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

How to use SUGAMMADEX CIPLA 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Cipla 100 mg/ml Solution for Injection EFG

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.
If you have any further questions, ask your anesthesiologist (anesthetist) or doctor.
If you experience any side effects, talk to your anesthesiologist or another doctor, even if you think the side effects are not listed in this leaflet. See section 4.

Contents of the pack

What Sugammadex Cipla is and what it is used for
What you need to know before you are given Sugammadex Cipla
How Sugammadex Cipla is given
Possible side effects
Storing Sugammadex Cipla
Contents of the pack and further information

1. What Sugammadex Cipla is and what it is used for

What is sugammadex

This medicine contains the active substance sugammadex. Sugammadex is considered a Selective Relaxant Binding Agentas it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What sugammadex is used for

If you have to undergo surgery, your muscles must be completely relaxed, making it easier for the surgeon to perform the operation. For this, you will be given medications during general anesthesia to relax your muscles. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Since these medications also block the respiratory muscles, you will need help breathing (artificial respiration) during and after surgery until you can breathe on your own again.

This medicine is used to speed up the recovery of your muscles after surgery so that you can breathe on your own again sooner. It does this by combining with rocuronium bromide or vecuronium bromide in your body. It can be used in adults when rocuronium bromide or vecuronium bromide is used and in children and adolescents (between 2 and 17 years) when rocuronium bromide is used for moderate muscle relaxation.

2. What you need to know before you are given Sugammadex Cipla

Do not receive Sugammadex Cipla

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

Tell your anesthesiologist if this applies to you.

Warnings and precautions

Talk to your anesthesiologist before you are given Sugammadex Cipla

if you have any kidney disease or have had it in the past. This is important because sugammadex is eliminated from your body by the kidneys.
if you have liver disease or have had it before.
if you have fluid retention (edema).
if you have a disease that increases the risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

Children and adolescents

This medicine is not recommended for children under 2 years of age.

Other medicines and Sugammadex Cipla

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

Sugammadex may affect other medicines or be affected by them.

Some medicines reduce the effect of sugammadex

It is especially important that you tell your anesthesiologist if you have recently taken:

toremifene (used to treat breast cancer).
fusidic acid (an antibiotic).

Sugammadex Cipla may affect hormonal contraceptives

This medicine may make hormonal contraceptives - such as the "Pill", vaginal ring, implants, or an Intrauterine Hormonal Device (IUD-h) - less effective because it reduces the amount of progestogen you receive. The amount of progestogen lost due to the use of this medicine is approximately the same as when you miss a birth control pill.
If you are taking the Pillon the same day you are given this medicine, follow the instructions for missing a pill in the pill leaflet.
If you are using otherhormonal contraceptives (e.g., vaginal ring, implant, or IUD-h), you should use a non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the recommendations in the leaflet.

Effects on blood tests

In general, sugammadex does not affect laboratory tests. However, it may affect the results of a blood test when progesterone levels are measured. Talk to your doctor if your progesterone levels need to be analyzed on the same day you receive this medicine.

Pregnancy and breastfeeding

Tell your anesthesiologist if you are pregnant or think you may be pregnant or if you are breastfeeding.

This medicine may still be given to you, but it needs to be discussed first.

It is not known if sugammadex passes into breast milk. Your anesthesiologist will help you decide whether to stop breastfeeding or avoid treatment with sugammadex, considering the benefit of breastfeeding to the baby and the benefit of this medicine to the mother.

Driving and using machines

Sugammadex has no known effects on the ability to drive and use machines.

Sugammadex Cipla contains sodium

This medicine contains up to 9.5 mg of sodium (main component of cooking/table salt) per ml. This is equivalent to 0.5% of the maximum recommended daily sodium intake for an adult.

3. How Sugammadex Cipla is given

This medicine will be given to you by your anesthesiologist or under their supervision.

Dose

Your anesthesiologist will calculate the dose of this medicine you need based on:

your weight
the amount of muscle relaxant that is still affecting you.

The usual dose is 2-4 mg per kg of body weight for adults and for children and adolescents between 2-17 years. A dose of 16 mg/kg may be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Cipla is given

This medicine will be given to you by your anesthesiologist. It is injected once into a vein.

If you are given more Sugammadex Cipla than recommended

Since your anesthesiologist will be carefully monitoring the situation, it is unlikely that you will be given too much Sugammadex Cipla. But even if this happens, it is unlikely to cause any problems. Toxicology Service, phone: 91 562 04 20.

If you have any further questions on the use of this medicine, ask your anesthesiologist or another doctor.

4. Possible side effects

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

If these side effects occur while you are under anesthesia, your anesthesiologist will detect and treat them.

Common (may affect up to 1 in 10 people)

Cough
Respiratory difficulties that may include cough or movements as if you were awake or taking a breath
Light anesthesia – you may start to wake up, so you may need more anesthetic. This can cause you to move or cough at the end of the operation
Complications during the procedure, such as changes in heart rate, cough, or movement
Decrease in blood pressure due to surgery

Uncommon (may affect up to 1 in 100 people)

Difficulty breathing due to muscle spasms in the airways (bronchospasm) that occur in patients with a history of lung problems
Allergic reactions (hypersensitivity to medicines) - such as rash, skin redness, swelling of your tongue and/or pharynx, difficult breathing, changes in blood pressure or heart rate, which sometimes result in a severe drop in blood pressure. Allergic reactions or severe allergic reactions can be life-threatening
Allergic reactions were reported more frequently in healthy conscious volunteers
Reappearance of muscle relaxation after surgery

Frequency not known

When this medicine is given, a significant slowing of the heart can occur, which can even lead to cardiac arrest

Reporting of side effects

If you experience any side effects, talk to your anesthesiologist or another doctor, even if you think the side effects are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Sugammadex Cipla

Storage will be the responsibility of healthcare professionals.

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

Do not use this medicine after the expiry date which is stated on the carton and label after "EXP". The expiry date is the last day of the month shown.

Do not freeze. Store the vial in the outer packaging to protect it from light.

After first opening and dilution, chemical and physical stability has been demonstrated for 48 hours between 2 °C and 25 °C. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours between 2 °C and 8 °C, unless the dilution has been made in controlled and validated aseptic conditions.

6. Contents of the pack and further information

Composition of Sugammadex Cipla

The active substance is sugammadex.

Each ml of solution for injection contains sugammadex sodium equivalent to 100 mg of sugammadex.

Each 2 ml vial contains sugammadex sodium equivalent to 200 mg of sugammadex.

Each 5 ml vial contains sugammadex sodium equivalent to 500 mg of sugammadex.

The other ingredients are water for injections, hydrochloric acid 3.7% (for pH adjustment) and/or sodium hydroxide 0.4% w/v (for pH adjustment).

Appearance and packaging

Sugammadex Cipla is a clear, colorless to slightly yellow/brown solution for injection.

It comes in two different pack sizes, 10 vials of 2 ml or 10 vials of 5 ml of solution for injection.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Cipla Europe NV

De Keyserlei 58-60,

Box 19, 2018 Antwerp, Belgium

Manufacturer

Medichem S.A.

Narcís Monturiol 41A

08970 Sant Joan Despí

Barcelona, Spain

or

Combino Pharm Malta, Ltd

HF60 Hal Far Industrial Estate

Hal Far BBG3000

Malta

or

Pharmidea

4 Rupnicu Street

Olaine, Olaine district, LV-2114

Latvia

Local representative

Cipla Europe NV, Spanish branch,

C/ Guzmán el Bueno, 133 Edif Britannia-28003- Madrid

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany	Sugammadex Cipla
Spain	Sugammadex Cipla 100mg/ml solution for injection EFG
France	Sugammadex Cipla
Italy	Sugammadex Cipla

Date of last revision of this leaflet: May 2022

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

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This information is intended only for healthcare professionals:

For detailed information, consult the Summary of Product Characteristics or the Package Leaflet of Sugammadex Cipla.

The full Summary of Product Characteristics will be added as a detachable section at the end of the printed leaflet, so that the information for the patient (i.e., the leaflet) and the information for the healthcare professional (i.e., the Summary of Product Characteristics) are clearly differentiated.

Country of registration
Spain
Active substance
sugammadex
Prescription required
Yes
Manufacturer
Cipla Europe
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 SUGAMMADEX CIPLA 100 mg/mL Injectable Solution
BRIDION 100 mg/mL INJECTABLE SOLUTION
Dosage form: INJECTABLE, 100 mg
Active substance: sugammadex
Manufacturer: Merck Sharp & Dohme B.V.
Prescription required
BRIDION 100 mg/mL INJECTABLE SOLUTION
Dosage form: INJECTABLE, 100 mg
Active substance: sugammadex
Manufacturer: Merck Sharp & Dohme B.V.
Prescription required
SUGAMMADEX ACCORD 100 mg/ml INJECTABLE SOLUTION
Dosage form: INJECTABLE, 100 mg/ml
Active substance: sugammadex
Manufacturer: Accord Healthcare S.L.U.
Prescription required

Alternatives to SUGAMMADEX CIPLA 100 mg/mL Injectable Solution in other countries

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

Alternative to SUGAMMADEX CIPLA 100 mg/mL Injectable Solution in Poland

Sugammadex Iuta

Dosage form: Solution, 100 mg/ml

Active substance: sugammadex

Manufacturer: Juta Pharma GmbH

Prescription required

Sugammadex Accord

Dosage form: Solution, 100 mg/ml

Active substance: sugammadex

Importer: Accord Healthcare Polska Sp. z o.o. Accord Healthcare Single Member S.A. Laboratori Fundacio Dau

