Corinfar Retard, 20 mg 50 pcs

Indications

Corinfar® retard is used in adults to treat the following diseases:
• arterial hypertension;
• stable angina and vasospastic angina (Prinzmetal’s angina, variant angina).

If there is no improvement or you feel worse, you should consult a doctor.

Special instructions

Before using Corinfar® retard, consult your doctor or pharmacist.

Be sure to tell your healthcare provider if any of the following applies to you:
• if you have low blood pressure;
• if you have a significant increase in blood pressure;
• if you have coronary heart disease (especially with severe obstructive lesions of the coronary arteries) or cerebrovascular disease;
• if you have chronic heart failure;
• if you are taking any medications to treat heart disease;
• if you have aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy;
• if you have diabetes;
• if you have mild liver dysfunction;
• if you have high blood pressure and are undergoing hemodialysis;
• if you are taking phenytoin, carbamazepine, phenobarbital, macrolide antibiotics, drugs for the treatment of HIV infection, ketoconazole, antidepressants, fluoxetine, valproic acid and other inhibitors and/or inducers of the CYP3A4 isoenzyme;
• if you are more than 20 weeks pregnant;
• old age.

Children and teenagers
Do not give the drug to children from 0 to 18 years of age, since the safety and effectiveness of the use of the drug Corinfar® retard in children and adolescents has not been established.

Driving vehicles and working with machinery
In some patients, especially at the beginning of treatment, nifedipine may cause dizziness, which reduces the ability to drive vehicles or use other machinery. In the future, the degree of restrictions depends on the individual tolerance of nifedipine.
During the treatment period, especially at the beginning of treatment or when changing the dose, care must be taken when driving, engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

The drug Corinfar® retard contains lactose monohydrate
If you have an intolerance to certain sugars, consult your doctor before taking this drug.

Active ingredient

Nifedipine

Composition

The active ingredient is nifedipine.

Each tablet contains 20 mg of nifedipine.

Other ingredients (excipients) are lactose monohydrate, potato starch, microcrystalline cellulose, povidone K25, magnesium stearate, hypromellose, macrogol 6000, macrogol 35000, quinoline yellow dye (E104), titanium dioxide (E 171), talc.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using this drug.

Pregnancy
There are no adequate controlled studies in pregnant women. The available information is insufficient to exclude the possibility of side effects that pose a danger to the fetus and newborn.
In animal studies, nifedipine has been shown to be embryotoxic, fetotoxic and teratogenic.
Do not take Corinfar® retard if you are pregnant.

Breastfeeding
Nifedipine is excreted into breast milk.
Do not take Corinfar® retard if you are breastfeeding.

Fertility
In male patients, nifedipine may cause sperm damage. After several unsuccessful attempts at in vitro fertilization, exposure to nifedipine or similar antihypertensive agents can be assumed unless otherwise indicated. This may be the reason for unsuccessful attempts at in vitro fertilization.

Contraindications

Do not take Corinfar® retard:

• if you are allergic to nifedipine or any of the other ingredients of this medicine (listed in section 6 of the leaflet);
• if you have moderate or severe liver failure (Child-Pugh Classes B and C);
• if you have cardiogenic shock;
• if you have a collapse;
• if you have severe arterial hypotension (systolic blood pressure below 90 mmHg);
• if you have an acute period of myocardial infarction (during the first 4 weeks);
• if you have unstable angina;
• if you have hemodynamically significant obstruction of the left ventricular outflow tract (including severe aortic stenosis);
• if you are taking rifampicin (due to the inability to achieve effective plasma levels of nifedipine due to enzyme induction);
• if you are pregnant (up to 20 weeks);
• if you are breastfeeding.

If you think any of the following applies to you, tell your healthcare provider.

Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The most serious adverse reactions reported with nifedipine:

Uncommon – may occur in up to 1 in 100 people:

itching of the skin, in the eye area, runny nose, sneezing, rash, hives (allergic reaction);
swelling of the skin and mucous membranes, difficulty breathing, difficulty swallowing, soreness, cough, increasing hoarseness, respiratory failure, headache, possible convulsions, impaired consciousness (angioedema (Quincke’s edema)).

