Hydroxyurea Capsules USP 500mg (Tharolax)

Hydroxyurea Capsules USP 200mg
Hydroxyurea Capsules USP 300mg
Hydroxyurea Capsules USP 400mg
Hydroxyurea Capsules USP 500mg

Hydroxyurea Capsules USP 500mg Technical Specification:

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

What is in this leaflet:

1. What Hydroxyurea is and what it is used for
2. What you need to know before you take Hydroxyurea
3. How to take Hydroxyurea
4. Possible side effects
5. How to store Hydroxyurea
6. Contents of the pack and other information

1. WHAT HYDROXYUREA IS AND WHAT IT IS USED FOR

The name of your medicine is Hydroxyurea. Each capsule contains Hydroxyurea as the active ingredient. Hydroxyurea belongs to a group of medicines called anti-neoplastic medicines.

These medicines interfere with the growth of cancer cells.

Hydroxyurea is used to treat some types of cancer such as cervical cancer, and a type of leukaemia called chronic myeloid leukaemia (CML). The precise reason why you are being given Hydroxyurea is best discussed with your doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYDROXYUREA

Do not take Hydroxyurea Capsules:

• if you are allergic to Hydroxyurea or any of the other ingredients of this medicine (listed in section 6).
• if you have a history of any blood problems
• if you have severe anaemia

Warnings and precautions

Talk to your doctor or pharmacist before taking Hydroxyurea.

Your doctor will do regular blood tests before and whilst you are taking Hydroxyurea. You may need to control or treat the source conditions before starting treatment with Hydroxyurea.

Take special care with Hydroxyurea Capsules if:

• you have any kidney or liver problems
• you are pregnant, planning to become pregnant or are breastfeeding
• you have ever suffered from gout
• you have leg ulcers
• you have previously received radiotherapy or chemotherapy, or are currently taking any other medicines for cancer treatment, especially interferon therapy
• you have a folic acid deficiency

In the long term use of Hydroxyurea, secondary leukaemia has been reported. Skin cancer has been reported in patients receiving long term Hydroxyurea. You should protect your skin from the sun and regularly inspect your skin yourself during the treatment and after discontinuation of the therapy with Hydroxyurea. Your doctor will also inspect your skin during routine follow-up visits.

Other medicines and Hydroxyurea

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:

• Antiretroviral medicines (those that inhibit or destroy a retrovirus such as HIV), e.g., didanosine, stavudine and indinavir
• Myelosuppressive medicines (including chemotherapies) and radiation therapy
• Some vaccines, if you recently had a vaccination or are planning to have one, tell your doctor.

Always tell your doctor about other medicines you may be taking or have recently taken including those obtained without a prescription as some medicines can affect the actions of each other.

It may be necessary to adjust the dose of some medicines if they are taken at the same time as Hydroxyurea.

Hydroxyurea with food, drink or alcohol

You should check with your doctor before drinking alcohol to find out if it is advisable for you.

Pregnancy, breast-feeding and fertility

You should not take this medicine if you are pregnant, planning to become pregnant or are breastfeeding unless your doctor recommends it.

When appropriate both male and female patients should discuss safe contraceptive measure before and during treatment with Hydroxyurea.

In addition, if you are pregnant, planning to be or breastfeeding you should not handle the capsules.

Driving and using machines

You may feel drowsy. You should not drive or operate any machinery unless it has been shown not to affect you and have discussed it with your doctor.

Hydroxyurea contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE HYDROXYUREA

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You may be instructed to take your medicine on either a daily basis or an irregular basis.

The recommended dose is 20-30mg of Hydroxyurea per kg of your body weight once a day or 80 mg per kg of your body weight once every third day.

Elderly patients may be more sensitive to the effects of Hydroxyurea and may be given a lower dose.

