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Package Leaflet: Information for the User

Quinapril Normon 20 mg Film-Coated Tablets

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

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

Quinapril belongs to the angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by dilating blood vessels. This makes it easier for the heart to pump blood to all parts of the body and helps to reduce high blood pressure.

Your doctor has prescribed quinapril for the treatment of:

-high blood pressure.

-congestive heart failure.

The treatment with Quinapril Normon requires periodic monitoring by your doctor.

Do not take Quinapril Normon

• If you are allergic to quinapril or any of the other components of this medication (including those 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 a condition called angioneuritic edema (a swelling of the face, tongue, or throat that causes difficulty breathing).
• If you have a narrowing of the blood outlet from the heart.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.
• If you are taking sacubitril/valsartan, medications for heart failure.
• If you have kidney problems (kidney insufficiency).
• If you are more than 3 months pregnant (it is also recommended to avoid taking Quinapril Normon at the beginning of pregnancy – see Pregnancy section).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quinapril Normon:

• If, during treatment, even after the first dose, any of the following symptoms appear: facial swelling, eyes, lips, tongue, or difficulty breathing. Stop taking this medication and see your doctor immediately.
• Signs of deep skin inflammatory processes (angioedema), which can be potentially fatal and are more common in black patients. Certain cancer or diabetes medications may increase the risk of this pathology.
• If you are diabetic, you must carefully control your blood glucose levels (especially during the first month of treatment).
• If you are to be operated on, inform your doctor that you are taking Quinapril Normon.
• If you are following a low-sodium diet. Do not use salt substitutes that contain potassium without consulting your doctor.
• If you are pregnant or may be pregnant or plan to become pregnant. Quinapril Normon is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious damage to your baby if used at that time (see Pregnancy section).
• If you are taking or have recently taken any of the following medications used to treat high blood pressure (hypertension):
• • An angiotensin II receptor antagonist (ARA) (also known as "sartanes" – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskirén.
• If you are taking other medications to lower blood pressure, as this may lower your blood pressure too much.
• If you are taking medications that increase potassium levels in the blood.
• If you have kidney disease, follow dialysis sessions or have had a kidney transplant.
• If you have liver diseases.
• If you have symptoms of infection (for example, sore throat or fever) or any unusual bleeding.
• If you are to undergo desensitization (vaccine for allergy) against insect venom (bees, wasps...).
• If you are to have cholesterol removed from your blood using a machine (apheresis of low-density lipoproteins (LDL)).
• If you are taking Quinapril Normon with medications to relieve pain and inflammation (nonsteroidal anti-inflammatory drugs). Your doctor may perform various tests, periodically, to check if your kidneys are functioning properly. Additionally, Quinapril Normon may have less effect on your blood pressure.
• If you feel unwell or have dizziness, consult your doctor before taking the next dose. Processes such as vomiting, diarrhea, dehydration, and excessive sweating can lower your blood pressure too much.
• If you have kidney insufficiency or are over 65 years old and are taking a medication containing sulfametoxazol/trimetoprim.
• If you are taking medications or have conditions that may reduce sodium levels in the blood.
• Patients who, for therapeutic reasons, are receiving simultaneously an mTOR inhibitor (mammalian target of rapamycin inhibitor, for example temsirolimus) or a DPP-4 inhibitor (dipeptidyl-peptidase 4, for example, vildagliptin) or a neutral endopeptidase inhibitor (for example, racecadotril), may have an increased risk of angioneuritic edema.

Consult your doctor if you experience dizziness and vertigo. If dizziness appears, lie down until this sensation passes. After lying down, always get up slowly to avoid dizziness. If you faint or feel dizzy, inform your doctor.

As occurs with other ACE inhibitors, taking Quinapril Normon maycause dry cough, which disappears when the treatment is interrupted. In this case, consult your doctor.

Consult your doctor if any of the circumstances mentioned above have occurred at any time.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in the blood (for example, potassium), at regular intervals.

See also the information under the heading "Do not take Quinapril Normon."

Consult your doctor or pharmacist before taking a medication.

Patients over 65 years old

If you are elderly, you may be more sensitive to the effects mentioned above. If any of these effects appear, inform your doctor immediately.

Use of Quinapril Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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 Quinapril Normon" and "Warnings and precautions").

