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SYMKEVI 50 mg/75 mg FILM-COATED TABLETS

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About the medicine

How to use SYMKEVI 50 mg/75 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Symkevi 50 mg/75 mg film-coated tablets

Symkevi 100 mg/150 mg film-coated tablets

tezacaftor/ivacaftor

Read all of this leaflet carefully before you start taking 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 doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What is Symkevi and what is it used for
  2. What you need to know before you take Symkevi
  3. How to take Symkevi
  4. Possible side effects
  5. Storing Symkevi
  6. Contents of the pack and other information

1. What is Symkevi and what is it used for

Symkevi contains two active substances,tezacaftor and ivacaftor. This medicine helps the lung cells to work better in some patients with cystic fibrosis (CF). CF is an inherited condition where the lungs and digestive system can become clogged with thick, sticky mucus.

Symkevi works on a protein called CFTR (cystic fibrosis transmembrane conductance regulator), which is faulty in some people with CF (who have a mutation in the CFTRgene). Ivacaftor makes the protein work better while tezacaftor increases the amount of protein on the cell surface. Symkevi is usually taken with ivacaftor, another medicine.

Symkevi taken together with ivacaftor is for the long-term treatment of patients aged 6 years and older who have CF with certain genetic mutations that result in a reduction in the amount and/or function of the CFTR protein.

Symkevi taken together with ivacaftor helps with breathing by improving lung function. You may notice that you do not get sick as often and/or that it is easier to gain weight.

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take Symkevi

Do not take Symkevi:

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

Consult your doctor,without taking the tablets, if this applies to you.

Warnings and precautions

  • Tell your doctor if you have liver problems or have had them in the past. Your doctor may need to adjust your dose.
  • Your doctor will do some blood tests to check how your liver is working before and during treatment with Symkevi, especially if your blood tests have shown raised liver enzymes in the past. An increase in liver enzymes in the blood has been seen in CF patients taking Symkevi.
  • Liver damage and worsening of liver function have been seen in patients with severe liver disease who received other CFTR modulators. The worsening of liver function can be severe and may require a transplant.

Tell your doctor immediatelyif you have any symptoms that may indicate liver problems. These are listed in section 4.

  • Depression (including thoughts of suicide and suicidal behaviour) has been reported in patients taking Symkevi, usually in the first 3 months of treatment. Tell your doctor immediately if you (or someone taking this medicine) experience any of the following symptoms, which may be signs of depression: feeling sad or changed mood, anxiety, feeling emotionally upset or thoughts of self-harm or suicide.
  • Your doctor may do eye examinationsbefore and during treatment with Symkevi. In some children and adolescents who have taken this treatment, cataracts (clouding of the lens in the eye) have occurred without affecting vision.
  • Tell your doctor if you have kidney problemsor have had them in the past.
  • Tell your doctorbefore starting treatment if you have had an organ transplant.

Children under 6 years

Symkevi must not be used in children under 6 years. It is not known if Symkevi is safe and effective in children under 6 years.

Other medicines and Symkevi

Tell your doctor or pharmacistif you are taking, have recently taken or might take any other medicines. Some medicines may affect how Symkevi works or may increase the chance of side effects. In particular, tell your doctor if you are taking any of the medicines listed below. Your doctor may need to change the dose of one of your medicines if you are taking some of these.

  • Antifungals(used to treat fungal infections). These include ketoconazole, itraconazole, posaconazole, voriconazole and fluconazole.
  • Antibiotics(used to treat bacterial infections). These include telithromycin, clarithromycin, erythromycin, rifampicin and rifabutin.
  • Anticonvulsants(used to treat epilepsy and seizures). These include phenobarbital, carbamazepine and phenytoin.
  • Herbal products.These include St. John's Wort (Hypericum perforatum).
  • Immunosuppressants(used after an organ transplant). These include ciclosporin, tacrolimus, sirolimus and everolimus.
  • Cardiac glycosides(used to treat certain heart conditions). These include digoxin.
  • Anticoagulants(used to prevent blood clots). These include warfarin.
  • Medicines for diabetes.These include glimepiride and glipizide.

