Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - gefitinib

Document Subject

Generated Narrative: MedicinalProductDefinition mp553de2aa690a5750d1825c26ecd3f9ed

identifier: http://ema.europa.eu/identifier/EU/1/18/1321/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Gefitinib Mylan 250 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-553de2aa690a5750d1825c26ecd3f9ed

identifier: http://ema.europa.eu/identifier/EU/1/18/1321/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - gefitinib

Attesters

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

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.

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.
• if you have ever had stomach problems (gastrointestinal perforation)

Tell your doctor immediately if you experience dehydration or eye problems whilst taking this medicine (see section 4).

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 as they may affect the way gefitinib works:

• 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).
• 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 are 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 .

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.
• The tablet should be swallowed with some water, 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.

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 this medicine.

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

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.

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 30x1 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 DUBLIN Ireland

Manufacturer Ardena Pamplona S.L. Pol gono Mochol
C/ No in, N 1
31110 No in (Navarra)
Spain

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

Belgi /Belgique/Belgien Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 Lietuva Mylan Healthcare UAB
Tel: +370 5 205 1

: +359 2 44 55 Luxembourg/Luxemburg Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 (Belgique/Belgien)

esk republika Viatris CZ. s.r.o. Tel: + 420 222 004 Magyarorsz g Mylan EPD Kft. Tel.: + 36 1 465 2Danmark Viatris ApS Tlf: + 45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Viatris Healthcare GmbH
Tel: + 49 800 0700 Nederland Mylan BV Tel: + 31 (0)20 426 3Eesti BGP Products Switzerland GmbH Eesti filiaal
Tel: + 372 6363 Norge Viatris AS Tlf: + 47 66 75 33
Generics Pharma Hellas
: +30 210 993 6 sterreich Arcana Arzneimittel GmbH Tel: +43 1 416 2Espa a Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 Polska Mylan Healthcare Sp. z.o.o. Tel.: + 48 22 546 64 France Viatris Sant
T l: +33 4 37 25 75 Portugal Mylan, Lda. Tel: + 351 214 127 Hrvatska Mylan Hrvatska d.o.o.
Tel: +385 1 23 50 Rom nia BGP Products SRL Tel: +40 372 579 Ireland Mylan Ireland Limited Tel: +353 1 8711Slovenija Viatris d.o.o. Tel: + 386 1 23 63 sland Icepharma hf. Simi: + 354 540 8Slovensk republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 Italia Mylan Italia S.r.l Tel: + 39 02 612 46Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9
Varnavas Hadjipanayis Ltd : + 357 2220 7Sverige Viatris AB
Tel: + 46 (0)8 630 19 Latvija Mylan Healthcare SIA Tel: +371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: