Package Insert: Information for the Patient

Lidet 500 mg gastro-resistant EFG tablets

Naproxeno

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

Keep this package insert, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What Lidet is and for what it is used

2. What you need to know before starting to take Lidet

3. How to take Lidet

4. Possible adverse effects

5. Storage of Lidet

6. Contents of the package and additional information

Lidetcontains naproxen as its active ingredient, a substance that belongs to a group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). These medications are used to reduce inflammation and pain in the joints and muscles.

This medication is indicated for the treatment of symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis (inflammation affecting the joints of the spine), acute musculoskeletal disorders (such as sprains and strains) and dysmenorrhea (menstrual pain), in patients over 16 years old.

Do not take Lidet

• If you are allergic to naproxen, naproxen sodium, or any of the other components of this medication (listed in section 6).
• If you are allergic to acetylsalicylic acid (aspirin), other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac, or any other pain-relieving medication that causes asthma, rhinitis, nasal polyps, or urticaria.
• If you have or have had nasal polyps, frequently sneeze or have nasal discharge, have a stuffy nose, or feel itchy (rhinitis).
• If you have asthma or allergies (such as hay fever) or have ever experienced swelling in the face, lips, eyes, or tongue.
• If you have or have had stomach or intestinal problems such as ulcers or bleeding.
• If you have previously experienced stomach bleeding or perforation while taking nonsteroidal anti-inflammatory drugs (NSAIDs).
• If you have severe liver, kidney, or heart disease.
• If you are in the third trimester of pregnancy.

Do not take this medication if you are in any of the above circumstances. If you are unsure, consult your doctor or pharmacist before taking Lidet.

Warnings and precautions

If you have heart problems, have had a stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, or high cholesterol, or if you smoke), consult your doctor or pharmacist about treatment.

Consult your doctor or pharmacist before starting this medication if any of the following apply:

• If you have asthma or allergic conditions (such as rhinitis or nasal polyps), or have ever experienced swelling of the face, lips, eyes, or tongue.

• If you feel weak (perhaps due to illness) or are an older person.

• If you have nasal polyps or frequently sneeze or have nasal discharge, or have a stuffy nose or feel itchy (rhinitis).

• If you have kidney or liver problems.

• If you have blood clotting problems.

• If you have blood vessel problems (arteries) anywhere in your body.

• If you have too much fat (lipids) in your blood (hyperlipidemia).

• If you have an autoimmune disease, such as systemic lupus erythematosus (SLE, which causes joint pain, skin rashes, and fever) and ulcerative colitis or Crohn's disease (conditions that cause intestinal inflammation, abdominal pain, diarrhea, vomiting, and weight loss).

Lidet and similar medications may be associated with a small increased risk of heart attack or stroke. At higher doses and with prolonged treatment, the risk is greater. Do not exceed the recommended dose or treatment duration.

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

If you are in any of the above circumstances, or if you are unsure if you have them, consult your doctor or pharmacist before taking this medication.

Children and adolescents

Lidet is not recommended for children under 16 years of age.

Other medications and Lidet

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes any medication purchased without a prescription or herbal remedies.

It is essential to inform your doctor if you are taking especially any of the following medications:

• Other pain medications such as aspirin, ibuprofen, diclofenac, and paracetamol.
• Blood-thinning medications such as aspirin/acetylsalicylic acid, warfarin, heparin, and clopidogrel.
• Hydantoins (epilepsy medications), such as phenytoin.
• Sulfonamide medications, such as hydrochlorothiazide, acetazolamide, indapamide, including sulfonamide antibiotics (for infections).
• Sulfonylureas (diabetes medications), such as glimepiride or glipizide.
• "ACE inhibitors" or any other blood pressure medication such as cilazapril, enalapril, or propranolol.
• Angiotensin II receptor antagonists, such as candesartan, eprosartan, or losartan.
• Diuretics (blood pressure medications) such as furosemide.
• "Cardiac glycosides" (heart medications) such as digoxin.
• Glucocorticoids (inflammation medications) such as hydrocortisone, prednisolone, and dexamethasone.
• "Quinolone antibiotics" (infection medications) such as ciprofloxacin or moxifloxacin.
• Certain medications for mental health issues such as lithium or "SSRIs" such as fluoxetine or citalopram.
• Probenecid (gout medication).
• Methotrexate (used to treat skin conditions, arthritis, or cancer).
• Ciclosporin or tacrolimus (for skin conditions or after an organ transplant).
• Zidovudine (used to treat HIV/AIDS and HIV infections).
• Mifepristone (used to terminate pregnancy or induce labor if the baby is deceased).

