Package leaflet: Information for the patient

Emlutini140 mg hard capsules

Emlutini

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

What is in this leaflet

1. What Emlutini is and what it is used for

2. What you need to know before you take Emlutini

3. How to take Emlutini

4. Possible side effects

5. How to store Emlutini

6. Contents of the pack and other information

1. What Emlutiniis and what it is used for

What Emlutini is

Emlutini is an anticancer medicine that contains the active substance Emlutini. It belongs to a class of medicines called protein kinase inhibitors.

What Emlutini is used for

It is used to treat the following blood cancers in adults:

-Mantle Cell Lymphoma (MCL), a type of cancer affecting the lymph nodes, when the disease has come back or has not responded to treatment.

-Chronic Lymphocytic Leukaemia (CLL) a type of cancer affecting white blood cells called lymphocytes that also involves the lymph nodes. It is used when the disease has come back or has not responded to treatment or in patients with high risk CLL (patients whose cancer cells have certain DNA changes called “17p deletion” or “TP53 mutation”) for whom chemotherapy given together with an antibody is not a suitable therapy.

-Waldenström’s macroglobulinaemia, a type of cancer affecting white blood cells called lymphocytes. It is used when the disease has come back or has not responded to treatment or in patients for whom chemotherapy given together with an antibody is not a suitable therapy.

How Emlutini works

In MCL and CLL, Emlutini works by blocking Bruton's tyrosine kinase, a protein in the body that helps these cancer cells grow and survive. By blocking this protein, Emlutini helps kill and reduce the number of cancer cells. It also slows down the worsening of the cancer.

2. What you need to know before you take Emlutini

Do not take Emlutini

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

             if you are taking a herbal medicine called St. John’s Wort, used for depression. If you are not sure about this, talk to your doctor, pharmacist or nurse before taking this medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Emlutini:

            if you have ever had unusual bruising or bleeding or are on any medicines or supplements that increase your risk of bleeding

            if you have a history of irregular heart beat (atrial fibrillation) or severe heart failure, which makes you short of breath and may lead to swollen legs

            if you have liver or kidney problems

            if you have recently had any surgery, especially if this might affect how you absorb food or medicines from your stomach or gut

            if you are planning to have any surgery– your doctor may ask you to stop taking Emlutini for a short time.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking this medicine.

Tests and check-ups before and during treatment

Tumour lysis syndrome (TLS): Unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened during treatment of cancer and sometimes even without treatment. This may lead to changes in kidney function, abnormal heartbeat, or seizures. Your doctor or anotherhealthcare provider may do blood tests to check for TLS.

Lymphocytosis: Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood in the first few weeks of treatment. This is expected and may last for a few months. This does not necessarily mean that your blood cancer is getting worse. Your doctor will check your bloodcounts before or during the treatment and in rare cases they may need to give you another medicine. Talk to your doctor about what your test results mean.

Children and adolescents

Emlutini should not be used in children and adolescents. This is because it has not been studied in these age groups.

Other medicines and Emlutini

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, herbal medicines and supplements. This is because Emlutini may affect the way some other medicines work. Also some other medicines can affect the way Emlutini works.

Emlutini may make you bleed more easily. This means you should tell your doctor if you take other medicines that increase your risk of bleeding. This includes:

            acetyl salicylic acid and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen or naproxen

            blood thinners such as warfarin, heparin or other medicines for blood clots

            supplements that may increase your risk of bleeding such as fish oil, vitamin E or flaxseed.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Emlutini.

Also tell your doctor if you take any of the following medicines – they can increase or decrease the amount of Emlutini in your blood:

            medicines called antibiotics to treat bacterial infections – clarithromycin, telithromycin, ciprofloxacin, erythromycin or rifampicin

            medicines for fungal infections – ketoconazole, itraconazole, fluconazole or voriconazole

            medicines for HIV infection – ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir, atazanavir, darunavir/ritonavir or fosamprenavir

            medicines to prevent nausea and vomiting associated with chemotherapy - aprepitant

            medicines for depression - nefazodon

            medicines called kinase inhibitors for treatment of other cancers – crizotinib or imatinib

            medicines called calcium channel blockers for high blood pressure or chest pain – diltiazem or verapamil

            heart medicines/anti-arrhythmics – amiodarone or dronedarone

            medicines to prevent seizures or to treat epilepsy, or medicines to treat a painful condition of the face called trigeminal neuralgia – carbamazepine or phenytoin.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Emlutini.

If you are taking digoxin, a medicine used for heart problems, it should be taken at least 6 hours before or after Emlutini.

Emlutini with food

Do not take Emlutini with grapefruit or Seville oranges (bitter oranges) – this includes eating them, drinking the juice or taking a supplement that might contain them. This is because it can increase the amount of Ibrutinib in your blood.

