Paracetamol 250mg suppositories

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Paracetamol
Available from:
Typharm Ltd
ATC code:
N02BE01
INN (International Name):
Paracetamol
Dosage:
250mg
Pharmaceutical form:
Suppository
Administration route:
Rectal
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04070100; GTIN: 5060010284291
Authorization number:
PL 19255/0011

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L I M I T E D

L I M I T E D

Colours

(Printed)

Title:

Ref:

Date:

Size (mm):

Modified:

Paracetamol 250mg Suppositories

PIL - Patient Information Leaflet

05/01/16

160(W) x 265(H)

06/11/19

Colours

(Non printed)

Process

Black

REFERENCE

TRIM

Number of

suppositories

1 - 2

Minimum length of

time between doses

4 – 6 hours

4 – 6 hours

Maximum number of

suppositories in 24 hours

What is in this leaflet

What Paracetamol Suppositories are and what they are used for

What you need to know before you use Paracetamol Suppositories

3. How to use Paracetamol Suppositories

4. Possible side effects

5. How to store Paracetamol Suppositories

6. Contents of the pack and other information

1. WHAT PARACETAMOL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR

Paracetamol Suppositories contain a medicine called paracetamol. This belongs to a group of medicines called

pain-killers (analgesics). A suppository is a small, torpedo-shaped medicine which is inserted into the back passage

(rectum).

Paracetamol Suppositories are used to treat pain and high temperature (fever) in children from 6 to 12 years of age.

They can be used in children who find it difficult to take paracetamol as tablets or syrup.

You must talk to a doctor if your child does not feel better or if your child feels worse after 3 days.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL SUPPOSITORIES

Do not give Paracetamol Suppositories to your child:

if your child is allergic to paracetamol, soya, peanuts or any of the other ingredients of this medicine (listed in

Section 6).

Warnings and precautions

Talk to a doctor or pharmacist before using Paracetamol Suppositories.

Take special care with the use of Paracetamol Suppositories and talk to your child’s pharmacist or doctor if:

your child has problems with their liver or kidneys.

Other medicines and Paracetamol Suppositories

Tell your child’s doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

This is because Paracetamol Suppositories can have an affect on the way some medicines work and some medicines

can have an affect on how Paracetamol Suppositories work.

In particular tell your child’s doctor or pharmacist if your child is taking any of the following:

Other medicines containing paracetamol – do not give your child Paracetamol Suppositories at the same time.

Medicines to treat nausea (feeling sick) and vomiting (being sick), such as metoclopramide and domperidone.

Colestyramine, used to reduce the level of cholesterol (fat) in the blood.

Medicines called anticoagulants, such as warfarin, used for treating blood clots or “thinning the blood”.

Medicines called anticonvulsants used for treating epilepsy or fits (e.g. phenytoin, carbamazepine).

The antibiotic rifampicin.

3. HOW TO USE PARACETAMOL SUPPOSITORIES

This medicine is for rectal use only. Always use this medicine exactly as described in this leaflet or as your child’s

doctor or pharmacist have told you. Check with your child’s doctor or pharmacist if you are not sure.

The recommended dose is:

Do not give your child more suppositories than stated above.

How to use the suppositories:

Your child’s bowels need to be empty when you give them this medicine. If your child needs to go to the toilet,

make sure that they do it before you give them the suppository.

It may be easier to give your child the suppository if they are lying on their front or side on a bed.

Wash your hands. Then peel the wrapping apart to take out the suppository. Do not break the suppository before

use.

Gently push the suppository into your child’s back passage with the pointed end first. To make it easier to give the

suppository you may warm it slightly between your hands beforehand.

Try to keep your child still for a minute or two and then wash your hands.

If you need to give another suppository, then follow the above procedure again.

If you have given more Paracetamol Suppositories to your child than you should

Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too

much paracetamol can cause delayed, serious liver damage.

If you forget to give Paracetamol Suppositories to your child

Do not give a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medication, ask your child’s doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop giving Paracetamol Suppositories to your child immediately and call your child’s doctor if you notice your

child has any signs of allergic reaction.

Signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue.

The following side effects can happen with this medicine.

Common side effects (affects more than 1 in 100 people taking this medicine):

Redness or soreness in and around the back passage.

Rare side effects (affects less than 1 in 1000 people taking this medicine):

Blood problems. If these happen, your child may bruise or bleed more easily than usual, be more susceptible to

infections, or get a high temperature (fever) and ulcers in the mouth and throat.

