10 mg, 20 mg tablets
Hydrocortisone
1. What Hydrocortisone Orifarm is and what it is used for
Hydrocortisone Orifarm contains hydrocortisone produced synthetically.
Hydrocortisone belongs to a group of medicines called steroids. The full name is Corticosteroids. Corticosteroids occur naturally in the body and help maintain health and well-being. Adding extra corticosteroids (such as hydrocortisone ) to the body is an effective way to treat various diseases that involve inflammation in the body. Hydrocortisone suppresses inflammation of those who otherwise could worsen your condition. You need to take this medicine regularly to get the full benefit of it.
Hydrocortisone Orifarm is used for:
- To replace hydrocortisone in children and adolescents (up to 18 years of age) when part of the adrenal gland does not function normally
- Acute treatment of adults and children with severe asthma , hypersensitivity reactions to drugs, serum sickness ( hypersensitivity reaction to proteins ), local swelling of the skin and / or mucous membranes ( angioedema ), and life-threatening allergic reactions ( anaphylaxis ).
Hydrocortisone contained in Hydrocortisone Orifarm 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 you use Hydrocortisone Orifarm
Do not use Hydrocortisone Orifarm
- if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
High doses of corticosteroids can weaken your immune system. If this applies to you, you should not be given vaccines that contain live attenuated viruses or bacteria as they may give you an infection.
Before you take Hydrocortisone Orifarm
Talk to your doctor first, if
- You have or have had a severe depression or manic-depressive illness ( bipolar disorder ). This is true even if you had a depression before or while taking steroids such as hydrocortisone .
- Someone close family member has had these diseases.
If any of these apply to you, talk to your doctor before taking hydrocortisone.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Hydrocortisone Orifarm, if you have or have had:
- diabetes (diabetes)
- stomach ulcers or ulcers in the intestine
- osteoporosis (osteoporosis)
- glaucoma – increased pressure in the eye
- heart problems ( heart failure , recent myocardial infarction)
- high blood pressure
- kidney or liver problems
- epilepsy
- inflammatory bowel disease
- recently underwent an operation in which an artificial opening between two normally separated spaces was created ( anastomosis )
- mental health problems
- thyroid problems
- chickenpox, measles or shingles . Avoid contact with people who are infected with or have chickenpox, measles or shingles . If you come in contact with these diseases, consult a doctor immediately
- infection caused by intestinal parasites (eg amoebiasis or strongyloidiasis). Hydrocortisone can enable or exacerbate such infection s
- tuberculosis
- herpes simplex infection of the eye. Hydrocortisone can activate or worsen fungal and viral infections in the eye
- muscle weakness, having earlier taken the steroid you.
Contact a doctor if you develop any new infections during treatment with Hydrocortisone Orifarm. 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.
If hydrocortisone is given to a premature baby, the function and structure of the heart may need to be monitored.
Contact your doctor if you experience blurred vision or other visual disturbances.
Mental problems during treatment with hydrocortisone
Mental health problems can occur when you take steroids such as hydrocortisone (see also section 4 Possible side effects ).
- These diseases can be serious.
- They usually start within a few days or weeks after starting treatment.
- It is more likely to get these diseases at high doses .
- Most of these diseases go away if the dose is reduced or if the medication is stopped. However, if diseases do occur, they may require treatment.
Talk to your doctor if you (or anyone taking this medicine) show signs of mental health problems. This is especially important if you are depressed or have suicidal thoughts, and when your dose is reduced or treatment is stopped. In a few cases, mental health problems have occurred during the reduction of dose one.
Stress, injuries, surgeries
If you are taking or have recently taken Hydrocortisone Orifarm and you become ill, stressed, injured, or undergoing surgery, talk to your doctor. Your dose of Hydrocortisone Orifarm may need to be increased (or you may need to start taking it again for a short time) to prevent a sharp drop in blood pressure.
In acute adrenal insufficiency must hydrocortisone is given in a higher dose s intravenously with fluid and electrolytes.
Vaccines
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. Some vaccines should be avoided during corticosteroid therapy, see section “Do not use Hydrocortisone Orifarm”.
Blood clotting ability ( coagulation ability )
Corticosteroids can affect the blood’s ability to coagulate, so caution is advised if you are also taking any medicine that affects your blood’s ability to coagulate (see section “Other medicines and Hydrocortisone Orifarm”).
Children
Corticosteroid therapy may cause growth retardation and the risk of side effects may be higher.
Other medicines and Hydrocortisone Orifarm
Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription.
In particular, do not take this medicine and contact your doctor or pharmacist if you are taking any of the following:
- Phenytoin , carbamazepine and barbiturates – used to treat epilepsy .
- Rifampicin or rifabutin – used to treat tuberculosis .
- Efavirenz and nevirapine – used to treat HIV – infection .
- St. John’s wort ( Hypericum perforatum ) – used to treat mild depression and mild anxiety.
- Ketoconazole tablets – used to treat Cushing’s syndrome – when the body produces an excess of cortisol .
- Itraconazole, posaconazole, voriconazole and amphotericin B – used to treat fungal infections.
- Erythromycin, telithromycin, clarithromycin and fluoroquinolones – used to treat bacterial infections.
- Antihypertensive drugs.
- Blood thinners ( anticoagulants ), e.g. warfarin or acetylsalicylic acid .
- Medicines for diabetes (including insulin ).
- Diuretics ( diuretics )
- Cardiac glycosides (for the treatment of heart failure ), e.g. digoxin .
- Medicines used to treat asthma or other respiratory problems (eg theophylline, bambuterol, phenoterol, formoterol, ritodrine, salmeterol , salbutamol , terbutaline ).
- Medicines for inflammation , pain or fever (ie NSAIDs ), e.g. ibuprofen , diclofenac or naproxen .
- Somatropin ( growth hormone ).
- Mifepristone (for termination of pregnancy).
- Vaccines. Corticosteroids can reduce the effect of vaccines and increase the risk of affecting the nervous system). Vaccines containing live attenuated viruses or bacteria should be avoided altogether (see section “Do not take Hydrocortisone Orifarm”).
Some medicines may increase the effects of Hydrocortisone Orifarm and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).
Hydrocortisone Orifarm with food and drink
Hydrocortisone Orifarm can be taken with a meal, which may reduce any indigestion.
Avoid drinking grapefruit juice during treatment. Grapefruit juice can impair the body’s breakdown of hydrocortisone and thus increase the amount of hydrocortisone in the blood.
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.
Pregnancy
During pregnancy, hydrocortisone should only be given after special consideration.
Breast-feeding
Hydrocortisone passes into breast milk. A risk to the newborn / infant cannot be ruled out.
Fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Hydrocortisone Orifarm has no influence on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.
Hydrocortisone Orifarm contains lactose
One Hydrocortisone Orifarm 10 mg tablet contains 37.5 mg lactose and Hydrocortisone Orifarm 20 mg tablet contains 75 mg lactose.
Lactose is a sugar. 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 Orifarm
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 this treatment is too strong or too weak, talk to your doctor or pharmacist.
In replacement therapy, the first dose in the morning is usually higher than the later doses, to mimic the normal circadian rhythm of corticosteroid secretions.
Emergency treatment for adults and children
– Take 6-8 tablets (60 – 80 mg) every 4-6 hours for 24 hours. Thereafter, the dose should be gradually reduced over several days according to the doctor’s instructions.
Compensation treatment for children and adolescents (aged 1 month to 18 years)
Hydrocortisone Orifarm can be used in children between the ages of 1 month and 18 years where tablet preparation is deemed appropriate.
