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JANILA 10MG TABLETS

Active substance(s): HYDROCORTISONE MICRONISED / HYDROCORTISONE MICRONISED / HYDROCORTISONE MICRONISED

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PATIENT INFORFFFMAPATIENT INFORMATION LEAFLETTION LEAFL
Package leaflet: Information for the patient
Janila 10 mg Tablets
Hydrocortisone
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 any 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.
Your medicine name is Janila 10 mg Tablets but will be referred to as ‘Janila tablets’ throughout the rest
of this leaflet.
Important things you need to know about Hydrocortisone
■ Hydrocortisone is a steroid medicine. This can be 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 for more information).
Some side effects 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 straight
away.
■ Some side effects only happen after weeks or months. These include weakness of arms and legs or
developing a rounder face (read section 4 below for more information)
■ If you take this medicine for more than 3 weeks, you will be given a blue ‘steroid 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, if you have never had them. They could
affect you severely. If you do come into contact with chicken pox 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.
What is in this leaflet
1. What Janila tablets are and what they are used for
2. What you need to know before you take Janila tablets
3. How to take Janila tablets
4. Possible side effects
5. How to store Janila tablets
6. Contents of the pack and other information
1.What Janila tablets are and what they are used for upper –lower case.
Janila tablets contain a medicine called hydrocortisone. This 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 Janila
tablets) is an effective way to treat various illnesses involving inflammation in the body.
Janila tablets reduce this inflammation, which could otherwise go on making your condition worse. You
must take this medicine regularly to get maximum benefit from it.
Janila tablets are used for:
• adding hydrocortisone in children, which is usually made naturally in the body, when part of the
adrenal gland is not working properly
• to treat severe asthma and allergic reactions in adults and children.
Ask your doctor to explain why you have been given Janila tablets if you are not sure.
2. What you need to know before you take Janila tablets
Before you take Janila tablets check with your doctor first:
• if you have ever had severe depression or manic depression (bipolar disorder). This includes having
had depression before or while taking steroid medicines like Hydrocortisone tablets
• if any of your close family has had these illnesses.
Talk to your doctor before taking Janila tablets if any of these applies to you.
Do not take Janila tablets:
• if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6)
• if you have thrush, candida or any other fungal infection
• if you have systemic infections which are yet to be treated
• if you have received a type of vaccine (live vaccines).
Talk to your doctor or pharmacist before taking Janila tablets if you are not sure.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Janila tablets if:
• you have recently had a heart attack
• you have a heart condition called congestive heart disease
• you have septicaemia, tuberculosis or have had it in the past
• you have a stomach ulcer or other digestive problem
• you have chickenpox or shingles
• you have a herpes infection in the eye called ocular herpes simplex
• you had muscle weakness after taking steroids in the past
• you have recently visited a tropical country;
• you have bowel problems such as ulcerative colitis;
• you have epilepsy;
• you have HIV infection;
• you have cerebral malaria;
• you have thrombophlebitis (swelling and redness along a vein which is tender when touched)
• you have metastatic carcinoma (cancer that has spread from one part of the body to another)
• you have history of drug allergies.
Also, talk to your doctor if any of the following problems run in your family or if you have any of
them:
• diabetes
• heart problems
• high blood pressure

