Felodipin Omet Pharma (Felodipine)
Extended-release calcium channel blocker for hypertension and angina pectoris
Quick Facts About Felodipin Omet Pharma
Key Takeaways
- Felodipine is a calcium channel blocker that lowers blood pressure by relaxing blood vessel walls, without negative effects on heart function.
- Extended-release tablets must be swallowed whole — never crush, split, or chew them, as this could cause a dangerous dose release.
- Grapefruit juice must be completely avoided during treatment, as it can increase felodipine blood levels by up to 300%.
- The most common side effect is ankle swelling (peripheral edema), which tends to diminish over time with continued treatment.
- Felodipine is contraindicated during pregnancy and should not be used by patients with untreated heart failure or acute myocardial infarction.
What Is Felodipin Omet Pharma and What Is It Used For?
Quick Answer: Felodipin Omet Pharma is a prescription calcium channel blocker containing felodipine. It treats high blood pressure (hypertension) and stable angina pectoris by relaxing blood vessel walls, improving blood flow and reducing cardiac workload.
Felodipin Omet Pharma belongs to the dihydropyridine class of calcium channel blockers (CCBs), one of the most widely prescribed groups of antihypertensive medications worldwide. The active ingredient, felodipine, works by selectively blocking L-type calcium channels in vascular smooth muscle cells. This prevents calcium ions from entering the muscle cells, which in turn relaxes the blood vessel walls and reduces peripheral vascular resistance. The net effect is a significant reduction in blood pressure without negatively impacting the heart's pumping ability.
Unlike some other calcium channel blockers (such as verapamil or diltiazem), felodipine has high vascular selectivity. This means it primarily acts on blood vessels rather than the heart muscle, making it particularly well-suited for patients who need blood pressure reduction without changes to heart rate or cardiac output. Clinical studies have consistently demonstrated that felodipine effectively reduces both systolic and diastolic blood pressure across diverse patient populations, including elderly patients and those with diabetes.
The medication is used to treat two primary conditions. Hypertension (high blood pressure) is the most common indication, where felodipine helps prevent the long-term cardiovascular complications of sustained elevated blood pressure, including stroke, heart attack, heart failure, and kidney disease. The European Society of Hypertension (ESH) and the European Society of Cardiology (ESC) both recognize calcium channel blockers as first-line treatments for hypertension. Stable angina pectoris is the second indication, where the vasodilatory effect of felodipine improves coronary blood flow and reduces the heart's oxygen demand, thereby alleviating chest pain caused by physical exertion or emotional stress.
The extended-release formulation of Felodipin Omet Pharma is designed to provide a controlled, gradual release of felodipine over a 24-hour period. This ensures consistent blood pressure control throughout the day and night, reducing the peak-to-trough variability that can occur with immediate-release formulations. The sustained-release mechanism also helps minimize side effects by avoiding high peak drug concentrations in the blood.
How Does Felodipine Work?
Calcium plays a central role in muscle contraction, including the smooth muscle that lines blood vessel walls. When calcium ions flow into smooth muscle cells through L-type calcium channels, the muscle contracts, narrowing the blood vessel and increasing blood pressure. Felodipine blocks these calcium channels, preventing the calcium influx and allowing the blood vessels to remain relaxed and dilated.
The dihydropyridine class, to which felodipine belongs, is characterized by its preferential action on vascular smooth muscle over cardiac muscle. This vascular selectivity ratio is among the highest in its class, meaning felodipine lowers blood pressure effectively while having minimal direct effects on the heart's electrical conduction system or contractile force. In practical terms, this translates to effective blood pressure lowering with a low risk of bradycardia (slow heart rate) or reduced cardiac output.
After oral administration, felodipine is almost completely absorbed from the gastrointestinal tract, but undergoes extensive first-pass metabolism in the liver, resulting in a bioavailability of approximately 15%. The drug is primarily metabolized by the CYP3A4 enzyme system, which is clinically relevant because many other drugs and foods (notably grapefruit juice) can inhibit this enzyme, leading to significant drug interactions.
What Should You Know Before Taking Felodipin Omet Pharma?
