STREFEN 8.75 MG TABLETS 16

STREFEN 8,75MG PASTILLES 16 View larger

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For warnings, the precautions and cons-indications, please see the instructions.

Description

For warnings, the precautions and cons-indications, please   consult the user guide .

Strefen is a symptomatic treatment of acute sore throat.

For adults and children over 12 years.


Composition:

  • 8.75 mg flurbiprofen (nonsteroidal anti-inflammatory)
  • Excipients: l évomenthol, honey, potassium hydroxide, macrogol 300, sucrose solution, glucose solution. Flavor: lemon 502904 A (lemon essential oil, lemon terpenes, butylated, alpha-tocopherol).

Dosage:

  • 1 tablet to renew if needed after 3 to 6 hours, without exceeding the maximum dose of 5 tablets per day and a maximum of 3 days of treatment.


Cons-indications   :

  • Allergy, asthma, pregnancy, gastrointestinal ulcer, severe liver or kidney disease, treatment with anticoagulants.

Oral

Read carefully the instructions

Packaging:   box 16 pellets

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

STREFEN

Orbuccal preparation with anti-inflammatory aim

flurbiprofen

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

PRESENTATIONS (summary)

STREFEN: pastille (lemon flavoring); box of 16.
-

STREFEN orange without sugar: pellet (orange flavor); box of 16.
-

Laboratory Reckitt Benckiser Healthcare France

COMPOSITION (summary)
p past p past
flurbiprofen 8.75 mg 8.75 mg
sugars 2.5 g

INDICATIONS (summary)
This drug contains nonsteroidal anti-inflammatory drugs ( NSAIDs ). It combats inflammation and pain.
It is used to relieve acute sore throat.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
In case of fever, swallowing or persisting symptoms after 3 days, consult your doctor. It can tell the difference between a pharyngitis and an angina. In case of bacterial angina, antibiotic treatment is necessary to avoid further complications, cardiac or renal.
Although this medication is over-the-counter, do not use it without medical advice in the following cases: high blood pressure , heart failure , rhinitis or chronic sinusitis, history of stomach ulcer or duodenal ulcer or haemorrhagic risk digestive ( Crohn 's disease , ulcerative colitis ).
Some situations should lead to further treatment only after medical advice:
  • 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.
Lemon pellets contain a significant amount of sugar (sucrose).
Driver: This medicine may cause dizziness and difficulty in seeing.
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:
NSAIDs pass into breast milk; this medication is not recommended during breast-feeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
The pellets should be sucked without being chewed. Catches should be spaced 3 to 6 hours apart.

Usual dosage:

  • Adult and child over 12 years: 1 tablet, 1 to 5 times a day.
TIPS (summary)
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
POSSIBLE ADVERSE EFFECTS (summary)
Tingling or metallic taste in the mouth.
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.


antibiotic
A substance capable of blocking the multiplication of certain bacteria or killing them. The spectrum of an antibiotic is the set of bacteria on which this product is usually active. Unlike bacteria, viruses are not susceptible to antibiotics. The first antibiotics were extracted from mushroom cultures: penicillium (penicillin), streptomyces (streptomycin). They are currently manufactured by chemical synthesis. Antibiotics are divided into families: penicillins, cephalosporins, macrolides, tetracyclines (cyclines), sulphonamides, aminoglycosides, lincosanides, phenicolates, polymyxins, quinolones, imidazoles, etc.
Inappropriate use of antibiotics may lead to the development of resistance: use antibiotics only on medical prescription, adhere to its dosage and duration, do not give or advise another person an antibiotic prescribed for you .


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.


high blood pressure
Excess blood pressure (tension) in the arteries. This pressure is provided by the heart and is expressed by two digits. It is maximal during contraction of the heart, or systole (first digit), and minimal during cardiac rest, or diastole (second digit). High blood pressure is characterized by a maximum (systolic) pressure greater than or equal to 16, or a minimum (diastolic) pressure greater than or equal to 9.5. Treatment is initiated when these numbers are exceeded or for lower blood pressure in some people with cardiovascular risk factors: heredity, smoking, diabetes, excess cholesterol. Permanent antihypertensive therapy reduces damage to the heart and blood vessels due to high blood pressure.


inflammation
Natural reaction of the organism against an element recognized as foreign. It manifests itself locally by redness, heat, pain or swelling.


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.


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.


pharyngitis
Inflammation or infection of the pharynx.


