Capecitabine Glenmark

Package Leaflet: Information for the Patient

Capecitabine Glenmark, 150 mg, Film-Coated Tablets

Capecitabine Glenmark, 500 mg, Film-Coated Tablets

Capecitabine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, as You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication Has Been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication May Harm Them, Even if Their Symptoms are the Same as Yours.
• If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist (See Section 4).

Package Leaflet Contents

• 1. What is Capecitabine Glenmark and What is it Used for
• 2. Important Information Before Taking Capecitabine Glenmark
• 3. How to Take Capecitabine Glenmark
• 4. Possible Side Effects
• 5. How to Store Capecitabine Glenmark
• 6. Package Contents and Other Information

1. What is Capecitabine Glenmark and What is it Used for

Capecitabine Glenmark is a Medication Belonging to the Group of "Cytostatics" that Inhibit the Growth of Cancer Cells. Capecitabine Glenmark Contains Capecitabine, Which is Not a Cytostatic Medication itself. Only After Being Absorbed by the Patient's Body Does it Turn into an Active Anti-Cancer Medication (More of this Medication Accumulates in Cancer Tissue than in Healthy Tissues).
Capecitabine Glenmark is Used to Treat Colon, Rectal, Stomach, or Breast Cancer.
In Addition, it is Also Used to Prevent Recurrence of Colon Cancer After Complete Surgical Removal of the Tumor.
Capecitabine Glenmark May be Used as a Single Medication or in Combination with Other Medications.

2. Important Information Before Taking Capecitabine Glenmark

When Not to Take Capecitabine Glenmark:

• If You are Allergic to Capecitabine or Any of the Other Ingredients of this Medication (Listed in Section 6). If You Know You are Allergic or Hypersensitive to this Medication, You Must Inform Your Doctor Immediately.
• If You Have Had Severe Reactions to Previous Use of Fluoropyrimidine Medications (a Group of Anti-Cancer Medications such as Fluorouracil),
• If You are Pregnant or Breastfeeding,
• If You Have a Very Low White Blood Cell or Platelet Count (Leukopenia, Neutropenia, or Thrombocytopenia),
• If You Have Severe Liver or Kidney Disease,
• If You Have a Complete Lack of Dihydropyrimidine Dehydrogenase (DPD) Enzyme Activity (Complete DPD Deficiency),
• If You are Currently Taking or Have Taken Brivudine in the Last 4 Weeks (Used to Treat Chickenpox or Shingles). See "When Not to Take Capecitabine Glenmark" Section.

Warnings and Precautions:

Before Starting Capecitabine Glenmark, Discuss the Following with Your Doctor or Pharmacist:

• If You Have Been Diagnosed with Partially Reduced Dihydropyrimidine Dehydrogenase (DPD) Enzyme Activity,
• If a Family Member Has a Partial or Complete Lack of Dihydropyrimidine Dehydrogenase (DPD) Enzyme Activity,
• If You Have Liver or Kidney Disease,
• If You Have a History of Heart Disease (e.g., Irregular Heartbeat or Chest Pain, Jaw, and Back Pain that Worsens with Physical Effort Due to Blood Flow Problems to the Heart),
• If You Have a History of Brain Disease (e.g., Tumors with Brain Metastases or Nerve Damage (Neuropathy)),
• If You Have Been Diagnosed with Calcium Imbalance (Based on Blood Test Results),
• If You Have Diabetes,
• If You are Unable to Absorb Water and Food Due to Severe Nausea and Vomiting,
• If You Have Diarrhea,
• If You are Dehydrated or Become Dehydrated,
• If You Have Electrolyte Imbalance (Electrolyte Disorders, Based on Blood Test Results),
• If You Have a History of Eye Problems, as Additional Eye Monitoring May be Necessary,
• If You Have Severe Skin Reactions.