Taking Symkevi with food and drink

Avoid foods or drinks that contain grapefruit during treatment as they may increase the side effects of Symkevi by increasing the amount of Symkevi in the blood.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

  • Pregnancy: it may be better to avoid using this medicine during pregnancy. Your doctor will help you decide what is best for you and your baby.
  • Breast-feeding: tezacaftor and ivacaftor may pass into breast milk. Your doctor will consider the benefit of breast-feeding for the child and the benefit of treatment for you in order to help you decide whether to stop breast-feeding or stop the treatment.

Driving and using machines

Symkevi may cause dizziness. If you feel dizzy, do not drive, ride a bicycle or use machines unless you are sure that you are not affected.

Symkevi contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose unit, which is essentially “sodium-free”.

3. How to take Symkevi

Always take this medicine exactly as your doctor has told you.

If you are not sure, ask your doctor or pharmacist.

There are different doses of Symkevi for different age groups. Check that you have been prescribed the correct dose (see below).

Symkevi is usually taken with ivacaftor.

Age

Morning

Evening

(1 tablet)

(1 tablet)

6 to <12 years with weight <30 kg

50 mg of tezacaftor/75 mg of ivacaftor

75 mg of ivacaftor

6 to <12 years with weight ≥30 kg

100 mg of tezacaftor/150 mg of ivacaftor

150 mg of ivacaftor

12 years or older

100 mg of tezacaftor/150 mg of ivacaftor

150 mg of ivacaftor

Take the tablets approximately 12 hours apart.

Take the Symkevi and ivacaftor tablets with fat-containing foods.Fat-containing meals or snacks are those prepared with butter or oils or those that contain eggs. Examples of other fat-containing foods are:

  • Cheese, whole milk, whole milk dairy products, yoghurt, chocolate
  • Meat, oily fish
  • Avocado, hummus (chickpea paste), soy products (tofu)
  • Nuts, nut bars or nutritional drinks that contain fat

The tablets are taken by mouth.

Swallow the tablets whole.Do not chew, crush or break the tablets before swallowing.

You should keep taking all your other medicines unless your doctor tells you to stop.

If you have liver problems,moderate or severe, your doctor may need to reduce your dose of the tablets as your liver will not process this medicine as quickly as usual.

If you take more Symkevi than you should

Consult your doctor or pharmacist.If possible, take the medicine and this leaflet with you. You may experience side effects, including those mentioned in section 4 below.

If you forget to take Symkevi

  • If you miss a morning dose of Symkevi or an evening dose of ivacaftor, and you remember within 6 hoursof the time you were supposed to take the dose, take the missed tablet as soon as possible.
  • If more than 6 hourshave passed, do not take the missed tablet. Wait and take the next tablet at the usual time.
  • Do nottake 2 tablets to make up for a missed dose.

If you stop taking Symkevi

Your doctor will tell you how long you need to take Symkevi. It is important that you take this medicine regularly. Do not make any changes unless your doctor tells you to.

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

Medicine questions

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4. Possible side effects

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

Serious side effects

Possible signs of liver problems

An increase in liver enzymes in the blood is very common in patients with CF. This may be a sign of liver problems:

  • Pain or discomfort in the upper right side of the stomach (abdominal area)
  • Yellowing of the skin or the white part of the eyes
  • Lack of appetite
  • Feeling sick or being sick
  • Dark urine

Depression

Signs of depression include feeling sad or changed mood, anxiety or feeling emotionally upset.

Tell your doctor immediatelyif you experience any of these symptoms.

Side effects seen with Symkevi:

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

  • Headache
  • Common cold

Common(may affect up to 1 in 10 people)

  • Feeling sick
  • Stuffy nose (nasal congestion)
  • Dizziness

Side effects seen with ivacaftor:

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

  • Infection of the upper respiratory tract (common cold), including sore throat and nasal congestion
  • Headache
  • Dizziness
  • Stomach pain (abdominal pain)
  • Diarrhoea
  • Increased liver enzymes in the blood
  • Rash
  • Changes in the type of bacteria in the mucus

Common(may affect up to 1 in 10 people)

  • Runny nose
  • Ear pain, discomfort in the ear
  • Ringing in the ears
  • Redness inside the ears
  • Inner ear disorder (feeling dizzy or that everything is spinning)
  • Nasal congestion
  • Redness of the throat
  • Lump in the breast

Uncommon(may affect up to 1 in 100 people)

  • Blocked ears
  • Breast inflammation
  • Enlargement of the breasts in men
  • Changes or pain in the nipples

Additional side effects in children and adolescents

The side effects seen in children and adolescents are similar to those seen in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Symkevi

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 after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

The active substances are tezacaftor and ivacaftor.