If you are hospitalized or visit another doctor, dentist, or pharmacist, inform them that you are taking Quinapril Normon or any other medication. Inform your doctor that you are receiving treatment with Quinapril Normon if you are to undergo any surgical procedure.

Quinapril Normon may interact with the following medications. It is especially important to inform your doctor if you are taking:

• Lithium (medication for depression and bipolar disorders).
• Tetracyclines (a type of antibiotics).
• Diuretics (medications that increase urine production).
• Potassium supplements, or medications that increase potassium levels in the blood, or medications or salt substitutes that contain potassium.
• Medications containing sulfametoxazol/trimetoprim (antibiotic).
• Medications for diabetes (insulin or oral hypoglycemic agents).
• Medications for pain and inflammation (nonsteroidal anti-inflammatory drugs or NSAIDs).
• Certain medications for cancer or diabetes.
• Medications containing gold.
• Medications used after transplants (immunosuppressants) and medications for cancer treatment (cytostatics).
• Alcohol, barbiturates, and narcotics.
• Medications for lowering blood pressure (anti-hypertensives).
• Antacids.
• Alopurinol (for gout).
• Procainamide (to correct irregular heartbeats).
• Corticosteroids.
• The mTOR inhibitors (for example temsirolimus) or DPP-4 inhibitors (for example, vildagliptin) or neutral endopeptidase inhibitors (for example, racecadotril), may possibly increase the risk of angioneuritic edema.

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

Use of Quinapril Normon with food and beverages

Quinapril Normon can be taken with or without food.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

Pregnancy:

Inform your doctor if you think you are or may be pregnant. Normally, your doctor will instruct you to stop taking Quinapril Normon before becoming pregnant or as soon as you know you are pregnant and will instruct you to take another medication instead of Quinapril Normon. Quinapril Normon is not recommended at the beginning of pregnancy, and it should not be taken after the third month of pregnancy, as it may cause serious damage to your baby if used at that time.

Lactation:

Consult your doctor or pharmacist before using a medication.

Inform your doctor if you are breastfeeding or about to start breastfeeding. Quinapril Normon is not recommended during breastfeeding in newborns (first weeks after birth) and especially in premature babies. In the case of older babies, your doctor will advise you on the benefits and risks of administering this medication during breastfeeding, compared to other treatments.

Driving and operating machines

Quinapril Normon may cause a sudden drop in blood pressure, causing dizziness and, in some cases, fainting. This may occur especially during the first days of treatment. Therefore, do not perform tasks that require special attention (for example, driving a car or operating hazardous machinery) until you know how you tolerate the treatment.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Quinapril Normon. Your doctor may increase or decrease the dose as needed until they find the dose you need. Do not stop treatment beforehand, as your blood pressure may rise or your heart function may worsen.

This treatment has been indicated by your doctor specifically for you and your disease. The dose will be established by the doctor according to the needs of each patient. Depending on the individual response, the doctor may modify the quinapril dosing. Follow your doctor's instructions faithfully regarding the dose and mode of use.

Quinapril is administered orally. Your doctor will indicate how many tablets you should take each day.

Use in children:The safety and efficacy of quinapril in children have not been established. Do not administer to children without consulting a doctor.

Instructions for correct use of the medication

The Quinapril Normon 20 mg tablet is administered orally and should be swallowed without chewing. Take the tablets with a sufficient amount of liquid (a glass of water). You can take them with meals or without them.

If you estimate that the action of this medication is too strong or too weak, do not change the dose yourself and inform your doctor or pharmacist.

If you take more Quinapril Normon than you should

In case of overdose or accidental ingestion, consult your doctor or the Toxicological Information Service, Teléfono 91 562 04 20. Bring this leaflet with you.

A severe overdose may cause a marked and probably prolonged drop in blood pressure. Symptomatic treatment will be performed to compensate for the effects of this medication.

In severe cases, appropriate 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 forgot to take Quinapril Normon

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

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

If you interrupt treatment with Quinapril Normon

Your doctor will indicate the duration of your treatment with Quinapril Normon. Do not stop taking Quinapril Normon without consulting them. Normally, medications for treating high blood pressure or heart failure should be taken for life. If you stop taking Quinapril Normon, it may worsen.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Quinapril side effects vary in intensity from one individual to another, and should be taken into account especially at the beginning of treatment, when changing the dose or switching medications.

