Famotidine 20mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

Buy It Now

Active ingredient:
Famotidine
Available from:
DE Pharmaceuticals
ATC code:
A02BA03
INN (International Name):
Famotidine
Dosage:
20mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 01030100
Authorization number:
; PL 00289/0344

PACKAGE LEAFLET

Package leaflet: Information for the patient

Famotidine 20 mg Film-coated Tablets

Famotidine 40 mg Film-coated Tablets

famotidine

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 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 or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Famotidine is and what it is used for

What you need to know before you take Famotidine

How to take Famotidine

Possible side effects

How to store Famotidine

Contents of the pack and other information

1.

What Famotidine is and what it is used for

Famotidine belongs to a group of medicines called histamine (H

) antagonists or anti-ulcer

medicines. These anti-ulcer medicines control the levels of acid in the stomach. Famotidine

can lower the amount of acid you produce in your stomach.

Famotidine can be used for the following:

To help treat non-cancerous stomach ulcers and ulcers in the first part of your

intestine (duodenal ulcers)

To help prevent the return of ulcers in the first part of the intestine

To help treat Zollinger-Ellison syndrome (with a condition caused by too

much stomach acid)

To help treat acid reflux (burning pain caused by stomach acid escaping back

up the food pipe) and the symptoms of an inflamed food pipe (oesophagitis)

2.

What you need to know before you take Famotidine

Do not take Famotidine if:

you are allergic to famotidine or any of the ingredients of this medicine (listed

in section 6) or to any other medicines called H

antagonists

Warnings and precautions

Talk to your doctor or pharmacist before taking Famotidine if:

you have kidney problems

Famotidine may hide the symptoms of other diseases. Your doctor may carry out tests to

diagnose your condition and/or exclude other diseases before you start taking Famotidine.

During treatment

If you take a high dose for a long time your doctor may carry out blood tests to check your

blood cells and liver function.

Children and adolescents

Famotidine should not be given to children or adolescents

Other medicines and Famotidine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, especially any of the following:

itraconazole or ketoconazole, medicines used to treat fungal infections. Take

ketoconazole 2 hours before your famotidine dose

probenecid, a medicine used to treat gout

antacids. Take your famotidine dose one to two hours before an antacid

sucralfate, a medicine used for stomach ulcers. Do not take sucralfate within two hours of

your famotidine dose

atazanavir, used in the treatment of HIV

calcium carbonate, when used as a medicine for high blood phosphate levels

(hyperphosphataemia) in patients on dialysis

Pregnancy and breast-feeding

Pregnancy

f you are pregnant, think you may be pregnant or are planning to have a babyI, talk to your

doctor first before taking this medicine. If you do get pregnant while taking famotidine you

must tell the doctor straightaway.

Breast-feeding

Famotidine passes into breast milk. If you are breast-feeding or planning to breast feed, ask

your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Do not drive or operate machines if you feel dizzy or get a headache while taking famotidine.

Famotidine contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact

your doctor before taking this medicine.

3.

How to take Famotidine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with you

doctor or pharmacist if you are not sure.

Famotidine Tablets can be taken before or after food.

Use in adults

(including the elderly)

Non-cancerous stomach or intestinal ulcers

- The recommended dose is 40 mg of

famotidine taken at night. In some cases treatment may last for up to 8 weeks.

To prevent intestinal ulcers from returning

- The recommended dose is 20 mg of

famotidine at bedtime.

To treat Zollinger-Ellison syndrome

- The recommended starting dose is 20 mg of

famotidine every 6 hours. Your doctor may need to increase this dose further depending how

well the ulcers are healing. If you have already been taking a similar medicine or your

symptoms are severe, your doctor may start you on a higher dose of famotidine.

To treat mild symptoms of oesophagitis

(inflammation of the food pipe)

, due to

acid reflux

- The recommended dose is 20 mg of famotidine twice daily.

Treatment usually lasts for 6 weeks, but if necessary, for 12 weeks.

To treat more severe symptoms of oesophagitis

(inflammation toof the food pipe) - The

recommended dose is 40 mg of famotidine twice daily. Treatment usually lasts for 6

weeks, but if necessary, for 12 weeks.

Use in people with kidney problems

If you suffer from kidney problems, your doctor may give you a lower dose of famotidine. If

you are having dialysis, your doctor may advise you to take a 20 mg tablet after dialysis.

Use in children and adolescents

Famotidine should not be given to children or adolescents.

If you take more Famotidine than you should

If you take too much of your medicine contact your doctor or go straight to the nearest

hospital emergency department immediately.

If you forget to take Famotidine

If you forget to take your dose of Famotidine, unless it is almost time for your next dose,

take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Famotidine

If you have had stomach or intestinal ulcers for a long time you should not stop taking

Famotidine if you feel better, without asking for advice from your doctor first.

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.

Stop taking Famotidine and contact your doctor or go to your nearest hospital

emergency department immediately if you notice any of the following:

Very rare

(may affect up to 1 in 10,000 people)

a serious allergic reactions including rash, itching or hives, shortness of breath,

wheezing or trouble breathing, or swelling of the face, hands, feet, mouth, throat or

eyes.

yellowing of the skin or whites of the eyes, dark urine, pale stools, persistent

lack of appetite or abdominal pain which may be signs of serious liver

problems.

a severe blistering rash with bleeding in the lips, eyes, mouth, nose and

genitals or severe skin reactions which starts with painful red areas or severe

skin reactions which starts with painful red areas, then large blisters and ends

with peeling of the surface layers of the skin. You may have Stevens-Johnson

syndrome or condition known as Toxic Epidermal Necrolysis (TEN), which

may be life-threatening.

a burning sensation in the chest, shortness of breath and a persistent cough (these

may be signs you have a lung infection (pneumonia) which may be severe). You may

also get tired, have blue lips or fingertips (cyanosis) or lose weight.

fits or seizures where you may lose consciousness, cry out or have jerky movements,

feel a warning (aura) beforehand and afterwards may be confused, tired or have a

severe headache. If you have kidney problems you are more at risk of seizures.

changes to the electrical activity of the heart seen on an EEG. You may feel light

headed. Patients given this type of medicine by injection, have experienced some

changes in heart rhythm or an irregular heart beat

Stop taking Famotidine and contact your doctor as soon as possible if you notice any of

the following:

Very rare

(may affect up to 1 in 10,000 people)

an increase in the number of infections, you may get such as fever, severe chills, sore

throat or mouth ulcers (these may be the signs that you have a low number of white

blood cells in the body)

low numbers of other blood cells, causing tiredness, shortness of breath, coldness in

your hands and feet and pale skin (low number of red blood cells), unusual bruising

or bleeding more easily than normal, difficulty in healing after a cut (low number of

platelets)

depression, confusion, feeling disorientated, anxious or agitated, or seeing, hearing or

feeling things that are not real (hallucinations)

Other side effects

Common

(may affect up to 1 in 10 people)

headache

dizziness

constipation

diarrhoea

Uncommon

(may affect up to 1 in 100 people)

dry mouth

feeling unusually tired

feeling or being sick

loss of appetite

changes in taste

wind

feeling bloated

itchy skin or rash

Rare

(may affect up to 1 in 1,000 people)

an increase in liver enzymes in the blood, seen in a blood test

enlarged breasts in men. However it is not certain this effect is caused by famotidine.

Very rare

(may affect up to 1 in 10,000 people)

difficulty getting or maintaining an erection or a reduction in your sex drive

tingling or numbness in the fingers and toes

difficulty sleeping

drowsiness

chest tightness

a change in blood liver enzymes seen in a blood test

hair loss

joint pain or muscle cramps

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. You can also report the 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 Famotidine

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Store in the original package in order to protect from light and

moisture.

Do not use this medicine after the expiry date which is stated on the label. 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 throw away medicines you no longer use. These measures help protect the

environment.

6.

Contents of the pack and other information

What Famotidine contains

Each film-coated tablet contains either 20 mg or 40 mg of the active ingredient famotidine.

The other ingredients are microcrystalline cellulose, pregelatinised starch, talc, magnesium

stearate. The coating contains lactose monohydrate (see section 2 “Famotidine contains

lactose”), hypromellose, titanium dioxide (E171) and triacetin. The 40 mg film-coated tablet

coating also contains iron oxide yellow (E172) and iron oxide red (E172)

What Famotidine looks like and contents of the pack

The 20 mg film-coated tablets are white, ‘D’ shaped with two sides that curve out, marked

'FD/20' on one side and 'G' on the other.

The 40 mg film-coated tablets are light brown, diamond shaped with two sides that curve

out, marked 'FD40' on one side and 'G/G' on the other. Famotidine Tablets are available in

blister packs of

10, 20,

30, 50, 56, 60, 90 or 100

film-coated tablets. Your pharmacist

will dispense the number of tablets prescribed by your doctor.

Marketing Authorisation Holder

Mylan

Potters Bar, Hertfordshire, EN6 1TL,

United Kingdom

Manufacturer

Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL United Kingdom

Gerard Laboratories, 35-36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Mylan B.V., Dieselweig 25, 3752 LB Bunschoten, The Netherlands

This leaflet was last revised in

09/2018

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Famotidine 20 mg Film Coated Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 20 mg famotidine

Excipient with known effect:

Each tablet contains 3.42 mg lactose.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Film Coated Tablet

White, film coated, D shaped, biconvex tablets marked with ‘G’ on one side

and ‘FD/20’ on the other side.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Famotidine tablets are indicated for the following conditions;

Duodenal ulcers

Prevention of relapses of duodenal ulceration

Benign gastric ulcers

Zollinger-Ellison syndrome

Symptomatic treatment of mild to moderate reflux oesophagitis.

4.2

Posology and method of administration

Posology

Adults

Duodenal ulcers – The initial recommended dose is 40 mg of famotidine to be taken at

night.

Healing

generally

occurs

most

patients

within

weeks.

This

period,

however, may be shortened if an endoscopic examination reveals that the ulcer has

healed. However, in those patients whose ulcers have not healed within this 4 week

period, treatment should continue for a further 4 weeks.

Prevention of relapses of duodenal ulceration – To prevent ulcers from reoccurring

the recommended dose is 20 mg of famotidine to be taken at night.

Benign gastric ulcers – The recommended dose of 40 mg of famotidine to be taken at

night. Treatment should continue for between 4-8 weeks unless earlier healing is

revealed by endoscopy.

Zollinger-Ellison syndrome – Patients who are not receiving any antisecretory therapy

should be started on a dose of 20 mg of famotidine every 6 hours. The dosage should

then be adjusted to individual response. Doses up to 800 mg daily have been used up

to one year without the development of significant adverse effects or tachyphylaxis.

If the desired inhibition of acid secretion cannot be attained with a daily dosage of

800 mg, alternative treatment should be considered to regulate acid secretion, since no

long term experience with dosages of more than 800 mg of famotidine/day have been

recorded.

Treatment should be continued for as long as necessary. Patients who have been

receiving

other

-receptor

antagonist

treatment

switched

directly

famotidine

treatment

higher

dosage

than

initial

dosage

that

usually

recommended. The starting dosage will depend on the severity of the disease and the

dosage of the last dose of H

-antagonist previously used.

Symptomatic treatment of mild to moderate oesophagitis – The recommended dose in

case of mild oesophagitis is 20 mg of famotidine twice daily, in case of mild to

moderate

oesophagitis

recommended

dose

40 mg

twice

daily.

Generally

treatment should be conducted for 6 weeks. If the condition has not improved,

treatment should be continued for a further 6 weeks.

Elderly

The dosage regimen recommended for elderly patients is the same as for adults.

Use in impaired renal function.

Famotidine is primarily eliminated via the kidneys. For patients with impaired renal

function in whom creatinine clearance is less than 30ml/min, the daily dosage of

famotidine should be reduced by 50%. Caution is advised in patients with renal

impairment.

Dialysis patients should also take dosages that are reduced by 50%. Famotidine 20 mg

tablets should be administered at the end of dialysis or thereafter since some of the

active ingredient is removed via dialysis

Paediatric population

The efficacy and safety of famotidine in children have not been established.

Method of administration

For oral use.

Famotidine tablets can be taken with or without food (see section 5.2).

