NIFEDIPINA 20 mg Modified-Release Tablet

Зміст інструкції

1. Nifedipina Sandoz 20 mg modified release tablets
   1. What is Nifedipina Sandoz and what is it used for
   2. What you need to know before taking Nifedipina Sandoz
   3. How to take Nifedipina Sandoz
   4. Possible side effects
   5. How to store Nifedipina Sandoz
   6. Contents of the pack and other information

Nifedipina Sandoz 20 mg modified release tablets

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

1. What is Nifedipina Sandoz and what is it used for

Nifedipina Sandoz contains the active ingredient nifedipine, which belongs to a group of
medicines called calcium channel blockers (calcium antagonists).
Nifedipina Sandoz is used:

• for the treatment of high blood pressure (hypertension);
• for the treatment of a type of chest pain called stable chronic angina pectoris (exertional angina).

In patients with high blood pressure, Nifedipina Sandoz works by relaxing the blood
vessels, so that blood passes through them more easily. In patients with
angina, Nifedipina Sandoz 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 Sandoz

Do not take NIFEDIPINA SANDOZ

• 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);
• 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 Sandoz.
Take this medicine with caution and always under the control 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 taking beta-blockers or other medicines to lower blood pressure (antihypertensives) at the same time;
• if you are pregnant and have an emergency situation such as eclampsia, a serious illness, potentially fatal, characterized by convulsions (see section “Fertility, pregnancy and breastfeeding”);
• if you are breastfeeding;
• if you suffer from reduced liver function. In this case, careful monitoring and even a reduction of the dose may be necessary;
• if you are taking other medicines that can cause an increase in nifedipine levels in the blood. In this case, the doctor will need to carefully monitor your blood pressure and, if necessary, reduce the dose of the medicine (See section Other medicines and Nifedipina Sandoz);
• if you suffer from or are at risk of developing diabetes. In this case, you must carefully check your blood sugar levels and, if levels are high, therapy should be discontinued.

If you are to undergo surgery, inform your doctor or nurse in
as it may be necessary to discontinue treatment with Nifedipina Sandoz for at least
36 hours, to avoid an excessive drop in pressure due to the use of fentanyl, a
medicine used to relieve pain (See section “Other medicines and Nifedipina
Sandoz”).
If you are to undergo a laboratory test to determine the levels of vanillyl-
mandelic acid in the urine (a test to diagnose a tumor of the adrenal gland),
know that, in the presence of nifedipine and depending on the method used, the values ​​may
result falsely increased.

Other medicines and Nifedipina Sandoz
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 rifampicin, an antibiotic used to
treat some types of infections (See section “Do not take Nifedipina Sandoz”).
Be particularly careful and inform your doctor if you are taking the following medicines:

• rifampicin, an antibiotic belonging to the class of rifamycins. The use of this medicine together with Nifedipina Sandoz is contraindicated (see section “Do not take Nifedipina Sandoz”).
• antibiotics belonging to the class of macrolides, 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 II receptor antagonists, other calcium channel blockers, α-adrenergic blockers, PDE5 inhibitors, α-methyldopa);
• diltiazem, used to treat high blood pressure;
• digoxin, a medicine for the heart;
• quinidine, used to treat heart rhythm disturbances;
• tacrolimus, used to prevent organ rejection after a transplant;
• ticlopidine, used in case of blood circulation problems;
• fentanyl, used to relieve pain in case of surgery. In this case, inform the doctor or nurse of the ongoing treatment with Nifedipina Sandoz as it may be necessary to suspend treatment for at least 36 hours;
• magnesium sulfate intravenously during pregnancy (may cause an excessive drop in blood pressure with consequent damage to both mother and fetus).

Nifedipina Sandoz with food, beverages and alcohol
Grapefruit and grapefruit juice should not be consumed by those taking
Nifedipina Sandoz. 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 blood pressure lowering effect of Nifedipina Sandoz.
Avoid drinking alcoholic beverages during treatment with Nifedipina Sandoz.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect 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 Sandoz during pregnancy, unless absolutely necessary and under
strict medical supervision (for example in case of eclampsia).
Breastfeeding
Do not take this medicine if you are breastfeeding, as nifedipine passes into
breast milk. Stop breastfeeding if you need to take this medicine and consult
your doctor.
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 at the root of the problem.

Driving and using machines
The use of Nifedipina Sandoz can affect your ability to drive vehicles and operate
machinery because side effects such as dizziness may occur, especially
at the beginning of treatment, when changing the medicine and if you drink alcohol. If this
happens to you, avoid driving vehicles or using machinery.

Nifedipina Sandoz contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed
you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Nifedipina Sandoz

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose in adults is 1 tablet twice a day. Take the second
tablet at least 4 hours and at most 12 hours after taking the first tablet.
The doctor will adjust the dose and duration of treatment according to your condition.
If you suffer from angina pectoris and do not obtain sufficient therapeutic result after 14
days of treatment, ask your doctor who may decide to prescribe nifedipine 10
mg in immediate release formulation.