Stop taking Quinapril Normon and contact your doctor immediately if:

- Difficulty breathing with or without facial, lip, tongue, and/or throat inflammation occurs.

- Facial, lip, tongue, and/or throat inflammation occurs that may cause difficulty swallowing.

The following are possible side effects during treatment with Quinapril Normon, listed by frequency.

Side effectsfrequent(may affect between 1 to 10 people per 100)are: Headache, dizziness, nasal mucosa inflammation (rhinitis), cough, fatigue, weakness (asthenia), nausea and/or vomiting, muscle pain (myalgia), diarrhea, chest pain, abdominal pain, digestive discomfort (dyspepsia), difficulty breathing (dyspnea), back pain, pharyngeal inflammation (pharyngitis), difficulty falling asleep (insomnia), elevated levels of certain substances in blood tests (potassium, creatinine, and urea nitrogen), decreased sodium levels in the blood, low blood pressure (hypotension), and paresthesia.

Side effectsinfrequent (may affect between 1 to 10 people per 1,000)are: Palpitations, vasodilation, chest tightness (angina pectoris), increased heart rate (tachycardia), myocardial infarction, flatulence, dry mouth or throat, depression, nervousness, confusion, drowsiness, transient interruption of blood supply to an area of the brain (transient ischemic attack), vertigo, tinnitus, nasal sinus inflammation (sinusitis), upper respiratory tract infection, bronchitis, allergic reaction with facial, tongue, or throat swelling that may cause difficulty breathing (angioedema), urinary tract infections, kidney function alteration, proteinuria, impotence, decreased visual acuity (amblyopia), fever, and excessive fluid accumulation in the body (edema).

Side effectsrare (may affect up to 1 person per 1,000)are: Balance alteration, syncope, respiratory disease (eosinophilic pneumonia), taste alteration, constipation, tongue inflammation, urticaria, and various skin lesions that may be severe (erythema multiforme, pemphigus).

Side effectsvery rare (may affect up to 1 person per 10,000)are: Blurred vision, intestinal obstruction (ileus), intestinal inflammation (intestinal angioedema), and skin rash similar to psoriasis.

Side effectswith unknown frequency(cannot be estimated from available data) are: Decreased white blood cell count that may favor infections (agranulocytosis), decreased red blood cell count (anemia), decreased neutrophil count (neutropenia), decreased platelet count (thrombocytopenia), severe allergic reaction (anaphylactoid reaction), dark urine, nausea, vomiting, muscle cramps, confusion, and seizures. These may be symptoms of a condition called SIADH (inadequate antidiuretic hormone secretion), stroke, decreased blood pressure upon standing that may cause dizziness (postural hypotension), bronchospasm, in individual cases, upper airway obstruction by angioedema (which may be fatal), pancreatitis, hepatitis, jaundice (cholestatic jaundice), severe skin disease with blister formation and skin loss (necrolytic epidermal necrosis), various severe skin lesions (dermatitis exfoliativa, Stevens-Johnson syndrome), hair loss (alopecia), photosensitivity, inflammation of serous tissues, skin changes associated with fever, muscle and joint pain (myalgias, arthralgias, arthritis), vasculitis, certain changes in blood test values (eosinophilia, leukocytosis, and/or elevated antinuclear antibodies and erythrocyte sedimentation rate), psoriasis or worsening of existing psoriasis (skin disease characterized by red plaques covered with silvery scales), reduced hematocrit, reduced hemoglobin, elevated liver enzymes and bilirubin. In some patients with a congenital enzyme deficiency (congenital glucose-6-phosphate dehydrogenase deficiency), cases of hemolytic anemia have been reported.

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Quinapril Normon 20 mg film-coated tablets

-The active ingredient is quinapril. Each film-coated tablet contains 20 mg of quinapril.

-The other components are: magnesium carbonate, hydroxypropylcellulose, crospovidone, magnesium stearate, Eudragit E 12.5%, titanium dioxide (E-171), talc, macrogol 6000, and iron oxide yellow (E-172).

Appearance of the product and content of the packaging

Orange-colored, round, biconvex, and scored on one side.

The tablets are packaged in blisters of 28.

Holder of the marketing authorization and responsible for manufacturing

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Last review date of this leaflet: February 2023

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