Thalitero 100mg Capsule 10?S Allschoolabs -

Specification

INTRODUCTION
THALITERO 100MG CAPSULE contains Thalidomide which belongs to the group of medicines called Immunomodulating Agents. It is used in combination with other medicines (melphalan and prednisone) for the treatment of a type of cancer called multiple myeloma in patients aged over 65 years and have not been prescribed with any other medicine and in patients above 65 years of age who cannot tolerate high doses of chemotherapy.
Multiple Myeloma is a certain type of cancer which affects a specific white blood cell called plasma cell. It is also indicated in treatment of skin symptoms associated with severe Erythema Nodosum Leprosum (ENL). ENL is a complication of leprosy which presents on the skin as tender bumps.
Before starting the treatment with THALITERO 100MG CAPSULE, your doctor might want you to take some diagnostic tests to understand your existing condition.
Before taking THALITERO 100MG CAPSULE, inform your doctor if you have or had liver, heart or kidney disease, diabetes, frequent infections, hepatitis B, numbness, pain and tingling in hands or feet, severe skin rash, seizures, thyroid problems, blood clots, high blood pressure or high cholesterol, healing wounds and had surgery in in the previous 7 days.
THALITERO 100MG CAPSULE is not recommended for use in pregnant and breast-feeding women. Consult with your doctor before taking it.
It should be used with caution in men as it passes through the semen. Men must not donate semen while getting treated with THALITERO 100MG CAPSULE and should use effective contraception. THALITERO 100MG CAPSULE should not be taken by children under 12 years of age due to lack of safety and effectiveness.
The most common side effects of taking THALITERO 100MG CAPSULE are constipation, sleepiness, tiredness, nausea, stomach pain and dry mouth. Ask for your doctor?s advice if any of these worsen or doesn?t improve.
USES OF THALITERO 100MG CAPSULE

Treats multiple myeloma (in combination with other medicines)

Treats skin symptoms associated with severe erythema nodosum leprosum (ENL)

HOW THALITERO 100MG CAPSULE WORKS
THALITERO 100MG CAPSULE effectively helps in the treatment of multiple myeloma by helping the body?s immune system and inhibiting the production of a certain type of protein (Interleukin-6) which is responsible for the growth of cancer cells. THALITERO 100MG CAPSULE also stops the development of blood vessels in the cancer cells and stimulates the immune system to kill the cancer cells.??
DIRECTIONS FOR USE
Take THALITERO 100MG CAPSULE as advised by your doctor. Take this medicine after having food, swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of THALITERO 100MG CAPSULE for you depending upon your age, disease condition and body weight.
SIDE EFFECTS OF THALITERO 100MG CAPSULE

COMMON

Constipation

Indigestion

Nausea, vomiting

Stomach pain, dry mouth

Rash, dry skin

Fainting, tiredness

Dizziness, sleepiness

Shaking (tremor)

Headache, blurred vision

Difficulty in co-ordinating movements

Loss of balance

Swelling of the hands and feet

Feeling generally unwell

Weakness, feeling cold

Depression, mood changes, anxiety, confusion

Low blood pressure (spinning feeling in your head, making it difficult to stand up and move normally)

Slow heart rate

Muscle cramps

Decreased sexual drive

Abnormal periods

RARE
Stop taking THALITERO 100MG CAPSULE and contact your doctor immediately if you experience any of the following side effects:?
Signs of progressive multifocal leukoencephalopathy (PML) (blurred, loss of or double vision, weakness in an arm or a leg, difficulty speaking, changes in walking or problems with balance, decreased sensation or loss of sensation, persistent numbness, memory loss or confusion)

Extremely intense and serious skin reactions appearing as rashes with or without blisters. Skin irritation, sores or swelling in the mouth, throat, eyes, nose and around the genitals, oedema, flu-like symptoms and fever

Allergic reactions which may include localised or generalised pruritic rash, angioedema and anaphylactic reaction and appear as hives, rashes, swelling of eyes, mouth or face, difficulty of breathing or itching

Peripheral neuropathy (tingling, numbness, abnormal coordination or pain in hands and feet)

Signs of pulmonary embolism, blood clot in lungs (sudden pain in chest or difficulty in breathing)

Signs of blood clots in veins of the legs (pain or swelling in legs, especially in lower leg or calves)

Signs of heart attack (chest pain spreading to the arms, neck, jaw, back or stomach, sweating, breathless, nausea, vomiting)

Signs of stroke (temporary difficulty in seeing or speaking)

Signs of infections (fever, sore throat, chills, cough, mouth ulcers)

Bleeding or bruising without any injury

HOW TO MANAGE SIDE EFFECTS
Nausea:
Stick to simple meals while taking this medicine. Avoid eating oil rich or spicy foods. If the symptom does not improve, consult with your doctor.
Vomiting:
Drink clear or ice-cold drinks, eat light, bland foods and avoid eating fried, oily or sweet foods. If the symptom does not improve, consult with your doctor.
Constipation:
Eat plenty of fiber rich foods such as vegetables, fresh fruits, cereals and drink plenty of water while taking THALITERO 100MG CAPSULE. Exercise more regularly. If the symptom does not improve, consult with your doctor.
Dry mouth:
Sip water regularly and other sugar free liquids. Do not use mouthwashes that contain alcohol because they can make your mouth dry, use mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Consult your doctor if the symptom does not improve.
Headache:
Try to take rest and don?t involve yourself in exertive activities. Apply a pain-relieving balm on your forehead if necessary. If the symptom does not improve, consult with your doctor.
WARNING & PRECAUTIONS

PREGNANCY
THALITERO 100MG CAPSULE is not recommended for use in pregnant women as it may increase the chances of serious birth defects in the baby such as shortened arms or legs, eye or ear defects, improperly formed hands or feet and problems with internal organs. Your doctor might ask you take pregnancy tests regularly while getting treated with THALITERO 100MG CAPSULE and even after the treatment stops. Consult your doctor before taking THALITERO 100MG CAPSULE.?
BREASTFEEDING
THALITERO 100MG CAPSULE is not recommended for use in breastfeeding women as it is not known if it passes through the breast milk. Consult your doctor before taking THALITERO 100MG CAPSULE.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizzy, tired, sleepy or blurring of vision after taking THALITERO 100MG CAPSULE.
ALCOHOL
Avoid the consumption of alcohol while taking THALITERO 100MG CAPSULE as it can make you sleepier.
KIDNEY
THALITERO 100MG CAPSULE should be taken with caution in patients with kidney problems. Consult your doctor before taking THALITERO 100MG CAPSULE.
LIVER
THALITERO 100MG CAPSULE should be taken with caution in patients with liver problems and hepatitis B virus infection. Consult your doctor before taking THALITERO 100MG CAPSULE.
ALLERGY
Do not take THALITERO 100MG CAPSULE if you are allergic to Thalidomide or any other ingredients of this medicine.?
HEART DISEASE
THALITERO 100MG CAPSULE should be taken with caution in patients with heart diseases such as history of heart attack. Consult your doctor before taking THALITERO 100MG CAPSULE.
OTHERS
Before taking THALITERO 100MG CAPSULE, inform your doctor if you:
Have or had a blood clot

Have high blood pressure or high levels of cholesterol

Have existing nerve damage (tingling, abnormal co-ordination or pain in hands or feet)

Have had serious skin reactions

Have diabetes

Have thyroid problems or seizures

Have healing wounds

Had any surgery in the previous 7 days
Use in paediatrics:
THALITERO 100MG CAPSULE is not recommended for use in children below 12 years of age due to lack of safety and effectiveness. Consult your child?s doctor for advice.
Use in geriatrics:
Your doctor will advise the correct dose and duration of THALITERO 100MG CAPSULE for you depending upon your age, disease condition and body weight.
INTERACTIONS
A. Drug?Drug Interactions:
Before taking THALITERO 100MG CAPSULE, inform your doctor if you are taking any of the following medicines:
Medicines that cause drowsiness (Ex. triazolam, temazepam)

Medicines used to treat depression or anxiety (Ex. citalopram, fluoxetine)

Medicines used to treat heart problems or high blood pressure (Ex. ramipril, azilsartan, propranolol)

Anticoagulants such as aspirin (used to prevent or treat blood clots)

Hormonal contraceptives, hormone replacement therapy (Ex. Estradiol, levonorgestrel)

Medicines used to treat anaemia (Ex. cyanocobalamin)

Medicines used in the treatment of cancer (Ex. vincristine)

Medicines used in the treatment of AIDS (Ex. zalcitabine, didanosine)
Overdosage:
If you or anyone else accidentally take too much of THALITERO 100MG CAPSULE, consult your doctor immediately or visit the nearby hospital. The symptoms of overdosage of THALITERO 100MG CAPSULE are numbness and tingling in hand or feet, excessive sleepiness, constipation, dry mouth, skin rash and weakness.
SYNOPSIS

Drug :?? Thalidomide

Pharmacological Category :?? Immunomodulating Agents

Therapeutic Indication :?? Multiple Myeloma, Skin reactions of Erythema, Nodosum Leprosum? ? ? ? ??

Dosage Forms :?? Capsule

MORE INFORMATION

Keep THALITERO 100MG CAPSULE out of reach of children

Store at room temperature

FAQs ABOUT THALITERO 100MG CAPSULE
What is THALITERO 100MG CAPSULE and why is it given?
THALITERO 100MG CAPSULE contains Thalidomide which belongs to the group of medicines called Immunomodulating Agents. It is used in combination with other medicines (melphalan and prednisone) for the treatment of a type of cancer called multiple myeloma in patients aged over 65 years and have not been prescribed with any other medicine and in patients above 65 years of age who cannot tolerate high doses of chemotherapy. It is also used to treat skin symptoms associated with Severe Erythema Nodosum Leprosum (ENL).
Can I donate blood while taking THALITERO 100MG CAPSULE?
No, you must not donate blood while getting treated with THALITERO 100MG CAPSULE and for at least 7 days after stopping the treatment. This is because THALITERO 100MG CAPSULE has dose-dependent effects and can cause serious birth defects in babies or even foetal death. Consult your doctor before donating.
How to manage if I forget to take a dose of THALITERO 100MG CAPSULE?
If you forget to take a dose of THALITERO 100MG CAPSULE at your regular time and less than 12 hours have passed, then take THALITERO 100MG CAPSULE immediately. If it has been more than 12 hours, do not take the missed dose, take your next dose at the same time of the day.
What precautions do men need to follow while taking THALITERO 100MG CAPSULE?
If you are a man taking THALITERO 100MG CAPSULE and have a partner who has a potential to become pregnant, make sure that you use effective methods of contraception as THALITERO 100MG CAPSULE passes into the semen. You must not donate semen while on treatment with THALITERO 100MG CAPSULE. Consult with your doctor for advice.
What all parameters need to be monitored while taking THALITERO 100MG CAPSULE?
While taking THALITERO 100MG CAPSULE, your doctor might monitor your thyroid gland functioning, amount of tumour in the body and your blood cell count as it is important to keep a check on all of these. Consult with your doctor for advice before taking this medicine.
REFERENCES
1. KD. Tripathi. Anticancer Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page ? 877.
2.?Irene M. Ghobrial, S. Vincent Rajkumar. Management of Thalidomide Toxicity. NIH National Library of Medicine, National center for biotechnology information. Pubmedcentral. October 2003. [Accessed on 21st June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3134146/
3. Christian D.K. Becker, Dirk O. Stichtenoth, Michael G. Wichmann, Christof Schaefer, Ladislaus Szinicz. Blood Donors on Medication ? an Approach to Minimize Drug Burden for Recipients of Blood Products and to Limit Deferral of Donors. NIH National Library of Medicine, National center for biotechnology information. Pubmedcentral. March 2009. [Accessed on 21st June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2928823/
4. Thalidomide. NIH National Library of Medicine, National center for biotechnology information. Pubchem. [Accessed on 21st June 2022]?https://pubchem.ncbi.nlm.nih.gov/compound/Thalidomide
5. Celgene Limited. Medsafe. [Revised in January 2021]. [Accessed on 21st June 2022] https://www.medsafe.govt.nz/Consumers/cmi/t/thalomid.pdf
USEFUL DIAGNOSTIC TESTS