DEXIBUPROFEN STRIDES 400 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET

Package Leaflet: Information for the User

Dexibuprofen Strides400mg film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Dexibuprofen Strides and what is it used for

The name of this medicine is Dexibuprofen Strides 400 mg film-coated tablets EFG. The tablets of this medicine contain the active substance "dexibuprofen", which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs, such as dexibuprofen, are used as painkillers and to control inflammation. They work by reducing the amount of prostaglandins (substances that control inflammation and pain) produced by the body.

This medicine is used to relieve:

• pain and inflammation caused by osteoarthritis (when the joints wear out);
• menstrual pain;
• mild to moderate pain, such as muscle and joint pain or toothache.

2. What you need to know before you take Dexibuprofen Strides

Do not takeDexibuprofen Stridesif:

• you are allergic to dexibuprofen or any of the other ingredients of this medicine (listed in section 6);
• you are allergic to acetylsalicylic acid or other painkillers (your allergy could cause you difficulty breathing, asthma, runny nose, skin rash, or swelling of the face);
• you have had bleeding or perforation of the gastrointestinal tract caused by an NSAID;
• you have or have had recurrent stomach or duodenal ulcers (vomiting blood, black stools, or bloody diarrhea could be a sign that the stomach or intestine is bleeding);
• you have cerebral bleeding (cerebrovascular hemorrhage) or other active bleeding;
• you have worsening of an inflammatory disease of the intestines (ulcerative colitis, Crohn's disease);
• you have severe heart failure or severe kidney or liver disease;
• you are in the third trimester of pregnancy (see also section 2, "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

With ibuprofen, signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain, have been reported. Stop using Dexibuprofen Strides immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Consult your doctor or pharmacist before starting to take this medicine

The presence of other medical problems may affect the use of dexibuprofen. Before taking this medicine, make sure your doctor knows if:

• you have ever had a stomach or duodenal ulcer;
• you have had intestinal ulcers, ulcerative colitis, or Crohn's disease;
• you have kidney or liver disease or are an alcoholic;
• you have bleeding disorders (see also the section "Other medicines and Dexibuprofen Strides");
• you have edema (fluid retention in body tissues);
• you have heart disease or high blood pressure;
• you have asthma or any other respiratory disorder;
• you have systemic lupus erythematosus (a disease that affects joints, muscles, and skin) or mixed connective tissue disease (a disease of collagen that affects connective tissue) or
• you have problems getting pregnant (see section 2 "Pregnancy, breastfeeding, and fertility").

Skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP), have been reported in association with dexibuprofen treatment. Discontinue treatment with Dexibuprofen Strides and seek immediate medical attention if you experience symptoms related to skin rashes, mucosal lesions, blisters, and other signs of allergy, as they may be the first signs of a severe skin reaction. See section 4.

If you need higher doses, especially if you are over 60 years old or have had stomach or duodenal ulcers, there is a greater risk of gastrointestinal side effects. Your doctor may consider prescribing protectors along with this medicine.

Anti-inflammatory/analgesic medicines like dexibuprofen may slightly increase the risk of myocardial infarction or stroke, especially if used in high doses. Do not exceed the recommended dose or treatment duration.

Before taking this medicine, you should consult your doctor or pharmacist if:

• you have heart problems such as heart failure, angina pectoris (chest pain), or if you have had a myocardial infarction, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

It is possible that your doctor may need to perform periodic checks if:

• you have heart, liver, or kidney problems;
• you are over 60 years old;
• you need to take this medicine for prolonged treatment.

Your doctor will indicate how often you should have these checks.

You may experience headaches if you take high doses of painkillers (off-label use) for a long time. In this case, do not take more Dexibuprofen Strides for the headache.

Avoid taking NSAIDs if you have a varicella-zoster virus infection (chickenpox).

In some patients, the onset of action may be delayed if dexibuprofen is taken for rapid relief of pain in acute pain conditions, especially if taken with food (see section 3).

Other medicines andDexibuprofen Strides

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Dexibuprofen may affect other medicines or be affected by them. For example:

• Anticoagulant medicines (e.g., those that thin the blood/prevent clotting; e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine) may prolong bleeding time or may cause bleeding if taken with dexibuprofen.
• Medicines that lower high blood pressure (e.g., ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan) may reduce the benefits of these medicines.

Other medicines may also affect or be affected by treatment with dexibuprofen. Therefore, you should always consult your doctor or pharmacist before using this medicine with other medicines. In particular, you should inform your doctor or pharmacist if, in addition to those mentioned, you are taking any of the following medicines:

• Non-steroidal anti-inflammatory drugs (medicines for pain relief, fever, and inflammation). Taking dexibuprofen with other NSAIDs or acetylsalicylic acid (aspirin) increases the risk of stomach ulcers or bleeding in the digestive system.
• Lithium used to treat certain mood disorders. Dexibuprofen Strides may increase the effect of lithium.
• Methotrexate. Dexibuprofen Strides may increase the adverse effects of methotrexate.

• Certain medicines called ACE inhibitors or angiotensin II receptor antagonists. These may increase the risk of kidney problems in rare cases.
• Diuretics (medicines used to increase urine production).
• Corticosteroids. May increase the risk of ulcers and bleeding.
• Certain antidepressants (selective serotonin reuptake inhibitors) may increase the risk of gastrointestinal bleeding.
• Digoxin (heart medicine). Dexibuprofen may increase the adverse effects of digoxin.
• Immunosuppressants such as cyclosporin.
• Aminoglycoside antibiotics (medicines to treat infections).
• Medicines that increase potassium levels in the blood. ACE inhibitors, angiotensin II receptor antagonists, cyclosporin, tacrolimus, trimethoprim, and heparins.
• Phenytoin used to treat epilepsy. Dexibuprofen may increase the adverse effects of phenytoin.
• Phenytoin, phenobarbital, and rifampicin. Concomitant administration may reduce the effects of dexibuprofen.
• Sulfonylurea (oral antidiabetic medicine)
• Pemetrexed (medicine to treat some types of cancer).
• Zidovudine (medicine to treat AIDS/HIV).

TakingDexibuprofen Strideswith food, drinks, and alcohol

You can take this medicine without food, but it is better to take it with a meal to reduce the possibility of stomach problems, especially in prolonged treatments.

You should limit or avoid alcohol consumption while taking this medicine, as it may increase gastrointestinal side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take dexibuprofen if you are in the last 3 months of pregnancy, as it may cause kidney and heart problems in the fetus. It may affect your tendency and that of your baby to bleed and delay or prolong labor more than expected. Avoid taking dexibuprofen during the first 6 months of pregnancy unless your doctor advises you to do so. In these cases, the dose and duration will be limited to the minimum possible. From the 20th week of pregnancy, dexibuprofen may cause kidney problems in the 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.

Breastfeeding

Only small amounts of dexibuprofen are excreted in breast milk. However, if you are breastfeeding, you should not take this medicine for long periods or in high doses.

Fertility

Dexibuprofen may make it difficult to conceive. You should inform your doctor if you plan to become pregnant or have problems getting pregnant.

Driving and using machines

If you experience side effects such as dizziness, drowsiness, fatigue, or blurred vision after taking this medicine, you should not drive or use hazardous machines (see section 4 "Possible side effects").

Dexibuprofen Stridescontains sodium

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

3. How to take Dexibuprofen Strides

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Method of administration

Dexibuprofen Strides is administered orally. Take this medicine with a glass of water or other liquid. Dexibuprofen Strides acts faster if taken without food. However, it is recommended to take it with food to reduce the possibility of stomach problems, especially in prolonged treatments.

Do not take more than 400 mgin a single dose.

Do not take more than 1,200 mgper day.

Osteoarthritis

The recommended dose is 600 to 900 mg of dexibuprofen, divided into up to 3 doses. For example, 400 mg twice a day. In case of acute processes or exacerbations, the doctor may increase the dose up to 1,200 mg per day.

Menstrual pain

The recommended dose is 600 to 900 mg of dexibuprofen, divided into up to 3 doses. For example, 400 mg twice a day.

Mild to moderate pain

The recommended dose is 600 mg of dexibuprofen, divided into up to 3 doses.

In case of acute pain, the doctor may increase the dose up to 1,200 mg per day.

The score line is only for breaking the tablet if you find it difficult to swallow it whole. Breaking the tablet will not provide an "exact" half dose.

To break the tablet, place it on a hard surface and press down with your two index fingers or thumbs.

Your doctor may also prescribe other available presentations of this medicine (200 mg or 300 mg) so that you have a more suitable dose.

Patient with liver or kidney disease: Your doctor may have prescribed a lower dose of dexibuprofen than usual. Do not increase the dose prescribed by your doctor.

Elderly patients

If you are over 60 years old, your doctor may have prescribed a lower dose than usual. If taking "dexibuprofen" does not cause you problems, your doctor may increase the dose.

Children and adolescents

As there is not enough experience in children and adolescents, this medicine should not be used in ages under 18 years.

If you take moreDexibuprofen Stridesthan you should

If you have taken more tablets than you should or if a child has taken this medicine by accident, always go immediately to your doctor or the nearest hospital for advice on the risk and the necessary measures.

The symptoms of an overdose may include nausea, stomach pain, vomiting (which may be blood-stained), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, confusion, and trembling eye movements. Agitation, drowsiness, disorientation, or coma may also occur. Sometimes, patients develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the action of circulating clotting factors. Acute kidney failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics. Additionally, there may be low blood pressure and decreased breathing.