Pregnancy, breast-feeding and fertility

Do not get pregnant while you are taking this medicine. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.

Emlutini should not be used during pregnancy. There is no information about the safety of Emlutini in pregnant women.

Women of childbearing age must use a highly effective method of birth control during and up to three months after receiving Emlutini, to avoid becoming pregnant while being treated with Emlutini. If using hormonal contraceptives such as birth control pills or devices, a barrier method

of contraception (e.g. condoms) must also be used.

            Tell your doctor immediately if you become pregnant.

            Do not breast-feed while you are taking this medicine.

Driving and using machines

You may feel tired or dizzy after taking Emlutini, which may affect your ability to drive or use any tools or machines.

3. How to take Emlutini

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to take

Mantle Cell Lymphoma (MCL)

The recommended dose of Emlutini is four capsules (560 mg) once a day.

Chronic Lymphocytic Leukaemia (CLL)/Waldenström’s macroglobulinaemia (WM)

The recommended dose of Emlutini is three capsules (420 mg) once a day.

Your doctor may adjust your dose.

Taking this medicine

            Take the capsules orally (by mouth) with a glass of water.

            Take the capsules about the same time each day.

            Swallow the capsules whole. Do not open, break or chew them.

If you take more Emlutini than you should

If you take more Ibrutini than you should, talk to a doctor or go to a hospital straight away.

Take the capsules and this leaflet with you.

If you forget to take Emlutini

             If you miss a dose, it can be taken as soon as possible on the same day with a return to the normal schedule the following day.

            Do not take a double dose to make up for a forgotten dose.

            If you are not sure, talk to your doctor, pharmacist or nurse about when to take your next dose.

If you stop taking Emlutini

Do not stop taking this medicine unless your doctor tells you.

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

4. Possible side effects

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

The following side effects may happen with this medicine:

Stop taking Emlutini and tell a doctor straight away if you notice any of the following side effects:

itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat – you may be having an allergic reaction to the medicine.

Tell a doctor straight away if you notice any of the following side effects:

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

             fever, chills, body aches, feeling tired, cold or flu symptoms, being short of breath – these could be signs of an infection (viral, bacterial or fungal). These could include infections of the lung, the nose, sinus or throat (upper respiratory tract infection), or urinary tract or sinus, or skin.

            nose bleeds, bruising or increased tendency of bruising or small red or purple spots caused by bleeding under the skin.

Common (may affect more than 1 in 100 people)

            severe infections throughout the body (sepsis)

            blood in your stools or urine, heavier periods, bleeding that you cannot stop from an injury, confusion, headache with slurred speech or feeling faint – these could be signs of serious internal bleeding in your stomach, gut or brain

            fast heart rate, missed heart beats, weak or uneven pulse (symptoms of atrial fibrillation)

            an increase in the number or proportion of white blood cells shown in blood tests

            low white blood cell counts with fever (febrile neutropenia)

            blurred vision

            dry mouth

            not having enough water in the body (dehydration)

            high level of “uric acid” in the blood (shown in blood tests), which may cause gout.

Uncommon (may affect more than 1 in 1,000 people)

            severely increased white blood cell count that may cause cells to clump together

            unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened during treatment of cancer and sometimes even without treatment (tumour lysis syndrome).

Other very common side effects

            mouth sores

            headache or feeling dizzy

             constipation

             feeling or being sick (nausea or vomiting)

             diarrhoea, your doctor may need to give you a fluid and salt replacement or another medicine

             skin rash

             painful arms or legs

             back pain or joint pain

             muscle cramps or aches

             low number of cells that help blood clot (platelets), very low number of white blood cells, low number of red blood cells (anaemia) – shown in blood tests

             swollen hands, ankles or feet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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. How to store Emlutini

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 bottle label after EXP.

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

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Emlutini contains

            The active substance is Ibrutinib. Each hard capsule contains 140 mg of Ibrutinib.

             The other ingredients are:

- capsule content: croscarmellose sodium, magnesium stearate, microcrystalline cellulose and sodium lauril sulfate

- capsule shell: gelatin and titanium dioxide (E171)

The capsules are provided in a plastic bottle with a child resistant polypropylene closure. Each bottle contains either 90 or 120 capsules. Each pack contains one bottle.

Marketing Authorisation Holder

Tongmeng(Lao) Pharmaceutical and Food Co., Ltd

Rd13 South,31km,Ban Naphasuk,Saithany District

Vientiane

Lao PDR

Manufacturer

Tongmeng(Lao) Pharmaceutical and Food Co., Ltd

Rd13 South,31km,Ban Naphasuk,Saithany District

Vientiane

Lao PDR

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: