DEXKETOPROFEN SANDOZ 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Dexketoprofen Sandoz 25 mg film-coated tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

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

Dexketoprofen Sandoz is a pain reliever belonging to the group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs).

It is used to treat mild to moderate pain, such as muscle pain, menstrual pain (dysmenorrhea), and toothache.

2. What you need to know before taking Dexketoprofen Sandoz

Do not take Dexketoprofeno Sandoz if:

• you are allergic to dexketoprofen or any of the other ingredients of this medication (listed in section 6),
• you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory medications,
• 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 in 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 or other non-steroidal anti-inflammatory medications,
• you have suffered from photoallergic or phototoxic reactions (a special form of redness or blisters on the skin due to sun exposure) during treatment with ketoprofen (a non-steroidal anti-inflammatory medication) or fibrates (medications used to reduce blood fat levels),
• you have or have had in the past peptic ulcer, stomach or intestinal bleeding, ulceration, or perforation,
• you have chronic digestive problems (e.g., indigestion, heartburn),
• you have suffered from stomach or intestinal bleeding or perforation in the past due to previous use of non-steroidal anti-inflammatory medications (NSAIDs) used for pain,
• you have a chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis),
• you have severe heart failure, moderate or severe kidney problems, or severe liver problems,
• you have bleeding disorders or blood coagulation disorders,
• you are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or insufficient fluid intake,
• you are in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take dexketoprofen if:

• you have a history of allergy or have had allergy problems in the past,
• you have kidney, liver, or heart problems (hypertension and/or heart failure), as well as fluid retention or have had any of these problems in the past,
• 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),
• you have heart problems, a history of stroke, or think you may be at risk of suffering from these disorders (e.g., if 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; medications like dexketoprofen may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes. This risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or treatment duration,
• you are an elderly patient: you may experience a higher incidence of side effects (see section 4). If you experience any of these effects, consult your doctor immediately,
• you are a woman with fertility problems (dexketoprofen may reduce your fertility, so you should not take it if you are planning to become pregnant or if you are undergoing fertility studies),
• you have a blood disorder or blood cell production disorder,
• you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue),
• you have or have had in the past chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease),
• you have or have had in the past stomach or intestinal disorders,
• you have chickenpox, as non-steroidal anti-inflammatory medications (NSAIDs) can exceptionally worsen the infection,
• you are taking other medications that increase the risk of peptic ulcer 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 or anticoagulants like warfarin. In these cases, consult your doctor before taking dexketoprofen: your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other medications that block gastric acid production),
• you have asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps, so you have a higher risk of allergy to acetylsalicylic acid or NSAIDs than the rest of the population. Administration of this medication may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs,
• you have had major surgery.

Like other NSAIDs, dexketoprofen may mask the symptoms of infections and fever.

During prolonged use of dexketoprofen, your doctor will regularly check your liver enzymes, kidney function, and blood count.

Children and adolescents

Dexketoprofen has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and it should not be used in children or adolescents under 18 years of age.

Other medications and Dexketoprofen Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. There are some medications that should not be taken together, and other medications that may require a dose change if taken together.

Always inform your doctor, dentist, or pharmacist if, in addition to dexketoprofen, you are taking or are being administered any of the following medications:

Not recommended combinations:

• acetylsalicylic acid, corticosteroids, and other anti-inflammatory medications,
• warfarin, heparin, and other medications used to prevent blood clot formation,
• lithium, used to treat some mood disorders,
• methotrexate, used for rheumatoid arthritis and cancer,
• hydantoins and phenytoin, used for epilepsy,
• sulfamethoxazole, used for bacterial infections.

Combinations that require caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used for high blood pressure control 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.

Combinations to be taken into account:

• quinolone antibiotics (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 medications; i.e., medications 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.

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

Taking Dexketoprofen Sandoz with food and drinks

Take the film-coated tablets with a sufficient amount of water. Take the tablets with food, as this helps reduce the risk of experiencing side effects in the stomach or intestine. However, in case of acute pain, take the tablets on an empty stomach, i.e., at least 30 minutes before meals, as this allows the medication to act a little faster.

Pregnancy, breastfeeding, and fertility

Do not take dexketoprofen during the last 3 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.

Do not take this medication during the first 6 months of pregnancy unless it is clearly necessary and as directed 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, this medication may cause kidney problems in your fetus if taken for more than a few days, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication, as dexketoprofen may not be suitable for you. The use of dexketoprofen should be avoided by women who are planning to become pregnant or are pregnant. Treatment at any time during pregnancy should be directed by your doctor.

The use of dexketoprofen is not recommended if you are trying to conceive or during fertility studies.

Driving and using machines

This medication may slightly affect your ability to drive and use machines, as it may cause drowsiness or dizziness as side effects of treatment. If you notice these effects, do not use machines or drive until they disappear. Consult your doctor.

Dexketoprofen Sandoz contains sodium

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

3. How to take Dexketoprofen Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The suitable dose of dexketoprofen for your needs may vary, depending on the type, intensity, and duration of the pain. Your doctor will indicate how many tablets you should take per day and for how long.

Generally, the recommended dose is 1 tablet (25 mg) every 8 hours, not exceeding 3 tablets per day (75 mg).

If you are elderly or have 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 later according to the general recommended dose (75 mg) if the medication has been well tolerated.

The tablet can be divided into equal doses.

If your pain is intense and you need quick relief, take the tablet on an empty stomach (at least 30 minutes before meals) as it will be absorbed more easily (see section 2 "Taking Dexketoprofen Sandoz with food and drinks").

If you take more Dexketoprofen Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Dexketoprofen Sandoz

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Possible side effects are listed below according to their frequency.

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

Rare side 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 the ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.

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

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), open sores 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, blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, 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, or bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory medications, and especially if you are an elderly patient.

Stop taking Dexketoprofen Sandoz immediately if you notice the appearance of a skin rash or any lesion in the mouth or genitals, or any other sign of allergy.

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

Medications like Dexketoprofen Sandoz may be associated with a small increased risk of suffering from heart attacks ("myocardial infarction") or strokes.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dexketoprofen Sandoz

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

Do not use this medication after the expiration date stated on the packaging and on the blister after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect from light.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Dexketoprofeno Sandoz

The active ingredient is dexketoprofen trometamol.

Each tablet contains 36.90 mg of dexketoprofen trometamol equivalent to 25 mg of dexketoprofen.

The other components are corn starch, microcrystalline cellulose, sodium carboxymethyl cellulose (type A, potato), glycerol distearate, hypromellose (E-464), titanium dioxide (E-171), and macrogol 400.

Appearance of the Product and Packaging Contents

Scored, white, biconvex, and cylindrical tablets marked with "DT2" on one side.

The tablets are packaged in blisters (PVC-PVDC/aluminum).

Package sizes

10, 20, 30, 40, 50, 500 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Galenicum Health, S.L.U.

Sant Gabriel, 50,

Esplugues de Llobregat,

08950 Barcelona

Spain

or

SAG Manufacturing, S.L.U.

Ctra N-I, km 36

28750 San Agustín de Guadalix

Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: ?????????????? ?????? 25 mg ????????? ????????

Ireland: Dexketoprofen Rowex 25 mg Film-coated Tablets

Portugal: Dexcetoprofeno Sandoz

Romania: Dexketoprofen trometamol Sandoz 25 mg film-coated tablets

Date of the last revision of thisleaflet:October 2021

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