Capecitabine Glenmark

Package Leaflet: Information for the Patient

Capecitabine Glenmark, 150 mg, Film-Coated Tablets

Capecitabine Glenmark, 500 mg, Film-Coated Tablets

Capecitabine

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

• You should 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.

Contents of the Pack and Other Information

• 1. What Capecitabine Glenmark is and what it is used for
• 2. Before you take Capecitabine Glenmark
• 3. How to take Capecitabine Glenmark
• 4. Possible side effects
• 5. How to store Capecitabine Glenmark
• 6. Contents of the pack and other information

1. What Capecitabine Glenmark is and what it is used for

Capecitabine Glenmark is a medicine used to treat cancer. It belongs to a group of medicines called cytostatics, which stop cancer cells from growing. Capecitabine Glenmark contains capecitabine, which itself is not a cytostatic agent. Only after being absorbed by the body is it changed into the active cytostatic drug (more of this drug is formed in tumor tissue than in normal tissue). Capecitabine Glenmark is used to treat colon, rectal, stomach, or breast cancer. It is also used to prevent colon cancer from coming back after it has been removed by surgery. Capecitabine Glenmark can be used alone or in combination with other medicines to treat cancer.

2. Before you take Capecitabine Glenmark

Do Not Take Capecitabine Glenmark:

• if you are allergic to capecitabine or any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney or liver problems,
• if you have a known deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD),
• if you are pregnant or breastfeeding,
• if you have been treated in the last 4 weeks with a certain type of radiation treatment called brivudine, used to treat shingles or chickenpox.

Warnings and Precautions:

Before taking Capecitabine Glenmark, tell your doctor or pharmacist if:

• you have partial deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD),
• you have liver or kidney problems,
• you have heart problems (e.g., irregular heartbeat, chest pain, or jaw pain, arm, neck, or back pain that worsens with exercise due to heart problems),
• you have brain problems (e.g., tumors that have spread to the brain or nerve damage),
• you have diabetes,
• you have severe vomiting or diarrhea and cannot absorb food and water,
• you have diarrhea,
• you are dehydrated or become dehydrated,
• you have electrolyte imbalances (electrolyte disturbances, as shown by blood tests),
• you have had eye problems in the past, as you may need extra monitoring of your eyes,
• you have severe skin reactions.

DPD Deficiency: DPD deficiency is a rare genetic disorder that usually does not cause health problems unless you take certain medicines. If you have DPD deficiency and take Capecitabine Glenmark, you are at increased risk of severe side effects (listed in section 4). It is recommended that you have a test before starting treatment to check if you have DPD deficiency. If you have no enzyme activity, you should not be treated with Capecitabine Glenmark. If your enzyme activity is reduced (partial deficiency), your doctor may prescribe a lower dose of the medicine. Even if your test result is negative, you may still experience severe and life-threatening side effects.

Children and Adolescents

Capecitabine Glenmark is not intended for use in children and adolescents. Do not give Capecitabine Glenmark to children and adolescents.

Capecitabine Glenmark with Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, and any you plan to take. This is especially important because taking more than one medicine at the same time can increase the risk of side effects.

Do Not Take Brivudine (an Antiviral Medicine Used to Treat Shingles or Chickenpox) at the Same Time as Capecitabine Glenmark (Including During Breaks When You Are Not Taking Tablets).

If You Have Taken Brivudine, Wait at Least 4 Weeks After Stopping Brivudine Before Starting Capecitabine Glenmark. See Section "Do Not Take Capecitabine Glenmark".

You should also be careful when taking any of the following medicines:

• medicines used to treat gout (allopurinol),
• blood thinners (acenocoumarol, warfarin),
• medicines used to treat epilepsy or seizures (phenytoin),
• interferon alfa,
• if you are undergoing radiation therapy and taking other anticancer medicines (folic acid, oxaliplatin, bevacizumab, cisplatin, irinotecan),
• medicines used to treat folic acid deficiency.

Taking Capecitabine Glenmark with Food and Drink

Take Capecitabine Glenmark within 30 minutes after a meal.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Capecitabine Glenmark if you are pregnant or think you may be pregnant. During treatment with Capecitabine Glenmark and for 2 weeks after your last dose, you must not breastfeed. Women who are able to become pregnant should use effective contraception while taking Capecitabine Glenmark and for 6 months after the last dose. Men whose partners are able to become pregnant should use effective contraception while taking Capecitabine Glenmark and for 3 months after the last dose.

Driving and Using Machines

Capecitabine Glenmark may cause dizziness, nausea, or fatigue. Therefore, it may affect your ability to drive or use machines.

Capecitabine Glenmark Contains Lactose

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

3. How to Take Capecitabine Glenmark

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Capecitabine Glenmark should only be prescribed by a doctor who is experienced in treating cancer. Your doctor will work out the correct dose of Capecitabine Glenmark for you based on your body surface area, which is calculated from your height and weight. The usual dose for adults is 1250 mg/m² taken twice daily (morning and evening). Here are two examples: a person with a body weight of 64 kg and a height of 164 cm has a body surface area of 1.7 m² and should take 4 x 500 mg tablets and 1 x 150 mg tablet twice daily. A person with a body weight of 80 kg and a height of 180 cm has a body surface area of 2.00 m² and should take 5 x 500 mg tablets twice daily.

Your Doctor Will Tell You How Much to Take, When, and for How Long to Take It.

Your doctor may tell you to take a combination of 150 mg and 500 mg tablets to make up the correct dose.

• Take the tablets morning and evening with food.
• Take the tablets whole with water within 30 minutes after a meal. Do not crush or cut the tablets.If you have difficulty swallowing the tablets whole, tell your doctor.
• It is important to take the tablets as instructed by your doctor.

The tablets are usually taken for 14 days, followed by a 7-day rest period (when no tablets are taken). This 21-day period is one treatment cycle. When Capecitabine Glenmark is used in combination with other medicines, the usual dose for adults may be lower than 1250 mg/m², and the tablets may be taken daily without a rest period.

If You Take More Capecitabine Glenmark Than You Should

Contact your doctor as soon as possible if you take more Capecitabine Glenmark than you should. If you take too much Capecitabine Glenmark, you may experience the following symptoms: nausea or vomiting, diarrhea, inflammation or ulceration of the gut or mouth, abdominal pain or bleeding, or bone marrow depression (reduced blood cell counts). Tell your doctor if you experience any of these symptoms.

If You Forget to Take Capecitabine Glenmark

Do not take the missed dose. Do not take a double dose to make up for a forgotten dose. Continue with your next scheduled dose and talk to your doctor.

If You Stop Taking Capecitabine Glenmark

There are no side effects caused by stopping Capecitabine Glenmark. However, if you are taking anticoagulant medicines (e.g., phenprocoumon), your doctor may need to adjust the dose of the anticoagulant medicine when you stop taking Capecitabine Glenmark. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following symptoms, stop taking Capecitabine Glenmark and contact your doctor immediately:

• Diarrhea: if you have 4 or more bowel movements per day or diarrhea at night.
• Vomiting: if you vomit more than once in 24 hours.
• Nausea: if you have a reduced appetite and eat less than usual.
• Mouth Ulceration: if you have pain, redness, swelling, or ulcers in your mouth.
• Hand-and-Foot Syndrome: if you have pain, swelling, redness, or tingling of hands and/or feet.
• Fever: if you have a fever over 38°C.
• Infections: if you have signs of infection, such as fever, chills, or other symptoms.
• Chest Pain: if you have pain in the center of your chest, especially during exercise.
• Stevens-Johnson Syndrome: if you have painful redness or purple rash that spreads and blisters, and other skin or mucous membrane symptoms, especially if you have had sensitivity to light, respiratory infections (e.g., bronchitis), or fever.
• Angioedema: if you have swelling, especially of the face, lips, tongue, or throat, difficulty swallowing or breathing, itching, or hives. These may be symptoms of angioedema.

If side effects are recognized early, they usually get better within 2-3 days after stopping treatment. If side effects persist, contact your doctor. Your doctor may prescribe a lower dose of Capecitabine Glenmark. If you experience severe mouth ulcers, inflammation of the gut, diarrhea, low white blood cell count, or nerve damage during the first cycle of treatment, this may be related to DPD deficiency (see section 2: "Warnings and Precautions"). Hand-and-foot syndrome can lead to loss of fingerprints (due to the peeling of skin on the fingers). Additionally, if Capecitabine Glenmark is used alone, very common side effects (affecting more than 1 in 10 people) include:

• abdominal pain,
• skin rash, dry skin, or itching,
• fatigue,
• loss of appetite.

Side effects can become severe, so it is essential to always contact your doctor immediatelyif they occur. Your doctor may reduce the dose or temporarily stop Capecitabine Glenmark to reduce the duration and severity of these side effects. Other side effects: Common side effects (affecting up to 1 in 10 people) include:

• reduced white blood cell or red blood cell count (as shown by blood tests),
• dehydration, weight loss,
• insomnia, depression,
• headache, drowsiness, dizziness, abnormal sensations (tingling or numbness), taste changes,
• eye irritation, increased tear production, redness of the eyes (conjunctivitis),
• vein inflammation (thrombophlebitis),
• shortness of breath, nosebleeds, cough, runny nose,
• cold sores or other herpes infections,
• lung or respiratory infections (e.g., pneumonia or bronchitis),
• gastrointestinal bleeding, constipation, abdominal pain, indigestion, gas, dry mouth,
• skin rash, hair loss, redness of the skin, dry skin, itching, skin discoloration, skin peeling, skin inflammation, nail changes,
• joint or limb pain, chest or back pain, fever, swelling of the limbs, feeling unwell,
• liver problems (as shown by blood tests) and increased bilirubin levels in the blood.

Uncommon side effects (affecting up to 1 in 100 people) include:

• blood infections, urinary tract infections, skin infections, fungal infections (including mouth infections), flu, gastrointestinal infections,
• lipomas (fatty lumps under the skin),
• reduced blood cell count, including platelets (as shown by blood tests),
• allergic reactions,
• diabetes, low potassium, magnesium, or calcium levels in the blood, high blood sugar levels,
• confusion, panic attacks, depression, loss of sex drive,
• speech problems, memory problems, lack of coordination, balance problems, fainting, nerve damage, and sensory problems,
• blurred or double vision,
• vertigo, ear pain,
• irregular heartbeat, palpitations, heart attack,
• blood clots in deep veins, high or low blood pressure, hot flushes, cold extremities, purple spots on the skin,
• blood clots in the lungs (pulmonary embolism), lung collapse, coughing up blood, asthma, shortness of breath during exercise,
• intestinal blockage, fluid accumulation in the abdomen, inflammation of the small or large intestine, stomach, or esophagus, abdominal pain, discomfort in the abdomen, heartburn, blood in the stool,
• jaundice (yellowing of the skin and eyes),
• skin ulcers, blisters, or peeling, sunburn, redness of the hands, swelling, or pain in the face,
• joint or muscle swelling, bone or muscle pain, muscle weakness or stiffness,
• fluid accumulation in the kidneys, increased urination at night, incontinence, blood in the urine, increased creatinine levels in the blood (a sign of kidney problems),
• unusual vaginal bleeding,
• swelling, chills, and muscle stiffness.

Some of these side effects can occur more frequently when capecitabine is used with other anticancer medicines. The following additional side effects have been reported:

• low sodium, magnesium, or calcium levels in the blood, high blood sugar levels,
• nerve pain,
• ringing or buzzing in the ears (tinnitus), hearing loss,
• vein inflammation,
• hiccups, voice changes,
• mouth or jaw pain,
• sweating, night sweats,
• muscle cramps,
• urination problems, blood or protein in the urine,
• discoloration or reaction at the injection site (caused by medicines given by injection at the same time).

Rare side effects (affecting up to 1 in 1,000 people) include:

• narrowing or blockage of the tear duct (stenosis of the lacrimal duct),
• liver problems,
• inflammation of the liver that can cause jaundice (cholestatic hepatitis),
• certain changes in the electrocardiogram (ECG) - QT prolongation,
• certain types of irregular heartbeat (including ventricular fibrillation, torsades de pointes, and bradycardia),
• inflammatory eye problems that can cause eye pain and vision problems,
• skin inflammation that can cause red, scaly skin changes, associated with an immune system disorder,
• angioedema (swelling, especially of the face, lips, tongue, or throat, difficulty swallowing or breathing, itching, or hives).

Very rare side effects (affecting up to 1 in 10,000 people) include:

• severe skin reactions, such as skin rash, blisters, and peeling, including blisters in the mouth, nose, genitals, hands, feet, and eyes (red and swollen eyes).

Reporting of Side Effects

If you experience 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 the "Further information" section. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Capecitabine Glenmark

Keep this medicine out of the sight and reach of children. Store in the original package. Do not store above 30°C. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Capecitabine Glenmark Contains

• The active substance is capecitabine. Each film-coated tablet contains 150 mg or 500 mg of capecitabine.
• The other ingredients are:
• tablet core: lactose anhydrous, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate.
• tablet coating: hypromellose, titanium dioxide (E171), yellow iron oxide and red iron oxide (E172), talc.

What Capecitabine Glenmark Looks Like and Contents of the Pack

Capecitabine Glenmark 150 mg film-coated tablets are light peach-colored, oblong, biconvex, and engraved with "150" on one side and are smooth on the other side. Capecitabine Glenmark 500 mg film-coated tablets are peach-colored, oblong, biconvex, and engraved with "500" on one side and are smooth on the other side. Capecitabine Glenmark is available in packs of 30, 60, or 120 film-coated tablets.

Marketing Authorisation Holder

Glenmark Pharmaceuticals s.r.o., Hvĕzdova 1716/2b, 140 78 Prague 4, Czech Republic

Manufacturer

Glenmark Pharmaceuticals s.r.o., Hvĕzdova 1716/2b, 140 78 Prague 4, Czech Republic

For Further Information

Glenmark Pharmaceuticals Sp. z o.o., ul. Osmańska 14, 02-823 Warsaw, Poland. Date of Last Revision: May 2022