Felodipine Ratiopharm

Patient Information Leaflet

Felodipine ratiopharm 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.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

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

Felodipine ratiopharm 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 ratiopharm is used to treat high blood pressure (hypertension) and chest pain caused by conditions such as physical exertion or stress (angina pectoris).

2. What you need to know before taking Felodipine ratiopharm

Do not take Felodipine ratiopharm

• 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 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 ratiopharm, 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.
Consult your doctor before taking Felodipine ratiopharm, especially if you have liver problems.
Taking Felodipine ratiopharm may cause swelling of the gums. Good oral hygiene helps prevent gum swelling (see section 4).

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

Other medicines and Felodipine ratiopharm
Inform your doctor if you are taking, have recently taken, or might take any other medicines. Some medicines/herbal products may affect treatment with Felodipine ratiopharm, 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 (a medicine 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 remedy used for the treatment of depression) may reduce the effectiveness of Felodipine ratiopharm and should therefore be avoided.

Felodipine ratiopharm with food and drink
Do not drink grapefruit juice while taking Felodipine ratiopharm, as this may increase the effect of Felodipine ratiopharm and the risk of adverse effects.

Pregnancy and breastfeeding
Pregnancy
Felodipine ratiopharm must not be used during pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Felodipine ratiopharm is not recommended for breastfeeding mothers; your doctor may choose an alternative treatment if you wish to breastfeed.

Driving and using machines
Felodipine ratiopharm 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 ratiopharm contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Felodipine ratiopharm

Always take Felodipine ratiopharm exactly as instructed by your doctor. If you have any doubts, consult your doctor.
The prolonged-release tablets of Felodipine ratiopharm 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.
Note: The 2.5 mg dose cannot be achieved with Felodipine ratiopharm, as these prolonged-release tablets cannot be divided. Other products with a dosage lower than 5 mg are available.

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 the dose.

Elderly patients
Your doctor will start treatment with the lowest available dose (2.5 mg).

If you take more Felodipine ratiopharm than you should
If you take more Felodipine ratiopharm 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 doses prescribed by your doctor.
If you experience symptoms such as feeling faint, lightheadedness, or dizziness, contact your doctor immediately.

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

If you have any questions about the use of this medicine, speak to 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 ratiopharm and inform your doctor immediately:

• Hypersensitivity and allergic reactions: signs may include the formation of skin lumps (hives) 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 and persist, inform your doctor.
A slight swelling of the gums has been reported in patients with inflammation of the mouth (gums/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
• Urticaria (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 ratiopharm, contact your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at http://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 ratiopharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 in use. This will help protect the environment.

6. Package contents and other information

What Felodipine ratiopharm contains
The active substance is felodipine.
Each tablet contains 5 mg of felodipine.
Each tablet contains 10 mg of felodipine.
The other ingredients are:
Silicon dioxide (anhydrous) (E551), yellow iron oxide (E172), hypromellose (E464), lactose
monohydrate, magnesium stearate (E572), microcrystalline cellulose (E460), povidone (E1201), propylene
glycol, propyl gallate (E310), red iron oxide (E172), talc (E553b) and titanium dioxide (E171).

Description of the appearance of Felodipine ratiopharm and contents of the pack
5 mg
Felodipine ratiopharm 5 mg prolonged-release tablets are round-shaped, light pink in colour and film-coated.
10 mg
Felodipine ratiopharm 10 mg prolonged-release tablets are round-shaped, reddish-brown in colour and film-coated.

14 prolonged-release tablets
28 prolonged-release tablets
30 prolonged-release tablets
50 prolonged-release tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder
ratiopharm GmbH Graf-Arco Strasse, 3 – 89079 Ulm, Germany

Manufacturer responsible for batch release
ratiopharm bv – Ronde Tocht 11, 1507 CC Zaandam – The Netherlands
Merckle GmbH Ludwig Merckle-Strasse 3 – 89143 Blaubeuren – Germany

This medicinal product is authorised in the European Economic Area countries with the following names:

5 mg
The Netherlands: Felodipine ratiopharm 5 mg, tabletten met gereguleerde afgifte
Italy: Felodipina ratiopharm 5 mg compresse a rilascio prolungato

10 mg
The Netherlands: Felodipine ratiopharm 10 mg, tabletten met gereguleerde afgifte
Italy: Felodipina ratiopharm 10 mg compresse a rilascio prolungato

This leaflet was last revised in July 2015