Toprec 25 mg Ketoprofene 20 Tablets reduces painful conditions.
Toprec is a drug indicated in adults (over 15 years old), for the symptomatic treatment of painful conditions of mild to moderate intensity and/or febrile.
The treatment should not be taken beyond 5 days for pain, or 3 days for fever, without medical advice. If the pain or fever does not subside after the days indicated, consult your doctor or pharmacist.
In the event of poisoning or accidental overdose, treatment should be discontinued and you should consult your doctor.
The occurrence of side effects may be reduced by using the lowest possible dose for the shortest duration necessary to relieve symptoms.
This treatment should preferably be taken during a meal. The systematic catches make it possible to reduce the oscillations of pain and/or fever.
The generally recommended dosage is 1 tablet of Toprec at 25 mg, renewable if necessary, without exceeding 3 tablets at 25 mg per day (i.e. 75 mg per day).
The latter are to be swallowed as they are with a skin of water, preferably during a meal.
Comment on the recommendations for use and dosage of Toprec 25 mg Ketoprofene 20 Tablets with our partner Avis checked after your purchase .
Toprec 25 mg Ketoprofene is formulated based on:
per tablet
Ketoprofen
25mg
Excipients: lactose, wheat starch, hydrated silica, gelatin, magnesium stearate.
Excipients with known effect: lactose (85.70 mg per tablet) and wheat starch (containing gluten).
What are the side effects and contraindications?
Presentation - Packaging
Toprec 25 mg Ketoprofene comes in the form of a box containing 20 tablets.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on : 09/01/2025
ATTENTION
TOPREC 25 mg, tablet, WHICH IS A NON-STEROIDIC ANTI-INFLAMMATORY (NSAID), CAN CAUSE FTAL DEATH IF TAKEN FROM THE 6TH MONTH OF PREGNANCY (24 weeks of amenorrhea) EVEN AFTER A SINGLE TAKE.
Do not use if you are 6 months or more pregnant (24 weeks or more).
Before the 6th month or if you are planning a pregnancy, you should not take this medicine unless absolutely necessary, as determined by your doctor.
Ketoprofen
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any of the side effects listed above, please tell 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 do not feel any improvement or if you feel less well.
Keep out of the reach of children.
What does this leaflet contain?
1. What is TOPREC 25 mg, tablet and what is it used for?
2. What do I need to know before taking TOPREC 25 mg, tablet?
3. How do I take TOPREC 25 mg, tablet?
4. What are the possible side effects?
5. How should TOPREC 25 mg tablets be stored?
6. Package contents and other information.
1. WHAT IS TOPREC 25 mg, tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OTHER ANALGESICS AND ANTIPYRETICS
(N: central nervous system).
TOPREC 25 mg, tablet contains ketoprofen. This medicine belongs to a family of non-steroidal anti-inflammatory drugs. These drugs are used in particular to reduce inflammation and relieve pain.
Therapeutic indications
TOPREC 25 mg, tablet is intended for adults and adolescents aged 15 and over.
TOPREC 25 mg, tablet is used for the short-term treatment of fever and/or pain such as headaches, flu-like symptoms, toothache, aches and pains, painful menstruation.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING TOPREC 25 mg, tablet?
Never take TOPREC 25 mg, tablet if you are 24 weeks or more pregnant (6 months or more of pregnancy) (see "Pregnancy, breast-feeding and fertility" below).
During the first 5 months of pregnancy, you should not take TOPREC 25 mg, tablet, unless absolutely necessary, as determined by your doctor.
If you are considering pregnancy and are taking an NSAID, talk to your healthcare professional.
Never take TOPREC 25 mg, tablet:
- If you are allergic to ketoprofen or to any of the other ingredients listed in section 6.
- If you have ever had bronchospasm, asthma attacks, rhinitis, urticaria or other allergic reactions triggered by ketoprofen or other drugs in the same family as TOPREC 25 mg, tablet (aspirin, non-steroidal anti-inflammatory drugs).
Serious, rarely fatal, allergic reactions have been reported in patients with such a history.
- If you are pregnant, from the beginning of the6th month of pregnancy (beyond 24 weeks of amenorrhea),
- If you have a history of stomach or intestinal bleeding, ulceration or perforation of the digestive tract.