Dihydropyrimidine Dehydrogenase (DPD) Deficiency:DPD Deficiency is a Genetic Disorder that Usually Does Not Cause Health Problems Until the Patient Takes Certain Medications. If You Have a DPD Deficiency and Take Capecitabine Glenmark, the Risk of Severe Side Effects (Listed in Section 4) Increases.
It is Recommended to Perform a Test to Check for DPD Deficiency Before Starting Treatment. If You Have a Complete Lack of this Enzyme, You Should Not be Treated with Capecitabine Glenmark. If the Enzyme Activity is Reduced (Partial Deficiency), Your Doctor May Prescribe a Lower Dose of the Medication. Even if the DPD Deficiency Test Result is Negative, Severe and Life-Threatening Side Effects May Still Occur.

Children and Adolescents

Capecitabine Glenmark is Not Indicated for Children and Adolescents. Do Not Give Capecitabine Glenmark to Children and Adolescents.

Capecitabine Glenmark and Other Medications

Before Starting Treatment, Tell Your Doctor or Pharmacist About All Medications You are Currently Taking or Have Recently Taken, as Well as Any Medications You Plan to Take.
This is Especially Important, as Taking More than One Medication at the Same Time Can Enhance or Weaken its Effect.

Do Not Take Brivudine (an Anti-Viral Medication Used to Treat Shingles or Chickenpox) at the Same Time as Capecitabine Glenmark (Including During Treatment Breaks Without Taking Tablets).

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

You Should Also Exercise Caution if You are Taking Any of the Following Medications:

• Medications Used to Treat Gout (Allopurinol),
• Blood Thinners (Acenocoumarol, Warfarin),
• Medications Used to Treat Epilepsy or Seizures (Phenytoin),
• Interferon Alpha,
• If You are Undergoing Radiotherapy and Taking Other Anti-Cancer Medications (Folinic Acid, Oxaliplatin, Bevacizumab, Cisplatin, Irinotecan),
• Medications Used to Treat Folic Acid Deficiency.

Capecitabine Glenmark with Food and Drink

Take Capecitabine Glenmark No Later than 30 Minutes After a Meal.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Consult Your Doctor or Pharmacist Before Taking this Medication.
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 the Last Dose, Do Not Breastfeed.
Women of Childbearing Age Should Use Effective Contraception During Treatment with Capecitabine Glenmark and for 6 Months After the Last Dose.
Men Whose Partners are of Childbearing Age Should Use Effective Contraception During Treatment with Capecitabine Glenmark and for 3 Months After the Last Dose.

Driving and Operating Machinery

Capecitabine Glenmark May Cause Dizziness, Nausea, or Fatigue.
Therefore, Taking Capecitabine Glenmark May Impair Your Ability to Drive or Operate Machinery.

Capecitabine Glenmark Contains Lactose

If Your Doctor Has Told You That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking this Medication.

3. How to Take Capecitabine Glenmark

Always Take this Medication Exactly as Your Doctor or Pharmacist Has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist.
Capecitabine Glenmark Should be Prescribed by a Doctor Experienced in the Use of Anti-Cancer Medications.
Your Doctor Will Determine the Dose and Treatment Schedule Suitable for You .The Dose of Capecitabine Glenmark is Based on Your Body Surface Area, Which is Calculated from Your Height and Weight. The Usual Dose for Adults is 1250 mg/m²Taken Twice a Day (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 Tablets of 500 mg and 1 Tablet of 150 mg Twice a Day. 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 Tablets of 500 mg Twice a Day.

Your Doctor Will Decide What Dose You Should Take, When, and for How Long.

Your Doctor May Recommend Taking a Combination of 150 mg and 500 mg Tablets for Each Dose.

• Take the Tablets Morning and Eveningas Directed by Your Doctor.
• Take the Tablets Whole, with WaterWithin 30 Minutes After Finishing a Meal(Breakfast and Dinner). Do Not Crush or Cut the Tablets. If You are Unable to Swallow Capecitabine Glenmark Tablets Whole, Tell Your Doctor.
• It is Important to Take the Medication as Directed by Your Doctor.

