NIFEDICOR 20 mg /Ml Krople Doustne, Roztwór

Treść ulotki

1. Nifedicor 20mg/ml oral drops, solution
   1. What is Nifedicor and what is it used for
   2. What you need to know before taking Nifedicor
   3. How to take Nifedicor
   4. Possible side effects
   5. How to store Nifedicor
   6. Contents of the pack and other information

Nifedicor 20mg/ml oral drops, solution

nifedipine

Read this 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. Do not pass it on to others, even if they have the same symptoms as you, as it may 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 Nifedicor is and what it is used for
• 2. What you need to know before you take Nifedicor
• 3. How to take Nifedicor
• 4. Possible side effects
• 5. How to store Nifedicor
• 6. Contents of the pack and other information

1. What is Nifedicor and what is it used for

Nifedicor contains the active ingredient nifedipine. Nifedipine belongs to a group of medicines called
calcium channel blockers (calcium antagonists), which work by dilating blood vessels, thus decreasing
blood pressure and increasing blood supply to the heart muscle.
Nifedicor is indicated in adultsfor the treatment of:

• a heart disease characterized by reduced blood flow to the heart (ischemic heart disease), which manifests with chest pain (chronic-stable or exertion angina pectoris and vasospastic angina pectoris, also called variant or Prinzmetal's angina)
• high blood pressure (arterial hypertension)
• sudden increases in blood pressure (hypertensive crises)
• Raynaud's syndrome (primary and secondary), a disease characterized by altered blood circulation to the extremities).

2. What you need to know before taking Nifedicor

Do not take Nifedicor

• if you are allergic to nifedipine or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or suspect you may be pregnant and if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
• if you suffer from a marked narrowing (stenosis) of the aorta (an artery of the heart)
• in case of cardiovascular shock (decrease in blood pressure with severe reduction in heart function)
• if you are taking rifampicin (an antibiotic) at the same time (see section “Other medicines and Nifedicor”)
• if you suffer from a heart condition that manifests with sudden chest pain that worsens over time (unstable angina pectoris)
• if you have had a heart attack and less than 4 weeks have passed.

Warnings and precautions
Consult your doctor or pharmacist before taking Nifedicor.
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you have very low blood pressure (below 90 mmHg)
• if you suffer from heart failure (a serious heart condition)
• if you suffer from liver failure (a serious liver disease). In this case, you will need to monitor your blood pressure and, if necessary, your doctor may reduce your dose of nifedipine.
• if you are being treated with beta-blockers or other medicines for the treatment of high blood pressure (see section “Other medicines and Nifedicor”)
• if you are undergoing dialysis (a medical therapy used to filter the blood)
• if you suffer from a severe increase in blood pressure (malignant hypertension)
• if you suffer from a severe kidney disease (renal failure) with decreased blood volume (hypovolemia)
• if you have diabetes (a condition characterized by an excess of sugars in the blood), or if you are at risk of developing diabetes. In this case, you will need to carefully monitor your blood sugar levels and in

case of high levels, your doctor will tell you to stop treatment (see section 4 “Possible side effects”).

• if you experience an emergency situation during pregnancy, such as eclampsia, a serious disease, potentially fatal, characterized by high blood pressure and convulsions, and are taking magnesium sulfate intravenously, because you may experience an excessive decrease in blood pressure, which can cause harm to both you and the baby (see sections “Do not take Nifedicor” and “Pregnancy, breastfeeding and fertility”)
• if you are breastfeeding (see sections “Do not take Nifedicor” and “Pregnancy, breastfeeding and fertility”).

During treatment with Nifedicor, you may experience an excessive lowering of blood pressure, resulting in an accelerated heartbeat (tachycardia) and possible problems at the heart and circulation level. In addition, especially at the beginning of treatment, chest pain (angina pectoris) may occur.
If this medicine has been prescribed for you because you suffer from chest pain, consult your doctor because you may experience an increase in the frequency, duration and intensity of the chest pain, especially at the beginning of treatment.
In rare cases, a heart attack has been reported, although it is not known whether these episodes are due to the underlying disease.
At the beginning of treatment and until your doctor has accurately established the dose suitable for you, you should carefully monitor your blood pressure

Children and adolescents
The use of Nifedicor is not recommended in children and adolescents under the age of 18 years, as only limited safety and efficacy data are available in this population.

