LIDALTRIN DIU 20 mg/12.5 mg FILM-COATED TABLETS

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

Treatment with Lidaltrin-Diu requires periodic monitoring by your doctor.

Do not takeLidaltrin-Diu

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

? if you are allergic (hypersensitive) to quinapril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed 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 blood pressure-lowering medicine that contains aliskiren.

? 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 suffering from angioedema may increase:

• Racecadotril, a medicine used to treat diarrhea.
• 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

Consult your doctor or pharmacist before starting to take Lidaltrin-Diu.

? if you have liver disease.

? if you suffer from a connective tissue disease (lupus erythematosus), as it may worsen.

? if you are diabetic.

? if you are going to have surgery, inform your doctor that you are taking Lidaltrin-Diu.

? if you are taking other medicines.

? if you are on a strict salt-free diet. Do not use salt substitutes that contain potassium without consulting your doctor. Your doctor may perform periodic tests to check the salt levels in your blood.

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

• 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-Diu".

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

? inform your doctor if you are pregnant (or think you may be). Lidaltrin-Diu is not recommended during the start of pregnancy and should not be administered if you are pregnant for more than three months, as it can cause serious harm to your baby when administered from this time on (see section Pregnancy).

? if you have kidney disease, undergo dialysis sessions, or have had a kidney transplant. Your doctor may perform various tests periodically to check if your kidneys are working 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 medicines to reduce your blood pressure, as it may reduce it excessively (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 sensation passes. After being lying down, always get up slowly to avoid the sensation of dizziness. If you faint or feel dizzy, inform your doctor.
• as with other ACE inhibitors, when taking Lidaltrin-Diu, dry cough may appear. In this case, consult your doctor. This cough will disappear when you stop treatment.
• ? if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV radiation while taking Lidaltrin-Diu.
• ? if you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can 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, go to the doctor immediately.

Children and adolescents

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

Other medicines and Lidaltrin-Diu

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

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-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 medicine. Lidaltrin-Diu may interact with the following medicines. Do not take these medicines at the same time as Lidaltrin-Diu, unless your doctor has prescribed them:

• lithium (medicine for depression)
• tetracyclines (antibiotic)
• diuretics (medicines to increase urine production)
• potassium supplements, or medicines or salt substitutes that contain potassium
• corticosteroid medicines
• medicines for diabetes (insulin or oral hypoglycemics)
• alcohol, barbiturates, and narcotics
• muscle relaxants
• non-steroidal anti-inflammatory drugs (NSAIDs)
• amines pressor medicines
• medicines to reduce blood pressure (antihypertensives)
• anion exchange resins (medicines that reduce cholesterol levels).
• 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; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots).

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

Taking Lidaltrin-Diu with food, drinks, and alcohol

Lidaltrin-Diu 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 medicine.

• Pregnancy

Your doctor will usually advise you to stop taking Lidaltrin-Diu before you become pregnant or as soon as you know you are pregnant and recommend that you take another medicine instead of Lidaltrin-Diu. Lidaltrin-Diu is not recommended during the start of pregnancy, and it should not be administered if you are pregnant for more than three months, as it can cause serious harm to your baby when administered from this time on.

• Breastfeeding

The use of Lidaltrin-Diu is not recommended during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially in newborns and premature babies.

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Driving and using machines

Lidaltrin-Diu may cause a sudden drop in blood pressure, leading to dizziness and in some cases fainting. This can occur during the first days of treatment. Therefore, special attention should be paid to tasks such as driving, using hazardous machinery, etc.

Lidaltrin-Diu 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-Diu

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the dose of this medicine that is most suitable for you.

Do not take more tablets than those specified by your doctor. Depending on the individual response and the patient's conditions, the doctor may modify the dose of Lidaltrin-Diu. Follow your doctor's instructions faithfully regarding the dose and method 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 (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 indicate the duration of your treatment with Lidaltrin-Diu. Do not stop treatment before, as it may be harmful to your health.

If you feel that the effect of this medicine 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.

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

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

If you forget to take Lidaltrin-Diu

Do not take a double dose to make up for forgotten doses.

If you stop taking Lidaltrin-Diu

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

4. Possible side effects

Like all medicines, Lidaltrin-Diu can cause side effects, although not everybody gets them. Adverse reactions are usually transient and mild.

The following side effects have been observed:

• Common (may affect up to 1 in 10 people):
  • headache
  • dizziness
  • vertigo
  • inflammation of the nasal mucosa (rhinitis)
  • cough
  • fatigue
  • nausea and/or vomiting
  • muscle pain (myalgia)
  • viral infection
  • infection of the upper respiratory tract
  • diarrhea
  • chest pain
  • abdominal pain
  • disorder of digestive function (dyspepsia)
  • back pain
  • inflammation of the pharynx (pharyngitis)
  • inflammation of the bronchi (bronchitis)
  • weakness (asthenia)
  • vasodilation
  • difficulty sleeping (insomnia)
  • sleepiness
  • decreased sodium levels in the blood

• Uncommon (may affect up to 1 in 100 people):
  • allergic reaction (anaphylactoid reaction)
  • increased abnormal sensitivity to sunlight (photosensitivity)
  • palpitations
  • low blood pressure (hypotension)
  • increased heart rate (tachycardia)
  • decrease in blood pressure when standing up (postural hypotension)
  • fainting
  • flatulence
  • dry mouth or throat
  • inflammation of the liver (hepatitis)
  • inflammation of the pancreas (pancreatitis)
  • decrease in platelet count (thrombocytopenia)
  • inflammation of the nasal sinuses (sinusitis)
  • difficulty breathing (dyspnea)
  • nervousness
  • tingling (paresthesia)
  • hair loss (alopecia)
  • skin diseases (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, pemphigus, pruritus, rash)
  • urinary tract infections
  • impotence
  • excessive fluid accumulation in the body (edema)
  • joint pain (arthralgia)
  • decrease in red blood cell lifespan (hemolytic anemia)

• Rare (may affect up to 1 in 10,000 people):
  • Acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion).

• Frequency not known (cannot be estimated from the available data):
  • Skin and lip cancer (non-melanoma skin cancer).
  • Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].
  • Dark urine, nausea, vomiting, muscle cramps, confusion, and convulsions. 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 silver scales).

• Laboratory findings:
  • alterations in serum electrolytes
  • blood alterations (agranulocytosis, leucopenia)
  • alterations in various laboratory tests.

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 notice any other adverse reaction not described above, consult your doctor or pharmacist.

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 Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es

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

5. Storage of Lidaltrin-Diu

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

Do not store above 30°C. Store protected from light and moisture.

Do not use Lidaltrin-Diu 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. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lidaltrin-Diu

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

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

Appearance of the product and contents of the pack

The film-coated tablets of Lidaltrin-Diu are pink, triangular, biconvex, and scored. Each pack 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 medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) https://www.aemps.gob.es/