Capecitabine Glenmark Tablets are Usually Taken for 14 Days, Followed by a 7-Day Break (During Which No Tablets are Taken). This 21-Day Period is One Treatment Cycle.
In Combination with Other Medications, the Usual Dose for Adults May be Lower than 1250 mg/m², and the Treatment Duration May Vary (e.g., Daily, Without Breaks).

Taking More than the Recommended Dose of Capecitabine Glenmark

If You Take More Capecitabine Glenmark than Recommended, Contact Your Doctor Immediately Before Taking the Next Dose.
If You Take a Much Higher Dose than Recommended, the Following Symptoms May Occur: Nausea or Vomiting, Diarrhea, Inflammation or Ulceration of the Intestines or Mouth, Abdominal Pain or Bleeding from the Intestines or Stomach, or Bone Marrow Suppression (Reduced Number of Certain Types of Blood Cells). Inform Your Doctor if You Experience Any of These Symptoms.

Missing a Dose of Capecitabine Glenmark

Do Not Take a Missed Dose. Do Not Take a Double Dose to Make Up for a Missed Dose. Continue Treatment as Directed and Contact Your Doctor.

Stopping Capecitabine Glenmark Treatment

There are No Withdrawal Symptoms Associated with Stopping Capecitabine Glenmark. If You are Taking Anticoagulant Medications (Containing e.g., Phenprocoumon), Stopping Capecitabine Glenmark May Require a Dose Adjustment of the Anticoagulant Medication by Your Doctor.
If You Have Any Further Questions About Taking this Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Capecitabine Glenmark Can Cause Side Effects, Although Not Everybody Gets Them.
You Must STOPTaking Capecitabine Glenmark and Contact Your Doctor Immediately if You Experience Any of the Following Symptoms:

• Diarrhea:if You Have 4 or More Bowel Movements in a Day or Diarrhea at Night.
• Vomiting:if You Vomit More than Once Every 24 Hours.
• Nausea:if You Lose Your Appetite, and the Amount of Food You Eat is Significantly Less than Usual.
• Mouth Ulcers:if You Have Pain, Redness, Swelling, or Ulcers in Your Mouth.
• Hand and Foot Syndrome: if You Have Pain, Swelling, Redness, or Tingling of Your Hands and/or Feet.
• Fever: if You Have a Fever Over 38°C.
• Infections:if You Have Symptoms of an Infection Caused by Bacteria, Viruses, or Other Pathogens.
• Chest Pain:if You Have Pain in the Middle of Your Chest, Especially During Physical Effort.
• Stevens-Johnson Syndrome: if You Have Painful Redness or Purple Rash that Spreads, and Blisters and/or Other Skin Lesions Appear, Especially if You Have Had Previous Sensitivity to Light, Respiratory Tract Infections (e.g., Bronchitis), and/or Fever .
• Angioedema:if You Experience Any of the Following Symptoms, Seek Medical Help Immediately, as You May Need Urgent Treatment: Swelling, Mainly of the Face, Lips, Tongue, or Throat, Causing Difficulty Swallowing or Breathing, Itching, and Hives. These May be Symptoms of Angioedema.

If These Side Effects are Recognized Early, They Usually Disappear Within 2-3 Days of Stopping Treatment. If the Side Effects Persist, Contact Your Doctor Immediately. Your Doctor May Recommend Continuing Treatment with a Reduced Dose.
If You Experience Severe Mouth Ulcers (Ulcers in the Mouth and/or Throat), Mucositis, Diarrhea, Neutropenia (Increased Risk of Infections), or Neurotoxicity During the First Treatment Cycle, it May be Related to DPD Deficiency (See Section 2: "Warnings and Precautions").
Hand and Foot Syndrome May Lead to Loss of Fingerprints (Due to Damage to the Skin on Your Palms or Soles), Which Can Affect Your Identification.
Additionally, if Capecitabine Glenmark is Used as a Single Anti-Cancer Medication, Very Common Side Effects (Affecting More than 1 in 10 People) Include:

• Abdominal Pain,
• Rash, Dryness, or Itching of the Skin,
• Fatigue,
• Lack of Appetite (Anorexia).

