Spedifen 200 MG

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Meda Meda

Spedifen 200 MG TABLETS 20 DENTAL PAIN: This medicine is a nonsteroidal anti-inflammatory drugs (NSAIDs). He struggles against the pain and reduce fever. Its anti-inflammatory properties are manifested in high doses. It is used in the treatment of acute fever and pain (headache, dental pain, aches, painful periods ...). The tablets are also used in adults for the treatment of migraine.

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Partners with: ANTEMIG PILEJE 30 TABLETS, Midogem Comfort 30 ml Herbalgem, Strong Migraine Midogem Herbalgem 10ml

Used for : migraine, achiness, toothache, gripaux states

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Spedifen 200 MG TABLETS 20 DENTAL PAIN

 

 

Description Spedifen 200 mg

 

The drug Spedifen 200 contains a non-steroidal anti-inflammatory: ibuprofen. Spedifen 200 is indicated in adults and children over 30 kg (approximately 11-12 years) in the acute treatment of dental pain. It can also be used in the treatment of fever and / or pain such as headache, flu symptoms, aches, painful periods.


Using advice and opinion on Spedifen 200 mg

 

The drug Spedifen 200 Dental Pain contains a nonsteroidal anti-inflammatory: ibuprofen. Spedifen 200 is indicated in adults and children over 30 kg (approximately 11-12 years) in the acute treatment of dental pain. It can also be used in the treatment of fever and / or pain such as headache, flu symptoms, dental pain, aches, painful periods.
 

Spedifen composition 200 mg

 

amount per bag Ibuprofen 200 mg Sodium 55 mg Sucrose 1.8 g

 

Introducing Spedifen 200 mg

 

Box of 20 tablets

 

Warnings on drugs


Attention, the drug is not a product like any other. Read the package leaflet before ordering. Do not let the drugs out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please tell your online pharmacist ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the manual for this product on the website of the National Agency for Drug Safety and health products.

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VIDAL OF THE FAMILY

SPEDIFEN 400 mg

Non-steroidal anti-inflammatory drug

ibuprofen

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

SPEDIFEN 400 mg: tablet; box of 12.
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SPEDIFEN 400 mg: granules for oral solution (mint flavoring, anise); box of 12 sachets-dose.
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Laboratory Zambon France

COMPOSITION (summary)
p cp p sachet
Ibuprofen 400 mg 400 mg
Sodium 83 mg 55 mg
Sucrose + 1.8 g
aspartame +

INDICATIONS (summary)
This drug is a non- steroidal anti-inflammatory drug ( NSAID ). It combats pain and lowers the fever. Its anti-inflammatory properties manifest in high doses.
It is used in the short-term treatment of fever and pain (headaches, dental pain, muscle aches, painful periods ...).
The tablets are also used in the treatment of the migraine crisis in adults, after at least a medical opinion.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
Prolonged treatment or overdosage of NSAIDs may result in serious adverse reactions.
Certain situations must lead to continuation of treatment only after a medical opinion:
  • severe heartburn or black and foul-smelling stools that may indicate irritation or bleeding of the digestive tract;
  • rash without obvious cause;
  • asthma attack ;
  • unusual and intense fatigue, or a sharp and significant decrease in the volume of urine in a person suffering from heart failure , dehydration or diuretic treatment.
The use of NSAIDs is not recommended in children with varicella: it may increase the risk of infectious, exceptional but potentially serious complications.
Precautions are necessary in the elderly or in case of a history of stomach or duodenal ulcer or haemorrhagic risk, especially digestive ( Crohn 's disease , ulcerative colitis ).
NSAIDs have an inhibitory effect on ovulation and are likely to decrease fertility in women. This effect is reversible upon discontinuation of treatment.
Some doctors consider that anti-inflammatories can decrease the effectiveness of intrauterine devices (IUDs) and expose them to an unwanted pregnancy risk. This risk is highly controversial.
Conductor: This medication may be responsible, in rare cases, for dizziness or disturbances of vision.
DRUG INTERACTIONS (summary)
This medication may interact with other medicines, including: Inform your doctor or pharmacist if you are taking a diuretic , an ACE inhibitor , an angiotensin II inhibitor , a beta-blocker, or a medicine containing ciclosporin.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
Adverse effects to the unborn child have been demonstrated when NSAIDs are used during the last 4 months of pregnancy; the risk exists even with a single intake and even if the pregnancy is over term. The use of this medication is contraindicated during this period.
During the first 5 months, the effect of this medication is poorly understood: only your doctor can evaluate the possible risk of its use in your case.

