5 mg, 10 mg prolonged-release tablet 
Felodipine

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

Felodipine Stada belongs to a group of medicines called 1,4-dihydropyridine derivatives/calcium channel blockers. These drugs relax the muscles in the blood vessel walls and dilate the blood vessels. This in turn lowers blood pressure.

Felodipine Stada is used to treat patients with high blood pressure ( essential hypertension ).

Felodipine contained in Felodipine Stada may also be approved for the treatment of other conditions not mentioned in this product information. 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 STADA

Do not take Felodipine STADA if you

  • is allergic to felodipine, other similar substances (calcium channel blockers of the type 1,4-dihydropyridine derivative), or any of the other ingredients of this medicine (listed in section 6)
  • has very low heart rate and low blood pressure ( cardiogenic shock )
  • has severe narrowing ( stenosis ) of the heart valves (mitral valve or aortic valve)
  • has enlarged heart muscle (obstructive hypertrophic cardiomyopathy )
  • has a significant obstruction in the heart valve
  • has an obstruction in the outflow from the heart
  • gets chest pain (unstable angina)
  • has had a heart attack in the last two months
  • have untreated and/or decompensated heart failure that causes swelling of the arms and legs, weakness, and shortness of breath
  • if you have severe hepatic impairment
  • if you are or think you may be pregnant.

Warnings and cautions

Talk to your doctor or pharmacist before taking Felodipine Stada

  • have severe renal impairment
  • have mild to moderate hepatic impairment
  • have stable heart failure
  • has a fast pulse ( tachycardia )
  • have constriction ( stenosis ) of the heart valves (mitral valve or aortic valve)
  • have disorders of the heart conduction system (eg 2nd or 3rd-degree atrioventricular block)

Felodipine can cause a sharp drop in blood pressure that results in a rapid pulse ( tachycardia ). This can lead to impaired blood supply (myocardial ischemia ) or stroke in sensitive patients.

Other medicines and Felodipine STADA

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

Particularly:

  • other antihypertensive drugs such as hydrochlorothiazide, beta-blockers (to treat high blood pressure ), nitrates (to treat coronary heart disease and chest pain), or tricyclic antidepressants (to treat depression)
  • amiodarone, diltiazem, or verapamil (for treating heart problems)
  • digoxin (to treat heart failure )
  • fluconazole , itraconazole, ketoconazole , miconazole , or voriconazole (to treat fungal or yeast infections)
  • erythromycin, clarithromycin, or telithromycin (macrolide antibiotics)
  • rifampicin (to treat tuberculosis )
  • ciclosporin, tacrolimus (to inhibit the immune system, eg after an organ transplant)
  • phenobarbital, phenytoin, or carbamazepine (to treat epilepsy )
  • cimetidine (to treat heartburn or stomach ulcers )
  • nevirapine, ritonavir, saquinavir, efavirenz (to treat HIV – infection )
  • an herbal medicine containing St. John’s wort (Hypericum perforatum).

Felodipine STADA with food and drink

Take Felodipine Stada on an empty stomach or after a light meal, which does not have a high content of fat or carbohydrates.

Do not drink grapefruit juice during treatment with Felodipine Stada as in some cases it may enhance the effect of the tablets. Contact your doctor if you have any further questions.

Pregnancy and breastfeeding

Pregnancy

Felodipine should not be taken throughout pregnancy. If you think you are pregnant, planning to become pregnant, or become pregnant while taking Felodipine Stada, stop taking the medicine immediately and contact your doctor as soon as possible.

Breast-feeding

Felodipine is excreted in human milk and therefore the use of Felodipine Stada during breast-feeding is not recommended. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Felodipine Stada may cause dizziness and fatigue. These effects usually occur at the beginning of treatment, after dose increases, or after concomitant consumption of alcohol. If you feel affected, do not drive or use machines.

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 STADA contains lactose

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 STADA

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

Patients with high blood pressure ( hypertension )

AdultsInitially, 5 mg once daily. If necessary, your doctor may increase your dose to one to 10 mg daily or prescribe additional medicines to lower your blood pressure. The maximum dose is 10 mg felodipine daily.

Elderly: Your doctor will decide on your starting dose.

Children: Not recommended.

Impaired kidney and/or liver function

Patients with severe liver problems should not take Felodipine Stada and patients with severe kidney problems should not take Felodipine Stada.

If you have liver disease, your doctor will monitor your condition and possibly prescribe a lower dose.

