Prospect: Patient Information

Lidaltrin-Diu 20 mg/12.5 mg Film-Coated Tablets

Quinapril / Hydrochlorothiazide

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-Diu and for what it is used

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

3.- How to take Lidaltrin-Diu

4.- Possible adverse effects

5.- Storage of Lidaltrin-Diu

6.- Contents of the package and additional information

Lidaltrin-Diuis a combination of quinapril, which belongs to the family of medications called angiotensin-converting enzyme (ACE) inhibitors, and hydrochlorothiazide, which belongs to the family of diuretics. Quinapril acts by dilating blood vessels in the body and hydrochlorothiazide acts by eliminating water.

Lidaltrin-Diuis used to treat high blood pressure (hypertension).

The treatment with Lidaltrin-Diurequires periodic monitoring by your doctor.

Do not takeLidaltrin-Diu

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

?if you are allergic (hypersensitive) to quinapril, hydrochlorothiazide, or to any of the other components of this medication (included in section 6).

?if you have a history of angioedema of the head and neck (swelling of the face, eyes, lips, tongue, or difficulty breathing) or intestinal angioedema.

?if you have severe renal dysfunction (anuria, severe renal failure).

• if you have diabetes or renal insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.

? sif 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.

? sif 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-Diu.

?if you have liver disease.

?if you have a disease of the connective tissue (lupus erythematosus), as exacerbations may occur.

?if you are diabetic.

?if you are to be operated on, inform your doctor that you are taking Lidaltrin-Diu.

?if you are taking other medications.

?if you are following a strict low-sodium diet. Do not use salt substitutes that contain potassium without consulting your doctor. Your doctor may perform periodic tests to monitor blood sodium levels.

• 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 “sartanes” - for example, valsartan, telmisartan, ibersartan), particularly if you have renal problems related to diabetes

- aliskirén

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-Diu”.

?if you have certain diseases (cirrhosis, salt deficiency, increased diuresis, or edema) or if you are being treated with corticosteroids or ACTH, as alterations in sodium and potassium in the blood may occur.

?inform your doctor if you are pregnant (or if you suspect you may be). Lidaltrin-Diu is not recommended for use at the beginning of pregnancy and 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 diseases, 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 diseases (renal insufficiency), 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 abnormally (hypotension). Other processes such as vomiting, diarrhea, dehydration, and excessive sweating may also reduce 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-Diu may cause dry cough. In this case, consult your doctor. This cough will disappear when you stop treatment.
• if you have had skin cancer or if an unexpected skin lesion appears during treatment. The use of hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Lidaltrin-Diu.
• if you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within a few hours to a week after taking Lidaltrin-Diu.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Lidaltrin-Diu, seek medical attention immediately.

Children and adolescents

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

Other medications and Lidaltrin-Diu

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 aliskirén (see also the information under the headings “Do not take Lidaltrin-Diu” and “Warnings and precautions”).

if you are hospitalized or visit another doctor, dentist, or pharmacist, inform them that you are taking Lidaltrin-Diu, or any other medication. Lidaltrin-Diu may interact with the following medications. Do not take these medications at the same time as Lidaltrin-Diu, 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
• corticosteroids
• diabetes medications (insulin or oral hypoglycemics)
• alcohol, barbiturates, and narcotics
• muscle relaxants
• nonsteroidal anti-inflammatory drugs (NSAIDs)
• aminoguanidine
• antihypertensive medications
• resin exchange anions (medications that reduce cholesterol levels).
• 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 blood to prevent clots).

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

Lidaltrin-Diu with food, drinks, and alcohol

Lidaltrin-Diu may be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

• Pregnancy

Your doctor will usually recommend that you stop taking Lidaltrin-Diu before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Lidaltrin-Diu. Lidaltrin-Diu is not recommended for use at the beginning of pregnancy, and in no case should it 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-Diu is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns and premature babies.

Use in athletes

Inform athletes that this medication contains a component that may result in a positive analytical result for doping control.

Driving and operating machines

Lidaltrin-Diu 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 attention should be paid to tasks such as driving, operating hazardous machinery, etc.

