In this manual :
1. WHAT IS NUROFEN 400 mg, softgel and WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING NUROFEN 400 mg, soft capsule
3. HOW DO I TAKE NUROFEN 400 mg, softgels?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE NUROFEN 400 mg, softgels?
6. ADDITIONAL INFORMATION
1. WHAT IS NUROFEN 400 mg, softgel and WHAT IS IT USED FOR?
Pharmacotherapeutic class
NON-STEROIDAL ANTI-INFLAMMATORY AND ANTI-RHEUMATIC DRUGS.
This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen. It is suitable for adults and children weighing more than 30 kg (approximately 11-12 years), in the short-term treatment of fever and/or pain such as headaches, flu-like conditions, toothache, aches and pains, painful periods.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING NUROFEN 400 mg, softgels?
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Do not take NUROFEN 400 mg, softgel 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),
- a history of allergy to other components of the softgel,
- 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.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take special precautions with NUROFEN 400 mg, soft capsule:
At high doses, greater than 1200 mg/day, this medicine has anti-inflammatory properties and may cause the sometimes serious side effects seen with non-steroidal anti-inflammatory drugs.
Drugs such as NUROFEN 400 mg, softgel may increase the risk of heart attack ("myocardial infarction") or stroke. The risk is greater the higher the doses used and the longer the duration of treatment.
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, NUROFEN 400 mg, softgel may affect 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 NUROFEN 400 mg, softgel.
Elderly subjects have a higher risk of adverse reactions, especially gastrointestinal bleeding, ulcers and perforations. Renal, hepatic and cardiac functions should be closely monitored. Dosage should be kept as low as possible for the shortest time necessary to relieve symptoms.
The use of this medicine is not recommended in patients with fructose intolerance (a rare hereditary disease).
This medicine contains an azoic colouring agent (cochineal red A (E124)) and may cause allergic reactions.
BEFORE USING THIS MEDICINE, CONSULT YOUR DOCTOR IN CASE OF:
- a history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose. The administration of this speciality may lead to an asthma attack, particularly in certain subjects who are allergic to acetylsalicylic acid (aspirin) or to a non-steroidal anti-inflammatory drug(see section "Never take NUROFEN 400 mg, softgel in the following cases"),
- coagulation disorders, taking an anticoagulant treatment. This medicine may cause serious gastrointestinal symptoms,
- 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 NUROFEN 400 mg, softgel(see "Taking or using other medicines"),
- concomitant treatment with methotrexate at doses higher than 20 mg per week or with pemetrexed(see section "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.
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This medicine contains a non-steroidal anti-inflammatory drug:ibuprofen.
You should not take other medicines containing non-steroidal anti-inflammatory drugs (including selective cyclooxygenase 2 inhibitors) and/or acetylsalicylic acid (aspirin) with this medicine. Carefully read the package inserts of other medications you are taking to make sure you are not taking non-steroidal anti-inflammatory drugs and/or acetylsalicylic acid (aspirin).
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Interactions with other medications
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 NUROFEN 400 mg, softgel:
- 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.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
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 thefirst 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.
Effects on ability to drive and use machines
Driving and use of machinery:
In rare cases, dizziness and visual disturbances may occur when taking this medicinal product.
List of excipients with a known effect
Important information about some of the ingredients of NUROFEN 400 mg, softgel:
This medicine contains sorbitol (E420) and cochineal red A (E124).
3. HOW TO TAKE NUROFEN 400 mg, soft capsule
Instructions for proper use
The occurrence of adverse effects can be minimized by using the lowest possible dose for the shortest time necessary to relieve symptoms.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Suitable for adults and children weighing more than 30 kg (11-12 years).
Painful and/or febrile conditions
The usual dosage is 1 capsule of 400 mg per dose, to be repeated if necessary, without exceeding 3 capsules of 400 mg per day (i.e. 1200 mg per day).
The 400 mg capsule is reserved for pain or fever that is more intense or not relieved by a 200 mg ibuprofen capsule.
The elderly are at increased risk of adverse effects, so use the lowest possible dose for the shortest time necessary to relieve symptoms.
Do not exceed the recommended doses or duration of treatment (3 days in case of fever, 5 days in case of pain).
The maximum dosage is 3 capsules per day (1200 mg).
Mode and route of administration
Oral use.
Swallow the softgel without chewing, with a large glass of water.
The softgels 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
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The duration of use is limited to:
- 3 days in case of fever,
- 5 days in case of pain
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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 NUROFEN 400 mg, softgel, is too strong or too weak: consult your doctor or pharmacist.
Symptoms and instructions in case of overdose
If you have taken more NUROFEN 400 mg Softgels than you should have:
In case of accidental overdose or intoxication, STOP THE TREATMENT AND CONSULT YOUR DOCTOR IMMEDIATELY.
Instructions in case of missed dose(s)
If you forget to take NUROFEN 400 mg, softgel:
Do not take a double dose to make up for the single dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, NUROFEN 400 mg Softgels may have side effects, although not everyone is susceptible.
Medicines such as NUROFEN 400 mg Softgels may increase the risk of heart attack (myocardial infarction) or stroke.
Allergic reactions may occur:
- skin: rash on the skin, itching, swelling, aggravation of chronic urticaria,
- respiratory: asthma attack type,
- generalised: sudden swelling of the face and neck with breathing difficulties (angioedema).
In rare cases, gastrointestinal bleeding may occur(see "Special precautions with NUROFEN 400 mg softgels"). The higher the dosage used, the more frequent it is.
In exceptional cases, headaches with nausea, vomiting and neck stiffness may occur.
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, 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, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW DO I USE NUROFEN 400 mg, softgel?
Keep out of the reach and sight of children.
Do not use NUROFEN 400 mg, soft capsule after the expiry date stated on the box.
Store at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does NUROFEN 400 mg softgel contain?
The active substance is:
Ibuprofen ........................................................................................................................................ 400 mg
For one softgel.
The other components are:
Macrogol 600, potassium hydroxide solution.
Composition of the capsule shell: gelatine, liquid sorbitol (partially dehydrated), purified water, cochineal red A (E124), soya lecithin, medium chain triglycerides.
Opacode ink NSP-78-18022.
Pharmaceutical form and content
What is NUROFEN 400 mg, softgel and what does it contain?
This medicine is in the form of a soft capsule. Box of 8, 10, 12, 14 and 15 softgels.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
RECKITT BENCKISER HEALTHCARE FRANCE
15, RUE AMPERE
91748 MASSY CEDEX
Operator
RECKITT BENCKISER HEALTHCARE FRANCE
35, RUE AMPERE
91748 MASSY CEDEX
Manufacturer
CATALENT GERMANY SCHORNDORF GMBH
STEINBEISSTRASSE 1 & 2
73614 SCHORNDORF
GERMANY
or
CATALENT UK PACKAGING LIMITED
SEDGE CLOSE HEADWAY, GREAT OAKLEY CORBY,
NORTHAMPTONSHIRE NN18 8HS
UNITED KINGDOM
or
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED
THANE ROAD, NOTTINGHAM
NOTTINGHAMSHIRE NG90 2DB
GREAT BRITAIN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date of approval of this leaflet was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
HEALTH ADVICE/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 30 kg (approx. 11-12 years): 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.
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