Nifedipine Doc Generici

Package leaflet: Information for the patient

NIFEDIPINE DOC Generics 20 mg prolonged-release hard capsules

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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What NIFEDIPINE DOC Generics is and what it is used for
2. What you need to know before taking NIFEDIPINE DOC Generics
3. How to take NIFEDIPINE DOC Generics
4. Possible side effects
5. How to store NIFEDIPINE DOC Generics
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 substance 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 caused by heart problems known as angina.
In patients with high blood pressure, NIFEDIPINA DOC Generici works by relaxing the blood vessels, allowing blood to flow through them more easily. In patients with angina, NIFEDIPINA DOC Generici improves blood supply to the heart muscle, thereby increasing oxygen delivery to the heart and preventing chest pain.

2. What you need to know before taking NIFEDIPINE DOC Generics

Do not take NIFEDIPINE DOC Generics

• if you are allergic to nifedipine or any of the other ingredients of this medicine (listed in section 6);
• if you have a circulatory problem causing insufficient blood flow to the body (cardiovascular shock), characterized by difficulty breathing, pallor, cold sweating, and dry mouth;
• if you are taking a medicine containing rifampicin, an antibiotic used to treat certain types of infections.

Warnings and precautions
Talk to your doctor or pharmacist before taking NIFEDIPINE DOC Generics.
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 needs to monitor your blood pressure regularly;
• if you have reduced heart function;
• if you have been diagnosed with severe aortic valve stenosis;
• if you are pregnant, if you experience an emergency condition during pregnancy such as eclampsia—a serious, potentially fatal condition characterized by seizures—or if you are receiving intravenous magnesium sulfate during pregnancy (this may cause excessive drop in blood pressure, leading to harm to both mother and fetus);
• if you are breastfeeding;
• 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 such cases, your doctor must closely monitor your blood pressure and, if necessary, reduce the dose (see section "Other medicines and NIFEDIPINE DOC Generics");
• if you have or are at risk of developing diabetes. In this case, blood glucose levels should be carefully monitored, and if high levels occur, treatment should be discontinued.

Other medicines and NIFEDIPINE DOC Generics
Inform 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 certain types of infections (see "Do not take NIFEDIPINE DOC Generics").
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;
• beta-blockers or other medicines to lower blood pressure;
• digoxin, a medicine for heart conditions;
• 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, leading to harm to both mother and fetus).

NIFEDIPINE DOC Generics with food and drinks
Grapefruit and grapefruit juice must not be consumed by people taking NIFEDIPINE DOC Generics. This is because grapefruit and grapefruit juice can increase nifedipine blood concentrations, which may cause an unpredictable increase in the blood pressure-lowering effect of NIFEDIPINE DOC Generics.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take NIFEDIPINE DOC Generics during pregnancy unless strictly necessary. Consult your doctor if you are pregnant or planning a pregnancy.

Breastfeeding
This medicine is not recommended if you are breastfeeding, as nifedipine passes into breast milk.

Fertility
In men experiencing infertility during in vitro fertilization (an assisted reproductive technique), and when no other causes can be identified, it is advisable to consider calcium antagonists such as nifedipine as a possible contributing factor.

Driving and using machines
The use of NIFEDIPINE DOC Generics may affect your ability to drive or operate machinery, as undesirable effects such as dizziness may occur, especially at the beginning of treatment, when changing medication, or when consuming alcohol. If this happens, avoid driving or operating machinery.

NIFEDIPINE DOC Generics contains sucrose, lactose and sunset yellow FCF (E 110)
This medicine contains sucrose and lactose, two types of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.
This medicine contains sunset yellow FCF (E 110), a type of dye. It may cause allergic reactions.

3. How to take NIFEDIPINA DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose in adults is 1 capsule twice daily.
Your doctor will adjust the dose and duration of treatment according to your condition. The maximum
recommended dose is 60 mg per day.
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
There is no experience with 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
Swallow the capsules whole, with some water, regardless of meals.
Remove the capsule from the blister pack only at the time of administration, avoiding prolonged exposure to direct sunlight.
If you take more NIFEDIPINA DOC Generici than you should
If you (or someone else) have ingested several capsules at the same time, or if you suspect that a child has
ingested any capsules, consult a doctor immediately. Overdose may cause disturbances of consciousness up to coma, low blood pressure, heart rhythm abnormalities, high blood sugar levels (hyperglycaemia), decreased blood pH (metabolic acidosis), reduced oxygen supply (hypoxia), and serious heart problems such as cardiogenic shock with fluid accumulation in the lungs (pulmonary oedema).
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
Take this leaflet, any remaining capsules, and the original packaging with you to the hospital or doctor so that they know which capsules have been taken.
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 for the next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking NIFEDIPINA DOC Generici
The duration of treatment should be determined by your doctor. Discontinue treatment gradually, especially if you are taking high doses, to avoid rapid increases in blood pressure or circulatory problems.
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 side effects may occur:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• allergic reaction;
• swelling caused by allergic-type fluid accumulation;
• swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing and breathing (potentially life-threatening);
• anxiety, sleep disorders;
• dizziness, recurrent headache, vertigo, tremor;
• visual disturbances;
• increased heart rate, heightened awareness of heartbeat;
• low blood pressure, transient loss of consciousness;
• nosebleeds and sensation of nasal congestion;
• abdominal and intestinal pain, nausea, difficulty digesting, excessive intestinal gas, dry mouth;
• transient increase in liver enzymes;
• skin irritation;
• muscle cramps, joint swelling;
• excessive urine production, difficulty urinating;
• problems achieving and/or maintaining an erection;
• non-specific pain, chills.

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

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

Not known (frequency cannot be determined from available data)

• decrease in certain types of white blood cells;
• severe allergic reaction;
• high blood sugar levels (hyperglycaemia);
• reduced sensitivity, drowsiness;
• eye pain;
• chest pain due to heart problems (angina pectoris);
• shortness of breath;
• vomiting, heartburn, indigestion;
• yellowish discoloration of the skin and whites of the eyes due to liver dysfunction;
• blistering or peeling of the skin or mucous membranes (toxic epidermal necrolysis);
• increased sensitivity to sunlight;
• skin condition characterized by bleeding (purpura);
• joint and muscle pain;
• reduced haemoglobin levels (a protein that carries oxygen within red blood cells) in the blood;
• reduced platelet count;
• liver inflammation;
• sexual dysfunction;
• stomach burning;
• sore throat, cough, asthma, sweating, fever;
• breathing difficulty.

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 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 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 NIFEDIPINE DOC Generici

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.
It is advisable not to expose the capsules to direct sunlight for prolonged periods.
Do not dispose of any medicine 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 NIFEDIPINA DOC Generici contains

• The active substance is nifedipine. Each prolonged-release hard capsule contains 20 mg of nifedipine.
• The other components are: Capsule contents: sucrose, maize 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 Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan
Manufacturer
Lamp San Prospero S.p.A., Via della Pace 25/A, 41030 San Prospero (MO)