Hydrocortisone tablets 5mg
Hydrocortisone Tablets 10mg
Package leaflet: Information for the user
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 further questions, ask your doctor, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
- Hydrocortisone is a steroid medicine prescribed for many different conditions including serious illnesses.
- You need to take it regularly to get the maximum benefit.
- Do not stop taking this medicine without talking to your doctor – you may need to reduce the dose gradually.
- Hydrocortisone can cause side effects in some people (read Section 4 below). Some problems such as mood changes (feeling depressed or ?high?) or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor as soon as possible.
- Some side effects only happen after weeks or months. These include weakness of arms and legs or developing a rounder face (read Section 4 for more information).
- If you take this medicine for more than 3 weeks, you will get a blue ?Steroid Treatment? card always keep it with you and show it to any doctor or nurse treating you.
- Keep away from people who have chickenpox or shingles, even if you have had them previously (read Section 2 for further information). If you do come into contact with chickenpox or shingles, see your doctor straight away.
Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.
Hydrocortisone – benefit information.
Hydrocortisone belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as hydrocortisone) is an effective way to treat various illnesses involving inflammation in the body. Hydrocortisone reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get the maximum benefit from it.
What is in this leaflet
What Hydrocortisone Tablets are and what they are used for
2. What you need to know before you take Hydrocortisone Tablets
3. How to take Hydrocortisone Tablets
4. Possible side effects
5. How to store Hydrocortisone Tablets
6. Contents of the pack and other information
1. WHAT HYDROCORTISONE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Hydrocortisone 10 mg Tablets (referred to as Hydrocortisone Tablets in this leaflet). The active ingredient in your medicine is hydrocortisone. This belongs to a group of medicines known as corticosteroids. These are used to replace adrenal hormones in your body, which you may be lacking.
Hydrocortisone Tablets are used:
- in children: as replacement therapy for children with congenital adrenal hyperplasia which affects the body’s natural production of steroids;
- in adults and children: to treat severe asthma and allergic reactions.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYDROCORTISONE TABLETS
Do not take Hydrocortisone Tablets:
- if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6);
- have an infection;
- have been vaccinated recently or are going to have any vaccinations.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Hydrocortisone Tablets if:
- you have ever had severe depression or manic-depressive illness (bipolar disorder). This includes having had symptoms of depression in the past while taking steroid medicines like Hydrocortisone Tablets;
- any of your close family has had these illnesses.
Check with your doctor before taking this medicine if you have or have had any of the following:
- tuberculosis (TB);
- liver problems;
- kidney problems;
- high blood pressure;
- heart problems including recent heart attacks;
- diabetes (or a family history of diabetes);
- osteoporosis (thinning of the bones);
- glaucoma (increased pressure in the eye) or family history of glaucoma;
- HIV infection;
- stomach ulcers or other digestive problems;
- muscle weakness with steroids;
- existing or previous history of severe mood-related disorders;
- thyroid problems;
- chickenpox, shingles or measles;
- if you experience an increase of body temperature (fever due to any reason), feeling unwell, undergoing a stressful situation or if you are undergoing any minor surgical procedure;
- inform your doctor or pharmacist as your daily dose may be increased temporarily.
You should see your doctor if you develop any new infections whilst taking these tablets. Taking hydrocortisone for a long period of time increases your chance of getting infections, which might be worse than normal and may very rarely be fatal.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
If the patient is a child, it is important that the doctor monitors growth and development at intervals during treatment.
Hydrocortisone Tablets should be used with caution in the elderly as side effects can be heightened in this age group.
If you are taking or have recently taken (within the last 3 months) Hydrocortisone Tablets and you become ill (particularly important in cases of gastroenteritis or vomiting/diarrhoea), suffer stress, get injured or are about to have a surgical procedure you must tell your doctor immediately that you are taking Hydrocortisone Tablets. Your dose of hydrocortisone may need to be increased (or you may have to start taking it again for a short time) to prevent a sharp fall in blood pressure.
If for any other reason your general health is declining although you take your medicine as prescribed; seek medical advice immediately.
Particular care should be taken by patients on long-term treatment as there is an increased risk of side effects.
If you have been on Hydrocortisone Tablets for longer than 3 weeks and wish to stop taking them, do not stop suddenly as this could result in a severe drop in blood pressure which could be fatal. Your doctor will advise on how to reduce the number of tablets you are taking.
It is important to avoid exposure to people who have chickenpox, measles or shingles, especially if you have not already had these illnesses or are not sure if you have had them. Hydrocortisone increases the risk of a severe bout of chickenpox. If exposed you must contact your doctor immediately.
Mental health problems while taking hydrocortisone
Mental health problems can occur while taking steroids like hydrocortisone (see also Section 4).
