Felodipine Zentiva

Patient Information Leaflet

FELODIPINE ZENTIVA

5 mg prolonged-release tablets
10 mg prolonged-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 reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
  Contents of this leaflet:

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

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

Felodipine Zentiva 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 Zentiva is used to treat high blood pressure (hypertension) and chest pain caused, for example, by physical exertion or stress (angina pectoris).

2. What you should know before taking Felodipine Zentiva

Do not take Felodipine Zentiva

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

Warnings and precautions
Felodipine Zentiva, 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 insufficient blood supply to the heart often include dizziness and chest pain. If these symptoms occur, go to the emergency room immediately.
Consult your doctor before taking Felodipine Zentiva, especially if you have liver problems.
Taking Felodipine Zentiva may cause swelling of the gums. Good oral hygiene helps prevent gum swelling (see section 4).

Children
The use of Felodipine Zentiva is not recommended in children.

Other medicines and Felodipine Zentiva
Tell your doctor if you are taking, have recently taken, or might take any other medicines. Some medicines/herbal products may affect treatment with Felodipine Zentiva.
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)
• medicines for the treatment of HIV, protease inhibitors (such as ritonavir)
• medicines for the treatment of HIV infections (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)
• herbal products containing St. John’s wort (Hypericum perforatum) (a herbal product used for the treatment of depression) may reduce the effectiveness of Felodipine Zentiva and should therefore be avoided.

Felodipine Zentiva with food, drinks and alcohol
Do not drink grapefruit juice while taking Felodipine Zentiva, as this may increase the effect of Felodipine Zentiva and the risk of side effects.

Pregnancy and breastfeeding
Pregnancy
Felodipine Zentiva must not be used during pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or are planning to breastfeed. Felodipine Zentiva is not recommended for breastfeeding mothers; your doctor may choose another treatment if you wish to breastfeed.

Driving and using machines
Felodipine Zentiva may have a minor 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 Zentiva contains lactose
Felodipine Zentiva contains lactose, which is 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 Felodipine Zentiva

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Felodipine Zentiva prolonged-release tablets should 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, a starting dose of 2.5 mg daily may be considered, but in such case 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. 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 Zentiva than you should
If you take more Felodipine Zentiva than recommended, you may experience very low blood pressure and possibly palpitations, a high heart rate, or rarely a low heart rate. Therefore, it is very important to take exactly the number of doses prescribed by your doctor. If you develop symptoms such as feeling faint, lightheadedness, or dizziness, contact your doctor immediately.

If you forget to take Felodipine Zentiva
If you forget to take a tablet, skip that dose completely. 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 Felodipine Zentiva
If you stop treatment with this medicine, your condition may return. Consult your doctor and seek advice before stopping treatment with Felodipine Zentiva. Your doctor will advise you on how long you should continue taking this medicine.

If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If any of the following symptoms occur, stop treatment with Felodipine Zentiva and inform your doctor immediately:

• Hypersensitivity and allergic reactions: symptoms may include the formation of skin nodules (wheals) 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 develop 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
• Low blood pressure (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
• Hives
• 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 Zentiva, 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 Zentiva

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton and bottle after "Exp.". The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the packaging is torn or damaged.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Felodipina Zentiva contains

• The active substance is felodipine. Each prolonged-release tablet contains 5 mg or 10 mg of felodipine.
• The other components are: tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose, magnesium stearate.
  Tablet coating: lactose monohydrate, hypromellose, macrogol 4000, yellow iron oxide (E172), red iron oxide (E172), and titanium dioxide (E171).

Description of the appearance of Felodipina Zentiva and package contents
Felodipina Zentiva 5 mg prolonged-release tablets
Prolonged-release tablet, round, biconvex, light red to red-grey in colour, with the imprint "F5" on one side.

Felodipina Zentiva 10 mg prolonged-release tablets
Prolonged-release tablet, round, biconvex, light red to red-grey in colour, with the imprint "F10" on one side.

The tablets are packaged in blisters or bottles in pack sizes of 7, 10, 14, 20, 28, 30, 50, 50x1, 98, 100, 100x1 and 250 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Viale Bodio, 37/b
20158 Milan
Italy

Manufacturers
Salutas Pharma GmbH –
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
S.C. Zentiva S.A.
50 Theodor Pallady Bvd
3 district - 032266 Bucharest
Romania

This summary of product characteristics was last approved on: