Nurofenflash 200mg 12 tablets

In this manual :

1. WHAT IS NUROFENFLASH 200 mg, film-coated tablet AND WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE TAKING NUROFENFLASH 200 mg, film-coated tablet

3. HOW DO I TAKE NUROFENFLASH 200 mg, film-coated tablet?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE NUROFENFLASH 200 mg, film-coated tablet?

6. ADDITIONAL INFORMATION

1. WHAT IS NUROFENFLASH 200 mg, film-coated tablet AND WHAT IS IT USED FOR?

OTHER ANALGESICS AND ANTIPYRETICS.

This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen.

It is indicated in adults and children over 20 kg (approximately 6 years of age) for the short-term treatment of fever and/or pain such as headaches, flu-like conditions, dental pain, aches and pains and painful periods.

2. WHAT YOU SHOULD KNOW BEFORE TAKING NUROFENFLASH 200 mg, film-coated tablet

Not applicable.

Never use NUROFENFLASH 200 mg, film-coated tablet in the following cases:

• after 5 months of pregnancy (24 weeks of amenorrhea),
• a history of allergy or asthma triggered by this or related drugs, including other non-steroidal anti-inflammatory drugs, acetylsalicylic acid (aspirin),
• history of allergy to other components of the tablet,
• history of gastrointestinal bleeding or ulcers from previous NSAID therapy,
• active or recurrent ulcer or bleeding from the stomach or intestine,
• ongoing gastrointestinal hemorrhage, brain hemorrhage or other bleeding,
• severe liver disease,
• severe kidney disease,
• severe heart disease,
• systemic lupus erythematosus,
• children under 6 years of age because they may swallow incorrectly and choke.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.

Take special precautions with NUROFENFLASH 200 mg, film-coated tablet:

At high doses, greater than 1200 mg/day, this drug has anti-inflammatory properties and may cause the sometimes serious side effects seen with non-steroidal anti-inflammatory drugs.

Drugs such as NUROFENFLASH 200 mg, film-coated tablet may increase the risk of heart attack ("myocardial infarction") or stroke. The higher the dose and the longer the duration of treatment, the greater the risk.

Do not exceed the recommended doses or duration of treatment.

If you have heart problems, have had a stroke, or think you may have risk factors for these conditions (for example, high blood pressure, diabetes, high cholesterol, or smoking), please talk to your doctor or pharmacist.

Special Warnings

If you are a woman, NUROFENFLASH 200 mg film-coated tablet may impair your fertility. It is not recommended for use in women who wish to conceive a child. In women who have difficulty conceiving or in whom reproductive tests are being performed, please talk to your doctor or pharmacist before taking NUROFENFLASH 200 mg film-coated tablet.

Elderly subjects have a higher risk of adverse events, particularly gastrointestinal bleeding, ulcers and perforations. Renal, hepatic and cardiac function should be closely monitored. Dosage should be kept as low as possible for the shortest time necessary to relieve symptoms.

BEFORE USING THIS MEDICATION, CONSULT YOUR PHYSICIAN IF YOU HAVE:

• a history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose. The administration of this medicine may cause an asthma attack, especially in some people who are allergic to acetylsalicylic acid (aspirin) or to a non-steroidal anti-inflammatory drug(see section "Never take NUROFENFLASH 200 mg, film-coated tablet in the following cases"),
• coagulation disorders, taking an anticoagulant treatment. This drug may cause serious gastrointestinal manifestations,
• a history of digestive problems (hiatal hernia, digestive haemorrhage, ulcer of the stomach or duodenum),
• heart, liver or kidney disease,
• chicken pox. This medication is not recommended due to exceptional severe skin infections,
• concomitant treatment with other drugs that increase the risk of peptic ulcer or bleeding, for example, oral corticosteroids, antidepressants (those of the SSRI type, i.e. Selective Serotonin Reuptake Inhibitors), drugs that prevent blood clots such as aspirin, or anticoagulants such as warfarin If you have any of these conditions, talk to your doctor before taking NUROFENFLASH 200 mg film-coated tablet(see "Taking or using other medicines"),
• if you are taking methotrexate at doses higher than 20 mg per week or pemetrexed(see "Taking or using other medicines").