Other medicines and Nifedicor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines:

• rifampicin (an antibiotic). Do nottake rifampicin together with Nifedicor because the effect of Nifedicor will be significantly reduced (see section “Do not take Nifedicor”)
• tacrolimus (a medicine used if you have had an organ transplant)
• quinidine, digoxin (medicines used for heart disorders)
• medicines used to reduce high blood pressure such as:
• diuretics
• beta-blockers. In this case, the doctor will monitor you closely because you may experience a significant reduction in blood pressure.
• ACE inhibitors
• AT-1 antagonists
• other calcium antagonists (other medicines similar to Nifedicor)
• alpha-adrenergic blocking agents
• 5 phosphodiesterase inhibitors (medicines used to treat erectile dysfunction)
• α-methyldopa
• medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), as they may decrease the amount of Nifedicor in the blood and therefore its effect. The doctor may increase the dose of Nifedicor to be taken.

In addition, tell your doctor if you are taking any of the following medicines:

• macrolide antibiotics (a class of antibiotics, e.g. erythromycin)
• quinupristin/dalfopristin, a combination of two antibiotics
• diltiazem (a medicine used to treat high blood pressure)
• medicines used in the treatment of HIV infection (e.g. ritonavir)
• medicines used for skin fungal infections (e.g. ketoconazole)
• medicines used to treat depression (fluoxetine and nefazodone)
• valproic acid (a medicine used to treat epilepsy)
• cimetidine (a medicine used for stomach ulcers)
• cisapride (a medicine used for gastroesophageal reflux) These medicines can increase the amount of Nifedicor in the blood, which can cause an increase in its effects: your doctor will tell you to monitor your blood pressure values and, if necessary, may decrease the dose of Nifedicor to be taken.

Laboratory tests

• This medicine can lead to false increases in the values of vanillylmandelic acid in the urine determined by spectrophotometric method, therefore inform your doctor or healthcare operator if you are taking this medicine, before undergoing this type of examination.

Nifedicor with food and drink
Avoidconsuming grapefruit or grapefruit juice when taking Nifedicor because it can cause a large drop in blood pressure. If you drink grapefruit juice regularly, this effect can last for more than 3 days after stopping.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do nottake Nifedicor if you are pregnant. (See section “Do not take Nifedicor”)
The doctor may prescribe this medicine to you only if strictly necessary. If you are pregnant and the doctor has prescribed Nifedicor for you, for severe hypertension that cannot be treated with other medicines, for example if you suffer from eclampsia (a serious pregnancy condition) and are given magnesium sulfate (a medicine to treat eclampsia) intravenously, you will need to closely monitor your blood pressure because you may experience an excessive decrease in blood pressure, which can harm both you and the baby.

Breastfeeding

Do nottake Nifedicor if you are breastfeeding. (See section “Do not take Nifedicor”),
because nifedipine passes into breast milkand the effects on the newborn are unknown. The doctor may prescribe this medicine to you only if strictly necessary. In this case, you should stop breastfeeding for 3-4 hours after taking this medicine.

Fertility
If you are a man and have difficulty conceiving with in vitro fertilization, calcium antagonists such as nifedipine should be considered as a possible cause.

Driving and operating machinery
This medicine can affect your ability to drive vehicles or operate machinery, especially at the beginning of therapy, if you change the medicine you are taking, or if you drink alcohol.

3. How to take Nifedicor

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The doctor will establish the most suitable dose for you, the duration of treatment, and will assess whether to increase or decrease the
dose for the duration of therapy.

Adults

• Heart disease (ischemic cardiopathy) that manifests with chest pain (angina pectoris)
• High blood pressure (arterial hypertension)
• Raynaud's syndrome (disease due to altered blood circulation)

The recommended dose is: 10 drops (= 10 mg), 3 times a day.
If necessary, the doctor will determine whether to gradually increase the dose up to a maximum of 20 drops =20
mg 3 times a day (= 60 mg).
If the dose you have to take is 20 drops 3 times a day, you must allow at least 2 hours between one
dose and the next.

• Hypertensive crisis (sudden increase in blood pressure)

The recommended dose is: 10 or 20 drops (= 10 or 20 mg), 1 time a day.
If the effect on blood pressure with this dose is insufficient, your doctor may prescribe
another 10 drops (= 10 mg), to be taken about 30 minutes after the first dose. If necessary, the doctor can
reduce the intervals between doses and/or increase the dose and will keep it under strict control as it may increase
the risk of developing hypotension (excessive reduction of blood pressure).
Dilute the drops in water and take them immediately.
Take the drops undiluted sublingually if you want a particularly prompt action.
To open the bottle: press on the cap and unscrew simultaneously.
Drop the drops into a glass holding the bottle in a vertical position with the opening facing down.
To close the bottle: screw the cap on tightly.

When to take Nifedicor
Take this medicine preferably away from meals

Use in people with liver problems
The doctor will carefully check blood pressure values and assess whether to prescribe a
lower dose of Nifedicor.

