patient information leaflet and label of ramprinavir®

8/6/2019 PATIENT INFORMATION LEAFLET AND LABEL OF RAMPRINAVIR

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MODULE 8 ASSIGNMENT

TITLE/ TOPIC : PATIENT INFORMATION LEAFLET AND

LABEL OF RAMPRINAVIR

SUBMITTED BY : ADERSH.S.U.

BATCH : 20092011

REGISTRATION NO. : s044603

MENTOR NAME : Dr. LINCY JAISON

LEARNING GROUP NO. : 03

LOCATION : BANGALORE

DATE OF SUBMISSION : On BB Hard Copy

11/03/2011 07/03/2011


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PART 1:

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

RAMPRINAVIR

CAPSULES FOR HIV INFECTIONS

Read this entire leaflet carefully before you starts using this medicine.

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. Do not pass it on to others. It may harm them,

even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in thisleaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Ramprinaviris and what it is used for2. Before you take Ramprinavir3. How to take Ramprinavir4. Possible side effects5. How to store Ramprinavir6. Further information

1. What Ramprinavir is and what it is used for

Ramprinavir is used for the treatment of HIV (Human Immunodeficiency Virus)

infection.

Ramprinavir belongs to a group of medicines called viral neutralizers. The active

component of Ramprinavir is Zinovuprin. It is a HIV epitope, contains attenuated

pathogens. It elicits the immune system, especially B lymphocytes, the white blood cells,

to produce a type of antibodies called broadly neutralizing antibodies (bNAb). Broadly

neutralizing antibodies neutralizes almost all varieties of highly mutable HIV, block them

from infecting the target cells. The cell binding part of HIV is the target for bNAbs which

are relatively resistant to changes due to mutation.


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Ramprinavir is used in combination with other medications, as a combination therapy.

You must keep taking all medicines prescribed by your doctor along with Ramprinavir,

for treating HIV infections as well as to treat all concomitant illness.

If youre pregnant, your doctor may want you to take Ramprinavir, to help prevent you

passing HIV on to your unborn baby. Ramprinavir may be given to your baby afterbirth,

to help prevent it from getting infected with HIV.

2. Before you take RamprinavirDont take Ramprinavir:

If you are allergic (hypersensitive) to Zenovuprin or any of the ingredients of

Ramprinavir

If you are with conditions such as anaemia (very low red blood cell count) or

neutropenia (very low white blood cell count)

Take special care with Ramprinavir:

Serious side effects are found in some people who are taking Ramprinavir. You need to

take care of the extra risks:

If you are either type I or type II diabetic and taking insulin

If you had experiences of any liver disorders

If you are obese (seriously overweight)

You need to talk to your doctor if any of these applies to you.

Ramprinavir and other medicines:

You must take special care if you are taking any other medicines while taking

Ramprinavir. Remember to inform your doctor or pharmacist if you start taking herbal

medicines or any other medicines you bought without prescription, while taking

Ramprinavir, as soon as possible.


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Avoid these medicines with Ramprinavir:

Zalitabine, which is an anti-retroviral drug

Norfloxacin, which is an anti-microbial drug

Medicines that contribute many side effects or worsen the side effects when used

along wit Ramprinavir include:

Ureidopencillin, which is used for Klebsiella infections

Clotrimazole, used to treat fungal infections

Amodiaquine, used to treat malarial infections

Clofazine, which is an antileprotic drug

Topotecan, Etopolide or Lomustine, cytotoxic drugs used for the treatment ofcancer

Inform your doctor if you are taking any of these

Few medicines that interact with Ramprinavir:

Levodopa, used to treat Parkinsonism

Chloropromazine, which is an antiemetic

Inform your doctor if you are taking either Levodopa or Chloropromazine.

Pregnancy:

If you are pregnant or planning to become pregnant:

Ask about the benefits and risks of taking Ramprinavir, to your doctor.

Passing of HIV on to the unborn baby can be prevented by the regular use of Ramprinavir

during pregnancy.

Talk to your doctor about the possible side effects that can be caused by the Ramprinavir

to the unborn baby. Extra check-ups may be given to your baby to make sure it is

developing normally, if you have taken Ramprinavir, while you were pregnant


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Breast feeding:

Women who are HIV positive must not breast feed, because HIV infection can be passed

on to the baby in breast milk.

Driving and using machines:

Ramprinavir can cause dizziness and other side effects that make you less alert. Avoid

driving or using machines if you are not feeling well.

Stay in contact with your doctor:

You need to stay in regular contact with your doctor, to stop your illness getting worse.

3. How to take Ramprinavir

Always take Ramprinavir exactly as your doctor has prescribed you to. Get back to your

doctor or pharmacist if you are not sure.

Swallow the capsules whole, with some water

Doses of Ramprinavir:

How much will you need to take:

Adults and adolescents with weight at least 30 kg:

The usual dose of Ramprinavir is 150mg thrice a day. Take each dose 8 hours apart.

Children weighing more than 21kg and less than 30kg:

A usual dose of 100mg Ramprinavir capsules twice a day.

Children weighing at least 14kg and less than or equal to 21kg:

The usual dose of Ramprinavir is one 100 mg capsule taken in the morning and two 100

mg capsules taken in the evening.

Children weighing at least 8kg and less than 14kg:

A usual dose of Ramprinavir is one 100mg capsules twice daily.