• an eye condition called ‘glaucoma’
• kidney or liver problems
• a type of muscle weakening problem called ‘myasthenia gravis’
• thinning of the bones (osteoporosis)
• low thyroid levels (hypothyroidism).
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.
If you are taking or have recently taken (within the last 3 months) Janila tablets and you become ill, suffer
stress, get injured or are about to have a surgical procedure you must tell your doctor immediately that
you are taking Janila tablets. Your dose of Janila tablets 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 you have been on Janila 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.
Contact your doctor if you experience blurred vision or other visual disturbances.
Talk to your doctor or pharmacist before taking a tablet if you are not sure if any of the above run in your
family or if you have them.
Mental problems while taking Janila tablets
Mental problems can happen while taking steroids like Janila tablets (see also section 4, Possible side
effects).
• these illnesses can be serious
• 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 happen they might need treatment.
Talk to your doctor if you (or someone taking this medicine), shows any signs of mental problems.
This is particularly important if you are depressed or might be thinking about suicide. In a few cases,
mental problems have happened when doses are being lowered or stopped.
Also talk to your doctor if you are on long term therapy with hydrocortisone and develop lesions of any
color on any part of skin or inside mouth, swelling in the arms and legs, which can be very painful,
breathlessness, coughing of blood, nausea, vomiting, stomach pain and diarrhoea. These may be
symptoms of Kaposi's sarcoma.
Important - Steroid Treatment Card
All patients taking steroids for more than three 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 and
who your doctor is, in case of an emergency.
Always keep it with you and show it to any doctor or nurse treating you.
If you have an accident, fall ill or see a different doctor while taking Janila tablets, show them your
steroid card or tell whoever treats you that you are taking Janila tablets because your dose may need to be
changed.
Other medicines and Janila tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
including those 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).
In particular do not take this medicine and tell your doctor or pharmacist if you are taking any of
the following:
• aspirin
• medicines for fits (epilepsy) such as phenytoin, phenobarbital, carbamazepine and primidone
• cough and cold medicines that contain a decongestant called ephedrine
• medicines used for TB (tuberculosis) called rifabutin or rifampicin
• medicines used to thin the blood such as warfarin
• water tablets (diuretics)
• some medicines for fungal infections such as amphotericin, ketoconazole, itraconazole, posaconazole
or voriconazole
• a medicine for cancer called aminoglutethimide
• some medicines for heart failure such as digoxin, furosemide or bumetanide
• a medicine used for some infections called erythromycin, telithromycin or clarithromycin
• oral contraceptive pills and hormone replacement therapy (HRT)
• a type of growth hormone called somatropin
• some medicines for high blood pressure
• some medicines for heart disease such as guanethidine, isosorbide mononitrate, isosorbide
dinitrate and theophylline
• medicines sometimes used for asthma, low blood pressure or in cough and cold remedies called
sympathomimetics
• calcium supplements
• medicines for pain and inflammation called NSAIDs such as ibuprofen, diclofenac or naproxen
• a medicine for urea cycle disorder called sodium phenylbutyrate (usually started by a specialist doctor
or consultant)
• medicines for diabetes
• efavirenz or nevirapine (medicines used in the treatment of HIV infections)
• methotrexate (a medicine used to treat rheumatoid arthritis)
• St. John's Wort (a herbal medicine used for treating depression)
• sodium benzoate (a preservative)
• medicines that effect stomach emptying, such as metoclopramide or domperidone
• medicines used to treat myasthenia gravis
• orally ingested chemicals used to make X-rays clearer
• ciclosporin (a medicine used for psoriasis or in patients who have organ transplants).
Talk to your doctor or pharmacist before taking Janila tablets if you are not sure if any of the above apply
to you.
Janila tablets and infections
Infections are easier to get and harder to spot while you are taking Janila tablets. Stay away from anyone
you know with:
• chickenpox
• shingles
• measles.
Talk to your doctor if you think you may have picked up an infection.
Janila tablets with food and drink

Janila tablets can be taken with or without food. Do not take this medicine with grapefruit juice as the
juice will conflict with the action of this medicine.
Receiving vaccines or tests while you are taking Janila tablets
Tell your doctor that you are taking Janila tablets if you are to receive any vaccinations or have any
diagnostic or laboratory tests. This is because steroids can affect the results of some tests.
Having surgery while you are taking Janila tablets
If you are having surgery requiring an anaesthetic tell your doctor you are taking Janila tablets.
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.
Driving and using machines
Steroids may cause a feeling of movement, even while you are still and this can cause you to feel tired
and dizzy (vertigo). Changes in your eyesight or muscle weakness may also happen. If you are affected,
do not drive or operate machinery.
Janila tablets contain lactose
This medicine contains lactose, which is a type of sugar. 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 Janila tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
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.
Taking this medicine
Take this medicine by mouth. The amount you take each day will depend on your illness. The number of
tablets to be taken will be on the label of your medicine. Talk to your doctor or pharmacist.
The recommended doses are:
Dosage for Acute Emergencies
The usual 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 usual 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
• children will be prescribed the lowest possible dose
• the doctor will monitor your child’s growth and development.
If you take more Janila tablets than you should
If you take more tablets than prescribed, contact your doctor as soon as possible. Over dosage can cause
symptoms such as nausea (feeling sick), vomiting (being sick), sodium and water retention and occasional
gastrointestinal bleeding.

