Spec Perindopril Side effects

• Side effects of Spec Perindopril in details
• Spec Perindopril contraindications
• Spec Perindopril reviews

What are the possible side effects of Spec Perindopril?

Get emergency medical help if you have any of these signs of an allergic reaction to Spec Perindopril: hives; severe stomach pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• little or no urinating;

• swelling, rapid weight gain;

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

• pale skin, easy bruising or bleeding; or

• jaundice (yellowing of the skin or eyes).

Common Spec Perindopril side effects may include:

• dizziness;

• back pain; or

• cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Spec Perindopril in details

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

The following adverse reactions are discussed elsewhere in labeling:

• Anaphylactoid reactions, including angioedema
• Hypotension
• Neutropenia and agranulocytosis
• Impaired renal function
• Hyperkalemia
• Cough

Hypertension

Spec Perindopril has been evaluated for safety in approximately 3,400 patients with hypertension in U.S. and foreign clinical trials. The data presented here are based on results from the 1,417 Spec Perindopril-treated patients who participated in the U.S. clinical trials. Over 220 of these patients were treated with Spec Perindopril® (Spec Perindopril erbumine) for at least one year.

In placebo-controlled U.S. clinical trials, the incidence of premature discontinuation of therapy due to adverse events was 6.5% in patients treated with Spec Perindopril and 6.7% in patients treated with placebo. The most common causes were cough, headache, asthenia and dizziness.

Among 1,012 patients in placebo-controlled U.S. trials, the overall frequency of reported adverse events was similar in patients treated with Spec Perindopril and in those treated with placebo (approximately 75% in each group). The only adverse events whose incidence on Spec Perindopril was at least 2% greater than on placebo were cough (12% vs. 4.5%) and back pain (5.8% vs. 3.1%).

Dizziness was not reported more frequently in the Spec Perindopril group (8.2%) than in the placebo group (8.5%), but its likelihood increased with dose, suggesting a causal relationship with Spec Perindopril.

Stable Coronary Artery Disease

Spec Perindopril has been evaluated for safety in EUROPA, a double-blind, placebo-controlled study in 12,218 patients with stable coronary artery disease. The overall rate of discontinuation was about 22% on drug and placebo. The most common medical reasons for discontinuation that were more frequent on Spec Perindopril than placebo were cough, drug intolerance and hypotension.

Postmarketing Experience

Voluntary reports of adverse events in patients taking Spec Perindopril that have been received since market introduction and are of unknown causal relationship to Spec Perindopril include: cardiac arrest, eosinophilic pneumonitis, neutropenia/agranulocytosis, pancytopenia, anemia (including hemolytic and aplastic), thrombocytopenia, acute renal failure, nephritis, hepatic failure, jaundice (hepatocellular or cholestatic), symptomatic hyponatremia, bullous pemphigoid, pemphigus, acute pancreatitis, falls, psoriasis, exfoliative dermatitis and a syndrome which may include: arthralgia/arthritis, vasculitis, serositis, myalgia, fever, rash or other dermatologic manifestations, a positive antinuclear antibody (ANA), leukocytosis, eosinophilia or an elevated erythrocyte sedimentation rate (ESR).

Clinical Laboratory Test Findings

Hematology

Small decreases in hemoglobin and hematocrit occur frequently in hypertensive patients treated with Spec Perindopril, but are rarely of clinical importance. In controlled clinical trials, no patient was discontinued from therapy due to the development of anemia. Leukopenia (including neutropenia) was observed in 0.1% of patients in U.S. clinical trials.

Liver Function Tests

Elevations in ALT (1.6% Spec Perindopril versus 0.9% placebo) and AST (0.5% Spec Perindopril versus 0.4% placebo) have been observed in placebo-controlled clinical trials. The elevations were generally mild and transient and resolved after discontinuation of therapy.

What is the most important information I should know about Spec Perindopril?

• Spec Perindopril may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Spec Perindopril with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Spec Perindopril may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. Avoid sudden changes in posture.
• Drink plenty of fluids while taking Spec Perindopril and avoid engaging in activities that cause excessive sweating. Dehydration, excessive sweating, vomiting, or diarrhea may increase the risk of low blood pressure. Contact your health care provider at once if any of these occur.
• A persistent, unproductive cough may occur. Tell your doctor if this occurs. If caused by Spec Perindopril, this type of cough generally recovers after Spec Perindopril is stopped.
• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
• Spec Perindopril may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.
• Spec Perindopril may not work as well in black patients. They may also be at greater risk of side effects. Contact your doctor if your symptoms do not improve or if they become worse.
• Tell your doctor or dentist that you take Spec Perindopril before you receive any medical or dental care, emergency care, or surgery.
• Rarely, Spec Perindopril may lower the ability of your body to fight infection. This risk may be greater if you have certain other health problems (eg, kidney problems, collagen vascular disease). Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Check with your doctor before you use a salt substitute or a product that has potassium in it.
• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
• Lab tests, including liver function, kidney function, blood pressure, and blood electrolyte levels, may be performed while you use Spec Perindopril. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Spec Perindopril with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness and rash.
• Spec Perindopril should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Spec Perindopril may cause birth defects or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Spec Perindopril is found in breast milk. If you are or will be breast-feeding while you use Spec Perindopril, check with your doctor. Discuss any possible risks to your baby.

Spec Perindopril contraindications

Hypersensitivity to Spec Perindopril or to any of the excipients of Spec Perindopril or to any other ACE inhibitor; history of angioedema associated with previous ACE inhibitor therapy; hereditary or idiopathic angioedema.

Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency should not take Spec Perindopril.

Use in pregnancy: Spec Perindopril should not be used during the 1st trimester of pregnancy. When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible. Controlled studies with ACE inhibitors have not been done in humans, but in a limited number of cases with 1st trimester exposure, there do not appear to have been any malformations consistent with human foetotoxicity as described as follows.

Spec Perindopril is contraindicated during the 2nd and 3rd trimesters of pregnancy.

Prolonged ACE inhibitor exposure during the 2nd and 3rd trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).

Should exposure to Spec Perindopril have occurred from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.

References

1. European Chemicals Agency - ECHA. "1H-Indole-2-carboxylic acid, 1-[(2S)-2-[[(1S)-1-(ethoxycarbonyl)butyl]amino]-1-oxopropyl]octahydro-, (2S,3aS,7aS): The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).
2. NCIt. "Perindopril: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
3. KEGG. "Target-based classification of drugs". http://www.genome.jp/kegg-bin/get_ht... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology