Package Insert: Information for the User

Dexketoprofen Tevagen 25 mg Oral Solution

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those provided by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 4 days.

This medication is a pain reliever belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).

It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle pain or joint pain, menstrual pain (dysmenorrhea), or tooth pain.

Dexketoprofeno is indicated for adult patients.

Do not take Dexketoprofeno Tevagen

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dexketoprofeno Tevagen:

Children and adolescents

This medicine has not been studied in children or adolescents. Therefore, safety and efficacy have not been established, and the medicine should not be used in children or adolescents.

Infections

This medicine may mask the signs of an infection, such as fever and pain. Consequently, it may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Avoid using this medicine if you have chickenpox.

Other medicines and Dexketoprofeno Tevagen

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medicine, even those purchased without a prescription. There are some medicines that should not be taken together, and other medicines that may require a change in dose if taken together.

Always inform your doctor, dentist, or pharmacist if, in addition to this medicine, you are taking any of the following medicines:

Not recommended associations:

Associations requiring caution:

Associations to be taken into account:

• Quinolones (e.g., ciprofloxacin, levofloxacin) used to treat bacterial infections;
• Ciclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic agents; that is, medicines used to break down blood clots;
• Probenecid, used to treat gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• SSRI-type antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation.
• Beta-blockers, used to treat high blood pressure and heart conditions.
• Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking other medicines with Dexketoprofeno Tevagen, consult your doctor or pharmacist.

Taking Dexketoprofeno Tevagen with food, drinks, and alcohol

Generally, it is recommended to take the medicine with meals to reduce the possibility of causing stomach upset (see also section 3, "Administration form").

The use of NSAIDs in combination with alcohol may worsen the adverse reactions caused by the active ingredient.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Do not take dexketoprofen if you are in the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected. Do not take dexketoprofen during the first six months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, dexketoprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Women planning to become pregnant or are pregnant should avoid using this medicine. Treatment at any time during pregnancy should only take place under the guidance of a doctor.

This medicine is not recommended for use while trying to conceive or while studying fertility problems.

Regarding potential effects on female fertility, see also section 2, "Warnings and precautions".

Driving and operating machinery

This medicine may affect your ability to drive and operate machinery, as it may cause dizziness, somnolence, and vertigo as adverse effects of treatment. If you notice these effects, do not use machinery or drive until these symptoms disappear. Consult your doctor.

Dexketoprofeno Tevagen contains saccharose, parahydroxybenzoate of methyl (E-218), ethanol, and sodium

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate of methyl.

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medicine. It may cause tooth decay.

This medicine contains 0.1% ethanol (alcohol), which corresponds to 13.8 mg per tablet.

This medicine contains less than 1mmol of sodium (23 mg) per tablet; that is, it is essentially "sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The dose you need of this medication may vary depending on the type, intensity, and duration of pain.

Use the most effective dose for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor as soon as possible if symptoms (such as fever and pain) persist or worsen (see section 2).

If pain persists for more than 4 days, discontinue treatment and consult your doctor.

Adults aged 18 years and older

Generally, 1 tablet (25 mg of dexketoprofeno) every 8 hours, without exceeding 3 tablets per day (75 mg).

If you are an elderly person or suffer from kidney or liver disease, it is recommended to start treatment with a maximum of 2 tablets per day (50 mg). In elderly patients, this initial dose may be increased subsequently in accordance with the recommended general dose (75 mg of dexketoprofeno) if this medication has been well tolerated.

Use in children and adolescents

This medication should not be used in children and adolescents (under 18 years).

Instructions for proper use

The oral solution can be taken directly from the package or after removing the contents from a glass of water. Once the package is opened, consume all its contents.

Take the medication with food, as this helps to reduce the risk of experiencing adverse effects in the stomach or intestine. However, if your pain is intense and you need quick relief, take the tablets with an empty stomach (at least 15 minutes before eating) as they will be absorbed more easily.