Use in children and adolescents
The use of Nifedicor is not recommended in children and adolescents under the age of 18 years.

If you take more Nifedicor than you should
In case of accidental ingestion/intake of an excessive dose of Nifedicor, immediately inform
your doctor or go to the nearest hospital.
In cases of severe poisoning with Nifedicor, the symptoms may be:

• disturbances of consciousness up to coma
• decrease in blood pressure
• alterations of the heart rate, i.e. increase or decrease of the heartbeats per minute (tachycardia/bradycardia)
• increase in blood sugar (hyperglycemia)
• increase in acids in the blood (metabolic acidosis)
• lack of oxygen (hypoxia)
• decrease in blood pressure with severe reduction of heart function and swelling of the lungs (cardiogenic shock with pulmonary edema).

If you forget to take Nifedicor
Do not take a double dose to make up for a missed dose.

If you stop taking Nifedicor
Donot abruptly stop treatment with this medicine, as discontinuation must occur in
a gradual manner and under strict medical control.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediatelyif you experience any of the following seriousside effects during treatment with Nifedicor; your doctor will explain how to stopusing the medicine:

• anaphylactic/anaphylactoid reaction
• swelling of hands, feet, ankles, face, lips, tongue and/or throat (allergic edema/angioedema)

Also, if you have diabetes (a condition characterized by excess sugar in the blood) or are at risk of developing diabetes, you may experience an increase in blood sugar (hyperglycemia) during treatment with Nifedicor. If this occurs, contact your doctor immediately, who will explain how to stopusing the medicine.
The following side effects have been observed and reported during treatment with Nifedicor, with the following frequencies:

Common (may affect up to 1 in 10 people)

• headache
• swelling due to fluid retention (edema)
• blood vessel dilation (vasodilation)
• constipation
• feeling unwell

Uncommon (may affect up to 1 in 100 people)

• allergic reaction
• anxiety reactions
• sleep disorders
• dizziness
• recurrent moderate to severe headache (migraine)
• vertigo
• tremor
• visual disturbances
• increased heart rate (tachycardia)
• feeling of increased heart rate (palpitations)
• decreased blood pressure (hypotension)
• fainting (syncope)
• nosebleeds (epistaxis)
• nasal congestion
• stomach and intestinal pain (gastrointestinal and abdominal pain)
• nausea
• difficulty digesting food (dyspepsia)
• excessive gas in the intestines (flatulence)
• dry mouth
• temporary increase in liver enzymes (liver enzymes)
• skin irritation (erythema)
• muscle cramps
• swelling of the bone joints
• excessive urination (polyuria)
• difficulty urinating (dysuria)
• erectile dysfunction
• generalized pain (non-specific pain)
• chills

Rare (may affect up to 1 in 1000 people)

• itching
• redness of the skin accompanied by itching (urticaria)
• skin rash
• feeling of numbness and tingling in legs, arms or other parts of the body (paresthesia)
• altered sensitivity to stimuli (dysesthesia)
• enlargement of the gums (gingival hyperplasia)

Not known (frequency cannot be estimated based on available data)

• reduction of white blood cells in the blood (agranulocytosis/leukopenia)
• increased blood sugar (hyperglycemia)
• decreased sensitivity (hypoesthesia)
• drowsiness
• eye pain
• chest pain (angina pectoris)
• difficulty breathing (dyspnea, pulmonary edema)
• vomiting
• reduced function of the muscle that connects the esophagus to the stomach (gastroesophageal sphincter insufficiency)
• yellowing of the skin and the whites of the eyes (jaundice)
• severe skin disease characterized by erythema, blistering lesions with areas of skin detachment (toxic epidermal necrolysis)
• allergic reaction due to photosensitivity (photosensitivity reaction)
• bruising on the skin due to bleeding from small blood vessels (palpable purpura)
• bone pain (arthralgia)
• muscle pain (myalgia)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Nifedicor

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Nifedicor contains

• the active ingredient is nifedipine (0.5 ml contains 10 mg of nifedipine, equivalent to 10 drops)
• the other component is polyethylene glycol 200

Description of the appearance of Nifedicor and contents of the pack
It is presented as a clear yellow solution, contained in an amber glass bottle of 30 ml,
with a dropper incorporated and closed by a child-resistant cap.

Marketing Authorisation Holder
Viatris Healthcare Limited,
Damastown Industrial Park,
Mulhuddart,Dublin 15,
DUBLIN,Ireland

Manufacturer
Doppel Farmaceutici S.r.l.,
Via Martiri delle Foibe, 1
26016 Cortemaggiore (PC)