Medication Guide

IBUPROFEN and FAMOTIDINE

(EYE bue PROE fen and fa moe' ti deen)

tablets, for oral use

What is the most important information I should know about ibuprofen and famotidine tablet?

Ibuprofen and famotidine tablet can cause serious side effects including:

• Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:

o with increasing doses of medicine containing NSAIDs
o with longer use of medicine containing NSAIDs

Do not take ibuprofen and famotidine tablet right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking ibuprofen and famotidine tablet after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take ibuprofen and famotidine tablet after a recent heart attack.

• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:

o anytime during use o without warning symptoms o that may cause death

The risk of getting an ulcer or bleeding increases with:

o past history of stomach ulcers, or stomach or intestinal bleeding with the use of NSAIDs o smoking o drinking alcohol o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” o  older age o  poor health o  increasing doses of NSAIDs o  advanced liver disease o  longer use of NSAIDs o  bleeding problems

You should take ibuprofen and famotidine tablet exactly as prescribed, at the lowest dose possible and for the shortest time needed.

Ibuprofen and famotidine tablet contains a non-steroidal anti-inflammatory drug NSAID (ibuprofen). Do not use ibuprofen and famotidine tablet with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your healthcare provider first, because they may contain an NSAID also.

Ibuprofen and famotidine tablet may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your healthcare provider.

Ibuprofen and famotidine tablet contains ibuprofen, an NSAID and famotidine, a histamine H2 -receptor blocker medicine.

What is ibuprofen and famotidine tablet?

Ibuprofen and famotidine tablet is a prescription medicine used to:

• relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis.
• decrease the risk of developing ulcers of the stomach and upper intestines (upper gastrointestinal ulcers) in people taking ibuprofen for rheumatoid arthritis and osteoarthritis.

It is not known if ibuprofen and famotidine tablet is safe and effective in children.

Do not take ibuprofen and famotidine tablet:

• if you are allergic to ibuprofen, famotidine, any other histamine H2-receptor blocker, or any of the ingredients in ibuprofen and famotidine tablet. See the end of this Medication Guide for a complete list of ingredients.
• if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
•  right before or after heart bypass surgery.

Before taking ibuprofen and famotidine tablet, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems.
• have high blood pressure.
• have heart problems.
• have asthma.
• have bleeding problems.
• are pregnant or plan to become pregnant. Taking ibuprofen and famotidine tablet at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take ibuprofen and famotidine tablet when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take ibuprofen and famotidine tablet after about 30 weeks of pregnancy.
• are breastfeeding or plan to breast feed. Ibuprofen and famotidine can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ibuprofen and famotidine tablet.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.Ibuprofen and famotidine tablet and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

How should I take ibuprofen and famotidine tablet?

• Take ibuprofen and famotidine tablet exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how many ibuprofen and famotidine tablet to take and when to take it.
• Do not change your dose or stop ibuprofen and famotidine tablet without first talking to your healthcare provider.
• Swallow ibuprofen and famotidine tablets whole with liquid. Do not split, chew, crush or dissolve the ibuprofen and famotidine tablet. Tell your healthcare provider if you cannot swallow the tablet whole. You may need a different medicine.
• If you forget to take your dose of ibuprofen and famotidine tablet, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take 2 doses at one time to make up for a missed dose.
• You should not take an ibuprofen tablet and famotidine tablet together instead of taking ibuprofen and famotidine tablet, because they will not work in the same way.

What are the possible side effects of ibuprofen and famotidine tablet?

Ibuprofen and famotidine tablet can cause serious side effects, including:

See “What is the most important information I should know about ibuprofen and famotidine tablet?

heart attack	kidney problems including kidney failure
stroke	life-threatening allergic reactions
liver problems including liver failure	asthma attacks in people who have asthma
new or worse high blood pressure	life-threatening skin reactions
heart failure	low red blood cells (anemia)

Other side effects of ibuprofen and famotidine tablet include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms:

shortness of breath	slurred speech
chest pain	swelling of the face or throat
weakness in one part or side of your body

Stop taking ibuprofen and famotidine tablet and call your healthcare provider right away if you get any of the following symptoms:

nausea	vomit blood
more tired or weaker than usual	there is blood in your bowel movement or it is black and sticky like tar
diarrhea
itching	unusual weight gain
your skin or eyes look yellow	skin rash or blisters with fever
indigestion or stomach pain	swelling of the arms, legs, hands, and feet
flu-like symptoms

If you take too much ibuprofen and famotidine tablet, call your poison control center at 1-800-222-1222. These are not all the possible side effects of ibuprofen and famotidine tablet. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs

• Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
•  Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

General information about the safe and effective use of ibuprofen and famotidine tablet

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ibuprofen and famotidine tablet for a condition for which it was not prescribed. Do not give ibuprofen and famotidine tablet to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

What are the ingredients in ibuprofen and famotidine tablet?

Active ingredients: ibuprofen and famotidine

Inactive ingredients: Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1/brilliant blue FCF aluminum, FD&C blue #2/indigo carmine aluminum lake, ferrosoferric oxide, hypromellose, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc and titanium Dioxide.

Manufactured by:

Alkem Laboratories Ltd.,

INDIA.

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054.

For more information, you can call on Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901).

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: November, 2021

PT 3450-02