10 mg tablets of hydrocortisone
1. What Hydrocortisone Orion is and what it is used for
Hydrocortisone Orion contains a medicine called hydrocortisone. 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 that might otherwise aggravate your condition. You need to take this medicine regularly to get the full benefit of it.
Hydrocortisone Orion is used for:
- To replace hydrocortisone in children and adolescents when part of the adrenal gland does not function normally
- Acute treatment of severe asthma , hypersensitivity reaction 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 Orion may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 use Hydrocortisone Orion
Do not use Hydrocortisone Orion
- if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6)
- if you have tuberculosis or any other acute or chronic bacterial , fungal, viral or parasitic infection without appropriate antimicrobial treatment.
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 Orion
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 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 before taking Hydrocortisone Orion, if you have or have had:
- 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
- myasthenia gravis (a disease that affects the muscles) and at the same time uses cholinesterase inhibitors (drug group that can be used in myasthenia gravis )
- chickenpox, measles or shingles . Avoid contact with people who are infected 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 activate or aggravate such infections .
- 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 your doctor if you develop any new infections during treatment with Hydrocortisone Orion. 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.
Contact a 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 Orion and you become ill, stressed, injured, or undergoing surgery, talk to your doctor. Your dose of Hydrocortisone Orion 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.
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 take Hydrocortisone Orion”.
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 Orion”).
Children
Corticosteroid therapy may cause growth retardation and the risk of side effects may be higher.
If hydrocortisone is given to a premature baby, the function and structure of the heart may need to be monitored.
Other medicines and Hydrocortisone Orion
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Hydrocortisone Orion and your doctor may want to monitor you closely if you are taking these medicines (eg some HIV medicines: ritonavir, cobicistat).
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 (for epilepsy )
- rifampicin and rifabutin (for tuberculosis )
- herbal medicine containing St. John’s wort (Hypericum perforatum)
- efavirenz and nevirapine ( HIV medicines)
- medicines for fungal infections ( ketoconazole , itraconazole, posaconazole, voriconazole, amphotericin B)
- erythromycin, telithromycin, clarithromycin, fluoroquinolones ( antibiotics )
- drugs containing estrogen and birth control pills
- antihypertensive drugs
- blood-thinning drugs ( anticoagulants ), e.g. warfarin
- acetylsalicylic acid
- drugs against diabetes
- cholinesterase inhibitors (eg pyridostigmine)
- diuretics ( diuretics )
- cardiac glycosides (for the treatment of heart failure ), e.g. digoxin
- theophylline and beta2 sympathomimetics e.g. bambuterol, fenoterol, formoterol, ritodrine, salmeterol , salbutamol , terbutaline (used to treat asthma or other respiratory problems)
- anti-inflammatory painkillers (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 neurological complications (complications affecting the nervous system). Vaccines containing live attenuated viruses or bacteria should be avoided altogether (see section “Do not take Hydrocortisone Orion”).
Hydrocortisone Orion with food and drink
Hydrocortisone Orion can be taken with or without food.
Avoid drinking grapefruit juice during treatment, as it may 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 for advice before using this medicine.
Pregnancy
Hydrocortisone passes through the placenta. Apart from replacement therapy, treatment with corticosteroids that affect the whole body should be given with caution during pregnancy. If you have received hydrocortisone in treatment doses during pregnancy, your newborn baby should be monitored for insufficient hormone production in the adrenal glands.
Breast-feeding
The active substance in Hydrocortisone Orion is excreted in human milk. Prolonged use of high doses of Hydrocortisone Orion during breastfeeding may impair the baby’s ability to produce sufficient amounts of steroid hormones.
Fertility
Corticosteroids can affect fertility as they can impair sperm quality and cause menstruation to stop ( amenorrhea ).
Driving and using machines
Hydrocortisone Orion does not normally affect your ability to drive or use machines. In some patients, however, steroids can cause a feeling of movement, even when you are still, and this can lead to feelings of dizziness. Vision changes or muscle weakness may also occur. If you are affected by this, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.
Hydrocortisone Orion contains lactose
One Hydrocortisone Orion tablet contains 64.6 mg of 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 Orion
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one and the treatment time depends on your disease.
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.
The tablet can be divided into two equal doses.
Swallow the tablets with a small amount of liquid, with or without food.
If you have the impression that the effect of treatment is too strong or too weak, talk to your doctor.
Emergency treatment for adults
- 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 Orion can be used for replacement therapy in children between the ages of 1 month and 18 years, where a dose of 10 mg, and tablet formulation, 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 patient’s response to treatment.
- 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 . The doctor will adjust the dose depending on the patient’s response to treatment: higher doses 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.
If you use more Hydrocortisone Orion 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 a large overdose has been taken, activated charcoal can be given as first aid, but in addition, a doctor must be contacted as soon as possible for other treatment.
If you forget to use Hydrocortisone Orion
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 Orion
You may only discontinue or discontinue treatment in consultation with your doctor. It is dangerous to reduce dose one of Hydrocortisone Orion too quickly. Your doctor will reduce the dose gradually.
Stopping taking Hydrocortisone Orion can lead to insufficient amounts of steroid hormones in the body. If you suddenly stop taking Hydrocortisone Orion, 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 or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects can be more severe in the elderly and children.
