Nifedipine Eg

Patient Information Leaflet

NIFEDIPINE EG 20 mg prolonged-release hard capsules, 30 mg prolonged-release film-coated tablets, 60 mg prolonged-release film-coated tablets

Generic medicine
Please read 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What NIFEDIPINA EG is and what it is used for

NIFEDIPINA EG contains the active substance nifedipine, which belongs to a group of medicines called calcium channel blockers (calcium antagonists).
NIFEDIPINA EG is used to treat high blood pressure (hypertension) or certain types of chest pain caused by heart problems known as chronic stable angina pectoris (exertional angina).

2. What you need to know before taking NIFEDIPINE EG

Do not take NIFEDIPINE EG

• if you are allergic to nifedipine or to any of the other ingredients of this medicine (listed in section 6);
• if you have a circulatory disorder causing insufficient blood flow to the body (cardiovascular shock);
• if you have a Kock pouch (“diversion” following surgical removal of the colon and rectum);
• if you are taking a medicine containing rifampicin, an antibiotic used to treat certain types of infections;
• if you are pregnant, think you might be pregnant, or are breastfeeding (see section Pregnancy, breastfeeding and fertility).

Warnings and precautions
Talk to your doctor or pharmacist before taking NIFEDIPINE EG.
Take this medicine with caution and always under medical supervision in the following cases:

• if you have very low blood pressure. In this case, your doctor must regularly monitor your blood pressure;
• if you suffer from heart failure (reduced heart function);
• if you suffer from severe aortic stenosis (severe narrowing of the heart's aortic valve);
• if you are simultaneously taking medicines known as beta-blockers or other medicines to lower blood pressure (antihypertensives);
• if you are pregnant and experiencing an emergency condition such as eclampsia (a serious, potentially fatal condition characterized by seizures), or if you are receiving intravenous magnesium sulfate (see section Other medicines and NIFEDIPINE EG);
• if you have impaired liver function. In this case, careful monitoring and possibly a dose reduction may be required;
• if you are taking other medicines that may increase nifedipine blood levels. In this case, your doctor must closely monitor your blood pressure and, if necessary, reduce the dose (see section Other medicines and NIFEDIPINE EG);
• if you have diabetes or are at risk of developing diabetes. In this case, you must carefully monitor your blood glucose levels and discontinue treatment if levels increase;
• if you have undergone intestinal surgery known as a Kock pouch (ileostomy after proctocolectomy);
• if you have narrowing of the stomach or intestine (severe gastrointestinal tract stenosis);
• if you are undergoing dialysis and suffer from high blood pressure (malignant hypertension), have severe reduction in kidney function (irreversible renal failure) associated with reduced blood volume (hypovolemia).

If during treatment with this medicine you experience chest pain (angina-like symptoms), consult your doctor.
This medicine may interfere with radiological test results (radiological examinations using barium contrast), leading to false positive results (such as filling defects that may be interpreted as polyps).

Children and adolescents
NIFEDIPINE EG is not recommended for children and adolescents under 18 years of age, as there is no experience with the use of this medicine in the pediatric population.

Other medicines and NIFEDIPINE EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine together with rifampicin, an antibiotic used to treat certain types of infections (see Do not take NIFEDIPINE EG).
Be especially careful and inform your doctor if you are taking the following medicines:

• macrolide antibiotics, such as erythromycin;
• medicines used to treat AIDS, such as ritonavir;
• medicines used to treat fungal infections, such as ketoconazole;
• fluoxetine and nefazodone, used to treat depression;
• quinupristin and dalfopristin, used to treat infections;
• valproic acid, phenytoin, carbamazepine, and phenobarbital, used to treat epilepsy;
• cimetidine and cisapride, used for stomach disorders;
• medicines used to lower blood pressure (diuretics, β-blockers, ACE inhibitors, angiotensin receptor antagonists, other calcium antagonists, α-adrenergic blockers, PDE5 inhibitors, α-methyldopa);
• diltiazem, used to treat high blood pressure;
• digoxin, a heart medicine;
• quinidine, used to treat heart rhythm disorders;
• tacrolimus, used to prevent organ rejection after transplantation;
• intravenous magnesium sulfate during pregnancy (may cause excessive drop in blood pressure, potentially harming both mother and fetus).