Liver problems. Symptoms may include jaundice (yellowing of the skin or whites of the eyes).

Reporting of side effects

If your child gets any side effects, talk to a doctor or pharmacist. 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 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 PARACETAMOL SUPPOSITORIES

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 and on the blister strip. The expiry date

refers to the last day of that month. Do not store over 30°C.

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 Paracetamol Suppositories contain

The active substance is paracetamol. Each suppository contains 250mg of paracetamol.

The other ingredients are hydrogenated fat and soyabean lecithin.

What Paracetamol Suppositories look like and contents of the pack

Cream coloured, torpedo shaped suppository, available in packs of 10 suppositories.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder: Amdeepcha Limited, 85 Yarmouth Road, Blofield, Norwich, Norfolk, NR13 4LQ, UK.

Manufacturer: Dr. Pfleger Arzneimittel GmbH, Dr. Robert Pfleger Strasse 12, Bamberg, D-96052, Germany.

This package leaflet was last revised in September 2019

6 years to 9 years (body weight 20-30kg)

10 years to 12 years (body weight 30-40kg)

Read all of this leaflet carefully before your child starts using this medicine because it contains important

information for you.

Always use this medicine exactly as described in this leaflet or as your child’s doctor or pharmacist has told you.

Keep this leaflet. You may need to read it again.

Ask your child’s pharmacist if you need more information or advice.

If your child gets any side effects, talk to a doctor or pharmacist. This includes any possible side effects not

listed in this leaflet. See section 4.

You must contact a doctor if your child does not feel better or if your child feels worse after 3 days.

The product is called Paracetamol 250mg Suppositories but will be referred to as Paracetamol Suppositories

throughout this leaflet.

2/PS250/05/1909/345.v2

2/PS250/05/1909/345.v2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol 250mg Suppositories

Paracetamol

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Object 1

Paracetamol 250mg Suppositories

Summary of Product Characteristics Updated 05-Sep-2017 | Typharm Limited

1. Name of the medicinal product

2. Qualitative and quantitative composition

3. Pharmaceutical form

4. Clinical particulars

4.1 Therapeutic indications

4.2 Posology and method of administration

4.3 Contraindications

4.4 Special warnings and precautions for use

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Fertility, pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

4.9 Overdose

5. Pharmacological properties

5.1 Pharmacodynamic properties

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

6. Pharmaceutical particulars

6.1 List of excipients

6.2 Incompatibilities

6.3 Shelf life

6.4 Special precautions for storage

6.5 Nature and contents of container

6.6 Special precautions for disposal and other handling

7. Marketing authorisation holder

8. Marketing authorisation number(s)

9. Date of first authorisation/renewal of the authorisation

10. Date of revision of the text

11. Dosimetry

12. Instructions for preparation of radiopharmaceuticals

1. Name of the medicinal product

Paraserts 250mg Suppositories

Paracetamol 250mg Suppositories

2. Qualitative and quantitative composition

Each suppository contains Paracetamol 250mg

For excipients, see 6.1

3. Pharmaceutical form

Suppositories

4. Clinical particulars

4.1 Therapeutic indications

For the treatment of mild to moderate pain such as toothache and/or pyrexia. Paraserts/Paracetamol

Suppositories may be especially useful in patients unable to take oral forms of paracetamol, e.g. post-

operatively or with nausea and vomiting.

4.2 Posology and method of administration

Method of administration: Rectal

Children:

6year – 12 years:

1-2 suppositories every 4 to 6 hours

10 – 12 years (30 – 40kg):

1-2 suppositories every 4 to 6 hours

Dosages should be based on the child's age and weight. These doses may be repeated up to a maximum of

4 times in 24 hours. The dose should not be repeated more frequently than every 4 hours. The

recommended dose should not be exceeded. Higher doses do not produce any increase in analgesic effect.

The product should not be used for more than 3 days, except on the advice of a doctor. Only whole

suppositories should be administered – do not break the suppository before administration

4.3 Contraindications

Hypersensitivity to either paracetamol, soy, peanuts or any of the other ingredients.

4.4 Special warnings and precautions for use

Paraserts/Paracetamol Suppositories should not be combined with other analgesic medications that

contain paracetamol. Paracetamol should be given with care to patients with impaired kidney or liver

function.

In general, the habitual use of painkillers, especially with combinations of more than one pain killing

active ingredient, can lead to permanent kidney damage with the risk of liver failure (analgetic

nephropathy).

Label and Leaflet will state the following warnings:

Label:

“Immediate medical advice should be sought in the event of an overdose, even if the child seems well”.