4.3

Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1

or to other H

-receptor antagonists.

Cross sensitivity in this class of compounds has been observed. Therefore, famotidine

should not be administered to patients with a history of hypersensitivity to other H

receptor antagonists.

4.4

Special warnings and precautions for use

Gastric neoplasm

The presence of gastric malignancy should be excluded prior to the use of famotidine

for the treatment of gastric ulcers. Symptomatic responses of gastric ulcers following

treatment with famotidine do not preclude the presence of gastric malignancy.

Renal dysfunction

As famotidine is excreted primarily via the kidneys, caution should be exercised when

treating patients who are suffering from impaired renal function. A reduction in daily

dosage to 20 mg at night should be considered if creatinine clearance falls below

10 ml/min (see section 4.2).

Paediatric population

The safety and efficacy for the use of famotidine in children has not been established.

Use in the elderly

When Famotidine was administered to elderly patients in clinical trials, no increase in

the incidence or change in the type of drug-related side effects was observed. No

dosage adjustment is required based on age alone.

General

In case of long-term treatment with high dosage, monitoring of blood count and liver

function is recommended.

In case of long-standing ulcer disease, abrupt withdrawal after symptom relief should

be avoided

This medicine contains lactose. Patients with rare hereditary problems of galactose

intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should

not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction

No clinically important drug interactions have been identified.

Famotidine does not interact with the cytochrome P450 drug metabolising enzyme

system. Compounds metabolised by this system, which have been tested in man have

included warfarin, theophylline, phenytoin, diazepam, propranolol, aminopyrine and

antipyrine.

Indocyanide green as an index of hepatic blood flow and/or hepatic drug extraction

has been tested and no significant effects have been found.

Studies in patients stabilised on phenprocoumon therapy have shown no

pharmacokinetic interaction with famotidine and no effect on the pharmacokinetic or

anticoagulant activity of phenprocoumon.

In addition, studies with famotidine have shown no augmentation of expected blood

alcohol levels resulting from alcohol ingestion.

lterations of gastric pH may affect the bioavailability of certain drugs, resulting in a

decrease in the absorption of atazanavir.D The absorption of ketoconazole and

itraconazole could be reduced; ketoconazole should be administered two hours before

administering famotidine.

PProbenecid inhibits the renal tubular secretion of famotidine and has been shown to

cause a 50% increase in famotidine plasma concentrations. Therefore concomitant use

of probenecid and famotidine should be avoided.

Concomitant use of famotidine and antacids may reduce the famotidine absorption

and lead to lower plasma levels of famotidine. Therefore, famotidine should be

administered 1-2 hours before taking an antacid.

Concomitant

sucralfate

inhibits

absorption

famotidine.

Therefore,

sucralfate should as a rule not be administered within two hours of the famotidine

dose.

Risk of loss of efficacy of calcium carbonate when co-administered as phosphate

binder with famotidine in haemodialysis patients.

4.6

Fertility, pregnancy and lactation

Pregnancy

Famotidine is not recommended for use in pregnancy, and should be prescribed only

if clearly needed. Before a decision is made to use famotidine during pregnancy, the

physician should weigh the potential benefits from the drug against the possible risks

involved.

Breast-feeding

Famotidine is secreted in human breast milk. Therefore breast-feeding mothers should

either stop taking famotidine or stop breast-feeding.

4.7

Effects on ability to drive and use machines

Some patients have experienced adverse reactions such as dizziness and headache

while taking famotidine. Patients should be informed that they should avoid driving

vehicles or operating machinery or doing activities which require prompt vigilance if

they experience these symptoms (see section 4.8).

4.8

Undesirable effects

Famotidine has been demonstrated to be generally well-tolerated.

Adverse reactions are ranked under the heading of frequency, the most frequent first,

using the following convention: very common (

1/10), common (

1/100 to < 1/10),

uncommon (

1/1,000 to < 1/100), rare (

1/10,000 to < 1/1,000), very rare (<

1/10,000), including isolated cases and not known (cannot be estimated from the

available data).

Blood and lymphatic system disorders

Very rare

Thrombocytopenia, leucopenia,

agranulocytosis, pancytopenia,

neutropenia.

