Hydroxyurea Capsules USP 500mg (Tharolax) Taj Pharma

  1. Name of the medicinal product

Hydroxyurea Capsules USP 500mg /  Hydroxycarbamide (Tharolax 500)
Hydroxyurea Capsules USP 400mg /  Hydroxycarbamide (Tharolax 400)
Hydroxyurea Capsules USP 300mg /  Hydroxycarbamide (Tharolax 300)
Hydroxyurea Capsules USP 200mg /  Hydroxycarbamide (Tharolax 200)

  1. Qualitative and quantitative composition

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

b) Each hard gelatin capsule contains
Hydroxyurea USP                                    400mg
Excipients                                                   q.s.
Colours: Approved colours used in capsule shell

c) Each hard gelatin capsule contains
Hydroxyurea USP                                   300mg
Excipients                                                   q.s.
Colours: Approved colours used in capsule shell

d) Each hard gelatin capsule contains
Hydroxyurea USP                                    200mg
Excipients                                                   q.s.
Colours: Approved colours used in capsule shell

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Capsule, hard.

  1. Clinical particulars

4.1 Therapeutic indications

The treatment of chronic myeloid leukaemia:

  • as pre-TKI treatment phase before confirmation of BCR-ABL fusion with an immediate need for therapy due to high leukocyte and thrombocyte counts
  • as palliative care in patients in blastic phase with leucocytosis and thrombocytosis

The treatment of cancer of the cervix in conjunction with radiotherapy.

4.2 Posology and method of administration

Posology

Adults

Treatment regimens can be continuous or intermittent. The continuous regimen is particularly suitable for chronic myeloid leukaemia, while the intermittent regimen, with its diminished effect on the bone marrow, is more satisfactory for the management of cancer of the cervix.

Hydroxyurea should be started 7 days before concurrent irradiation therapy. If Hydroxyurea is used concomitantly with radiotherapy, adjustment of radiation dosage is not usually necessary.

An adequate trial period for determining the antineoplastic effect of Hydroxyurea is six weeks. Where there is a significant clinical response therapy may be continued indefinitely, provided that the patient is kept under adequate observation and shows no unusual or severe reactions. Therapy should be interrupted if the white cell count drops below 2.5×109L or the platelet count below 100×109/L (see section 4.4).

In these cases, the counts should be reevaluated after three days and therapy resumed when the counts return to acceptable levels. Hematopoietic rebound is usually rapid. If rapid rebound has not occurred during combined Hydroxyurea and irradiation therapy, irradiation may also be interrupted. Anemia, even if severe, can be managed without interrupting Hydroxyurea therapy.

Severe gastric distress, such as nausea, vomiting, and anorexia, resulting from combined therapy may usually be controlled by interruption of Hydroxyurea administration.

Pain or discomfort from inflammation of the mucous membranes at the irradiated site (mucositis) is usually controlled by measures such as topical anesthetics and orally administered analgesics. If the reaction is severe, Hydroxyurea therapy may be temporarily interrupted; if it is extremely severe, irradiation dosage may, in addition, be temporarily postponed.

Continuous therapy

Hydroxyurea 20-30 mg/kg should be given daily in single doses. Dosage should be based on the patient’s actual or ideal weight, whichever is the less. Therapy should be monitored by repeat blood counts.

Intermittent therapy

Hydroxyurea 80 mg/kg in single doses should be given every third day. Using the intermittent regimes the likelihood of WBC depression is diminished, but if low counts are produced, 1 or more doses of Hydroxyurea should be omitted.

Concurrent use of Hydroxyurea with other myelosuppressive agents may require adjustments of dosages.

Special Populations

Children

Because of the rarity of these conditions in children, dosage regimens have not been established.

Elderly

Elderly patients may be more sensitive to the effects of Hydroxyurea, and may require a lower dosage regimen.

Renal Impairment

Since renal excretion is a pathway of elimination, consideration should be given to decreasing the dosage of Hydroxyurea in this population.

Method of administration

For oral use.

NB: If the patient prefers, or is unable to swallow capsules, the contents of the capsules may be emptied into a glass of water and taken immediately. The contents of capsules should not be inhaled or allowed to come into contact with the skin or mucous membranes. Spillages must be wiped immediately.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Marked leucopenia (<2.5wbcx109/L), thrombocytopenia (< 100×109/L), or severe anaemia.

4.4 Special warnings and precautions for use

The complete status of the blood, including bone marrow examination, if indicated, as well as kidney function and liver function should be determined prior to, and repeatedly during, treatment. If bone marrow function is depressed, treatment with Hydroxyurea should not be initiated. The determination of haemoglobin level, total leukocyte counts, and platelet counts should be performed at least once a week throughout the course of Hydroxyurea therapy. If WBC falls below 2.5×109/L or platelet count to <100×109/L, therapy should be interrupted. Counts should be rechecked after 3 days and treatment resumed when they rise significantly towards normal.

Hydroxyurea may produce bone marrow suppression; leukopenia is generally its first and most common manifestation. Thrombocytopenia and anaemia occur less often and are seldom seen without a preceding leukopenia. Bone marrow depression is more likely in patients who have previously received radiotherapy or cytotoxic cancer chemotherapeutic agents; Hydroxyurea should be used cautiously in such patients. The recovery from myelosuppression is rapid when Hydroxyurea therapy is interrupted.

Severe anaemia must be corrected with whole blood replacement before initiating therapy with Hydroxyurea. If, during treatment, anaemia occurs, correct without interrupting Hydroxyurea therapy. Erythrocytic abnormalities; megaloblastic erythropoeisis, which is self-limiting, is often seen early in the course of Hydroxyurea therapy. The morphologic change resembles pernicious anaemia, but is not related to vitamin B12 or folic acid deficiency. The macrocytosis may mask the incidental development of folic acid deficiency; regular determinations of serum folic acid are recommended. Hydroxyurea may also delay plasma iron clearance and reduce the rate of iron utilisation by erythrocytes but it does not appear to alter the red blood cell survival time.

Patients who have received irradiation therapy in the past may have an exacerbation of postirradiation erythema when Hydroxyurea is given.

Hydroxyurea should be used with caution in patients with marked renal dysfunction.

Hydroxyurea is not licensed for use in combination with antiretroviral agents for HIV disease and it may cause treatment failure and toxicities (in some cases fatal) in HIV patients (see section 4.5).

In patients receiving long-term therapy with Hydroxyurea for myeloproliferative disorders, such as polycythemia, secondary leukaemia has been reported. It is unknown whether this leukaemogenic effect is secondary to Hydroxyurea or associated with the patient’s underlying disease. Skin cancer has been reported in patients receiving long-term Hydroxyurea. Patients should be advised to protect skin from sun exposure. In addition, patients should conduct self-inspection of the skin during the treatment and after discontinuation of the therapy with Hydroxyurea and be screened for secondary malignancies during routine follow-up visits.

Cutaneous vasculitic toxicities including vasculitic ulcerations and gangrene have occurred in patients with myeloproliferative disorders during therapy with Hydroxyurea. The risk of vasculitic toxicities is increased in patients who receive prior or concomitant interferon therapy. The digital distribution of these vasculitic ulcerations and progressive clinical behaviour of peripheral vasculitic insufficiency leading to digital infarct or gangrene were distinctly different than the typical skin ulcers generally described with Hydroxyurea. Due to potentially severe clinical outcomes for the cutaneous vasculitic ulcers reported in patients with myeloproliferative disease, Hydroxyurea should be discontinued if cutaneous vasculitic ulcerations develop and alternative cytoreductive agents should be initiated as indicated.

The possibility of an increase in serum uric acid, resulting in the development of gout or, at worst, uric acid nephropathy, should be borne in mind in patients treated with Hydroxyurea, especially when used with other cytotoxic agents. It is therefore important to monitor uric acid levels regularly and maintain a high fluid intake during treatment.

