FELODIPINA 5 mg Таблетки С Пролонгированным Высвобождением

Содержание инструкции

1. Felodipina Mylan Generics 5 mg prolonged-release tablets, 10 mg prolonged-release tablets
   1. What is Felodipina Mylan Generics and what is it used for
   2. What you need to know before taking Felodipina Mylan Generics
2. Felodipine may mildly or moderately alter the ability to drive vehicles and use
   1. How to take Felodipina Mylan Generics
   2. Possible side effects
   3. How to store Felodipina Mylan Generics
   4. Contents of the pack and other information
3. FELODIPINA MYLAN GENERICS is available in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 98

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

(Felodipina)
Generic medicine

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 Mylan Generics is and what it is used for
• 2. What you need to know before you take Felodipina Mylan Generics
• 3. How to take Felodipina Mylan Generics
• 4. Possible side effects
• 5. How to store Felodipina Mylan Generics 6 Contents of the pack and other information

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

Felodipina Mylan Generics 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 Mylan Generics is used in 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 Mylan Generics

Do not take Felodipina Mylan Generics

• if you are pregnant. You should inform your doctor as soon as possible if you become pregnant during treatment with this medicine
• If you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from uncompensated heart failure
• if you have an acute myocardial infarction (heart attack)
• if you have recently onset chest pain or angina pectoris that lasts for more than 15 minutes or more, or is more severe than usual
• if you suffer from a disorder concerning 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, can in rare cases
cause a considerable lowering of blood pressure which, in some patients, can
determine an insufficient blood supply to the heart. Symptoms of blood pressure
excessively low and of an 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 or pharmacist before taking Felodipina Mylan Generics, especially
if you have liver problems.
Taking felodipine may cause gum swelling. Careful oral hygiene
helps to prevent gums from swelling (see section 4).

Children
The use of felodipine is not recommended in children.

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

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

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

Felodipina Mylan Generics with food and drink
Do not drinkgrapefruit juice if you are taking this medicine. This may increase the effect of
Felodipina Mylan Generics and the risk of side effects.

Pregnancy and breastfeeding
Felodipina Mylan Generics should not be used during pregnancy.
Tell your doctor if you are breastfeeding or if you are about to start breastfeeding. Felodipine is not
recommended for breastfeeding mothers; your doctor may choose another treatment if you
wish to breastfeed.

Driving and using machines

Felodipine may mildly or moderately alter the ability to drive vehicles and use

machinery. In case of headache, nausea, dizziness or fatigue, the ability to react may
be compromised. It is recommended to exercise caution, especially at the beginning of treatment .
Important information about some excipients of Felodipina 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 them before taking this medicine.

3. How to take Felodipina Mylan Generics

Take this medicine following exactly the instructions of your doctor. If you have doubts,
consult your doctor or pharmacist.
The prolonged-release tablets of Felodipina Mylan Generics must 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 not
rich in fats or carbohydrates (sugar).

Hypertension
Treatment should be started with a dose of 5 mg once a day. If necessary, the
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.

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. The doctor may reduce the dose.

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

If you take moreFelodipina Mylan Genericsthan you should
If you take more doses of Felodipina Mylan Generics than recommended, you may have a
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 the doctor. If
symptoms such as feeling faint, lightheaded or dizzy occur, contact
your doctor immediately.

If you forget to takeFelodipina Mylan Generics
If you forget to take a tablet, completely skip that dose. Take the next
dose at the scheduled time. Do nottake a double dose to make up for a missed
dose.

If you stop taking Felodipina Mylan Generics
If you stop treatment with this medicine, the disease may reappear. Consult
your doctor and ask for advice before stopping treatment with Felodipina Mylan Generics. The
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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects , stoptaking
Felodipina Mylan Generics and inform your doctor immediately:

• Chest pain and dizziness, at the same time
• Hypersensitivity and allergic reactions. Signs may include skin blisters (blisters) 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 these 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 inflammation of the mouth
(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 fast heart rate
• Heart palpitations (palpitations)
• Blood pressure too low (hypotension)
• Feeling unwell (nausea)
• Stomach pain
• Burning, tingling or numbness
• Skin rash or itching
• Feeling tired
• Dizziness

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

• Fainting
• Feeling unwell
• Urticaria
• 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 bothersome or
unusual reaction during treatment with this medicine, consult your doctor immediately.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Felodipina Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25° C.
Do not use this medicine after the expiry date which is stated on the packaging after
“Exp.”
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 Mylan Generics contains
The active substance is felodipine. Each tablet contains 5 mg or 10 mg of felodipine. The
excipients are lactose monohydrate (see section 2 “Felodipina Mylan Generics contains
lactose”), microcrystalline cellulose, hypromellose, povidone, propyl gallate, colloidal anhydrous
silica, magnesium stearate, red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide
(E 171), talc, macrogol.

Description of the appearance of Felodipina Mylan Genericsand contents of the pack
The 5 mg tablets are light pink, round, with “5” imprinted. The 10 mg tablets are
reddish-brown, round, with “10” imprinted.

FELODIPINA MYLAN GENERICS is available in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 98

and 100 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20, 20124 Milan

Manufacturer
Generics (UK) Ltd, Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland
Mylan dura GmbH, Wittichstraße 6, D - 64295 Darmstadt
Arcana Arzneimittel GmbH, Zimbagasse 5, 1147 Vienna, Austria