CORAL 30 mg Modified-Release Tablet

Зміст інструкції

1. CORAL 30 mg film-coated modified-release tablets, 60 mg film-coated modified-release tablets
   1. What is CORAL and what is it used for
   2. What you need to know before taking CORAL
   3. How to take CORAL
   4. Possible side effects
   5. How to store CORAL
   6. Contents of the pack and other information

CORAL 30 mg film-coated modified-release tablets, 60 mg film-coated modified-release tablets

Nifedipine
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is CORAL and what is it used for

CORAL contains the active substance nifedipine, which belongs to the category of medicines called calcium antagonists.
Coral is used for the treatment of the following conditions:

• angina pectoris (exertional angina), which consists of severe chest pain in the region behind the sternum, due to an insufficient supply of blood and oxygen to the heart (generally following exertion). Nifedipine works by dilating the coronary arteries, thereby increasing the supply of blood and oxygen to the heart tissue. Furthermore, as it also acts at the level of peripheral vessels, it reduces the oxygen requirement of the heart.
• highblood pressure (arterial hypertension), as it causes relaxation of blood vessels and increases the elimination of sodium and water. This results in a lowering of blood pressure, particularly marked in patients with high blood pressure.

2. What you need to know before taking CORAL

Do not take CORAL

• If you are allergic to nifedipine or any of the other ingredients of this medicine listed in section 6.
• If you are or suspect you are pregnant (up to the 20th week) and during breastfeeding (see “Pregnancy and breastfeeding”).
• If you are in cardiovascular shock (sudden drop in blood pressure)
• If you are taking a medicine containing rifampicin(an antibiotic used to treat certain types of infections. In this case, the levels of nifedipine in the blood may be insufficient (see “Other medicines and Coral”)
• If you have a Kock pouch (“diversion” after a destructive operation on the colon and rectum).

Warnings and precautions
Talk to your doctor or pharmacist before taking CORAL. Be careful with CORAL
especially:

• If you have very low blood pressure (systolic pressure below 90 mm of mercury), if you suffer from heart failure (weak heart) or severe aortic stenosis (narrowing of a heart valve);
• If you are being treated with beta-blockers (medicines used to treat certain heart rhythm disorders and to lower blood pressure) or medicines that lower blood pressure (antihypertensives);
• If you have a severe narrowing of the gastrointestinal tract,because, since the tablet consists of a non-absorbable shell, symptoms of intestinal blockage (intestinal obstruction) may occur. Exceptionally, these shells can lead to the formation of voluminous masses in the stomach, called bezoars, which cannot be eliminated through the intestine and sometimes require surgical intervention. In isolated cases, blockage symptoms have also manifested in patients who have never experienced gastrointestinal disorders. If you undergo X-rays of the digestive tract with barium contrast, be aware that Coral may give images that may be falsely interpreted as polyps.
• If you are pregnant: given that the available information does not allow excluding the possibility of adverse effects on the unborn child and newborn. For this reason, Coral should not be used in the first 20 weeks of pregnancy (see “Do not take Coral” and “Pregnancy and breastfeeding”) and, in the following weeks, can only be used after a very careful assessment of the possible risks and expected benefits and when other therapies are not suitable or have not been effective. Your doctor will then decide whether treatment with Coral is suitable for you. If they prescribe Coral for you, they will likely subject you to frequent blood pressure checks, especially if it is administered in association with magnesium sulfate intravenously, due to the possibility of an excessive drop in blood pressure, which can harm both you and the fetus.
• If you are breastfeeding: Do not take CORAL (See “Pregnancy, breastfeeding”) as nifedipine passes into breast milk and the effects of oral absorption of small amounts of nifedipine are unknown. For immediate-release formulations, it is recommended to delay breastfeeding or milk expression for 3 or 4 hours after taking the medicine in order to reduce the infant's exposure to nifedipine. Since there is no data on possible effects on the newborn, if treatment with nifedipine is necessary during this period, breastfeeding should be discontinued;
• If your liver is not functioning properly. In this case, careful monitoring may be necessary and, if your disorder is severe, a reduction in the dose of CORAL may also be necessary
• If you need to undergo a laboratory test to determine the values of vanillyl-mandelic acid in the urine (a test to diagnose a tumor of the adrenal gland), be aware that, in the presence of nifedipine and depending on the method used, the values may be falsely increased
• If you are on dialysis and if you suffer from abnormally high blood pressure (malignant hypertension).
• If you experience chest pain (sometimes angina-like discomfort).
• If you suffer from a condition known as congestive heart failure and should experience the onset of swelling (edema).
• If you have diabetes or are at risk.