You can take this medicine at any time of the day, before or after meals. The capsules should be swallowed whole with a glass of water. However if you find it difficult to swallow them, the contents of the capsule can be emptied into a glass of water and taken immediately. If some of the powder floats on the surface of the water, DO NOT WORRY this is just filler from the capsule.

DO NOT inhale the contents of the capsules and if you spill any on the skin wipe it immediately.

While you are being treated with Hydroxyurea it is important that you drink plenty of fluids. This will help your kidneys work well.

If you are going to have radiation therapy, this medicine will usually be started 7 days before starting radiation treatment.

You should keep taking your capsules until your doctor tells you to stop.

Children

There is limited experience with the use of Hydroxyurea in this age group

If you take more Hydroxyurea than you should

If you take too many capsules you should go to your nearest hospital Casualty Department immediately and take the medicine carton with you. The symptoms of overdose include; soreness, swelling of hands and feet and redness of the skin.

If you forget to take Hydroxyurea

If you forget to take a dose of this medicine DO NOT take the missed dose at all. Take your next dose when it is due; DO NOT take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, 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 notice any of the following symptoms swelling of the face, lips, tongue or throat, itching or skin rashes, difficulty breathing, unexplained fever, chills or sore throat, breathing difficulties, wasting of muscles and peeling of the skin and nails, you should stop taking the tablets and tell your doctor immediately as these may be signs of an allergic reaction:

If you notice any of these symptoms you should see your doctor immediately.

• unexplained shortness of breath or cough with fever, skin ulceration, especially with severe infection
• blood disorders (reduction in white blood cells, red blood cells and platelets)
• lower back pain or pain in your side
• black tarry stools or blood in the stools
• unusual bleeding or bruising
• numbness or tingling of hands or feet
• fever, cough or breathing problems, this could be a sign of serious lung disease (frequency not known)

The following side effects have been seen in some people:

• skin changes and muscle weakness (dermatomyositis) – you may experience symptoms such as muscle tenderness, muscle weakness or tiredness (especially when climbing stairs, walking or rising from a chair etc), a rash on the face, hands or other parts of the body (which in some cases may be scaly, purple and raised).
• absence or low amount of sperm in the semen (azoospermia or oligospermia).
• loss of appetite
• weakness, loss of energy
• sickness, diarrhoea, constipation, abdominal pain
• sores on the lips or mouth
• difficulty or pain passing urine
• skin problems may occur including rashes, darkening of the skin, peeling of the skin, purple raised patches of skin and redness. There may be a worsening of existing redness or discomfort in the skin or mucous membranes if you have had radiation treatment in the past.
• temporary hair loss
• kidney problems
• skin cancer
• problems with the flow of the bile (cholestasis), the bile which is made by the liver to aid in the digestion of food may not flow properly. A build-up of bile can cause itchiness, yellow skin, very dark urine and very pale stools
• inflammation of the liver (hepatitis) which cause flu-like symptoms, including tiredness, loss of appetite, fever, aching, and feeling sick/being sick, pressure or pain below the right ribs and might also include yellowing of the skin or eyes
• drowsiness, dizziness, fits, confusion or hallucinations (seeing hearing or feeling things that are not there)
• headache
• Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE HYDROXYUREA

Do not store your tablets above 25?C

Store in the original package in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the blister or carton after EXP.

The expiry date refers to the last day of that month.

Keep this medicine out of the sight and reach of children.

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.

6. Contents of the pack and other information

What Hydroxyurea contains

Each hard gelatin capsule contains
Hydroxyurea USP                                    500mg
Excipients q.s.
Colours: Approved colours used in a capsule shell

The other ingredients are Citric acid, anhydrous, Lactose monohydrate, Magnesium stearate, Sodium phosphate, Gelatin capsules, Erythrosine, Indigotine, Titanium dioxide, Sodium laurilsulfate.

What Hydroxyurea looks like and contents of the pack

Bottle/Aluminium Blister Packs.

Pack Size of: 7, 14, 28, 30, 50, 60, 90, 100 or 200 tablets.

Not all pack sizes may be marketed.

7. Manufactured in India By:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)

Hydroxyurea Capsule PAN India Manufacturers, Suppliers

Taj Pharmaceuticals Limited is one of India’s most respectable and widely recognized manufacturers of high-quality anticancer Hydroxyurea Capsule 500mg. We excel at maintaining the highest industry standards in our automated capsule section, the automation process in the manufacturing of Hydroxyurea Capsules; leads to least human intervention; and hence no contamination. We further work to become one of the top suppliers and exporters in the anticancer in the pharmaceutical sector; specially for affordable best priced drug such as Hydroxyurea Capsules. We have a cutting-edge Oncology manufacturing facility that is equipped with all the necessary modern machines, tools, equipment, fully automated capsule filling machine and resources required for the production of Hydroxyurea Capsules.

What is Hydroxyurea Capsule?

Hydroxyurea Capsule 500mg is used in the treatment of critical anticancer patients; Hydroxyurea Capsule is used in combination with other oncology drugs as first line treatment. Hydroxyurea Capsule manufactured by Taj Pharma is utilized in the treatment of symptoms related to chronic myelogenous leukemia (CML cancer) in patients. Hydroxyurea Capsule can be used as an affordable, best priced medicine for patients suffering from sickle cell anemia to lower pain; and further decrease the need for blood transfusion.

Hydroxyurea Capsules Manufacturers, Suppliers in India:

Taj Pharmaceuticals is of the prominent Hydroxyurea Capsule Manufacturers in India, bringing the best quality Hydroxyurea 500mg Capsule. Our company Taj Pharma has rich experience in the niche manufacturing of anticancer Hydroxyurea Capsule. Hydroxyurea Oral Capsule manufactured by Taj Pharma is utilized in the treatment of symptoms related to chronic myelogenous leukemia (CML cancer) in patients. Hydroxyurea Capsule is given solely or with other oncology medicines, radiation treatment in treating cancer of chronic myelogenous leukemia (CML); this is cancer of the white blood cells (WBC); Further, also for cancers such as neck, head mouth, tongue, tonsils, cheek, throat, sinuses etc.

Taj Pharmaceuticals is a reputed Manufacturer of Hydroxyurea Capsule and Best-Known Anticancer medicine Suppliers in India; Global Importers prefer Taj Pharma as our company is best known for the topmost standards and consistent quality of its CML medicine Hydroxyurea Capsule. Oncology drug Hydroxyurea is available in Oral Capsule form and strength available are 500mg, 100mg, 1000mg Oral Capsule from for intake by mouth.

Hydroxyurea anticancer Capsules is used in combination with other anticancer drugs for treatment of chronic myelogenous leukemia (CML cancer) in patients, Hydroxyurea Capsule is used to treat cancer of the white blood cells called chronic myeloid leukemia (CML). Hydroxyurea shall be given simultaneously with radiation remedy for head, neck and other cancer (advanced squamous cell cancer). Hydroxyurea Capsule restricts the spread of cancer cells, further ultimately destroys. Hydroxyurea medicine is also used for sickle-cell anemia to decrease pain caused by cancer spread and eliminates the need for blood transfusion in the cancer suffering patients.

Taj Pharma is a well-known Hydroxyurea Oral Capsule 500mg Manufacturer in India that assures high-quality and high standards. Strict quality control ensures that every batch of Hydroxyurea Capsule brings a harmonious standard. Hydroxyurea 500mg Capsule among the medicines called ‘anticancer’ utilized to treat chronic myelogenous leukemia (CML cancer) in patients. Hydroxyurea Capsule 500mg may be used as a primary treatment in cancer patients by restricting the spread of cancer-cells, ultimately destroying cancer cells as well. Hydroxyurea Capsules are also used for sickle-cell anemia by reducing pain caused by tumor spread and reduces the need for blood transfusion in the cancer suffering patients.