Side Effects Can Worsen, So it is Essential to Always Contact Your Doctor Immediatelyif They Appear. In Such Cases, Your Doctor May Recommend Reducing the Dose and/or Temporarily Stopping Capecitabine Glenmark. This Approach Allows for Shortening the Duration or 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 (Detected by Blood Tests),
• Dehydration, Weight Loss,
• Insomnia, Depression,
• Headache, Drowsiness, Dizziness, Abnormal Sensations in the Skin (Feeling of Numbness or Tingling), Changes in Taste,
• Irritation of the Eyes, Excessive Tear Production, Redness of the Eyes (Conjunctivitis),
• Vein Inflammation (Thrombophlebitis),
• Shortness of Breath, Nosebleeds, Cough, Runny Nose,
• Cold Sores (Herpes) on the Lips or Other Herpes Infections,
• Lung or Respiratory Tract Infections (e.g., Pneumonia or Bronchitis),
• Bleeding from the Intestines, Constipation, Abdominal Pain, Indigestion, Excessive Gas, Dry Mouth,
• Skin Rash, Hair Loss (Alopecia), Redness of the Skin, Dryness of the Skin, Itching (Pruritus), Skin Discoloration, Skin Peeling, Skin Inflammation, Changes in Nail Appearance,
• Joint or Limb Pain, Chest or Back Pain,
• Fever, Swelling of the Limbs, Feeling of General Malaise,
• Liver Function Disorders (Detected by Blood Tests) and Increased Bilirubin Levels in the Blood (Released by the Liver).

Uncommon Side Effects (Affecting Up to 1 in 100 People) Include:

• Blood Infections, Urinary Tract Infections, Skin Infections, Nose and Throat Infections, Fungal Infections (Including in the Mouth), Flu, Gastroenteritis,
• Fatty Tissue Tumors (Lipomas),
• Reduced Blood Cell Count, Including Platelet Count (Detected by Blood Tests), Blood Thinning (Detected by Blood Tests),
• Allergic Reactions (Hypersensitivity),
• Diabetes, Reduced Potassium Levels in the Blood, Malnutrition, Increased Triglyceride Levels in the Blood,
• Disorientation, Panic Attacks, Depressed Mood, Reduced Libido,
• Speech Difficulties, Memory Impairment, Lack of Coordination, Balance Disorders, Fainting, Nerve Damage (Neuropathy) and Sensory Problems,
• Blurred or Double Vision,
• Vertigo, Ear Pain,
• Irregular Heartbeat and Palpitations (Heart Rhythm Disorders), Chest Pain and Heart Attack,
• Blood Clots in Deep Veins, High or Low Blood Pressure, Hot Flashes, Cold Limbs, Purple Spots on the Skin,
• Blood Clots in the Lungs (Pulmonary Embolism), Lung Collapse, Coughing Up Blood, Asthma, Shortness of Breath During Effort,
• Bowel Obstruction, Fluid Accumulation in the Abdomen, Inflammation of the Small or Large Intestine, Stomach, or Esophagus, Lower Abdominal Pain, Abdominal Discomfort, Heartburn (Gastroesophageal Reflux), Blood in Stool,
• Jaundice (Yellowing of the Skin and Eyes),
• Blisters and Peeling of the Skin, Sunlight-Induced Skin Reaction, Redness of the Hands,
• Swelling or Stiffness of the Joints, Bone Pain, Muscle Weakness or Stiffness,
• Fluid Accumulation in the Kidneys, Increased Urination at Night, Urinary Incontinence, Blood in Urine, Increased Creatinine Levels in the Blood (Indicating Kidney Function Disorder),
• Unusual Vaginal Bleeding,
• Swelling, Chills, and Muscle Stiffness.