Breastfeeding:
Ibuprofen is low in breast milk: however, as a precaution, it is not recommended during breast-feeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
In order to limit the occurrence of digestive disorders , this medication should be taken during meals. However, in the case of acute pain, the fasting catch ensures a faster effect.
The tablets should be swallowed as they are with a glass of water, without being chewed.
The contents of the sachets are dissolved in half a glass of water.

Usual dosage:

Pain and fever:
  • Adult and child over 30 kg (about 11 years): 1 tablet or sachet, to be renewed if necessary after a minimum period of 6 hours, without exceeding 3 tablets or sachets per day. In the absence of medical advice, the duration of treatment should be limited to 5 days in case of pain and 3 days in case of fever.
Migraine attack:
  • Adult: 1 tablet, to be taken at the beginning of the crisis. There is no need to take a tablet if the effect is insufficient. On the other hand, if the symptoms reappear, it is possible to take 1 additional tablet within a minimum delay of 8 hours between the 2 catches. Do not exceed 3 days of treatment.
TIPS (summary)
This 400 mg dosage is intended for use when ibuprofen 200 mg is insufficiently effective. It can nevertheless be used from the outset in the treatment of severe pain.
Do not exceed the recommended dosage or duration of treatment recommended by your doctor or pharmacist to limit side effects.
Taking this medication does not dispense with the usual measures to help cede the migraine attack: lie down in a dark room.
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
POSSIBLE ADVERSE EFFECTS (summary)
Nausea, vomiting, gastritis .
Rarely:

GLOSSARY (summary)


NSAIDs
Abbreviation for non-steroidal anti-inflammatory drug. Family of anti-inflammatory drugs that are not derived from cortisone (steroids), and the best known of which is aspirin.


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


anemia
Reduction in the level of hemoglobin in the blood, which usually results in a decrease in the number of red blood cells. Iron is essential for the synthesis of hemoglobin. Iron deficiency during pregnancy, a vegetarian diet, abundant or repeated haemorrhage (menstruation) is a common cause of anemia. Other causes, more rare, are related to vitamin deficiencies of group B.


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


antiplatelet agents
Medication that prevents the platelets from clumping and therefore the clots from forming. The oldest platelet antiaggregant is aspirin taken in small doses.
Anti-aggregants should not be confused with anticoagulants with a different mechanism of action.


anti coagulants
Medication that prevents blood from coagulating and therefore prevents clots from forming in the blood vessels.
Anticoagulants are used to treat or prevent phlebitis, pulmonary embolism, certain infarcts. They also prevent the formation of clots in the heart during rhythm disorders such as atrial fibrillation or in the case of an artificial heart valve.
There are two main types of anticoagulants:
  • oral anticoagulants, which block the action of vitamin K (antivitamin K, or AVK) and whose effectiveness is controlled by a blood test: INR (formerly TP);
  • injectable anticoagulants derived from heparin, the efficacy of which can be controlled by the blood assay of anti-Xa activity, Howell's Time (TH) or Cephalin Kaolin Time (TCK) depending on the products used. A regular dosage of blood platelets is necessary throughout the life of a heparin derivative.


anti-inflammatory
Medicine that fights against inflammation. It can be either derived from cortisone (steroidal anti-inflammatory), or not derived from cortisone (nonsteroidal anti-inflammatory or NSAID).


asthma
Disease characterized by difficulty breathing, often resulting in wheezing. Asthma, permanent or occurring by crisis, is due to a narrowing and inflammation of the bronchi.


beta blockers
Family of drugs used primarily in cardiology. They block the action of adrenaline (and other related hormones) on the heart, vessels and bronchi.