Hydroxyurea Capsules 500mg is a ‘Cytotoxic Agent’ to be supplied on demand from Oncology / Cancer Hospitals, institutions and strictly on prescription of an Oncologist only. Hydroxyurea Capsules should be dispensed in a tight container; open capsules must be stored in a bottle and must be used within three months. Hydroxyurea Capsules shall be taken one time in a day at the same time each day. Further, patients must read the attached dispensing label as per their end country. Hydroxyurea must be kept out of reach of children. Hydroxyurea Capsules 500mg is classified under therapeutic categories such as anticancer, anti academic, sickle cell anemia. Hydroxyurea capsules should be stored at 20° to 25°C (68° to 77°F).

Hydroxyurea anticancer Capsule 500mg manufactured at Taj Pharma following ICH norms, i.e., the product is manufactured to comply with good quality standards under GMP Conditions, considered the Best in the world. Further, Taj Pharma uses USP (United States Pharmacopeia)/BP (British Pharmacopeia)/EP (European Pharmacopeia) grade best active ingredient of Hydroxyurea (Hydroxycarbamide) to manufacture its Oral Capsules to comply with international standards of European products.

Hydroxyurea Capsule USP (United States Pharmacopeia)

The active ingredients used for manufacturing and supply of Hydroxyurea (Hydroxycarbamide) capsules is procured as per USP (United States Pharmacopeia); tested once it arrives the Taj Pharma manufacturing plant. Once the Quality Control Department passes the Quality of the received API Hydroxyurea; then only it is further processed for the manufacturing of capsules.

Why Taj Pharmaceuticals Limited?

Taj Pharmaceuticals Limited is one of India’s dominant manufacturers of Hydroxyurea Capsule 500mg, and it’s the top called anticancer medicine used in chronic myeloid leukemia (CML). Hydroxyurea Capsule 500mg manufactured and supplied by Taj Pharma follows international EU-GMP and US-FDA certification. Taj Pharma Oral Capsule manufacturing is word class with the best fully automated machines equipped to handle any risk of cross contaminations while handling of any anticancer drug manufacturing. Hydroxyurea Capsule 500mg is fully validated with stability studied short and long term accelerated and Zone IV-B stabilities. Taj Pharma also has CTD, eCTD Dossier for Hydroxyurea Capsule 500mg and all international quality documents such as COPP, FSC, WHO-GMP etc. to support hospital tenders. Taj Pharma also has set procedures and follows full cold chain product SOP (standard operating procedures) for safe arrival of products in the importing countries.

We are exporting our Hydroxyurea Capsule product in Following Countries:

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, Iraq.

North and Central America: Belize, Costa Rica, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Suriname,

South America: Brazil, Argentina, Bolivia, Chile, Colombia, Ecuador, French Guiana, Guyana, Paraguay, Peru, Uruguay, Venezuela

Caribbean Countries: Jamaica, Cuba, Dominican Republic, Haiti, Guadeloupe, Martinique, Puerto Rico, Saint-Barthélemy, Saint-Martin, St Lucia, Trinidad & Tobago,

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine,

African Countries: Kenya, Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia, Mozambique, Malawi, Seychelles, Gambia, Somalia, Sierra Leone, Libya

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Countries: Turkey, Cyprus, Cayman Island, Papua New Guinea (PNG), All West Indies Country

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Hydroxyurea Capsule Regulatory Documents:

1. Hydroxyurea Capsules Certificate of Analysis (COA)
2. Hydroxyurea Capsules Method of Analysis (MOA)
3. Hydroxyurea Capsules Stability Data (Accelerated stability / Long term stability / Zone 4b)
4. Hydroxyurea Capsules CTD Dossier / ACTD Dossiers / eCTD Dossiers
5. Hydroxyurea Capsules Certificate of Pharmaceuticals Product (COPP)

Contact the most reliable manufacturers of Hydroxyurea 500mg Capsule, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

Hydroxyurea Capsule Gallery: