Nifedicor

Package leaflet: Information for the patient

Nifedicor 20mg/ml oral drops, solution

nifedipine
Please read all of this leaflet carefully before 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 give it to other people, even if they have the same symptoms as yours, because it could 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 Nifedicor is and what it is 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

1. What Nifedicor is and what it is used for

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

• a heart disease characterized by reduced blood flow to the heart (ischaemic heart disease), which manifests as chest pain (chronic stable angina or effort angina, and vasospastic angina, also known as variant angina or Prinzmetal's angina)
• high blood pressure (arterial hypertension)
• sudden episodes of increased blood pressure (hypertensive crises)
• Raynaud's syndrome (primary and secondary), a condition characterized by impaired blood circulation to the extremities of the body.

2. What you should know before taking Nifedicor

Do not take Nifedicor

• if you are allergic to nifedipine or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant, suspect you may be pregnant, or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
• if you have severe narrowing (stenosis) of the aorta (a heart artery)
• in case of cardiovascular shock (decreased 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 heart disease characterized by sudden chest pain that worsens over time (unstable angina pectoris)
• if you have had a heart attack within the last 4 weeks.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nifedicor.
Take this medicine with caution and always under medical supervision 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, your blood pressure should be monitored and, if necessary, your doctor may reduce your dose of nifedipine.

• if you are being treated with -blockers or other medicines for high blood pressure (see section “Other medicines and Nifedicor”)

• if you are undergoing dialysis (a medical treatment used to filter the blood)

• if you suffer from severe high blood pressure (malignant hypertension)

• if you have severe kidney disease (renal failure) with reduced blood volume (hypovolemia)

• if you have diabetes (a condition characterized by excess sugar in the blood), or are at risk of developing diabetes. In this case, you should carefully monitor your blood glucose levels (blood sugar), and if levels are high, your doctor will instruct you to stop treatment (see section 4 “Possible side effects”)

• if during pregnancy you experience an emergency condition such as eclampsia, a serious, potentially life-threatening condition characterized by high blood pressure and seizures, and you are receiving intravenous magnesium sulfate, because you may experience excessive lowering of blood pressure, which could harm both you and your 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 excessive lowering of blood pressure, resulting in increased heart rate (tachycardia) and possible heart and circulatory problems. Additionally, especially at the beginning of treatment, chest pain (angina pectoris) may occur.
If this medicine has been prescribed for chest pain, consult your doctor, as you may experience an increase in frequency, duration, and intensity of chest pain, particularly at the start of treatment.
In rare cases, heart attacks have been reported, although it is not known whether these events were due to the underlying disease.
At the beginning of treatment and until your doctor has precisely determined the appropriate dose for you, you must carefully monitor your blood pressure.

Children and adolescents
The use of Nifedicor is not recommended in children and adolescents under 18 years of age, 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, inform your doctor if you are taking any of the following medicines:

• rifampicin (an antibiotic). Do not take 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 lower high blood pressure such as:
  • diuretics
• beta-blockers. In this case, your doctor will monitor you closely because you may experience a marked reduction in blood pressure.
• ACE inhibitors
• AT-1 antagonists
• other calcium antagonists (other medicines similar to Nifedicor)
• -adrenergic blocking agents
• 5-phosphodiesterase inhibitors (medicines used to treat erectile dysfunction)
• -methyldopa
  • medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), as they may reduce the amount of Nifedicor in the blood and thus its effect. Your doctor may increase your dose of Nifedicor.

Also, inform 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 fungal skin 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 may increase the amount of Nifedicor in the blood, potentially increasing its effects: your doctor will instruct you to monitor your blood pressure and, if necessary, may reduce your dose of Nifedicor.

Laboratory tests

• This medicine may cause false increases in urinary vanillylmandelic acid levels when measured by spectrophotometric methods; therefore, inform your doctor or healthcare provider that you are taking this medicine before undergoing such tests.

Nifedicor with food and drinks
Avoid consuming grapefruit or grapefruit juice while taking Nifedicor, as it may cause a significant drop in blood pressure. If you regularly drink grapefruit juice, this effect may last for more than 3 days after stopping.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Nifedicor if you are pregnant. (See section “Do not take Nifedicor”)
Your doctor may prescribe this medicine only if strictly necessary. If you are pregnant and your doctor prescribes Nifedicor for severe hypertension that cannot be treated with other medicines, for example if you have eclampsia (a serious pregnancy-related condition) and are receiving intravenous magnesium sulfate (a medicine for treating eclampsia), you must closely monitor your blood pressure, as excessive lowering may occur, which could harm both you and your baby.
Breastfeeding
Do not take Nifedicor if you are breastfeeding. (See section “Do not take Nifedicor”), because nifedipine passes into breast milk and its effects on the newborn are unknown. Your doctor may prescribe this medicine only if strictly necessary. In this case, you must stop breastfeeding for 3–4 hours after taking this medicine.
Fertility
If you are a man experiencing difficulty conceiving through in vitro fertilization, calcium antagonists such as nifedipine should be considered as a possible cause.

Driving and using machines
This medicine may affect your ability to drive or use machinery, especially at the beginning of treatment, when changing your medication, or when consuming alcoholic beverages.

