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FAMOTIDINE 20MG FILM-COATED TABLETS

Active substance(s): FAMOTIDINE

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TEVA UK Ref:

231-30-85105-X LEA FAMOTIDINE 20 MG AND 40MG TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

Version:

1

1 August 2016

Colours Used:

BLACK
PANTONE® GREEN C
Template

PAGE 1: FRONT FACE (INSIDE OF REEL)

(Main)

Pharma code 551

Other medicines and famotidine
Do not take Famotidine in combination with:
• probenecid (used to treat gout)
Package leaflet: Information for the patient
• atazanavir in combination with ritonavir and
tenofovir (for HIV infection).
Read all of this leaflet carefully before you start
Talk to your doctor if you are taking any of the
taking this medicine because it contains
following (also see 'Taking in combination with
important information for you.
other medicines' in section 3, How to take
• Keep this leaflet. You may need to read it again.
Famotidine):
• If you have any further questions, ask your
• antacids (used to treat excessive stomach acid)
doctor or pharmacist.
• ketoconazole, itraconazole (used to treat severe
• This medicine has been prescribed for you
fungal infections)
only. Do not pass it on to others. It may harm
• sucralfate (used to treat ulcers of the gut).
them, even if their signs of illness are the same
• atazanavir with ritonavir (for HIV infection).
as yours.
• If you get any side effects, talk to your doctor or Tell your doctor or pharmacist if you are
taking/using, have recently taken/used or might
pharmacist. This includes any possible side
take/use any other medicines.
effects not listed in this leaflet. See section 4.
Pregnancy and breast-feeding
What is in this leaflet
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
1. What Famotidine is and what it is used for
ask your doctor or pharmacist for advice before
2. What you need to know before you take
taking this medicine.
Famotidine
3. How to take Famotidine
Pregnancy
4. Possible side effects
Experience with the use of famotidine during
5. How to store Famotidine
pregnancy is limited. If you are pregnant, you
6. Contents of the pack and other information
may only take famotidine if your doctor considers
the benefits of taking the tablets to be greater
What Famotidine is and what it is
than the possible risks to your unborn child.
used for
Breast-feeding
Famotidine, the active substance contained in
Famotidine belongs to a group of medicines
famotidine, passes into human milk. As there is
called histamine H2 antagonists, which reduce the no known information about the effects of
amount of acid in the stomach.
famotidine on the infant when absorbed and
Famotidine 20 mg is used:
impaired stomach acid secretion cannot be ruled
• to treat ulcers of the stomach and small
out, you should not breast-feed during treatment.
intestine (duodenum)
In consultation with your doctor, you may have to
• to prevent ulcers of the small intestine
stop taking famotidine.
(duodenum) recurring
Driving and using machines
• to treat Zollinger-Ellison Syndrome, a condition Some patients have experienced side effects such
where the stomach produces too much acid
as dizziness and headache while taking
• to treat the symptoms (e.g. heartburn) of mild
famotidine. You should therefore avoid driving
reflux oesophagitis (mild inflammation of the
vehicles or operating machinery or doing
gullet).
activities which require prompt vigilance if you
Famotidine 40 mg is used:
experience these symptoms (see section 4.
• to treat ulcers of the stomach and small
Possible side effects).
intestine (duodenum)
Famotidine contains lactose
• to treat Zollinger-Ellison Syndrome, a condition If you have been told by your doctor that you
where the stomach produces too much acid
have an intolerance to some sugars, contact your
• to treat mild to moderate reflux oesophagitis
doctor before taking this medicine.
(mild to moderate inflammation of the gullet), a
condition which causes heartburn.
How to take Famotidine

Top of page cut-off to middle of registration mark: 44 mm.