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.


sugar
General term for various substances of which the most widely used is sucrose. Other sugars can be contained in drugs: glucose, fructose, lactose, etc. Glucose is the sugar used by the body; it is the only one to circulate in considerable quantity in the blood.
Sweeteners (false sugar) are allowed in diabetics or people on a diet, and are very low in calories.


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.


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 - Last updated: 10/05/2017

Name of the medicinal product

STREFEN 8.75 mg tablet

flurbiprofen

framed

Read this leaflet carefully before you start taking this medicine. It contains important information for you.

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

· Keep this leaflet, you may need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any of the 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 feel less well after 3 days.

· Do not use this medication for children.

What is in this leaflet?

1. What is STREFEN 8.75 mg, lozenge and in which cases it is used?

2. What information should I know before using STREFEN 8.75 mg tablets?

3. How to use STREFEN 8.75 mg, tablet?

4. What are the possible side effects?

5. How to store STREFEN 8.75 mg tablets?

6. Package contents and other information.

1. WHAT IS STREFEN 8.75 mg, tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: Respiratory system, throat preparations, other throat preparations - ATC code: R02AX01

It belongs to the class of non-steroidal anti-inflammatory drugs.

This medication is a symptomatic treatment of acute sore throats of adults and children (from 12 years).

2. BEFORE YOU USE STREFEN 8.75 mg pellet?

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

Do not take STREFEN 8.75 mg tablets in the following cases:

· from the 25th week of amenorrhea (beginning of the 6th month of pregnancy),

· a history of allergy or asthma triggered by the use of this drug or a related drug, including other non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (aspirin),

· antecedent of allergy to the other constituents of the pellet,

· history of gastrointestinal bleeding or ulcers associated with previous NSAID treatments,

· ulcer of the stomach or duodenum, evolving or recurrent,

· severe liver disease,

· severe kidney disease,

· serious heart disease,

· child under 12 years of age.

Warnings and Precautions

Drugs such as STREFEN 8.75 mg tablet may increase the risk of heart attack ("myocardial infarction") or stroke. The higher the dose, the longer the treatment time, the greater the risk.

Do not exceed recommended dosage or treatment time.

If you have heart problems, have had a stroke, or if you think you have risk factors for this type of illness (eg high blood pressure, diabetes, high cholesterol, or please contact your doctor or pharmacist.

· in case of high fever (> 38 °), suddenly appeared with a major difficulty to swallow, it is necessary to consult.

· the persistence of the symptoms beyond the 3rd day imposes a medical consultation.

BEFORE TREATMENT,

PREVENT YOUR DOCTOR, IF:

· 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 some people who are allergic to acetylsalicylic acid (aspirin) or to a non-steroidal anti-inflammatory drug (see section "Never take STREFEN 8.75 mg pellet" )

· anticoagulant or anticoagulant therapy. This medication may cause severe gastrointestinal symptoms,

· treatment with another non-steroidal anti-inflammatory drug, an oral anticoagulant, with lithium, with aspirin at analgesic, antipyretic or anti-inflammatory doses, with methotrexate at doses greater than 20 mg per week, with heparins and unfractionated heparins (in curative doses and / or in the elderly),

· digestive antecedents (hiatal hernia, digestive hemorrhage, old stomach or duodenal ulcer),

· heart disease, liver or kidney disease,

DURING TREATMENT, IN CASE OF :

· gastrointestinal haemorrhage (blood discharge through the mouth, presence of blood in the stool or coloration of the stools in black), STOP IMMEDIATELY TREATMENT AND IMMEDIATELY CONTACT MEDICAL OR MEDICAL SERVICE emergency .

· of allergy-related signs including asthma attack or abrupt swelling of the face and neck (angioedema), ( see section 4. " What are the possible side effects ? "), STOP IMMEDIATELY TREATMENT AND CONTACT IMMEDIATELY A DOCTOR OR AN EMERGENCY MEDICAL SERVICE.

· onset or aggravation of chronic urticaria: PREVENT YOUR DOCTOR.

Precautions for use

The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

This medicinal product contains 1.07 g of glucose and 1.4 g of sucrose per tablet (ie 2.5 g of sugar per tablet): take it into account in the daily diet in the case of a low-sugar diet or diabetes.

IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

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

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 the leaflets for other medicines you are taking to ensure that there are no nonsteroidal anti-inflammatory drugs and / or aspirin.

children

Do not use this medication for children.

