Coral

Package leaflet: Information for the patient

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

Nifedipine
Generic medicine
Please read all of this leaflet carefully before you take 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. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including 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 taking 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 CORAL is and what it is used for

CORAL contains the active substance nifedipine, which belongs to a class of medicines called calcium antagonists.
CORAL is used to treat the following conditions:

• Exertional angina (angina pectoris), which is characterized by severe chest pain behind the breastbone due to inadequate blood and oxygen supply to the heart (usually occurring during physical exertion). Nifedipine works by dilating the coronary arteries, thereby increasing blood and oxygen supply to the heart tissue. In addition, since it also acts on peripheral blood vessels, it reduces the heart's oxygen demand.
• High blood pressure (arterial hypertension), as it causes relaxation of the blood vessels and increases the elimination of sodium and water. This results in a lowering of blood pressure, particularly pronounced 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 week 20) and during breastfeeding (see "Pregnancy and breastfeeding").
• If you are in a state of 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, nifedipine blood levels may become insufficient (see "Other medicines and CORAL").
• If you have a Kock pouch ("diversion" following removal surgery of the colon and rectum).

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

• You have very low blood pressure (systolic pressure below 90 mm Hg), suffer from heart failure (weak heart), or have severe aortic stenosis (narrowing of a heart valve);
• You are being treated with β-blockers (medicines used to treat certain heart rhythm disorders and to reduce blood pressure) or medicines that lower blood pressure (antihypertensives);
• 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. Rarely, these shells may lead to the formation of large masses in the stomach called bezoars, which cannot be eliminated through the intestine and sometimes require surgical intervention. In isolated cases, symptoms of obstruction have occurred even in patients who had never experienced gastrointestinal problems. If you undergo X-rays of the digestive tract with barium contrast, be aware that CORAL may produce images that could be falsely interpreted as polyps.
• You are pregnant: Since available information does not allow exclusion of the possibility of adverse effects on the fetus and newborn. For this reason, CORAL must not be used during the first 20 weeks of pregnancy (see "Do not take CORAL" and "Pregnancy and breastfeeding"). In subsequent weeks, it may be used only after a very careful assessment of potential risks and expected benefits, and when other therapies are unsuitable or ineffective. Your doctor will decide whether treatment with CORAL is appropriate for you. If prescribed CORAL, you will likely undergo frequent blood pressure checks, especially if intravenous magnesium sulfate is also administered, due to the risk of excessive blood pressure drop, which could harm both you and the fetus.
• You are breastfeeding: Do not take CORAL (see "Pregnancy, breastfeeding") because 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 by 3 to 4 hours after taking the medicine to reduce infant exposure to nifedipine. Since there are no data on possible effects on the newborn, if nifedipine treatment becomes necessary during this period, breastfeeding should be discontinued.
• Your liver is not functioning properly. In this case, careful monitoring may be required and, if your condition is severe, a reduction in the dose of CORAL may be necessary.
• You are undergoing a laboratory test to measure vanillylmandelic acid levels in urine (a test used to diagnose adrenal gland tumors), be aware that, in the presence of nifedipine and depending on the method used, results may be falsely elevated.
• You are on dialysis or have abnormally high blood pressure (malignant hypertension).
• You experience chest pain (sometimes angina-like symptoms).
• You suffer from a condition known as congestive heart failure and develop swelling (edema).
• You have diabetes or are at risk.

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

Other medicines and CORAL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Regarding CORAL, please note:
Nifedipine is metabolized in the body through a specific system of molecules (enzymes). If medicines that affect or use this same system are taken concomitantly, a decrease or increase in blood concentration—and thus in the effect—of nifedipine or the other medicine may occur. Dose adjustments of nifedipine or the other medicine and/or more frequent blood pressure monitoring may then be necessary.
Medicines that may alter the effect of nifedipine include:

• Rifampicin (an antibiotic); never take CORAL with medicines containing rifampicin (see "Do not take CORAL").
• Certain antibiotics belonging to the macrolide class, such as erythromycin;
• Certain medicines for AIDS, such as ritonavir, amprenavir, indinavir, nelfinavir, or saquinavir;
• Certain antifungal medicines, such as ketoconazole, itraconazole, or fluconazole;
• Fluoxetine, nefazodone (medicines for depression);
• Quinupristin/dalfopristin (an antibiotic used for specific infections);
• Phenytoin, carbamazepine, phenobarbital, valproic acid (medicines for seizures);
• Diltiazem (a medicine used to lower blood pressure);
• Cimetidine, cisapride (medicines used for stomach ulcers).

