This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use BACTIL FLAS 10 mg ORAL LYOPHILIZED

Introduction

Patient Information Leaflet

Bactil Flas 10 mg Oral Lyophilisates

Ebastine

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or more information, consult your pharmacist.
If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

Contents of the Leaflet

What Bactil Flas 10 mg is and what it is used for
What you need to know before taking Bactil Flas 10 mg
How to take Bactil Flas 10 mg
Possible side effects
Storage of Bactil Flas 10 mg
Package contents and additional information

1. What Bactil Flas 10 mg is and what it is used for

Bactil Flas 10 mg belongs to a group of medicines called antihistamines (anti-allergics).

Bactil Flas is indicated for the relief of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and watery eyes) and urticaria (hives) with mild symptoms, in adults and adolescents from 12 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 7 days.

2. What you need to know before taking Bactil Flas 10 mg

*Do not takeBactil Flas 10mg***

if you are allergic to ebastine or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bactil Flas 10 mg:

if your electrocardiogram results are altered.
if you have high potassium levels in your blood.
if you have severe liver disease (see "How to take Bactil Flas 10 mg").
if you are being treated with a type of medicine used to treat fungal infections called azole antifungals or with medicines used to treat certain infections called macrolide antibiotics (see "Taking Bactil Flas 10 mg with other medicines").
if you are being treated with rifampicin, a type of medicine used to treat tuberculosis.

Do not use this medicine if you have an acute allergic emergency, as ebastine (the active ingredient of this medicine) takes 1 to 3 hours to take effect.

If you experience symptoms such as throat tightness, difficulty breathing, hoarseness, or difficulty speaking, wheezing, low blood pressure, repeated vomiting, and/or loss of consciousness, you should seek urgent medical attention due to the risk of anaphylaxis.

Children

Bactil Flas 10 mg should not be administered to children under 12 years of age.

Taking Bactil Flas 10 mg with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

Especially if you are being treated with any of the medicines mentioned below, as it may be necessary to change the dose or interrupt treatment with one of them:

medicines used to treat allergies (antihistamines) because Bactil Flas 10 mg may increase their effect.
ketoconazole and itraconazole, used to treat fungal infections, or with erythromycin, an antibiotic used to treat certain infections, as they may cause an alteration in your electrocardiogram.
rifampicin, used to treat tuberculosis, as it may decrease the antihistamine effect of Bactil Flas 10 mg.

Interference with diagnostic tests

Bactil Flas 10 mg may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days after stopping treatment.

Taking Bactil Flas 10 mg with food and drinks

Taking the medicine with food or drinks does not affect its efficacy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There is limited data on the use of the medicine in pregnant women. As a precaution, it is recommended to avoid using Bactil Flas 10 mg during pregnancy.

Breastfeeding

It is not known if the medicine passes into breast milk, so it should not be used during breastfeeding.

Driving and using machines

No effects on psychomotor function or the ability to drive or use machinery have been observed at the recommended therapeutic doses. However, since drowsiness and dizziness are among the side effects, observe your response to the medication before driving or using machinery.

Bactil Flas 10 mg contains aspartame

This medicine contains 1 mg of aspartame in each oral lyophilisate. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Bactil Flas 10 mg

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Dosage

Use in adults and adolescents over 12 years of age

1 oral lyophilisate (10 mg of ebastine), 1 time a day.

However, in some cases, a dose of 20 mg of ebastine 1 time a day may be necessary to control symptoms. In these cases, 2 Bactil Flas 10mg oral lyophilisates (10 mg of ebastine) 1 time a day are recommended.

Use in patients with severe liver disease

The dose should not exceed 10 mg of ebastine per day (1 oral lyophilisate).

Method of administration

This medicine is taken orally.

The oral lyophilisates can be taken with or without food.