Rare – may affect up to 1 in 1,000 people:

pressing, often burning pain in the heart (behind the sternum), weakness, palpitations, pallor of the skin (manifestation of angina attacks);
frequent appearance of bruises, even after minor blows, increased bleeding time from wounds, poor regeneration of the wound surface, gingival bleeding, the appearance of nosebleeds (thrombocytopenic purpura).

Unknown – the frequency of occurrence cannot be determined based on the available data:

urticaria and swelling of the skin, breathing problems, most often reminiscent of an asthmatic attack, darkening of the eyes, dizziness, a sharp decrease in blood pressure, loss of consciousness (anaphylactic/anaphylactoid reactions);
the appearance of red spots, rashes and blisters on the skin and mucous membranes, detachment of the upper skin (toxic epidermal necrolysis (Lyell’s syndrome));
acute pain in the left half of the chest, shortness of breath, weakness, dizziness, the appearance of sticky sweat, a feeling of fear, panic attacks, heart rhythm disturbances (myocardial infarction);
dyspnea.

Stop taking Corinfar® retard and seek immediate medical attention if any of the above serious adverse reactions occur.

Other adverse reactions reported with nifedipine preparations:

Common – may occur in no more than 1 in 10 people:

headache;
weakness;
peripheral edema;
asymptomatic decrease in blood pressure, development or worsening of heart failure, “flushes” of blood to the facial skin, flushing of the facial skin, sensation of heat (manifestation of excessive dilation of blood vessels (vasodilation));
constipation;
asthenia.

Uncommon – may occur in up to 1 in 100 people:

sleep disorders, anxiety;
migraine;
visual impairment, including short-term loss of vision against the background of the maximum concentration of nifedipine in the blood plasma;
feeling of heartbeat;
marked decrease in blood pressure, fainting;
nosebleeds, nasal congestion;
pain in the abdomen (gastrointestinal and abdominal pain);
nausea, diarrhea, constipation (dyspepsia);
flatulence;
dryness of the oral mucosa;
increased activity of “liver” transaminases in the blood;
limited intense redness of the skin (erythema);
muscle cramps;
swelling of the joints;
disturbance of urination (polyuria, dysuria);
erectile dysfunction;
nonspecific pain;
chills.

Rare – may affect up to 1 in 1,000 people:

painful burning sensation (burning sensation under the skin), tingling or aching pain (paresthesia, dysesthesia);
skin itching, jaundice, constipation, bitter taste in the mouth, pain in the right hypochondrium, dark urine and discoloration of feces (intrahepatic cholestasis);
manifestation of sensitivity to sunlight in the form of a skin rash (photodermatitis);
bleeding, pain, swelling of the gums;
difficulty breathing, cough;
pain in muscles and joints (myalgia, arthralgia).

Very rare – may occur in no more than 1 person in 10,000:

anemia;
autoimmune hepatitis;
weight gain;
an increase in glucose levels in the blood serum compared to normal (hyperglycemia);
shortness of breath, including asthmatic symptoms (bronchospasm);
enlargement of the mammary gland with hypertrophy of the glands and adipose tissue in elderly patients (gynecomastia);
secretion of milk from the mammary glands, which is not associated with the process of feeding the child (galactorrhea).

Unknown – the frequency of occurrence cannot be determined based on the available data:

decreased level of leukocytes in the blood (leukopenia, agranulocytosis);
dullness of sensations, weakening of sensitivity in certain parts of the body (hypesthesia);
drowsiness;
increased fatigue;
numbness in the limbs (limb paresthesia);
depression;
parkinsonian disorders (impaired motor skills (ataxia), “mask-like” face, shuffling gait, stiffness in hand movements, tremor of the hands and fingers, difficulty swallowing);
eye pain;
arrhythmia;
pulmonary edema;
vomit;
insufficiency of the lower esophageal (gastroesophageal) sphincter;
increased appetite;
finely spotted capillary hemorrhages in the skin, under the skin or in the mucous membranes (purpura);
joint inflammation (arthritis);
deterioration of renal function in patients with renal failure.

Reporting Adverse Reactions

If you experience any unwanted reactions, consult your doctor or pharmacist. This also includes any adverse reactions not listed in the package insert.

Interaction

Tell your doctor or pharmacist if you are taking, have recently taken, or may start taking any other medications.

Be sure to tell your doctor if you are taking any of the following medications:

• rifampicin (a drug used to treat tuberculosis);
• phenytoin (anti-epileptic drug);
• carbamazepine (anti-epileptic drug);
• phenobarbital (anti-epileptic drug);
• valproic acid (anti-epileptic drug);
• erythromycin (a drug to treat bacterial infections);
• ritonavir (a drug used to treat HIV infection);
• ketoconazole (antifungal drug);
• cimetidine (a drug for the treatment of gastric and duodenal ulcers);
• ranitidine (a drug for the treatment of gastric and duodenal ulcers);
• diltiazem (a drug to treat high blood pressure);
• fluoxetine (antidepressant);
• nefazodone (antidepressant);
• quinidine (antiarrhythmic drug);
• quinupristin/dalfopristin (a drug for the treatment of staphylococcal infections);
• cisapride (laxative);
• digoxin (a drug used to treat heart failure);
• theophylline (a drug for the treatment of broncho-obstructive syndrome);
• tacrolimus (immunosuppressant);
• vincristine (antitumor agent);
• indirect anticoagulants (coumarin and indanedione derivatives);
• anticonvulsants;
• non-steroidal anti-inflammatory drugs;
• sulfinpyrazone (a drug to treat gout);
• cephalosporins (drugs for the treatment of infectious and inflammatory diseases).

Corinfar® retard with food, drinks and alcohol
During the treatment period, it is not recommended to drink alcoholic beverages due to the risk of an excessive decrease in blood pressure.
Grapefruit juice inhibits the breakdown of nifedipine, which may increase or prolong the antihypertensive effect and cause a drop in blood pressure, so drinking grapefruit juice is not recommended while taking nifedipine. The inhibitory effect may last up to 3 days after the last dose of grapefruit juice.
Simultaneous food intake delays, but does not reduce, the absorption of the active substance from the gastrointestinal tract.

Overdose

Symptoms

Nifedipine causes peripheral vasodilation with severe and possibly prolonged systemic arterial hypotension: headache, facial flushing, prolonged pronounced decrease in blood pressure, depression of the sinus node, bradycardia and/or tachycardia, bradyarrhythmia. In case of severe poisoning – loss of consciousness, coma.

Treatment

Treatment of overdose consists of standard procedures for removing the drug from the body. The administration of activated carbon, gastric lavage (if necessary, lavage of the small intestine), and restoration of stable hemodynamic parameters are indicated.

In case of an overdose of long-acting nifedipine preparations, it is necessary to ensure the most complete removal of the drug from the body, and, if possible, lavage of the small intestine in order to prevent further absorption of the active substance. When using laxatives, it should be taken into account that BMCC can cause a decrease in the tone of the intestinal muscles, up to intestinal atony.

The antidote to nifedipine is calcium preparations. Intravenous administration of 10-20 ml of a 10% solution of calcium chloride or calcium gluconate is indicated, followed by switching to a long-term infusion. If the administration of calcium supplements fails to achieve a sufficient increase in blood pressure, it is possible to use alpha adrenergic agonists (dopamine, norepinephrine).

For bradyarrhythmia – intravenous administration of atropine, beta-adrenergic agonists. For life-threatening bradyarrhythmias, installation of a temporary pacemaker is recommended. With the development of heart failure – intravenous administration of strophanthin. Infusion therapy is recommended to be carried out with caution due to the risk of volume overload of the heart.

Careful monitoring of the activity of the heart, lungs and excretory system is necessary. It is recommended to monitor the concentration of glucose (insulin release may decrease) and the content of electrolytes (potassium, calcium) in the blood.

Hemodialysis is ineffective due to the high degree of binding to plasma proteins and the relatively small volume of distribution. Plasmapheresis is possible.

Storage conditions

Keep the drug out of the reach of children and so that the child cannot see it.
Do not use the drug after the expiration date indicated on the blister, bottle label or on the carton after the words “Best before”. The expiration date is the last day of the given month.
Store at a temperature not exceeding 25 ° C in the original packaging.
Do not throw the drug into the sewer. Ask your pharmacist how to dispose of (destroy) a drug that is no longer needed. These measures will protect the environment.

Shelf life

5 years

Manufacturer

Pliva Hrvatska d.o.o., Croatia