Crohn
inflammation of the intestine, which can cause ulcers and narrowing. It often becomes chronic and can be accompanied by persistent diarrhea and malnutrition.


diuretic
Medication allowing increased kidney water removal. Most often, this loss of water follows the loss of salts caused by the drug (salidiuretic).
Diuretics are mainly used in the treatment of high blood pressure, while their mechanism of action in this disease is poorly understood. They are also prescribed in acute or chronic heart failure, edema and other rarer ailments.
These drugs cause loss of sodium and potassium (except for some of them called "potassium-sparing"). Their prolonged administration therefore requires regular blood potassium control, to avoid heart problems that may result from hypokalemia (lack of potassium in the blood). Lack of sodium is another possible but less frequent consequence of the prolonged use of diuretics; it is also detected by a blood test.


duodenum
A part of the intestine into which food from the stomach penetrates.


skin rash
Appearance of pimples or plaques on the skin. These lesions can be due to a food, a drug, and translate an allergy or a toxic effect. Many viruses can also cause pimple eruptions: rubella, roseola and measles are the most common.


gastritis
Inflammation of the stomach favored by stress, tobacco, alcohol and certain drugs such as aspirin or anti-inflammatory drugs.


hemorrhage
Loss of blood from an artery or vein. Hemorrhage can be external, but also internal and go unnoticed.


angiotensin II inhibitor
These drugs are sometimes called sartans, for the names of the molecules belonging to this family end with sartan (losartan, candesartan, etc.).
This family of drugs blocks the action of angiotensin II, a substance that increases blood pressure and tires the heart.
Angiotensin II inhibitors are used to treat high blood pressure.


ACE inhibitor
This family of drugs blocks the action of an enzyme, which converts angiotensin I (naturally inactive substance) to angiotensin II. This last substance increases blood pressure and fatigue the heart.
ACE inhibitors are used to treat high blood pressure, heart failure or myocardial infarction.


heart failure
Inability of the heart to fulfill its function as a pump. The main symptoms of heart failure are fatigue and shortness of breath during an effort.


Hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


lupus erythematosus
Skin disease causing redness of the central part of the face. There are two main forms: discoid lupus (only cutaneous) and disseminated lupus (associated with lesions of the deep organs).


migraine
Special headache usually affecting the right or left half of the head, often associated with a fear of light and noise.


blood count
The count measures the number of red blood cells (red blood cells), white blood cells (leukocytes) and platelets in the blood. The blood formula specifies the percentage of different white blood cells: neutrophils, eosinophils, basophils, lymphocytes, monocytes.
Abbreviation: NFS.


edema
Accumulation of water or lymph causing localized swelling.


phenylketonuria
An inherited disease that is characterized by the absence of an enzyme and that leads to the accumulation in the blood of a toxic product. Screening is systematic at birth. Treatment is based on a specific diet during early childhood.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


ulcerative colitis
Inflammatory disease of the rectum and colon, which evolves by flare-ups. Each flare is accompanied by fever, bloody stools.


overdose
Excessive intake of a drug may result in an increase in the intensity of adverse effects or even in the development of specific adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.


crisis management
As opposed to long-term treatment, short-term and episodic treatment in the context of seizure or outbreak diseases.


transaminases
Enzymes dosed in the blood, which rate rises during some hepatitis. They are included in blood tests as SGOT and SGPT or ASAT and ALAT.


digestive disorders
Set of symptoms indicating irritation or malfunction of the digestive tract. One or more disorders may be present: nausea, vomiting, aerophagia, abdominal pain, heartburn, bloating, flatulence, diarrhea or constipation, etc. Antibiotics can promote candidiasis, often responsible for digestive disorders.


ulcer
Injury of skin, mucous membranes or cornea.
  • Leg ulcer: chronic wound due to poor circulation of blood.
  • Gastroduodenal ulcer: a localized wound in the mucosa of the stomach or duodenum due to excess acidity and very often to the presence of a bacterium (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and certain medications (aspirin, NSAIDs, etc.).


dizziness
Symptom that can mean an impression of loss of balance (common sense) or, more strictly, a sense of rotation on oneself or the environment (medical sense).