- these illnesses can be severe;
- usually, they start within a few days or weeks of starting the medicine;
- they are more likely to happen at high doses;
- most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do occur they might need treatment.
Talk to a doctor if you (or someone taking this medicine) show any signs of mental health problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental health problems have happened when doses are being lowered or the medicine stopped altogether.
Important – Steroid Treatment Card
All patients taking steroids for more than a few weeks should carry a ?Steroid Treatment? card, which is available from your doctor or pharmacist. These cards have the details of the medicine you are taking. Always keep it with you and show it to any doctor or nurse treating you.
Other medicines and Hydrocortisone Tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Hydrocortisone and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
The effectiveness of Hydrocortisone Tablets may be altered if other medicines are being taken at the same time.
In particular, do not take this medicine if you are taking any of the following:
- anticoagulants such as warfarin (medicines used to thin the blood);
- salicylates such as aspirin;
- non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac or naproxen (medicines used to treat mild to moderate pain);
- medicines for diabetes (including insulin);
- erythromycin, telithromycin or clarithromycin (medicines used to treat bacterial infections);
- an oral contraceptive pill;
- somatropin (a type of growth hormone);
- efavirenz or nevirapine (medicines used in the treatment of HIV infections);
- acetazolamide (a medicine used to treat glaucoma);
- amphotericin, ketoconazole, itraconazole, posaconazole or voriconazole (used to treat fungal infections);
- mifepristone (a medicine used to assist medical termination of pregnancy);
- diuretics (water tablets);
- carbenoxolone (a medicine used to treat ulcers);
- methotrexate (a medicine used to treat rheumatoid arthritis);
- St. John?s Wort (a herbal medicine used for treating depression);
- medicines used to treat epilepsy such as phenytoin, phenobarbital, carbamazepine and primidone;
- rifabutin and rifampicin (antibiotics used to treat TB);
- aminoglutethimide (a medicine used in the treatment of cancer);
- cardiac glycosides, such as digoxin (used to treat heart failure and irregular heartbeat);
- theophylline and sympathomimetics such as bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline (used to treat asthma and other breathing problems);
- antihypertensives (medicines used to treat high blood pressure).
Test results while taking Hydrocortisone Tablets
Hydrocortisone Tablets could affect the results of some tests performed by your doctor or in hospital, so tell your doctor or nurse that you are taking these tablets before any tests are carried out.
Hydrocortisone Tablets with food, drink and alcohol
Hydrocortisone Tablets can be taken with or without food. Do not take this medicine with grapefruit juice as the juice may affect the action of this medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether you should take Hydrocortisone Tablets during this time.
Small amounts of hydrocortisone may pass into breast milk. Therefore you should talk to your doctor before taking Hydrocortisone Tablets if you are breast-feeding or intend to breast-feed.
Driving and using machines
Medicines such as hydrocortisone may cause changes in vision and/or muscle weakness. If you have any of these symptoms you should not drive or operate machinery.
Hydrocortisone Tablets 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.
3. HOW TO TAKE HYDROCORTISONE TABLETS
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 should take this medicine by mouth. The amount you take each day will depend on your illness.
Always remember to carry your ?Steroid Treatment? card with you. Make sure your doctor or pharmacist gives you this and has filled out the details, including the dose and how long you will have treatment.
The recommended dose is:
Dosage for Acute Emergencies
The recommended dose for adults is 60-80 mg every 4-6 hours for 24 hours then gradually lowering the dose over several days.
Use in children and adolescents
When used for replacement therapy, the recommended dose for children is 10-30 mg divided into two doses each day. The first dose taken in the morning may be larger than the second dose taken in the evening.
If you take more Hydrocortisone Tablets than you should
If you take more tablets than have been prescribed for you, contact your doctor as soon as possible. Overdosage can cause symptoms such as nausea (feeling sick), vomiting (being sick), sodium and water retention and occasional gastrointestinal bleeding.
If you forget to take Hydrocortisone Tablets
Skip the missed dose and then take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
If you stop taking Hydrocortisone Tablets
Do not stop taking this medicine just because you feel better. You should follow your doctor?s instructions on stopping this medicine. Your doctor may want you to reduce gradually the number of tablets you take before stopping completely. Never let your tablets run out before receiving the next prescription. It may be dangerous to go without treatment (see Section 2).
Stopping Hydrocortisone Tablets may leave you without enough steroid hormones in your body. This may cause withdrawal symptoms such as fever, muscle and joint pain, blocked/runny nose, swelling of the eye, painful itchy skin rash and weight loss.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them. If you are taking the medicine as a replacement steroid, you should be less likely to get side effects than people taking steroids for other illnesses. Side effects can be heightened when this medicine is used by elderly patients.