Immune system disorders

Very rare

Hypersensitivity reactions (anaphylaxis,

angioneurotic oedema, bronchospasm).

Metabolism and nutrition disorders

Uncommon

Anorexia.

Psychiatric disorders

Very rare

Reversible psychological disturbances

including hallucinations, disorientation,

confusion, anxiety disorders, agitation,

depression, insomnia, reduced libido.

Nervous system disorders

Common

Uncommon

Very rare

Headache, dizziness.

Taste disorder.

Paraesthesia, somnolence,

convulsions, grand mal seizures

(particularly in patients with impaired

renal function).

Cardiac disorders

Very rare

Atrioventricular block with H

-receptor

antagonists administered intravenously,

arrhythmias, QT prolongation (especially

in patients with impaired renal function)

Respiratory, thoracic and mediastinal

disorders

Very rare

Interstitial pneumonia, sometimes fatal.

Gastrointestinal disorders

Common

Uncommon

Constipation, diarrhoea.

Dry mouth, nausea and/or vomiting,

flatulence, abdominal discomfort or

distension.

Hepatobiliary disorders

Very rare

Liver enzyme abnormalities, hepatitis,

cholestatic jaundice.

Isolated cases of worsening of existing

hepatic disease.

Skin and subcutaneous tissue disorders

Uncommon

Very rare

Rash, pruritus, urticaria.

Alopecia, Stevens-Johnson

syndrome/toxic epidermal necrolysis

sometimes fatal.

Musculoskeletal and connective tissue

disorders

Very rare

Arthralgia, muscle cramps.

Reproductive system and breast

disorders

Very rare

Impotence.

General disorders and administration

site conditions

Uncommon

Very rare

Fatigue.

Chest tightness.

Investigations

Rare

Increase in laboratory values

(transaminases, gamma GT, alkaline

phosphatase, bilirubin).

Adverse effects – Causal relationship unknown

Rare cases of gynaecomastia have been reported, however, in controlled clinical trials

the incidences were not greater that those seen with placebo.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product. Healthcare professionals are asked to report any suspected adverse reactions

via the Yellow Card Scheme at www/mhra.gov.uk/yellowcard.

4.9

Overdose

The adverse reactions in overdose cases are similar to the adverse reactions

encountered in normal clinical experiences (see section 4.8).

In the event of overdose the usual measures to remove unabsorbed material from the

gastrointestinal tract, clinical monitoring and supportive therapy should be employed.

Patients suffering from Zollinger-Ellison syndrome have tolerated doses of up to

800 mg/day. These patients have been treated for more than a year without the

development of any significant adverse effects.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for peptic ulcer and gastro-oesophageal reflux

disease (GORD), H

-receptor antagonists, ATC code: A02BA03

Clinical efficacy and safety

In healthy volunteers, single oral doses of famotidine (5 mg to 40 mg) produced dose-

related inhibition of basal and pentagastrin, betazole or insulin-stimulated gastric

secretion. In addition, pepsin levels were also reduced and there was a decrease in the

volume of the basal gastric juice and the gastric juice secreted on stimulation. Similar

inhibitory effects on gastric secretion were also noted in patients with benign gastric

or duodenal ulceration.

In contrast to control subjects on cimetidine 300 mg or on placebo, inhibition of

gastric secretion persisted in volunteers given a second pentagastrin challenge 5-

7 hours after the initial dose of famotidine.

A single oral dose of 40 mg of famotidine, given at 9 pm was effective for more than

12 hours after administration and had some continuing effect through the breakfast

meal. The duration of action of the 80 mg dose of famotidine administered at 9 pm

was no longer than the 40 mg dose.

In several studies, 10 mg and 20 mg doses of famotidine increased basal serum gastrin

levels, however the levels remained unchanged in others. Gastric emptying, and

hepatic and portal blood flows were unaltered by famotidine. In addition, famotidine

did not cause changes in endocrine function.

5.2

Pharmacokinetic properties

Absorption

The drug is rapidly absorbed and takes effect within an hour of oral administration,

reaching

dose-related

peak

plasma

concentrations

within

hours.

