Package leaflet: Information for the patient

Ivacaftor Ranbaxy, 150 mg, film-coated tablets
Ivacaftor
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Ivacaftor Ranbaxy is and what it is used for
Important information before taking Ivacaftor Ranbaxy
How to take Ivacaftor Ranbaxy
Possible side effects
How to store Ivacaftor Ranbaxy
Contents of the pack and other information

1. What Ivacaftor Ranbaxy is and what it is used for

Ivacaftor Ranbaxy contains the active substance ivacaftor. Ivacaftor acts on the cystic fibrosis transmembrane conductance regulator (CFTR) protein—a membrane protein that forms a channel on the cell surface, allowing movement of particles such as chloride ions into and out of the cell. In patients with cystic fibrosis (CF), mutations in the CFTR gene (see below) result in reduced chloride ion transport. Ivacaftor affects specific defective CFTR proteins by increasing the frequency of channel opening, thereby enhancing chloride transport into and out of the cell.

Ivacaftor Ranbaxy tablets are indicated:

as monotherapy in patients with cystic fibrosis aged 6 years and older and weighing 25 kg or more, who have the R117H mutation in the CFTR gene or one of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

2. Important information before using Ivacaftor Ranbaxy

When not to use Ivacaftor Ranbaxy:

if the patient is allergic to ivacaftor or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Ivacaftor Ranbaxy, discuss this with your doctor or pharmacist.

Tell your doctor if the patient has or has previously had any liver problems. A dose adjustment by the doctor may be necessary.
Increased liver enzyme activity in the blood has been observed in some patients receiving Ivacaftor Ranbaxy. Inform your doctor immediately if the patient experiences any of the following symptoms, which may indicate liver dysfunction:
Pain or discomfort in the upper right part of the abdomen,
Yellowing of the skin or the whites of the eyes,
Loss of appetite,
Nausea or vomiting,
Dark-coloured urine.
Your doctor will order blood tests before starting treatment and during treatment to monitor liver function, especially during the first year of treatment and in patients who previously had high liver enzyme levels in blood tests.
Tell your doctor if the patient has or has previously had any kidney problems.
Ivacaftor Ranbaxy is not recommended for transplant recipients.
Tell your doctor if the patient is using hormonal contraception—for example, women taking oral contraceptive pills. This may increase the likelihood of developing a rash during treatment with Ivacaftor Ranbaxy.
In some children and adolescents taking Ivacaftor Ranbaxy, cases of lens abnormalities (cataracts) without affecting vision have been observed. Your doctor may perform eye examinations before and during treatment.
Ivacaftor Ranbaxy should only be used in patients who have been confirmed to have one of the CTFR gene mutations listed in section 1 (What Ivacaftor Ranbaxy is and what it is used for).

Children and adolescents
This medicine must not be used in children under 1 month of age, as the safety and efficacy of the medicine have not been established in this age group.
Ivacaftor Ranbaxy and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Some medicines may affect the action of Ivacaftor Ranbaxy or increase the risk of adverse effects.
In particular, tell your doctor if the patient is taking any of the following medicines. Your doctor may decide to adjust the dose or perform additional monitoring tests.
Antifungal medicines (used to treat fungal infections). These include:
fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole.
Antibacterial medicines (used to treat bacterial infections). These include:
clarithromycin, erythromycin, rifabutin, rifampicin, and telithromycin.
Anticonvulsant medicines (used to treat epileptic seizures). These include:
carbamazepine, phenobarbital, and phenytoin.
Herbal medicines. These include: St John's wort (Hypericum perforatum).
Immunosuppressive medicines (used after organ transplantation). These include: cyclosporine,
everolimus, sirolimus, and tacrolimus.
Cardiac glycosides (used to treat certain heart rhythm disorders). These include: digoxin.
Anticoagulant medicines (used to prevent blood clots). These include: warfarin.
Medicines for diabetes. These include: glimepiride or glipizide.
Medicines to lower blood pressure. These include: verapamil.
Taking Ivacaftor Ranbaxy with food and drink
Avoid consuming food or drinks containing grapefruit during treatment, as they may increase the adverse effects of Ivacaftor Ranbaxy by increasing the amount of ivacaftor in the body.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. If possible, it is better to avoid using Ivacaftor Ranbaxy during pregnancy, and the doctor will help decide what is best for the patient and her child.
Ivacaftor passes into breast milk. If the patient plans to breastfeed, she should consult her doctor before taking Ivacaftor Ranbaxy. The doctor will decide whether to recommend discontinuing breastfeeding or stopping treatment with ivacaftor. The doctor will consider the benefits of breastfeeding for the child and the benefits of treatment for the patient.
Driving and using machines
Ivacaftor Ranbaxy may cause dizziness. If the patient experiences dizziness, they should not drive, ride a bicycle, or operate machinery.
Ivacaftor Ranbaxy contains lactose and sodium
If the patient has previously been diagnosed with an intolerance to certain sugars, they should contact their doctor before taking this medicine.
Ivacaftor Ranbaxy contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".