- If you suffer from stomach or intestinal ulcers or have had them before.
- If you have bleeding in the stomach, intestine, brain or other organs.
- If you suffer from serious liver, kidney or heart disease.
- If you are allergic to wheat, as this medicine contains wheat starch.
If you are taking another medicine, make sure that the combination with this medicine is not contraindicated (see "Other drugs and TOPREC 25 mg, tablet").
Warnings and precautions
Talk to your doctor or pharmacist before taking TOPREC 25 mg, tablet if any of the following apply to you:
- You have a history of asthma associated with nasal polyps or inflammation of the nose or sinuses (rhinitis or chronic sinusitis).
Taking this medicine may cause respiratory discomfort or an asthma attack, particularly in people allergic to aspirin or non-steroidal anti-inflammatory drugs (see "Never take TOPREC 25 mg, tablet").
- If you suffer from heart disease (hypertension and/or heart failure), liver or kidney disease, or water retention.
- You suffer from coagulation disorders.
- You suffer from chronic inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).
- You have a history of digestive problems (such as a previous stomach or duodenal ulcer).
- You are already taking a drug that increases the risk of peptic ulcer disease or bleeding (see "Other drugs and TOPREC 25 mg, tablet").
- You have an infection. Please see "Infections" below.
- You have ever had an exaggerated skin reaction to the sun or UV rays (tanning booths).
- You have diabetes, kidney disease (renal failure), or are already taking a drug that may increase potassium levels in the blood (hyperkalemia); this drug may induce hyperkalemia.
- You have already developed fixed erythema pigmentosum (redness in the form of round or oval patches and swelling of the skin which generally recurs in the same place(s), blistering, urticaria and itching) with ketoprofen.
People at cardiovascular risk
Tell your doctor if you are in any of the following situations:
- You have heart problems.
- You have already had a stroke.
- You think you have risk factors for cardiovascular disease (e.g. high blood pressure, diabetes, high cholesterol, smoking).
Medicines such as TOPREC 25 mg, 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 recommended doses or treatment duration.
Infections
TOPREC 25 mg, tablet may mask signs of infection such as fever and pain. It is therefore possible that TOPREC 25 mg, tablet may delay adequate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while you have an infection and the symptoms of this infection persist or worsen, consult a doctor immediately.
During treatment :
Stop treatment and seek medical advice or emergency medical care immediately:
- If an asthma attack or difficulty in breathing occurs after taking this medication. This may be a sign of allergy to this drug.
- If you develop a rash of pimples or patches on the skin, itching, or sudden swelling of the face and neck. In this case, you may be allergic to the drug.
- If you vomit blood through your mouth, if you have blood in your stools or if your stools are colored black. This may be localized bleeding in your stomach and/or intestine (digestive hemorrhage).
- If you suffer from gastrointestinal ulceration.
Stop treatment and tell your doctor if you experience blurred vision.
Tell your doctor if you think you have an infection (especially if you have a fever), or if your symptoms worsen. As with all non-steroidal anti-inflammatory drugs, ketoprofen may mask the symptoms of an infection.
Elderly and underweight patients
If you are elderly or of low body weight, you are at greater risk of adverse reactions, particularly gastrointestinal bleeding, ulcers and perforations.
Your doctor will ask you to have blood tests to monitor the function of your kidneys, liver and heart, and will reduce the dose.
Other medicines and TOPREC 25 mg, tablet
|
This medicine contains a non-steroidal anti-inflammatory agent: ketoprofen. You must not take other medicines containing non-steroidal anti-inflammatory drugs and/or aspirin at the same time as this medicine. Carefully read the package inserts of any other medicines you are taking to ensure that they do not contain non-steroidal anti-inflammatory drugs and/or aspirin. |
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medication. Some drugs should not be taken together, and others may require a change in dose when taken together.
