect up to 1 in 10 people):

•Headache

•Dizziness

•Runny nose (rhinitis)

•Cough

•Fatigue

•Nausea and/or vomiting

•Muscle pain (myalgia)

•Diarrhea

•Chest pain

•Abdominal pain

•Indigestion (dyspepsia)

•Difficulty breathing (dyspnea)

•Back pain

•Throat inflammation (pharyngitis)

•Difficulty falling asleep (insomnia)

•Low blood pressure (hypotension)

•Tickling or prickling sensation (paresthesias)

•Decreased 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

•Widening of blood vessels (vasodilation)

•Pressure or squeezing sensation in the chest (angina pectoris)

•Increased heart rate (tachycardia)

•Low blood pressure when standing up (postural hypotension)

•Syncope

•Flatulence

•Dry mouth or throat

•Pancreatitis (inflammation of the pancreas)

•Decreased platelet count (thrombocytopenia)

•Depression

•Nervousness

•Drowsiness

•Dizziness

•Hair loss (alopecia)

•Skin disorders (dermatitis exfoliativa, 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 facial, lip, tongue, and/or throat inflammation, difficulty breathing, swallowing, and speaking (angioedema of the head and neck)

•Intestinal angioedema

•Respiratory disorders (eosinophilic pneumonitis)

•Liver disorders (hepatitis, hepatic 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 antidiuretic hormone secretion).

•Poriasis or worsening of existing psoriasis (skin disorder characterized by red plaques covered with silvery scales).

-Lab findings:

•Abnormal blood cell counts (agranulocytosis, neutropenia)

•Increased potassium levels in the blood (hyperkalemia)

•Abnormal results in various laboratory tests

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not store at a temperature above 25°C. Store protected from light and humidity.

Do not use Lidaltrin after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at theSIGREpoint ofyour pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lidaltrin

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

Appearance of the product and contents of the packaging

The film-coated tablets of Lidaltrin 5 mg are yellow, biconvex, oval, with a notch and with the mark “5” on both faces. Each package contains 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of the last review of thisleaflet:March 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/