Bilastine EG: Uses, Dosage & Side Effects
Second-generation antihistamine for allergic rhinitis and urticaria
Quick Facts About Bilastine EG
Key Takeaways About Bilastine EG
- Non-sedating antihistamine: Bilastine does not significantly cross the blood-brain barrier, resulting in minimal drowsiness compared to older antihistamines
- Must be taken on an empty stomach: Food and fruit juice reduce absorption by up to 30% – take 1 hour before or 2 hours after meals
- Once-daily dosing: A single 20 mg tablet provides 24-hour symptom relief for allergic rhinitis and urticaria
- No dose adjustment for mild-to-moderate kidney or liver impairment: However, use with caution in patients with severe renal impairment
- No significant interaction with alcohol: At the recommended dose, bilastine does not potentiate the effects of alcohol on psychomotor performance
What Is Bilastine EG and What Is It Used For?
Bilastine EG is a prescription, non-sedating second-generation antihistamine containing 20 mg of bilastine per tablet. It is used to relieve the symptoms of allergic rhinoconjunctivitis (seasonal and perennial hay fever) and chronic spontaneous urticaria (hives) in adults and adolescents aged 12 years and older.
Bilastine belongs to a class of medications known as second-generation H1 antihistamines. These drugs work by selectively blocking the histamine H1 receptors on the surface of cells throughout the body. When the immune system encounters an allergen – such as pollen, dust mites, animal dander, or mould spores – it releases histamine from mast cells and basophils. Histamine then binds to H1 receptors, triggering the characteristic symptoms of allergic reactions: sneezing, nasal congestion, itchy and watery eyes, and skin rashes. By occupying these receptors, bilastine prevents histamine from exerting its effects, thereby alleviating allergic symptoms.
What distinguishes bilastine from many other antihistamines is its pharmacokinetic profile. Unlike first-generation antihistamines such as diphenhydramine and chlorpheniramine, which readily cross the blood-brain barrier and cause significant drowsiness, bilastine has very low penetration into the central nervous system. This means it provides effective antihistamine action with minimal sedation – a crucial advantage for patients who need to remain alert during daily activities, drive vehicles, or operate machinery.
Bilastine was first developed by FAES Farma in Spain and received European Medicines Agency (EMA) approval in 2010. It is now available in numerous countries worldwide under various brand names, including Bilastine EG, which is a generic formulation containing the same active ingredient at the same strength. The medication has been extensively studied in clinical trials involving thousands of patients, consistently demonstrating efficacy comparable to cetirizine and fexofenadine while maintaining a favourable sedation profile.
Approved Indications
Bilastine EG is approved for the symptomatic treatment of two primary conditions:
- Allergic rhinoconjunctivitis (hay fever): This includes both seasonal allergic rhinitis (triggered by pollen from grasses, trees, and weeds) and perennial allergic rhinitis (caused by year-round allergens such as house dust mites, pet dander, and moulds). Bilastine relieves sneezing, runny nose, nasal congestion, and itchy, watery eyes associated with these conditions.
- Chronic spontaneous urticaria (CSU): Also known as chronic idiopathic urticaria, this condition involves recurring hives (itchy, raised wheals on the skin) lasting six weeks or more without an identifiable external trigger. Bilastine reduces the itching, number and size of wheals, and the associated discomfort that significantly impacts quality of life.
Bilastine EG treats the symptoms of allergic conditions but does not cure the underlying allergy. For long-term management of severe allergies, your healthcare provider may recommend allergen immunotherapy (desensitisation) in addition to symptom relief with antihistamines.
What Should You Know Before Taking Bilastine EG?
Before taking Bilastine EG, inform your healthcare provider about all existing medical conditions, other medications you are taking, and whether you are pregnant or breastfeeding. Bilastine EG must be taken on an empty stomach for optimal absorption.
Like all prescription medications, Bilastine EG requires careful consideration before use. Understanding the contraindications, precautions, and special populations helps ensure safe and effective treatment. Your prescribing healthcare provider should be made aware of your complete medical history and current medication list before initiating treatment with bilastine.
Contraindications
Bilastine EG should not be taken if you have a known hypersensitivity (allergy) to bilastine or any of the excipients (inactive ingredients) in the formulation. Signs of a hypersensitivity reaction may include difficulty breathing, swelling of the face or throat, severe skin rash, or a rapid drop in blood pressure. If you experience any of these symptoms, discontinue the medication immediately and seek emergency medical attention.
Warnings and Precautions
Several important precautions should be observed when taking Bilastine EG:
- Renal impairment: Bilastine is primarily excreted unchanged through the kidneys. In patients with moderate-to-severe renal impairment, plasma levels of bilastine may be significantly increased. While no dose adjustment is currently recommended for mild-to-moderate renal impairment, patients with severe renal insufficiency (creatinine clearance below 30 mL/min) should use bilastine with caution and under close medical supervision.
- Concurrent use with P-glycoprotein inhibitors: Bilastine is a substrate of P-glycoprotein (P-gp), a transporter protein that affects drug absorption and distribution. Medications that inhibit P-gp, such as ketoconazole, erythromycin, ciclosporin, ritonavir, and diltiazem, can increase bilastine plasma concentrations. If co-administration is necessary, closer monitoring may be warranted.
- Food and fruit juice interaction: Food and fruit juice (particularly grapefruit juice) significantly reduce the bioavailability of bilastine. The medication should always be taken on an empty stomach, at least one hour before or two hours after eating or drinking fruit juice. This is a critical instruction for therapeutic efficacy.
- Elderly patients: Clinical experience with bilastine in patients aged 65 years and older is limited. While no dose adjustment is recommended based on age alone, elderly patients should be monitored for potential adverse effects, particularly given the higher likelihood of concomitant renal impairment in this population.
Pregnancy and Breastfeeding
The safety of bilastine during pregnancy has not been established through adequate controlled clinical trials in pregnant women. Animal reproduction studies have not shown direct harmful effects on the foetus, but the absence of human data means that Bilastine EG should only be used during pregnancy if the potential benefit justifies the potential risk. If you are pregnant, planning to become pregnant, or suspect pregnancy, consult your healthcare provider before taking this medication.
It is not known whether bilastine is excreted in human breast milk. Animal studies have shown excretion of bilastine in the milk of lactating rats. As a precautionary measure, breastfeeding is not recommended during treatment with Bilastine EG. If antihistamine therapy is required during breastfeeding, your healthcare provider may recommend an alternative antihistamine with a more established safety profile in lactation, such as loratadine or cetirizine.
Do not take Bilastine EG if you are allergic to bilastine or any of its ingredients. If you experience signs of a serious allergic reaction – including swelling of the face, lips, tongue, or throat, difficulty breathing, or severe skin rash – seek emergency medical help immediately.
How Does Bilastine EG Interact with Other Drugs?
Bilastine EG can interact with P-glycoprotein inhibitors such as ketoconazole, erythromycin, and ciclosporin, which can increase bilastine levels in the blood. Grapefruit juice also reduces bilastine absorption. At the standard dose, bilastine does not potentiate alcohol effects.
Understanding drug interactions is essential for safe use of any medication. Bilastine has a relatively favourable interaction profile compared to some other antihistamines, primarily because it is not significantly metabolised by cytochrome P450 (CYP) enzymes in the liver. Instead, bilastine is absorbed unchanged and primarily excreted via the kidneys and bile. However, bilastine is a substrate of P-glycoprotein (P-gp) and organic anion transporting polypeptide (OATP) transporters, which are important for its absorption and distribution.
Because bilastine does not undergo significant hepatic metabolism, it avoids the CYP-mediated drug interactions that affect many other antihistamines. For example, loratadine is metabolised by CYP3A4 and CYP2D6, making it susceptible to interactions with common inhibitors of these enzymes. Bilastine's reliance on transporter-mediated elimination rather than enzymatic metabolism means a different, and generally more limited, interaction profile.
Major Interactions
| Interacting Drug | Mechanism | Effect | Recommendation |
|---|---|---|---|
| Ketoconazole | P-gp and OATP inhibition | Increases bilastine AUC by approximately 2-fold | Use with caution; monitor for increased side effects |
| Erythromycin | P-gp inhibition | Increases bilastine plasma levels by approximately 2-fold | Use with caution; consider alternative antibiotic if possible |
| Ciclosporin | P-gp inhibition | May significantly increase bilastine exposure | Avoid concurrent use or use under close medical supervision |
| Ritonavir | P-gp inhibition | May increase bilastine plasma concentrations | Use with caution; monitor for adverse effects |
| Diltiazem | P-gp inhibition | Increases bilastine AUC by approximately 50% | Generally safe; be aware of potential increased exposure |
| Grapefruit juice | OATP inhibition in the gut | Reduces bilastine bioavailability by approximately 30% | Avoid grapefruit juice when taking bilastine |
Minor Interactions
At the recommended therapeutic dose of 20 mg, bilastine has demonstrated a favourable safety profile with respect to several common co-administered substances:
- Alcohol: Clinical studies using psychomotor performance tests have shown that bilastine 20 mg does not potentiate the impairing effects of alcohol. However, as with all antihistamines, patients should exercise caution until their individual response is known.
- Benzodiazepines (e.g., lorazepam): Co-administration studies have not shown significant potentiation of central nervous system depressant effects at the standard bilastine dose.
- Other antihistamines: While there is no pharmacokinetic interaction, combining multiple antihistamines is generally not recommended as it does not provide additional benefit and may increase the risk of adverse effects.
Always inform your healthcare provider and pharmacist about all medications, supplements, and herbal products you are taking. Even though bilastine has fewer metabolic drug interactions than many antihistamines, transporter-mediated interactions can still be clinically significant.
What Is the Correct Dosage of Bilastine EG?
The standard dose of Bilastine EG for adults and adolescents aged 12 and older is one 20 mg tablet taken once daily on an empty stomach. The tablet should be swallowed whole with water, at least 1 hour before or 2 hours after food or fruit juice.
Correct dosing is essential for achieving optimal therapeutic benefit from Bilastine EG while minimising the risk of adverse effects. The dosage regimen is straightforward, with once-daily administration providing consistent 24-hour symptom control for most patients.
Adults
Standard Adult Dose
20 mg (one tablet) once daily, taken orally on an empty stomach. The tablet should be taken at least one hour before or two hours after food or fruit juice. Swallow the tablet whole with a glass of water.
The duration of treatment depends on the type, duration, and course of complaints. For seasonal allergic rhinitis, bilastine is typically taken throughout the pollen season. For chronic spontaneous urticaria, continuous treatment may be necessary for extended periods, as determined by your healthcare provider.
Children and Adolescents
Adolescents (12–17 years)
20 mg (one tablet) once daily, the same dosage as adults. Clinical trials have established the safety and efficacy of bilastine 20 mg in adolescents aged 12 years and older.
Children (6–11 years)
Bilastine EG 20 mg tablets are not recommended for children under 12 years of age. In some markets, an oral solution formulation (2.5 mg/mL) is available for children aged 6 to 11 years at a dose of 10 mg (4 mL) once daily. Consult your healthcare provider for age-appropriate formulations.
Children Under 6 Years
Bilastine is not recommended for children under 6 years of age due to insufficient data on safety and efficacy in this age group.
Elderly
Patients Aged 65 Years and Older
No dose adjustment is required based on age alone. However, as elderly patients are more likely to have decreased renal function, care should be taken in dose selection and renal function should be monitored. The standard 20 mg once-daily dose is generally appropriate unless renal impairment is present.
Patients with Renal or Hepatic Impairment
Special Populations
Mild-to-moderate renal impairment: No dose adjustment is required. Severe renal impairment: Use with caution; bilastine plasma levels may be elevated. Hepatic impairment: As bilastine is not significantly metabolised by the liver, no dose adjustment is expected to be necessary. However, clinical data in patients with hepatic impairment are limited.
| Patient Group | Dose | Frequency | Special Instructions |
|---|---|---|---|
| Adults (18+ years) | 20 mg | Once daily | Empty stomach; 1 hr before or 2 hrs after food |
| Adolescents (12–17 years) | 20 mg | Once daily | Same as adults |
| Children (6–11 years) | 10 mg* | Once daily | *Oral solution only (not 20 mg tablet) |
| Children (<6 years) | Not recommended | — | Insufficient safety data |
| Elderly (65+ years) | 20 mg | Once daily | Monitor renal function |
| Severe renal impairment | 20 mg | Once daily | Use with caution; elevated plasma levels possible |
Missed Dose
If you forget to take a dose of Bilastine EG, take it as soon as you remember, provided it is still taken on an empty stomach. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose. Setting a daily reminder or taking the medication at the same time each day can help prevent missed doses.
Overdose
In clinical trials, bilastine has been administered at doses up to 220 mg (eleven times the recommended dose) without causing serious adverse events. At doses of 100 mg, the most commonly reported symptoms were dizziness, headache, and somnolence. There is no specific antidote for bilastine overdose. In the event of suspected overdose, standard supportive measures should be employed, including gastric lavage if ingestion was recent and monitoring of vital signs. Contact your local poison control centre or emergency services if overdose is suspected.
Always take Bilastine EG exactly as prescribed by your healthcare provider. Do not increase the dose without medical advice. If you have taken more than the recommended dose, contact your healthcare provider or poison control centre immediately.
What Are the Side Effects of Bilastine EG?
Bilastine EG is generally well tolerated. The most common side effects include headache, drowsiness, and dizziness, occurring at rates similar to placebo in clinical trials. Serious side effects are rare.
Like all medicines, Bilastine EG can cause side effects, although not everybody gets them. In extensive clinical trials involving over 4,800 patients, bilastine 20 mg demonstrated a safety profile very similar to placebo. The overall incidence of adverse events was comparable between bilastine-treated patients and those receiving placebo, confirming the medication's favourable tolerability.
It is important to distinguish between common, expected side effects and rare but serious adverse reactions. Most side effects of bilastine are mild, transient, and resolve without the need to discontinue treatment. However, if you experience any persistent or severe symptoms, you should contact your healthcare provider for guidance.
The side effects listed below are categorised according to the frequency classification system used by the European Medicines Agency (EMA) and the World Health Organization (WHO), based on data from clinical trials and post-marketing surveillance.
Common (affects 1 to 10 in every 100 patients)
- Headache
- Somnolence (drowsiness)
- Dizziness
Uncommon (affects 1 to 10 in every 1,000 patients)
- Fatigue
- Nasal dryness
- Abdominal pain
- Nausea
- Increased appetite
- Upper abdominal discomfort
- Dry mouth
- Anxiety
- Insomnia
- Tinnitus (ringing in the ears)
- ECG abnormalities (QTc prolongation – rare and generally not clinically significant at recommended doses)
- Weight increase
- Vertigo
- Herpes labialis (cold sores)
Rare (affects fewer than 1 in every 1,000 patients)
- Tachycardia (rapid heartbeat)
- Palpitations
- Skin rash or pruritus (itching)
- Dyspnoea (difficulty breathing)
- Gastroenteritis
One of the key advantages of bilastine over first-generation antihistamines is its minimal sedative effect. In controlled clinical trials, the incidence of somnolence with bilastine 20 mg was not significantly different from placebo. Objective psychomotor testing, including driving simulation studies, has confirmed that bilastine at the recommended dose does not impair driving ability or cognitive function. This stands in contrast to first-generation antihistamines (such as diphenhydramine), which cause significant impairment comparable to alcohol intoxication.
If you experience any side effects not listed above, or if any of the listed side effects become severe or persistent, inform your healthcare provider or pharmacist. You can also report side effects directly to your national pharmacovigilance authority to help provide more information on the safety of this medicine.
How Should You Store Bilastine EG?
Store Bilastine EG at room temperature below 30°C (86°F), in the original packaging, protected from moisture. Keep out of sight and reach of children.
Proper storage of Bilastine EG ensures that the medication retains its full potency and safety throughout its shelf life. Like all pharmaceutical products, exposure to extreme temperatures, moisture, or light can degrade the active ingredient and excipients, potentially reducing efficacy or causing the formation of harmful degradation products.
Follow these storage guidelines to maintain the quality of your medication:
- Temperature: Store at or below 30°C (86°F). Do not freeze. Avoid storing in locations subject to high temperatures, such as inside a vehicle during summer months or near heating appliances.
- Moisture protection: Keep the tablets in their original blister packaging until immediately before use. The aluminium/polyamide/PVC blisters protect the tablets from humidity. Do not transfer tablets to pill organisers for extended periods.
- Light: While bilastine is generally stable to light exposure, it is best practice to store the medication in its original carton to provide additional protection.
- Shelf life: Do not use Bilastine EG after the expiry date printed on the carton and blister. The expiry date refers to the last day of that month.
- Children: Keep this medicine out of the sight and reach of children. Store in a locked medicine cabinet if possible.
- Disposal: Do not dispose of unused or expired medications via household waste or wastewater. Return any unused medication to your pharmacy for safe disposal, in accordance with local environmental regulations.
When travelling, keep Bilastine EG in your hand luggage in its original packaging. Avoid storing medications in checked luggage where temperatures in the cargo hold may fall below freezing. If travelling to hot climates, consider using an insulated medication pouch to maintain appropriate storage temperatures.
What Does Bilastine EG Contain?
Each Bilastine EG tablet contains 20 mg of bilastine as the active ingredient, along with several inactive excipients including microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.
Understanding the complete composition of a medication is important, particularly for patients with known allergies or sensitivities to specific excipients. The inactive ingredients (excipients) in a tablet serve various functions, including binding the tablet, aiding disintegration for absorption, and ensuring manufacturing consistency.
Active Ingredient
Each film-coated tablet contains 20 mg of bilastine. Bilastine is a piperidine derivative with the chemical name 2-[4-(2-(4-(1-(2-ethoxyethyl)-1H-benzimidazol-2-yl)piperidin-1-yl)ethyl)phenyl]-2-methylpropionic acid. It is a white to off-white crystalline powder that is practically insoluble in water.