“Do not give with any other Paracetamol-containing products.”

Leaflet:

“Immediate medical advice should be sought in the event of an overdose, even if the child seems well,

because of the risk of delayed, serious liver damage.”

4.5 Interaction with other medicinal products and other forms of interaction

The absorption of paracetamol is speeded by metaclopramide or domperidone, and absorption is reduced

by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be increased by long term regular daily use

of paracetamol, with increased risk of bleeding. Occasional doses of paracetamol do not have a significant

effect on these anticoagulants.

Enzyme-inducing medicines, such as some antiepileptic drugs (phenytoin, phenobarbital, carbamazepine)

have been shown in pharmacokinetic studies to reduce the plasma AUC of paracetamol to approx. 60 %.

Other substances with enzyme- inducing properties, e.g. rifampicin are also suspected of causing lowered

concentrations of paracetamol. In addition, the risk of liver damage during treatment with maximum

recommended doses of paracetamol will be higher in patients being treated with enzyme-inducing agents.

4.6 Fertility, pregnancy and lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the

recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in clinically significant amounts. Available published data

do not contraindicate breast feeding.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

>1/100

Rare

<1/1000

General:

Allergic reactions

Skin:

Exanthema, urticaria

Liver:

Liver damage

Genitourinary:

Increase in creatinine (mostly secondary to hepatorenal

syndrome)

There have been some reports of blood dyscrasias- Thrombocytopenia and argranulocytosis, with the use

of paracetamol- containing products, but the causal relationship has not been established.

4.9 Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more

of paracetamol may lead to liver damage if the patient has risk factors (see below).

It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione

when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue.

Risk Factors:

If the patient

a. Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St

John's Wort or other drugs that induce liver enzymes.

b. Regularly consumes ethanol in excess of recommended amounts

c. Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation,

cachexia.

Symptoms:

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and

abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of

glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress

to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with

acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop in the

absence of severe liver damage. Cardiac arrythmias and pancreatitis have been reported.

Management:

Immediate treatment is essential in the management of paracetamol overdose.

Despite a lack of significant early symptoms, patients should be referred to hospital urgently for

immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the

severity of overdose or the risk of organ damage. Management should be in accordance with established

treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken by mouth within 1

hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier

concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after

ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-

ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should

be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a

problem, oral methionine may be a suitable alternative for remote areas, outside hospital.

Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should

be discussed with NPIS or a liver unit.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Anilides, ATC Code: N02 BE01

Paracetamol is an aniline derivative with analgesic and antipyretic actions similar to those of aspirin but

with no demonstrable anti-inflammatory activity. It does not affect thrombocyte aggregation or bleeding

time.

Paracetamol is generally well tolerated by patients hypersensitive to acetylsalicylic acid. It produces

analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-

regulation centre.

5.2 Pharmacokinetic properties

Paracetamol is well absorbed by both oral and rectal routes. Peak plasma concentrations occur about 2 to

3 hours after rectal administration. The plasma half life is about 2 ¼ hours and is prolonged in cirrhosis.

Paracetamol is primarily metabolised in the liver by conjugation to glucuronide and sulphate. A small

amount (about 3-10% of a therapeutic dose) is metabolised by oxidation and the reactive intermediate

metabolite thus formed is bound preferentially to the liver glutathione and excreted as cystein and

mercapturic acid conjugates. Excretion occurs via the kidneys. 2- 3% of a therapeutic dose is excreted

unchanged; 80-90% as glucuronide and sulphate and a smaller amount as cystein and mercapturic acid

derivatives.

5.3 Preclinical safety data

Paracetamol crosses the placenta.

Non-clinical data reveal no special hazard for humans based on conventional studies of safety

pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction

and development.

6. Pharmaceutical particulars

6.1 List of excipients

Hydrogenated fat

Soyabean Lecithin

6.2 Incompatibilities

None relevant

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 30°C

6.5 Nature and contents of container

PVC-Blister packet

In pack size of 10 suppositories

6.6 Special precautions for disposal and other handling

None

7. Marketing authorisation holder

Amdeepcha Limited

85 Yarmouth Road, Blofield

Norwich, Norfolk NR13 4LQ, UK

8. Marketing authorisation number(s)

PL 19255/0011

9. Date of first authorisation/renewal of the authorisation

02/11/2011

10. Date of revision of the text

01/09/2017

11. Dosimetry (if applicable)

Not Applicable

12. Instructions for preparation of radiopharmaceuticals (if applicable)

Not Applicable

Company Contact Details

Typharm Limited

Address

14D Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk, NR13 6LH

Telephone

+44 (0)1603 722480

Medical Information Direct Line

+44 (0)2037 694160

Customer Care direct line

+44 (0)1603 722480

http://typharm.com

+44 (0)1603 263804

Medical Information e-mail

[email

protected]

