5 mg, 10 mg prolonged-release tablet is 
felodipine

What Felodipine Hexal is and what it is used for

Felodipine Hexal 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 Hexal 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 Hexal may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Felodipine Hexal 

Do not take Felodipine Hexal

  • if you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6)
  • 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 untreated heart failure
  • if you have any disease of the heart valves or myocardial infarction, before talking to your doctor
  • if you are pregnant. Tell your doctor as soon as possible if you become pregnant while taking this medicine.

Warnings and cautions

Felodipine Hexal, 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 Hexal, especially if you have liver problems.

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

Children

Felodipine Hexal is not recommended for use in children. 

Other medicines and Felodipine Hexal

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines / herbal medicines may affect the treatment with Felodipine Hexal.

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 Hexal and should therefore be avoided. 

Felodipine Hexal with food and drink 

Do not drink grapefruit juice when treated with Felodipine Hexal, as it may increase the effect of Felodipine

Hexal and the risk of side effects.

Pregnancy and breastfeeding 

Pregnancy

Do not use Felodipine Hexal if you are pregnant.

Breast-feeding

Tell your doctor if you are breast-feeding or planning to start breast-feeding. Felodipine Hexal 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 Hexal may have a minor or moderate effect 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 sharpened attention. 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. Descriptions 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 Hexal contains sodium and lactose

This medicine contains less than 1 mmol (23 mg) sodium per prolonged-release tablet, it is essentially ‘sodium-free’.

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 take Felodipine Hexal 

Always take this medicine exactly as your doctor or pharmacist has told you.

Ask your doctor or pharmacist if you are unsure.

Felodipine Hexal 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.

For a dose of 2.5 mg, a drug of suitable strength should be used.

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.

Older people

Your doctor may start treatment with the lowest possible dose.

If you take more Felodipine Hexal then you should

If you have ingested too much medicine or if e.g. a child inhaled the medicine accidentally contact a doctor,

hospital or the Poison Information Center for risk assessment and counseling.

If you have taken more doses of Felodipine Hexal 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 Hexal 

If you forget to take a tablet, skip that dose altogether. Take the next dose at the right time. Do not take

double dose to compensate for a missed dose.

If you stop taking Felodipine Hexal 

If you stop taking the medicine, the disease may return. Contact your doctor and ask for advice before stopping Felodipine Hexal. 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 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 happens to you, stop taking Felodipine Hexal immediately and tell a 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 user in 10

  • Swollen ankles.

Common: may affect up to 1 in 10 users

  • 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 users

  • 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 troublesome or unusual reactions while taking Felodipine Hexal, talk to your doctor immediately.

5. How to store Felodipine Hexal

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister, can, and carton after EXP or EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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. Felodipine Hexal 5 mg prolonged-release tablet each prolonged-release tablet contains 5 mg felodipine.
    Felodipine Hexal 10 mg prolonged-release tablet each prolonged-release tablet contains 10 mg felodipine.
  • The other ingredients are microcrystalline cellulose, lactose monohydrate, sodium laurilsulfate, hypromellose, magnesium stearate in the tablet core; lactose monohydrate, hypromellose, macrogol 4000, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171) in the film coating.

What the medicine looks like and the contents of the pack

Felodipine Hexal 5 mg prolonged-release tablet is

Light red to gray red, round, biconvex prolonged-release tablet, approximately 7 mm in diameter, marked ‘F5’

on the one hand.

Felodipine Hexal 10 mg prolonged-release tablet is

Light red to gray red, round, biconvex prolonged-release tablet, approximately 9 mm in diameter, marked

‘F10’ on one side.

The prolonged-release tablets are packed in PVC / Al blister or an HDPE jar and placed in cardboard.

Pack sizes:

7, 14, 20, 28, 30, 50, 50×1, 98, 100, 100×1, 250 prolonged-release tablets are.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder 

HEXAL A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany

Muhammad Nadeem

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