Other medication in STREFEN 8.75mg, tablet

Before taking STREFEN 8.75 mg tablet, tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicines, even if it is a non-prescription medication because there are some medications that should not be taken together and others that may require dose modification when taken together:

· 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

· some antidepressants (selective serotonin reuptake inhibitors)

· deferasirox

· pemetrexed

· pentoxifylline

· ciclosporin, tacrolimus.

Pregnancy and breast feeding

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.

Fertility

If you are a woman, STREFEN 8.75 mg, pellet can alter your fertility. Its use is not recommended in women who wish to conceive a child.

Pregnancy

Up to 24 weeks of amenorrhea (5 elapsed month of pregnancy), your doctor may, if necessary, to prescribe this drug in a timely manner.

From the 25th week of gestation (early 6 th month of pregnancy), you should IN NO EVENT OF YOURSELF take this drug because its effect on your child may have serious consequences, especially on a plane cardio-pulmonary and renal and this even with a single intake.

feeding

In case of breast-feeding, the use of this medication should be avoided.

Driving and using machines

In rare cases, taking this medicine may cause dizziness.

Strefen 8.75 mg, tablet contains: glucose, sucrose

3. HOW TO USE STREFEN 8.75 mg, tablet?

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

RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS.

The recommended dose is: 1 pellet to be renewed if necessary after 3 to 6 hours, without exceeding the maximum dosage of 5 pellets per 24 hours and without exceeding 3 days of treatment.

Administration mode

Mouth.

Suck the pellets slowly without chewing them.

Duration of the treatment

The duration of the treatment is limited to 3 days.

If the pain persists more than 3 days or if it worsens or if a new disorder occurs, inform your doctor.

If you take more STREFEN 8.75 mg, tablet than you should:

Immediately consult your doctor or pharmacist.

If you forget to take STREFEN 8.75 mg, tablet:

Do not take a double dose to make up for the single dose that you have forgotten to take.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, STREFEN 8.75 mg pellet can cause side effects, although not everybody gets them.

Drugs such as STREFEN 8.75 mg tablet may increase the risk of heart attack ("myocardial infarction") or stroke.

· A sensation of burning, tingling or metallic taste in the mouth by sucking the tablet has sometimes been reported in clinical trials with flurbiprofen tablets.

· Can occur:

o allergic reactions:

o rash: rash, itching, edema, hives,

o respiratory disorders: asthma attack,

o general: abrupt swelling of the face and neck of allergic origin (angioedema), allergic shock)

o exceptionally: detachment of the skin can spread very seriously to the whole body (Lyell's syndrome).

Immediately stop treatment and tell your doctor .

· In some cases, digestive hemorrhage may occur (discharge from the mouth or stool, stool coloration in black). This is all the more frequent when the dosage used is high.

Immediately stop treatment and tell your doctor .

· During treatment, there may be:

o digestive disorders such as nausea, vomiting, stomach pain, difficult digestion, transit disorders (diarrhea, constipation),

o dizziness, headache, blurred vision,

o disorders of the functioning of the kidneys.

You should tell your doctor .

· Cases of gastrointestinal ulcer have been observed. Because this drug is a nonsteroidal anti-inflammatory drug, the risk of gastrointestinal perforation can not be ruled out.

· Exceptionally, some biological changes, possibly requiring control of the blood, hepatic and renal balance, have been observed.

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 STREFEN 8.75 mg tablet?

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

Do not use STREFEN 8.75 mg tablets after the expiry date which is stated on the carton.

Store at a temperature not exceeding 25 ° C.

Medicines should not be disposed of via wastewater or household waste. 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 is STREFEN 8.75 mg, pellet?

The active substance is:

Flurbiprofen ................................................. .................................................. 8.750 mg

For a pellet.

The other components are:

Lemon flavor, levomenthol, honey, potassium hydroxide, macrogol 300, sucrose solution, glucose solution.

What is STREFEN 8.75 mg, lozenge and contents of the pack

This medication is in the form of a tablet. Box of 16.

Marketing Authorization Holder

RECKITT BENCKISER HEALTHCARE FRANCE

38 RUE VICTOR BASCH

CS 11018

91305 MASSY CEDEX

Marketing Authorization Operator

RECKITT BENCKISER HEALTHCARE FRANCE

38 RUE VICTOR BASCH

CS 11018

91305 MASSY CEDEX

Maker

RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED

NOTTINGHAM SITE

THANE ROAD, NOTTINGHAM

NOTTINGHAMSHIRE, NG 90 2 DB

UK

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]

<{MM / YYYY}> <{YYYY month}.>

Other

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

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