Stock Availability

+44 (0)1603 722480

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PAR Paracetamol 125mg, 250mg, 500mg and 1000mg Suppositories

PL 12762/0414-417

PARACETAMOL 125MG, 250MG, 500MG AND

1000MG SUPPOSITORIES

PL 12762/0414-0417

UKPAR

TABLE OF CONTENTS

Lay Summary

Page 2

Scientific discussion

Page 3

Steps taken for assessment

Page 11

Steps taken after authorisation – summary

Summary of Product Characteristics

Page 12

Product Information Leaflet

Page 28

Labelling

Page 36

1

PAR Paracetamol 125mg, 250mg, 500mg and 1000mg Suppositories

PL 12762/0414-417

PARACETAMOL 125MG, 250MG, 500MG AND 1000MG

SUPPOSITORIES

PL 12762/0414-0417

LAY SUMMARY

On 02 November 2011, the Medicines and Healthcare products Regulatory Agency

(MHRA) granted Goldshield pharmaceuticals Limited Marketing Authorisations

(licences) for the medicinal products Paracetamol 125mg, 250mg, 500mg and

1000mg Suppositories (PL 12762/0414-0417). These are pharmacy (P) medicines.

Paracetamol 125mg is indicated for the relief of pain and to treat high temperature

(fever) in children from 1 to 5 years of age.

Paracetamol 250mg Suppositories is indicated for the relief of pain and to treat high

temperature (fever) in children from 6 to 12 years of age and adults.

Paracetamol 500mg Suppositories is indicated for the relief of pain and to treat high

temperature (fever) in children over 10 years of age and adults.

Paracetamol 1000mg Suppositories is indicated for the relief of pain and to treat high

temperature (fever) in adults.

Paracetamol 125mg, 250mg, 500mg and 1000mg Suppositories contain an active

ingredient known as paracetamol. This belongs to a group of medicines called

pain-killers (analgesics). A suppository is a small, torpedo-shaped, medicine which is

inserted into the back passage (rectum). They are used in people who find it difficult

to take paracetamol as tablets or syrup.

No new or unexpected safety concerns arose from these applications and it was,

therefore, judged that the benefits of taking Paracetamol 125mg, 250mg, 500 and

1000mg Suppositories outweigh the risks; hence Marketing Authorisations were

granted.

2

PAR Paracetamol 125mg, 250mg, 500mg and 1000mg Suppositories

PL 12762/0414-417

PARACETAMOL 125MG, 250MG, 500MG AND 1000MG

SUPPOSITORIES

PL 12762/0414-0417

SCIENTIFIC DISCUSSION

TABLE OF CONTENTS

Introduction

Page 4

Pharmaceutical assessment

Page 5

Non-clinical assessment

Page 8

Clinical assessment

Page 9

Overall conclusions and risk assessment

Page 10

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PAR Paracetamol 125mg, 250mg, 500mg and 1000mg Suppositories

PL 12762/0414-417

INTRODUCTION

Based on the review of the data on quality, safety and efficacy, the MHRA granted

Goldshield

pharmaceuticals

Limited

Marketing

Authorisations

medicinal

products Paracetamol 125mg, 250mg, 500 and 1000mg Suppositories

(PL 12762/0414-417) on 02 November 2011. These are pharmacy (P) medicines.

Paracetamol 125mg Suppositories is indicated for the treatment of mild to moderate

pain and fever in children from 1 to 5 years of age.

Paracetamol 250mg, 500mg and 1000mg Suppositories are indicated for the treatment

of mild to moderate pain such as toothache and/or pyrexia in children 6 years and over

and adults.

Paracetamol 125mg, 250mg, 500 and 1000mg Suppositories may be especially useful

in patients unable to take oral forms of paracetamol for example, post-operatively or

with nausea and vomiting.

The applications were submitted as bibliographic applications, for an active of

well-established use, according to Article 10(a) of Directive 2001/83/EC, as amended.

Paracetamol 125mg, 250mg, 500 and 1000mg Suppositories contain the active

ingredient paracetamol which is an aniline derivative with analgesic and antipyretic

actions similar to those of aspirin but with no demonstrable anti-inflammatory

activity. Paracetamol does not affect thrombocyte aggregation or bleeding time.