NIFEDIPINE EG with food, beverages and alcohol
Do not consume grapefruit or grapefruit juice while taking NIFEDIPINE EG, as they may increase nifedipine blood levels and prolong its effect.
Avoid alcoholic beverages during treatment with NIFEDIPINE EG.

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 NIFEDIPINE EG during pregnancy. Consult your doctor if you are pregnant or planning a pregnancy. This medicine should only be used during pregnancy if your clinical condition specifically requires treatment with nifedipine (e.g., severe hypertension unresponsive to standard therapies).

Breastfeeding
Do not take this medicine if you are breastfeeding, as nifedipine passes into breast milk.
Discontinue breastfeeding if you need to take this medicine and consult your doctor.

Fertility
In cases of failed in vitro fertilization where no other causes can be identified, the use of calcium antagonists such as nifedipine may be considered a possible contributing factor due to their association with functional alterations of spermatozoa.

Driving and using machines
The use of NIFEDIPINE EG may affect your ability to drive or operate machinery, as it may cause side effects such as dizziness, especially at the beginning of treatment, when changing medication, or when consuming alcohol. If this occurs, avoid driving or operating machinery.

NIFEDIPINE EG 20 mg prolonged-release hard capsules contain sucrose, lactose and sunset yellow (E 110)
This medicine contains certain types of sugar: sucrose and lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
This medicine contains a colouring agent called sunset yellow (E 110), which may cause allergic reactions.

3. How to take NIFEDIPINE EG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The recommended dose for adults is 1 capsule of 20 mg twice daily or 1 tablet of 30 mg once daily.
Your doctor will adjust the dose and duration of treatment according to your condition.
In the treatment of chronic stable angina (exertional angina), your doctor may gradually increase the dose up to a maximum of 120 mg taken once daily in the morning.
In the treatment of high blood pressure, your doctor may gradually increase the dose up to a maximum of 60 mg taken once daily in the morning.

Use in patients with liver problems
If you have liver problems, your doctor must monitor your blood pressure and, in more severe cases, may need to reduce the dose.

Use in children and adolescents
NIFEDIPINE EG is not recommended for use in children and adolescents under 18 years of age.

Method of administration
Swallow the capsules whole with a glass of water, preferably taken away from meals.
Swallow the tablets whole with some water, in the morning on an empty stomach. Do not chew or break the tablets.
Remove the tablet or capsule from the blister pack only at the time of administration, avoiding exposure to sunlight and moisture.

If you take more NIFEDIPINE EG than you should
If you (or someone else) have taken several tablets or capsules at the same time, or if you suspect that a child has ingested any tablets or capsules, contact a doctor immediately or go to the nearest hospital emergency department.
Take this leaflet, any remaining tablets or capsules, and the original container with you to the hospital or doctor so that they know which tablets or capsules have been taken.
An overdose may cause disturbances of consciousness up to coma, low blood pressure, changes in heart rhythm, increased blood sugar levels (hyperglycaemia), changes in blood pH (metabolic acidosis), reduced oxygen supply (hypoxia), and serious heart problems such as cardiogenic shock with fluid accumulation around the lungs (pulmonary oedema).

If you forget to take NIFEDIPINE EG
If you forget to take a tablet or capsule, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking NIFEDIPINE EG
The duration of treatment must be determined by your doctor. Stop the treatment gradually, especially if you are taking high doses, to avoid rapid increases in blood pressure or circulatory problems.

If you have any questions 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 will get them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

• headache;
• oedema, peripheral oedema (swelling due to fluid accumulation, generalised or in the extremities);
• vasodilation (palpitations, hot flushes, sensations of warmth);
• constipation;
• general malaise, unusual weakness.