Always tell your doctor or pharmacist if you are taking or receiving any of the following medicines before taking TOPREC 25 mg, tablet:
- medicines in the same family as TOPREC 25 mg, tablet (aspirin, non-steroidal anti-inflammatory drugs) which are used to reduce inflammation and fever and/or to relieve pain,
- corticosteroids,
- drugs that prevent the formation of clots and thin the blood (oral anticoagulants such as warfarin, thrombin inhibitors such as dabigatran, direct factor Xa inhibitors such as lapixaban, rivaroxaban and edoxaban, antiplatelet agents, injectable heparin). Should it be necessary to take or use any of these drugs at the same time, your doctor will need to monitor you closely because of the increased risk of bleeding,
- lithium (used for certain mood disorders),
- certain anti-cancer drugs (pemetrexed, methotrexate),
- drugs used to lower blood pressure and treat certain heart diseases (angiotensin-converting enzyme inhibitors, diuretics, beta-blockers, angiotensin II antagonists, nicorandil and cardiac glycosides),
- certain antidepressants (selective serotonin reuptake inhibitors),
- deferasirox (used to lower iron levels in the blood),
- certain immunosuppressive drugs used in organ transplants (ciclosporin, tacrolimus).
TOPREC 25 mg, tablet with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
From the beginning of the 6th month (24th week of amenorrhea) until the end of pregnancy, TOPREC 25 mg, tablet is contraindicated. Under NO CIRCUMSTANCES should you take this medicine during this period, as its effects on your unborn child may be serious or even fatal. In particular, toxicity to the heart, lungs and/or kidneys has been observed, even with a single dose. It can also affect you and your baby, promoting bleeding and leading to a later or longer-than-expected delivery.
Before the beginning of the 6th month (up to the 24th week of amenorrhea) or if you are planning a pregnancy, you should not take this medicine unless absolutely necessary. This will be determined by your doctor. In such cases, the dose should be as low as possible and the duration of treatment as short as possible.
NSAIDs, including TOPREC 25 mg, tablet, can cause miscarriage and, in some cases, malformations after exposure in early pregnancy.
From 2 1/2 months of pregnancy (12 weeks of amenorrhea), TOPREC 25 mg, tablet can cause kidney problems in your baby, if taken for several days, leading to a low level of amniotic fluid in the baby (oligohydramnios).
From the beginning of the 5th month of pregnancy (20 weeks of amenorrhea), a narrowing of the blood vessels in your baby's heart (constriction of the ductus arteriosus) may be observed. If treatment lasting several days is required during the 5th month of pregnancy (between 20 and 24 weeks' gestation), your doctor may recommend additional monitoring.
If you have taken this medicine while pregnant, tell your doctor immediately, so that you can be offered appropriate monitoring if necessary.
Breast-feeding
As this drug passes into breast milk, it is not recommended to take it while breast-feeding.
Fertility
This drug, like all non-steroidal anti-inflammatory drugs (NSAIDs), may impair fertility in women, leading to difficulties in becoming pregnant, which may be reversible on discontinuation of treatment. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.
Driving vehicles and using machines
In rare cases, this medicine may cause dizziness, drowsiness, convulsions or visual disturbances. You are advised not to drive or operate machinery if you experience any of these symptoms.
TOPREC 25 mg, tablet contains lactose and gluten.
- If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine. This medicine contains a sugar (lactose). Patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases) should not take this medicine.
- This medicine contains very little gluten (from wheat starch). It is considered "gluten-free" and is therefore unlikely to cause problems in the case of celiac disease.
If you have an allergy to wheat (other than Cattle Disease), you should not take this medicine (see "Never take TOPREC 25 mg, tablet").
3. HOW TO TAKE TOPREC 25 mg, Tablet
Dosage
The dose is 1 tablet, repeated if necessary.
Do not exceed 3 tablets per day (i.e. 75 mg per day).
Frequency of administration
Take regularly to avoid spikes in pain or fever.
To alleviate symptoms, the lowest effective dose should be used for the shortest possible duration. If you have an infection and symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Method and route of administration
This drug is taken orally.
Tablets should be swallowed with a large glass of water, preferably during a meal, or alternatively with a snack.
Duration of treatment
Do not continue treatment without your doctor's advice:
- If pain persists for more than 5 days or fever for more than 3 days, or if they worsen.
- If new symptoms occur.
If you have taken more TOPREC 25 mg, tablet than you should have
In case of overdose or accidental intoxication, STOP THE TREATMENT AND SEEK MEDICAL ATTENTION IMMEDIATELY.
At high doses, this drug may cause undesirable effects, sometimes serious, which are those observed with anti-inflammatory drugs.