3. How to take Ivacaftor Ranbaxy

This medicine should always be taken as prescribed by the doctor. If in doubt, consult the doctor.
The doctor will decide which medicine and dose are appropriate for the patient.
The recommended dose is 150 mg every 12 hours (a total of 300 mg per day) taken orally with a meal containing fat.
All other medicines being taken should be continued unless the doctor decides otherwise.
If the patient has impaired liver function (moderate or severe), the doctor may reduce the tablet dose, as the liver in such patients eliminates the medicine more slowly than in patients with normal liver function.
This medicine is intended for oral administration.
The tablet should be swallowed whole. Do not crush, chew or dissolve the tablets. Ivacaftor Ranbaxy tablets should be taken with a meal containing fat.
Meals or snacks containing fat include, for example, those prepared with butter or oil, or containing eggs. Other foods containing fat:

cheese, whole milk, full-fat dairy products, yoghurt, chocolate;
meats, fatty fish;
avocado, hummus, soy-based products (tofu);
nuts, energy bars or drinks containing fat.

Taking more Ivacaftor Ranbaxy than prescribed
The patient may experience adverse effects, including those listed below in section 4. If this occurs, consult a doctor or pharmacist. If possible, bring the medicine and this leaflet with you.
Missing a dose of Ivacaftor Ranbaxy
Take the missed dose if less than 6 hours have passed since it was due. Otherwise, wait until the next scheduled dose. Do not take a double dose to make up for a missed dose.
Stopping Ivacaftor Ranbaxy
Ivacaftor Ranbaxy should be taken for as long as recommended by the doctor. Do not stop taking it without medical advice. If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of these adverse reactions, immediately consult a doctor.

Very common adverse reactions (may occur in more than 1 in 10 people):
Upper respiratory tract infection (common cold), including sore throat and nasal congestion
Headache
Dizziness
Diarrhea
Stomach or abdominal pain
Change in the type of bacteria present in the patient's mucus
Rash

Common adverse reactions (may occur in up to 1 in 10 people):
Catarrh
Ear pain, ear discomfort
Tinnitus (ringing in the ears)
Redness inside the ear
Inner ear disorders (dizziness or sensation of spinning)
Sinus problems (sinus congestion)
Redness of the throat
Breast lumps

Uncommon adverse reactions (may occur in up to 1 in 100 people):
Hearing impairment
Mastitis (inflammation of the breast)
Gynecomastia (enlargement of the breasts in males)
Changes or pain around the nipple

Additional adverse reactions in children and adolescents
Adverse reactions observed in children and adolescents are similar to those observed in adults. However, increased liver enzyme activity in the blood is more frequently observed in young children.

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Ivacaftor Ranbaxy

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ivacaftor Ranbaxy contains
The active substance is ivacaftor.
Each coated tablet contains 150 mg of ivacaftor.

Other ingredients are:
Tablet core: microcrystalline cellulose, lactose monohydrate, hypromellose acetate succinate, sodium croscarmellose, sodium lauryl sulfate (E487), colloidal anhydrous silica, and magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (PEG 3350), talc, indigo carmine, aluminium lake (E132).

See end of section 2 – Ivacaftor Ranbaxy contains lactose and sodium.
What Ivacaftor Ranbaxy looks like and contents of the pack
Ivacaftor Ranbaxy 150 mg coated tablets are light blue, capsule-shaped, measuring 16.5 mm x 8.4 mm, printed with "RM67" on one side and plain on the reverse.
Available pack sizes:
Blister packs in cardboard cartons containing 28, 30, 50, 56, 60, and 100 coated tablets.
Perforated single-dose blisters in cardboard cartons containing 28 x 1 and 56 x 1 coated tablets.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
Tel. 22 642 07 75
Manufacturer/Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia S.A.
124 Fabricii Street
400 640 Cluj Napoca
Romania
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Netherlands: Ivacaftor SUN 150 mg filmomhulde tabletten
Germany: Ivacaftor BASICS 150 mg Filmtabletten
France: IVACAFTOR SUN 150 mg, comprimé pelliculé
Spain: Ivacaftor SUN 150 mg comprimidos recubiertos con película EFG
Romania: Ivacaftor SUN 150 mg comprimate filmate
Italy: Ivacaftor SUN