Ramprinavir capsules are not suitable for babies under 3 months old


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Pregnancy, child birth and newborn babies:

You should not take Ramprinavir if you are at first 16 weeks of your pregnancy. You can

start taking a dose of 500mg Ramprinavir after the 16th

week until the delivery. Your new

born baby also may be given with Ramprinavir to help it prevent from getting infected

with HIV.

Ramprinavir overdosing:

If you take too much Ramprinavir:

If you take much Ramprinavir accidently, there is less likely the chances of developing

serious problems. Consumption of too much of Ramprinavir can cause symptoms such as

giddiness, tiredness, headache etc.

Dont stop taking Ramprinavir without proper advice.

4. Possible side effects

Ramprinavir can cause possible side effects to some, but not to everyone. Side effects

may observe in blood tests and may not appear until 4 to 5 weeks after you start taking

Ramprinavir. Your doctor may advise you to stop taking Ramprinavir if you get any of

these side effects.

Very common side effects:

Headache

Nausea

Theses may affect more than 1 in every 20 people taking Ramprinavir

Common side effects:

Vomiting

Diarrhoea

Stomach pain

Giddiness

These may affect up to 1 in every 20 people taking Ramprinavir


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Uncommon side effects:

Suffocation

Fever

Skin rashes

Flatulence


Rare side effects:

Chest pain

Loss of apatite

Jaundice

Insomnia

Feeling drowsy

Often urination


If any of these side effects gets worsen, inform your doctor or pharmacist as soon as

possible.

5. How to store Ramprinavir

Keep Ramprinavir away from direct sunlight

Do not store Ramprinavir above 350C

Store Ramprinavir in its original package

Keep Ramprinavir out of the reach of childrenDo not take Ramprinavir after the expiry date shown on the carton.

Do not try to dispose the unwanted Ramprinavir by yourself, hand it over to the

pharmacist.


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6. Further information:

WhatRamprinavir contains:

The active substance is Zinovuprin

The other ingredients are:

Microcrystalline cellulose, magnesium stearate, sodium starch glycollate, gelatine,

opacode S-1-27831 black and titanium dioxide E281.

What Ramprinavir looks like and contents of the pack:

Ramprinavir capsules are marked A6N100. They are yellow, sealed with a dark-red

band, and supplied in bottles of 200 capsules.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Nair Pharma UK, Boulevards, Bedford, London

Manufacturer:

Nair Pharma International, Colemore Row, Great Western Arcade, Birmingham

Other formats:

To request a copy of this leaflet in Braille or to listen to audio, please call, free of charge

0800 198 4926 (UK only)

Please be ready to give the following information:

Product name: Ramprinavir Capsules

Reference Number: 00012/1345

Leaflet date: March 2011

Ramprinavir is a registered trade mark of the Nair Pharma International group of

companies.

2011 Nair Pharma International group of companies


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LABELLING

1. NAME OF THE MEDICINAL PRODUCT

Ramprinavir Capsules for HIV infection

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each gram of Ramprinavir contains 50mg Zinovuprin

3. LIST OF EXCIPIENTS

Microcrystalline cellulose, magnesium stearate, sodium starch glycollate, gelatine,opacode S-1-27831 black and titanium dioxide E281

4. PHARMACEUTICAL FORM AND CONTENTS

Ramprinavir is a yellow coloured capsule sealed with a dark-red band, and supplied in

bottles of 200 capsules

5. METHOD(S) AND ROOTS OF ADMINISTRATION

Oral use

150mg thrice a day for adults

100mg twice a day for children

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BESTORED OUT OF THE REACH AND SIGHT OF CHILDREN

Keep Ramprinavir out of the reach and sight of children


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7. OTHER SPECIAL WARNING(S), IF NECESSARY

Dont use if the seal is opened

Inform your doctor if you are taking either Levodopa or Chloropromazine, because it iscontraindicative with Ramprinavir

8. EXPIRY DATE

Exp. March 2014

9. SPECIAL STORAGE CONDITIONS

Store in room temperature (20270C)

Keep Ramprinavir away from direct sunlight

Do not refrigerate

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF

UNUSED/UNWANTED MEDICINAL PRODUCTS

Do not try to dispose the unwanted Ramprinavir by yourself. Take it back to your

pharmacist, he will dispose it carefully

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION

HOLDER

Nair Pharma UK, Boulevards, Bedford, London

Tel - +44 1723 2916

Fax- +44 1723 2917

12.MARKETING AUTHORISATION NUMBER(S)

EU/00012/1345


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13.BATCH NUMBER

27356

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

Swallow the capsules whole, with some water

16.INFORMATION IN BRAINLLE

Ramprinavir Capsules for HIV infection


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PART 2:

CHANGES TO BE MADE TO MEET FDA REQUIREMENTS

The following changes should be made to the package insert (patient information leaflet), if the

drug has to be marketed in the United States

Detail description of the drug. It should include the details of the active substance(s) and

excipients, physical, chemical and molecular structure.

Warning and special consideration has to be made in the beginning.

Clinical pharmacology information of the drug including preclinical as well as clinical

evaluation data

Information regarding geriatric pharmacokinetic profile is required

Post marketing surveillance information, if available should be included in the packageinsert

Detail information regarding the adverse drug reactions

Patient counselling information is required

Manufacturing date must be included

Clinical trial information should be included in the label

patient information leaflet and label of ramprinavir®

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