Oral

bioavailability is not affected by the presence of food in the stomach. Repeated doses

do not lead to accumulation of the drug.

Distribution

There is relatively low (15-20%) protein binding of famotidine in the plasma.

The plasma half-life after a single oral dose or multiple repeated doses (for 5 days)

was approximately 3 hours.

Biotransformation

drug

metabolised

liver,

with

formation

inactive

sulfoxide

metabolite.

Elimination

Famotidine is excreted mainly unchanged in the urine (25-60%); a small amount of

the drug may be excreted as the sulfoxide.

Linearity/non-linearity

Famotidine displays linear kinetics.

5.3

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to

that already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Tablet core:

Cellulose, microcrystalline

Starch, pregelatinised

Talc

Magnesium stearate

Film-coating:

Lactose monohydrate

Hypromellose

Titanium dioxide (E171)

Triacetin

6.2

Incompatibilities

Not applicable

6.3

Shelf life

2 years.

6.4

Special precautions for storage

Do not store above 25

C. Store in the original package in order to protect from light

and moisture.

6.5

Nature and contents of container

Polyvinylchloride aluminium foil blisters packed into cartons containing 10,

20, 28, 30, 50, 56, 60, 90 or 100 tablets. Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling

No special requirements

UKPAR Famotidine 20mg & 40mg Tablets

PL 32019/0033-0034

1

FAMOTIDINE 20MG TABLETS

PL 32019/0033

&

FAMOTIDINE 40MG TABLETS

PL 32019/0034

(FAMOTIDINE)

UKPAR

TABLE OF CONTENTS

Lay Summary

Page 2

Scientific discussion

Page 3

Steps taken for assessment

Page 11

Steps taken after authorisation

Page 12

Summary of Product Characteristics

Page 13

Product Information Leaflet

Page 20

Labelling

Page 22

UKPAR Famotidine 20mg & 40mg Tablets

PL 32019/0033-0034

2

FAMOTIDINE 20MG & 40MG TABLETS

PL 32019/0033-0034

(FAMOTIDINE)

LAY SUMMARY

The Medicines and Healthcare products Regulatory Agency (MHRA) granted Roger

Oakes Limited Marketing Authorisations (licences) for the medicinal products

Famotidine 20mg Tablets (PL 32019/0033) and Famotidine 40mg Tablets (PL

32019/0034) on 6

July 2009. These are prescription-only medicines (POM).

The active ingredient, famotidine, is one of a group of medicines known as ‘H2-

receptor antagonists’ which work by reducing the amount of acid your stomach

produces.

Famotidine Tablets are used to treat the following:

Stomach ulcers (gastric / duodenal ulcers)

Irritation and inflammation caused by stomach acid leaking into the gullet

(reflux oesophagitis)

Zollinger-Ellison Syndrome (a rare disorder that involves recurrent ulcers and

tumours in the stomach and intestines)

These applications are duplicates of previously granted applications for Famotidine

20mg Tablets and Famotidine 40mg Tablets (PL 11311/0226-0227), held by Tillomed

Laboratories Limited, and authorised in the UK on 13

November 2003. The test and

reference products are identical.

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

therefore judged that the benefits of taking Famotidine 20mg and 40mg Tablets

outweigh the risks; hence Marketing Authorisations have been granted.

UKPAR Famotidine 20mg & 40mg Tablets

PL 32019/0033-0034

3

FAMOTIDINE 20MG & 40MG TABLETS

PL 32019/0033-0034

(FAMOTIDINE)

SCIENTIFIC DISCUSSION

TABLE OF CONTENTS

Introduction

Page 4

Pharmaceutical assessment

Page 5

Preclinical assessment

Page 8

Clinical assessment

Page 9

Overall conclusion and risk benefit assessment

Page 10

UKPAR Famotidine 20mg & 40mg Tablets

PL 32019/0033-0034

4

INTRODUCTION

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

Oakes Limited Marketing Authorisations for the medicinal products Famotidine 20mg

Tablets (PL 32019/0033) and Famotidine 40mg Tablets (PL 32019/0034) on 6

July

2009. The products are prescription-only medicines.

These applications were submitted as simple abridged ‘informed consent’ applications

according to article 10c of Directive 2001/83/EC (as amended), cross-referring to the

Marketing Authorisations Famotidine 20mg Tablets and Famotidine 40mg Tablets

(PL 11311/0226-0227), granted to Tillomed Laboratories Limited on 13

November

2003 through the Mutual Recognition Procedure.