- Congenital increased number of cells in the adrenal cortex (congenital adrenal hyperplasia):Dosage one is individual and determined by the doctor depending on the patient’s height and weight. The daily dose is divided into 3 doses . The doctor will adjust the dose depending on the individual effect.
- Insufficient production of steroid hormones from the adrenal glands (adrenal insufficiency): The doctor will determine an individual dose based on the patient’s height and weight. The daily dose is divided into 3 doses . Your doctor will adjust the dose depending on your individual effect: a higher dose may be needed.
Use in special patient groups or special situations
Your doctor may want to change your dose or monitor your treatment closely if you are elderly, have liver problems or adrenal problems, stress, injuries or infection, or if you have surgery planned.
Can be taken with a meal, which can reduce any indigestion. The tablets should be swallowed with water. The tablets can be divided into two equal doses.
Avoid drinking grapefruit juice during treatment, as it may increase the amount of hydrocortisone in the blood.
If you use more Hydrocortisone Orifarm 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 use Hydrocortisone Orifarm
Skip the missed dose one and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you stop using Hydrocortisone Orifarm
If treatment is to be stopped after prolonged use, it is important that the dosage is gradually reduced according to the doctor’s recommendations.
Stopping taking Hydrocortisone Orifarm can lead to insufficient levels of steroid hormones in the body. If you suddenly stop taking Hydrocortisone Orifarm, you may experience withdrawal symptoms such as muscle or joint pain, fever, weakness, nausea, high pressure in the skull, and low blood pressure.
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.
The side effects may be more pronounced in the elderly and children.
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 was given as a treatment for other conditions than as replacement therapy for adrenal insufficiency, often in higher doses.
Has been reported (occurs in an unknown number of users):
- Increased susceptibility to infection (if you have a “dormant” infection (eg tuberculosis or herpes ) in the body, it may flare up).
- Adrenal insufficiency after discontinuation, discontinuation symptoms (headache, nausea, dizziness, loss of appetite, weakness, mood swings, lethargy and unwanted reactions to stressful situations)
- Patients who have diabetes can worsen their disease.
- Growth in children can be inhibited.
- After a long period of use, the medicine may cause high pressure in the eye and cloudiness in the lens.
- During long-term treatment, there may be a descaling of the skeleton with a risk of bone fractures.
- Increased white blood cell count .
- An accumulation of water in the body can occur which leads to high blood pressure .
- Potassium deficiency in the blood (noticeable during blood tests, among other things).
- Swelling of the face, swollen abdomen and tapered arms and legs.
- Thin or sensitive skin, the skin can turn red-pink with possible blisters, acne, stretch marks, allergic skin inflammation and abnormal hair.
- Wound healing may be impaired.
- The mood can often be affected in the form of elation, mental disorders.
- Hypersensitivity.
- Insomnia.
- High blood pressure .
- Exacerbation of heart failure .
- Indigestion. A stomach ulcer or ulcer on the intestine may worsen during treatment.
- Blood clot.
- Elevated pressure in the skull in children.
- Dimsyn.
- Thickening of the heart muscle ( hypertrophic cardiomyopathy ) in premature infants.
- 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 Orifarm
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C.
Do not use this medicine after the expiry date which is stated on the label and carton 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 hydrocortisone; 1 tablet contains 10 mg and 20 mg hydrocortisone respectively .
- The other ingredients are gelatin, potato starch, lactose monohydrate , magnesium stearate (E 470b), talc (E 553b).
What the medicine looks like and contents of the pack
Appearance
Hydrocortisone Orifarm 10 mg: convex, white, round, tablets with a scoreline on one side, marked “1” on the other side, diameter 6 mm.
Hydrocortisone Orifarm 20 mg: convex, white, round, tablets with a scoreline on one side, diameter 8 mm.
Pack sizes
10 mg and 20 mg tablets:
Plastic jar: 30 and 100 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
Manufacturer
Viminco A / S
Lodshusvej 11
4230 Skælskør
Denmark
and
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com