Uncommon (may affect up to 1 in 100 people)

• allergic reaction;
• allergic-type oedema;
• angioedema (rapid swelling of the skin, face and mucous membranes including potentially life-threatening laryngeal oedema);
• anxiety, sleep disorders/insomnia, irritability;
• dizziness, recurrent headache, vertigo, tremor;
• visual disturbances;
• increased heart rate, palpitations (awareness of heartbeat);
• chest pain (pseudo-angina);
• low blood pressure, transient loss of consciousness;
• nosebleeds and nasal congestion;
• gastrointestinal and abdominal pain, nausea, dyspepsia, excessive intestinal gas, dry mouth, diarrhoea;
• increased liver enzymes;
• skin irritation, rash with pustules, blisters and vesicles (exanthema, erythema);
• muscle cramps, joint swelling;
• excessive urine production, difficulty urinating;
• problems achieving and/or maintaining erection;
• non-specific pain or limb pain, chills.

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

• skin condition characterised by blood accumulation (purpura);
• pruritus, urticaria, skin rash;
• paraesthesia/dysesthesia (altered sensation such as tingling and numbness);
• gum swelling, bloating sensation in stomach and intestine;
• altered liver function.

Not known (frequency cannot be estimated from the available data)

• decrease in white blood cells (agranulocytosis, leucopenia);
• anaphylactic/anaphylactoid reaction (severe allergic reaction);
• increased blood sugar levels;
• decreased sensation, somnolence;
• eye pain;
• chest pain;
• shortness of breath, breathing difficulty;
• vomiting;
• gastroesophageal sphincter insufficiency (digestive system disorder);
• difficulty swallowing;
• intestinal problems (intestinal ulcer or obstruction);
• bezoars (formation of large masses in the stomach);
• heartburn;
• jaundice (yellowing of the skin and whites of the eyes);
• blistering or peeling of the skin or mucous membranes (toxic epidermal necrolysis), exfoliative dermatitis;
• photosensitivity;
• palpable purpura (bleeding from small blood vessels);
• joint and muscle pain;
• breast enlargement in men;
• redness, vasodilation and increased temperature (erythromelalgia);
• reduction in haemoglobin (a protein that carries oxygen within red blood cells) in the blood;
• reduction in the number of platelets in the blood;
• increased alkaline phosphatase or LDH;
• liver inflammation (hepatitis);
• sexual dysfunction;
• sore throat, cough, asthma, sweating, fever.

In dialysis patients suffering from excessively high blood pressure and low blood volume, a severe drop in blood pressure may occur.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 NIFEDIPINE EG

Keep this medicine out of the sight and reach of children.
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.
Store in the original packaging to protect the medicine from light and moisture.
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. Package contents and other information

What NIFEDIPINE EG contains
NIFEDIPINE EG 20 mg prolonged-release hard capsules

• The active substance is nifedipine. Each hard capsule contains 20 mg of nifedipine.
• The other components are: sucrose, maize starch, lactose monohydrate, povidone (K30), methacrylic acid copolymer (Eudragit L), talc. Coating: titanium dioxide (E 171), sunset yellow (E 110), gelatin.

NIFEDIPINE EG 30 mg and NIFEDIPINE EG 60 mg prolonged-release film-coated tablets

• The active substance is nifedipine. Each film-coated tablet contains 30 mg or 60 mg of nifedipine.
• The other components are: hypromellose, povidone, carboxymethylcellulose, magnesium stearate, colloidal silica, talc, macrogol 6000, simethicone, titanium dioxide (E 171), iron oxide red (E 172).

Description of the appearance of NIFEDIPINE EG and contents of the pack
NIFEDIPINE EG 20 mg prolonged-release hard capsules
Pack of 50 prolonged-release hard capsules.
NIFEDIPINE EG 30 mg and NIFEDIPINE EG 60 mg prolonged-release film-coated tablets
Pack of 14 prolonged-release film-coated tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milano
Manufacturers
NIFEDIPINE EG 20 mg prolonged-release hard capsules
Doppel Farmaceutici S.r.l., Via Volturno, 48 Quinto De' Stampi - Rozzano (MI)
NIFEDIPINE EG 30 mg & 60 mg prolonged-release film-coated tablets
Fine Foods & Pharmaceuticals NTM S.p.A., Via Follereau 25 - 24027 Nembro (BG)