20 mg tablets
What Hydrocortisone Takeda is and what it is used for
Hydrocortisone Takeda contains hydrocortisone produced synthetically. Hydrocortisone is a hormone that occurs naturally in the body, it is normally formed in the adrenal cortex. Some diseases cause an insufficient production of hydrocortisone in the adrenal cortex. It can i.a. cause symptoms in the form of salt disorders, fatigue, gastrointestinal problems, and low blood pressure. Changes in skin pigmentation may also occur. Hydrocortisone Takeda is given to patients whose adrenal cortex for some reason does not produce enough hydrocortisone.
Hydrocortisone contained in Hydrocortisone Takeda 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.
What you need to know before using Hydrocortisone Takeda
Do not use Hydrocortisone Takeda
- if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Hydrocortisone Takeda, if you have or have had:
- tuberculosis , fungal or viral infection
- osteoporosis (osteoporosis)
- glaucoma (increased pressure in the eye)
- stomach ulcers or ulcers in the intestine
- inflammatory bowel disease
- high blood pressure
- heart problems ( heart failure ).
- mental health problems.
If you need a vaccine during treatment with corticosteroids, you should be aware that the protection of the vaccine may not be as effective as usual. Always inform vaccinating staff that you are using Hydrocortisone Takeda.
Contact a doctor if you develop any new infection during treatment with Hydrocortisone Takeda. Long-term treatment with high doses of hydrocortisone may increase the risk of developing an infection as hydrocortisone can mask the common symptoms of infection.
The dose may need to be changed in case of stress such as fever, stress (eg during operations), and acute illness, always consult a doctor at such times
Contact your doctor if you experience blurred vision or other visual disturbances.
Lifelong treatment with hydrocortisone is usually required. If treatment is to be stopped after prolonged use, it is important that the dosage is gradually reduced according to the doctor’s recommendations.
Children and young people
Corticosteroid therapy may cause growth retardation in children.
If hydrocortisone is given to a premature baby, the function and structure of the heart may need to be monitored.
Other medicines and Hydrocortisone Takeda
Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription.
The effect of the drug decreases with the concomitant use of antiepileptic drugs such as carbamazepine, phenytoin, and phenobarbital, as well as rifampicin (anti-tuberculosis drug ).
Some medicines may increase the effects of Hydrocortisone Takeda and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).
Hydrocortisone Takeda counteracts the effect of tablets against diabetes, somatropin ( growth hormone ), and reduces the effect of salicylates (painkillers) while increasing the effect of ciclosporin (agents that affect the immune system).
During concomitant treatment with diuretics and medicines containing amphotericin B (antifungal), there is an increased risk of low levels of potassium in the blood.
Concomitant treatment with fluoroquinolones (a type of antibiotic ) may increase the risk of tendon rupture.
Pregnancy, breastfeeding and fertility
Hydrocortisone Takeda is not expected to have a detrimental effect on the fetus during normal dosing as it replaces the body’s own production of hydrocortisone. With long-term treatment, however, there is a risk of reduced production in the adrenal cortex in the newborn child. Therefore, during pregnancy, hydrocortisone should be given only after special consideration.
Hydrocortisone passes into breast milk. A risk to the newborn / infant cannot be ruled out.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Hydrocortisone Takeda has no influence on the ability to drive and use machines.
Hydrocortisone Takeda contains lactose
Hydrocortisone Takeda 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.
3. How to use Hydrocortisone Takeda
Always use this medicine exactly as your doctor or pharmacist has told you. Dosage one is individual and determined by your doctor. Ask your doctor or pharmacist if you are unsure.
If you have the impression that the effect of Hydrocortisone Takeda is too strong or too weak, talk to your doctor or pharmacist.
The tablets can be taken with food, then the risk of possible side effects from the stomach/intestine is reduced. The tablets should be swallowed whole with a glass of water, but can also be divided, chewed, or crushed.
The tablet can be divided into two equal doses.
If you use more Hydrocortisone Takeda 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. Bring this leaflet and the tablets you still have with you to see your doctor.
If you forget to use Hydrocortisone Takeda
Do not take a double dose to make up for a forgotten dose.
If you stop using Hydrocortisone Takeda
If treatment is to be stopped after prolonged use, it is important that the dosage is gradually reduced according to the doctor’s recommendations.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When treated with hydrocortisone to replace the hydrocortisone that the body normally produces, the risk of side effects is small compared to if you give hydrocortisone for anti-inflammatory purposes, as the dose is often significantly higher.
The side effects listed below have been reported when hydrocortisone is given as a treatment for other conditions than as replacement therapy for adrenal insufficiency, often in higher doses:
- increased susceptibility to infection (if you have a “dormant” infection such as tuberculosis or herpes in the body, it can flare up)
- adrenal insufficiency after discontinuation, discontinuation symptoms (headache, nausea, dizziness, loss of appetite, weakness, mood swings, lethargy and unwanted reactions to stressful situations)
- worsening of diabetes
- growth retardation in children
- vision changes due to cataracts or glaucoma (increased pressure in the eye)
- with long-term treatment, there may be a decalcification of the skeleton ( osteoporosis ) with a risk of bone fractures
- increased number of leukocyte s
- swelling of the face, swollen abdomen and tapered arms and legs
- thin or sensitive skin, red or purple spots, acne , stretch marks, allergic dermatitis, abnormal hair
- impaired wound healing
- mental disorders (eg euphoria , psychosis )
- high blood pressure
- worsening of heart failure
- thickening of the heart muscle ( hypertrophic cardiomyopathy ) in premature infants
- worsening of gastric ulcers or ulcers on the intestine
- blood clot
- increased pressure in the skull in children
- fluid accumulation (accumulation of sodium ) in the body leading to high blood pressure , potassium deficiency in the blood.
- weight gain.
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 Hydrocortisone Takeda
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 and carton.
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
- The active substance is hydrocortisone 20 mg per tablet.
- The other ingredients are magnesium stearate, gelatin, talc, lactose monohydrate 75 mg / tablet and potato starch.
What the medicine looks like and contents of the pack
Hydrocortisone Takeda is a white, round tablet with a notch.
Pack size: 100 tablets
Marketing Authorization Holder and Manufacturer
Takeda Pharma AB
Vasagatan 7, 6 tr
111 20 Stockholm
Tel: 08-731 28 00