Some of these Side Effects Occur More Frequently When Capecitabine Glenmark is Used in Combination with Other Anti-Cancer Medications. The Following Side Effects May Occur:

• Reduced Sodium, Magnesium, or Calcium Levels in the Blood, Increased Blood Sugar Levels,
• Nerve Pain,
• Ringing or Buzzing in the Ears (Tinnitus), Hearing Loss,
• Vein Inflammation,
• Hiccup, Voice Changes,
• Pain or Abnormal Sensations in the Mouth, Jaw Pain,
• Sweating, Night Sweats,
• Muscle Cramps,
• Urination Difficulties, Blood or Protein in Urine,
• Discoloration at the Injection Site (Caused by Medications Administered by Injection).

Rare Side Effects (Affecting Up to 1 in 1,000 People) Include:

• Narrowing or Blockage of the Tear Duct (Narrowing of the Lacrimal Canal),
• Liver Function Disorders,
• Inflammatory Liver Disease Leading to Bile Duct Obstruction (Cholestatic Hepatitis),
• Certain Abnormalities in the Electrocardiogram (ECG) - Prolonged QT Interval,
• Certain Types of Heart Rhythm Disorders (Including Atrial Fibrillation, Torsades de Pointes, and Bradycardia),
• Inflammatory Eye Disorders Causing Eye Pain and Potential Vision Problems,
• Skin Inflammation Causing Red, Scaling Lesions, Associated with Immune System Disorders,
• Angioedema (Swelling, Mainly of the Face, Lips, Tongue, or Throat, Itching, and Hives).

Very Rare Side Effects (Affecting Up to 1 in 10,000 People) Include:

• Severe Skin Reactions, Such as Skin Rash, Ulcers, and Blisters, Including in the Mouth, Nose, Genital Area, Hands, Feet, and Eyes (Red and Swollen Eyes).

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your 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
Email: ndl@urpl.gov.pl .
Side Effects Can Also be Reported to the Marketing Authorization Holder.
By Reporting Side Effects, You Can Help Provide More Information on the Safety of this Medication.

5. How to Store Capecitabine Glenmark

Keep the Medication Out of Sight and Reach of Children.
Aluminium/Aluminium Blister
There are No Special Storage Instructions for the Medication.
PVC/PVDC/Aluminium Blister
Do Not Store Above 30°C.
Do Not Use this Medication After the Expiry Date Stated on the Carton or Blister After: EXP. The Expiry Date is the Last Day of the Month Shown.
Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Needed. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Capecitabine Glenmark Contains

• The Active Substance is Capecitabine. Each Capecitabine Glenmark Tablet Contains 150 mg or 500 mg of Capecitabine.
• Other Ingredients are:
• Tablet Core: Lactose Anhydrous, Sodium Croscarmellose, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate.
• Tablet Coating: Hypromellose, Titanium Dioxide (E171), Yellow and Red Iron Oxide (E172), Talc.

What Capecitabine Glenmark Looks Like and Contents of the Package

Capecitabine Glenmark 150 mg is a Light Peach-Colored, Oval, Biconvex, Film-Coated Tablet with "150" Engraved on One Side, and Smooth on the Other Side.
Capecitabine Glenmark 500 mg is a Peach-Colored, Oval, Biconvex, Film-Coated Tablet with "500" Engraved on One Side, and Smooth on the Other Side.
Capecitabine Glenmark is Available in the Following Package Sizes:
Aluminium/Aluminium Blister or PVC/PVDC/Aluminium Blister Packaged in a Carton Containing 30, 60, or 120 Film-Coated Tablets.
Not All Package Sizes May be Marketed.

Marketing Authorization 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 More Information on this Medication and its Names in EU Member States, Contact Your Local Representative of the Marketing Authorization Holder:

Glenmark Pharmaceuticals Sp. z o. o.
Osmańska 14
02-823 Warsaw
Date of Last Update of the Package Leaflet:May 2022