Do not remove the oral lyophilisate from the packaging until you are ready to take it.
Do not extract the dose from the oral lyophilisate by pressing on it. Immediately before taking, with dry hands, open the blister pack by carefully lifting the foil from the point where it is detached (Figure 1).
Stretch the tab to detach it (Figure 2).
Press the lyophilisate carefully upwards (without touching it) (Figure 3).
Remove the lyophilisate carefully (Figure 4).
The dose should be taken immediately after opening the blister pack. Place the oral lyophilisate on the tongue, where it will dissolve quickly, and swallow it with saliva. Do not take water or any other liquid.

Hand holding a transparent vial with liquid and a needle inserted into a rubber stopper Hands holding a rectangular device with a thin cable connected to one end Hands holding a medical device with a sharp tip and a pressed button Hypodermic needle inserted into the skin at an angle and a dotted line indicating depth

Figure 1 Figure 2 Figure 3 Figure 4

You should consult a doctor if your symptoms worsen or do not improve after 7 days.

If you take more Bactil Flas 10 mg than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

4. Possible side effects

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

The following side effects have been observed in clinical trials and post-marketing experience:

Very common (may affect more than 1 in 10 people):

Headache

Common (may affect up to 1 in 10 people):

Drowsiness
Dry mouth

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

Hypersensitivity reactions: allergic reactions (such as anaphylaxis and angioedema)
Nervousness, insomnia
Dizziness, decreased sensation of touch or sensitivity, decreased or altered taste
Palpitations, tachycardia
Abdominal pain, vomiting, nausea, digestive problems
Hepatitis, cholestasis, abnormal liver function tests (increased transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
Urticaria, skin rash, dermatitis
Menstrual disorders
Edema (swelling due to fluid accumulation), fatigue

Frequency not known (cannot be estimated from the available data):

Weight gain
Increased appetite

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bactil Flas 10 mg

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Bactil Flas 10 mg

The active ingredient is ebastine. Each oral lyophilisate contains 10 mg of ebastine.
The other ingredients (excipients) are gelatin (E-441), mannitol (E-421), aspartame (E-951), and peppermint flavor.

Appearance of the product and package contents

Bactil Flas 10 mg is presented in the form of oral lyophilisates. The lyophilisate is round, white, and has a peppermint flavor.

Each package contains 10 oral lyophilisates.

Other presentations

Bactil Forte Flas 20 mg Oral Lyophilisates

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Almirall, S.L.

General Mitre, 151

08022 – Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of last revision of this leaflet: December 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

Country of registration
Spain
Active substance
ebastine
Prescription required
No
Manufacturer
Laboratorios Almirall S.L.
This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
Alternatives to BACTIL FLAS 10 mg ORAL LYOPHILIZED
BACTIL 10 mg FILM-COATED TABLETS
Dosage form: TABLET, 10 mg ebastine
Active substance: ebastine
Manufacturer: Laboratorios Almirall S.L.
Prescription not required
BACTIL FORTE 20 mg FILM-COATED TABLETS
Dosage form: TABLET, 20 mg ebastine
Active substance: ebastine
Manufacturer: Laboratorios Almirall S.L.
Prescription not required
BACTIL FORTE 20 mg ORAL LYOPHILIZED
Dosage form: ORALLY DISINTEGRATING TABLET/LIOTAB, 20 mg
Active substance: ebastine
Manufacturer: Laboratorios Almirall S.L.
Prescription not required

Alternatives to BACTIL FLAS 10 mg ORAL LYOPHILIZED in other countries

The best alternatives with the same active ingredient and therapeutic effect.

Alternative to BACTIL FLAS 10 mg ORAL LYOPHILIZED in Poland

Evastix

Dosage form: Tablets, 20 mg

Active substance: ebastine

Manufacturer: APL Swift Services (Malta) Ltd. Arrow Generiques SAS Generis Farmaceutica, S.A.

Prescription required

Evastix

Dosage form: Tablets, 10 mg

Active substance: ebastine

Manufacturer: APL Swift Services (Malta) Ltd. Arrow Generiques SAS Generis Farmaceutica, S.A.

Prescription required

Alternative to BACTIL FLAS 10 mg ORAL LYOPHILIZED in Ukraine

OSTIBAN

Dosage form: tablets, 20 mg

Active substance: ebastine

Manufacturer: Generis Farmasutika, S.A.

Prescription not required

OSTIBAN

Dosage form: tablets, 10 mg

Active substance: ebastine

Manufacturer: Generis Farmasutika, S.A.

Prescription not required

ESPA-BASTIN

Dosage form: tablets, 20 mg

Active substance: ebastine

Manufacturer: Laboratorios Medikamentos Internas'onales, S. A.

Prescription not required

ESPA-BASTIN

Dosage form: tablets, 10 tablets in a blister

Active substance: ebastine

Manufacturer: Laboratorios Medikamentos Internas'onales, S. A.

Prescription not required

ELERT

Dosage form: tablets, tablets 10mg

Active substance: ebastine

Manufacturer: MIKRO LABS LIMITED

Prescription not required

KESTIN

Dosage form: tablets, 20 mg

Active substance: ebastine

Manufacturer: Indastrias Farmas'utikas Almirall SA

Prescription not required

Online doctors for BACTIL FLAS 10 mg ORAL LYOPHILIZED

Discuss dosage, side effects, interactions, contraindications, and prescription renewal for BACTIL FLAS 10 mg ORAL LYOPHILIZED – subject to medical assessment and local rules.

5.0(4)

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Dr. Mar Tabeshadze is a licensed endocrinologist and general practitioner in Spain. She provides online consultations for adults, offering medical support for a wide range of endocrine conditions and related health concerns.

Diagnostic consultations for suspected endocrine disorders
Management of thyroid conditions, including in pregnant women
Early detection and treatment of type 1 and type 2 diabetes, with personalised therapy plans
Obesity treatment: identifying underlying causes of weight gain, combining medication and non-pharmacological strategies, and long-term support
Diagnosis and treatment of endocrine-related skin, hair, and nail issues
Ongoing care for patients with osteoporosis, pituitary, and adrenal gland disorders

Dr. Tabeshadze takes a patient-centred approach based on evidence-based medicine. Her goal is to help patients achieve hormonal balance, manage chronic conditions effectively, and improve overall well-being through targeted, personalised care.

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Svetlana Kovalenko

Family medicine14 years of experience

Dr Svetlana Kovalenko is a family medicine doctor with over 14 years of experience and a medical degree from Kharkiv National Medical University. She offers online consultations for adults, supporting patients with both acute and chronic conditions, preventive care, and personalised medical advice.

What patients commonly consult her for:

High blood pressure, type 2 diabetes, cholesterol management
Cold and flu symptoms: fever, cough, sore throat
Fatigue, sleep problems, headaches, general discomfort
Ongoing care for chronic conditions and medication review
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Dr Kovalenko combines evidence-based practice with a respectful, patient-centred approach. She takes time to explain, listens attentively, and helps each person make confident, informed decisions about their health.

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Anna Biriukova

General medicine5 years of experience

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
Leg swelling, chronic fatigue, reduced exercise tolerance.
EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
Post-COVID-19 cardiac monitoring and care.

Endocrinology – Diabetes, thyroid, metabolism:

Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
Individual treatment plans including oral medications and insulin therapy.
GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
Metabolic syndrome – obesity, lipid disorders, insulin resistance.

Gastroenterology – Digestive health:

Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).

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Respiratory infections – cough, colds, bronchitis.
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Adult vaccinations – planning, contraindications assessment.
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Maryna Kuznetsova

Cardiology16 years of experience

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dyslipidaemia and lipid metabolism disorders
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blood pressure monitoring and antihypertensive therapy
arrhythmias: diagnosis, follow-up, and treatment adjustment
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Taisiya Minorskaya

Family medicine12 years of experience

Dr Taisiya Minorskaya is a family medicine doctor with an official licence to practise in Spain and over 12 years of clinical experience. She provides online consultations for adults and children, combining evidence-based medicine with a personalised, modern European approach.

