Gupisone 5 mg 20 Tablets

help to maintain health and wellbeing. Boosting your body with extra corticosteroid (such as Prednisolone) is an effective way to treat various illnesses such as allergic reactions (for example asthma, eczema) and inflammatory conditions (for example arthritis).

1. What this product is and what it is used for
   
   GUPISONE tablets contain the active ingredient prednisolone. Prednisolone 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 wellbeing. Boosting your body with extra corticosteroid (such as Prednisolone) is an effective way to treat various illnesses such as allergic reactions (for example asthma, eczema) and inflammatory conditions (for example arthritis). Prednisolone acts by reducing the inflammation caused by these illnesses, which could otherwise go on making your condition worse.
   
   You must take this medicine regularly to get maximum benefit from it.
   
   2. What you need to know before you use this product
   
   Do not take this medicine:
   
   § If you are allergic to prednisolone, or any of the other ingredients in this medicine (listed in section 6). Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
   
   § If you have an infection that affects your whole body (systemic infection), which is not already being treated (such as measles, chickenpox or shingles)
   
   § If you are suffering from a herpes infection of the eye.
   
   Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking GUPISONE.
   
   Warnings and Precautions
   
   Talk to your doctor or pharmacist before taking GUPISONE, especially if:
   
   § You have or have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like GUPISONE or any of your close family has had these illnesses
   
   § You have or have ever had mental problems such as ‘depression’ or ‘psychoses’
   
   § You have epilepsy (fits)
   
   § You or anyone in your family has diabetes
   
   § You have high blood pressure
   
   § You have kidney, liver or heart problems
   
   § You have brittle or weak bones called osteoporosis
   
   § You are receiving treatment for a condition called myasthenia gravis (a rare muscular disorder)
   
   § You have ever had blood clots (deep vein thrombosis or thromboembolism)
   
   § You or anyone in your family has an eye problem called glaucoma
   
   § You have or have ever had a stomach ulcer
   
   § You have or have ever had a bad reaction such as muscle weakness to any steroid
   
   § You have been in contact with anyone who has chickenpox, shingles or measles. Contact your doctor immediately for advice
   
   § You have or have ever had ‘tuberculosis’ (TB)
   
   § You are receiving any vaccines (please see below, “Vaccinations”).
   
   § You have Scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. The doctor may advise that you have your blood pressure and urine regularly checked.
   
   If any of the above apply to you, your doctor may want to see you more often during your treatment.
   
   If any of the above applies to you, or if you are not sure, talk to your doctor before taking this medicine.
   
   Contact your doctor if you experience blurred vision or other visual disturbances.
   
   Mental problems while taking GUPISONE
   
   Mental health problems can happen while taking steroids like GUPISONE (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), show 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.
   
   Other medicines and GUPISONE
   
   Please 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 GUPISONE Tablets and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
   
   GUPISONE Tablets and some other medicines can affect the way each other work.
   
   In particular, talk to your doctor if you are taking any of the following:
   
   § Medicines for thinning your blood (such as warfarin)
   
   § Medicines for diabetes (such as insulin)
   
   § Medicines for epilepsy (such as carbamazepine and phenytoin)
   
   § medicines for high blood pressure (such as furosemide and bendroflumethiazide)
   
   § Medicines which contain oestrogens including oral contraceptives
   
   § Medicines to treat infections (such as rifampicin, erythromycin and ketoconazole – used in fungal infections)
   
   § Medicines to treat asthma (such as salbutamol and salmeterol)
   
   § Anti-inflammatory medicines (such as aspirin and ibuprofen)
   
   § Ciclosporin – used to suppress the immune system
   
   § Methotrexate – used to treat a variety of illnesses such as arthritis
   
   § Mifepristone – used for abortion
   
   § Oral contraceptives (the ‘pill’).
   
   Vaccinations
   
   If you have just had any injections or vaccinations, tell your doctor before you take GUPISONE. If you are going to have any injections or vaccinations, tell your doctor or nurse that you are taking GUPISONE. This includes those needed for a foreign holiday. Some vaccines should not be given to patients taking GUPISONE. This is because GUPISONE can affect the way some vaccines work. Talk to your doctor if you are not sure.
   
    
   
   Pregnancy and breast-feeding
   
   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.
   
   GUPISONE contain lactose
   
   This medicine contains lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking this medicine.
   
   3. How to use this product.
   
   If you have been given this medicine for more than three weeks, you will be given ‘steroid card’ by your doctor or pharmacist. It contains information about your medicine, including dose instructions. This is important if you fall ill or are in an accident. You should carry the card with you at all times.
   
   Always take this medicine exactly as your doctor has told you, especially if you are elderly.
   
