Lonsurf - patient leaflet, side effects, dosage

Patient leaflet - Lonsurf

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Lonsurf 15 mg/6.14 mg film-coated tablets

Lonsurf 20 mg/8.19 mg film-coated tablets

trifluridine/tipiracil

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

1. What Lonsurf is and what it is used for

Lonsurf is a type of cancer chemotherapy which belongs to the group of medicines called „cytostatic antimetabolite medicines“.

Lonsurf contains two different active substances: trifluridine and tipiracil.

Trifluridine stops the growth of cancer cells.
Tipiracil stops the trifluridine from being broken down by the body, helping trifluridine to work longer.

Lonsurf is used to treat adults with colon or rectal cancer – sometimes called ‘colorectal’ cancer and stomach cancer (including cancer of the junction between the oesophagus and the stomach).

It is used when the cancer has spread to other parts of the body (metastases).
It is used when other treatments have not worked – or when other treatments are not suitable for you.

2. What you need to know before you take Lonsurf

Do not take Lonsurf

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

Do not take Lonsurf if the above applies to you. If you are not sure, talk to your doctor before taking Lonsurf.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lonsurf if:

you have kidney problems
you have liver problems

If you are not sure, talk to your doctor or pharmacist before taking Lonsurf.

Treatment may lead to the following side effects (see section 4):

a reduced number of certain types of white blood cells (neutropenia) which are important for protecting the body against bacterial or fungal infections. As a consequence of neutropenia, fever (febrile neutropenia) and blood infection (septic shock) may occur
a reduced number of red blood cells (anaemia)
a reduced number of platelets in the blood (thrombocytopenia) which are important to stop bleeding and work by clumping and clotting blood vessel injuries
gastrointestinal problems.

Tests and checks

Your doctor will do blood tests before each cycle of Lonsurf. You start a new cycle every 4 weeks.

The tests are needed because Lonsurf can sometimes affect your blood cells.

Children and adolescents

This medicine is not indicated for use in children and adolescents below the age of 18 years. This is because it may not work or be safe.

Other medicines and Lonsurf

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 and herbal medicines. This is because Lonsurf can affect the way some other medicines work. Also some other medicines can affect the way Lonsurf works.

In particular tell your doctor or pharmacist if you are taking medicines used for treatment of HIV, such as zidovudine. This is because zidovudine may not work as well if you are taking Lonsurf. Talk to your doctor about whether to switch to a different HIV medicine.

If the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Lonsurf.

Pregnancy and breast-feeding

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

If you become pregnant, you and your doctor will have to decide if the benefits of Lonsurf are greater than the risk of harm to the baby.

Do not breast-feed if you are taking Lonsurf as it is not known whether Lonsurf passes into the mother’s milk.

Contraception

You must not become pregnant while taking this medicine. This is because it may harm your unborn baby.

You and your partner should use effective methods of contraception while taking this medicine. You should also do this for 6 months after you stop taking the medicine. If you or your partner become pregnant during this time, you must talk to your doctor or pharmacist straight away.

Driving and using machines

It is not known whether Lonsurf changes your ability to drive or use machines. Do not drive or use any tools or machines if you experience symptoms that affect your ability to concentrate and react.

Lonsurf contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Lonsurf

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

How much to take

Your doctor will decide the right dose for you – the dose depends on your weight and height and if you have kidney problems.
Lonsurf comes in two strengths. Your doctor may prescribe both strengths for your prescribed dose.
Your doctor will tell you how many tablets to take each time.
You will take a dose 2 times a day.

When to take Lonsurf

You will take Lonsurf for 10 days during the first 2 weeks, and then have 2 weeks off. This 4-week period is called a ‘cycle.’ The specific dosing schedule is as follows:

Week 1
– take the dose 2 times a day for 5 days
– then have 2 days off – no medicine

Week 2
– take the dose 2 times a day for 5 days
– then have 2 days off – no medicine

Week 3

– No medicine

Week 4

– No medicine

You will then start again with another cycle of 4 weeks following the above pattern.

How to take

Take this medicine by mouth.
Swallow the tablets whole with a glass of water.
Take within 1 hour after your morning and evening meals.
Wash your hands after handling this medicine.

If you take more Lonsurf than you should

If you take more Lonsurf than you should, talk to a doctor or go to a hospital straight away. Take your pack(s) of medicine with you.

If you forget to take Lonsurf

If you forget a dose, talk to your doctor or pharmacist.
Do not take a double dose to make up for a forgotten dose.

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

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:

Serious side effects

Tell your doctor immediately if you notice any of the following serious side effects (many of the side effects are shown in laboratory tests – for example those affecting your blood cells):

Neutropenia (very common), febrile neutropenia (common) and septic shock (uncommon). The signs include chills, fever, sweating or other signs of bacterial or fungal infection (see section 2).
Anaemia (very common). The signs include feeling short of breath, tiredness or looking pale (see section 2).
Vomiting (very common) and diarrhoea (very common), which may lead to a dehydration if severe or persistent.
Severe gastrointestinal problems: abdominal pain (common), ascites (uncommon), colitis (uncommon), acute pancreatitis (uncommon), ileus (uncommon) and subileus (uncommon). The signs include intense stomach or abdominal pain that can be associated with vomiting, blocked or partly blocked bowel, fever or swelling of the abdomen.
Thrombocytopenia (very common). The signs include unusual bruising or bleeding (see section 2).
Pulmonary embolism (uncommon): blood clots in lungs. The signs include shortness of breath and pain in the chest or in the legs.
Interstitial lung disease has been reported in patients receiving the medicine. The signs include difficulty in breathing, shortness of breath, with cough or fever.

