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Famotidine Sandoz

famotidine film-coated tablets
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Famotidine Sandoz. It does not contain all the information that is known about Famotidine Sandoz. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

WHAT FAMOTIDINE SANDOZ IS USED FOR

This medicine is used to treat peptic ulcers (gastric and duodenal ulcers), reflux oesophagitis (reflux disease) or a rare condition called Zollinger-Ellison syndrome. It is also used to help stop duodenal ulcers and reflux disease from coming back.
Peptic ulcers
This medicine is used to heal peptic ulcers. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum, which is the tube leading out of the stomach. These ulcers usually cause pain and discomfort (indigestion), which is felt between the navel and the breast bone. The pain may occur before or after meals, or in the middle of the night.
It is also used to help stop duodenal ulcers from coming back.
Reflux disease
This medicine is used to treat reflux oesophagitis (also called reflux disease), and to stop it from coming back. This condition is caused by the washing back, or reflux of food and acid from the stomach into the food pipe (also called the oesophagus). This causes a painful burning sensation in the chest rising up to the throat (heartburn), and usually occurs after eating or at night.
Zollinger-Ellison syndrome
This medicine is used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease.
It contains the active ingredient famotidine.
Famotidine belongs to a group of medicines called histamine H2 antagonists or histamine H2 blockers.
It works by reducing the amount of acid made by the stomach. This helps to reduce the pain and also allows the ulcer and/or reflux disease to heal in most people.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is not recommended for use in children, as the safety and effectiveness have not been established.

BEFORE YOU TAKE FAMOTIDINE SANDOZ

When you must not take it

Do not take this medicine if you have an allergy to:
famotidine, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description
any other similar medicines such as other 'H2 antagonists or H2 blockers'.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not breastfeed if you are taking this medicine.
The active ingredient in Famotidine Sandoz passes into breast milk and there is a possibility that your baby may be affected.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
kidney disease
lung disease
diabetes
any other medical conditions that may make you more susceptible to pneumonia.
Tell your doctor if you are pregnant or plan to become pregnant or plan to breastfeed.
This medicine is not recommended for use during pregnancy. If there is a need to consider Famotidine Sandoz during pregnancy, your doctor will discuss with you the benefits and risks involved.
The active ingredient in Famotidine Sandoz passes into breast milk.
If you have not told your doctor about any of the above, tell him/her before you start taking Famotidine Sandoz.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may affect the way other medicines work. However, Famotidine Sandoz has not been shown to interfere with other medicines.

HOW TO TAKE FAMOTIDINE SANDOZ

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how many tablets you need to take each day. This depends on your condition.
To heal peptic ulcers, the usual dose is one 40mg tablet taken at night.
To help stop duodenal ulcers from coming back, the usual dose is one 20mg tablet taken at night.
For the treatment of reflux disease, the usual dose is one 20mg tablet taken twice a day.
For Zollinger-Ellison syndrome, the dose depends on how much acid your stomach makes. Your doctor will decide how much you need to take.
If you have impaired kidney function, your doctor may also lower your dose.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take.
Follow the instructions they give you.
If you take the wrong dose, Famotidine Sandoz may not work as well and your problem may not improve.

How to take it

It does not matter if you take the tablets with or without food.
The tablets should be swallowed whole with a full glass of water.
If you need to break Famotidine Sandoz, hold the tablet with both hands and snap along the break line.

When to take Famotidine Sandoz

If you are taking one dose a day, take the tablet at night. If you are taking two doses a day, take one tablet in the morning and one at night.
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take Famotidine Sandoz

You will need to take this medicine for 4 to 8 weeks to treat your peptic ulcer. Your doctor will tell you how long to take the tablets.
Do not stop taking Famotidine Sandoz just because you feel better.
Stopping your tablets too early may let the ulcer come back.
Sometimes you need more than 8 weeks treatment with Famotidine Sandoz to stop the ulcer from coming back. Your doctor will decide if you need more treatment.
For the treatment of reflux disease and Zollinger-Ellison syndrome, you usually need to take this medicine for longer. Your doctor will let you know how long you need to take the tablets.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Famotidine Sandoz. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

WHILE YOU ARE TAKING FAMOTIDINE SANDOZ

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Famotidine Sandoz.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

Do not take Famotidine Sandoz to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Famotidine Sandoz affects you.
This medicine may cause certain side effects such as dizziness, confusion or hallucinations with some people and may affect your ability to drive or operate machinery. Individual responses may vary.
Make sure you know how you react to this medicine before you drive a car or operate machinery.

Suggestions that may help your condition

Below are some self help measures that may help your condition. Talk to your doctor or pharmacist for more information.
Alcohol -
your doctor or pharmacist may advise you to limit your alcohol intake.
Aspirin and many other medicines used to treat arthritis, period pain, headache -
these medicines may irritate the stomach and make your condition worse. Your doctor or pharmacist may suggest other medicines you can take.
Caffeine -
may irritate your stomach. Your doctor or pharmacist may advise you to limit the number of drinks that contain caffeine such as coffee, tea, cocoa or cola drinks.
Eating habits -
eat smaller more frequent meals. Eat slowly and chew your food carefully. Try not to rush at meal times.
Food -
avoid foods that cause you pain or discomfort.
Weight -
losing some weight may help your condition.
Smoking -
your doctor or pharmacist may advise you to stop smoking or at least cut down.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Famotidine Sandoz.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
headache
dizziness
constipation
diarrhoea.
These are generally mild side effects of the medicine.
Tell your doctor as soon as possible if you notice any of the following:
nausea, vomiting
abdominal discomfort or swelling
loss of appetite
dry mouth
fatigue
muscle pain, cramps, painful joints
hallucinations, confusion, agitation, depression, anxiety, inability to sleep, sleepiness, tingling in the fingers or toes, decreased sexual drive
taste disorder
unusual hair loss or thinning.
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
If any of the following happen, stop taking Famotidine Sandoz and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
swelling of the hands, feet or ankles
any severe skin reaction
hives or nettle rash (pinkish, itchy swellings on the skin)
yellowing of the skin and/or eyes, also called jaundice
convulsions (very rare) especially in people with kidney problems
pneumonia.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Also, tell your doctor if you notice any skin rash or itchiness.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.

AFTER TAKING FAMOTIDINE SANDOZ

Storage

Keep your medicine in the original container.
If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store Famotidine Sandoz or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

PRODUCT DESCRIPTION

What it looks like

Famotidine Sandoz comes in two strengths:
Famotidine Sandoz 20mg .- white, oblong, biconvex film-coated tablets with a break score on one side. Available in blister packs of 60 tablets.
Famotidine Sandoz 40mg .- white, oblong, biconvex film-coated tablets with a break score on one side. Available in blister packs of 30 tablets.

Ingredients

Active ingredient:
Famotidine Sandoz 20mg .- 20mg famotidine
Famotidine Sandoz 40mg .- 40mg famotidine.
Inactive ingredients:
microcrystalline cellulose
pregelatinized maize starch
sodium starch glycollate type A
colloidal anhydrous silica
purified talc
magnesium stearate
lactose
hypromellose
titanium dioxide
macrogol 4000.
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
19 Harris Street
Pyrmont NSW 2009
Australia
Tel: 1800 634 500
Novartis New Zealand Ltd
Private Bag 65904 Mairangi Bay
Auckland 0754
New Zealand
Tel: 0800 354 335
This leaflet was revised in October 2011.
Australian Register Numbers
20mg tablets: AUST R 94330 (blisters)
40mg tablets: AUST R 94332 (blisters)