FELODIPINA 5 mg Extended-Release Tablet

Зміст інструкції

1. Felodipina Sandoz 5 mg prolonged-release tablets, 10 mg prolonged-release tablets
   1. What is Felodipina Sandoz and what is it used for
   2. What you need to know before taking Felodipina Sandoz
   3. How to take Felodipina Sandoz
   4. Possible side effects
   5. How to store Felodipina Sandoz
   6. Contents of the pack and other information

Felodipina Sandoz 5 mg prolonged-release tablets, 10 mg prolonged-release tablets

Felodipina

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others even if their symptoms are the same as yours because 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 Felodipina Sandoz is and what it is used for
• 2. What you need to know before you take Felodipina Sandoz
• 3. How to take Felodipina Sandoz
• 4. Possible side effects
• 5. How to store Felodipina Sandoz
• 6. Contents of the pack and other information

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

Felodipina Sandoz contains the active ingredient felodipine, which belongs to a group of medicines
called calcium antagonists. This medicine lowers blood pressure by dilating small
blood vessels. It does not negatively affect heart function.
Felodipina Sandoz is used for the treatment of high blood pressure (hypertension) and chest pain and discomfort, due for example to physical activity or stress (angina pectoris).

2. What you need to know before taking Felodipina Sandoz

Do not take Felodipina Sandoz

• if you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6).
• if you have an acute myocardial infarction (heart attack).
• if you have recently started experiencing chest pain or angina pectoris that lasts for more than 15 minutes or is more severe than usual.
• if you suffer from decompensated heart failure.
• if you suffer from a disorder affecting a heart valve or the heart muscle, until you have consulted your doctor.
• if you are pregnant. You should inform your doctor as soon as possible if you become pregnant during treatment with this medicine.

Warnings and precautions
Felodipina Sandoz, like other medicines used to lower blood pressure, can in rare
cases cause a considerable drop in blood pressure which, in some patients,
can lead to insufficient blood supply to the heart. Symptoms of excessively low blood pressure and insufficient blood supply to the heart often include dizziness and
chest pain. If you experience these symptoms, go to the emergency room immediately.
Consult your doctor before taking Felodipina Sandoz, especially if you have liver problems.
Taking Felodipina Sandoz may cause gum swelling. Thorough oral hygiene
helps to prevent gum swelling (see section 4).

Children
The use of Felodipina Sandoz is not recommended in children.

Other medicines and Felodipina Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Some medicines/herbal products can affect the treatment with Felodipina Sandoz, for
example:

• cimetidine (medicine for the treatment of stomach ulcers)
• erythromycin (medicine for the treatment of infections)
• itraconazole (medicine for the treatment of fungal infections)
• Ketoconazole (medicine for the treatment of fungal infections)
• protease inhibitor medicines for the treatment of HIV (such as ritonavir)
• medicines for the treatment of HIV infections (such as efavirenz, nevirapine)
• phenytoin (medicine for the treatment of epilepsy)
• carbamazepine (medicine for the treatment of epilepsy)
• rifampicin (medicine for the treatment of infections)
• barbiturates (medicines for the treatment of anxiety, insomnia and epilepsy)
• tacrolimus (medicine used in organ transplantation)

Medicines containing St John's Wort (Hypericum perforatum)(herbal product used
for the treatment of depression) can reduce the effectiveness of Felodipina Sandoz and, therefore,
should be avoided.

Felodipina Sandoz with food and drink
Do not drink grapefruit juice if you are taking Felodipina Sandoz, as this may increase
the effect of Felodipina Sandoz and the risk of side effects.

Pregnancy and breastfeeding
Pregnancy
Do not take Felodipina Sandoz if you are pregnant.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Felodipina Sandoz is not
recommended for mothers who are breastfeeding and your doctor may choose another treatment if
you wish to breastfeed.

Driving and using machines
Felodipina Sandoz may mildly or moderately impair the ability to drive and operate
machinery. Headache, nausea, dizziness or fatigue may impair your ability to react.
Caution is recommended, especially at the beginning of treatment.

Felodipina Sandoz contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.

3. How to take Felodipina Sandoz

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
The prolonged-release tablets of Felodipina Sandoz must be taken in the morning and
swallowed whole with water. The tablets must not be divided, crushed or chewed.
This medicine can be taken on an empty stomach or after a light meal low in
fat or carbohydrates.

Hypertension
Treatment may begin with a dose of 5 mg once a day. If necessary, your doctor may
increase the dose or add another medicine to lower blood pressure. The
usual dose expected for the long-term treatment of this disease is 5-10 mg once
a day. In elderly patients, it may be considered to administer an initial dose of
2.5 mg per day.
For a dose of 2.5 mg, a medicine with the appropriate dosage must be used.

