ipaflex 200 mg Naproxen Uses, Side Effects

Naproxen contained in Ipaflex may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What You Need To Know Before Taking Ipaflex

Do Not Take Ipaflex

If you are allergic to Ipaflex Naproxen sodium or any of the other ingredients of this medicine (listed in section 6)
If you are allergic to peanuts or soy because this medicine contains soy lecithin
If you have severe kidney disease
If you have severe liver disease
if you have or have had internal bleeding after using aspirin, ibuprofen, or other painkillers NSAIDs -lakemedel
If you have or have had more than 2 episodes of internal bleeding such as
- Bleeding from the stomach or intestines or if you have had a stroke
If you have or have had stomach ulcers, inflamed gastric mucosa, or if you have a stomach ache
If you have ever had allergic symptoms such as
- Asthma
- Runny nose
- Itching after using aspirin, ibuprofen , other pain medications, or NSAIDs -lakemedel
If you have an increased tendency to bleed or if you are being treated with blood-thinning medicines (so-called anticoagulants )
If you have severe heart failure
if you are under 12 years of age
During the last three months of pregnancy

Do not use Ipaflex if any of the above apply to you. If you have any further questions, ask your doctor or pharmacist before taking Ipaflex.

Warnings And Cautions

Talk to your doctor, pharmacist, or nurse before taking Ipaflex if:

You have problems with blood coagulation
You have an infection
You have liver problems
You have kidney problems
You have recently undergone major surgery
You have ever had asthma or allergies (eg hay fever) or swelling of the face, lips, or tongue
You get stomach or intestinal problems such as stomach pain or heartburn
The pain does not get better or if it comes back often or gets worse (even if it is mild)
You have colitis or Crohn’s disease. Symptoms include
- Inflammation of the intestines
- Pain in the gastrointestinal tract
- Diarrhea
- Vomiting
- Weight loss. There may be lumps in the nose ( polyps ), frequent sneezing or runny nose, nasal congestion, or itching in the nose ( rhinitis ).
You have an autoimmune disease such as
- Systemic lupus erythematosus which causes joint pain, rash on the skin, and fever
You are over 65 years old
You have chickenpox

If you have previously had stomach problems, you should not use Ipaflex other than on a doctor’s prescription.

Heart problems

Talk to your doctor or pharmacist before taking this medicine if:

You have heart problems
You’ve had a stroke
You have high blood pressure
You have diabetes
You have high cholesterol
You are smoking
Risk of heart attack and stroke

Medicines such as Ipaflex may cause a small increased risk of heart attack or stroke. The risk increases with the higher dose and the longer you use the drug. Do not exceed the recommended dose.

Do not use this medicine for more than 5 days. Talk to your doctor if you want to take it for a long time.

Skin reactions

In very rare cases, severe skin reactions have been reported with NSAID use. These included redness and blistering and were fatal in some cases (exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis / Lyell syndrome, see section 4).

The risk of these reactions seems to be greatest at an early stage of use as they occurred during the first month of treatment in most cases. At the first sign of a rash, damage to the mucous membranes, or other signs of an allergic reaction, stop taking Ipaflex and contact a doctor immediately.

Children And Young People

This medicine should not be used by children under 12 years of age without a doctor’s prescription.

Other Medicines And Ipaflex

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

The risk of side effects from the following medicines may be increased if they are taken with Ipaflex:

Methotrexate for the treatment of skin conditions or rheumatoid arthritis
ACE inhibitors or angiotensin -II- antagonists are for high blood pressure
Ciclosporin or tacrolimus for autoimmune diseases
other medicines for pain and inflammation including other NSAIDs such as acetylsalicylic acid and ibuprofen. Do not use different types of painkillers at the same time without a doctor’s prescription.

The risk of bleeding from the gastrointestinal tract may increase if Ipaflex is taken with the following medicines:

Steroids such as prednisolone, hydrocortisone, and dexamethasone
Clopidogrel and other anticoagulants to prevent blood clots
Selective serotonin reuptake inhibitors for depression

Ipaflex may increase the effect of certain other medicines, such as:

Blood thinners (anticoagulants), such as
- Warfarin
Lithium for mental illness

Ipaflex may reduce the effect of certain medicines for the treatment of high blood pressure, for example:

Diuretics (Diuretics).

Probenecid (used to treat gout ) can make Ipaflex Naproxen stay in the body longer. Talk to your doctor or pharmacist before taking probenecid.

Tell your doctor or pharmacist if you are taking acetylsalicylic acid to prevent blood clots.

If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking this medicine.

Ipaflex With Alcohol

Avoid alcohol as the risk of certain side effects may increase if you drink alcohol while taking Ipaflex.

Pregnancy And Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Pregnant women should not use ipaflex 200 mg naproxen during the last three months of pregnancy. Taking Ipaflex should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.

Breast-feeding

Naproxen, the active substance in Ipaflex, passes into breast milk. Therefore, Ipaflex should not be used during breastfeeding.

Fertility

Ipaflex 200 mg naproxen belongs to a group of medicines ( NSAIDs ) that can impair the fertility of women. This effect stops when you stop taking the medicine.

