Quinapril Normon 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Quinapril Normon 40 mg film-coated tablets EFG

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

• Keep this leaflet; 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Quinapril Normon is and what it is used for
2. What you need to know before taking Quinapril Normon
3. How to take Quinapril Normon
4. Possible side effects
5. How to store Quinapril Normon
6. Contents of the pack and other information

1. What Quinapril Normon is and what it is used for

Quinapril belongs to a group of medicines called angiotensin-converting enzyme (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 reduce high blood pressure.

Your doctor has prescribed quinapril for the treatment of:

• high blood pressure (hypertension).
• congestive heart failure.

2. What you need to know before taking Quinapril Normon

Treatment with Quinapril Normon requires periodic monitoring by your doctor.

Do not take Quinapril Normon

• If you are allergic to quinapril or to any of the other components 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 a condition called angioneurotic edema (swelling of the face, tongue, or throat causing breathing difficulties).
• If you have a narrowing of the blood outlet from the heart.
• If you have diabetes or kidney disease and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are taking sacubitril/valsartan, medicines for heart failure.
• If you have kidney problems (renal insufficiency).
• If you are more than 3 months pregnant (it is also advisable to avoid taking Quinapril Normon early in pregnancy – see Pregnancy section).

Warnings and precautions

Talk to your doctor or pharmacist before starting Quinapril Normon:

• If, during treatment—even after the first dose—you develop any of the following symptoms: swelling of the face, eyes, lips, tongue, or difficulty breathing. Stop taking this medicine and contact your doctor immediately.
• These may be signs of deep skin inflammation (angioedema), which can be potentially life-threatening and are more common in patients of black race. Certain cancer or diabetes medications may increase the risk of this condition.
• If you have diabetes, carefully monitor your blood glucose levels (especially during the first month of treatment).
• If you are due to undergo surgery, inform your doctor that you are taking Quinapril Normon.
• If you are on a low-salt diet. Do not use potassium-containing salt substitutes without consulting your doctor.
• If you are pregnant, think you may be pregnant, or plan to become pregnant. Quinapril Normon is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used during this time (see Pregnancy section).
• If you are taking or have recently taken any of the following medicines used to treat high blood pressure (hypertension):
  • An angiotensin II receptor antagonist (ARA) (also known as “sartans” – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskiren.
• If you are taking other medicines to lower blood pressure, as your blood pressure might drop too much.
• If you are taking medicines that increase potassium levels in the blood.
• If you have kidney disease, are undergoing dialysis, or have had a kidney transplant.
• If you have liver disease.
• If you have symptoms of infection (e.g., sore throat or fever) or unusual bleeding.
• If you are scheduled to undergo desensitization (allergy vaccination) against hymenoptera venom (bees, wasps, etc.).
• If you are undergoing cholesterol removal from the blood using a machine (low-density lipoprotein (LDL) apheresis).
• If you are taking Quinapril Normon together with medicines for pain and inflammation (non-steroidal anti-inflammatory drugs). Your doctor may perform periodic tests to check your kidney function. In addition, Quinapril Normon may be less effective in lowering your blood pressure. If you feel unwell or experience dizziness, consult your doctor before taking the next dose. Conditions such as vomiting, diarrhea, dehydration, and excessive sweating may cause your blood pressure to drop too much.
• If you have kidney impairment or are over 65 years old and are taking a medicine containing sulfamethoxazole/trimethoprim.
• If you are taking medicines or have conditions that may reduce sodium levels in the blood.
• Patients receiving concomitant therapy with an mTOR inhibitor (mammalian target of rapamycin inhibitor, e.g., temsirolimus), a DPP-4 inhibitor (dipeptidyl peptidase-4 inhibitor, e.g., vildagliptin), or a neutral endopeptidase inhibitor (e.g., racecadotril) may have an increased risk of angioedema.

Talk to 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, a dry cough may occur while taking Quinapril Normon, which resolves when treatment is stopped. In such a case, consult your doctor.

Talk to your doctor if any of the above-mentioned conditions have ever occurred in your case.

Your doctor may periodically monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).

