Gefitinib Sandoz

Leaflet attached to the packaging: patient information

Gefitinib Sandoz, 250 mg, coated tablets

Gefitinib

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Gefitinib Sandoz and what is it used for
• 2. Important information before taking Gefitinib Sandoz
• 3. How to take Gefitinib Sandoz
• 4. Possible side effects
• 5. How to store Gefitinib Sandoz
• 6. Contents of the pack and other information

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

Gefitinib Sandoz contains the active substance gefitinib, which inhibits the activity of a protein called the epidermal growth factor receptor (EGFR). This protein is involved in the process of growth and spread of cancer cells. Gefitinib Sandoz is used to treat adult patients with non-small cell lung cancer. This type of cancer develops in lung tissue.

2. Important information before taking Gefitinib Sandoz

When not to take Gefitinib Sandoz

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

Warnings and precautions

Before taking Gefitinib Sandoz, the patient should discuss it with their doctor or pharmacist if:

• the patient has ever had lung disease, as some lung problems may worsen during treatment with Gefitinib Sandoz;
• the patient has ever had liver function disorders.

Children and adolescents

Gefitinib Sandoz should not be taken by children and adolescents under 18 years of age.

Gefitinib Sandoz and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. In particular, they should tell their doctor or pharmacist if they are taking:

• phenytoin or carbamazepine (anti-epileptic medicines);
• rifampicin (a medicine used to treat tuberculosis);
• itraconazole (a medicine used to treat fungal infections);
• barbiturates (a type of medicine used to treat sleep disorders);
• herbal medicines containing St. John's Wort (Hypericum perforatum), used to treat depression and anxiety;
• proton pump inhibitors, H2 receptor antagonists, and antacids (medicines used to treat stomach ulcers, heartburn, and acid reflux); these medicines may affect the way Gefitinib Sandoz works.
• warfarin (a blood-thinning medicine). If the patient is taking a medicine containing this active substance, their doctor may order more frequent blood tests.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, may become pregnant, or is breastfeeding, they should tell their doctor before taking this medicine. The patient should avoid becoming pregnant while taking Gefitinib Sandoz, as it may harm the unborn child. Because of the potential risk to the baby, women who are breastfeeding should not take Gefitinib Sandoz.

Driving and using machines

If the patient feels weak while taking this medicine, they should be careful when driving, using tools, or operating machines.

Gefitinib Sandoz contains sodium and lactose

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is essentially 'sodium-free'. If the patient has been told they have an intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Gefitinib Sandoz

This medicine should always be taken exactly as the doctor has instructed. If the patient has any doubts, they should consult their doctor or pharmacist.

• The recommended dose is one 250 mg tablet per day.
• The tablet should be taken every day at the same time.
• The tablet can be taken with or without food.
• Antacids (which reduce the amount of acid in the stomach) can be taken at least 2 hours after or 1 hour before taking Gefitinib Sandoz.

If the patient has difficulty swallowing the tablet, they should mix it with still water. No other liquids should be used. The tablets should not be crushed. The contents should be mixed until the tablet dissolves (this may take up to 20 minutes), and then the mixture should be swallowed immediately after preparation. To ensure that the entire dose is taken, the glass should be refilled with half a glass of water and swallowed.

Taking more than the recommended dose of Gefitinib Sandoz

If the patient has taken more tablets than they should, they should immediately consult their doctor or pharmacist.

Missing a dose of Gefitinib Sandoz

The action to be taken if a dose is missed depends on the time remaining until the next dose is due.

• If there are 12 or more hours until the next dose is due, the missed tablet should be taken as soon as possible, and the next tablet at the usual time.
• If there are less than 12 hours until the next dose is due, the missed tablet should not be taken, and the next tablet should be taken at the usual time.

A double dose should not be taken to make up for a missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gefitinib Sandoz can cause side effects, although not everybody gets them.

If any of the following side effects occur, the patient should contact their doctor immediately, as urgent treatment may be necessary.

• Allergic reaction (common), especially with symptoms such as swelling of the face, lips, tongue, or throat, difficulty swallowing, hives, and difficulty breathing;
• Serious shortness of breath or sudden worsening of breathlessness, which may be accompanied by cough or fever. These may be symptoms of a lung inflammation called 'interstitial lung disease'. They may occur in approximately 1 in 100 patients taking Gefitinib Sandoz and may be life-threatening.
• Severe skin reactions (rare) affecting large areas of the body. Symptoms may include: redness, pain, blistering, peeling, and skin ulcers. The reactions may affect the lips, nose, eyes, and genitals.
• Dehydration (common) caused by prolonged or severe diarrhea, vomiting, nausea, or loss of appetite.
• Eye disorders (uncommon), such as pain, redness, tearing, sensitivity to light, vision changes, or ingrown eyelashes. These symptoms may indicate corneal ulcers.

If the following side effects occur, the patient should contact their doctor as soon as possible:

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

• diarrhea
• vomiting
• nausea
• skin reactions, such as acne-like rash, sometimes with dryness and (or) cracking of the skin
• loss of appetite
• weakness
• redness or pain in the mouth
• increased activity of the liver enzyme called 'alanine aminotransferase' seen in blood tests (if this activity is too high, the doctor may advise the patient to stop taking Gefitinib Sandoz).

Common (may affect less than 1 in 10 people):

• dry mouth
• dryness, redness, or itching of the eyes
• redness and pain of the eyelids
• nail disorders
• hair loss
• fever
• bleeding (e.g., nosebleeds or blood in the urine)
• presence of protein in the urine (detected in urine tests)
• increased levels of bilirubin and the liver enzyme called 'aspartate aminotransferase' seen in blood tests (if this activity is too high, the doctor may advise the patient to stop taking Gefitinib Sandoz)
• increased levels of creatinine seen in blood tests (assessing kidney function)
• urinary tract infection (feeling of burning during urination and frequent, sudden need to urinate).

Uncommon (may affect less than 1 in 100 people):

• pancreatitis (symptoms may include: very severe abdominal pain and severe nausea and vomiting)
• liver inflammation (with symptoms such as general malaise with jaundice [yellowing of the skin and eyes] or without jaundice); this side effect is uncommon but has led to death in some people
• perforation of the digestive tract
• skin reaction on the palms and soles, including tingling, numbness, pain, swelling, or redness (known as palmar-plantar erythrodysesthesia or hand-foot syndrome).

Rare (may affect less than 1 in 1000 people):

• inflammation of the skin blood vessels (may cause bruising or non-blanching rash on the skin)
• hemorrhagic cystitis (feeling of burning during urination and frequent, sudden need to urinate with blood in the urine).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Gefitinib Sandoz

The medicine should be stored out of sight and reach of children. This medicine should not be taken after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. There are no special storage precautions. Store in the original package to protect from moisture. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gefitinib Sandoz contains

• The active substance is gefitinib. One coated tablet contains 250 mg of gefitinib.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, povidone K30, magnesium stearate, sodium lauryl sulfate, polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), purified water, iron oxide red (E 172), iron oxide yellow (E 172).

What Gefitinib Sandoz looks like and contents of the pack

Gefitinib Sandoz is a brown, round, biconvex, coated tablet with a diameter of 11.1 mm, with the inscription "250" on one side and smooth on the other. The coated tablets are packed in non-perforated blisters of aluminum/OPA/aluminum/PVC, in a cardboard box. Pack sizes: 30 coated tablets.

Marketing authorization holder

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria

Manufacturer

Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus, Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia

For more information on this medicine and its authorized names in the European Economic Area, please contact:

Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warsaw, tel. 22 209 70 00, Date of last revision of the leaflet:10/2021, Sandoz logo