She helps with:

Viral infections and cold symptoms (flu, sore throat, cough, runny nose)
Review and adjustment of antibiotics
Skin rashes and allergic reactions
Chronic condition flare-ups, high blood pressure, headaches, fatigue
Lab and test interpretation
Medication review and adaptation to European standards
Patient navigation: what tests are needed, which specialists to see, when an in-person visit is required

Dr Minorskaya also specialises in the diagnosis and management of gastrointestinal conditions, including bloating, abdominal pain, chronic nausea, IBS, and SIBO. She supports patients with unexplained physical symptoms that may be linked to somatisation or stress, helping them find relief and improve quality of life.

She offers care for people undergoing GLP-1 therapy (Ozempic, Mounjaro, and others) for weight management. Her support follows Spanish clinical guidelines, from treatment planning and side effect counselling to regular follow-ups and coordination with private or public healthcare providers.

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Jonathan Marshall Ben Ami

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Dr. Jonathan Marshall Ben Ami is a licensed family medicine doctor in Spain. He provides comprehensive care for adults and children, combining general medicine with emergency care expertise to address both acute and chronic health concerns.

Dr. Ben Ami offers expert diagnosis, treatment, and follow-up for:

Respiratory infections (cold, flu, bronchitis, pneumonia).
ENT conditions such as sinusitis, ear infections, and tonsillitis.
Digestive issues including gastritis, acid reflux, and irritable bowel syndrome (IBS).
Urinary tract infections and other common infections.
Management of chronic diseases: high blood pressure, diabetes, thyroid disorders.
Acute conditions requiring urgent medical attention.
Headaches, migraines, and minor injuries.
Wound care, health check-ups, and ongoing prescriptions.

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Yevgen Yakovenko

General surgery11 years of experience

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

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Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

12+ years of clinical experience in university hospitals in Germany and Spain.
International education: Ukraine – Germany – Spain.
Member of the German Society of Surgeons (BDC).
Certified in radiological diagnostics and robotic surgery.
Active participant in international medical conferences and research.

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Antonio Cayatte

General medicine43 years of experience

Dr Antonio Cayatte is a physician in General and Acute Medicine with over 30 years of experience across clinical care, medical research, and education. He offers online consultations for adults with a wide range of symptoms, both acute and chronic.

His clinical background includes:

assessment of sudden or unclear symptoms
ongoing care for chronic conditions
follow-up after hospital discharge
interpretation of test results
medical support while abroad

Dr Cayatte earned his degree from the University of Lisbon and taught internal medicine at Boston University School of Medicine. He holds active medical registrations in both Portugal and the UK and is a Fellow of the American Heart Association.

Consultations are available in English and Portuguese. Patients value his clarity, professionalism, and balanced approach to evidence-based care.

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Andrei Popov

General medicine6 years of experience

Dr. Andrei Popov is a licensed pain management specialist and general practitioner based in Spain. He provides expert online care for adults dealing with both chronic and acute pain, as well as a wide range of everyday health concerns.

He specialises in diagnosing and treating pain conditions that affect quality of life, including:

Chronic pain lasting more than 3 months.
Migraines and recurring headaches.
Neck, back, lower back, and joint pain.
Post-traumatic pain following injury or surgery.
Nerve-related pain, fibromyalgia, and neuralgia.

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Respiratory infections (colds, bronchitis, pneumonia).
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Preventive care and routine health check-ups.

Online consultations last up to 30 minutes and include a detailed symptom review, personalised treatment planning, and medical follow-up when needed.

Dr. Popov’s approach is rooted in evidence-based medicine, combined with individualised care tailored to each patient’s history, lifestyle, and clinical needs.

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Lina Travkina

Family medicine12 years of experience

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

Preventive consultations and check-up planning.
Medical advice and follow-up consultations.
Test interpretation and diagnostic guidance.
Structured support for undiagnosed complaints.
Second opinion on diagnoses and treatment plans.
Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
Post-operative recovery support and pain management.
Preconception counselling and postpartum support.
Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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