Famotidine Tablets are indicated for the following:

Duodenal and benign gastric ulcers which have been confirmed by

radiological or endoscopic examination

Zollinger-Ellison syndrome

Reflux oesophagitis confirmed by endoscopy, including curative treatment of

erosion or ulcer associated with reflux oesophagitis.

Famotidine is an effective competitive H

receptor antagonist, the effect of which is

particularly clearly concentrated on H

receptors. It reduces the concentration and

amount of acid and pepsin of the gastric juices in the basal and stimulated secretion.

The effect of oral administration of famotidine is rapid. The effect of famotidine is

long lasting when recommended doses are used, and it is effective with relatively low

concentrations in the blood. The duration of effect, plasma concentration and

secretion in the urine are dose dependent.

Oral administration of famotidine leads to the antacid effect starting within an hour of

administration. The peak effect is dose dependent and it is achieved within 1-3 hours

of administration.

No new data were submitted nor was it necessary for these simple applications, as the

data are identical to that of the previously granted cross-reference products. As the

cross-reference products were granted prior to the introduction of current legislation,

no PAR was generated for them.

UKPAR Famotidine 20mg & 40mg Tablets

PL 32019/0033-0034

5

PHARMACEUTICAL ASSESSMENT

LICENCE NUMBERS:

PL 32019/0033 & 0034

PROPRIETARY NAME:

Famotidine 20mg & 40mg Tablets

ACTIVE INGREDIENTS:

Famotidine

COMPANY NAME:

Roger Oakes Limited

E.C. ARTICLE:

Article 10c of Directive 2001/83/EC (as amended)

LEGAL STATUS:

1.

INTRODUCTION

These are simple abridged applications, submitted under Article 10c of Directive

2001/83/EC (as amended) for Famotidine 20mg & 40mg Tablets. The proposed MA

holder is Roger Oakes Limited.

The reference products are Famotidine 20mg and 40mg Tablets (PL 11311/0226-

0227), granted to Tillomed Laboratories Limited on 13

November 2003. The test and

reference products are identical.

2.

MARKETING AUTHORISATION APPLICATION FORM

2.1 Name(s)

The proposed names of the products are Famotidine 20mg Tablets and Famotidine

40mg Tablets. The products have been named in line with current requirements.

2.2 Strength, pharmaceutical form, route of administration, container and pack

sizes

Each film-coated tablet contains 20mg or 40mg of the active ingredient famotidine.

The tablets are marketed in PVC - aluminium blister strips, which are packaged with

the Patient Information Leaflet (PIL) into cardboard outer cartons in pack sizes of 5,

7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 90, 98, and 100.

The approved shelf-life (36 months) and storage conditions (‘Do not store above

C’ and ‘Store in the original package’) are consistent with the details registered for

the cross-reference product.

2.3 Legal status

The products are available by supply through pharmacies, subject to a medical

prescription.

2.4 Marketing authorisation holder / Contact Persons/Company

The proposed Marketing Authorisation holder is ‘Roger Oakes Limited, Allstoe

House, Church Lane, Greetham, Rutland LE15 7NF’.

The QP responsible for pharmacovigilance is stated and their CV is included.

2.5

Manufacturers

The proposed manufacturing site is consistent with that registered for the cross-

reference products and evidence of GMP compliance has been provided.

UKPAR Famotidine 20mg & 40mg Tablets

PL 32019/0033-0034

6

2.6 Qualitative and quantitative composition

The proposed compositions are consistent with the details registered for the cross-

reference products.

2.7 Manufacturing process

The proposed manufacturing process is consistent with the details registered for the

cross-reference products and the maximum batch sizes are stated.

2.8 Finished product / shelf-life specification

The proposed finished product specifications are in line with the details registered for

the cross-reference products.