Nifedipine may alter the effect of the following medicines:

• Nifedipine may enhance the blood pressure-lowering effect of other antihypertensive medicines (diuretics, β-blockers, ACE inhibitors, angiotensin-1 receptor antagonists (AT-1), other calcium antagonists, α-blockers, PDE5 inhibitors, α-methyldopa). In particular, if taken together with medicines belonging to the β-blocker group, your doctor must monitor you closely, as it may worsen the heart's ability to pump blood.
• Digoxin, quinidine (heart medicines).
• Tacrolimus (a medicine used to prevent transplant rejection).

The following medicines do not appear to alter nifedipine blood concentrations and/or their metabolism is not affected by nifedipine: Ajmaline (an antiarrhythmic medicine), acetylsalicylic acid at a dose of 100 mg (a medicine for flu symptoms or blood thinning), benazepril, doxazosin, candesartan cilexetil, irbesartan, debrisochine, talinolol (medicines for high blood pressure), omeprazole, pantoprazole, ranitidine (medicines for heartburn), orlistat (a weight-loss medicine), rosiglitazone (a medicine for diabetes), triamterene, hydrochlorothiazide (diuretics).

CORAL with food and drinks
Do not drink grapefruit juice during treatment with CORAL. Taking them together may increase plasma concentrations of nifedipine and prolong its effect. If you regularly drink grapefruit juice, this effect may last for more than 3 days after the last intake.
Do not consume alcoholic beverages while taking nifedipine, as this could impair your ability to drive or operate machinery (see "Driving and use of machines").

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take CORAL during the first 20 weeks of pregnancy or while breastfeeding (see "Do not take CORAL").
Nifedipine should not be used during pregnancy unless the patient's clinical condition requires nifedipine treatment. Nifedipine use 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.
Available information is insufficient to exclude adverse effects on the fetus and newborn.

Breastfeeding
Nifedipine is not recommended during breastfeeding because it has been reported to pass into breast milk and the effects of oral absorption of small amounts of nifedipine are unknown.
As a precaution, discontinue breastfeeding and inform your doctor.
If your doctor has instructed you to take nifedipine in immediate-release formulations, delay breastfeeding or milk expression for 3 to 4 hours after drug administration to reduce neonatal exposure to nifedipine (see section "Warnings and precautions").

Driving and use of machines
CORAL may cause dizziness or lightheadedness, especially at the beginning of treatment, when changing medication, or when taken with alcoholic beverages. If you experience these effects, do not drive or operate machinery.

3. How to take CORAL

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Treatment should ideally be tailored to the individual needs of each patient. Your doctor
will determine the dose based on the severity of the disease and your response to treatment.
The recommended dose is:
one 30 mg coated tablet once daily in the morning.
The dose may be gradually increased, at the doctor's discretion, 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, taken once daily in the morning.
Use in patients with impaired liver function
If your liver does not function properly, careful monitoring of blood pressure may be required and, in
severe cases, a dose reduction may be necessary.
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 whole with a little water in the
morning on an empty stomach.
The tablets must not be chewed or broken.
Do not change your dose without first informing your doctor. Your doctor will assess whether the dose
should be increased or decreased and for how long treatment should continue.
The tablet is substantially protected from light both inside and outside the packaging, due to the
photosensitive substance contained in the tablet.
Within the packaging, the tablets are also protected from moisture and should therefore be removed
from the carton only when ready to be taken. See the information provided in section 3.
Take CORAL for the duration indicated by your treating physician.
If you take more CORAL than you should
It is important to follow the dose prescribed by your doctor. In case of accidental ingestion/overdose
of CORAL, contact your doctor immediately or go to the nearest hospital.
Symptoms
In cases of severe nifedipine intoxication, the following symptoms have been observed: disturbances
of consciousness up to coma, drop in blood pressure, cardiac rhythm disturbances of tachy/brady type
(increased/decreased heart rate), hyperglycaemia (increased blood sugar levels), decreased blood pH
due to increased levels of acidic substances in the blood (metabolic acidosis), lack of oxygen (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 your dose, take it as soon as you remember on the same day. If you miss a day, take
your normal dose the next day. Do not take a double dose to make up for a forgotten dose.
If you are unsure what to do, consult your doctor or pharmacist.
If you stop taking CORAL
Do not stop taking this medicine without first consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following adverse reactions have been observed during clinical trials with nifedipine:

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

• swelling in the extremities due to fluid accumulation (peripheral edema);
• headache (cephalalgia);
• malaise;
• edema, including peripheral edema (generalized swelling or swelling in the extremities);
• vasodilation (dilation of blood vessels);
• constipation (stool hardening),