If you take more Dexketoprofeno Tevagen than you should

If you have taken too much medication, immediately inform your doctor or pharmacist or go to the emergency service of your nearest hospital or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount taken. Please remember to always carry the medication package or this leaflet with you.

If you forgot to take Dexketoprofeno Tevagen

Do not take a double dose to compensate for the missed doses. Take the next dose when due (in accordance with section 3 “How to Take Dexketoprofeno Tevagen”).

If you have any doubts about the use of this medication, consult your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The possible side effects are listed below in order of frequency.

Due to the plasma concentration levels of dexketoprofen achieved with the oral solution formulation being higher than those obtained with tablets, a potential increase in the risk of adverse reactions (gastrointestinal) cannot be ruled out.

Frequent side effects(may affect up to 1 in 10 people)

Nausea and/or vomiting, stomach pain, diarrhea, digestive disorders (dyspepsia).

Uncommon side effects(may affect up to 1 in 100 people)

Dizziness, vertigo, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flushes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation and chills, general discomfort.

Rare side effects (may affect up to 1 in 1,000 people)

Peptic ulcer, perforation of a peptic ulcer or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swelling of ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, lower back pain, frequent urination, menstrual irregularities, prostate disorders, abnormal liver function tests (blood analysis), liver cell damage (hepatitis), acute renal insufficiency.

Very rare (may affect up to 1 in 10,000 people)

Anaphylactic reaction (hypersensitivity reaction that may also lead to collapse), skin ulcers, mouth, eye, and genital area (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), lack of air, tachycardia, low blood pressure, pancreatitis inflammation, liver cell damage (hepatitis), blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Inform your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g., stomach pain or burning, bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory drugs, and especially if you are elderly.

Stop taking this medicine immediately if you notice the appearance of a skin rash or any lesions inside the mouth or on the genitals, or any other sign of allergy.

During treatment with non-steroidal anti-inflammatory drugs, cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines like Dexketoprofeno Tevagen may be associated with a small increase in the risk of suffering a heart attack (“myocardial infarction”) or stroke (“cerebrovascular accident”).

In patients with autoimmune disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs may rarely cause fever, headache, and neck stiffness.

The most commonly observed side effects are of a gastrointestinal nature. They may cause peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients.

After administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, worsening of colitis and Crohn's disease have been reported. Less frequently, gastric wall inflammation (gastritis) has been observed.

Like other NSAIDs, meningitis may occur, which may predominantly occur in patients with systemic lupus erythematosus or mixed connective tissue disease, and hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the overwrap after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Dexketoprofeno Tevagen

• The active ingredient is dexketoprofen trometamol (36.90 mg) equivalent to 25 mg of dexketoprofen.
• The other components (excipients) are: ammonium glycyrrhizate, neohesperidin dihydrochalcone, methyl parahydroxybenzoate (E-218), sodium saccharin, sucrose, macrogol, lemon aroma (contains ethanol), povidone, anhydrous sodium hydrogen phosphate, dihydrogen sodium phosphate dihydrate, and purified water. .

Appearance of Dexketoprofeno Tevagen and content of the container

Transparent yellow-orange solution with a lemon-citrus odor, packaged in single-dose sachets of 10 ml.

It is presented in containers containing 10 or 15 single-dose sachets.

Holder of the marketing authorization:

Teva Pharma, S.L.U.

Anabel Segura, 11 Edificio Albatros B, 1st floor

Alcobendas, 28108 Madrid

Spain

Responsible for manufacturing

SAG MANUFACTURING S.L.U.

Crta N-I, Km 36, San Agustin de Guadalix,

28750 Madrid

Spain

GALENICUM HEALTH S.L.

Calle De San Gabriel 50 Industrial Estate Esplugues De Llobregat

08950 Esplugues De Llobregat (Barcelona)

Spain

Last review date of this leaflet: November 2023

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es .