DEXKETOPROFEN TEVAGEN 25 mg ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Dexketoprofen Tevagen 25 mg Oral Solution

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 4 days.

Contents of the Package Leaflet

1. What is Dexketoprofen Tevagen and what is it used for
2. What you need to know before taking Dexketoprofen Tevagen
3. How to take Dexketoprofen Tevagen
4. Possible side effects
5. Storage of Dexketoprofeno Tevagen
6. Contents of the pack and further information

1. What is Dexketoprofen Tevagen and what is it used for

This medicine is a pain reliever belonging to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

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

Dexketoprofen is indicated in adult patients.

2. What you need to know before taking Dexketoprofen Tevagen

Do not take Dexketoprofen Tevagen

• If you are allergic (hypersensitive) to dexketoprofen trometamol or to any of the other components of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or to another non-steroidal anti-inflammatory medicine;
• If you have asthma or have suffered from asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or difficulty breathing) or wheezing in the chest after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs;
• If you have suffered from photoallergic or phototoxic reactions (a special type of redness or sunburn) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• If you have a peptic ulcer, stomach or intestinal bleeding, or if you have had a history of bleeding, ulceration, or perforation of the stomach or intestine;
• If you have chronic digestive problems (e.g., indigestion, heartburn);
• If you have had a history of stomach or intestinal bleeding or perforation due to the previous use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain;

• If you have chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If you have severe heart failure, moderate to severe renal impairment, or severe hepatic impairment;
• If you have bleeding disorders or blood coagulation disorders;
• If you are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;
• If you are in the third trimester of pregnancy or breastfeeding;

Warnings and Precautions

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

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), or fluid retention or have had any of these diseases in the past;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (e.g., due to excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of suffering from these disorders (e.g., you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) you should consult your doctor or pharmacist about this treatment. Medicines like Dexketoprofen Tevagen may be associated with a small increased risk of suffering from heart attacks ("myocardial infarctions") or strokes. Any risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• If you are an elderly patient, you may suffer from a higher incidence of side effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (see section 2, "Pregnancy, Breastfeeding, and Fertility");
• If you have a blood disorder and blood cell production disorder;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you have suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) in the past;
• If you have suffered from stomach or intestinal disorders in the past;
• If you have an infection; see the heading "Infections" below;
• If you are taking other medicines that increase the risk of peptic ulcers or bleeding, such as oral corticosteroids, some antidepressants (of the SSRI type, Selective Serotonin Reuptake Inhibitors), agents that prevent blood clot formation such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking this medicine: it may be that your doctor prescribes an additional medicine to protect your stomach (e.g., misoprostol or other medicines that block the production of gastric acid).
• If you have asthma, combined with chronic rhinitis or sinusitis, and/or nasal polyps, as you have a higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the rest of the population. The administration of this medicine may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

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 hide the signs of an infection, such as fever and pain. Consequently, this medicine may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial 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 Dexketoprofen Tevagen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. There are some medicines that should not be taken together, and others may need a dose change 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 combinations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clot formation;
• Lithium, used to treat some mood disorders;
• Methotrexate, used for rheumatoid arthritis and cancer, at high doses of 15 mg/week;
• Hydantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections;

Combinations that require caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart disorders;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used for bacterial infections;
• Chlorpropamide and glibenclamide, used for diabetes;
• Methotrexate, used at low doses, less than 15 mg/week.

Combinations to be taken into account:

• Quinolones (e.g., ciprofloxacin, levofloxacin) used for bacterial infections;
• Cyclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medicines; i.e., medicines used to dissolve blood clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for pregnancy termination);
• Antidepressants of the SSRI type (Selective Serotonin Reuptake Inhibitors);
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation.
• Betablockers, used for high blood pressure and heart disorders.
• Tenofovir, deferasirox, pemetrexed.

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

Taking Dexketoprofen 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, "Method of Administration").

