Gefitinib Mylan - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Gefitinib Mylan 250 mg film-coated tablets gefitinib

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, pharmacist or nurse.

• – 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, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Gefitinib Mylan is and what it is used for

• 2. What you need to know before you take Gefitinib Mylan

• 3. How to take Gefitinib Mylan

• 4. Possible side effects

• 5. How to store Gefitinib Mylan

• 6. Contents of the pack and other information

1. What Gefitinib Mylan is and what it is used for

Gefitinib Mylan contains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor’ (EGFR). This protein is involved in the growth and spread of cancer cells.

Gefitinib Mylan is used to treat adults with non-small cell lung cancer. This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung.

2. What you need to know before you take Gefitinib Mylan

Do not take Gefitinib Mylan:

• – if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in

section 6).

• – if you are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Gefitinib Mylan

• – if you have ever had any other lung problems. Some lung problems may get worse during

treatment with Gefitinib Mylan.

• – if you have ever had problems with your liver.

Children and adolescents

Gefitinib Mylan is not indicated in children and adolescents under 18 years.

Other medicines and Gefitinib Mylan

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

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• – Phenytoin or carbamazepine (for epilepsy).

• – Rifampicin (for tuberculosis).

• – Itraconazole (for fungal infections).

• – Barbiturates (a type of medicine used for sleeping problems).

• – Herbal remedies containing St John’s wort (Hypericum perforatum , used for depression and

anxiety).

• – Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to

reduce acids in the stomach).

These medicines may affect the way this medicine works.

• – Warfarin (a so-called oral anticoagulant, to prevent blood clots). If you are taking a medicine

containing this active substance, your doctor may need to do blood tests more often.

If any of the above applies to you, or if you are not sure, check with your doctor or pharmacist before taking Gefitinib Mylan.

Pregnancy and breast-feeding

Talk to your doctor if you are pregnant,may become pregnant or breast-feeding.

It is recommended that you avoid becoming pregnant during treatment with this medicine because Gefitinib Mylan could harm your baby.

Do not take Gefitinib Mylan if you are breast-feeding. This is for the safety of your baby.

Driving and using machines

You may feel weak while taking treatment with this medicine. If this happens, do not drive or use any tools or machines.

Gefitinib Mylan 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.

Gefitinib Mylan contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Gefitinib Mylan

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

• The recommended dose is one 250 mg tablet per day.
• Take the tablet at about the same time each day.
• You can take the tablet with or without food.
• Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking Gefitinib Mylan.

If you have trouble swallowing the tablet, dissolve it in half a glass of still (non-fizzy) water. Do not use any other liquids. Do not crush the tablet. Swirl the water until the tablet has dissolved. This may take up to 20 minutes. Drink the liquid straight away.

To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it.

If you take more Gefitinib Mylan than you should

If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.

If you forget to take Gefitinib Mylan

What to do if you forget to take a tablet depends on how long it is until your next dose.

• If it is 12 hours or more until your next dose: take the missed tablet as soon as you remember. Then take the next dose as usual.
• If it is less than 12 hours until your next dose: skip the missed tablet. Then take the next tablet at the usual time.

Do not take a double dose (two tablets at the same time) 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.

Tell your doctor immediately if you notice any of the following side effects – you may need urgent medical treatment:

• Allergic reaction (common), particularly if symptoms include swollen face, lips, tongue or throat, difficulty to swallow, hives, nettle rash and difficulty breathing.
• Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever. This

may mean that you have an inflammation of the lungs called ‘interstitial lung disease’. This may affect about 1 in 100 patients taking gefitinib and can be life-threatening.

• Severe skin reactions (rare) affecting large areas of your body. The signs may include redness,

pain, ulcers, blisters, and shedding of the skin. The lips, nose, eyes and genitals may also be affected.

• Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
• Eye problems (uncommon), such as pain, redness, watery eyes, light sensitivity, changes in vision or ingrowing eyelashes. This may mean that you have an ulcer on the surface of the eye (cornea).

Tell your doctor as soon as possible if you notice any of the following side effects:

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

• Diarrhoea.
• Vomiting.
• Nausea.
• Skin reactions such as an acne-like rash, which is sometimes itchy with dry and/or cracked skin.
• Loss of appetite.
• Weakness.
• Red or sore mouth.
• Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, your doctor may tell you to stop taking this medicine.

