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FAMOTIDINE 40 MG FILM-COATED TABLETS

Active substance: FAMOTIDINE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER

Read all of this leaflet carefully before you
start taking 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 get serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:

1. What Famotidine is and what it is used for
2. Before you take Famotidine
3. How to take Famotidine
4. Possible side effects
5. How to store Famotidine
6. Further information

FAMOTIDINE IS AND WHAT IT IS
1 WHAT FOR
USED
Famotidine belongs to a group of medicines
called histamine H2 antagonists, which reduce
the amount of acid in the stomach.
Famotidine 20 mg is used:
• to treat ulcers of the stomach and small
intestine (duodenum)
• to prevent ulcers of the small intestine
(duodenum) recurring
• to treat Zollinger-Ellison Syndrome, a
condition where the stomach produces too
much acid
• to treat the symptoms (e.g. heartburn) of
mild reflux oesophagitis (mild inflammation
of the gullet).
Famotidine 40 mg is used:
• to treat ulcers of the stomach and small
intestine (duodenum)
• to treat Zollinger-Ellison Syndrome, a
condition where the stomach produces too
much acid
• to treat mild to moderate reflux oesophagitis
(mild to moderate inflammation of the
gullet), a condition which causes heartburn.

2

BEFORE YOU TAKE FAMOTIDINE

Do NOT take Famotidine if you:
• are allergic (hypersensitive) to famotidine or
any of the other ingredients of famotidine
• are a child.

Taking other medicines
Do NOT take Famotidine in combination with:
• probenecid (used to treat gout)
• atazanavir in combination with ritonavir and
tenofovir (for HIV infection).
Talk to your doctor if you are taking any of the
following (also see ‘Taking in combination with
other medicines’ in section 3, How to take
Famotidine):
• antacids used to treat indigestion, e.g. milk
of magnesia
• ketoconazole, itraconazole (used to treat
severe fungal infections)
• sucralfate (used to treat ulcers of the gut)
• atazanavir with ritonavir (for HIV infection).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
Famotidine is not recommended during
pregnancy, unless your doctor considers that
the benefit outweighs the possible risk.
If you are breast-feeding, you should avoid
taking Famotidine as it passes into breast milk.
Ask your doctor for advice before taking any
medicine.
Driving and using machines
Famotidine is not expected to affect your
ability to drive or operate machines.
Important information about some of the
ingredients of 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 Famotidine exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure. If you see
another doctor or go into hospital, let the doctor
or staff know what medicines you are taking.
The tablets should be swallowed preferably
with a drink of water.
The usual dose is:
Adults (including the elderly):

Pharma code 551

(Main)

Famotidine 20 mg
• Treatment of ulcers of the stomach or small
intestine:
Take special care with Famotidine
Two 20 mg tablets taken in the evening before
Tell your doctor before you start to take this
going to bed. Treatment may last 4 to 8 weeks.
medicine if you:
• To prevent ulcers of the small intestine
• have kidney problems (see section 3, ‘How
recurring:
to take Famotidine’, below)
One 20 mg tablet taken in the evening.
• are taking atazanavir for HIV infection (see
Your doctor will decide how long your
‘Taking other medicines’ below).
treatment will last.
Famotidine is not suitable for the treatment of • Zollinger-Ellison Syndrome:
minor, transient symptoms.
Usually one 20 mg tablet taken every 6 hours,
but your doctor may adjust this dose, based
Your doctor may also carry out further
on your response to the medicine.
investigations to exclude cancer if you suffer
Your doctor will decide how long your
from a gastric ulcer. Please especially report to
treatment will last.
your 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
• difficulty swallowing
a day.
• vomiting blood
Treatment usually lasts for 6 weeks, but your
• looking pale and feeling weak (anaemia)
doctor may continue your treatment for up
• blood in your stools.
to 12 weeks.
Famotidine 40 mg
Some ulcers may be due to a bacterium called • Treatment of ulcers of the stomach or small
Helicobacter pylori. Your doctor will carry out
intestine:
some tests to determine if you need additonal
One 40 mg tablet taken in the evening before
treatment for this infection to help your ulcer
going to bed. Treatment may last 4 to 8 weeks.
to heal.