Method of administration

  • Swallow the tablets whole at the same time each day (preferably in the morning) together with a glass of water. Do not split or crush them.
  • DO NOT take grapefruit juice tablets as it may enhance the effect of Felodipine Stada.
  • Take the tablets on an empty stomach or with a light meal, which does not have a high content of fat or carbohydrates.
  • Take the tablets as long as your doctor has told you to. It can be dangerous to stop treatment without asking your doctor.

If you take more Felodipine STADA then you should

Do not take more tablets than your doctor has told you to do. If you take more tablets than you should, go to the nearest emergency room or contact your doctor immediately. Bring the pack and remaining tablets to see your doctor. Overdose can lead to intoxication, fainting, and dizziness caused by very low blood pressure and sometimes low heart rate ( bradycardia ).

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Felodipine STADA

If you forget to take a dose, take it as soon as you remember. Then continue as usual. Do not take a double dose to make up for a forgotten dose. If you have any further questions, ask your doctor or pharmacist.

If you stop taking Felodipine STADA

Do not stop treatment too soon as felodipine may cause withdrawal symptoms. If you stop taking the tablets too quickly, you may develop high blood pressure again. Talk to your doctor before stopping taking the tablets and follow your doctor’s advice.

4. Possible side effects

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

Stop taking Felodipine Stada and contact your doctor if you get an allergic reaction such as swelling of the face, lips, tongue, mouth, and throat which may cause difficulty breathing and difficulty swallowing.

Tell your doctor if you get any of the following side effects:

Very common (may affect more than 1 user in 10)

  • headache
  • tinnitus (ringing sounds or ringing in the ears)
  • hot flashes

These side effects occur mainly at the start of treatment or after dose increases and decrease with continued use. swelling of the arms and legs (especially the ankles, the degree of swelling in the ankles is dose-dependent).

Common (may affect up to 1 in 10 people)

  • chest pain (angina) or aggravated (more often, duration, severity) chest pain in patients who already have angina. This usually occurs at the beginning of treatment.

Uncommon (may affect up to 1 in 100 people)

  • numbness and tingling ( paresthesias )
  • dizziness
  • fatigue
  • restlessness
  • palpitation
  • increased heart rate ( tachycardia )
  • very low blood pressure ( hypotension )
  • fainting ( syncope )
  • shortness of breath ( dyspnoea )
  • gastrointestinal disorders (eg stomach pain)
  • nausea or vomiting
  • diarrhea
  • constipation
  • skin and hypersensitivity reactions such as itching ( pruritus ), hives ( urticaria ), rash (exanthema), hypersensitivity to sunlight ( photosensitivity )
  • increased sweating
  • swelling and inflammation of the gums ( gingivitis )
  • joint or muscle pain ( myalgia and arthralgia )
  • shaking
  • increased need to urinate (pollakiuria)
  • weight gain.

Rare (may affect up to 1 in 1,000 people)

  • palpable, often painful purple discoloration of the skin (leukocytoclastic vasculitis )
  • impotence / sexual dysfunction .

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

  • heart attack (myocardial infarction)
  • liver function problems that manifest themselves in increased liver enzymes e.g. transaminase levels in blood samples
  • scaly skin reactions (exfoliative dermatitis )
  • breast growth in men ( gynecomastia )
  • heavy menstruation ( menorrhagia )
  • a hypersensitivity reaction is e.g. angioedema (a severe allergic reaction that causes swelling of the face or throat), and fever.

5. How to store Felodipine STADA

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 carton after EXP. The expiration date is the last day of the specified 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. Other information

Content declaration

The active substance is felodipine.

Each 5 mg film-coated tablet contains 5 mg felodipine.

Each 10 mg film-coated tablet contains 10 mg felodipine.

Other ingredients are:

  • Lactose monohydrate (5 mg tablet contains 22.75 mg lactose; 10 mg tablet contains 20.38 mg lactose )
  • microcrystalline cellulose
  • hypromellose
  • povidone
  • propyl gallate
  • colloidal anhydrous silica
  • magnesium stearate.

Other content topics in the film coating are:

  • hypromellose titanium dioxide (E171)
  • red and yellow iron oxide (E172)
  • talc
  • propylene glycol.

What the medicine looks like and the contents of the pack

Felodipine Stada 5 mg: light pink, round, biconvex, film-coated prolonged-release tablets marked with 5.

Felodipine Stada 10 mg: reddish-brown, round, biconvex, film-coated prolonged-release tablets are marked with 10.

Blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 120, 250, 500 and 1000 prolonged-release tablets .

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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