Children and adolescents
The safety and efficacy of nifedipine in children under 18 years of age have not been established.

Other medicines and CORAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Regarding CORAL, know that:
Nifedipine is transformed in the body through a particular system of molecules (called
enzymes). If medicines that influence or use this same system are administered in association, a reduction or increase in the concentration in the blood, and therefore the effect of nifedipine or the other medicine, may be observed. It may then be necessary to adjust the dose of nifedipine or the other medicine and/or more frequent monitoring of blood pressure.
Medicines that can alter the effect of nifedipine are:

• rifampicin(an antibiotic); never take Coral together with medicines containing rifampicin(see “Do not take Coral”).
• certain antibiotics belonging to the macrolide class, such as erythromycin;
• certain medicines against AIDS, such as ritonavir, amprenavir, indinavir, nelfinavir or saquinavir;
• certain medicines against fungal infections, such as ketoconazole, itraconazole or fluconazole
• fluoxetine, nefazodone(medicines against depression);
• quinupristin/dalfopristin(antibiotic used for particular infections);
• phenytoin, carbamazepine, phenobarbital, valproic acid(medicines against seizures);
• - Diltiazem (medicine used to lower blood pressure); cimetidine, cisapride(medicines used in stomach ulcers)

Nifedipine can alter the effect of the following medicines:

• nifedipine can enhance the blood pressure-lowering effect of other medicinesthat lower blood pressure (diuretics, β-blockers, ACE inhibitors, angiotensin II receptor antagonists (AT-1), other calcium channel blockers, α-blockers, PDE5 inhibitors, α-methyldopa) .In particular, if you take beta-blocker medicines in association, the doctor will have to monitor you carefully, because it can also worsen the heart's ability to pump blood.
• digoxin, quinidine(medicines for the heart).
• tacrolimus(medicine used against transplant rejection).

Medicines that contain the following substances do not seem to alter the concentration of
nifedipine in the blood and/or their metabolism is not affected by nifedipine: ajmaline
(medicine
against arrhythmias), acetylsalicylic acidat a dose of 100 mg (medicine against flu symptoms or
to thin the blood), benazepril, doxazosin, candesartan cilexetil, irbesartan, debrisochine,
talinolol(medicines against high blood pressure), omeprazole, pantoprazole, ranitidine(medicines
against heartburn), orlistat(weight loss medicine), rosiglitazone(medicine against
diabetes), triamterene, hydrochlorothiazide(diuretics).

CORAL with food and drink
Do not drink grapefruit juice during treatment with CORAL. Simultaneous intake may
cause an increase in plasma concentrations of nifedipine in the blood and prolong its
effect. If you drink grapefruit juice regularly, this effect can last for more than 3 days
from the last intake.
Do not drink alcoholic beverages if you are using nifedipine, as this may impair your ability to drive or
operate machinery (see Driving and using machines).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Coral if you are in the first 20 weeks of pregnancy or if you are breastfeeding
(see “Do not take Coral”)
Nifedipine should not be used during pregnancy unless the patient's clinical condition requires treatment with nifedipine. The use of nifedipine should be reserved for
women with severe hypertension who have not responded to standard therapy
(see “Warnings and precautions”).
Adequate and well-controlled studies in pregnant women have not been conducted.
The available information is not sufficient to exclude adverse effects on the fetus and newborn.

Breastfeeding
The use of nifedipine during breastfeeding is not recommended because it has been reported to pass into
breast milk and the effects of oral absorption of small amounts of nifedipine are unknown
. In this case, as a precaution, discontinue breastfeeding with breast milk and inform
the doctor.
If your doctor has told you to take nifedipine in immediate-release formulations,
delay breastfeeding or do not express milk for 3 or 4 hours after administering the
medicine in order to reduce the infant's exposure to nifedipine (see paragraph “Warnings
and Precautions”).

