Patient Information Leaflet

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

Felodipine
Generic medicine
Please read all of 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Felodipine Sandoz is and what it is used for
What you need to know before taking Felodipine Sandoz
How to take Felodipine Sandoz
Possible side effects
How to store Felodipine Sandoz
Contents of the pack and other information

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

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

2. What you need to know before taking Felodipine Sandoz

Do not take Felodipine Sandoz

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

Warnings and precautions
Felodipine Sandoz, like other medicines used to lower blood pressure, may in rare cases cause a marked decrease in blood pressure, which in some patients may lead to inadequate blood supply to the heart. Symptoms of excessively low blood pressure and inadequate blood supply to the heart often include dizziness and chest pain. If you experience these symptoms, go to the emergency room immediately.
Talk to your doctor before taking Felodipine Sandoz, especially if you have liver problems.
Taking Felodipine Sandoz may cause swelling of the gums. Good oral hygiene helps prevent gum swelling (see section 4).
Children
The use of Felodipine Sandoz is not recommended in children.
Other medicines and Felodipine Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines/herbal products may affect treatment with Felodipine Sandoz, for example:

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

Medicinal products containing St. John's Wort (Hypericum perforatum) (a herbal product used for the treatment of depression) may reduce the effectiveness of Felodipine Sandoz and should therefore be avoided.
Felodipine Sandoz with food and drink
Do not drink grapefruit juice while taking Felodipine Sandoz, as this may increase the effect of Felodipine Sandoz and the risk of side effects.
Pregnancy and breastfeeding
Pregnancy
Do not take Felodipine Sandoz if you are pregnant.
Breastfeeding
Inform your doctor if you are breastfeeding or are planning to start breastfeeding. Felodipine Sandoz is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed.
Driving and using machines
Felodipine Sandoz may have a slight or moderate effect on the ability to drive and use machines. If you experience headache, nausea, dizziness, or fatigue, your reaction ability may be impaired. Caution is advised, especially at the beginning of treatment.
Felodipine Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Felodipine Sandoz

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The prolonged-release tablets of Felodipine 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 start with a dose of 5 mg once daily. If necessary, your doctor may increase the dose or add another medicine to lower blood pressure. The usual dose for long-term treatment of this condition is 5–10 mg once daily. In elderly patients, consideration may be given to starting with an initial dose of 2.5 mg daily.
For a dose of 2.5 mg, a medicine with the appropriate dosage strength should be used.
Stable angina pectoris
Treatment should be initiated with a dose of 5 mg once daily, and if necessary, your doctor may increase the dose to 10 mg once daily.
If you have liver problems
The level of felodipine in your blood may be higher. Your doctor may reduce your dose.
Elderly patients
Your doctor will start treatment with the lowest available dose.
If you take more Felodipine Sandoz than you should
If you take more Felodipine Sandoz than recommended, you may experience very low blood pressure and sometimes palpitations, a fast heart rate, or rarely a slow heart rate. Therefore, it is very important to take only the number of prescribed doses. If symptoms such as fainting, dizziness, or lightheadedness occur, contact your doctor immediately.
If you forget to take Felodipine Sandoz
If you forget to take a tablet, skip that dose completely. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Felodipine Sandoz
If you stop treatment with this medicine, your condition may return. Consult your doctor and seek advice before stopping treatment with Felodipine Sandoz. Your doctor will advise you on how long you should continue taking this medicine.
If you have any questions 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 gets them.
If you experience any of the following symptoms, stop treatment with Felodipine Sandoz and inform your doctor immediately:

Hypersensitivity and allergic reactions: signs may include the formation of skin wheals (lumps) 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 following an increase in dose. If such reactions occur, they are usually transient and decrease in intensity over time. If any of the following symptoms appear or persist, inform your doctor. Mild gum swelling has been reported in patients with inflammation of the mouth (gingivitis/periodontitis). Good oral hygiene can help prevent or resolve this problem.
Very common: may affect more than 1 in 10 people

Ankle swelling

Common: may affect up to 1 in 10 people

Headache
Flushing

Uncommon: may affect up to 1 in 100 people

Abnormally increased 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 also occur. If you experience any bothersome or unusual reaction during treatment with Felodipine Sandoz, consult your doctor immediately.
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 Felodipine Sandoz

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

The active substance is felodipine. Each tablet contains 5 mg or 10 mg of felodipine.
The other components 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
Round, biconvex prolonged-release tablet, colour ranging from light red to red-grey,
with the inscription "F5" on one side.
Felodipina Sandoz 10 mg prolonged-release tablets
Round, biconvex prolonged-release tablet, colour ranging from light red to red-grey,
with the inscription "F10" on one side.
Available in the following pack sizes:
Blister packs and bottles containing 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 European Economic Area countries under the following names:
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