2.9 Drug substance specification

The proposed drug substance specifications are consistent with the details registered

for the cross-reference products.

2.10 TSE Compliance

The magnesium stearate is of vegetable origin. The only excipient used that contains

material of animal or human origin is lactose monohydrate. The applicant has

provided a declaration that milk used in the production of lactose monohydrate is

sourced from healthy animals under the same conditions as that for human

consumption.

3.

EXPERT REPORTS

Satisfactory expert reports and curriculum vitae of experts were provided.

4.

PRODUCT NAME & APPEARANCE

See 2.1 for details of the proposed product names. The appearance of the products

(White, oblong, biconvex tablet, scored on one side) is consistent with that of the

cross-reference products.

5.

SUMMARY OF PRODUCT CHARACTERISTICS

The approved SmPCs are consistent with the details registered for the cross-reference

products.

6.

PATIENT INFORMATION LEAFLET (PIL) / CARTON

The patient information leaflet has been prepared in the user tested format and in line

with the details registered for the cross-reference products. The approved PIL is

satisfactory.

UKPAR Famotidine 20mg & 40mg Tablets

PL 32019/0033-0034

7

Cartons

Colour mock-ups of the labelling have been provided and are satisfactory. The

approved artwork is comparable to the artwork registered for the cross-reference

products and complies with statutory requirements. In line with current legislation the

applicant has included the name of the products in Braille on the outer packaging and

has included sufficient space for a standard UK pharmacy dispensing label.

7.

CONCLUSIONS

The grounds for these applications are considered adequate. Marketing Authorisations

were therefore granted.

UKPAR Famotidine 20mg & 40mg Tablets

PL 32019/0033-0034

8

PRECLINICAL ASSESSMENT

These applications were submitted as simple abridged applications according to article 10c

of Directive 2001/83/EC (as amended).

No new preclinical data have been supplied with these applications and none are

required for applications of this type. A preclinical expert report has been written by a

suitably qualified person and is satisfactory.

UKPAR Famotidine 20mg & 40mg Tablets

PL 32019/0033-0034

9

CLINICAL ASSESSMENT

These applications were submitted as simple abridged applications according to article 10c

of Directive 2001/83/EC (as amended).

As these are duplicate applications for PLs 11311/0226 and 0227, no new clinical data

have been supplied with the applications, and none are required for applications of

this type. A clinical expert report has been written by a suitably qualified person and

is satisfactory.

UKPAR Famotidine 20mg & 40mg Tablets

PL 32019/0033-0034

10

OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT

QUALITY

The data for these applications are consistent with that previously assessed for the

cross-reference products and as such has been judged to be satisfactory.

PRECLINICAL

No new preclinical data were submitted and none are required for applications of this

type.

EFFICACY

Medicinal products containing famotidine have been available in the UK for much

more than ten years. Their use is well established with recognised efficacy and

acceptable safety.

These applications are identical to the cross-reference products Famotidine 20mg

Tablets and Famotidine 40mg Tablets (PL 11311/0226-0227, Tillomed Laboratories

Limited).

No new or unexpected safety concerns arise from these applications.

PRODUCT LITERATURE

The approved SmPCs, PIL and labelling are satisfactory and consistent with that for

the cross-reference products.

A package leaflet has 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. The results indicate that the package leaflet is well-structured

and organised, easy to understand and written in a comprehensive manner. The testing

shows that patients/users are able to act upon the information that the leaflet contains.

The approved labelling artwork complies with statutory requirements. In line with

current legislation, the name of the product in Braille appears on the outer packaging

and sufficient space has been included for a standard UK pharmacy dispensing label.

The Marketing Authorisation Holder (MAH) has stated that not all pack sizes may be

marketed. However, they have committed to submitting mock-ups for all packaging

for assessment before those pack sizes are commercially marketed.

RISK BENEFIT ASSESSMENT

The quality of the products is acceptable and no new preclinical or clinical safety

concerns have been identified. The applicant’s products are identical to the cross-

reference products. Extensive clinical experience with famotidine is considered to

have demonstrated the therapeutic value of the active substance. The risk: benefit is,

therefore, considered to be positive.

Similar products

Search alerts related to this product

View documents history

Share this information