Paracetamol is generally well tolerated by patients hypersensitive to acetylsalicylic

acid. It produces analgesia by elevation of the pain threshold and antipyresis through

action on the hypothalamic heat-regulation centre.

No new non-clinical studies were conducted for these applications, which is

acceptable given that these are bibliographic applications for products containing an

active of well-established use.

The Marketing Authorisation Holder has submitted three bioequivalence studies to

support these applications. However, no new clinical studies are required for these

applications, which is acceptable given that these are bibliographic applications for

products containing an active of well-established use.

No new or unexpected safety concerns were raised during the assessment of these

applications and it was, therefore, judged that the benefits of using Paracetamol

125mg, 250mg, 500 and 1000mg Suppositories outweigh the risks; hence Marketing

Authorisations were granted.

4

PAR Paracetamol 125mg, 250mg, 500mg and 1000mg Suppositories

PL 12762/0414-417

PHARMACEUTICAL ASSESSMENT

ACTIVE SUBSTANCE:

INN:

Paracetamol

Chemical Name:

N-(4-hydroxyphenyl)acetamide

Structure:

Molecular Formula:

Molecular weight:

151.2

Appearance:

A white, crystalline powder.

Solubility:

It is sparingly soluble in water, freely soluble in alcohol and

very slightly soluble in dichloromethane.

Paracetamol is the subject of a European Pharmacopoeia monograph.

All aspects of the manufacture and control of the active substance paracetamol are

covered by a European Directorate for the Quality of Medicines (EDQM) Certificates

of Suitability.

Suitable specifications have been provided for all packaging used. The primary

packaging has been shown to comply with current guidelines concerning contact with

foodstuff.

Appropriate stability data have been generated to support a suitable retest period for

the active substance when stored in the proposed packaging.

MEDICINAL PRODUCT

Other Ingredients

Other ingredients consist of the pharmaceutical excipients, namely hydrogenated fat

and soyabean lecithin.

Hydrogenated fat complies with its respective European Pharmacopoeia monograph

and soyabean lecithin complies with its respective United States Pharmacopoeia

monograph. Suitable batch analysis data have been provided for each excipient.

None of the excipients contain materials of animal or human origin. No genetically

modified organisms (GMO) have been used in the preparation of these excipients.

Pharmaceutical Development

The objective of the development programme was to formulate safe, efficacious,

stable products containing the active ingredient paracetamol.

5

PAR Paracetamol 125mg, 250mg, 500mg and 1000mg Suppositories

PL 12762/0414-417

Suitable pharmaceutical development data have been provided for these applications.

Comparative dissolution data were provided for batches of the test products and

appropriate reference products. The dissolution profiles were satisfactory.

Manufacturing Process

A description and flow-chart of the manufacturing method have been provided.

In-process controls are satisfactory based on process validation data and controls on

the finished product. Process validation data have been provided.

Finished Product Specification

The finished product specifications proposed are satisfactory. Test methods have been

described and have been adequately validated. Batch data have been provided and

comply with the release specifications.

Container Closure System

The finished products are packaged in polyvinyl chloride (PVC) blister packs and

packaged into cartons in pack sizes of 10 suppositories.

Satisfactory specifications and Certificates of Analysis have been provided for all

packaging components. All primary packaging are controlled to current European

Pharmacopoeia standards and complies with guidelines concerning materials in

contact with food and guidelines concerning plastic packaging for pharmaceutical use.

Stability of the Product

Stability studies were performed in accordance with current guidelines on batches of

finished products packed in the packaging proposed for marketing. These data support

a shelf-life of 36 months for the finished products which is satisfactory. Storage

conditions are ‘Do not store above 30ºC’

Suitable post approval stability commitments have been provided to continue stability

testing on batches of finished product.

Bioequivalence/Bioavailability

Bioequivalence studies were not necessary to support this type of applications.

However, the Marketing Authorisation Holder has submitted three bioequivalence

studies as supporting evidence but the data had no real impact on the assessment

decision

Summary of Product Characteristics (SmPC), Product Information Leaflets

(PILs) and Labelling

The SmPCs, PILs and labelling are pharmaceutically satisfactory.

6

PAR Paracetamol 125mg, 250mg, 500mg and 1000mg Suppositories

PL 12762/0414-417

Package leaflets have been submitted to the MHRA along with results of

consultations with target patient groups (’user testing’), in accordance with Article 59

of Council Directive 2001/83/EC, as amended. The results indicate that the package

leaflets are well-structured and organised, easy to understand and written in a

comprehensive manner. The test shows that the patients/users are able to act upon the

information that it contains.