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Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Updated on: 24/07/2017

Name of the medicinal product

SPEDIFEN 400 mg film-coated tablet

Ibuprofen

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should contact your doctor if you experience no improvement or if you feel less well after 3 days in case of fever, 5 days in pain, 3 days in case of migraine.

What is in this leaflet?

1. What is SPEDIFEN 400 mg film-coated tablets and when is it used?

2. What should I tell you before taking SPEDIFEN 400 mg film-coated tablets?

3. How to take SPEDIFEN 400 mg film-coated tablets?

4. What are the possible side effects?

5. How to store SPEDIFEN 400 mg film-coated tablets?

6. Package contents and other information.

1. WHAT IS SPEDIFEN 400 mg film-coated tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group - ATC code: OTHER ANALGESICS AND ANTIPYRETICS - N02B

This medicine contains a non-steroidal anti-inflammatory drug: ibuprofen. In adults and children over 30 kg (approximately 11-12 years of age), it is indicated in the short-term treatment of fever and / or pain such as headache, flu-like conditions, pain dental, aches, painful periods.

It is indicated in the adult , after at least a medical opinion , in the treatment of the migraine crisis mild or moderate, with or without aura.

2. BEFORE YOU TAKE SPEDIFEN 400 mg film-coated tablets.

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

Do not take SPEDIFEN 400 mg film-coated tablets:

· after 5 months of pregnancy (24 weeks of amenorrhea),

· if you have a history of wheezing, asthma, runny nose, allergy (swelling or urticaria) after using aspirin or other similar painkillers / anti-inflammatories (NSAIDs),

· if you are allergic to ibuprofen or any of the other ingredients of this medication mentioned in section 6,

· if you have a history of gastrointestinal bleeding or ulcers associated with previous NSAID treatments,

· if you have an ulcer or bleeding from the stomach or bowel in progress or recurring,

· if you have gastrointestinal hemorrhage, cerebral hemorrhage or other ongoing hemorrhage such as ulcerative colitis (chronic inflammation of the intestine),

· if you have severe liver disease,

· if you have a serious kidney disease,

· if you have a predisposition to bleeding,

· if you have a serious heart disease,

· if you have systemic lupus erythematosus.

Warnings and Precautions

Talk to your doctor or pharmacist before using SPEDIFEN 400 mg film-coated tablets.

In high doses, greater than 1200 mg / day, this drug has anti-inflammatory properties and can cause serious disadvantages that are observed with non-steroidal anti-inflammatory drugs.

Anti-inflammatory / analgesic drugs such as ibuprofen are likely to be associated with a slightly increased risk of heart attack or stroke, especially when used at high doses.

Do not exceed recommended dosage or treatment time.

Talk with your doctor or pharmacist before taking SPEDIFEN 400 mg film-coated tablets if you have:

- heart problems, angina pectoris (chest pain) or if you have had a heart attack, surgical bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries ) or any type of stroke (including "mini-strokes" or transient ischemic attacks (TIAs))

- high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

The diagnosis and follow-up of the migraine crisis in children requires medical advice.

If you are a woman, SPEDIFEN 400 mg film-coated tablet can alter your fertility. This effect is reversible upon discontinuation of treatment. Its use is not recommended in women who wish to conceive a child. In women with reproductive difficulties or in whom breast function tests are ongoing, please tell your doctor or pharmacist before taking SPEDIFEN 400 mg film-coated tablets.

Elderly patients have a higher risk of adverse effects, particularly for gastrointestinal haemorrhage, ulcers and perforations. Renal, hepatic and cardiac functions should be closely monitored. The dosage should be as low as possible for the shortest time needed to relieve symptoms.

NSAIDs such as ibuprofen may mask and / or aggravate the symptoms of an infection.

Do not exceed the recommended dose or treatment time (3 days for fever, 5 days for pain and 3 days for migraine).

The regular and prolonged use of analgesics can lead to headaches and kidney damage. If this happens or is suspected, stop treatment and contact a doctor.

Particular attention should be paid to the introduction of ibuprofen if you are severely dehydrated.