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, 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 and your baby's tendency to bleed and delay or prolong delivery more than expected. You should 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 the 20th week of pregnancy, dexketoprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Women who are planning a pregnancy or are pregnant should avoid using this medicine. Treatment at any time during pregnancy should only be done under the guidance of a doctor.

The use of this medicine is not recommended while trying to conceive or while investigating a fertility problem.

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

Driving and Using Machines

This medicine may slightly affect your ability to drive and use machines, as it may cause dizziness or drowsiness and vertigo as side effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Ask your doctor for advice.

Dexketoprofen Tevagen contains Saccharose, Methyl Parahydroxybenzoate (E-218), Ethanol, and Sodium

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

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

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

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

3. How to Take Dexketoprofen Tevagen

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

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

The lowest effective dose should be used for the shortest time necessary to alleviate the symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

If the pain persists for more than 4 days, you should stop treatment and consult your doctor.

Adults over 18 years

Generally, it is recommended to take 1 sachet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 sachets 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 sachets per day (50 mg). In elderly patients, this initial dose may be increased later according to the general recommended dose (75 mg of dexketoprofen) if the medicine has been well tolerated.

Use in Children and Adolescents

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

Instructions for Proper Use

The oral solution can be taken directly from the sachet or after pouring the contents of the sachet into a glass of water. Once the sachet is opened, consume its entire contents.

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

If you Take More Dexketoprofen Tevagen than you Should

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

If you Forget to Take Dexketoprofen Tevagen

Do not take a double dose to make up for forgotten doses. Take the next dose when it is due (according to section 3 "How to Take Dexketoprofen Tevagen").

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Possible adverse effects are detailed below according to their frequency.

Because the plasma concentration levels of dexketoprofen achieved with the oral solution pharmaceutical form are higher than those obtained with tablets, a potential increase in the risk of adverse reactions (gastrointestinal) cannot be ruled out.

Frequent Adverse Effects(may affect up to 1 in 10 people)

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

Uncommon Adverse Effects(may affect up to 1 in 100 people)

Dizzy sensation (vertigo), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, febrile sensation, and chills, general malaise.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

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

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

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), ulcers on the skin, mouth, eyes, and genital areas (Stevens-Johnson syndrome and Lyell syndrome), swelling of the face or swelling of the lips and throat (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, liver cell damage (hepatitis), blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Decrease in the number of white blood cells (neutropenia), decrease in the number of platelets (thrombocytopenia).

Inform your doctor immediately if you notice any adverse effect of a gastrointestinal type at the start of treatment (e.g., stomach pain or burning or bleeding), if you have previously suffered from any of these adverse effects due to prolonged treatment with anti-inflammatory drugs, and especially if you are of advanced age.

Stop taking this medicine immediately if you notice the appearance of a skin rash or any lesion 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 increased risk of suffering a heart attack ("myocardial infarction") or stroke ("cerebrovascular accident").

In patients with immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs can rarely cause fever, headache, and neck stiffness.

The most commonly observed adverse effects are of a gastrointestinal type. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, 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, inflammation of the stomach wall (gastritis) has been observed.

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

Reporting of Adverse Effects

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

5. Conservation of Dexketoprofeno Tevagen

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

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

Store below 30°C.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 flavor (contains ethanol), povidone, anhydrous sodium hydrogen phosphate, dihydrate sodium dihydrogen phosphate, and purified water.

Appearance of Dexketoprofeno Tevagen and Package Contents

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

It is presented in packages that contain 10 or 15 single-dose envelopes.

Marketing Authorization Holder:

Teva Pharma, S.L.U.

Anabel Segura, 11 Edificio Albatros B, 1st floor

Alcobendas, 28108 Madrid

Spain

Manufacturer

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 Poligono Industrial Esplugues De Llobregat

08950 Esplugues De Llobregat (Barcelona)

Spain

Date of the Last Revision of this Prospectus:November 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.