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

If you forget to takeDexibuprofen Strides

Do not take a double dose to make up for forgotten doses. Take the next tablet at the usual time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

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

• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Stop takingthis medicationand go immediately to a doctor if you experience one of the following symptoms:

• Severe stomach pain, especially when starting to take dexibuprofen (uncommon: may affect up to 1 in 100 people);
• Black stools, bloody diarrhea, or vomiting blood (uncommon: may affect up to 1 in 100 people);
• Skin rash, intense blistering, or severe skin peeling, mucosal lesions (very rare: may affect up to 1 in 10,000 people) or any sign of hypersensitivity. (uncommon: may affect up to 1 in 100 people);
• Fever, sore throat and mouth, pseudo-flu-like symptoms, feeling of fatigue, nosebleeds, and skin bleeding. These symptoms may be due to a reduction in the body's white blood cells (agranulocytosis) (very rare: may affect up to 1 in 10,000 people);
• Severe or persistent headache (very rare: may affect up to 1 in 10,000 people).
• Yellowing of the skin and whites of the eyes (jaundice) (rare: may affect up to 1 in 1,000 people);
• Facial, lingual, or pharyngeal swelling, difficulty swallowing or breathing (angioedema) (uncommon: may affect up to 1 in 100 people);
• Blisters on hands and feet (Stevens-Johnson syndrome) (very rare: may affect up to 1 in 10,000 people);
• Skin peeling (toxic epidermal necrolysis) (very rare: may affect up to 1 in 10,000 people);
• Reddish, non-raised, target-shaped, or circular spots on the torso, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Red, scaly, and generalized rash with bumps under the skin and blisters, mainly in skin folds, torso, and upper limbs, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). See also section 2. (frequency not known: cannot be estimated from available data);
• A severe skin reaction known as "DRESS syndrome" may occur. DRESS symptoms include: generalized skin, elevated body temperature, enlarged lymph nodes, and increased eosinophils (a type of white blood cell) (frequency not known: cannot be estimated from available data).

Other Possible Adverse Effects

Very Common: may affect up to 1 in 10 people

• Indigestion, stomach pain.

Common: may affect up to 1 in 10 people

• Diarrhea, vomiting, or discomfort;
• feeling of fatigue or drowsiness, dizziness, headache;
• skin rash.

Uncommon: may affect up to 1 in 100 people

• Gastrointestinal ulcers and bleeding, black stools, mouth ulcers, gastritis;
• purpura (bruises), itching, pruritic rash;
• facial or throat swelling (angioedema);
• sleep disturbances, restlessness, anxiety, blurred vision, ringing or buzzing in the ears (tinnitus);
• nasal discharge, difficulty breathing.

Rare: may affect up to 1 in 1,000 people

• Severe allergic reaction;
• psychotic reactions, depression, irritability;
• feeling of confusion, disorientation, or agitation;
• hearing problems;
• flatulence, constipation, perforations in the digestive system (symptoms are severe stomach pain, fever, feeling of discomfort), esophagitis, worsening of diverticular disease (small pouches in the intestines that can become infected or inflamed), colitis, or Crohn's disease;
• liver problems, hepatitis (inflammation of the liver), and jaundice (yellowing of the skin and eyes);
• blood disorders, including those that reduce the number of white or red blood cells or platelets.

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

• Hypersensitivity reactions, including symptoms such as fever, rash, abdominal pain, headache, feeling of dizziness, and vomiting;
• photosensitivity;
• aseptic meningitis (symptoms are headache, fever, neck stiffness, and general feeling of discomfort), severe allergic reactions (difficulty breathing, asthma, rapid heartbeat, low blood pressure, and shock), allergic reaction with inflammation of the blood vessels;
• redness of the skin, mucous membranes, or throat;
• hair loss;
• kidney inflammation, disorder, or failure;
• systemic lupus erythematosus (autoimmune disease);
• certain very rare bacterial infections that attack the tissue covering the muscle, can worsen.

During treatment with NSAIDs, edema (swelling of the limbs), high blood pressure, and heart failure may occur.

Medicines like Dexibuprofen Strides may slightly increase the risk of suffering from heart attacks or strokes.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. 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. Storage of Dexibuprofen Strides

Keep this medicine out of sight and reach of children.

Store below 25°C.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines 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 you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofDexibuprofen Strides

• The active ingredient is dexibuprofen.
• The other components are: anhydrous colloidal silica, microcrystalline cellulose, hypromellose (type 2910), sodium croscarmellose, talc, water, polyvinyl alcohol, titanium dioxide (E171), macrogol.

Appearance ofDexibuprofen Stridesand Package Contents

Dexibuprofen Strides 400 mg film-coated tablets EFG

Film-coated tablet, white, capsule-shaped, biconvex, and with a dividing line on both sides. The size of the 400 mg tablet is 17.5 mm (length) x 6.5 mm (width).

Packages are available in PVC/PVDC/aluminum blisters.

Package sizes: 4, 10, 20, 30, 50, 60, 90, 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Strides Pharma (Cyprus) Limited

Themistokli Dervi 3

Julia House

Nicosia 1066

Cyprus

Manufacturer:

Fairmed Healthcare GmbH

Maria-Goeppert-Strasse 3

23562 Lübeck

Germany

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

Austria Dexibuprofen Fairmed Healthcare 400 mg Filmtabletten

Czech Republic Dexibuprofen Strides

Spain Dexibuprofeno Strides 400 mg film-coated tablets EFG

Hungary Dexibuprofen Strides 400 mg filmtabletta

Slovakia Dexibuprofen Strides 400 mg filmom obalené tablety

Sweden Dexibuprofen Strides 400 mg film-coated tablets

Poland Dexibuprofen Strides

Date of Last Revision of this Leaflet:September 2024

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