PATIENT INFORMATION LEAFLET

Felotens XL 5 mg and 10 mg Prolonged Release Tablets

(Felodipine)

Please read this leaflet carefully before you start to take your medicine. Don’t throw this leaflet away; you might want to read it again while you are taking Felotens XL Prolonged Release Tablets.

This leaflet does not contain all the information about felodipine.

So, if you have any questions or are not sure about anything, please ask your doctor or pharmacist.

Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give this medicine to anyone else. It may harm them even if they have the same symptoms as you.

The name of your medicine is Felotens XL Prolonged Release Tablets.

The active ingredient in Felotens XL Prolonged Release Tablets is felodipine. The tablets come in two strengths:

• Felotens XL 5 mg Prolonged Release Tablets: Each tablet contains felodipine 5 mg.
• Felotens XL 10 mg Prolonged Release Tablets: Each tablet contains felodipine 10 mg.

The other ingredients are lactose monohydrate, microcrystalline cellulose, hypromellose, povidone, propyl gallate, colloidal anhydrous silica, magnesium stearate, ferric oxide (E172), titanium dioxide (E171), talc and propylene glycol.

Felotens XL Prolonged Release Tablets are film coated and release felodipine slowly in the body (prolonged release).

Felotens XL 5 mg Prolonged Release Tablets are light pink with imprint 5 and Felotens XL 10 mg Prolonged Release Tablets are reddish brown with imprint 10.

They come in packs of 30 tablets.

Felotens XL Prolonged Release Tablets are only available from your pharmacist with a prescription from your doctor.

What is this medicine for?

Felodipine belongs to a group of medicines called dihydropyridine calcium antagonists. It is used to treat high blood pressure and prevent attacks of angina.

How Does Your Medicine Work?

Calcium antagonists work by blocking the entry of calcium into muscle cells. Felodipine affects the muscle in blood vessels more than other muscles. It causes a relaxation of the muscle and a widening of the blood vessels. As the blood vessels get wider, blood pressure falls and the heart does not need to work so hard to pump blood around the body, reducing the risk of angina.

Before taking Felotens XL Prolonged Release Tablets for the first time

If you answer YES to any of the following questions, or are not sure, talk to your doctor before taking this medicine;

• Have you ever had a reaction to felodipine, dihydropyridine calcium antagonists or any of the other ingredients of the tablets? Check by reading the list of ingredients above.
• Have you had, or been told that you have, any of the following conditions of the heart or circulation:
  • failure of the circulation (cardiogenic shock),
  • unstable angina pectoris,
  • heart attack (myocardial infarction – within the last 4 weeks),
  • problems with the chambers of and vessels leaving the heart such as aortic stenosis or severe left ventricular dysfunction?
• Do you have any liver disease?
• Are you or could you be pregnant?
• Are you breast-feeding?

Advice When Taking Felotens XL Prolonged Release Tablets

The following advice may be helpful when you are taking Felotens XL Prolonged Release Tablets:

 

• Felotens XL Prolonged Release Tablets should not affect your ability to drive. However, if you feel light-headed or dizzy, do not drive and check with your doctor.
• If you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking Felotens XL Prolonged Release Tablets. This is especially important if you are likely to have an anaesthetic or an operation.
• Tell your pharmacist that you are taking Felotens XL Prolonged Release Tablets before buying any medicines.
• Moderate amounts of alcohol will not affect Felotens XL Prolonged Release Tablets. However, check with your doctor whether drinking is advisable for you.
• As you start to feel better, you may try to do too much and feel faint, especially in hot weather. Discuss with your doctor a safe level of exercise for you.

How to Take Your Medicine

Felotens XL Prolonged Release Tablets should be taken by mouth.

• Always read the label before taking any medicine.
• Felotens XL Prolonged Release Tablets should be swallowed whole, not crushed or chewed, with some liquid (e.g. a glass of water, but not grapefruit juice).
• The tablets should be taken regularly in the morning without food or with a light meal.

High blood pressure:

The normal starting dose is 5 mg once daily. The dose will be adjusted by your doctor to give you the best response.

The usual maintenance dose is 5–10 mg daily; though a higher dose of 20 mg daily may be appropriate for some patients.

Angina:

The normal starting dose is 5 mg once daily. The dose may be increased by your doctor to 10 mg daily if necessary.

• Always follow your doctor’s instructions. Do not alter the dose or stop taking Felotens XL Prolonged Release Tablets unless your doctor has told you to. Sudden stoppage may be harmful.
• If you are elderly, your doctor may start you on the lowest dose of one 2.5 mg tablet daily.
• Keep your doctors appointments, even if you feel well.
• If you forget to take a dose do not worry. Take your normal dose when it is due, but never take two doses at the same time to catch up.
• If you or anyone else accidentally takes an overdose of Felotens XL Prolonged Release Tablets, contact your nearest hospital casualty department or your doctor immediately. Take the container and any remaining tablets with you if you go to the hospital. If the person has fainted, lay them down and raise their feet higher than their head.

Are There Any Undesirable Effects To This Medicine?

Like many medicines, Felotens XL Prolonged Release Tablets may occasionally cause some unwanted effects. These are usually mild and occur when you start taking your medicine, then go away as treatment continues.

The most commonly reported unwanted effects are flushing, headache, palpitations, dizziness and fatigue. These reactions usually go away and are most likely to occur at the start of treatment or after an increase in dosage.

Swollen ankles have been reported – the symptoms are worse at higher doses.

Patients with gingivitis/periodontitis (inflammation of the mouth and gums) have reported mild gum swelling. Careful dental hygiene can avoid or treat this.

There have been occasional reports of angina or a worsening of angina, usually after starting therapy. This is more likely in patients who have had a heart attack.

The following unwanted effects have been reported, however it is not confirmed that they were caused by treatment with felodipine:

• Skin: rarely rash and/or itching, isolated cases of sensitivity to light.
• Muscles and bones: isolated cases of muscle and joint pain.
• Nervous system: isolated cases of numbness and tingling.
• Gastrointestinal: isolated cases of nausea, growth of gum cells.
• Liver: isolated cases of increased liver enzymes.
• Heart: rarely – fast heartbeat and fainting.
• Circulation: water retention.
• Other: isolated cases of allergic reactions e.g. of the skin – swelling and hives.

Tell your doctor or pharmacist if you experience these or any other troublesome side effects.

Further Information

Do not use Felotens XL Prolonged Release Tablets after the expiry or “use by” date shown on the container.

• Always keep your medicine in a safe place out of reach of children, preferably in a locked cupboard.
• Do not store above 25°C. Store in the original package.
• When your doctor tells you that you can stop taking Felotens XL Prolonged Release Tablets, we suggest that you return any unused medicine to your pharmacist for safe disposal.

Further information is available from your doctor and pharmacist.