Some of these serious side effects may lead to death.

Other side effects

Tell your doctor if you notice any of the following side effects. Many of the side effects are shown in laboratory tests – for example those affecting your blood cells. Your doctor will be looking out for these side effects in your test results.

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

decreased appetite
feeling very tired (fatigue)
feeling sick (nausea)
reduced white blood cells called leucocytes – can increase your risk for infection

Common: may affect up to 1 in 10 people:

fever
hair loss
weight loss
changes in taste
constipation
feeling generally out of sorts (malaise)
low level of albumin in the blood
increased bilirubin in your blood – can cause yellowing of skin or eyes
reduced number of white blood cells called lymphocytes – can increase your risk for infection
swelling in your hands or legs or feet
redness, swelling, pain on the palms of your hands and soles of your feet (hand-foot syndrome)
feeling of numbness or pins and needles in hands or feet
mouth pain or problems
swelling of mucous membranes – this could be inside the nose, mouth, throat, eyes, vagina, lungs or gut
increased liver enzymes
protein in your urine
rash, itchy or dry skin
feeling short of breath, airway or lungs, chest infections

Uncommon: may affect up to 1 in 100 people

low or high blood pressure
blood clots, e.g. in the brain or legs
blood test results indicating problems with clotting making you bleed more easily
more noticeable heart-beat, chest pain
abnormal increase or decrease in heart rate
changes in your heart trace (ECG – electrocardiogram)
increased white blood cells
increased number of white blood cells called monocytes
increased lactate dehydrogenase level in your blood
low levels of phosphates, sodium, potassium or calcium in your blood
reduced white blood cells called granulocytes or monocytes – can increase your risk for infection
high blood sugar (hyperglycaemia), increased salt, urea, creatinine and potassium in your blood
blood test result indicating inflammation (C-Reactive Protein increased)
ear pain
feeling of spinning (vertigo)
feeling dizzy, headache
runny or bloody nose, sinus problems
sore throat, hoarse voice, problems with your voice
redness, itching of the eye, eye infections, watery eyes
dry eyes
vision troubles as blurred vision, double vision, decreased vision, cataracts
dehydration
bloating, passing gas, indigestion
pain or inflammation in upper or lower part of digestive tract
inflammation, swelling or bleeding in your bowel
inflammation and infection in your gut
inflammation or increased acid in your stomach or gullet, reflux
painful tongue, polyps inside your mouth, mouth ulcers, retching
bad breath, tooth decay, tooth or gum problems, bleeding gums, gum infections
skin flushing
swelling or pain in your joints or big toes
pain or discomfort in your arms or legs
pain, including pain from the cancer
bone pain, muscle pain, muscle weakness or spasms, pain in tendons, nerves or ligaments
feeling of being cold
shingles (pain and vesicular rash on skin over nerve tracts affected by nerve inflammation from herpes zoster virus)
liver disorder
inflammation or infection of bile ducts, increase in the diameter of the bile duct
kidney failure
viral infection
cough, infection of the sinuses, throat infection
inflammation or infection in your bladder
changes in urine test, blood in urine
problems passing water (urine retention), loss of bladder control (incontinence)
athlete’s foot – fungal infection of feet, yeast infections
accumulation of fluid in the lungs
changes in the menstrual cycle
anxiety
fainting (syncope)
burning sensation, unpleasant, increased or loss of sense of touch and other non-severe neurological troubles
raised itchy rash, red skin, blisters, skin sloughing off, hives, acne
sweating more than normal, sensitivity to light, nail problems
problem with sleeping or falling asleep
low level of total protein in the blood

Reporting of side effects

If you experience 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 inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lonsurf

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 outer carton or blister 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 to protect the environment.

6. Contents of the pack and other information

What Lonsurf contains

Lonsurf 15 mg/6.14 mg film-coated tablet

The active substances are trifluridine and tipiracil. Each film-coated tablet contains 15 mg trifluridine and 6.14 mg tipiracil
The other ingredients are:
– Tablet core: lactose monohydrate, starch pregelatinised (maize) and stearic acid (see section 2 “Lonsurf contains lactose”).
– Film coat: hypromellose, macrogol (8000), titanium dioxide (E171), and magnesium stearate.
– Printing ink: shellac, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine aluminium lake (E132), carnauba wax and talc.

Lonsurf 20 mg/8.19 mg film-coated tablet

The active substances are trifluridine and tipiracil. Each film-coated tablet contains 20 mg trifluridine and 8.19 mg tipiracil.
The other ingredients are:
– Tablet core: lactose monohydrate, starch pregelatinised (maize) and stearic acid (see section 2 “Lonsurf contains lactose”).
– Film coating: hypromellose, macrogol (8000), titanium dioxide (E171), iron oxide red (E172), and magnesium stearate.
– Printing ink: shellac, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine aluminium lake (E132), carnauba wax and talc.

What Lonsurf looks like and contents of the pack

Lonsurf 15 mg/6.14 mg is a white, biconvex, round, film-coated tablet, printed with “15” on one side and “102” and “15 mg” on the other side in grey ink.
Lonsurf 20 mg/8.19 mg is a pale red, biconvex, round, film-coated tablet, printed with “20” on one side and “102” and “20 mg” on the other side in grey ink.

Each pack contains 20 film-coated tablets (2 blisters of 10 tablets each) or 40 film-coated tablets (4 blisters of 10 tablets each), or 60 film-coated tablets (6 blisters of 10 tablets each). A desiccant is incorporated into each blister foil.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Les Laboratoires Servier

50 rue Carnot