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

Talk to your doctor or pharmacist before taking any medicine.

Patients over 65 years of age

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

Taking Quinapril Normon with other medicines

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

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 Quinapril Normon” and “Warnings and precautions”).

If you are hospitalized or visiting another doctor, dentist, or pharmacist, inform them that you are taking Quinapril Normon or any other medicine. Inform your doctor that you are being treated with Quinapril Normon if you are scheduled for any surgical procedure.

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

• Lithium (a medicine used to treat depression and bipolar disorders).
• Tetracyclines (a type of antibiotic).
• Diuretics (medicines that increase urine production).
• Potassium supplements, medicines that increase potassium levels in blood, or potassium-containing salt substitutes.
• Medicines containing sulfamethoxazole/trimethoprim (antibiotic).
• Medicines for diabetes (insulin or oral hypoglycemics).
• Medicines for pain and inflammation (non-steroidal anti-inflammatory drugs or NSAIDs).
• Certain medicines for cancer or diabetes.
• Medicines containing gold.
• Medicines used after organ transplants (immunosuppressants) and medicines for cancer treatment (cytostatics).
• Alcohol, barbiturates, and narcotics.
• Medicines to lower blood pressure (antihypertensives).
• Antacids.
• Allopurinol (used to treat gout).
• Procainamide (used to correct irregular heartbeats).
• Systemic corticosteroids.
• mTOR inhibitors (e.g., temsirolimus), DPP-4 inhibitors (e.g., vildagliptin), or neutral endopeptidase inhibitors (e.g., racecadotril), which may increase the risk of angioedema.

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

Taking Quinapril Normon with food and drink

Quinapril Normon 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 before using this medicine.

Pregnancy:

Inform your doctor if you think you are or may be pregnant. Your doctor will usually advise you to stop taking Quinapril Normon before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Quinapril Normon is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Inform your doctor if you are breastfeeding or about to start breastfeeding. This medicine is not recommended during breastfeeding in newborns (first weeks after birth), especially in premature infants. For older infants, your doctor will advise you on the benefits and risks of taking this medicine during breastfeeding compared to other treatments.

Driving and using machines

Quinapril Normon may cause a sudden drop in blood pressure, leading to dizziness and, in some cases, fainting. This is most likely to occur during the first few days of treatment. Therefore, at the beginning of treatment, do not perform tasks that require special attention (e.g., driving a car or operating dangerous machinery) until you know how you react to the treatment.

3. How to take Quinapril Normon

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor again.

Remember to take your medicine.

Your doctor will tell you how long to take Quinapril Normon. Your doctor may increase or decrease the dose as necessary until the right dose for you is found. Do not stop treatment prematurely, as your blood pressure may rise or your heart function may worsen.

This treatment has been prescribed by your doctor specifically for you and your condition. The dose will be determined by your doctor according to each patient's needs. Depending on your individual response, your doctor may adjust the quinapril dosage. Follow your doctor's instructions carefully regarding dose and method of use.

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

Use in children: The safety and efficacy of quinapril in children have not been established. It must not be given to children without consulting a doctor.

Instructions for correct use of the medicine

The Quinapril Normon 40 mg tablet is taken orally and must be swallowed without chewing. Take the tablets with a sufficient amount of liquid (a glass of water). It may be taken with or without food.

If you think that the effect of this medicine is too strong or too weak, do not change the dose yourself; 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 Toxicology Information Service, Telephone 91 562 04 20. Take this leaflet with you.

The most likely symptom expected after an overdose of quinapril is low blood pressure. Symptomatic treatment will be given 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 medicines that properly restore your blood pressure.

If you forget to take Quinapril Normon

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

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

If you stop taking Quinapril Normon

Your doctor will tell you how long to take Quinapril Normon. Do not stop taking Quinapril Normon without consulting your doctor. Medicines used to treat high blood pressure or heart failure are usually taken for life. Stopping Quinapril Normon may cause your condition to worsen.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse reactions to quinapril may vary in intensity from one individual to another and should be especially considered at the beginning of treatment, when changing the dose, or when switching medications.

