Package leaflet: Information for the patient

Felodipine Mylan Generics 5 mg prolonged-release tablets, 10 mg prolonged-release tablets

(Felodipine)
Generic medicinal product
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 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Felodipina Mylan Generics is and what it is used for

Felodipina Mylan Generics contains the active substance felodipine, which belongs to a group of medicines called calcium antagonists. This medicine lowers blood pressure by widening the small blood vessels. It does not negatively affect heart function.
Felodipina Mylan Generics 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 Mylan Generics

Do not take Felodipine Mylan Generics

if you are pregnant. You must inform your doctor as soon as possible if you become pregnant during treatment with this medicine
if you are allergic to felodipine or to any of the other ingredients of this medicine (listed in section 6)
if you have uncompensated heart failure
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 a disorder affecting a heart valve or the heart muscle, until you have consulted your doctor.

Warnings and precautions
Felodipine, like other medicines used to lower blood pressure, may in rare cases cause a considerable drop in blood pressure, which in some patients may lead to insufficient 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 these symptoms occur, go immediately to the emergency room.
Talk to your doctor or pharmacist before taking Felodipine Mylan Generics, especially if you have liver problems.
Taking felodipine may cause swelling of the gums. Good oral hygiene helps prevent gum swelling (see section 4).
Children
The use of felodipine is not recommended in children.
Other medicines and Felodipine Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines or herbal products may affect treatment with Felodipine Mylan Generics, for example:

Cimetidine (a medicine used to treat stomach ulcers)
Erythromycin (a medicine used to treat bacterial infections)
Itraconazole or ketoconazole (medicines used to treat fungal infections)
Medicines for the treatment of HIV (such as ritonavir, efavirenz, nevirapine)
Phenytoin or carbamazepine (medicines used to treat epilepsy)
Rifampicin (a medicine used to treat infections)
Barbiturates (medicines used to treat anxiety, insomnia, and epilepsy)
Tacrolimus (a medicine used after organ transplantation)

Herbal products containing St. John's wort (Hypericum perforatum) (a herbal remedy used for the treatment of depression) may reduce the effectiveness of felodipine and should therefore be avoided.
Felodipine Mylan Generics with food and drink
Do not drink grapefruit juice while taking this medicine. This may increase the effect of Felodipine Mylan Generics and the risk of side effects.
Pregnancy and breastfeeding
Felodipine Mylan Generics must not be used during pregnancy.
Inform your doctor if you are breastfeeding or planning to start breastfeeding. Felodipine is not recommended for breastfeeding mothers; your doctor may choose an alternative treatment if you wish to breastfeed.
Driving and using machines
Felodipine 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.
Important information about some of the excipients of Felodipine Mylan Generics
This medicine 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 Mylan Generics

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The prolonged-release tablets of Felodipine Mylan Generics should be taken in the morning and swallowed whole with a glass of 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 and carbohydrates (sugar).

Hypertension
Treatment should be initiated with a dose of 5 mg once daily. If necessary, your doctor may increase the dose or add another medicine to lower your blood pressure. The usual maintenance 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.

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 Mylan Generics than you should
If you take more Felodipine Mylan Generics than recommended, you may experience very low blood pressure and sometimes palpitations, a high heart rate, or rarely a low heart rate. Therefore, it is very important to take only the number of doses prescribed by your doctor. If you experience symptoms such as fainting, dizziness, or lightheadedness, contact your doctor immediately.

If you forget to take Felodipine Mylan Generics
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 Mylan Generics
If you stop treatment with this medicine, your condition may return. Consult your doctor and seek advice before stopping treatment with Felodipine Mylan Generics. Your doctor will tell you how long you should continue taking this medicine.

If you have any questions about the use of 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.
If you experience any of the following side effects, stop taking Felodipine Mylan Generics and contact a doctor immediately:

Chest pain and dizziness, at the same time
Hypersensitivity and allergic reactions. Signs may include skin blisters (vesicles) 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). Proper 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
Flushing

Uncommon (may affect up to 1 in 100 people)

Abnormally increased heart rate
Pounding heartbeat (palpitations)
Blood pressure too low (hypotension)
Feeling unwell (nausea)
Stomach ache
Burning sensation, tingling or numbness
Skin rash or itching
Feeling of tiredness
Dizziness

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

Fainting
Malaise
Hives
Joint pain
Muscle pain
Inability to achieve or maintain an erection (impotence) or other sexual problems

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

Gingivitis (swollen gums)
Increased levels of liver enzymes
Skin reactions due to increased sensitivity to sunlight
Inflammation of small blood vessels in the skin
Frequent need to urinate

Other side effects may occur. If you experience any unpleasant or unusual reaction during treatment with this medicine, contact your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Felodipine Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”
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 Felodipine Mylan Generics contains
The active substance is felodipine. Each tablet contains 5 mg or 10 mg of felodipine. The excipients are
monohydrate lactose (see section 2 “Felodipine Mylan Generics contains lactose”), microcrystalline
cellulose, hypromellose, povidone, propyl gallate, anhydrous colloidal silica, magnesium stearate, red
iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), talc, macrogol.
Description of the appearance of Felodipine Mylan Generics and pack contents
The 5 mg tablets are light pink, round, and marked with “5”. The 10 mg tablets are red-brown, round, and
marked with “10”.
Felodipine Mylan Generics is available in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Hungary