3. How to take Nifedicor

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Your doctor will determine the most appropriate dose for you, the duration of treatment, and whether to increase or decrease the dose throughout therapy.
Adults

• Heart disease (ischaemic heart disease) presenting as chest pain (angina pectoris)
• High blood pressure (arterial hypertension)
• Raynaud's syndrome (a disorder of blood circulation)

Recommended dose: 10 drops (= 10 mg), 3 times daily.
If necessary, your doctor may gradually increase the dose up to a maximum of 20 drops = 20 mg, 3 times daily (= 60 mg total).
If your prescribed dose is 20 drops 3 times daily, you must wait at least 2 hours between one dose and the next.

• Hypertensive crisis (sudden increase in blood pressure)

Recommended dose: 10 or 20 drops (= 10 or 20 mg), once daily.
If the blood pressure response to this dose is insufficient, your doctor may prescribe an additional 10 drops (= 10 mg), to be taken approximately 30 minutes after the first dose. If needed, your doctor may reduce the interval between doses and/or increase the dose, and you will be closely monitored, as this may increase the risk of developing hypotension (excessively low blood pressure).
Dilute the drops in water and take immediately.
Take the drops undiluted sublingually if a particularly rapid effect is desired.
To open the bottle: press down on the cap and unscrew simultaneously.
Let the drops fall into a glass, holding the bottle vertically with the opening facing downwards.
To close the bottle: screw the cap until tightly sealed.
When to take Nifedicor
Take this medicine preferably away from meals.
Use in patients with liver problems
Your doctor will carefully monitor your blood pressure values and may consider prescribing a lower dose of Nifedicor.
Use in children and adolescents
The use of Nifedicor is not recommended in children and adolescents under 18 years of age.
If you take more Nifedicor than you should
In case of accidental ingestion or overdose of Nifedicor, contact your doctor immediately or go to the nearest hospital.
In cases of severe poisoning with Nifedicor, symptoms may include:

• disturbances of consciousness up to coma
• low blood pressure
• changes in heart rhythm, i.e. increased or decreased heart rate (tachycardia/bradycardia)
• increased blood sugar (hyperglycaemia)
• increased acid levels in the blood (metabolic acidosis)
• lack of oxygen (hypoxia)
• low blood pressure with severe reduction in heart function and lung swelling (cardiogenic shock with pulmonary oedema).

If you forget to take Nifedicor
Do not take a double dose to make up for a missed dose.
If you stop taking Nifedicor
Do not stop treatment with this medicine abruptly, as discontinuation must occur gradually and under strict medical supervision.
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 everyone gets them.
Contact your doctor immediately if, during treatment with Nifedicor, you experience any of the following serious side effects; your doctor will then explain how to stop taking the medicine:

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

Additionally, if you have diabetes (a disease characterised by excess sugar in the blood) or are at risk of developing diabetes, you may experience increased blood sugar levels (hyperglycaemia) during treatment with Nifedicor. If this occurs, contact your doctor immediately, who will explain how to stop taking 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
• fluid retention causing swelling (oedema)
• widening of blood vessels (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)
• awareness of heartbeat (palpitations)
• decrease in blood pressure (hypotension)
• fainting (syncope)
• nosebleed (epistaxis)
• stuffy nose (nasal congestion)
• stomach and intestinal pain (gastrointestinal and abdominal pain)
• nausea
• difficulty digesting (dyspepsia)
• passing excessive intestinal gas (flatulence)
• dry mouth
• temporary increase in liver function enzymes (liver enzymes)
• skin irritation (erythema)
• muscle cramps
• swelling of bone joints
• excessive urine production (polyuria)
• difficulty urinating (dysuria)
• erectile dysfunction
• generalized pain (non-specific pain)
• chills

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

• itching (pruritus)
• red, itchy skin rash (urticaria)
• skin rash
• tingling or numbness in legs, arms or other body parts (paraesthesia)
• altered sensation to stimuli (dysaesthesia)
• increased size of the gums (gingival hyperplasia)

Not known (frequency cannot be estimated from available data)

• reduction in white blood cells in the blood (agranulocytosis/leucopenia)
• increased blood sugar levels (hyperglycaemia)
• decreased sensitivity (hypoesthesia)
• drowsiness
• eye pain
• chest pain (angina pectoris)
• breathing difficulties (dyspnoea, pulmonary oedema)
• vomiting
• reduced function of the muscle connecting the oesophagus to the stomach (gastroesophageal sphincter insufficiency)
• yellowing of the skin and whites of the eyes (jaundice)
• severe skin disease characterised by redness, blistering and areas of skin detachment (toxic epidermal necrolysis)
• allergic reaction due to light sensitivity (photosensitivity allergic reaction)
• purple spots on the skin due to bleeding from small blood vessels (palpable purpura)
• bone pain (arthralgia)
• muscle pain (myalgia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell 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 Nifedicor

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp." The expiry date refers to the last day of that month.
Do not dispose of medicines via 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 substance is nifedipine (0.5 ml contain 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 a clear yellow solution, contained in a 30 ml amber glass bottle with an integrated dropper, closed with a child-resistant cap.
Marketing Authorization 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)