If you are in any of the above circumstances, or if you are unsure if you have them, consult your doctor or pharmacist before taking this medication.

Pregnancy, breastfeeding, and fertility

• Do not take naproxen if you are in 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 tendency and that of your baby to bleed and delay or prolong delivery more than expected.
• Do not take naproxen 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 time possible.
• From week 20 of pregnancy, Lidet 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) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.
• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
• Lidet may make it difficult to become pregnant. Inform your doctor if you plan to become pregnant or have difficulty becoming pregnant.

Driving and operating machinery

Lidet may make you feel tired, drowsy, dizzy, have vision problems, and balance issues, feel depressed, or have difficulty sleeping. If you experience any of these symptoms, inform your doctor and do not drive, operate machinery, or use tools.

Follow exactly the administration instructions for this medication as indicated by your doctor.This medication should be taken exactly as directed.Consult your doctor or pharmacist again if you are unsure.

During your treatment with Lidet, your doctor will want to see you to check that you are taking the correct dose for you and to detect any possible side effects.This is especially important if you are an elderly person.

The recommended dose is:

Adults

Rheumatoid arthritis and ankylosing spondylitis

• The usual dose is between 500 mg and 1,000 mg in two separate doses, every 12 hours.

When you need a daily dose of 1,000 mg, you can take one 500 mg tablet twice a day, or two 500 mg tablets in a single dose (morning or evening).

Some patients may take a higher dose of between 750 mg and 1,000 mg per day to control pain. This would be the case for patients with:

• Severe night pain or morning stiffness.
• Recently changed tablets to a higher dose for another pain treatment.
• Arthritis, where pain is the main symptom.

Musculoskeletal disorders (such as sprains and strains) or painful menstrual periods

The initial usual dose is 500 mg, followed by 250 mg every 6-8 hours as needed. Do not take more than 1,250 mg per day after the first day.

Elderly patients with liver and kidney problems

Your doctor will decide your dose, which will usually be lower than that of other adults.

Use in children and adolescents

Due to the inadequate concentration of the medication, Lidet is not recommended for use in children under 16 years of age.

Administration form:

This medication is taken orally.

Swallow the tablets whole with a glass of water, during or after meals. Do not break or chew the tablets.

Make sure you have enough to drink (stay well hydrated) when taking naproxen. This is particularly important for people with kidney problems. While taking Lidet, your doctor will want to see you to check that you are taking the correct dose for you and to detect any side effects. This is particularly important if you are an elderly person.

If you take more Lidet than you should

If you have taken more Lidet than you should, consult your doctor immediately or go to the hospital. Bring the medication packaging.

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 forgot to take Lidet

If you forget to take a dose, do not take the missed dose. Wait to take your next regular dose.

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Lidet

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

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

Medicines like Lidetmay be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Important side effects to identify:

Stop taking Lidetand inform your doctor immediately if any of the following side effects occur. You may need urgent medical treatment:

Severe stomach or intestinal problems,the symptoms include:

• Stomach bleeding, seen as vomiting with blood or coffee ground-like fragments.
• Rectal bleeding (anus), seen as black and sticky bowel movements (stools) or bloody diarrhea.
• Ulcers or holes in your stomach or intestine. The symptoms include stomach pain, abdominal pain, fever, nausea, or vomiting.
• Problems with your pancreas. The symptoms include severe stomach pain that radiates to your back.
• Worsening of ulcerative colitis or Crohn's disease, seen as pain, diarrhea, vomiting, and weight loss.

Allergic reactions,the symptoms include:

• Swelling of your throat, face, hands, or feet.
• Difficulty breathing, chest tightness.
• Rashes, blisters, or itching.

