Point

Active Ingredients

Each tablet contains:

Naproxen sodium 275 mg.

Indications

Therapeutic group:

A pain reliever that belongs to the class of Non-Steroidal Anti Inflammatory drugs (NSAIDs).

Point tablets are intended to relieve mild and moderate pain such as toothache, backache and menstrual pain, reduce fever, treat rheumatic inflammations, tendinitis and musculoskeletal inflammations.

Instructions

Swallow the tablets with a glass of water.

You may split the tablets on the break line. There is no information about crushing/chewing.

Take this medicine with or after a meal.

The recommended dosage is usually:

Adults and children over 12 years old:

One tablet every 12 hours, as needed, or a starting dose of 2 tablets in 24 hours.

Do not exceed a dose of 2 tablets in 24 hours.

Older people over 65 years old:

Up to 1.5 tablets in 24 hours.

Do not exceed the recommended dose.

Stop taking this medicine and consult your doctor if your fever lasts longer than 3 days or pain persists for longer than 10 days.

There may be a connection between taking medicines like Point and a slight increase in the risk of heart attack or stroke. This risk evidently increases with longer use and higher doses. Therefore, do not exceed the recommended dose or deviate from the recommended duration of treatment.

Make sure that you have enough to drink when using this medicine, particularly if you have kidney problems.

If you forget to take this medicine at the required time, skip the missed dose and take the next dose on time. Do not take a double dose to make up for a missed dose.

Warnings

Do not use Point tablets if you are hypersensitive or allergic to naproxen, naproxen sodium or to any of the other ingredients in this medicine.

Do not use Point tablets if you are hypersensitive or allergic to aspirin, any other pain reliever or other NSAIDs (such as ibuprofen or diclofenac).

Do not use this medicine if you have now or have ever had any problems with your stomach or gut like an ulcer or bleeding.

Do not use this medicine if you have previously experienced bleeding or an ulcer in your digestive system while taking NSAIDs.

Do not use this medicine if you have severe problems with your kidneys, liver or heart.

Do not use this medicine if you are in the last three months of pregnancy.

Before treatment with Point, tell your doctor or pharmacist if you have heart problems, if you have had a stroke, or if you think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker).

Consult your doctor or pharmacist before starting treatment with Point if you have any of the following:

• Asthma, allergies (for example hay fever) or you have had swelling of the face, lips, eyes or tongue in the past
• Weakness (perhaps because of an illness) or you are an older person
• Polyps in your nose or you sneeze a lot or have a runny, stuffy, or itchy nose (rhinitis)
• Problems with your kidneys or liver
• Problems with the way that your blood clots
• Problems with the blood vessels (arteries)
• Too much fat in your blood (hyperlipidemia)
• Autoimmune diseases such as systemic lupus erythematosus (causes joint pain, skin rashes, and fever), inflammation of the large intestine (colitis) or Crohn’s disease (causing inflammation of the bowel, bowel pain, diarrhea, vomiting and weight loss)

This medicine is not intended for children under 12 years old.

Your doctor will want to see you while you are taking Point to make sure that the dose is right for you and to see whether any side effects have appeared. This is particularly important if you are older person.

If you are taking or have recently taken other medicines, including nonprescription medications and dietary supplements, tell your doctor or pharmacist. Particularly if you are taking:

• Pain killers like aspirin, ibuprofen, diclofenac, paracetamol
• Anticoagulants, like aspirin, warfarin, heparin or clopidogrel
• A hydantoin (for epilepsy), like phenytoin
• Sulfonamides, like hydrochlorothiazide, acetazolamide, indapamide and sulfonamide antibiotics (for infections)
• A sulfonylurea (for diabetes), like glimepiride or glipizide
• ACE inhibitors or any other medicine for high blood pressure like cilazapril, enalapril or propranolol
• Angiotensin-II receptor antagonists, like candesartan, eprosartan or losartan
• Diuretics (for high blood pressure), like furosemide
• Cardiac glycosides (for treatment of heart problems), like digoxin
• Steroids (for swelling and inflammation), like hydrocortisone, prednisolone and dexamethasone
• Quinolone antibiotics (for infections), like ciprofloxacin ormoxifloxacin
• Certain medicines for mental health disorders, like lithium, or SSRIs like fluoxetine or citalopram
• Probenecid (for gout)
• Methotrexate (used to treat skin problems, arthritis or cancer)
• Cyclosporine or tacrolimus (for skin problems or after an organ transplant)
• Zidovudine (for treatment of AIDS and HIV)
• Mifepristone (used to end pregnancy or to bring on labor if the unborn baby has died)

If you are pregnant or breastfeeding, think you may be pregnant or are trying to become pregnant, consult your doctor or pharmacist before using this medicine.

Point tablets have the potential side effect of kidney damage to the unborn baby and low amniotic fluid as of Week 20 of the pregnancy. It is recommended that you avoid use of NSAIDs as of Week 20 of pregnancy and consult with a healthcare professional if necessary.

Do not take this medicine if you are in the last three months of pregnancy (last trimester), as there is a risk of harm to your unborn baby.

Point may make it difficult to become pregnant. Tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Using this medicine can make you tired, drowsy, dizzy, have problems with your eyesight and balance, feel depressed and have difficulty sleeping. So be cautious about driving, operating dangerous machines, and any other activity that requires alertness.

Caution adolescents over 12 years old against riding a bicycle, playing near a road, and similar activities.

Each tablet contains about 25 mg sodium (the main ingredient in table salt). This amount is about equivalent to 1.25% of the adult recommended maximum daily intake of salt. Patients who need to limit their sodium intake should take this into account.

This medicine contains the yellow coloring agent FD&C which may cause an allergic reaction.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.