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

FAMOTIDINE 20 mg AND 40 mg
FILM-COATED TABLETS

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.

Rare (affects less than 1 in 1,000 patients
receiving the medicine):
• yellowing of the skin and whites of the eyes
• nettle rash
• joint pain
• abnormal blood test results.
Very rare (affects less than 1 in 10,000 patients
receiving the medicine):
• blood disorders which may be characterised
by fever or chills, sore throat, unusual
bleeding or unexplained bruising, ulcers in
your mouth or throat
• hallucinations
• disorientation
• confusion, anxiety, agitation
• depression
• pins and needles or numbness
• sleepiness or difficulty sleeping
• epileptic fits
• feeling of tightness in the chest
• hair loss
• muscle cramps
• impotence (inability to achieve or maintain
an erection)
• enlargement of one or both breasts in males
(reversible when treatment is stopped)
• decrease in sexual desire.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5

HOW TO STORE FAMOTIDINE

Keep out of the reach and sight of children.
Do not use Famotidine 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 medicine does not require any special
storage conditions.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6

FURTHER INFORMATION

What Famotidine Tablets contain:
If you forget to take Famotidine
If you forget to take a tablet, take one as soon • The active ingredient is famotidine.
• Each Famotidine 20 mg film-coated tablet
as you remember, unless it is nearly time to
contains 20 mg of famotidine.
take the next one. Do not take a double dose to
• Each Famotidine 40 mg film-coated tablet
make up for a forgotten dose. Take the
contains 40 mg of famotidine.
remaining doses at the correct time.
• The other ingredients are pregelatinised
If you have any further questions on the use of
starch, maize starch, microcrystalline
this product, ask your doctor or pharmacist.
cellulose, hyprolose, colloidal anhydrous
silica, magnesium stearate, lactose
4 POSSIBLE SIDE EFFECTS
monohydrate, hypromellose, macrogol 4000
and the colourings red and yellow iron oxide
Like all medicines, Famotidine can cause side
(E172) and titanium dioxide (E171).
effects, although not everybody gets them.
What Famotidine Tablets look like and
If the following happens, stop taking the tablets contents of the pack:
• The Famotidine 20 mg Tablets are beige,
and tell your doctor immediately or go to the
round, biconvex, film-coated tablets. They are
casualty department at your nearest hospital:
marked ‘93’ on one side and ‘896’ on the other.
• an allergic reaction (swelling of the lips, face
• The Famotidine 40 mg Tablets are tan, round,
or neck leading to severe difficulty in
biconvex, film-coated tablets. They are marked
breathing; skin rash or hives)
‘93’ on one side and ‘897’ on the other.
• a severe blistering rash in which the surface
• The product is available in pack sizes of 7, 14,
layers of the skin peel.
20, 21, 28, 30, 50, 56, 60, 100 and 200 tablets.
These are very serious but rare side effects (i.e.
The 40 mg strength is also available in a
affects 1 to 10 users in 10,000). You may need
pack size of 15 tablets.
urgent medical attention or hospitalisation.
Not all pack sizes may be marketed.
The following side effects have been reported
at the approximate frequencies shown:
Common (affects less than 1 in 10 patients
receiving the medicine):
• headache
• dizziness
• constipation
• diarrhoea.
Uncommon (affects less than 1 in 100 patients
receiving the medicine):
• dry mouth
• stomach problems, nausea, vomiting, wind
• loss of appetite
• skin rash
• itching
• tiredness.

Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder and
company responsible for manufacture is
TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: September 2010
PL 00289/0344-0345

85105-V

(Main)

• Zollinger-Ellison Syndrome:
Usually 20 mg taken every 6 hours. For this
dose Famotidine 20 mg is available. Your
doctor may adjust this dose and prescribe
Famotidine 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 kidney problems
Your doctor may prescribe a lower dose. If you
have severe kidney problems, the dose is
usually halved.

Pharma code 551

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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