Caution is advised if you have collagen / connective tissue diseases other than systemic lupus erythematosus (see section "Do not take SPEDIFEN 400 mg film-coated tablets").

The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).

This medicine contains sodium. This medicine contains 83 mg sodium per tablet. To be taken into account in patients controlling their sodium dietary intake.

BEFORE YOU USE THIS MEDICINE, CONSULT YOUR DOCTOR IN CASE:

· a history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose. Administration of this specialty may lead to an asthma attack, especially in certain individuals who are allergic to acetylsalicylic acid (aspirin) or to a non-steroidal anti-inflammatory drug (see section "Do not take SPEDIFEN 400 mg film-coated tablets"). ,

· coagulation disorders, and anticoagulant therapy. This medication may cause severe gastrointestinal symptoms,

· digestive antecedents (hiatal hernia, digestive hemorrhage, ulcer of the stomach or of the old duodenum),

· heart disease, liver or kidney disease,

· of varicella. This medication is not recommended because of exceptional severe infections of the skin,

· concomitant treatment with other drugs that increase the risk of peptic ulcer or haemorrhage, for example, oral corticosteroids, antidepressants (SSRIs, ie Selective Serotonin Reuptake Inhibitors ), medicines preventing the formation of blood clots such as aspirin or anticoagulants such as warfarin. If you are in any of these conditions, talk to your doctor before taking SPEDIFEN 400 mg film-coated tablets (see section "Other medicines and SPEDIFEN 400 mg film-coated tablets"),

· concomitant therapy with methotrexate at doses greater than 20 mg per week or with pemetrexed (see section "Other medicines and SPEDIFEN 400 mg film-coated tablet").

DURING TREATMENT, IN CASE OF:

· of vision problems, PREVENT YOUR DOCTOR,

· gastrointestinal haemorrhage (discharge from the mouth or stool, stool coloration in black), STOP TREATMENT AND IMMEDIATELY CONTACT AN EMERGENCY MEDICAL OR MEDICAL SERVICE,

· of appearances of cutaneous or mucosal signs that resemble a burn (redness with bubbles or blisters, ulcerations), STOP THE TREATMENT AND CONTACT IMMEDIATELY A DOCTOR OR AN EMERGENCY MEDICAL SERVICE,

· of allergy-related signs including asthma attack or sudden swelling of the face and neck ( see section "What are the possible side effects?" ), STOP TREATMENT AND CONTACT IMMEDIATELY A DOCTOR OR A MEDICAL SERVICE EMERGENCY.

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) at the same time as this medication. Read carefully the instructions for other medicines you are taking to ensure that there are no nonsteroidal anti-inflammatory drugs and / or acetylsalicylic acid (aspirin).

Adolescents (age ≥ 12 years and <18 years)

There is a risk of kidney damage in dehydrated children / adolescents.

Other medicines and SPEDIFEN 400 mg film-coated tablet

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

SPEDIFEN 400 mg film-coated tablets may affect or be affected by certain other medicines. For example :

· aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs

· corticosteroids

· anti-coagulant drugs (ie, which fluidize the blood / prevent the appearance of clots such as aspirin / acetylsalicylic acid, warfarin, ticlopidine)

· lithium

· methotrexate

· medicines that reduce high blood pressure (angiotensin-converting enzyme (ACE) inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan)

· some antidepressants (selective serotonin reuptake inhibitors)

· pemetrexed

· ciclosporin, tacrolimus

· zidovudine (treatment for HIV infection or acquired immunodeficiency syndrome)

· hypoglycaemic agents (treatment for diabetes including insulin)

· voriconazole or fluconazole (anti-mycotic treatment)

· mifepristone (abortion pill)

· antibiotics of the quinolone family

· phytotherapy products containing gingko biloba

· antibiotics aminoglycosides

Some other medicines are likely to affect or be affected by treatment with SPEDIFEN 400 mg film-coated tablets. Therefore, you should always consult your doctor or pharmacist before using SPEDIFEN 400 mg film-coated tablets at the same time as other medicines.