DURING TREATMENT, IN CASE OF:

• visual disturbances, Warn your doctor,
• gastrointestinal haemorrhage (discharge of blood from the mouth or stools, black stools), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY,
• signs on the skin or mucous membranes that resemble a burn (redness with bullae or blisters, ulcerations), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY,
• signs of allergy to this medicine, including asthma attack or sudden swelling of the face and neck(see "What are the possible side effects?"), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY.

Taking or using other medications:

PLEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER MEDICINE, EVEN IF IT IS A MEDICINE OBTAINED WITHOUT A PRESCRIPTION.

SOME MEDICATIONS CANNOT BE USED AT THE SAME TIME, WHILE OTHER MEDICATIONS REQUIRE SPECIFIC CHANGES (E.G., DOSE).

Always tell your doctor, dentist or pharmacist if you are taking any of the following medicines in addition to NUROFENFLASH 200 mg, film-coated tablet:

• aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs
• corticosteroids
• oral anticoagulants such as warfarin, injectable heparin, antiplatelet agents or other thrombolytics such as ticlopidine
• lithium
• methotrexate
• angiotensin-converting enzyme inhibitors, diuretics, beta-blockers and angiotensin II antagonists
• certain antidepressants (selective serotonin reuptake inhibitors)
• pemetrexed
• ciclosporin, tacrolimus.

Not applicable.

Not applicable.

Pregnancy and breastfeeding

ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE TAKING ANY MEDICATION.

Pregnancy

During the first trimester of pregnancy (12 weeks of amenorrhea, i.e. 12 weeks after the^first day of your last menstrual period), your doctor may prescribe this medicine if necessary.

From 2.5 to 5 months of pregnancy (12 to 24 weeks of amenorrhea), this medicine should only be used on the advice of your doctor and taken for short periods. Prolonged use of this medication is strongly discouraged.

If you are more than 5 months pregnant (more than 24 weeks of amenorrhea), you should NOT take this medicine under any circumstances, as its effects on your child may have serious consequences, particularly in terms of cardiopulmonary and renal health, even if you take it only once.

If you have taken this medicine when you are more than five months pregnant, please talk to your obstetrician-gynecologist so that appropriate monitoring can be offered to you.

Breastfeeding

This medicine passes into breast milk. As a precautionary measure, it should not be used during breastfeeding.

Not applicable.

Driving and use of machinery:

In rare cases, dizziness and visual disturbances may occur when taking this medicinal product.

Not applicable.

3. HOW TO TAKE NUROFENFLASH 200 mg, film-coated tablet

The occurrence of adverse reactions can be minimised by using the lowest possible dose for the shortest time necessary to relieve symptoms.

Dosage

SUITABLE FOR ADULTS AND CHILDREN FROM 20 KG (approximately 6 years).

Painful and/or febrile conditions

In children, the usual dosage is 20 to 30 mg/kg/day in 3 doses per day (without exceeding 30 mg/kg/day)

In children from 20 to 30 kg (about 6 to 11 years): 1 tablet (200 mg), to be repeated if necessary after 6 hours. In all cases, do not exceed 3 tablets per day (600 mg).

In adults and children weighing more than 30 kg (about 11-12 years): 1 to 2 tablets (200 mg), repeated if necessary after 6 hours. In all cases, do not exceed 6 tablets per day (1200 mg).

Elderly patients are at increased risk of adverse effects, so use the lowest possible dose for the shortest time necessary to relieve symptoms.

Do not exceed recommended doses or duration of treatment (3 days for fever, 5 days for pain).

The maximum dosage is 6 tablets per day (1200 mg).

Mode and route of administration

Oral use.

Swallow the tablet without chewing, with a large glass of water.

The tablets should preferably be taken with a meal.

Frequency of administration

Systematic administration avoids peaks of fever or pain. They should be taken at least 6 hours apart.

Duration of treatment

If the pain persists for more than 5 days or the fever for more than 3 days, or if they worsen, or if another disorder occurs, inform your doctor.

If you feel that the effect of NUROFENFLASH 200 mg film-coated tablet is too strong or too weak: consult your doctor or pharmacist.