Quick Answer: Do not take felodipine if you are pregnant, have untreated heart failure, are experiencing a heart attack, or are allergic to the active substance. Tell your doctor about all other medications you take, as many drugs interact with felodipine.
Contraindications
Felodipine is contraindicated (must not be used) in several specific situations. Understanding these contraindications is essential for safe use. You must not take Felodipin Omet Pharma in the following circumstances:
- You are pregnant — Felodipine has shown reproductive toxicity in animal studies and is contraindicated during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
- You are allergic to felodipine or any of the other ingredients in the tablet (see the Composition section below for a full list).
- You have untreated heart failure — Felodipine should not be used in patients with decompensated heart failure, as the vasodilatory effects may worsen the condition.
- You are having a heart attack (acute myocardial infarction) — Starting felodipine during an acute cardiac event is dangerous.
- You have new-onset or worsening angina — Unstable angina (chest pain lasting more than 15 minutes, occurring at rest, or more severe than usual) requires immediate medical evaluation, not oral antihypertensive treatment.
- You have significant heart valve disease or cardiomyopathy — Discuss with your doctor before starting felodipine if you have any structural heart disease.
Warnings and Precautions
Like all antihypertensive medications, felodipine can occasionally cause an excessive drop in blood pressure (hypotension). In rare cases, this can reduce blood flow to the heart itself, causing symptoms such as dizziness, lightheadedness, or chest pain. If you experience these symptoms, seek medical attention immediately. The risk of hypotension is higher at the start of treatment, after dose increases, or in patients who are also taking other blood pressure-lowering medications.
If you have liver problems, tell your doctor before starting felodipine. The drug is extensively metabolized in the liver, and impaired liver function can lead to elevated blood levels of felodipine, increasing the risk of side effects. Your doctor may need to prescribe a lower dose or choose an alternative medication.
Some patients taking felodipine develop gingival hyperplasia (swelling of the gums), particularly those with pre-existing gum inflammation or periodontal disease. Maintaining good oral hygiene, including regular brushing, flossing, and dental check-ups, can help prevent or minimize this side effect.
Use in children: Felodipin Omet Pharma is not recommended for use in children, as safety and efficacy have not been established in pediatric patients.
Pregnancy and Breastfeeding
Pregnancy: Felodipine must not be used during pregnancy. Animal reproduction studies have demonstrated adverse effects, and the potential risk to a human fetus is considered significant. If you are planning to become pregnant or discover that you are pregnant while taking felodipine, contact your doctor immediately. They will switch you to an antihypertensive medication with an established safety profile in pregnancy, such as labetalol, nifedipine (in its immediate-release form for acute use), or methyldopa.
Breastfeeding: Felodipine is not recommended during breastfeeding. While the exact extent of excretion into human breast milk is not fully characterized, your doctor may choose an alternative treatment if you wish to breastfeed. Do not stop taking your blood pressure medication without medical advice, as uncontrolled hypertension also poses risks.
Driving and Operating Machinery
Felodipine may have a mild to moderate effect on your ability to drive or operate machinery. Side effects such as headache, dizziness, nausea, or fatigue can impair your reaction time, particularly at the start of treatment or after a dose adjustment. Exercise caution until you know how the medication affects you. If you feel dizzy or unwell, do not drive or operate heavy machinery.
Important Information About Excipients
Felodipin Omet Pharma tablets contain lactose (a milk sugar). If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. The tablets also contain castor oil, which may cause stomach upset and diarrhea in some individuals.
How Does Felodipin Omet Pharma Interact with Other Drugs?
Quick Answer: Felodipine interacts with many medications, primarily through the CYP3A4 liver enzyme. CYP3A4 inhibitors (such as erythromycin, ketoconazole, and HIV protease inhibitors) increase felodipine levels, while CYP3A4 inducers (such as phenytoin, carbamazepine, and rifampicin) decrease them. Grapefruit juice is strictly contraindicated.
Felodipine is metabolized primarily by the cytochrome P450 3A4 (CYP3A4) enzyme in the liver and intestinal wall. Any substance that inhibits or induces this enzyme can significantly alter the blood levels of felodipine, potentially leading to increased side effects or reduced therapeutic efficacy. Always inform your doctor or pharmacist about all medications, herbal products, and supplements you are taking.
Major Interactions (Avoid Combination or Use with Caution)
| Drug / Substance | Category | Effect on Felodipine | Clinical Significance |
|---|---|---|---|
| Itraconazole | Antifungal | Increases felodipine levels (CYP3A4 inhibitor) | Risk of severe hypotension; avoid combination |
| Ketoconazole | Antifungal | Increases felodipine levels (CYP3A4 inhibitor) | Risk of severe hypotension; avoid combination |
| Ritonavir | HIV protease inhibitor | Markedly increases felodipine levels | Potentially dangerous hypotension; avoid or adjust dose |
| Erythromycin | Macrolide antibiotic | Increases felodipine levels (CYP3A4 inhibitor) | Monitor blood pressure closely; dose reduction may be needed |
| Rifampicin | Anti-tuberculosis | Dramatically decreases felodipine levels (CYP3A4 inducer) | May render felodipine ineffective; alternative treatment needed |
| Phenytoin | Anti-epileptic | Decreases felodipine levels (CYP3A4 inducer) | Reduced antihypertensive effect; dose adjustment needed |
| Carbamazepine | Anti-epileptic | Decreases felodipine levels (CYP3A4 inducer) | Reduced antihypertensive effect; dose adjustment needed |
| Grapefruit juice | Food interaction | Increases felodipine levels up to 300% | Strictly contraindicated; avoid all grapefruit products |
Other Notable Interactions
| Drug / Substance | Category | Effect |
|---|---|---|
| Cimetidine | H2 receptor antagonist (antacid) | Mild increase in felodipine levels; monitor blood pressure |
| Tacrolimus | Immunosuppressant | Felodipine may increase tacrolimus levels; monitor drug levels |
| Barbiturates | Sedatives / anti-epileptics | Decrease felodipine levels (CYP3A4 induction) |
| Efavirenz / Nevirapine | HIV antiretrovirals (NNRTIs) | May decrease felodipine levels (CYP3A4 induction) |
| St. John's Wort | Herbal supplement | Decreases felodipine levels; avoid combination |
The interaction between felodipine and grapefruit juice deserves special emphasis. Grapefruit contains furanocoumarins that irreversibly inhibit intestinal CYP3A4, the enzyme responsible for breaking down felodipine during absorption. Even a single glass of grapefruit juice can increase felodipine plasma concentrations by approximately 200-300%, dramatically amplifying both its blood pressure-lowering effect and side effects. This interaction can last for up to 24 hours after consuming grapefruit. Other citrus fruits, such as oranges and lemons, do not have this effect and are safe to consume.
St. John's Wort (Hypericum perforatum), a popular herbal remedy for mild depression, is a potent inducer of CYP3A4 and can significantly reduce the effectiveness of felodipine. If you are taking St. John's Wort, inform your doctor, as an alternative antidepressant or antihypertensive may be needed.
What Is the Correct Dosage of Felodipin Omet Pharma?
Quick Answer: The typical starting dose for adults is 5 mg once daily in the morning. The maintenance dose ranges from 5 mg to 10 mg daily. Elderly patients may start at 2.5 mg daily. The tablet must be swallowed whole with water and should not be crushed, split, or chewed.
Adults — Hypertension
Hypertension (High Blood Pressure)
Starting dose: 5 mg once daily, taken in the morning.
Maintenance dose: 5–10 mg once daily, adjusted based on blood pressure response.
If needed, your doctor may increase the dose or add another antihypertensive medication. The dose should be adjusted at intervals of no less than 2 weeks.
Stable Angina Pectoris
Starting dose: 5 mg once daily.
Maximum dose: 10 mg once daily, if clinically required.
Your doctor will assess your response and adjust the dose accordingly.
Elderly Patients
Elderly patients may be more sensitive to the blood pressure-lowering effects of felodipine. A lower starting dose of 2.5 mg once daily may be considered. Your doctor will titrate the dose gradually based on your individual response and tolerance.