Lidaltrin-Diu 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 indicate the dosage of this medication that is most suitable for you.

Do not take more tablets than those specified by your doctor. Depending on the individual response and patient conditions, your doctor may modify the dosage of Lidaltrin-Diu. Follow your doctor's instructions faithfully regarding dosage and mode of use.

Lidaltrin-Diu is administered orally. Your doctor will indicate 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 indicate the duration of your treatment with Lidaltrin-Diu. Do not discontinue treatment prematurely, as it may be harmful to your health.

If you feel that the effect of this medication is too strong or too weak, consult your doctor or pharmacist.

If you take more Lidaltrin-Diu than you should

Consult your doctor or pharmacist immediately.

A Lidaltrin-Diu overdose may cause a drop in blood pressure. In this case, sit down with your head down.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 915 62 04 20 indicating the medication and the amount used.

If you forgot to take Lidaltrin-Diu

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lidaltrin-Diu

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

Like all medications, Lidaltrin-Diumay cause side effects, although not everyone will experience them. Adverse reactions are usually transient and mild.

The following side effects have been observed:

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

•headache

•dizziness

•vertigo

•nasal mucosa inflammation (rhinitis)

•cough

•fatigue

•nausea and/or vomiting

•muscle pain (myalgia)

•viral infection

•upper respiratory tract infection

•diarrhea

•chest pain

•abdominal pain

•digestive function disorder (dyspepsia)

•back pain

•pharyngeal inflammation (pharyngitis)

•bronchial inflammation (bronchitis)

•weakness (asthenia)

•vasodilation

•difficulty falling asleep (insomnia)

•drowsiness

•decreased blood sodium levels

-Rare(may affect up to 1 in 100 people):

•allergic reaction (anaphylactoid reaction)

•abnormal increased reactivity to sunlight (photosensitivity)

•palpitations

•low blood pressure (hypotension)

•increased heart rate (tachycardia)

•postural hypotension

•syncope

•flatulence

•dry mouth or throat

•hepatitis

•pancreatitis

•thrombocytopenia

•sinusitis

•breathing difficulty (dyspnea)

•nervousness

•tingling (paresthesia)

•hair loss (alopecia)

•skin diseases (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, pemphigus, pruritus, rash)

•urinary tract infections

•impotence

•excessive fluid accumulation in the body (edema)

•joint pain (arthralgia)

•decreased red blood cell lifespan (hemolytic anemia).

-Very rare(may affect up to 1 in 10,000 people):

•acute respiratory distress (symptoms include severe breathing difficulty, fever, weakness, and confusion).

-Unknown frequency(cannot be estimated from available data):

•skin and lip cancer (non-melanoma skin cancer).

•vision loss or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

•dark urine, nausea, vomiting, muscle cramps, confusion, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion).

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

-Laboratory findings:

•electrolyte imbalances

•blood abnormalities (agranulocytosis, leukopenia)

•various laboratory test abnormalities.

These possible side effects may disappear during treatment. However, if they continue or are bothersome, inform your doctor, nurse, or pharmacist.

Other side effects may also occur in some patients. If you observe any other adverse reaction not described above, consult your doctor or pharmacist.

Reporting side effects

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

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

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

Do not store at a temperature above 30°C. Store protected from light and humidity.

Do not use Lidaltrin-Diuafter 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 thrown down the drains or in the trash.Dispose of the packaging and medicines you no longer need at theSIGREcollection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Lidaltrin-Diu

The active principles are quinapril (hydrochloride) and hydrochlorothiazide. Each tablet contains 20 mg of quinapril (as hydrochloride) and 12.5 mg of hydrochlorothiazide.

The other components (excipients) are lactose monohydrate, crospovidone, heavy magnesium carbonate (E504), magnesium stearate (E572), povidone (E1201), hypromellose (E464), hydroxypropylcellulose (E463), macrogol 400, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), and candelilla wax (E902).

Appearance of the product and content of the packaging

The film-coated tablets of Lidaltrin-Diuare pink, triangular, biconvex, and scored. Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Last review date of this leaflet: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/