This medication is likely to affect the results of diagnostic tests (bleeding time, blood sugar, etc.). If in doubt, ask your doctor for advice.

SPEDIFEN 400 mg film-coated tablets with food and beverages

Not applicable.

Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

This medication should not be taken during the first 5 months of pregnancy except on medical advice in case of absolute necessity, in brief use.

Do not take this medication in any way after 5 months of pregnancy, as its effects on your child can have serious consequences, especially on a cardiopulmonary and renal plan, even with a single dose.

If you are taking this medication when you are more than five months pregnant, please speak to your obstetrician gynecologist for appropriate monitoring.

Although the product passes into breast milk, no effect is reported on the newborn / suckling infant if ibuprofen is administered at therapeutic doses. Interruption of breastfeeding is generally not necessary in the case of short-term treatment at the recommended dose.

Ibuprofen belongs to the class of medicines that can alter female fertility. However, this effect is reversible upon discontinuation of treatment.

Avoid taking this medication if you are pregnant.

Driving and using machines

In rare cases, taking this medicine may cause dizziness and blurred vision.

In the case of single or short-acting treatment, this medication usually does not require any special precautions.

SPEDIFEN 400 mg film-coated tablets contain sodium and sucrose.

3. HOW TO TAKE SPEDIFEN 400 mg film-coated tablet?

The occurrence of adverse reactions can be minimized by using the lowest possible dose for the shortest duration necessary to alleviate the symptoms.

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Painful and / or febrile conditions

ADULTS TO ADULT AND CHILD WEIGHT MORE THAN 30 KG (11-12 years).

The usual dosage is 1 tablet at 400 mg per dose, to be renewed if necessary, without exceeding 3 tablets at 400 mg per day (ie 1200 mg per day).

The tablet dosed at 400 mg is reserved for pain or fever more intense or not relieved by a tablet dosed with 200 mg of ibuprofen.

Regular intakes help prevent fever or pain. They should be spaced at least 6 hours.

The elderly with an increased risk of adverse effects should use the lowest possible dose for the shortest time necessary to relieve symptoms.

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

The maximum dose is 3 tablets per day (1200 mg).

In the event of a migraine attack

RESERVED FOR ADULTS

1 tablet at 400 mg as soon as possible from the onset of the crisis.

If a patient is not relieved after the first dose, a second dose should not be taken during the same course. However the crisis can be treated with another treatment that is not a nonsteroidal anti-inflammatory or aspirin.

If the pain reappears a second dose can be taken as long as it meets an 8 hour interval between the 2 doses.

If in doubt, ask your doctor or pharmacist for advice.

Oral use.

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

The tablets should be taken preferably during a meal.

The duration of use is limited to:

· 3 days in case of fever,

· 3 days in case of migraine,

· 5 days in case of pain.

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

In case of a migraine attack the duration of treatment should not exceed 3 days.

If symptoms persist or if new symptoms appear, seek the advice of your pharmacist or doctor.

If you feel that the effect of SPEDIFEN 400 mg film-coated tablets is too strong or too weak, talk to your doctor or pharmacist.

If you take more than SPEDIFEN 400 mg film-coated tablets you should:

Immediately consult your doctor or pharmacist.

sYMPTOMS

Symptoms of overdose usually include nausea, stomach pain, vomiting (bloody), diarrhea (bloody), dizziness, spasms, nystagmus (involuntary movement of both eyes) and diplopia (double vision), headaches and buzzing ear. In cases of severe poisoning, impaired renal function, hypotension, decreased consciousness and coma may also occur.

Support for overdose

Transfer to hospital: There is no specific antidote to ibuprofen. The stomach should be emptied as quickly as possible. The patient should, if possible, vomit. Activated charcoal to decrease the absorption of ibuprofen can be administered to the patient.

If you forget to take SPEDIFEN 400 mg film-coated tablet:

Do not take a double dose to make up for a missed dose.

If you stop taking SPEDIFEN 400 mg film-coated tablets:

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

Medications such as SPEDIFEN 400 mg film-coated tablets may increase the risk of heart attack (myocardial infarction) or stroke.

In all cases listed below, stop treatment immediately and notify your doctor.

Side effects are assessed on the basis of the following frequencies:

· Very common: Touch more than 1 user out of 10

· Common: key 1 to 10 users out of 100

· Uncommon: affects 1 to 10 users in 1,000

· Rare: Touch 1 to 10 users out of 10,000

· Very rare: affects less than 1 user in 10,000

· Indeterminate: The frequency can not be estimated from the available data.

Very common

· Dyspepsia, diarrhea

Frequent

· Abdominal pain, nausea and gas (flatulence)

· Headache, feeling dizzy

· Skin disorder , skin rash

Rare

· Allergic reaction

· Asthma, aggravated asthma, wheezing, respiratory discomfort

· Gastrointestinal deep lesion or wound, vomiting, blood in stool, inflammation of the gastric mucosa, slight loss of blood in the stomach and / or intestine

· Subcutaneous or submucosal swelling (eg at the larynx level), haemorrhagic lesion of the skin, itching, urticaria

Rare

· Reduction in the number of platelets in the blood (hemorrhagic risk), reduction in the number of white blood cells (infectious risk), anemia of medullary origin

· Severe allergic reaction

· Visual disturbance

· Hearing Disorder

· Gastrointestinal perforation, constipation, blood vomiting, inflammation with gum ulcers, aggravated colon inflammation, aggravated Crohn's disease (inflammation of the digestive system)

· Hepatic

· Blood in the urine

· Abnormal liver function test

Very rare

· Severe forms of skin reactions such as skin rashes with redness and scaling, blisters or vesicles (eg, Stevens-Johnson syndrome, erythema multiforme, Lyell's syndrome)

· Renal insufficiency and inflammatory kidney disease (interstitial nephritis) and organic renal disease (papillary necrosis)

indeterminate

· Anemia

· Severe form of allergic reaction of anaphylactic shock type

· Symptoms of aseptic meningitis

· Papillary edema (swelling of the area of ​​birth of the optic nerve)

· Heart failure

· Blood clots, hypertension, hypotension

· Irritation of the throat

· Anorexia

· Hidden bleeding (passing unnoticed)

· Liver injury, hepatitis, jaundice

· Skin reaction during exposure to sunlight or UV rays, aggravated skin reaction

· Swelling

· Severe skin infections have been observed in cases of chicken pox

· Aggravation of chronic urticaria

· Significant decrease in urine

· Abnormal Kidney Function Test

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE SPEDIFEN 400 mg film-coated tablet?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

No special storage conditions.

Do not use this medication if you notice any signs of deterioration.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What SPEDIFEN 400 mg contains: film-coated tablet

· The active substance is:

Ibuprofen................................................. .................................................. 400 mg

For a film-coated tablet.

· The other components are:

Arginine, sodium bicarbonate, crospovidone, magnesium stearate, hypromellose, sucrose, titanium dioxide (E171), macrogol 4000.

What is SPEDIFEN 400 mg film-coated tablets and contents of the pack

This drug is in the form of film-coated tablet.

Box of 3, 6, 10, 12 or 15 tablets.

Marketing Authorization Holder

ZAMBON FRANCE SA

13 RUE RENE JACQUES

92138 ISSY-LES-MOULINEAUX CEDEX

Marketing Authorization Operator

ZAMBON FRANCE SA

13 RUE RENE JACQUES

92138 ISSY-LES-MOULINEAUX CEDEX

Maker

ZAMBON SPA

VIA DELLA CHIMICA, 9

36100 VICENZA

ITALY

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

HEALTH EDUCATION COUNCIL

"WHAT TO DO IN THE EVENT OF FEVER":

The normal temperature of the body is variable from one individual to another and between 36.5 ° C and 37.5 ° C. An increase of more than 0.8 ° C is considered a fever.

In adults and children over 30 kg (11-12 years of age): if the disorder is too troublesome, you can take a medication containing ibuprofen at the indicated dosage.

With this medication, the fever should drop rapidly. However:

· if other signs appear (such as a rash),

· if the fever persists for more than 3 days or if it worsens,

· if the headache becomes violent, or in case of vomiting,

CONSULT YOUR DOCTOR IMMEDIATELY.