Driving And Using Machines

Ipaflex uses may make you tired or dizzy, which may affect your attention. This should be taken into account when sharper attention is required, eg when driving a car.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ipaflex Contains

17.7 mg propylene glycol per capsule
76.8 mg sorbitol per capsule. Sorbitol is a source of fructose. If you (or your child) do not tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that prevents fructose from being broken down, consult a doctor before using this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.

How To Take Ipaflex

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Recommended dose

Adults and adolescents from 12 years:

1 capsule is taken every 8-12 hours if needed. On the first day of treatment, 2 capsules can be taken as a starting dose, followed by 1 capsule after 12 hours. Maximum 3 capsules per day. Contact a doctor if symptoms worsen or do not improve within 5 days.

People over 65:

Do not take more than 2 capsules per day, taken as 2 single doses.

Taking this medicine

Swallow the capsules whole with plenty of liquid.
Taken if possible before a meal. People with sensitive stomachs are advised to take Ipaflex with food.

Talk to your doctor or pharmacist if you think the effect of Ipaflex is too weak or too strong.

Higher doses than those recommended can lead to serious risks. Always take as low a dose as possible for the shortest possible time to reduce the risk of side effects. If you take more Ipaflex than you should

If you have ingested too much medicine or if e.g. a child inhaled the medicine accidentally contact a doctor, hospital, or Poison Information. Take the medicine pack with you. The following symptoms may occur:

Nausea
Vomiting
Abdominal pain
Diarrhea
Drowsiness
Dizziness

If You Forget To Take Ipaflex

Ipaflex uses

If you forget to take a dose, take it when you remember. If it is close to the next dose, you can skip the missed dose.
Do not take a double dose to make up for a forgotten capsule.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible Ipaflex Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Ipaflex and contact a doctor immediately if you get any of the following, very rare but serious reactions:

Red or purple rash with blisters and epidermis ( Stevens-Johnson syndrome and toxic epidermal necrolysis, Lyell´s syndrome)
Problems with blood formation ( anemia ) that can cause
- Fever
- Sore throat
- Small sores in the mouth
- Flu-like symptoms, fatigue, and bleeding from the nose or skin.
Swelling of the face, tongue, or throat
Difficulty swallowing
Hives and difficulty breathing (angioedema)

The following Ipaflex side effects may also occur with the use.

Common (may affect up to 1 in 10 people)

Stomach ache
Heartburn
Nausea
Feeling uncomfortable in the stomach
Headache
Dizziness

Uncommon Ipaflex side effects (may affect up to 1 in 100 people):

Gastric ulcer
Sometimes bleeding, which may cause bloody vomiting, black stools, or bloody diarrhea
Visual disturbances
Reduced urine output
Vomiting
Indigestion
Diarrhea
Constipation
Skin rash
Bleeding under the skin
Blisters
Itching
Insomnia
Anxiety
Irritability
Fatigue

Rare (may affect up to 1 in 1,000 people):

Bleeding from the stomach that may cause vomiting with blood or dark particles that look like coffee grounds
Photosensitivity

Very rare (may affect up to 1 in 10,000 people):

Signs of meningitis ( meningitis ) such as
- Fever
- Nausea
- Vomiting
- Stiff neck
- Headache
- Sensitivity to bright light
- Confusion
- Patients with autoimmune diseases such as systemic lupus erythematosus are at greater risk of developing these symptoms.
Skin reactions such as
- Hair loss
- Sweating
A fluttering sensation in the heart (palpitations)
Slow heartbeat
High blood pressure
Shortness of breath or asthma attack
Elevated liver enzyme levels
Jaundice
Hepatitis
Elevated potassium levels (seen by a blood test)
Need to urinate frequently
Kidney problems
Elevated creatinine (seen by a blood test)
Kidney damage is detected as blood or protein in the urine
Sudden swelling of the neck, hands, or feet
Depression
Abnormal dreams
Difficulty concentrating
Difficulty thinking clearly
Seizures
Feeling of discomfort in the abdomen, from the esophagus to the intestines
Hearing impairment
Tinnitus
Hearing loss

Has been reported (occurs in an unknown number of users):

Clearly defined, reddened rash with or without blisters that reappear in the same place on the skin or mucous membrane with repeated use of naproxen, even mild itching may occur (fixed drug rash)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How To Store Ipaflex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. date. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in the original package. Moisture sensitive.
Store in a cold place.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents Of The Packaging And Other Information

Content Declaration

The active substance is naproxen . One capsule contains 220 mg naproxen sodium equivalent to 200 mg naproxen .
The other ingredients (excipients) are
- Macrogol
- Lactic acid
- Propylene glycol (E 1520)
- Povidone
The capsule shell contains
- Gelatin
- Sorbitol (E 420)
- Glycerol
- Purified water
- Patent blue V (E131)

What The Medicine Looks Like And Contents Of The Pack

Ipaflex are transparent, blue, oblong capsules
The blister is made of PVDC / PE / PVDC / Alu.
One pack contains 10 or 20 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

Janssen-Cilag

Domaine de Maigremont

27 100 Val-de-Reuil

France

Ipaflex – Naproxen Uses, Dose, And Side Effects

1. What Ipaflex Is And What It Is Used For