If you forget to take TOPREC 25 mg, tablet
Do not take a double dose to make up for the one you forgot to take.
If you stop taking TOPREC 25 mg, tablet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
Drugs such as TOPREC 25 mg, tablet may increase the risk of heart attack ("myocardial infarction") or stroke.
In general, the frequency of adverse reactions is classified as follows:
- Very frequent (more than 1 in 10 people).
- Common (more than 1 in 100 and less than 1 in 10 people).
- Uncommon (more than 1 in 1000 and less than 1 in 100 people).
- Rare (more than 1 in 10,000 and less than 1 in 1,000).
- Very rare (less than 1 in 10,000 people).
- Frequency undetermined (cannot be estimated on the basis of available data).
Stop treatment immediately and tell your doctor if any of the following occur:
- Allergic skin reactions:
o uncommon: rash of pimples or patches, itching,
o undetermined frequency: urticaria, worsening of chronic urticaria, a particular allergic skin reaction called erythema pigmentosum fixe which usually reappears in the same place(s) on re-exposure to the drug and may resemble redness in the form of round or oval patches and swelling of the skin, blistering (urticaria) and itching.
- Allergic respiratory reactions:
o rare: asthma attack,
o undetermined frequency: rhinitis, difficulty breathing, particularly in patients allergic to aspirin or non-steroidal anti-inflammatory drugs.
- General allergic reactions:
o undetermined frequency: sudden swelling of the face and neck which may lead to difficulty in breathing (angioedema), and may even lead to sudden malaise with a drop in blood pressure (allergic shock).
- Undetermined frequency: digestive bleeding, digestive perforation (see section 2 "Warnings and precautions"). The higher the dose and the longer the duration of treatment, the more frequent the occurrence.
- Undetermined frequency: exaggerated skin reaction after exposure to sunlight or UV light (tanning booths).
- Undetermined frequency: a bullous rash with skin detachment that can rapidly spread to the whole body and endanger the patient (Stevens Johnson syndrome and Lyell syndrome).
Tell your doctor if any of the following reactions occur:
- Common side effects:
o nausea, vomiting, difficulty digesting, abdominal pain, stomach upset.
- Uncommon side effects:
o diarrhea, constipation, flatulence, inflammation of the stomach (gastritis),
o headache, dizziness, drowsiness,
o swelling(edema),
o fatigue.
- Rare side effects:
o inflammation in the mouth (stomatitis), gastrointestinal ulcer, inflammation of the intestine (colitis),
o tingling sensation,
o ringing in the ears,
o visual disturbances (blurred vision),
o weight gain,
o decrease in red blood cells (anemia) due to bleeding,
o increased liver enzymes, liver disease (hepatitis), increased bilirubin.
- Undesirable effects of undetermined frequency:
o aggravation of inflammation of the intestine, Crohn's disease, inflammation of the pancreas (pancreatitis),
o non-infectious inflammation of the meninges (aseptic meningitis), convulsions, dizziness, mood disorders, confusion, taste disorders,
o hypertension, heart failure, increase in blood vessel diameter (vasodilatation), inflammation of blood vessel walls (vasculitis),
o hair loss, pustules all over the body,
o decrease in the number of white blood cells (leukopenia), significant decrease in certain white blood cells that can cause serious infections (agranulocytosis), decrease in platelets, bone marrow failure, decrease in the number of red blood cells (hemolytic anemia),
o increased potassium levels in the blood (hyperkalemia), kidney disease, kidney failure.
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE TOPREC 25 mg, tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
No special storage precautions.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What TOPREC 25 mg tablet contains
- The active substance is :
Ketoprofen..................................................................................................................... 25 mg
For one tablet.
- The other components are :
Lactose, wheat starch, hydrated silica, gelatin, magnesium stearate.
What is TOPREC 25 mg, tablet and what does it contain?
This medicine comes in tablet form. Box of 20 or 100 tablets.
Not all presentations may be marketed.
Marketing authorization holder
82 AVENUE RASPAIL
94250 GENTILLY
Marketing authorization holder
82 AVENUE RASPAIL
94250 GENTILLY
Opella Healthcare International SAS
56, route de Choisy,
60200, Compiègne
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed later by the holder].
Detailed information on this drug is available on the ANSM (France) website.
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