Stop taking Quinapril Normon and contact your doctor immediately if:

• You develop difficulty breathing with or without swelling of the face, lips, tongue, and/or throat.
• You develop swelling of the face, lips, tongue, and/or throat that may cause difficulty swallowing.

The possible adverse effects during treatment with Quinapril Normon are listed below, according to their frequency.

Frequent adverse effects (may affect between 1 and 10 people in 100) are: Headache, dizziness, inflammation of the nasal mucosa (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, inflammation of the pharynx (pharyngitis), difficulty falling asleep (insomnia), higher than normal levels of certain substances in blood tests (potassium, creatinine, and blood urea nitrogen), decreased sodium levels in blood, low blood pressure (hypotension), and tingling sensations (paresthesias).

Uncommon adverse effects (may affect between 1 and 10 people in 1,000) are: Palpitations, dilation of blood vessels (vasodilation), oppressive chest pain (angina pectoris), increased heart rate (tachycardia), myocardial infarction, flatulence, dry mouth or throat, depression, nervousness, confusion, somnolence, temporary interruption of blood supply to an area of the brain (transient ischemic attacks), dizziness, ringing in the ears (tinnitus), inflammation of the sinuses (sinusitis), upper respiratory tract infection, inflammation of the bronchi (bronchitis), allergic reaction with swelling of the face, tongue, or throat that may cause difficulty breathing (angioedema), urinary tract infections, kidney function impairment, protein in the urine, impotence, decreased visual acuity (amblyopia), fever, and excessive accumulation of fluid in the body (edema).

Rare adverse effects (may affect up to 1 person in 1,000) are: Loss of balance, fainting (syncope), respiratory disorder (eosinophilic pneumonia), altered taste, constipation, swelling of the tongue, urticaria, and various skin lesions that may be severe (erythema multiforme, pemphigus).

Very rare adverse effects (may affect up to 1 person in 10,000) are: Blurred vision, intestinal obstruction (ileus), inflammation in the intestinal tract (intestinal angioedema), and psoriasis-like skin eruption.

Adverse effects with unknown frequency (cannot be estimated from available data) include: Decrease in the number of white blood cells, which may increase susceptibility to infections (agranulocytosis), decrease in the number of red blood cells (anemia), decrease in a type of white blood cells (neutropenia), decrease in the number of platelets (thrombocytopenia), allergic reaction that may be severe (anaphylactoid reaction), dark urine, nausea, vomiting, muscle cramps, confusion, and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion), stroke, drop in blood pressure upon standing that may cause dizziness (postural hypotension), narrowing of the bronchi preventing breathing (bronchospasm), in individual cases, obstruction of the upper airways due to angioedema (which may be life-threatening), inflammation of the pancreas (pancreatitis), inflammation of the liver (hepatitis), jaundice (cholestatic jaundice), severe skin disease with blistering and skin loss (epidermal necrolysis), various skin lesions that may be severe (exfoliative dermatitis, Stevens-Johnson syndrome), hair loss (alopecia), photosensitivity reaction (sensitivity to sunlight), inflammation of serous tissues, skin changes associated with fever, muscle and joint pain (myalgias, arthralgias, arthritis), inflammation of blood vessels (vasculitis), certain changes in blood test values (eosinophilia, leukocytosis and/or elevated antinuclear antibody titers and erythrocyte sedimentation rate), psoriasis or worsening of existing psoriasis (a skin disease characterized by red patches covered with silvery scales), reduced hematocrit, reduced hemoglobin, and elevated liver enzymes and bilirubin levels. In some patients with a congenital enzyme deficiency (glucose-6-phosphate dehydrogenase deficiency), cases of anemia due to destruction of red blood cells (hemolytic anemia) have been reported.

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 Quinapril Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quinapril Normon 40 mg film-coated tablets EFG

• The active substance is quinapril. Each film-coated tablet contains 40 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 yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Brown, round, biconvex tablets.

The tablets are packed in blisters of 28.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6
28760 – Tres Cantos
Madrid (Spain)

Date of the most recent revision of this leaflet: February 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.