Nifedipine Sandoz

Package leaflet: Information for the patient

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

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

Nifedipina Sandoz contains the active substance 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 known as chronic stable angina pectoris (exertional angina).

In patients with high blood pressure, Nifedipina Sandoz works by relaxing the blood
vessels, allowing blood to flow through them more easily. In patients with
angina, Nifedipina Sandoz works by increasing blood supply to the heart muscle, which thus receives more oxygen and consequently prevents chest pain.

2. What you need to know before taking Nifedipine Sandoz

Do not take NIFEDIPINE SANDOZ

• 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 problem causing insufficient blood flow to the body (cardiovascular shock);
• 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 Sandoz.
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 suffer from reduced heart function;
• if you have been diagnosed with severe narrowing of the aortic valve of the heart;
• if you are concurrently taking medicines called 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 life-threatening illness characterized by seizures (see section “Fertility, pregnancy and breastfeeding”);
• if you are breastfeeding;
• if you have impaired liver function. In this case, careful monitoring may be required and possibly a dose reduction;
• 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 Sandoz”);
• if you have diabetes or are at risk of developing diabetes. In this case, you should carefully monitor your blood sugar levels and, if levels are high, treatment should be discontinued.

If you are scheduled for surgery, inform your doctor or nurse, as it may be necessary to stop treatment with Nifedipine Sandoz for at least 36 hours to avoid excessive lowering of blood pressure due to the use of fentanyl, a medicine used to relieve pain (see section “Other medicines and Nifedipine Sandoz”).
If you are undergoing a laboratory test to measure vanillylmandelic acid levels in urine (a test used to diagnose adrenal gland tumours), be aware that in the presence of nifedipine and depending on the testing method used, results may be falsely elevated.

Other medicines and Nifedipine Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine in combination with rifampicin, an antibiotic used to treat certain types of infections (see section “Do not take Nifedipine Sandoz”).
Be especially careful and inform your doctor if you are taking the following medicines:

• rifampicin, an antibiotic belonging to the rifamycin class. Concomitant use of this medicine with Nifedipine Sandoz is contraindicated (see section “Do not take Nifedipine Sandoz”);
• antibiotics belonging to the macrolide class, 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 type 1 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;
• ticlopidine, used in cases of circulatory problems;
• fentanyl, used to relieve pain during surgery. In this case, inform your doctor or nurse about your ongoing treatment with Nifedipine Sandoz, as it may be necessary to discontinue treatment for at least 36 hours;
• intravenous magnesium sulfate during pregnancy (may cause excessive drop in blood pressure, resulting in harm to both mother and fetus).

Nifedipine Sandoz with food, drinks and alcohol
Grapefruit and grapefruit juice must not be consumed by anyone taking Nifedipine Sandoz. This is because grapefruit and grapefruit juice can increase nifedipine blood concentrations, potentially causing an unpredictable increase in the blood pressure-lowering effect of Nifedipine Sandoz.
Avoid consuming alcoholic beverages during treatment with Nifedipine Sandoz.

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

Pregnancy
Do not take Nifedipine Sandoz during pregnancy, except in cases of absolute necessity and under strict medical supervision (e.g. in cases of eclampsia).

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 men experiencing infertility during in vitro fertilization (an assisted reproductive technique), and when no other causes can be identified, consider the possibility that calcium channel blockers such as nifedipine may be contributing to the problem.

Driving and using machines
The use of Nifedipine Sandoz may affect your ability to drive or operate machinery, as side 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 using machinery.

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

3. How to take Nifedipine Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 1 tablet twice daily. Take the second tablet at least 4 hours and no more than 12 hours after taking the first tablet.
Your doctor will adjust the dose and duration of treatment according to your condition.
If you suffer from angina pectoris and do not achieve sufficient therapeutic effect after 14 days of treatment, ask your doctor, who may decide to prescribe nifedipine 10 mg in an immediate-release formulation.

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

Method of administration
Swallow the tablets whole with some water, regardless of meals.
Remove the tablet from the blister pack only immediately before taking it, avoiding prolonged exposure to direct sunlight.

If you take more Nifedipine Sandoz than you should
If you (or someone else) have taken several tablets at the same time, or if you think a child has ingested any tablets, contact a doctor immediately.
An overdose may cause disturbances of consciousness up to coma, low blood pressure, changes in heart rhythm, 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 tablets, and the container with you so that medical staff know which tablets have been taken.

If you forget to take Nifedipine Sandoz
If you forget to take a tablet, 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 Sandoz
The duration of treatment should be determined by your doctor. Stop treatment gradually, especially if you are taking high doses, to avoid rapid increases in blood pressure or circulation 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 everyone experiences them.
The following side effects may occur:

Common (may affect up to 1 in 10 people)

• headache (cephalalgia);
• swelling caused by fluid accumulation (edema, including peripheral edema);
• redness, hot flushes (vasodilatation);
• constipation;
• general feeling of discomfort, unusual weakness (asthenia).

Uncommon (may affect up to 1 in 100 people)

• allergic reaction;
• swelling due to allergic fluid accumulation (allergic edema);
• swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing and breathing (potentially life-threatening) (angioedema);
• anxiety, sleep disorders, irritability;
• dizziness, recurrent headaches, vertigo, tremor;
• visual disturbances;
• increased heart rate, heightened awareness of heartbeat (palpitations);
• low blood pressure, transient loss of consciousness (syncope);
• nosebleeds (epistaxis) and sensation of nasal congestion (nasal congestion);
• abdominal and intestinal pain, nausea, difficulty digesting (dyspepsia), excessive gas production in the intestine (flatulence), dry mouth, diarrhea, constipation (stipsis);
• increased liver enzymes;
• skin irritation, pustular, vesicular, or bullous rash (rash);
• muscle cramps, joint swelling;
• excessive urine production (polyuria), difficulty urinating (dysuria);
• problems achieving and/or maintaining an erection;
• non-specific pain, chills.

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

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

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

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

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

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

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, talk to 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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 tablets 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. Contents of the pack and other information

What Nifedipina Sandoz contains

• The active substance is nifedipine. Each prolonged-release tablet contains 20 mg of nifedipine.
• The other components are:
  Tablet core: microcrystalline cellulose, pregelatinized corn starch, lactose monohydrate, polysorbate 80, magnesium stearate;
  Coating: hypromellose, 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 containing 50 modified-release tablets.
Marketing Authorization 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)