NIFEDIPINA 20 mg Hard Capsules, Prolonged Release

Зміст інструкції

1. NIFEDIPINA DOC Generici 20 mg prolonged-release hard capsules
   1. What NIFEDIPINA DOC Generici is and what it is used for
   2. What you need to know before taking NIFEDIPINA DOC Generici
   3. How to take NIFEDIPINA DOC Generici
   4. Possible side effects
   5. How to store NIFEDIPINA DOC Generici
   6. Contents of the pack and other information

NIFEDIPINA DOC Generici 20 mg prolonged-release hard capsules

Equivalent Medicinal Product

Read this leaflet carefully before 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 they have the same symptoms as you, 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 NIFEDIPINA DOC Generici is and what it is used for
• 2. What you need to know before you take NIFEDIPINA DOC Generici
• 3. How to take NIFEDIPINA DOC Generici
• 4. Possible side effects
• 5. How to store NIFEDIPINA DOC Generici
• 6. Contents of the pack and other information

1. What NIFEDIPINA DOC Generici is and what it is used for

NIFEDIPINA DOC Generici contains the active ingredient nifedipine which belongs to a group of
medicines called calcium channel blockers (calcium antagonists).
NIFEDIPINA DOC Generici is used to treat high blood pressure (hypertension) or certain types of
chest pain due to heart problems called angina.
In patients with high blood pressure, NIFEDIPINA DOC Generici works by relaxing the blood vessels,
so that blood passes through them more easily. In patients with angina, NIFEDIPINA DOC
Generici works by increasing the blood supply to the heart muscle, which then receives more oxygen and
consequently prevents chest pain.

2. What you need to know before taking NIFEDIPINA DOC Generici

Do not take NIFEDIPINA DOC Generici

• if you are allergic to nifedipine or any of the other ingredients of this medicine (listed in section 6);
• if you have a blood circulation problem that results in insufficient blood flow to the body (cardiovascular shock) characterized by difficulty breathing, paleness, cold sweat and dryness of the mouth;
• if you are taking a medicine containing rifampicin, an antibiotic used to treat some types of infections.

Warnings and precautions
Talk to your doctor or pharmacist before taking NIFEDIPINA DOC Generici.
Take this medicine with caution and always under the supervision of your doctor in the following cases:

• if you have very low blood pressure. In this case, your doctor needs to check your blood pressure regularly;
• if you suffer from reduced heart function;
• if you have been told you have a severe narrowing of the aortic valve of the heart;
• if you are pregnant, if you experience an emergency situation during pregnancy such as eclampsia, a serious illness, potentially fatal, characterized by convulsions, or if you are taking magnesium sulfate intravenously during pregnancy (it may cause an excessive drop in blood pressure with consequent damage to both mother and fetus);
• if you are breastfeeding;
• if you suffer from reduced liver function. In this case, careful monitoring and even a dose reduction may be necessary;
• if you are taking other medicines that can cause an increase in nifedipine levels in the blood. In this case, your doctor will need to carefully monitor your blood pressure and, if necessary, reduce the dose of the medicine (See section Other medicines and NIFEDIPINA DOC Generici);
• if you have or are at risk of developing diabetes. In this case, blood sugar levels must be carefully monitored and, if levels are high, therapy should be discontinued.

Other medicines and NIFEDIPINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Do not take this medicine in combination with medicines containing rifampicin, an antibiotic used to
treat some types of infections (See Do not take NIFEDIPINA DOC Generici).
Be particularly careful and tell your doctor if you are taking the following medicines:

• antibiotics belonging to the macrolide class, such as erythromycin;
• medicines used for the treatment of AIDS, such as ritonavir;
• medicines used for the treatment of fungal infections, such as ketoconazole;
• fluoxetine and nefazodone, used for the treatment of depression;
• quinupristin and dalfopristin, used for the treatment of infections;
• valproic acid, phenytoin, carbamazepine and phenobarbital, used for the treatment of epilepsy;
• cimetidine and cisapride, used for stomach disorders;
• beta-blockers or other medicines to lower blood pressure;
• digoxin, a medicine for the heart;
• quinidine, used to treat heart rhythm disturbances;
• tacrolimus, used to prevent organ rejection after a transplant.
• magnesium sulfate intravenously during pregnancy (may cause an excessive drop in blood pressure with consequent damage to both mother and fetus).

NIFEDIPINA DOC Generici with food and drink
Grapefruit and grapefruit juice should not be consumed by those taking NIFEDIPINA
DOC Generici. This is because grapefruit and grapefruit juice can lead to an increase in
nifedipine concentrations in the blood, which can cause an unpredictable increase in the effect of
blood pressure lowering of NIFEDIPINA DOC Generici.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take NIFEDIPINA DOC Generici during pregnancy unless it is strictly necessary.
Talk to your doctor if you are pregnant or if you wish to become pregnant.
Breastfeeding
This medicine is not recommended if you are breastfeeding, as nifedipine passes into breast milk.
Fertility
In the case of men with difficulty conceiving with in vitrofertilization (an assisted reproductive
technique), and for whom no other causes can be identified, it is advisable to consider
the possibility that calcium channel blockers such as nifedipine may be underlying the problem.

Driving and operating machinery
The use of NIFEDIPINA DOC Generici may affect your ability to drive and operate machinery
because side effects such as dizziness may occur, especially at the beginning of treatment,
when you change the medicine and if you drink alcohol. If this happens to you, avoid driving or
operating machinery.

NIFEDIPINA DOC Generici contains sucrose, lactose and Sunset Yellow FCF (E 110)
This medicine contains sucrose and lactose, two types of sugar. If you have been diagnosed
with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains Sunset Yellow FCF (E 110), a type of dye. It can cause allergic
reactions.

3. How to take NIFEDIPINA DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose in adults is 1 capsule twice a day.
The doctor will adjust the dose and duration of treatment according to your condition. The maximum
recommended dose is 60 mg per day.

Use in people with liver problems
If you have liver problems, your doctor must check your blood pressure and, in the most severe cases, must reduce
the dose.

Use in children and adolescents
There is no experience on the use of NIFEDIPINA DOC Generici in children and adolescents. NIFEDIPINA
DOC Generici is therefore not recommended for use in children and adolescents under 18 years of age.
Method of administration
Take the capsules whole, with a little water, regardless of meals.
Remove the capsule from the blister only at the time of taking it, avoiding prolonged exposure to direct sunlight.

If you take more NIFEDIPINA DOC Generici than you should
If you (or someone else) have swallowed more capsules at the same time, or if you think a child has
swallowed some capsules, consult a doctor immediately. An overdose can cause disturbances of
consciousness up to coma, lowering of blood pressure, alterations of the heart rhythm, high levels of
sugar in the blood (hyperglycemia), decrease in blood pH (metabolic acidosis), decrease
in oxygen supply (hypoxia), serious heart problems such as cardiogenic shock with fluid accumulation
in the lungs (pulmonary edema).
In case of accidental intake/ingestion of an excessive dose of this medicine, warn
immediately your doctor or go to the Emergency Room of the nearest hospital.
Bring with you this leaflet, the remaining capsules and their packaging to the hospital or doctor so that
they know which capsules have been consumed.

If you forget to take NIFEDIPINA DOC Generici
If you forget to take a capsule, take it as soon as you remember, unless it is almost time to
take the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking NIFEDIPINA DOC Generici
The duration of treatment must be established by the doctor. Discontinue treatment gradually,
especially if you are taking high doses, to avoid rapid increases in blood pressure or problems
in blood circulation.
If you have any doubts about 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 everybody gets them.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• headache;
• swelling caused by fluid retention;
• relaxation of blood vessels (vasodilation);
• constipation;
• general feeling of unwellness.

Uncommon(may affect up to 1 in 100 people)

• allergic reaction;
• swelling caused by fluid retention of an allergic nature;
• swelling of the face, lips, mouth, tongue or throat which can cause difficulty in swallowing and breathing (potentially life-threatening);
• anxiety, sleep disorders;
• dizziness, recurrent headache, lightheadedness, tremor;
• vision disturbances;
• increased heart rate, accentuated perception of your heartbeat;
• low blood pressure, transient loss of consciousness;
• nosebleeds and feeling of nasal congestion;
• abdominal and intestinal pain, nausea, difficulty digesting, excessive gas production in the intestine, dry mouth;
• temporary increase in liver enzymes;
• skin irritation;
• muscle cramps, joint swelling;
• excessive urine production, difficulty urinating;
• problems achieving and/or maintaining an erection;
• nonspecific pain, chills.

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

• itching, hives, rash;
• tingling and numbness, burning sensation and pinprick pain on the skin;
• gum swelling.

Not known(frequency cannot be estimated from available data)

• decrease in certain types of white blood cells;
• severe allergic reaction;
• high blood sugar levels (hyperglycemia);
• decreased sensitivity, drowsiness;
• eye pain;
• chest pain due to heart problems (angina pectoris);
• shortness of breath;
• vomiting, heartburn and indigestion;
• yellowing of the skin and whites of the eyes due to a malfunctioning liver;
• formation of blisters or peeling of the skin or mucous membranes (toxic epidermal necrolysis);
• sensitivity to sunlight;
• skin condition characterized by bleeding (purpura);
• joint and muscle pain;
• reduction in hemoglobin levels (a protein that carries oxygen inside red blood cells) in the blood;
• reduction in the number of platelets;
• liver inflammation;
• sexual dysfunction;
• heartburn;
• sore throat, cough, asthma, sweating, fever;
• difficulty breathing.

In patients undergoing dialysis who suffer from excessively high blood pressure and have low blood volumes, a severe drop in blood pressure may occur.

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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store NIFEDIPINA DOC Generici

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”. The expiry date
refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
It is advisable not to expose the capsules to direct sunlight for prolonged periods.
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 NIFEDIPINA DOC Generici contains

• The active substance is nifedipine. Each prolonged-release hard capsule contains 20 mg of nifedipine.
• The other ingredients are: Capsule content: sucrose, corn starch, lactose, povidone K30, methacrylic acid copolymer, talc; Capsule shell: gelatin, sunset yellow FCF (E110), titanium dioxide (E 171).

Description of the appearance of NIFEDIPINA DOC Generici and contents of the pack
Pack of 50 prolonged-release hard capsules.

Marketing Authorisation Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano

Manufacturer
Lamp San Prospero S.p.A., Via della Pace 25/A, 41030 San Prospero (MO)