Driving and using machines
Coral can cause dizziness or lightheadedness, especially at the beginning of
treatment, when changing the medicine or in association with alcoholic beverages. If this happens to you,
do not drive vehicles or operate machinery.

3. How to take CORAL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Treatment should possibly be adapted to the needs of the individual patient. Your doctor will determine the dose based on the severity of the disease and how you respond to treatment.
The recommended dose is:
one 30 mg coated tablet once a day, in the morning.
The dose, at the doctor's discretion, may be gradually increased up to a maximum of 60 mg
(one 60 mg coated tablet) in arterial hypertension or 120 mg (two 60 mg coated tablets) in angina pectoris, taking the medicine once a day, in the morning.

Use in patients with impaired liver function
If your liver is not functioning properly, careful monitoring of blood pressure may be necessary and, in severe cases, a reduction in dosage.

Paediatric population
The safety and efficacy of nifedipine in children under 18 years of age have not been established.
Coral is for oral use. The film-coated tablet should be swallowed with some water in the morning on an empty stomach
The tablets must not be chewed or broken.
Do not change the dose you take without first informing your doctor. He will assess whether to increase or reduce the dose and for how long the treatment should continue.
The tablet is substantially protected from light both inside and outside the packaging, thanks to the photosensitive substance contained in the tablet.
Inside the packaging, the tablets are also protected from moisture and therefore should only be removed from the blister pack when you need to take them. See section 3.
Take CORAL for the period indicated by your treating doctor.

If you take more CORAL than you should
It is important to adhere to the dose indicated by your doctor. In case of accidental ingestion/administration of an excessive dose of CORAL, immediately inform your doctor or go to the nearest hospital.

Symptoms
In cases of severe nifedipine poisoning, the following symptoms have been observed: disturbances of consciousness up to coma, decreased blood pressure, alterations in heart rhythm of the tachy/bradycardic type (acceleration/slowing of the heart rate), hyperglycemia (increased blood sugar levels), decreased blood pH due to an increase in the amount of acidic substances in the blood (metabolic acidosis), oxygen deficiency (hypoxia), serious heart problems such as cardiogenic shock with fluid accumulation around the lung (pulmonary edema).

If you forget to take Coral
If you forget to take the medicine, take it as soon as you remember on the same day. If you happen to miss a day, take the normal dose the next day. Do not take a double dose to make up for a missed dose.
If you are unsure what to do, consult your doctor or pharmacist.

If you stop taking CORAL
Do not stop taking the medicine without first consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
During trials with nifedipine, the following side effects have been observed:

Common side effects (may affect up to 1 in 10 people)

• swelling at the extremity of the body due to fluid retention (peripheral edema);
• headache;
• feeling unwell
• - edema, including peripheral edema (generalized or extremity swelling),
• - vasodilation (dilation of blood vessels),
• - constipation,

Uncommon side effects:(may affect up to 1 in 100 people)