   Check with your doctor or pharmacist if you are not sure.
   
   Swallow the tablets whole with a glass of water in the morning after breakfast. It is important to take your medicine at the right times.
   
   The recommended doses are
   
   Adults: 20-60mg daily initially (higher doses may be required for specific conditions), reducing to a maintenance dose of 5-20mg daily.
   
   Elderly: doses may be adjusted by the doctor depending of the severity of the side effects.
   
   Use in children and adolescents
   
   Children do not take as many tablets as adults. Your doctor will tell you what the right number of tablets is for your child. Your doctor may change your dose in order to use the lowest effective dose, depending on your response to the medicine. Your doctor should check your progress at regular visits. Also, your doctor may have to check your progress after you have stopped using this medicine, since some of the effects may continue.
   
   If you take more GUPISONE than you should
   
   If you (or someone else) take more tablets than prescribed, or you think a child may have taken any tablets, contact your nearest hospital emergency department or tell your doctor immediately.
   
   If you forget to take GUPISONE
   
   If you forget to take a dose, take it as soon as you remember and then take your next dose at the usual time. Do not take double dose, to make up for a forgotten dose.
   
   If you stop taking GUPISONE
   
   If you have been given GUPISONE for more than 3 weeks your doctor will ensure that your dose is gradually reduced so as to avoid any withdrawal symptoms. It is important that you complete the course of treatment as per your doctor’s instructions.
   
   If you suddenly stop taking your medicine the following side effects can occur: lack of appetite, feeling sick, being sick, tiredness, skin peeling, inflammation of the inside of the nose, inflammation (swelling and redness) of the conjunctiva (the outermost layer of the eye and the inner surface of the eyelids), muscle or joint pain, fever, headache, weight loss, painful itch skin lumps or low blood pressure. If you notice any of these symptoms please contact your doctor as soon as possible.
   
   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 everybody gets them.
   
   You may experience side effects particularly when you first start taking this medicine. Talk to your doctor or pharmacist if you notice any of the following effects or any effects not listed in this leaflet.
   
   Stop taking GUPISONE and contact your doctor straight away if the following allergic reaction happens: puffy, swollen face, tongue or body, which may cause shortness of breath, shock and collapse.
   
   Tell your doctor straight away if you experience any of the following:
   
   § Inflammation of the pancreas (very severe abdominal pains)
   
   § Steroids including GUPISONE 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 GUPISONE. These side effect includes:
   
   -  Feeling depressed, including thinking about suicide.
   
   -  Feeling high (mania) or moods that go up and down
   
   -  Feeling anxious, having problems 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
   
   -  Feeling dependant or addicted to this product.
   
   The following side effects have been reported. Tell your doctor if you experience any of the following:
   
   Not known: frequency cannot be estimated from the available data
   
   Heart: high blood pressure, congestive heart failure in those already at risk
   
   Stomach and intestines: increased appetite, indigestion, feeling sick, feeling bloated, weight gain, stomach ulcers which may burst and cause bleeding, diarrhoea, very sore throat and white areas inside your mouth (oral thrush)
   
   Muscles or bones: brittle bones (osteoporosis), muscle weakness and pain
   
   Nervous system: dizziness, headache, difficulty in sleeping, worsening of epilepsy, raised pressure in the skull (causing pain behind the eyes)
   
   Skin: difficult healing of wounds, unusual increase in hair growth on body or face, skin rashes, unusual bruising, thinning of the skin, acne, appearance of reddish purple lines
   
   Hormones: filling or rounding of the face (Cushing’s syndrome), periods become irregular or stop completely, changes in blood glucose levels, weight gain, reduced growth in infancy, childhood and adolescence.
   
   Kidney: water and salt retention, loss of potassium in the urine. Scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.
   
   Blood: blood clots, increase in the number of white blood cells
   
   Eyes: increase pressure in the eye, cataracts, thinning of the tissue of the eye, bulging of the eye, blurring of vision
   
   Other: increased risk to infections, previous infections such as tuberculosis (TB) may reoccur more easily.
   
   If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
   
   To report any side effect(s):
   
   The National Pharmacovigilance and Drug Safety Center (NPC)
   
   Fax: +966-11-205-7662
   
   Call NPC at +966-11-2038222, Exts: 2317-2356-2340
   
   Reporting Hotline: 19999
   
   E-mail: [email protected]
   
   Website: www.sfda.gov.sa/npc
   
   5. How to store this product
   
   -    Keep out of the reach and sight of children.
   
   -    Do not take GUPISONE after the expiry date which is stated on the carton and on the blister.
   
   -    Store below 30°C, in a dry place.
   
   -    Do not take GUPISONE if you notice any visible sign of deterioration.
   
   -    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.