500 mg hard hydroxycarbamide capsules

1. What Hydrea is and what it is used for

Hydrea is a cytostatic, that is, drug that reduces cell division in rapidly dividing cells, such as cancer cells. This causes the cells to die.

Hydrea is used for chronic leukemia (blood cancer) and certain other types of blood diseases.

Hydroxycarbamide contained in Hydrea may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you take Hydrea

Do not take Hydrea

  • if you are allergic to hydroxycarbamide or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor before taking Hydrea

  • if you have impaired kidney function
  • if you have impaired liver function
  • if you have impaired bone marrow function (determined using blood tests)
  • if you are older. Lower dose er may be required.
  • if you intend to be vaccinated
  • if you have previously received radiation therapy
  • if you are currently receiving or have recently received interferon therapy .

Secondary leukemia and skin cancer have been reported in patients receiving long-term treatment with hydroxycarbamide.

You must protect the skin from sunlight and examine the skin yourself regularly during the treatment and after the treatment with Hydrea has ended. Your doctor will also examine your skin in connection with recurring follow-up visits.

Cases of low red blood cell count, because the blood cells are destroyed faster than they are replaced ( haemolytic anemia ), have been reported in patients treated with Hydrea. This will be checked by blood tests if you develop persistent anemia.

Treatment with Hydrea can in some cases mask folic acid deficiency and therefore your doctor may recommend regular check-ups of your folic acid levels.

It is important to drink plenty of fluids during treatment.

Children and young people

The safety and efficacy of Hydrea in children have not been established.

Other medicines and Hydrea

Tell your doctor or pharmacist if you have recently taken or might take any other medicines. The treatment effect may be affected if this medicine is taken at the same time as certain other medicines. The treating physician, therefore, needs to be aware of such concomitant medication.

Concomitant use of Hydrea with other drugs that affect the bone marrow (eg chemotherapy ) or radiation therapy may increase the risk of certain side effects.

Concomitant use of Hydrea and live vaccines is not recommended as it may increase the side effects of the vaccine and increase the risk of serious infection as the body’s normal defense mechanisms may be impaired by treatment with Hydrea.

Hydrea can increase the concentration of uric acid in the blood. Dose one of the drugs used against high levels of uric acid, e.g. allopurinol, may therefore need to be changed.

In patients treated with Hydrea in combination with HIV – infection (didanosine, stavudine), inflammation of the pancreas and liver damage (in some cases, these side effects have led to death), as well as nerve effects in the hands and feet ( peripheral neuropathy ),.

Pregnancy, breastfeeding and fertility

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.

You should avoid becoming pregnant while being treated with Hydrea.

Risk of fetal harm. Hydrea should not be used during pregnancy except on strict prescription by a doctor.

Due to the risk of serious side effects in the baby, Hydrea should not be used during breastfeeding. If your doctor thinks that treatment is necessary, you should stop breastfeeding during treatment with Hydrea.

Men
Sperm production can be affected. Before treatment, the possibility of preserving semen should be considered. Hydroxycarbamide can be harmful to DNA, the genetic material in the cells. It is recommended that you use a safe method of contraception during treatment and for at least one year after stopping treatment.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Hydrea contains lactose and sodium

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains 11.67 mg sodium (the main ingredient in table salt/table salt) per capsule. This corresponds to 0.6% of the maximum recommended daily sodium intake for adults.

3. How to take Hydrea

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Dose one is determined by the doctor, who adjusts it individually for you.

The capsules are swallowed whole.

The Hydrea capsules should be handled with care. Keep Hydrea away from children and pets. The following measures prevent exposure:

  • Wash hands with soap and water after each handling of the product or wear protective gloves.
  • If the capsule breaks or dissolves, wash hands thoroughly with water.

If you take more Hydrea than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Hydrea

Do not take a double dose to make up for a forgotten dose. Contact your doctor if you forget to take a dose.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor immediately if you experience the following symptoms:

  • Severe infection
  • Fatigue and / or pallor
  • Unexplained bruising or bleeding
    These symptoms may be signs of decreased activity in the blood-forming organs, a very common side effect (may affect more than 1 user in 10).
  • Difficulty breathingThis may be a sign of lung effects, a common side effect (may affect up to 1 in 10 people).
  • Sores on the skinThese symptoms may be signs of inflammation of the blood vessels of the skin, a very common side effect (may affect more than 1 user in 10).
  • Drug-induced feverHigh fever with or without concomitant symptoms in the gastrointestinal tract, lungs, skeleton and muscles, liver and bile, skin or heart and vessels have been reported with the use of the drug. These may occur several weeks after starting to use the medicine. Has been reported (occurs in an unknown number of users).
  • Fever, cough or difficulty breathingThese can be signs of serious lung disease. Has been reported (occurs in an unknown number of users).

Other side effects that may occur:

Very common (may affect more than 1 user in 10)

  • anemia
  • loss of appetite
  • inflammation of the pancreas (sometimes fatal)
  • nausea and vomiting
  • diarrhea
  • inflammation of the oral mucosa
  • constipation
  • irritation of the stomach and / or digestive tract
  • skin rashes, including rashes in the form of spots and blemishes and raised rashes
  • hair loss
  • inflammation of the skin, subcutaneous tissue and adjacent muscles
  • reddening of the face or arms and legs / hands and feet
  • exfoliating skin
  • pigment spots
  • skin and nail loss
  • increased amount of uric acid
  • increased amount of urea in the blood
  • increased amount of creatinine in the blood
  • urination difficulties
  • ceased or reduced sperm production
  • fever
  • chills
  • impotence
  • feeling sick

Common (may affect up to 1 in 10 people)

  • skin cancer
  • disorientation
  • hallucinations
  • seizures
  • dizziness
  • headache
  • nerve impact in hands and feet
  • drowsiness
  • increased amount of liver enzymes in the blood
  • impaired bile flow
  • liver inflammation ( hepatitis )
  • liver damage (sometimes fatal).

Rare (may affect up to 1 in 1,000 people)

  • abnormal blood levels caused by residual products of the disintegrating tumor and which can lead to changes in heart rhythm and impaired kidney function (tumor lysis syndrome)
  • local tissue death as a result of inflammation of the blood vessels of the skin with concomitant ulcers (usually associated with concomitant or previous treatment with interferon ).

Has been reported (occurs in an unknown number of users)

  • pigmented (colored) nails
  • inflammation of the skin which causes red, scaly spots and which can occur simultaneously with pain in the joints
  • low number of red blood cells due to their destruction faster than they are replaced ( hemolytic anemia ).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Hydrea

Do not store above 25 ° C.

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

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified 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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is hydroxycarbamide. One capsule contains 500 mg of hydroxycarbamide.
  • The other ingredients are lactose monohydrate 42.2 mg, anhydrous disodium phosphate, anhydrous citric acid, magnesium stearate, gelatin, erythrosine (E127), indigo carmine (E132), titanium dioxide (E171) and yellow iron oxide (E172).

What the medicine looks like and contents of the pack

Hydrea 500 mg hard capsules are two-part opaque gelatin capsules with a pink base and a green top. The capsules are marked with “BMS 303” in black.

Pack size: 100 capsules in a glass jar.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Bristol-Myers Squibb AB

Box 1172

171 23 Solna

Manufacturer

Corden Pharma Latina SpA

Via del Murillo Km 2,800

IT 04013 Sermoneta

Latina, Italy

Muhammad Nadeem

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