FELODIPINA 5 mg Extended-Release Tablet

Зміст інструкції

1. FELODIPINA ZENTIVA
   1. What is Felodipina Zentiva and what is it used for
   2. What you need to know before taking Felodipina Zentiva
   3. How to take Felodipina Zentiva
   4. Possible side effects
   5. How to store Felodipina Zentiva
   6. Package contents and other information

FELODIPINA ZENTIVA

5 mg prolonged-release tablets
10 mg prolonged-release tablets
Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it could 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 Zentiva is and what it is used for
• 2. What you need to know before you take Felodipina Zentiva
• 3. How to take Felodipina Zentiva
• 4. Possible side effects
• 5. How to store Felodipina Zentiva
• 6. Contents of the pack and other information

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

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

2. What you need to know before taking Felodipina Zentiva

Do not take Felodipina Zentiva

• if you are allergic to felodipine or 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 suffer from uncompensated heart failure.
• if you have an acute myocardial infarction (heart attack).
• if you have recently experienced chest pain or angina pectoris that lasts for more than 15 minutes or 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
Felodipina Zentiva, 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 Zentiva, especially if you have liver problems.
Taking Felodipina Zentiva may cause gum swelling. Thorough oral hygiene
helps to prevent gum swelling (see section 4).

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

Other medicines and Felodipina Zentiva
Tell your doctor if you are taking, have recently taken or might take any other
medicines. Some medicines/herbal products can affect treatment with Felodipina
Zentiva.
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)
• medicines for the treatment of HIV, protease inhibitors (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) may reduce the effectiveness of Felodipina Zentiva and, therefore, should be avoided. Felodipina Zentiva with food, beverages and alcoholDo not drink grapefruit juice if you are taking Felodipina Zentiva, as this may increase the effect of Felodipina Zentiva and the risk of side effects. Pregnancy and breastfeedingPregnancy Felodipina Zentiva should not be used during pregnancy. Breastfeeding Inform your doctor if you are breastfeeding or are planning to start breastfeeding. Felodipina Zentiva is not recommended for breastfeeding mothers; your doctor may choose another treatment if you wish to breastfeed. Driving and operating machineryFelodipina Zentiva may mildly or moderately impair the ability to drive vehicles and operate machinery. If you experience headache, nausea, dizziness or fatigue, your ability to react may be impaired. Caution is recommended, especially at the beginning of treatment. Felodipina Zentiva contains lactoseFelodipina Zentiva contains lactose, which is a type of sugar. If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.

3. How to take Felodipina Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The prolonged-release tablets of Felodipina Zentiva 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, but in this case 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 Zentiva than you should
If you take more doses of Felodipina Zentiva than recommended, you may have very low blood
pressure and sometimes palpitations, a high or, in rare cases, 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 Zentiva
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 Zentiva
If you stop treatment with this medicine, the disease may recur. Consult your doctor and
ask for advice before stopping treatment with Felodipina Zentiva. Your doctor will tell you
how long you should take this medicine.
If you have any doubts about the use of this medicine, ask your doctor.

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 Zentiva and
immediately inform your doctor:

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

The following side effects have been identified. In most cases, these reactions
appear 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 prevent or resolve this problem.

Very common(may affect more than 1 in 10 people):

• Ankle edema Common(may affect up to 1 in 10 people):
• Headache
• Hot flushes 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
• Urticaria
• 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 Zentiva, consult your doctor immediately.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 Zentiva

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack 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 in 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 Zentiva contains

• The active ingredient is felodipine. Each prolonged-release tablet contains 5 or 10 mg of felodipine.
• The other ingredients 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 contentsFelodipina Zentiva 5 mg prolonged-release tablets Prolonged-release tablet, round, biconvex, from light red to reddish-grey in colour, with the inscription F5 imprinted on one side.

Felodipina Zentiva 10 mg prolonged-release tablets
Prolonged-release tablet, round, biconvex, from light red to reddish-grey in colour, with
the inscription F10 imprinted on one side
The tablets are packaged in blisters or bottles in packs 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 Milano
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