People who take hydrocortisone to replace similar hormones in their bodies tend to have a lower risk of side effects than people who take hydrocortisone for other diseases. Your doctor will want to see you from time to time to keep an eye on any side effect s
Treatment with this drug can sometimes cause serious side effects. Tell your doctor immediately if you notice any of the following problems, or if you think you are at increased risk of getting an infection (for example, if you have been in contact with someone who has an infection ):
- a possibly life-threatening allergic reaction that causes i.a. skin rash, swelling of the face or wheezing
- irregular or very fast or slow pulse , lethargy
- in children, headache with vomiting, lethargy and drowsiness. These are symptoms of a cerebral pseudo-tumor that can increase the pressure in the skull and that usually occur after the end of treatment.
- ruptured or bleeding sores in the intestine (characterized by stomach pain, especially if it seems to spread to the back, bleeding from the rectum, black stools or bloody vomiting)
- acute inflammation of the pancreas (abdominal pain, possibly with shock , ie low blood pressure with decreased urine production and often unconsciousness)
- blood clot in a friend ( thrombosis ) in the leg. Symptoms are a swollen, red, hot, sore muscle
- heart failure – problems with the pumping function of the heart, which is characterized by swollen ankles, chest pain, difficulty breathing and palpitations or irregular heartbeat, irregular or very fast or slow pulse; hypertension (high blood pressure , which may be characterized by headache or general malaise).
Serious side effects: consult a doctor immediately
Steroids like hydrocortisone can cause serious mental problems. These are common in both adults and children. They can affect about 5 out of 100 people who take drugs such as hydrocortisone.
- to feel depressed, including having suicidal thoughts
- to feel high (mania) or that the mood goes up and down
- to feel anxious, have difficulty sleeping, have difficulty thinking or be confused and lose memory
- to feel, see or hear things that do not exist. To have strange and frightening thoughts, to start behaving differently or to have feelings of being alone.
If you notice any of these problems, talk to a doctor immediately.
Other side effects reported for hydrocortisone:
Common (may affect up to 1 in 10 people)
- high blood pressure
- increased susceptibility to infection, masked symptoms of infection
- insufficient hormone production in the pituitary gland (adrenocorticotropic hormone , ACTH) and in the adrenal glands ( cortisol ) with long-term use
- round or moon-shaped face
- worsening or development of diabetes
- cramps and spasms due to loss of potassium salts from the body. In rare cases, potassium loss can lead to palpitations (irregular heartbeat that you notice)
- accumulation of sodium in the body
- thin or sensitive skin, impaired wound healing, scars, red or purple spots, acne , stretch marks, bruises
- muscle weakness or muscle wasting, osteoporosis (osteoporosis – bone fractures occur more easily).
Uncommon (may affect up to 1 in 100 people)
- increased appetite
- mood swings, depression, mania (feeling high), psychosis (feeling, seeing or hearing things that do not exist, or having strange and frightening thoughts, behaving differently or having feelings of being alone), insomnia
- visual changes due to cataracts or glaucoma (increased pressure in the eye).
Rare (may affect up to 1 in 1,000 people)
- seizures
- degradation of bone tissue due to poor blood circulation, rupture of muscle tendons (pain and or swelling).
No known frequency (can not be calculated from the available data)
- increased white blood cell count
- weak reaction to stress (such as injuries, surgery or illness)
- elevated blood sugar
- potassium and calcium loss, loss of nitrogen due to the breakdown of the body’s protein stores, fluid accumulation in the body
- mental problems, behavioral problems, feelings of irritation or anxiety, difficulty sleeping, difficulty thinking (including confusion and memory loss)
- dizziness, headache
- swelling of the optic nerve papilla in the fundus (papillary edema), thinning of the surface of the eye, bulging eyes, blurred vision
- rupture of the heart muscle after a recent myocardial infarction
- thickening of the heart muscle ( hypertrophic cardiomyopathy ) in premature infants
- hiccup
- ulcerative inflammation of the esophagus, swelling, indigestion, fungal infection of the esophagus
- small round spots on the skin or mucous membranes, reddening of the skin, permanent enlargement of small blood vessels in the skin or mucous membranes, increased sweating, allergic skin inflammation, hives , increased body hair and facial hair growth in women
- muscle disease caused by steroids , bone fractures
- irregular or no menstruation in women
- weight gain, nausea, feelings of physical discomfort and fatigue.
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.
The Medical Products Agency
Box 26
751 03 Uppsala
www.lakemedelsverket.se
5. How to store Hydrocortisone Orion
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 blister, carton, and glass jar label. The expiration date is the last day of the specified month.
No special temperature instructions.
Store in a blister or tightly closed jar. Sensitive to light. Moisture sensitive.
The glass jar contains desiccant, which protects the tablets from moisture. The desiccant should not be removed from the container. Do not swallow the desiccant.
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 . Each tablet contains 10 mg of hydrocortisone .
- The other ingredients are lactose monohydrate , corn starch, talc, gelatin and magnesium stearate.
What the medicine looks like and contents of the pack
White, smooth tablet with a notch, with smooth, beveled edges and diameter about 7 mm, marked ‘ORN35’.
The tablets are available in blister packs of 30 or 100 tablets.
Brown glass jar, 15 ml with aluminum closure with desiccant, with 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Orion Pharma AB
medinfo@orionpharma.com