If you have taken more NUROFENFLASH 200 mg film-coated tablets than you should have:

In case of accidental overdose, or intoxication, STOP THE TREATMENT AND SEEK MEDICAL ATTENTION.

If you forget to take NUROFENFLASH 200 mg, film-coated tablet:

Do not take a double dose to make up for the single dose you forgot to take.

Not applicable

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, NUROFENFLASH 200 mg Film-coated Tablet may have side effects, although not everyone is likely to have them.

Medicines such as NUROFENFLASH 200 mg Film-coated Tablet may increase the risk of heart attack (myocardial infarction) or stroke.

• Allergic reactions may occur:

o skin: rash on the skin, itching, swelling, aggravation of chronic urticaria,

o respiratory: asthma attack,

o general: sudden swelling of the face and neck (angioedema).

In rare cases, gastrointestinal bleeding may occur(see section "Special precautions with NUROFENFLASH 200 mg film-coated tablet"). The higher the dosage used, the more frequent it is.

Exceptionally, headaches with nausea, vomiting and stiffness of the neck may be observed.

Very exceptionally, bullous manifestations of the skin or mucous membranes may occur (burning sensation accompanied by redness with bullae, blisters, ulcerations).

In exceptional cases, serious skin infections have been observed with chickenpox.

In all such cases, treatmentshould be stopped immediately and your doctor should be informed.

During treatment, it is possible that the following may occur

• digestive disorders: stomach ache, vomiting, nausea, diarrhea, constipation,
• exceptionally, dizziness or headaches, rare visual disturbances, significant decrease in urine output, kidney failure.

In all these cases, you must inform your doctor.

Exceptionally, changes in the liver or blood count (decrease in white or red blood cells) have been observed, which may be serious.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. HOW TO USE NUROFENFLASH 200 mg, film-coated tablet

Keep out of the reach and sight of children.

Do not use after the expiry date on the carton.

The expiry date refers to the last day of the month.

Store at a temperature not exceeding 25°C.

Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

What does NUROFENFLASH 200 mg, film-coated tablet contain?

The active substance is:

Ibuprofen ................................................................................................................................... 200.00 mg

As ibuprofen lysinate ............................................................................................... 342.00 mg

For one film-coated tablet.

The other components are:

Povidone, sodium carboxymethyl starch (type A), magnesium stearate.

Film coating: hypromellose, talc, white OPASPRAY.

Black printing ink.

*Composition of the black printing ink : shellac, black iron oxide (E172), propylene glycol, isopropyl alcohol, butanol, ethanol dihydrate, purified water.

What is NUROFENFLASH 200 mg, film-coated tablet and what does it contain?

This medicine is presented as a film-coated tablet. Box of 10, 12 or 20.

Holder

RECKITT BENCKISER HEALTHCARE FRANCE

15, RUE AMPERE

91748 MASSY CEDEX

Operator

RECKITT BENCKISER HEALTHCARE FRANCE

15, RUE AMPERE

91748 MASSY CEDEX

Manufacturer

RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED

NOTTINGHAM SITE

THANE ROAD, NOTTINGHAM

NOTTINGHAMSHIRE, NG 90 2 DB

UNITED KINGDOM

Not applicable.

The last date of approval of this package insert was {date}.

Not applicable.

Detailed information on this medicinal product is available on the Afssaps website (France).

Not applicable.

ADVICE / HEALTH EDUCATION

"WHAT TO DO IN CASE OF FEVER":

Normal body temperature varies from one individual to another and is between 36.5°C and 37.5°C. A rise of more than 0.8°C is considered a fever.

In adults and children over 20 kg (about 6 years of age): If the symptoms are too severe, you can take a medicine containing ibuprofen in the indicated dosage.

With this medicine, the fever should drop quickly. However:

• if other signs appear (such as a rash),
• if the fever lasts more than 3 days or gets worse,
• if the headache becomes severe, or in case of vomiting,

CONSULT YOUR DOCTOR IMMEDIATELY.

"WHAT TO DO IN CASE OF PAIN":

• If there is no improvement after 5 days of treatment,
• If the pain returns regularly,
• If it is accompanied by fever,
• If it wakes you up at night,

CONSULT YOUR DOCTOR IMMEDIATELY.