MAA Form

The MAA forms are satisfactory.

Expert Report

The pharmaceutical expert report is written by an appropriately qualified person and

is a suitable summary of the pharmaceutical aspects of the dossier.

Conclusion

The grant of Marketing Authorisations is recommended.

7

PAR Paracetamol 125mg, 250mg, 500mg and 1000mg Suppositories

PL 12762/0414-417

NON-CLINICAL ASSESSMENT

PHARMACODYNAMICS, PHARMACOKINETICS AND TOXICOLOGY

No new non-clinical data were submitted, which is acceptable given that these were

bibliographic applications for products containing active substance of well-established

use.

NON-CLINICAL EXPERT REPORT

The non-clinical expert report has been written by an appropriately qualified person

and is satisfactory, providing an appropriate review of the non-clinical aspects of the

dossier.

CONCLUSION

The grant of Marketing Authorisations is recommended.

8

PAR Paracetamol 125mg, 250mg, 500mg and 1000mg Suppositories

PL 12762/0414-417

CLINICAL ASSESSMENT

CLINICAL PHARMACOLOGY

The clinical pharmacology of paracetamol is well-known. With the exception of data

from the bioequivalence studies, no new pharmacodynamic or pharmacokinetic data

are provided or required for these applications.

EFFICACY

No new efficacy data were submitted or required for these applications. The Clinical

Efficacy of paracetamol in the alleviation of mild to moderate pain and fever can be

considered well established. The clinical overview provides a comprehensive

summary of the published data.

SAFETY

No new safety data were submitted or required for these applications. The applicant

has provided an acceptable safety review from the literature. No new safety issues

have been raised from these applications.

PHARMACOVIGILANCE SYSTEM AND RISK MANAGEMENT PLAN

The Pharmacovigilance System, as described by the applicant, fulfils the requirements

and provides adequate evidence that the applicant has the services of a qualified

person responsible for pharmacovigilance, and has the necessary means for the

notification of any adverse reaction suspected of occurring either in the Community or

in a third country.

The Marketing Authorisation Holder has provided an adequate justification for not

submitting a Risk Management Plan (RMP). As the applications concern are well

established use and the active substances are well known, for which safety concerns

requiring additional risk minimisation have not been identified, a risk minimisation

system is not considered necessary.

SUMMARY OF PRODUCT CHARACTERISTICS (SmPC), PRODUCT

FORMATION LEAFLETs (PILs) AND LABELS

The SmPCs, PILs and labels are acceptable.

CLINICAL EXPERT REPORT

The clinical expert report has been written by an appropriately qualified physician and

is a suitable summary of the clinical aspects of the dossier.

CONCLUSION

The grant of Marketing Authorisations is recommended.

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PAR Paracetamol 125mg, 250mg, 500mg and 1000mg Suppositories

PL 12762/0414-417

OVERALL CONCLUSION AND BENEFIT-RISK ASSESSMENT

QUALITY

The important quality characteristics of Paracetamol 125mg, 250mg, 500 and 1000mg

Suppositories are well-defined and controlled. The specifications and batch analytical

results indicate consistency from batch to batch. There are no outstanding quality

issues that would have a negative impact on the benefit-risk balance.

NON-CLINICAL

No new non-clinical data were submitted and none were required for this type of

applications. A non-clinical overview has been provided by an appropriately qualified

person and consists of a review of the published literature.

EFFICACY

No new data were submitted and none were required for this type of applications.

The published literature supports the efficacy of this product in the proposed

indication. The efficacy of paracetamol in general is clearly demonstrated by the

applicant via an extensive literature search, spanning a long period of time. The

efficacy of paracetamol is well-known. The presented evidence for well-established

use of the active substance is sufficient.

SAFETY

The safety profiles of paracetamol are well-known. The literature review identified no

new or unexpected safety issues or concerns.

PRODUCT LITERATURE

The approved SmPCs are satisfactory. The PILs and labelling are satisfactory, and

consistent with the approved SmPCs.

BENEFIT-RISK ASSESSMENT

The quality of the products is acceptable, and no new non-clinical or clinical safety

concerns have been identified. Paracetamol is a well-known active substance.

Extensive clinical experience with paracetamol demonstrated the therapeutic value of

the products. The benefit-risk is, therefore, considered to be positive.

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