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PEVANTI 25MG TABLETS

Active substance(s): PREDNISOLONE

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Package leaflet: Information for the patient

Pevanti 2.5mg, 5mg, 10mg, 20mg and 25mg Tablets
Prednisolone
Important things you need to know about Pevanti Tablets
• Pevanti 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.
• Pevanti can cause side effects in some people (read section 4 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 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 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
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it 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 or pharmacist. This includes any possible side effects not
listed in this leaflet.
• Your doctor may have given you this medicine before from another company. It may have looked
slightly different. However, either brand will have the same effect.
What is in this leaflet
1. What Pevanti Tablets are and what they are used for
2. What you need to know before you take Pevanti Tablets
3. How to take Pevanti Tablets
4. Possible side effects
5. How to store Pevanti Tablets
6. Contents of the pack and other information
1. WHAT PEVANTI TABLETS ARE AND WHAT THEY ARE USED FOR
Pevanti 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 TAKE PEVANTI TABLETS
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 apply to you. If you are not sure, talk to your doctor or pharmacist before
taking Pevanti Tablets.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Pevanti Tablets, 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 Pevanti Tablets 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”).
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.
Mental problems while taking Pevanti Tablets
Mental health problems can happen while taking steroids like Pevanti 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), 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 Pevanti Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes
medicines obtained without a prescription, including herbal medicines. This is because Pevanti Tablets and other
medicines can affect the way each other work.
In particular, talk to your doctor if you are taking any of the following medicines:
• 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 bendroflumethazide)
• medicines which contain oestrogens including oral contraceptives
• medicines to treat infections (such as rifampicin, ritonavir – used in HIV treatment, 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 Pevanti Tablets. If you are going to
have any injections or vaccinations, tell your doctor or nurse that you are taking Pevanti Tablets. This includes those

Date of Approval:

PROOF

3

To be implemented by:

03/12/2014
Product Description:

Originated by

Date:

Pevanti Tablets

ADD

21/10/2014 No

Tech Approved

Component:

Revised by

Version:

Leaflet

PAT

102060-61-62-63-64/LF/1

Manufacturer:

File Name:

CRF No.:

Viminco A/S

102060-61-62-63-64LF Pevanti Tabs v1_3 QA.CRF.098.2013

Market:

Software Package:

Barcode:

UK

Quark Xpress 10

N/A

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

8pt Swiss 721BT

148.5 x 378 mm

N/A

Colours: Black

Key Line:

M

Date:

needed for a foreign holiday. Some vaccines should not be given to patients taking Pevanti Tablets. This is because Pevanti
Tablets 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.
Pevanti Tablets 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 TAKE PEVANTI TABLETS
If you have been given this medicine for more than three weeks, you will be given a blue ‘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 – 20-60 mg daily initially (higher doses may be required for specific conditions), reducing to a maintenance dose
of 5-20 mg daily.
Elderly – doses may be adjusted by the doctor depending of the severity of the side effects.
Use in children
Children do not take as many tablets as adults. Your doctor will tell you what is the right number of tablets 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 Pevanti Tablets 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 Pevanti Tablets
If you forget to take a dose, take it as soon as you remember and then take your next dose at the usual time. Never take
a double dose, to make up for a forgotten dose.
If you stop taking Pevanti Tablets
If you have been given Pevanti Tablets 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: 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 or pharmacist.
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 Pevanti Tablets 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 Pevanti 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 Pevanti Tablets.
These side effects include:
- 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:
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
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.
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 PEVANTI TABLETS
Keep this medicine out of the sight and reach of children.
This medicinal product stored in HDPE bottles does not require any special storage precautions. Do not store above
25˚C for tablets stored in blisters. Do not use this medicine after the expiry date which is stated on the label and carton.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your Pharmacist how to dispose medicines
you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pevanti Tablets contain
- the active substance is prednisolone. Each tablet contains either 2.5 mg, 5 mg, 10 mg, 20 mg or 25 mg of prednisolone
- the other ingredients are: potato starch, lactose, talc, gelatine and magnesium stearate.
What Pevanti Tablets look like and contents of the pack
Pevanti Tablets are plain white, circular tablets with a score-line on one side. Pevanti 2.5 mg and 5 mg are biplane tablets.
Pevanti 10 mg tablets are biconvex with a break line on one side and “1” added on one side of the break line. Pevanti
20 mg and 25 mg are biconvex tablets.
Pevanti 2.5 mg, 5 mg, 10 mg and 20 mg Tablets come in packs of 30 tablets each in blisters or in packs of 25, 50, 100,
200 and 300 tablets in HDPE bottles
Pevanti 25 mg Tablets come in packs of 56 or 60 tablets each in blisters or in packs of 10, 56 and 100 tablets in HDPE
bottles.
Not all pack sized may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd,
Capital House, 85 King William Street, London, EC4N 7BL, UK
Manufacturer
Viminco A/S, Lodshuveh 11, 4230 Skælskør , Denmark
S.C. SANTA S.A., Str. Carpatilor nr. 60, obiectiv nr. 47, 48, 58
Brasov, jud. Brasov, Cod 500269, Romania
Millmount Healthcare Ltd,
Block-7, City North Business Campus, Stamullen, Co. Meath, Ireland
This leaflet was last revised in December 2014.
102060-61-62-63-64/LF/1

Date of Approval:

PROOF

3

To be implemented by:

03/12/2014
Product Description:

Originated by

Date:

Pevanti Tablets

ADD

21/10/2014 No

Tech Approved

Component:

Revised by

Version:

Leaflet

PAT

102060-61-62-63-64/LF/1

Manufacturer:

File Name:

CRF No.:

Viminco A/S

102060-61-62-63-64LF Pevanti Tabs v1_3 QA.CRF.098.2013

Market:

Software Package:

Barcode:

UK

Quark Xpress 10

N/A

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

8pt Swiss 721BT

148.5 x 378 mm

N/A

Colours: Black

Key Line:

M

Date:

Expand view ⇕

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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