Patient leaflet - Famotidine 20 mg tablets
1. What Famotidine is and what it is used for
Famotidine belongs to a group of medicines called histamine (H2) 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 H2 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
- Famotidine may decrease the effect of posaconazole oral suspension (a drinkable medicine used to prevent and treat some fungal infections).
- Famotidine may decrease the effect of dasatinib, erlotinib, gefitinib, pazopanib (medicines used to treat cancer).
Pregnancy and breast-feeding Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, 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 of 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.
Package leaflet: Information for the
patient
Famotidine 20 mg
Film-coated Tablets Famotidine 40 mg
Film-coated Tablets
26/03/2026
2
PL 04569/0422,
PL 04569/0423
4078435
4078435
ART-58483-01
400579148 400579150
Update in Labeling, Update in MA holder & Redesign for Viatris
...
United Kingdom Mylan Laboratories Ltd (Nashik-IN)
LIT. (B/F) FAMOTIDINE TABS (COMMON) UK V1
Folded size - 150 x 40 mm 75107030
40 gsm ITC Tribeni Paper
Supply Leaflet in Folded Form as Proposed Size 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
- 1.
What Famotidine is and what it is used
for
- 2.
What you need to know before you
take Famotidine
- 3. How to take Famotidine
- 4. Possible side effects
- 5. How to store Famotidine
- 6.
information
- 1. What Famotidine is and what it is used for
Famotidine belongs to a group of medicines called histamine (H2) 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)
- 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 H2 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
- Famotidine may decrease the effect of posaconazole oral suspension (a drinkable medicine used to prevent and treat some fungal infections).
- Famotidine may decrease the effect of dasatinib, erlotinib, gefitinib, pazopanib (medicines used to treat cancer).
Pregnancy and breast-feeding Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, 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 of 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.
Package leaflet: Information for the
patient
Famotidine 20 mg
Film-coated Tablets Famotidine 40 mg
Film-coated Tablets
26/03/2026
2
PL 04569/0422,
PL 04569/0423
4078435
4078435
ART-58483-01
400579148 400579150
Update in Labeling, Update in MA holder & Redesign for Viatris
...
United Kingdom Mylan Laboratories Ltd (Nashik-IN)
LIT. (B/F) FAMOTIDINE TABS (COMMON) UK V1
Folded size - 150 x 40 mm 75107030
40 gsm ITC Tribeni Paper
Supply Leaflet in Folded Form as Proposed Size 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 side effects directly via the Yellow Card Scheme Website 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 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, 28, 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
Viatris,
Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
Manufacturer
Viatris UK Healthcare Limited,
Building 20,
Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
This leaflet was last revised in 05/2026
4078435
75112115
26/03/2026
2
PL 04569/0422,
PL 04569/0423
4078435
4078435
ART-58483-01
400579148 400579150
Update in Labeling, Update in MA holder & Redesign for Viatris
...
United Kingdom Mylan Laboratories Ltd (Nashik-IN)
LIT. (B/F) FAMOTIDINE TABS (COMMON) UK V1
Folded size - 150 x 40 mm 75107030
40 gsm ITC Tribeni Paper
Supply Leaflet in Folded Form as Proposed Size 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 side effects directly via the Yellow Card Scheme Website 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 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.
- 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, 28, 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
Viatris,
Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
Manufacturer
Viatris UK Healthcare Limited,
Building 20,
Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
This leaflet was last revised in 05/2026
4078435
75112115
26/03/2026
2
PL 04569/0422,
PL 04569/0423
4078435
4078435
ART-58483-01
400579148 400579150
Update in Labeling, Update in MA holder & Redesign for Viatris
...
United Kingdom Mylan Laboratories Ltd (Nashik-IN)
LIT. (B/F) FAMOTIDINE TABS (COMMON) UK V1
Folded size - 150 x 40 mm 75107030
40 gsm ITC Tribeni Paper
Supply Leaflet in Folded Form as Proposed Size