Famotidine 20 mg and 40 mg
film-coated tablets

1

3

2

What you need to know before you
take Famotidine

Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure. If you see another
Do not take Famotidine
doctor or go into hospital, let the doctor or staff
• if you are allergic to famotidine or any of the
know what medicines you are taking.
other ingredients of this medicine (listed in
The recommended dose is:
section 6).
Adults (including the elderly):
• if you have had an allergic reaction to another
histamine H2 receptor antagonist in the past, as Famotidine 20 mg
• Treatment of ulcers of the stomach or small
cross sensitivity has been observed in this
intestine:
substance class.
Two 20 mg tablets taken in the evening before
Warnings and precautions
going to bed. Treatment may last 4 to 8 weeks.
• To prevent ulcers of the small intestine
Talk to your doctor before taking famotidine
recurring:
• if you have kidney problems (see section 3,
One 20 mg tablet taken in the evening.
'How to take Famotidine', below)
Your doctor will decide how long your
• if you are taking atazanavir for HIV infection
treatment will last.
(see 'Other medicines and famotidine' below).
• Zollinger-Ellison Syndrome:
Famotidine is not suitable for the treatment of
Usually one 20 mg tablet taken every 6 hours,
minor, transient symptoms.
but your doctor may adjust this dose, based on
Your doctor may also carry out further
your response to the medicine.
investigations to exclude cancer if you suffer from
Your doctor will decide how long your
a gastric ulcer. Please especially report to your
treatment will last.
doctor symptoms such as
• Symptoms (e.g. heartburn) of mild reflux
• unintentional weight loss
oesophagitis:
• repeated vomiting
One 20 mg tablet should be taken two times a
• difficulty swallowing
day.
• vomiting blood
Treatment usually lasts for 6 weeks, but your
• looking pale and feeling weak (anaemia)
doctor may continue your treatment for up to
• blood in your stools.
12 weeks.
Some ulcers may be due to a bacterium called
Famotidine 40 mg
Helicobacter pylori. Your doctor will carry out some • Treatment of ulcers of the stomach or small
tests to determine if you need additonal treatment
intestine:
for this infection to help your ulcer to heal.
One 40 mg tablet taken in the evening before
going to bed. Treatment may last 4 to 8 weeks.
Children
• Zollinger-Ellison Syndrome:
No sufficient experience has been gained on the
safety and efficacy of famotidine in children.
Usually 20 mg taken every 6 hours. For this
Therefore children should not be treated with
dose Famotidine 20 mg is available. Your doctor
famotidine.
may adjust this dose and prescribe Famotidine

REG0063336

Version 3.4

Approved

Page 1 of 3

TEVA UK Ref:

Version:

231-30-85105-X LEA FAMOTIDINE 20 MG AND 40MG TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

1

1 August 2016

Colours Used:

BLACK
PANTONE® GREEN C
Template

PAGE 2: REAR FACE (OUTSIDE OF REEL)

40 mg for this condition, based on your
response to the 20 mg tablets.
Your doctor will decide how long your
treatment will last.
• Mild to moderate reflux oesophagitis:
Usually one 40 mg tablet should be taken two
times a day. Your doctor may adjust this dose
based on your response to treatment.
Treatment usually lasts for 6 weeks, but your
doctor may continue your treatment for up to
12 weeks.
Patients with impaired kidney function
Your doctor may prescribe a lower dose. If you
suffer from a severely impaired kidney function,
the dose is usually halved.
Children:
Famotidine must not be taken by children.
How you should take Famotidine
The tablets should be swallowed preferably with
a drink of water.
Taking in combination with other medicines:
The following medicines may affect the
absorption of Famotidine if they are taken at the
same time
• Antacids:
Take Famotidine at least 1 to 2 hours before
taking an antacid.
• Ketoconazole or Itraconazole:
Take Famotidine at least 2 hours after taking
Ketoconazole or Itraconazole.
• Sucralfate:
Take Famotidine at least 2 hours before or 2
hours after taking Sucralfate.
If you take more Famotidine than you should
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child has
swallowed any of the tablets, contact your nearest
hospital casualty department or your doctor
immediately. Please take this leaflet, any
remaining tablets and the container with you to
the hospital or doctor so that they know which
tablets were consumed.
If you forget to take Famotidine
If you forget to take a tablet, take one as soon as
you remember, unless it is nearly time to take the
next one. Do not take a double dose to make up
for a forgotten dose. Take the remaining doses at
the correct time.
Regular intake of famotidine - in accordance with
the dosage recommendations and instructions of
the doctor - contributes significantly to the
success of treatment,
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