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

• allergic reaction;
• allergic edema/angioedema (swelling of the skin, face, and mucous membranes, including laryngeal edema, potentially life-threatening);
• anxiety-related reactions, sleep disturbances;
• dizziness, migraine (unilateral headache), vertigo, tremor;
• visual disturbances;
• tachycardia (rapid heartbeat), sensation of rapid or irregular heartbeat (palpitations);
• severe impairment of bile flow to the duodenum due to 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 (intestinal gas);
• diarrhea;
• dry mouth;
• transient increase in liver enzymes;
• erythema (redness of the skin);
• muscle cramps;
• joint swelling;
• polyuria (increased urine volume);
• dysuria (difficulty urinating);
• erectile dysfunction (difficulty achieving and maintaining erection);
• non-specific pain, limb pain;
• chills.

Rare side effects (may affect up to 1 in 1,000 people)

• pruritus, urticaria (itching and small skin spots);
• skin rash;
• altered sensation such as tingling (paraesthesia/dysesthesia);
• enlargement of gum tissue (gingival hyperplasia);
• inflammatory skin rash caused by sensitivity to sunlight (photosensitive dermatitis);
• breast development in men (gynecomastia).

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• agranulocytosis (lack of certain blood cells called granulocytes);
• decreased number of white blood cells in the blood (leukopenia);
• anaphylactic/anaphylactoid reaction (severe allergic or allergy-like reaction);
• increased blood sugar levels (hyperglycemia);
• decreased sensitivity (hypoesthesia);
• somnolence;
• eye pain;
• chest pain (angina pectoris);
• dyspnea (difficulty breathing, shortness of breath);
• bezoars (formation of large masses in the stomach);
• dysphagia (difficulty swallowing);
• intestinal obstruction (blockage of intestinal content transit);
• intestinal ulcer;
• vomiting;
• gastroesophageal sphincter insufficiency (regurgitation);
• jaundice (yellowing of the skin and whites of the eyes);
• toxic epidermal necrolysis (serious skin disease);
• photoallergic reaction (skin reaction following exposure to sunlight);
• palpable purpura (a specific type of skin rash);
• arthralgia (joint pain);
• myalgia (muscle pain);
• respiratory difficulty.

Occasionally reported:
episodes of hepatitis (liver inflammation), increased levels of enzymes known as alkaline phosphatase or LDH,
gastric burning (heartburn), sore throat, cough, nasal congestion, sexual dysfunction, fever, sweating,
reduced platelet count (thrombocytopenia), reduced number of red blood cells (anemia), joint stiffness.

With other formulations of nifedipine: severe reduction in white blood cells (agranulocytosis),
severe skin lesions characterized by areas of skin peeling (exfoliative dermatitis), a rare vasodilation syndrome
associated with increased skin temperature and redness of the feet, and less frequently of the hands (erythromelalgia).

A marked decrease in arterial pressure following vasodilation may occur in patients undergoing dialysis and affected by a condition known as malignant hypertension, which causes an abnormal increase in blood pressure.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 stated on the blister and carton. The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging and properly stored.
Protect the medicine from direct sunlight and moisture. Store in the original packaging to protect the medicine from moisture; the tablets should therefore be removed from the package only immediately before use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Pack contents and other information

What CORAL contains
The active substance is nifedipine.
CORAL 30 mg modified-release film-coated tablets
Each tablet contains 30 mg of nifedipine.
The other components are:
Hydroxypropylmethylcellulose, polyvinylpyrrolidone, carboxymethylcellulose, magnesium stearate, colloidal silicon dioxide, talc, polyethylene glycol 6000, simeticone, titanium dioxide (E 171), red iron oxide (E 172).
CORAL 60 mg modified-release film-coated tablets
Each tablet contains 60 mg of nifedipine.
The other components are:
Hydroxypropylmethylcellulose, polyvinylpyrrolidone, carboxymethylcellulose, magnesium stearate, colloidal silicon dioxide, talc, polyethylene glycol 6000, simeticone, titanium dioxide (E 171), red iron oxide (E 172).

Description of the appearance of CORAL and pack sizes
CORAL is available in the following pack sizes:
CORAL 30 mg modified-release film-coated tablets in a cardboard box containing 14 tablets in blister packs.
CORAL 60 mg modified-release film-coated tablets in a cardboard box containing 14 tablets in blister packs.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l.
Via Tiburtina 1143 – 00156 Rome, Italy

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

Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Adriatica, Zona industriale
73010 Zollino (Lecce), Italy

25 November 2021