"WHAT TO DO IN CASE OF PAIN":

· In the absence of improvement after 5 days of treatment.

· If the pain returns regularly.

· If it is accompanied by fever.

· If she wakes you up at night.

CONSULT YOUR DOCTOR IMMEDIATELY.

"WHAT TO DO IN THE EVENT OF MIGRAINE":

What is migraine?

Migraine is a disease that results in severe headaches, occurring in seizures, for 4 to 72 hours and can be repeated several times a month. It can sometimes be preceded by visual and / or sensory signs called aura (impression of luminosity or flicker of the visual field, illusion that a fly seems to cross the visual field ...).

Migraine or headache?
Misuse of language is often referred to as migraine instead of a simple headache (headache). The following questions can help you identify if you are migraineous. You can fill it alone or with the help of your pharmacist.

1.

Your headache evolves in crises from a few hours to 3 days (without treatment).

Between crises, you do not suffer from the head.

Yes

No

2.

You have presented at least 5 crises in your life.

Yes

No

3.

Your headache has at least 2 of the following characteristics:

Yes

No

 located at one side of the head,

 pulsatile,

 increased by effort (climb stairs, run, cough),

 the painful intensity of the crisis goes from strong to very strong.

4.

Your headache is accompanied by at least 1 of the following signs:

Yes

No

 desire to vomit or vomit,

 discomfort with light (photophobia) and / or noise (phonophobia).

If you answered YES:

 the 4 questions: you are surely migraineous,

 to 3 questions: you are probably migraineous,

 1 or 2 questions: you are probably not migraine.

Discuss these results with your doctor so that he / she can confirm the diagnosis and agree with you the most appropriate treatment.

How to deal with crises?

Certain elements such as fatigue, stress, food (chocolates, alcohol, etc.), sensory factors (noise, flashing light, perfumes, etc.) or physiological factors such as menstruation are likely to trigger migraine attacks.

Knowledge of the triggering factors as well as the warning signs that can precede the crisis makes it possible to start a treatment early (ideally within an hour after its start and while it is still of mild intensity). The earlier the treatment, the more effective and often short-lived (early treatment limits migraine recurrence).

Note on a diary or notebook the date of your seizures and their duration, the intensity of the pain, the triggering factors and the medications used for each attack will help your doctor assess your migraine and its treatment.

A failure on a first crisis does not necessarily mean failure on subsequent crises. The efficacy of 400mg ibuprofen should be evaluated on 2 or 3 seizures. To help you, you can answer the following questions and discuss them with your doctor and pharmacist.

Are you relieved 2 hours after taking?

Yes

No

Do you have side effects (digestive or other)?

Yes

No

Do you use a single medication intake?

Yes

No

Can you resume your usual activities 2 hours after taking?

Yes

No

When to see your doctor?

If most headaches are of benign origin, it should not be ignored that they may be the symptom of sometimes severe conditions requiring specialized treatments.

You should consult your doctor in the following cases:

· very first headache crisis,

· start of headache after 50 years,

· triggering headaches through physical exertion, sexual intercourse, coughing,

· installation of a headache in "thunderclap": sudden appearance of a headache from one second to the next,

· appearance of unusual signs accompanying the headache such as:

o disorders of balance,

o stiffness of the neck making neck movements difficult or impossible,

o double vision, blurred vision,

o difficulty speaking,

o decreased muscle strength, numbness of the arms and legs.

· body temperature> at 38 ° C,

· aggravation of headaches,

· headache that does not have its usual character,

· onset of continuous headaches.

Find all drugs and pharmaceuticals MEDA laboratory Care and nature, your bio pharmacy online!

Spedifen Pharmacy Online: secure and authorized for sale in your bio Spedifen licensed pharmacy ARS Care and Nature

 

Spedifen contains the ibuprofen active ingredient in salt form arginate. This acts against pain, exerts an anti-inflammatory effect and lowers fever. The effect begins approximately within 30 minutes. Spedifen is indicated for the treatment of various pain conditions and acute inflammatory. Spedifen must be used on doctor's prescription.

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