Patients with Liver Problems
Since felodipine is extensively metabolized in the liver, patients with hepatic impairment may experience elevated blood levels of the drug. Your doctor may prescribe a reduced dose and will monitor your blood pressure and any side effects more closely.
Children
Felodipin Omet Pharma is not recommended for children. Safety and efficacy have not been established in pediatric populations.
| Patient Group | Starting Dose | Usual Maintenance Dose | Maximum Dose |
|---|---|---|---|
| Adults (Hypertension) | 5 mg once daily | 5–10 mg once daily | 10 mg/day |
| Adults (Angina) | 5 mg once daily | 5–10 mg once daily | 10 mg/day |
| Elderly | 2.5 mg once daily | 2.5–5 mg once daily | 10 mg/day |
| Hepatic Impairment | Reduced (per physician) | Individually adjusted | Per physician |
| Children | Not recommended | Not recommended | Not recommended |
- Take the tablet in the morning, at approximately the same time each day.
- Swallow the tablet whole with water.
- Do not split, crush, or chew the tablet — this would destroy the extended-release mechanism.
- The tablet can be taken without food or after a light meal (low in fat and carbohydrates).
- Do not take the tablet with grapefruit juice.
Missed Dose
If you forget to take a dose, skip it entirely and take your next dose at the usual time. Do not take a double dose to make up for a missed one. Taking two doses close together could cause an excessive drop in blood pressure.
Overdose
If you take more felodipine than prescribed, you may experience symptoms of severe hypotension, including dizziness, lightheadedness, fainting, and rapid heartbeat (tachycardia). In rare cases, an excessively slow heart rate (bradycardia) may occur. If you suspect an overdose, or if a child has accidentally ingested the medication, contact your local poison control center or emergency medical services immediately. Treatment is supportive and may include intravenous fluids, vasopressors, and cardiac monitoring.
Stopping Treatment
Do not stop taking Felodipin Omet Pharma without consulting your doctor. Abruptly discontinuing antihypertensive medication can cause your blood pressure to rise again, potentially leading to cardiovascular complications. Your doctor will advise you on how long to continue treatment and, if necessary, will gradually reduce your dose before stopping.
What Are the Side Effects of Felodipin Omet Pharma?
Quick Answer: The most common side effect is ankle swelling (edema), affecting more than 1 in 10 users. Headache and facial flushing are also common. Most side effects occur at the start of treatment and tend to diminish over time. Seek immediate medical attention if you experience signs of a severe allergic reaction.
Like all medicines, felodipine can cause side effects, although not everybody gets them. Most side effects are mild, occur during the initial phase of treatment or after a dose increase, and tend to subside as your body adjusts to the medication. However, some side effects require prompt medical attention.
You experience signs of a severe allergic reaction (hypersensitivity), including raised welts or swelling of the skin, or swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty breathing or swallowing.
Mild gingival swelling (gum overgrowth) has been reported in patients with pre-existing inflammation of the gums (gingivitis or periodontitis). This side effect can be prevented or reduced through careful oral hygiene, including regular brushing and dental check-ups.
Very Common
Affects more than 1 in 10 people
- Peripheral edema (ankle swelling)
Common
Affects up to 1 in 10 people
- Headache
- Facial flushing (redness)
Uncommon
Affects up to 1 in 100 people
- Tachycardia (abnormally fast heart rate)
- Palpitations (feeling of heart pounding)
- Hypotension (low blood pressure)
- Nausea
- Abdominal pain
- Paresthesia (tingling, burning, or numbness)
- Skin rash or itching (pruritus)
- Fatigue
- Dizziness
Rare
Affects up to 1 in 1,000 people
- Syncope (fainting)
- Vomiting
- Urticaria (hives)
- Arthralgia (joint pain)
- Myalgia (muscle pain)
- Sexual dysfunction / impotence
Very Rare
Affects up to 1 in 10,000 people
- Gingival hyperplasia (gum overgrowth)
- Elevated liver enzymes
- Photosensitivity reactions (increased sensitivity to sunlight)
- Leukocytoclastic vasculitis (inflammation of small blood vessels in the skin)
- Urinary frequency
- Hypersensitivity reactions including fever and swelling of lips and tongue
The peripheral edema (ankle swelling) seen with felodipine is caused by the vasodilatory effect of the drug on precapillary arterioles. It is a pharmacological effect rather than a sign of heart failure. This type of edema is dose-dependent, meaning it is more common at higher doses, and may be reduced by adding an ACE inhibitor or ARB, which dilates the post-capillary venules and reduces the capillary pressure gradient.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this information. You can also report side effects directly to your national medicines regulatory authority. By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Felodipin Omet Pharma?
Quick Answer: Store at room temperature, out of sight and reach of children. Check the expiration date on the packaging and do not use the medication after it has expired. Do not use the medication if the packaging is damaged.
Proper storage of medication is essential to ensure that it remains effective and safe to use. Follow these guidelines for storing Felodipin Omet Pharma:
- Keep out of the sight and reach of children. Store the medication in a location where children cannot access it.
- Check the expiration date printed on the carton, blister pack, or bottle (after "EXP"). The expiration date refers to the last day of the indicated month. Do not use the medication after this date.
- Do not use if the packaging appears to be opened or damaged.
- Proper disposal: Do not dispose of medications in household waste or down the drain. Return unused or expired medications to your pharmacist for safe disposal. This helps protect the environment.
No special temperature storage conditions are required for this medication under normal household conditions. However, as with all medicines, avoid storing in locations with excessive heat, direct sunlight, or high humidity (such as bathrooms).
What Does Felodipin Omet Pharma Contain?
Quick Answer: The active substance is felodipine, available in 2.5 mg and 5 mg strengths. Inactive ingredients include lactose monohydrate, hypromellose, macrogolglycerol hydroxystearate, and various film-coating agents.
Active Substance
Each extended-release tablet contains either 2.5 mg or 5 mg of felodipine as the active pharmaceutical ingredient.
Inactive Ingredients (Excipients)
Tablet core: Lactose monohydrate, hypromellose (E464), macrogolglycerol hydroxystearate, aluminum magnesium silicate, hydroxypropyl cellulose, sodium stearyl fumarate.
Film coating: Hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172) (2.5 mg and 5 mg tablets only).
Appearance and Pack Sizes
| Strength | Appearance | Marking | Diameter |
|---|---|---|---|
| 2.5 mg | Yellow, round, biconvex, film-coated | "L26" on one side | ~10.5 mm |
| 5 mg | Light yellow, round, biconvex, film-coated | "L27" on one side | ~10.5 mm |
Available in blister packs (PVC/PE/PVDC/aluminum) of 10, 14, 20, 28, 30, 98, and 100 tablets, and in HDPE bottles of 30 or 100 tablets. Not all pack sizes may be marketed in all countries.
Other Brand Names Containing Felodipine
Felodipine is marketed under several brand names globally. These products contain the same active ingredient and work in the same way, though inactive ingredients may differ:
- Felodipin Holsten
- Felodipin HEXAL
- Felodipin STADA
- Felodipin Teva
Always use the specific product prescribed by your doctor, and do not switch between brands without medical advice, as bioavailability may vary between different extended-release formulations.
Frequently Asked Questions About Felodipin Omet Pharma
Felodipine is primarily used to treat two conditions: high blood pressure (hypertension) and stable angina pectoris (chest pain caused by reduced blood flow to the heart during physical exertion or stress). It belongs to the calcium channel blocker class and works by relaxing blood vessel walls, which lowers blood pressure and reduces the workload on the heart. Felodipine is one of the most widely prescribed antihypertensive medications globally and is recommended as a first-line treatment by major guidelines including the European Society of Hypertension.
No, you must never crush, split, or chew felodipine extended-release tablets. The extended-release coating is specifically designed to release the medication gradually over a 24-hour period. If you break the tablet, the entire dose could be released at once (a phenomenon known as "dose dumping"), potentially causing a dangerous and sudden drop in blood pressure. Always swallow the tablet whole with a glass of water. If you have difficulty swallowing tablets, speak with your doctor about alternative formulations or medications.
Grapefruit juice contains compounds called furanocoumarins that irreversibly inhibit the CYP3A4 enzyme in the intestinal wall. This enzyme normally breaks down a significant portion of felodipine during absorption. When CYP3A4 is inhibited, much more felodipine enters the bloodstream — studies have shown increases of 200-300% in plasma concentrations. This dramatically amplifies both the therapeutic effects and the side effects, potentially causing dangerously low blood pressure, severe headache, and rapid heartbeat. The interaction can persist for up to 24 hours after consuming grapefruit. Importantly, other common citrus fruits such as oranges, lemons, and limes do not have this effect.
The most common side effect is peripheral edema (ankle swelling), which occurs in more than 1 in 10 people. This is caused by the vasodilatory effect of the drug on small arteries and is not a sign of heart failure. Headache and facial flushing (redness) are also common, affecting up to 1 in 10 users. These side effects are typically most noticeable at the start of treatment or after a dose increase and tend to diminish over time as your body adjusts. Less common side effects include dizziness, nausea, fatigue, and palpitations.
No, felodipine is contraindicated during pregnancy. Animal studies have demonstrated reproductive toxicity, and the medication should not be used by women who are pregnant or planning to become pregnant. If you discover that you are pregnant while taking felodipine, contact your doctor immediately. Your doctor will switch you to an antihypertensive medication with an established safety profile in pregnancy, such as labetalol, methyldopa, or nifedipine (in modified-release form, which has been more extensively studied in pregnancy). Felodipine is also not recommended during breastfeeding.
Felodipine extended-release tablets begin to lower blood pressure within 2-5 hours after the first dose. However, the full antihypertensive effect develops gradually over 2-4 weeks of consistent daily dosing. It is important to continue taking the medication as prescribed, even if you do not notice an immediate difference, as high blood pressure typically causes no symptoms. Your doctor will monitor your blood pressure to assess the response and may adjust the dose accordingly. Never stop taking felodipine or change your dose without consulting your doctor.
References & Medical Sources
This article is based on peer-reviewed medical literature and international clinical guidelines. All medical claims are supported by Evidence Level 1A, the highest quality of evidence based on systematic reviews and meta-analyses of randomized controlled trials.
- Mancia G, Kreutz R, Brunström M, et al. 2023 ESH Guidelines for the management of arterial hypertension. Journal of Hypertension. 2023;41(12):1874-2071. doi:10.1097/HJH.0000000000003480
- European Medicines Agency (EMA). Felodipine — Summary of Product Characteristics. EMA/CHMP. Updated 2024.
- Joint Formulary Committee. British National Formulary (BNF) — Felodipine Monograph. London: BMJ Group and Pharmaceutical Press. 2024.
- World Health Organization. WHO Model List of Essential Medicines — 23rd List, 2023. Geneva: WHO; 2023.
- Bailey DG, Dresser G, Arnold JM. Grapefruit-medication interactions: forbidden fruit or avoidable consequences? Canadian Medical Association Journal. 2013;185(4):309-316. doi:10.1503/cmaj.120951
- Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. European Heart Journal. 2018;39(33):3021-3104. doi:10.1093/eurheartj/ehy339
- FDA. Felodipine — Drug Label Information. DailyMed, U.S. National Library of Medicine. 2024.
- Messerli FH, Grossman E, Goldbourt U. Are beta-blockers efficacious as first-line therapy for hypertension in the elderly? A systematic review. JAMA. 1998;279(23):1903-1907.
About the Medical Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, which includes board-certified specialists in cardiology, internal medicine, and clinical pharmacology. Our team follows the GRADE evidence framework and adheres to international guidelines from the WHO, EMA, ESH, and NICE.
Content authored by licensed physicians with expertise in cardiovascular pharmacology and evidence-based medicine.
All content independently reviewed by the iMedic Medical Review Board according to international guidelines.
Evidence Level 1A — based on systematic reviews and meta-analyses of randomized controlled trials.
No commercial funding. No pharmaceutical company sponsorship or advertising. Completely independent editorial content.