Excipients (Inactive Ingredients)
The typical excipients found in bilastine 20 mg tablets include:
- Microcrystalline cellulose: A bulking agent and binder that helps form the tablet structure
- Croscarmellose sodium: A disintegrant that helps the tablet break apart in the gastrointestinal tract for faster absorption
- Colloidal anhydrous silica: A flow agent that improves manufacturing consistency
- Magnesium stearate: A lubricant that prevents the tablet from sticking to manufacturing equipment
- Hypromellose: Used in the film coating to protect the tablet and aid swallowing
- Titanium dioxide (E171): A colouring agent in the film coating
- Macrogol: A plasticiser in the film coating
Bilastine EG tablets do not contain lactose, gluten, or sucrose. Patients with known intolerances to these substances can generally take bilastine without concern. However, always check the patient information leaflet supplied with your specific product for the complete list of excipients, as formulations may vary slightly between manufacturers.
Frequently Asked Questions About Bilastine EG
No. Bilastine EG should be taken on an empty stomach, at least 1 hour before or 2 hours after eating food or drinking fruit juice. Food and fruit juice (especially grapefruit juice) significantly reduce the absorption of bilastine, decreasing its bioavailability by approximately 30%. This can result in reduced therapeutic efficacy. For best results, take the tablet with a glass of plain water at a consistent time each day when your stomach is empty.
Bilastine EG is classified as a non-sedating antihistamine. In clinical trials, the incidence of somnolence with bilastine 20 mg was comparable to placebo. Objective psychomotor testing, including Vienna Test System assessments and driving simulation studies, has confirmed that bilastine at the recommended dose does not significantly impair cognitive function or driving ability. This makes it one of the least sedating antihistamines available. However, individual responses may vary, and a small number of patients may experience mild drowsiness, particularly during the first few days of treatment.
Bilastine EG typically begins to work within 1 hour of taking the tablet when taken on an empty stomach. Maximum plasma concentration is reached within 1 to 1.5 hours after oral administration. The antihistamine effect lasts for approximately 24 hours, which supports the once-daily dosing regimen. Some patients may notice symptom improvement even sooner, while the full therapeutic benefit for conditions like chronic spontaneous urticaria may take several days of regular use to become apparent.
Bilastine EG 20 mg tablets are approved for adults and adolescents aged 12 years and older. For children aged 6 to 11 years, bilastine is available in some countries as an oral solution (2.5 mg/mL) at a dose of 10 mg once daily. The 20 mg tablet should not be broken or crushed for children, as this formulation is not designed for dose splitting. Bilastine is not recommended for children under 6 years of age. Always consult your paediatrician or healthcare provider for age-appropriate treatment options.
While all three are second-generation antihistamines used for similar conditions, they have important pharmacological differences. Bilastine does not significantly cross the blood-brain barrier, resulting in even less sedation than cetirizine, which has a slightly higher incidence of drowsiness. Unlike loratadine, bilastine does not require hepatic metabolism via CYP enzymes to become active, leading to fewer potential drug interactions and more consistent efficacy across patients regardless of CYP enzyme polymorphisms. However, bilastine must be taken on an empty stomach, while cetirizine and loratadine can be taken with or without food. Each has its advantages, and the choice between them depends on individual patient factors.
Clinical studies using objective psychomotor performance tests (including the Multiple Sleep Latency Test and driving simulation) have shown that bilastine at the standard 20 mg dose does not potentiate the impairing effects of alcohol. This is a notable advantage over first-generation antihistamines and even some second-generation agents like cetirizine, which can enhance alcohol-related impairment. However, as individual responses may vary and alcohol itself causes impairment, it is generally advisable to exercise caution with alcohol consumption while taking any medication.
Bilastine EG can be used for both short-term and long-term treatment, depending on the condition being treated. For seasonal allergic rhinitis, it is typically taken during the allergy season (which may last several months). For chronic spontaneous urticaria, long-term continuous treatment is often necessary, and clinical studies have demonstrated safety and efficacy for continuous use of up to 12 months. Some patients with CSU may require treatment for several years. Your healthcare provider will periodically reassess the need for continued treatment. There is no evidence of tolerance (loss of efficacy) with prolonged use.
References
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- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd edition. Geneva: WHO; 2023.
- British National Formulary (BNF). Bilastine. Available at: bnf.nice.org.uk. Accessed December 2025.
- Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022;77(3):734-766.
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