If you forget to take Janila tablets
• if you forget to take your dose, skip the missed dose
• take the next dose as normal
• do not take a double dose to make up for a forgotten dose.
If you stop taking Janila tablets
It is dangerous to reduce your dose of Janila tablets too quickly. Stopping Janila tablets may leave
you without enough steroid hormones in your body. This may cause withdrawal symptoms such as:
• pains in muscles or joints
• fever
• general discomfort.
Your doctor or pharmacist will give you advice on how to reduce the number of tablets you take if you
need to do this.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
People taking steroids to replace similar naturally occurring hormones, should be less likely to get side
effects than, people taking steroids for other illnesses. Your doctor will monitor your condition to look
out for these effects.
The undesirable effects are listed below by the following frequency convention:
Not known: frequency cannot be estimated from the available data
Tell your doctor straight away if you notice any of these problems or if you think you are at
increased risk of infection (for example, if you have been in contact with someone who has an
infection):
• experience symptoms such as skin rash, swelling of the face or wheezing or trouble breathing as these
could be signs of a severe allergic reaction
• feeling of discomfort or illness
• irregular or very fast or slow pulse, faintness
• muscle cramps or spasms
• fits (convulsions), worsening of epilepsy, sedation, dizziness/spinning sensation. Pseudotumour cerebri
(raised pressure within the skull, indicated by headaches with vomiting, listlessness and drowsiness); this
usually occurs after treatment is stopped
• nausea
• taking Janila 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
• burst or bleeding ulcers (indicated by stomach pain especially if it seems to spread to your back,
bleeding from the back passage, black stools or vomiting with blood in the vomit)
• acute pancreatitis (abdominal pain, possibly accompanied by shock, that is low blood pressure with
decreased output of urine and often loss of consciousness)
• a worsening of sight
• change in number and motility of sperm in men
• thrombosis (a blood clot in a vein in your leg, symptoms of which are a swollen, red, hot, tender
muscle)
• thromboembolism (a blood clot which may go to the lung, symptoms of which are sudden chest pain
and coughing up blood)

• heart failure - problems with the pumping of your heart indicated by swollen ankles, chest pain,
difficulty in breathing and palpitations or irregular beating of the heart, irregular or very fast or slow
pulse; hypertension (high blood pressure, indicated by headaches or generally feeling unwell)
• increase in white blood cells (leucocytosis).
Steroids including Janila tablets can cause serious mental health problems. These are common in both
adults and children. They can affect about 5 in every 100 people taking medicines like Janila tablets.
• feeling depressed, including thinking about suicide
• feeling high (mania) or moods that go up and down
• feeling anxious, irritated, having problems while sleeping, difficulty in thinking or being confused and
losing your memory
• feeling, seeing or hearing things which do not exist (hallucinations). Having strange and frightening
thoughts, changing how you act or having feelings of being alone.
Tell your doctor if you experience any of the following:
Effects on your digestive system
• swollen abdomen
• ulcers or thrush in the gullet (discomfort on swallowing)
• indigestion
• bloating.
Effects on your muscles and bones
• muscle weakness or wasting
• osteoporosis (brittle bones – bones that break easily)
• broken bones or fractures
• breakdown of bone due to poor circulation of blood (pain in the hip)
• aseptic necrosis (joint inflammation in the knee and groin)
• torn muscle tendons (pain and/or swelling)
• swelling in joints.
Effects on your body water and salts
• cramps and spasms due to the loss of the potassium salts from your body. In rare cases, loss of
potassium can lead to palpitations (an uneven beating of your heart that you become aware of).
Effects on your hormones and metabolic system
• suppression of normal growth in children
• irregular or no periods in women
• increased hair on the body and face in women
• round or moon-shaped face
• increased appetite and weight gain
• increase in blood sugar levels, breakdown of body protein stores (loss of weight and muscle loss in arms
or legs), loss of calcium and nitrogen
•low adrenal gland function which reduces the production of steroids in your body (particularly after
surgery, an accident or illness).
Effects on your skin
• thin or delicate skin, bruising, red or purple spots
• slow healing of cuts or wounds
• acne, sweating, redness
• stretch marks.

• Kaposi's sarcoma (a type of cancer) has also been reported to occur in patients receiving corticosteroids.
However, once the treatment is stopped, this may go away.
Effects on your eyes
• changes in vision as a result of cataracts or glaucoma (increased pressure inside the eye)
• thinning of the surface of the eye
• eye infections may get worse
• bulging eyes
• blurred vision
• dry eyes.
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet.
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 at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Janila 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 foil and carton. The expiry date refers
to the last day of that month.
Do not store above 30°C. Keep the blister in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Janila tablets contain
- The active substance is hydrocortisone. Each tablet contains 10 mg of hydrocortisone.
- The other ingredients are lactose monohydrate, potato starch, gelatin, talc, sodium starch
glycolate and magnesium stearate.
What Janila tablets look like and contents of the pack
Janila tablets are white, round and flat with a breakline on one side and ‘H’ imprinted on other side. The
tablet can be divided into equal doses.
Janila tablets are available in blister packs of 30 tablets.
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd.,
Capital House,
85 King William Street,
London EC4N 7BL, UK
Manufacturer
Mibe GmbH Arzneimittel,

Münchener Straße 15,
06796 Brehna
The marketing authorisation holder will ensure that the package information leaflet is made available on
request from patient's organisations in formats appropriate for the blind and partially-sighted.
This leaflet was last revised in May 2017.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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