Common (may affect up to 1 in 10 people)

• Dry mouth.
• Dry, red or itchy eyes.
• Red and sore eyelids.
• Nail problems.
• Hair loss.
• Fever.
• Bleeding (such as nose bleed or blood in your urine).
• Protein in your urine (shown in a urine test).
• Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking Gefitinib Mylan.
• Increase of creatinine levels in a blood test (related to kidney function).
• Cystitis (burning sensations during urination and frequent, urgent need to urinate).

Uncommon (may affect up to 1 in 100 people)

• Inflammation of the pancreas. The signs include very severe pain in the upper part of the stomach area and severe nausea and vomiting.
• Inflammation of the liver. Symptoms may include a general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes). This side effect is uncommon; however, some patients have died from this.
• Gastrointestinal perforation.
• Skin reaction on the palms of the hands and soles of the feet including tingling, numbness, pain,

swelling or reddening (known as palmar-plantar erythrodysaesthesia syndrome or hand and foot syndrome).

Rare (may affect up to 1 in 1,000 people)

• Inflammation of the blood vessels in the skin. This may give the appearance of bruising or patches of non-blanching rash on the skin.
• Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).

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

5. How to store Gefitinib Mylan

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 blister and carton or pouch after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

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 Gefitinib Mylan contains

• – The active substance is gefitinib. Each film-coated tablet contains 250 mg of gefitinib.

• – The other ingredients are lactose monohydrate, microcrystalline cellulose (101), crospovidone (type A), povidone (K30), sodium laurilsulfate, magnesium stearate in the tablet core. The tablet coating contains polyvinyl alcohol (E1203), macrogol 4000 (E1521), talc (E553b), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

What Gefitinib Mylan looks like and contents of the pack

Gefitinib Mylan tablets are brown, round, biconvex film-coated tablets with approximately 11.1 mm x 5.6 mm of dimension and marked with “250” on one side and plain on the other.

It comes in PVC/PVDC/Aluminium blisters in packs of 30 film-coated tablets or in PVC/PVDC/Aluminium perforated unit dose blisters in packs of 30×1 film-coated tablets. The blisters may be packed into aluminium pouches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Pharmaceuticals Limited

Damastown Industrial Park,

Mulhuddart, Dublin 15,

DUBLIN

Ireland

Manufacturer

Idifarma Desarrollo Farmacéutico, S.L.

Polígono Mocholí

C/ Noáin, N° 1

31110 Noáin (Navarra)

Spain

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

België/Belgiqu­e/Belgien Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00	Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288
Et^rapuH Vlaíí.ian EOO^ Ten: +359 2 44 55 400	Luxembourg/Lu­xemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
Česká republika Mylan Healthcare CZ.s.r.o. Tel: + 420 222 004 400	Magyarorszag Mylan EPD Kft Tel: + 36 1 465 2100
Danmark Viatris ApS Tlf: + 45 28 11 69 32	Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74
Deutschland Mylan Healthcare GmbH Tel: + 49 800 0700 800	Nederland Mylan BV Tel: + 31 (0)20 426 3300
Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 052	Norge Mylan Healthcare Norge AS Tel: + 47 66 75 33 00
E/./.áňa Generics Pharma Hellas EnE Tnk +30 210 993 6410	Österreich Arcana Arzneimittel GmbH Tel: +43 1 416 2418
España Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712	Polska Mylan Healthcare Sp. z.o.o. Tel: + 48 22 546 64 00

France Mylan S.A.S Tel: +33 4 37 25 75 00	Portugal Mylan, Lda. Tel: + 351 21 412 72 56
Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599	România BGP Products SRL Tel: +40 372 579 000
Ireland Mylan Ireland Limited Tel: +353 1 8711600	Slovenija Mylan Healthcare d.o.o. Tel: + 386 1 23 63 180
Ísland Icepharma hf Simi: + 354 540 8000	Slovenská republika Mylan s.r.o. Tel: +421 2 32 199 100
Italia Mylan Italia S.r.l Tel: + 39 02 612 46921	Suomi/Finland Mylan Finland OY Puh/Tel: +358 20 720 9555
Kúnpog Varnavas Hadjipanayis Ltd Tnk + 357 2220 7700	Sverige Mylan AB Tel: + 46 855 522 750
Latvija Mylan Healthcare SIA Tel: +371 676 055 80	United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711600

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www. ema europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

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