Symkevi 50 mg of tezacaftor/75 mg of ivacaftor film-coated tablets

Each film-coated tablet contains 50 mg of tezacaftor and 75 mg of ivacaftor.

The other ingredients are:

  • Tablet core: hypromellose acetate succinate, sodium lauryl sulfate (E487), hypromellose 2910 (E464), microcrystalline cellulose (E460(i)), sodium croscarmellose (E468) and magnesium stearate (E470b) (see section 2 “Symkevi contains sodium”).
  • Tablet coating: hypromellose 2910 (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171) and talc (E553b).

Symkevi 100 mg of tezacaftor/150 mg of ivacaftor film-coated tablets

Each film-coated tablet contains 100 mg of tezacaftor and 150 mg of ivacaftor.

The other ingredients are:

  • Tablet core: hypromellose acetate succinate, sodium lauryl sulfate (E487), hypromellose 2910 (E464), microcrystalline cellulose (E460(i)), sodium croscarmellose (E468) and magnesium stearate (E470b) (see section 2 “Symkevi contains sodium”).
  • Tablet coating: hypromellose 2910 (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), talc (E553b) and yellow iron oxide (E172).

Appearance and packaging

Symkevi 50 mg/75 mg film-coated tablets are oblong tablets (12.70 mm x 6.78 mm) white in colour with “V50” printed on one side and plain on the other.

Symkevi 100 mg/150 mg film-coated tablets are oblong tablets (15.9 mm x 8.5 mm) yellow in colour with “V100” printed on one side and plain on the other.

Symkevi is available in the following pack sizes:

Pack size of 28 tablets (4 blister cards of 7 tablets each).

Marketing Authorisation Holder

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block 5, Northwood Court, Northwood Crescent,

Dublin 9, D09 T665,

Ireland

Tel.: +353 (0)1 761 7299

Manufacturer

Almac Pharma Services (Ireland) Limited

Finnabair Industrial Estate

Dundalk

Co. Louth

A91 P9KD

Ireland

Almac Pharma Services Limited

Seagoe Industrial Estate

Craigavon

County Armagh

BT63 5UA

United Kingdom

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other web sites about rare diseases and orphan medicines.

Online doctors for SYMKEVI 50 mg/75 mg FILM-COATED TABLETS

Discuss questions about SYMKEVI 50 mg/75 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders, weight loss, hair loss;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Doctor

Lina Travkina

Family medicine 13 years exp.

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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Doctor

Alina Tsurkan

Family medicine 13 years exp.

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:

  • IMT medical certificates for driving licence exchange in Portugal.
  • 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.

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Frequently Asked Questions

Is a prescription required for SYMKEVI 50 mg/75 mg FILM-COATED TABLETS?
SYMKEVI 50 mg/75 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in SYMKEVI 50 mg/75 mg FILM-COATED TABLETS?
The active ingredient in SYMKEVI 50 mg/75 mg FILM-COATED TABLETS is ivacaftor and tezacaftor. This information helps identify medicines with the same composition but different brand names.
Who manufactures SYMKEVI 50 mg/75 mg FILM-COATED TABLETS?
SYMKEVI 50 mg/75 mg FILM-COATED TABLETS is manufactured by Vertex Pharmaceuticals (Ireland) Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of SYMKEVI 50 mg/75 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether SYMKEVI 50 mg/75 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to SYMKEVI 50 mg/75 mg FILM-COATED TABLETS?
Other medicines with the same active substance (ivacaftor and tezacaftor) include SYMKEVI 100 MG/150 MG FILM-COATED TABLETS, INOMAX 400 PPM MOL, COMPRESSED MEDICAL GAS, INOMAX 400 PPM MOL, COMPRESSED MEDICAL GAS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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