• - allergic reaction,
• - allergic/angioedema (swelling of the skin, face and mucous membranes, including laryngeal edema, potentially life-threatening),
• anxious reactions, sleep disorders;
• dizziness, migraine (unilateral headache), vertigo, tremor;
• visual disturbances;
• tachycardia (fast heartbeat), sensation of a fast or irregular heartbeat (palpitations);
• ), severe impairment of bile flow to the duodenum due to an obstruction within the liver (intrahepatic cholestasis);
• ,
• - hypotension (low blood pressure),
• - syncope (fainting),
• - epistaxis (nosebleed),
• - nasal congestion (stuffy nose),
• - gastrointestinal and abdominal pain (stomach ache),
• - nausea,
• - dyspepsia (indigestion),
• - flatulence (presence of gas in the intestine),
• diarrhea
• - dry mouth,
• - transient increase in liver enzymes,
• - erythema (redness of the skin),
• - muscle cramps,
• - joint swelling,
• - polyuria (increased urine output),
• - dysuria (difficulty urinating),
• - erectile dysfunction (difficulty achieving and maintaining an erection),
• - nonspecific pain, limb pain.
• - chills. Rare side effects (may affect up to 1 in 1,000)
• itching, urticaria (itching and small spots on the skin),
• skin rash
• altered sensitivity, for example, tingling (paresthesia/dysesthesia);
• gum tissue enlargement (gingival hyperplasia);
• skin rash of an inflammatory nature caused by sun sensitivity reactions (photosensitive dermatitis);
• development of breasts in men (gynecomastia). Side effects with unknown frequency(frequency cannot be estimated on the basis of available data)
• agranulocytosis (lack of certain blood cells called granulocytes),
• reduction in the number of white blood cells (leukopenia);
• anaphylactic/anaphylactoid reaction (severe allergic or allergy-like reaction),
• increased blood sugar levels (hyperglycemia);
• decreased sensitivity (hypoesthesia)
• drowsiness,
• eye pain,
• chest pain (angina pectoris); dyspnea (difficulty breathing, shortness of breath),
• - bezoars (formation of bulky masses in the stomach),
• - dysphagia (difficulty swallowing),
• - intestinal obstruction (blockage of intestinal contents),
• - intestinal ulcer,
• - vomiting,
• - gastroesophageal sphincter insufficiency (regurgitation),
• - jaundice (yellowing of the skin and whites of the eyes),
• toxic epidermal necrolysis (severe skin disease)
• - photoallergic reaction (skin reaction following exposure to the sun),
• - palpable purpura (a particular type of skin rash),
• - arthralgia (joint pain),
• - myalgia (muscle pain)
• difficulty breathing.

Occasionally, the following have also been reported:
episodes of hepatitis (inflammation of the liver), increased enzymes known as alkaline phosphatase or LDH,
heartburn (pyrosis), sore throat, cough, nasal congestion, sexual sphere disorders, fever,
sweating, reduced number of platelets (thrombocytopenia), reduced number of
red blood cells (anemia), joint stiffness.
With other nifedipine formulations: severe reduction in the number of white blood cells (agranulocytosis),
severe skin lesions characterized by areas of skin detachment (exfoliative dermatitis), a
rare vasodilation syndrome due to increased skin temperature with redness
of the feet and, less frequently, the hands (erythromelalgia).
A marked reduction in blood pressure following vasodilation may occur in
patients undergoing dialysis who suffer from a condition known as malignant hypertension,
which causes an abnormal increase in blood pressure.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of
this medicine.

5. How to store CORAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the blister and the carton. The expiry
date refers to the last day of that month.
The expiry date refers to the product in intact packaging and correctly stored.
Keep the medicine protected from direct sunlight and humidity. Store in the original
packaging to protect the medicine from humidity; the tablets should therefore only be removed
from the package immediately before use.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What CORAL contains
The active ingredient is nifedipine.

CORAL 30 mg film-coated modified-release tablets
Each tablet contains 30 mg of nifedipine.
The other ingredients are:
Hydroxypropylmethylcellulose, polyvinylpyrrolidone, carboxymethylcellulose, magnesium stearate, colloidal
silicon dioxide, talc, polyethylene glycol 6000, simethicone, titanium dioxide (E 171), iron oxide red (E
172).

CORAL 60 mg film-coated modified-release tablets
Each tablet contains 60 mg of nifedipine.
The other ingredients are:
Hydroxypropylmethylcellulose, polyvinylpyrrolidone, carboxymethylcellulose, magnesium stearate, colloidal
silicon dioxide, talc, polyethylene glycol 6000, simethicone, titanium dioxide (E 171), iron oxide red (E
172).

Description of the appearance of CORAL and contents of the pack
CORALis available in the following packs:

CORAL 30 mg film-coated modified-release tabletsin a cardboard box containing 14
tablets in blisters.

CORAL 60 mg film-coated modified-release tabletsin a cardboard box containing 14
tablets in blisters.

Marketing Authorisation Holder and Manufacturer
MARKETING AUTHORISATION HOLDER
S.F. Group S.r.l.
Via Tiburtina 1143 – 00156 Rome
MANUFACTURER(S)

Special Product’s Line S.p.A.
Via Fratta Rotonda vado Largo n.1
03012 Anagni (FR) Italy

Lachifarma Srl
S.S. 16 Adriatica Zona industriale
73010 Zollino (Lecce)