This product contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Vaccinations

Concomitant use of Hydroxyurea with a live virus vaccine may potentiate the replication of the vaccine virus and/or may increase some of the adverse reactions of the vaccine virus because normal defence mechanisms may be suppressed by Hydroxyurea. Vaccination with a live vaccine in a patient taking Hydroxyurea may result in severe infection. The patient’s antibody response to vaccines may be decreased. The use of live vaccines should be avoided during treatment and for at least six months after treatment has finished and individual specialist advice sought (see section 4.5).

Respiratory disorders:

Interstitial lung disease including pulmonary fibrosis, lung infiltration, pneumonitis, and alveolitis/allergic alveolitis have been reported in patients treated for myeloproliferative neoplasm and may be associated with fatal outcome. Patient developing pyrexia, cough, dyspnoea or other respiratory symptoms should be closely monitored, investigated and treated. Promptly discontinue of hydroxyurea and treatment with corticosteroids appears to be associated with resolution of the pulmonary events (see section 4.8).

4.5 Interaction with other medicinal products and other forms of interaction

The myelosuppressive activity may be potentiated by previous or concomitant radiotherapy or cytotoxic therapy. Fatal and non-fatal pancreatitis has occurred in HIV-infected patients during therapy with Hydroxyurea and didanosine, with or without stavudine. Hepatotoxicity and hepatic failure resulting in death were reported during post-marketing surveillance in HIV-infected patients treated with Hydroxyurea and other antiretroviral agents. Fatal hepatic events were reported most often in patients treated with the combination of Hydroxyurea, didanosine and stavudine. This combination should be avoided. Peripheral neuropathy, which was severe in some cases, has been reported in HIV-infected patients receiving Hydroxyurea in combination with antiretroviral agents, including didanosine, with or without stavudine. (see section 4.4).

Studies have shown that there is an analytical interference of Hydroxyurea with the enzymes (urease, uricase, and lactic dehydrogenase) used in the determination of urea, uric acid and lactic acid, rendering falsely elevated results of these in patients treated with Hydroxyurea.

Vaccinations

There is an increased risk of severe or fatal infections with the concomitant use of live vaccines. Live vaccines are not recommended in immunosuppressed patients (see section 4.4).

4.6 Fertility, pregnancy and lactation

Drugs which affect DNA synthesis, such as Hydroxyurea, may be potent mutagenic agents. The physician should carefully consider this possibility before administering this drug to male or female patients who may contemplate conception. Since Hydroxyurea is a cytotoxic agent it has produced a teratogenic effect in some animal species.

In rats and dogs, high doses of Hydroxyurea reduced sperm production

Hydroxyurea is excreted in human breast milk. Because of the potential for serious adverse reactions in nursing infants from Hydroxyurea, a decision should be made whether to discontinue nursing or to discontinue Hydroxyurea, taking into account the importance of the drug to the mother.

Hydroxyurea can cause fetal harm when administered to a pregnant woman. Hydroxyurea should not normally be administered to patients who are pregnant, or to mothers who are breast feeding, unless the potential benefits outweigh the possible hazards.

When appropriate both male and female patients should be counselled concerning the use of contraceptive measures before and during treatment with Hydroxyurea.

4.7 Effects on ability to drive and use machines

Hydroxyurea may cause drowsiness. Patients receiving it should not drive or operate machinery unless it has been shown not to affect physical or mental ability.

4.8 Undesirable effects

Bone-marrow suppression is the major toxic effect of Hydroxyurea

Cutaneous vasculitic toxicities including vasculitic ulcerations and gangrene have occurred in patients with myeloproliferative disorders during therapy with Hydroxyurea. The risk of vasculitic toxicities is increased in patients who receive prior or concomitant interferon therapy.

In some patients, hyperpigmentation, atrophy of skin and nails, scaling, violet papules and alopecia have been observed following several years of long-term daily maintenance therapy with Hydroxyurea.

Cases of fatal and non-fatal pancreatitis and hepatotoxicity and severe peripheral neuropathy have been observed in HIV patients when Hydroxyurea was administered with antiretroviral agents, in particular didanosine plus stavudine. Patients treated with Hydroxyurea in combination with didanosine, stavudine and indinavir showed a median decline in CD4 cells of approximately 100/mm3 (see sections 4.4 and 4.5).

Adverse reactions observed with combined Hydroxyurea and irradiation therapy were similar to those reported with the use of Hydroxyurea alone, primarily bone marrow depression (leukopenia and anaemia) and gastric irritation. Nearly all patients receiving an adequate course of combined Hydroxyurea and irradiation therapy will develop leukopenia. Decreased platelet counts (<100,000/mm3) have occurred rarely and usually in the presence of marked leukopenia. Hydroxyurea may potentiate some adverse reactions usually seen with irradiation alone, such as gastric distress and mucositis.

The list is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥1/10), common (≥1/100, < 1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (< 1/10000), and not known (cannot be estimated from the available data).

System Organ Class Frequency MedDRA Term
Infections and Infestations Rare Gangrene
Neoplasms Benign and Malignant (including cysts and polyps) Common Skin cancer
Blood and Lymphatic System Disorders Very common Bone marrow failure, CD4 lymphocytes decreased, leukopenia, thrombocytopenia, platelet count decreased, anaemia
Metabolism and Nutrition Disorders Very common Anorexia
Psychiatric Disorders Common Hallucination, disorientation
Nervous System Disorders Common Convulsion, dizziness, peripheral neuropathy1, somnolence, headache
Respiratory, Thoracic, and Mediastinal Disorders Common Pulmonary fibrosis, pulmonary oedema, lung infiltration, dyspnoea
Unknown Interstitial lung disease, pneumonitis, alveolitis, allergic alveolitis, cough
Gastrointestinal Disorders Very common Pancreatitis1, nausea, vomiting, diarrhoea, stomatitis, constipation, mucositis, stomach discomfort, dyspepsia, abdominal pain, melaena
Hepatobiliary Disorders Common Hepatotoxicity1, hepatic enzyme increased, cholestasis, hepatitis
Skin and Subcutaneous Tissue Disorders Very common Cutaneous vasculitis, dermatomyositis, alopecia, rash maculo-papular, rash papular, skin exfoliation, skin atrophy, skin ulcer, erythema, skin hyperpigmentation, nail disorder
Very rare Systemic and cutaneous lupus erythematosus
Renal and Urinary Disorders Very common Dysuria, blood creatinine increased, blood urea increased, blood uric acid increased
General Disorders and Administration Site Conditions Very common Pyrexia, asthenia, chills, malaise
Reproductive system and breast disorders Very common azoospermia, oligospermia
1 Fatal and non-fatal pancreatitis and hepatotoxicity and severe peripheral neuropathy have been reported in HIV-infected patients who received hydroxyurea in combination with antiretroviral agents, in particular didanosine plus stavudine.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Immediate treatment consists of gastric lavage, followed by supportive therapy for the cardiorespiratory systems if required. In the long term, careful monitoring of the haemopoietic system is essential and, if necessary, blood should be transfused.

Acute mucocutaneous toxicity has been reported in patients receiving Hydroxyurea at a dosage several times greater than that recommended. Soreness, violet erythema, oedema on palms and foot soles followed by scaling of hands and feet, intense generalised hyperpigmentation of skin, and severe acute stomatitis were observed.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: other antineoplastic agents

Hydroxyurea is an orally active antineoplastic agent. Although the mechanism of action has not yet been clearly defined, Hydroxyurea appears to act by interfering with synthesis of DNA.

5.2 Pharmacokinetic properties

After oral administration Hydroxyurea is readily absorbed from the gastrointestinal tract. Peak plasma concentrations are reached in 2 hours; by 24 hours the serum concentrations are virtually zero. Approximately 80% of an oral or intravenous dose of 7 to 30 mg/kg may be recovered from the urine within 12 hours. Hydroxyurea crosses the blood-brain barrier. Hydroxyurea is well distributed throughout the body.

5.3 Preclinical safety data

Hydroxyurea is unequivocally genotoxic and a presumed transpecies carcinogen which implies a carcinogenic risk to humans.

  1. Pharmaceutical particulars

6.1 List of excipients

Citric acid, anhydrous, Lactose monohydrate, Magnesium stearate, Sodium phosphate, Gelatin capsules contain: Erythrosine, Indigotine, Yellow iron oxide, Titanium dioxide, Sodium laurilsulfate,

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

6.5 Nature and contents of container

Carton containing 100 capsules in blisters consisting of PVC/PCTFE/PVC and sealed with aluminium foil with PVC/PVDC backing.

6.6 Special precautions for disposal and other handling

People who are not taking Hydroxyurea should not be exposed to it. To decrease the risk of exposure, wear disposable gloves when handling Hydroxyurea. Anyone handling Hydroxyurea should wash their hands before and after contact with the capsules. If the powder is spilled, it should be immediately wiped with a damp disposable towel and discarded in a closed container, such as a plastic bag, as should the empty capsules. Hydroxyurea should be kept away from children. Pregnant women should not handle Hydroxyurea.

To minimise the risk of dermal exposure, always wear impervious gloves when handling capsules containing Hydroxyurea. This includes all handling activities in clinical settings, pharmacies, storerooms and home healthcare settings, including during unpacking and inspection, transport within a facility, and dose preparation and administration. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7.Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
at SURVEY NO.188/1 TO 189/1,190/1 TO 4,
ATHIYAWAD, DABHEL, DAMAN- 396210 (INDIA).

 

Hydroxyurea Capsules USP 500mg /  Hydroxycarbamide (Tharolax 500)
Hydroxyurea Capsules USP 400mg /  Hydroxycarbamide (Tharolax 400)
Hydroxyurea Capsules USP 300mg /  Hydroxycarbamide (Tharolax 300)
Hydroxyurea Capsules USP 200mg /  Hydroxycarbamide (Tharolax 200)

Package leaflet: Information for the patient

Hydroxyurea (Tharolax)

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 (Capsules) 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
  2. 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.

  1. 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 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 breast feeding
  • 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 folic acid deficiency

In 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 each others actions.

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.

  1. 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 bodyweight 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 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.

  1. 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 maybe 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 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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

  1. 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.

  1. Contents of the pack and other information

What Hydroxyurea contains

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

b) Each hard gelatin capsule contains
Hydroxyurea USP                                    400mg
Excipients                                                   q.s.
Colours: Approved colours used in capsule shell

c) Each hard gelatin capsule contains
Hydroxyurea USP                                   300mg
Excipients                                                   q.s.
Colours: Approved colours used in capsule shell

d) Each hard gelatin capsule contains
Hydroxyurea USP                                    200mg
Excipients                                                   q.s.
Colours: Approved colours used in capsule shell

  • The other ingredients are citric acid anhydrous, erythrosine, gelatin, indigotine, lactose monohydrate, magnesium stearate, sodium laurilsulfate, sodium phosphate, titanium dioxide, yellow iron oxide.

What Hydroxyurea looks like and contents of the pack

Hydroxyurea capsules are packed in blister packs of 100 capsules.

People who are not taking Hydroxyurea should not be exposed to it. To decrease the risk of exposure, wear disposable gloves when handling Hydroxyurea. Anyone handling Hydroxyurea should wash their hands before and after contact with the capsules. Pregnant women should not handle Hydroxyurea.

7.Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
at SURVEY NO.188/1 TO 189/1,190/1 TO 4,
ATHIYAWAD, DABHEL, DAMAN- 396210 (INDIA).

Warnings

Hydroxyurea contains a black-box warning because it can cause a severe drop in the number of blood cells in your bone marrow. This can increase your risk of a serious infection or bleeding.

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

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