Patient leaflet - Felogen XL 5 mg prolonged-release tablets
1. What Felogen XL is and what it is used for
Felogen XL contains felodipine, which belongs to a group of medicines called calcium antagonists. It lowers blood pressure by dilating small blood vessels. It does not negatively affect the heart function.
Felogen XL is used in the treatment of high blood pressure (hypertension) and heart and chest pain brought on by, for example, exercise or stress (angina pectoris).
2. What you need to know before you take Felogen XL
Do not take Felogen XL if:
- You are pregnant. You should tell your doctor as soon as possible if you become pregnant while taking this medicine
- You are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6)
- You suffer from uncompensated heart failure
- You have acute myocardial infarction (heart attack)
- You have chest pain of recent onset, or angina pectoris that is lasting for more than 15 minutes or longer, or is more severe than usual
- You have disease of a heart valve or heart muscle, until you have talked to your doctor.
Warnings and precautions
Felodipine, like other blood pressure-lowering medicines, may in rare cases lead to pronounced low blood pressure which in some patients may result in an inadequate blood supply to the heart muscles. Symptoms of excessive low blood pressure and inadequate blood supply to the heart itself frequently include dizziness and chest pain. If you experience these symptoms, seek emergency care immediately.
Talk to your doctor or pharmacist before taking Felogen XL, especially if you have problems with your liver
Taking felodipine may cause your gums to become swollen. Practice good oral hygiene to help prevent your gums from swelling (see section 4).
Children
The use of felodipine is not recommended in children.
Other medicines and Felogen XL
- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines or herbal remedies can affect treatment with felodipine. Examples are:cimetidine (medicine to treat stomach ulcers)
- erythromycin (medicine to treat bacterial infections)
- itraconazole or ketoconazole (medicines to treat fungal infections)
- medicines to treat HIV infection (such as ritonavir, efavirenz, nevirapine)
- phenytoin or carbamazepine (medicines to treat epilepsy)
- rifampicin (medicine to treat infections)
- barbiturates (medicine to treat anxiety, sleeping problems and epilepsy)
- tacrolimus (medicine used after organ transplants)
Medicines containing St John’s wort (Hypericum perforatum) (a herbal product used to treat depression) may reduce the effect of felodipine and should therefore be avoided
Felogen XL with food and drink
Do not drink grapefruit juice if you are taking this medicine, as this may increase the effect of Felogen XL and the risk of side effects.
Pregnancy and breast-feeding
Do not take Felogen XL if you are pregnant.
Tell your doctor if you are breast-feeding or are about to start breast-feeding. Felodipine is not recommended for mothers who are breast-feeding and your doctor may choose another treatment for you if you wish to breast-feed.
Driving and using machines
Felodipine can have minor or moderate influence on your ability to drive and use machines. If you experience headache, nausea, dizziness or fatigue your ability to react may be impaired. Caution is recommended especially at the start of treatment.
Important information about some of the ingredients of Felogen XL
This medicine contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Felogen XL
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Felogen XL prolonged-release tablets should be taken in the morning and be swallowed with water. The tablet must not be divided, crushed or chewed. This medicine can be taken without food or following a light meal not high in fat or carbohydrates (sugar).
Hypertension
Treatment should be started with 5 mg once a day. If necessary, your doctor may increase the dose or add another blood pressure-lowering medicine. The usual dose when treating this condition for a long time is 5-10 mg once a day. In elderly patients, a starting dose of 2.5 mg daily may be considered.
Stable angina pectoris
Treatment should be started with 5 mg once a day and, if needed, your doctor may increase the dose to 10 mg once a day.
If you have liver problems
The level of felodipine in your blood may be increased. Your doctor may lower the dose
Elderly people
Your doctor may initiate treatment with the lowest available dose.
If you take more Felogen XL than you should
If you take more than the recommended dose of Felogen XL you may suffer from very low blood pressure and sometimes palpitations, fast or, rarely, slow heart rate. Therefore, it is very important that you take the number of doses prescribed by your doctor. If you experience symptoms such as feeling faint, light-headedness or dizziness, contact your doctor immediately.
If you forget to take Felogen XL
If you forget to take a tablet, leave out that dose completely. Take your next dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Felogen XL
If you stop taking this medicine your condition may return. Please consult your doctor and seek advice before you stop taking Felogen XL. Your doctor will advise you how long to take your medicine.
If you have any further questions on 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 any of the following happen to you, stop taking Felogen XL and tell a doctor straight away:
- Chest pain and dizziness at the same time
- Hypersensitivity and allergic reactions: The signs may include raised lumps on your skin (weals) or swelling of your face, lips, mouth, tongue or throat
The following undesirable effects have been identified. Most of these reactions appear at the start of treatment or after a dose increase. Should such reactions occur, they are usually brief and diminish in intensity with time. If you experience any of the following symptoms and they persist, please tell your doctor.
Mild enlargement of the gums has been reported in patients with an inflammation in the mouth (gingivitis/periodontitis). The enlargement can be avoided or reversed by careful oral hygiene.
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 rapid heart rate
- Pounding heartbeat (palpitations)
- Low blood pressure (hypotension)
- Feeling sick (nausea)
- Stomach pain
- Feeling of burning, prickling or numbness
- Rash or itching
- Feeling tired
- Dizziness
Rare (may affect up to 1 in 1, 000 people)
- Fainting
- Being sick
- Nettle rash (hives)
- Pain in joints
- Pain in muscles
- Being unable to get 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
- A need to pass water (urine) frequently
Other undesirable effects may occur. If you have any bothersome or unusual reaction while taking this medicine, check with your doctor right away.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Felogen XL
Keep this medicine out of the sight and reach of children.
Do not store above 25ºC.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Felogen XL contains
The active substance is felodipine. Each tablet contains 5 mg or 10 mg felodipine.
The other ingredients are lactose monohydrate (see section 2, ‘Felogen XL contains lactose’, microcrystalline cellulose, hypromellose, povidone, propyl gallate, colloidal anhydrous silica, magnesium stearate, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), talc, macrogol.
What Felogen XL looks like and the contents of the pack
The 5 mg tablets are light pink, round, marked “5”. The 10 mg tablets are reddish-brown, round, marked “10”.
Felogen XL is available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Generics (UK) Limited
Station Close
Potters Bar
Hertfordshire
EN6 1TL
UK
Manufacturer
Mylan Hungary Kft, Mylan utca 1, Komarom, H-2900 Hungary.