Stable angina pectoris
Treatment should be started with a dose of 5 mg once a day and, if necessary, the
doctor may increase the dose to 10 mg once a day.

If you have liver problems
The level of felodipine in the blood may be higher. Your doctor may reduce the dose.

Elderly
Your doctor will start treatment with the lowest available dose.

If you take more Felodipina Sandoz than you should
If you take more doses of Felodipina Sandoz than recommended, you may have very low blood
pressure and sometimes palpitations, a high or, in rare cases, a low heart rate.
Therefore, it is very important to take the number of doses prescribed by your doctor. If symptoms such as feeling faint, lightheadedness or dizziness occur, contact
your doctor immediately.

If you forget to take Felodipina Sandoz
If you forget to take a tablet, completely skip that dose. Take the next
dose at the scheduled time. Do not take a double dose to make up for the missed
dose.

If you stop taking Felodipina Sandoz
If you stop treatment with this medicine, the disease may recur. Consult
your doctor and ask for advice before stopping treatment with Felodipina Sandoz. Your doctor will
tell you how long you need to take this medicine.
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.
If any of the following symptoms occur, stop treatment with Felodipina Sandoz
and inform your doctor immediately:

• Hypersensitivity and allergic reactions: signs may include the formation of skin wheals (nodules) or swelling of the face, lips, mouth, tongue or throat.

The following side effects have been identified. In most cases, these reactions
occur at the beginning of treatment or after an increase in the dose. If such reactions occur,
they are usually transient and decrease in intensity over time. If any of the following symptoms
appear and persist, inform your doctor.
Mild gum swelling has been reported in patients with oral inflammation
(gingivitis/periodontitis). Thorough oral hygiene can help prevent or resolve this problem.

Very common:may affect more than 1 in 10 people

• Swelling of the ankles

Common:may affect up to 1 in 10 people

• Headache
• Hot flushes

Uncommon:may affect up to 1 in 100 people

• Abnormally high heart rate
• Palpitations
• Blood pressure too low (hypotension)
• Nausea
• Abdominal pain
• Burning/tingling/numbness
• Skin rash or itching
• Fatigue
• Dizziness

Rare:may affect up to 1 in 1,000 people

• Fainting
• Vomiting
• Itchy skin rash
• Joint pain
• Muscle pain
• Impotence/sexual dysfunction

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

• Gingivitis (swollen gums)
• Increased liver enzymes
• Skin reactions due to increased sensitivity to sunlight
• Inflammation of small blood vessels in the skin
• Frequent need to urinate
• Hypersensitivity reactions such as fever or swelling of the lips and tongue

Other side effects may occur. If any troublesome or
unusual reaction occurs during treatment with Felodipina Sandoz, consult your doctor immediately.

Reporting of side effects
If you get any side effects, talk to 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 Felodipina Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP), which is stated on the packaging. The
expiry date refers to the last day of that month.
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 Felodipina Sandoz contains

• The active ingredientis felodipine. Each tablet contains 5 mg or 10 mg of felodipine.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose, magnesium stearate, macrogol 4000, yellow iron oxide, red iron oxide and titanium dioxide.

Description of the appearance of Felodipina Sandoz and contents of the pack

Felodipina Sandoz 5 mg prolonged-release tablets
Prolonged-release round, biconvex tablet, of a light red to reddish-grey colour,
bearing the inscription F5 on one side

Felodipina Sandoz 10 mg prolonged-release tablets
Prolonged-release round, biconvex tablet, of a light red to reddish-grey colour,
bearing the inscription F10 on one side
Available in the following pack sizes:
Blisters and bottles of 7, 14, 20, 28, 30, 50, 50 x 1, 98, 100, 100 x 1 and 250 prolonged-release
tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SANDOZ S.p.A. Largo U. Boccioni, 1 21040 Origgio (VA)

Manufacturers
SALUTAS Pharma GmbH Otto-von-Guericke-Allee, 1 39179 Barleben (Germany)
LEK S.A., Ul. Domaniewska 50 C – PL-02-672 Warszawa (Poland)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
DE Felodipin - 1 A Pharma 5 mg Retardtabletten
Felodipin - 1 A Pharma 10 mg Retardtabletten
EE Felodipin Hexal
Felodipin Hexal
HU Felodipin 1a Pharma 5 mg retard filmtabletta
Felodipin 1a Pharma 10 mg retard filmtabletta
IT Felodipina Sandoz 5 mg compresse a rilascio prolungato
Felodipina Sandoz 10 mg compresse a rilascio prolungato
LT Felodipin HEXAL 5 mg pailginto atpalaidavimo tablets