General instructions:

This medicine is prescribed for your current illness, so do not use it in similar cases or recommend it to others.

If the symptoms of your disease become severe, be sure to inform your doctor. In case of any side effect, be sure to consult your doctor, whether it is mentioned in this instruction sheet or not.

Indication:

This product, a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications.

Dosage and Administration:

The recommended daily dose of this product (ibuprofen and famotidine) 800 mg/26.6 mg is a single tablet administered orally three times per day.

This product tablets should be swallowed whole, and should not be cut to supply a lower dose. Do not chew, divide, or crush tablets.

If a dose is missed, it should be taken as soon possible. However, if the next scheduled dose is due, not take the missed dose, and should be take the next dose on time.  Not to take 2 doses at one time to make up for a missed dose.

Do not substitute this product with the single-ingredient products of ibuprofen and famotidine.

Contraindications:

Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ibuprofen or famotidine or any components of the drug product

History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, have been reported in such patients

In the setting of coronary artery bypass graft (CABG) surgery

This product should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists (such as Cimetidine and Ranitidine)

Breast-feeding & Pregnancy:

Avoid use of NSAIDs, including this product, in pregnant women starting at 30 weeks of gestation (third trimester).

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this product and any potential adverse effects on the breastfed infant from it or from the underlying maternal condition.

Drug Interactions:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking any of the following medicines – this is because your doctor may need to adjust your Brivaracetam dose:

Rifampicin – a medicine used to treat bacterial infections.

St John’s wort (also known as Hypericum perforatum).

Warnings:

Complete the course of treatment.

Take the medicine with or immediately after a meal with a full glass of water.

This medication may cause drowsiness, so avoid driving or operating machinery that requires full alertness during treatment.

Avoid taking this medicine with products containing alcohol.

Dosing Considerations:

Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

Avoid use of this product in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.

Active and clinically significant bleeding from any source can occur; discontinue this product if active bleeding occurs.

Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.

Avoid use of this product in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.

Seek emergency help if an anaphylactic reaction occurs.

This product is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin-sensitivity).

Discontinue this product at first appearance of skin rash or other signs of hypersensitivity.

Monitor hemoglobin or hematocrit in patient with any signs or symptoms of anemia.

Side Effects:

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Cardiovascular Thrombotic Events, GI Bleeding, Ulceration, and Perforation, Hepatotoxicity, Hypertension, Heart Failure and Edema, Renal Toxicity and Hyperkalemia, Anaphylactic Reactions

Seizures, Serious Skin Reactions, Hematologic,Toxicity , Aseptic Meningitis

Ophthalmological Effects

If you get any above side effects and other, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Storage:

Store below 30 °C and protect from light and moisture. Keep out of sight and reach of children.

Dosage Form:

Each Bilayer tablet of Anivil-Famex® Contains Ibuprofen 800 mg and Famotidin 26.6 mg.