Rare: may affect up to 1 in 1,000 people
• joint pain
• abnormal blood test results.
Very rare: may affect up to 1 in 10,000 people
• blood disorders which may be characterised by
fever or chills, sore throat, unusual bleeding or
unexplained bruising, ulcers in your mouth or
throat.
• depression
• anxiety
• agitation
• disorientation
• confusion,
• hallucinations
• difficulty falling or staying asleep
• decrease in sexual desire
• epileptic fits
• pins and needles or numbness
• drowsiness
• a lung disease characterized by progressive
scarring of the lungs (interstitial pneumonia)
• liver enzyme abnormalities
• yellowing of the skin and whites of the eyes
(hepatitis)
• hair loss
• muscle cramps
• impotence (inability to achieve or maintain an
erection)
• feeling of tightness in the chest
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 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 use this medicine after the expiry date
which is stated on the blister and outer packaging.
The expiry date refers to the last day of that
month.
This medicinal product does not require any
special storage conditions.
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 Famotidine Tablets contain:
• The active substance is famotidine.
• Each Famotidine 20 mg film-coated tablet
contains 20 mg famotidine.
Like all medicines, this medicine can cause side
• Each Famotidine 40 mg film-coated tablet
effects, although not everybody gets them.
contains 40 mg famotidine.
If the following happens, stop taking the tablets
• The other ingredients are pregelatinised starch,
and tell your doctor immediately or go to the
maize starch, microcrystalline cellulose,
casualty department at your nearest hospital:
hyprolose, colloidal anhydrous silica,
Very rare: may affect up to 1 in 10,000 people
magnesium stearate, lactose monohydrate,
• an allergic reaction (swelling of the lips, face or
hypromellose, macrogol 4000 and the
neck leading to severe difficulty in breathing;
colourings red and yellow iron oxide (E172) and
skin rash or hives)
titanium dioxide (E171).
• a severe blistering rash in which the surface
What Famotidine Tablets look like and contents of
layers of the skin peel (Stevens Johnson
the pack:
syndrome/toxic epidermal necrolysis).
• The Famotidine 20 mg Tablets are beige, round,
You may need urgent medical attention or
biconvex, film-coated tablets. They are marked
hospitalisation.
‘93’ on one side and ‘896’ on the other.
The following side effects have been reported at
• The Famotidine 40 mg Tablets are tan, round,
the approximate frequencies shown:
biconvex, film-coated tablets. They are marked
‘93’ on one side and ‘897’ on the other.
Common: may affect up to 1 in 10 people
• The product is available in pack sizes of 7, 14,
• headache
20, 21, 28, 30, 50, 56, 60, 100 and 200 tablets.
• dizziness
The 40 mg strength is also available in a pack
• constipation
size of 15 tablets.
• diarrhoea
Not all pack sizes may be marketed.
Uncommon: may affect up to 1 in 100 people
Marketing Authorisation Holder and Manufacturer
• loss of appetite
The Marketing Authorisation holder and company
• taste disorder
responsible for manufacture is TEVA UK Limited,
• dry mouth
• stomach problems, nausea, vomiting, excessive Eastbourne, BN22 9AG.
intestinal gas
This leaflet was last revised in August 2016
• skin rash
PL 00289/0344-0345
• itching
• nettle rash
• tiredness

4

Possible side effects

85105-X
160 x 323

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Teva Pharmaceuticals Europe B.V
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REG0063336

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