5 mg and 10 mg prolonged-release tablets are 
felodipine

What Felodipine Actavis is and what it is used for

Felodipine Actavis contains the active substance felodipine. It belongs to a group of medicines called calcium channel blockers. It lowers blood pressure by dilating the small blood vessels. It has no negative effect on the function of the heart.

Felodipine Actavis is used to treat high blood pressure ( hypertension ) and pain in the heart and chest caused by e.g. physical exertion or stress ( angina pectoris, or angina). Felodipine contained in Felodipine Actavis may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Felodipine Actavis

Do not take Felodipine Actavis

  • if you are pregnant. Tell your doctor as soon as possible if you become pregnant while taking this medicine.
  • if you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6).
  • if you have untreated heart failure
  • if you have an acute heart attack (heart attack)
  • if you have recent chest pain or angina that lasts for 15 minutes or more or is more severe than usual
  • if you have any disease of the heart valves or heart muscle before talking to your doctor.

Warnings and cautions

Felodipine Actavis, like other antihypertensive drugs, may in rare cases lead to a sharp drop in blood pressure, which in some patients may cause the heart to have an insufficient blood supply. Symptoms of very low blood pressure and insufficient blood supply to the heart itself often include dizziness and chest pain. If you get such symptoms, you should seek emergency care immediately.

Talk to your doctor before taking Felodipine Actavis, especially if you have liver problems.

When you take Felodipine Actavis you may get swollen gums. Good oral hygiene helps prevent the gums from swelling (see section 4).

Children

Felodipine Actavis is not recommended for use in children.

Other medicines and Felodipine Actavis

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Some medicines / herbal medicines may affect the treatment with Felodipine Actavis.

Examples of this are:

  • cimetidine (medicine for stomach ulcers )
  • erythromycin (medicines for infections )
  • itraconazole (antifungal)
  • ketoconazole ( antifungal )
  • medicines for HIV – infection (eg ritonavir, which is a protease inhibitor, or efavirenz, nevirapine)
  • phenytoin (medicine for epilepsy )
  • carbamazepine (medicine for epilepsy )
  • rifampicin (medicines for infections )
  • barbiturates (medicines for anxiety, sleep problems, and epilepsy )
  • tacrolimus (a medicine used in organ transplants).

Products containing St. John’s wort ( Hypericum perforatum ) (herbal remedy for depression) may reduce the effect of Felodipine Actavis and should therefore be avoided.

Felodipine Actavis with food and drink

Do not drink grapefruit juice while you are being treated with Felodipine Actavis, as this may increase the effect of Felodipine Actavis and the risk of side effects.

Pregnancy and breastfeeding

Pregnancy

Do not use Felodipine Actavis if you are pregnant.

Breast-feeding

Tell your doctor if you are breast-feeding or planning to start breast-feeding. Felodipine Actavis is not recommended for breastfeeding mothers and your doctor may choose another treatment for you if you want to start breast-feeding.

Driving and using machines

Felodipine Actavis may have a minor or moderate influence on your ability to drive and use machines. If you suffer from headaches, nausea, dizziness, or fatigue, your ability to react may be impaired. Caution is advised, especially at the beginning of treatment.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs, due to their effects and/or side effects. The description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Felodipine Actavis contains excipients

Felodipine Actavis contains lactose, which is sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Felodipine Actavis

Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

Felodipine Actavis prolonged-release tablets should be taken in the morning and swallowed with water. The tablets must not be split, crushed, or chewed. This medicine can be taken without food or after a light meal with a low fat and carbohydrate content.

High blood pressure

Treatment should be started with 5 mg once daily. If necessary, your doctor may increase the dose one or add another antihypertensive drug. The usual dose for long-term treatment is 5-10 mg once daily. For elderly patients, a starting dose of 2.5 mg per day may be considered.

Stable angina pectoris

Treatment should be started with 5 mg once daily. If necessary, your doctor may increase the dose from one to 10 mg once a day.

If you have liver problems

The concentration of felodipine in the blood may be increased. The doctor may reduce the dose one.

Elderly

Your doctor may start treatment with the lowest possible dose.

If you take more Felodipine Actavis then you should

If you have taken more doses of Felodipine Actavis than recommended, you may have very low blood pressure and sometimes palpitations, fast or in rare cases slower heart rate. Therefore, you must take the number of doses prescribed by your doctor. If you get symptoms such as feeling dizzy or dizzy, contact your doctor immediately.

If you forget to take Felodipine Actavis

If you forget to take a tablet, skip that dose altogether. Take the next dose at the right time.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Felodipine Actavis

If you stop taking the medicine, the disease may return. Contact your doctor and ask for advice before stopping Felodipine Actavis. Your doctor will tell you how long to take your medicine.

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happens to you, stop taking Felodipine Actavis immediately and tell your doctor:

  • Hypersensitivity reactions and allergic reactions. Signs of this may be raised streaks/swellings in the skin or swelling of the face, lips, mouth, tongue, or throat.

The following side effects have occurred. Most side effects occur at the beginning of treatment or after a dose increase. If such reactions occur, they are usually short-lived and subside over time. If you get any of the following symptoms and they do not go away, tell your doctor.

Mild gum swelling has been reported in patients with inflammation of the mouth (inflamed gums or tooth loss ). This swelling can be avoided or reduced by careful oral hygiene.

Very common: may affect more than 1 in 10 people

  • Swollen ankles.

Common: may affect up to 1 in 10 people

  • Headache
  • Blush.

Uncommon: may affect up to 1 in 100 people

  • Abnormally fast heart rate
  • Palpitation
  • For low blood pressure ( hypotension )
  • Nausea
  • Abdominal pain
  • Burning / stinging sensation, numbness
  • Skin rash or itching
  • Fatigue
  • Dizziness

Rare: may affect up to 1 in 1,000 people

  • Fainting
  • Vomiting
  • Hives
  • Joint pain
  • Muscle aches
  • Impotence / sexual dysfunction .

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

  • Gingivitis (swollen gums)
  • Elevated liver enzyme values
  • Skin reactions due to increased sensitivity to sunlight
  • Inflammation of small blood vessels in the skin
  • Frequent urination
  • Hypersensitivity reactions such as fever or swelling of the lips and tongue.

Other side effects may also occur. If you get any unpleasant or unusual reactions while taking Felodipine Actavis, talk to your doctor immediately.

Reporting of side effects is
if you get side effects are, speak with your doctor pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via the Medical Products Agency, Box 26, SE-751 03 Uppsala. Website: www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Felodipine Actavis

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 which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is felodipine.

One prolonged-release tablet Felodipine Actavis 5 mg contains 5 mg felodipine.

One prolonged-release tablet Felodipine Actavis 10 mg contains 10 mg felodipine.

Other ingredients are:

Microcrystalline cellulose, hypromellose, lactose monohydrate, povidone, propylene glycol, propyl gallate, magnesium stearate, colloidal anhydrous silica, talc, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).

What the medicine looks like and the contents of the pack

Felodipine Actavis 5 mg: light pink, round, biconvex, film-coated prolonged-release tablet marked 5 on one side.

Felodipine Actavis 10 mg: reddish-brown, round, biconvex film-coated prolonged-release tablet marked 10 on one side.

Felodipine Actavis 5 and 10 mg are available in pack sizes of 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 250, 500 and 1000 prolonged-release tablets .

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjordur

Iceland

Agent:

SanoSwiss UAB

Aukstaiciu str. 26A

LT-44169 Kaunas

Lithuania

+370 700 01320

info@sanoswiss.com

Content declaration

Muhammad Nadeem

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