Severe skin rashes,the symptoms include:

• Severe rash that develops rapidly, with blisters or skin peeling and possibly blisters in the mouth, throat, and eyes. You may also experience fever, headache, cough, and general malaise.
• Appearance of blisters on the skin when exposed to light (porphyria cutanea tarda) seen mainly on arms, face, and hands.

Liver problems,the symptoms include:

• Yellowing of your skin or the whites of your eyes (jaundice).
• Feeling tired, loss of appetite, nausea, or vomiting, pale bowel movements (hepatitis) and alterations (including hepatitis) shown in blood tests.

Heart attack,the symptoms include:

• Chest pain that may radiate to your neck and shoulders and down to your left arm.

Stroke,the symptoms include:

• Numbness and muscle pain. This may occur on one side of your body.
• Sudden alteration of your sense of smell, taste, vision, or hearing, confusion.

Meningitis,the symptoms include:

• Fever, nausea, vomiting, stiff neck, headache, sensitivity to bright light, and confusion (more likely in people with autoimmune disorders such as‘systemic lupus erythematosus’)

If you observe any of these severe side effects mentioned above, stop taking Lidetand tell your doctor immediately.

Other possible side effects:

Stomach and intestines

• Heartburn, indigestion, stomach pain, nausea, and vomiting, constipation, diarrhea, gas.

Blood

• Blood problems, such as anemia or changes in the number of white blood cells.

Mental health

• Difficulty sleeping or changes in your sleep patterns.

• Depression.

• Confusion or seeing and hearing things that may not exist (hallucinations).

Nervous system

• Headache.

• Seizures or convulsions, feeling dizzy or dizziness, or sleepiness.

• Tingling or numbness of the hands and feet.

• Difficulty with memory or concentration.

Eyes and ears

• Changes in vision, eye pain.

• Changes in hearing, including ringing in the ears (tinnitus) and hearing loss.

• Dizziness that causes balance problems.

Heart and circulation

• Swelling of the hands, feet, or legs (edema). This may be accompanied by chest pain, fatigue, shortness of breath (heart failure).

• Palpitations, slow heart rate, or high blood pressure.

• Problems with blood pumping from the heart to the rest of the body. Symptoms may include fatigue, shortness of breath, feeling dizzy, general pain.

Chest

• Difficulty breathing, including difficulty breathing, wheezing, or coughing.

• Pneumonia or inflammation of the lungs.

Skin and hair

• Rashes on the skin that include redness, hives, acne, and blisters on the body and face.

• Bruises, itching, sweating, skin more sensitive to the sun, or hair loss.

Urinary

• Blood in the urine or kidney problems.

Other

• Thirst, fever, feeling tired, or general malaise.

• Pain in the mouth or ulcers in the mouth.

• Muscle pain or weakness.

• Problems in women getting pregnant.

• Systemic lupus erythematosus (SLE). Symptoms include fever, skin rash, kidney problems, and joint pain.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

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

Keepthis medicationout of the sight and reach of children.

Store below25 °C. Store in the original packaging to protect it from light.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Lidet

• The active ingredient is naproxen. Each tablet contains 500 mg of naproxen.
• The other components (excipients) are: povidone K 90, sodium croscarmellose, and magnesium stearate included in the tablet core, and dispersion (30%) of the copolymer of methacrylic acid-ethyl acrylate (1:1), triethyl citrate, talc, and simethicone emulsion included in the tablet coating.

Appearance of the product and contents of the packaging

Lidet 500 mg gastro-resistant tablets : are round, biconvex, film-coated tablets, white or almost white in color, and approximately 13 mm in diameter.

They are presented in PVC/aluminum blisters contained in a cardboard box.

Each blister contains 10 gastro-resistant tablets.

The packaging size: 20, 40, and 60 gastro-resistant tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Jozefa Pilsudskiego 5

95-200 Pabianice, Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

{Poland} {Anapran EC}

{Spain} {Naproxeno Aristo 500 mg gastro-resistant tablets EFG}

Last review date of this leaflet: December 2022

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