Use in people with liver problems
If you have liver problems, your doctor must check your blood pressure and, in more
severe cases, must reduce the dose.
Method of administration
Take the tablets whole, with a little water, independently of meals.
Remove the tablet from the blister only at the time of taking it, avoiding exposing it to
long exposure to direct sunlight.

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

If you forget to take Nifedipina Sandoz
If you forget to take a tablet, take it as soon as you remember, unless it is
almost time to take the next dose. Do not take a double dose to compensate for the
forgotten dose.
If you stop taking Nifedipina Sandoz
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 everyone will experience them.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• headache;
• swelling caused by fluid retention (edema, including peripheral edema);
• redness, hot flushes (vasodilation);
• constipation;
• general feeling of unwellness, unusual weakness (asthenia).

Uncommon(may affect up to 1 in 100 people)

• allergic reaction;
• swelling caused by fluid retention of an allergic nature (allergic edema);
• swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing and breathing (potentially life-threatening) (angioedema);
• anxiety, sleep disorders, irritability;
• dizziness, recurrent headache, vertigo, tremor;
• vision disturbances;
• increased heart rate, accentuated perception of one's heartbeat;
• lowering of blood pressure, transient loss of consciousness (syncope);
• nosebleeds (epistaxis) and feeling of nasal congestion;
• pain in the abdomen and intestines, nausea, difficulty digesting (dyspepsia), excessive gas production in the intestines (flatulence), dry mouth, diarrhea, constipation (stipsis);
• increased liver enzymes;
• skin irritation, rash of pustules, blisters and bubbles (exanthema);
• muscle cramps, joint swelling;
• excessive urine production (polyuria), difficulty urinating (dysuria);
• problems achieving and/or maintaining an erection;
• unspecified pain, chills.

Rare(may affect up to 1 in 1000 people)

• itching, hives, rash;
• skin condition characterized by blood accumulation (purpura);
• tingling and numbness (paresthesia), burning sensation and needle-like pain on the skin (dysesthesia);
• swelling of the gums (gingival hyperplasia), feeling of fullness in the stomach and intestines.
• sensitivity to light (photosensitive dermatitis).

Very rare(may affect up to 1 in 10,000 people)

• breast enlargement in men (gynecomastia);
• severe and widespread erythema with skin scaling (exfoliative dermatitis);
• redness, vasodilation and increased temperature (erythromelalgia).

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

• decrease in the number of white blood cells (agranulocytosis, leukopenia);
• severe allergic reaction (anaphylactic/anaphylactoid reaction);
• increased blood sugar (hyperglycemia);
• decreased sensitivity, drowsiness;
• eye pain;
• chest pain (angina pectoris);
• shortness of breath (dyspnea);
• vomiting, heartburn and indigestion (gastroesophageal sphincter insufficiency);
• yellowing of the skin and whites of the eyes due to liver malfunction (jaundice);
• formation of blisters or peeling of the skin or mucous membranes (toxic epidermal necrolysis);
• sensitization to sunlight (photoallergic reaction);
• skin condition characterized by bleeding (palpable purpura);
• joint and muscle pain (arthralgia, myalgia);
• reduction of hemoglobin (a protein that carries oxygen inside red blood cells) in the blood (anemia);
• reduction of platelet count (thrombocytopenia);
• liver inflammation (hepatitis), increased alkaline phosphatase or LDH;
• sexual dysfunction;
• heartburn (pyrosis gastrica);
• intestinal cramps;
• insomnia;
• sore throat, cough, asthma, sweating, fever;
• difficulty breathing;
• joint and articular stiffness and inflammation.

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 experience any side effects, including those not listed in this leaflet, please 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 Sandoz

Keep this medicine out of the sight and reach of children.
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.
Store in the original package to protect the medicine from light.
It is recommended not to expose the tablets 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 Sandoz contains

• The active ingredient is nifedipine. Each prolonged-release tablet contains 20 mg of nifedipine.
• The other ingredients are: Tablet core :microcrystalline cellulose, pregelatinized corn starch, lactose monohydrate, polysorbate 80, magnesium stearate; Coating: hydroxypropylmethylcellulose, polyethylene glycol 4000, titanium dioxide, red iron oxide, black iron oxide (E172).

Description of the appearance of Nifedipina Sandoz and contents of the pack
Pack of 50 modified-release tablets.
Marketing Authorisation Holder
Sandoz S.p.A., Largo U. Boccioni 1, 21040, Origgio (VA), Italy
Manufacturer
Edmond Pharma S.r.l. - Via dei Giovi, 131 - 20037 Paderno Dugnano (Milan)