Prescription required

Sugammadex Aspen

Dosage form: Solution, 100 mg/ml

Active substance: sugammadex

Manufacturer: Combino Pharm Malta LTD Medichem S.A. Pharmidea

Prescription required

Sugammadex Aguettant

Dosage form: Solution, 50 mg/ml

Active substance: sugammadex

Importer: Laboratoire Aguettant

Prescription required

Sugammadex Aguettant

Dosage form: Solution, 10 mg/ml

Active substance: sugammadex

Importer: Laboratoire Aguettant

Prescription required

Sugammadex Baxter

Dosage form: Solution, 100 mg/ml

Active substance: sugammadex

Manufacturer: Solupharm Pharmazeutische Erzeugnisse GmbH

Prescription required

Alternative to SUGAMMADEX CIPLA 100 mg/mL Injectable Solution in Ukraine

SUGAMADEKS-VISTA

Dosage form: solution, 100 mg/ml, 2 ml or 5 ml in a vial

Active substance: sugammadex

Manufacturer: Vasserburger Arcnajmittel'verk GmbH

Prescription required

BRIDEKS

Dosage form: solution, 100 mg/ml; 2 ml in a vial

Active substance: sugammadex

Manufacturer: K.T.ROMFARM KOMPANI S.R.L.

Prescription required

Online doctors for SUGAMMADEX CIPLA 100 mg/mL Injectable Solution

Discuss dosage, side effects, interactions, contraindications, and prescription renewal for SUGAMMADEX CIPLA 100 mg/mL Injectable Solution – subject to medical assessment and local rules.

5.0(131)

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.

In addition to pain management, Dr. Popov helps patients with:

Respiratory infections (colds, bronchitis, pneumonia).
High blood pressure and metabolic conditions such as diabetes.
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.

Book a video appointment

Mar Tabeshadze

Endocrinology10 years of experience

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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Maryna Kuznetsova

Cardiology16 years of experience

Dr Marina Kuznetsova is an internal medicine doctor and cardiologist with a PhD in medicine. She provides online consultations for adults with chronic and acute conditions, with a strong focus on cardiovascular health. Her approach is based on current clinical guidelines and evidence-based treatment strategies.

Areas of expertise:

dyslipidaemia and lipid metabolism disorders
prevention and management of atherosclerosis
blood pressure monitoring and antihypertensive therapy
arrhythmias: diagnosis, follow-up, and treatment adjustment
cardiovascular care and recovery support after Covid-19

Dr Kuznetsova helps patients manage cardiovascular risk factors, optimise long-term treatment, and gain clarity in complex health situations – all through accessible and structured online care.

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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).

General internal medicine and preventive care:

Respiratory infections – cough, colds, bronchitis.
Lab test analysis, therapy adjustments, medication management.
Adult vaccinations – planning, contraindications assessment.
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Holistic approach – symptom relief, complication prevention, and quality of life improvement.

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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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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.

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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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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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Alina Tsurkan

Family medicine12 years of experience

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
Chronic diseases: hypertension, elevated cholesterol, weight management.
Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

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Personalised preventive care and wellness consultations.
Interpretation of test results and medical reports.
Follow-up care and medication review.
Support in managing multiple coexisting conditions.
Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

Book a video appointment

Dmytro Horobets

Family medicine6 years of experience

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Karim BenHarbi

General medicine8 years of experience

Dr. Karim Ben Harbi is a licensed general practitioner based in Italy. He provides online consultations for adults and children, combining international clinical experience with evidence-based medicine. His care approach is focused on accurate diagnosis, preventive care, and personalised health guidance.

Dr. Ben Harbi received his medical degree from Sapienza University in Rome. His training included hands-on experience in diverse settings — tropical medicine, rural healthcare, and urban outpatient practice. He also conducted clinical research in microbiology, exploring the role of the gut microbiome in chronic gastrointestinal issues.

You can consult Dr. Ben Harbi for:

General health concerns, prevention, and primary care.
Hypertension, type 1 and type 2 diabetes, metabolic issues.
Cold, cough, flu, respiratory infections, sore throat, fever.
Chronic digestive issues: bloating, gastritis, IBS, microbiome imbalance.
Skin rashes, mild allergic reactions, basic dermatological complaints.
Medication guidance, treatment adjustments, prescription review.
Paediatric concerns — fever, infections, general well-being.
Lifestyle optimisation: stress, sleep, weight, and diet counselling.

Dr. Ben Harbi offers reliable, accessible medical support through online consultations, helping patients make informed decisions about their health with a clear, structured, and compassionate approach.

Book a video appointment