Tell your doctor immediately if you notice:
- itching or skin rashes;
- swelling of the face, lips or throat;
- difficulty breathing or wheeziness,
these may be signs of an allergic reaction.
Severe side effects:
Steroids including hydrocortisone can cause severe mental health problems. These side effects are common in both adults and children. They can affect about five in every 100 people taking medicines like hydrocortisone.
Tell your doctor immediately if you are:
- depressed, including thinking about suicide;
- high (mania) or having moods that go up and down;
- anxious, having problems sleeping, having difficulty in thinking or being confused and losing your memory;
- feeling, seeing or hearing things which do not exist;
- having strange and frightening thoughts, changing how you act or having feelings of being alone.
Other side effects
Tell your doctor if you experience any of the following:
Not Known: frequency cannot be estimated from the available data
Psychiatric disorders: Psychological dependence.
Heart problems: Increased damage to the heart in the event of a heart attack, heart failure, high blood pressure, formation of blood clots.
Infections: Taking Hydrocortisone Tablets can make it easier for you to pick up infections which may very rarely be fatal. Infections such as chickenpox and measles can be made worse or TB may recur. Some fungal and viral infections, including herpes, may be activated. Diarrhoea and vomiting, sore throat/cold, a flu-like illness caused by a viral infection.
Digestive system: Bleeding ulcers (indicated by stomach pain, bleeding from the back passage, black stools or being sick with blood present), inflammation of the pancreas causing abdominal pain, stomach pain and discomfort, bloated feeling, infection, swelling or ulceration of the gullet (discomfort on swallowing, which can cause chest pain), thrush, indigestion, feeling sick, being sick, tooth decay.
Nervous system: Fits (convulsions), worsening of epilepsy, sleepiness, dizziness/spinning sensation, headache (sometimes severe).
Bone, muscle and joints: Muscle weakness or wasting, thinning of bones which makes fractures more likely (osteoporosis), broken bones or fractures, hip or shoulder pain due to poor blood circulation, risk of torn tendons, joint inflammation in the knee and groin (aseptic necrosis) or other joints.
Eyes: Changes in vision as a result of cataracts (clouding of the lens in the eye) or glaucoma (increased pressure inside the eye), blurred vision, dry eyes, thinning of the surface of the eye, existing eye infections may get worse.
Blood and lymphatic system: Increased number of white blood cells.
In Women: Irregular or lack of periods.
Endocrine system and metabolic systems: Development of Cushingoid facies (round or moon-shaped face), increased appetite and weight gain, increased hair on the body and face in women, increased blood sugar levels/diabetes, loss of calcium and nitrogen (shown on medical tests), salt and water retention (causing swelling and raised blood pressure), low adrenal gland function which reduces the production of steroids in your body (particularly after surgery, an accident or illness).
Skin: Slow healing of cuts or wounds, thin or delicate skin, redness of the skin/small dilated blood vessels, acne, bruising, itchy rash, stretch marks.
General: Generally feeling unwell (malaise), tiredness.
Investigations: Changes in the levels of various chemicals in the blood which are usually detected by blood or urine tests, intolerance to carbohydrates, decrease in cholesterol (good cholesterol) in the blood (shown in blood tests).
Reduction in blood potassium levels, Symptoms of which include fainting due to low blood pressure, feeling your heartbeat (palpitations), muscle weakness, tiredness or cramps, feeling sick or being sick, inability to pass stool regularly and properly, frequent passing of urine, excessive thirst and inability to eat properly.
Additional side effects in children and adolescents
Raised pressure within the skull (pseudotumour cerebri, indicated by headaches with vomiting, listlessness and drowsiness) has been reported in children; this usually occurs after treatment is stopped.
Suppression of normal growth in children.
Stopping Hydrocortisone Tablets too quickly may cause withdrawal symptoms such as fever, muscle and joint pain, blocked/runny nose, swelling of the eyes, painful itchy skin rash and weight loss. Too fast of a reduction of dose following long-term treatment can lead to kidney failure, low blood pressure and potentially death. You should follow your doctor’s instructions on stopping this medicine.
Because of these potential side effects, your doctor may want to monitor you at intervals during your treatment.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE HYDROCORTISONE TABLETS
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 carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25?C. Store in a cool and dry place.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Hydrocortisone Tablets contains
- the active substance is hydrocortisone. Each tablet contains 10 mg of hydrocortisone.
- the other ingredients are lactose monohydrate, pregelatinised maize starch powder and calcium stearate.
What Hydrocortisone Tablets look like and contents of the pack
Hydrocortisone 10 mg Tablets are white, round, biconvex tablets.
Hydrocortisone 10 mg Tablets are available in amber glass bottles containing 100 tablets, or in blister packs containing 30 tablets.
Not all pack sizes may be marketed.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)