LIDET 500 mg GASTRO-RESISTANT TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Lidet500 mg Gastro-Resistant Tablets EFG

Naproxen

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 pack and other information

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

1. What is Lidet and what is it used for

Lidet contains naproxen as the active substance, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines are used to reduce inflammation and pain in the joints and muscles.

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

2. What you need to know before you take Lidet

Do not take Lidet

• If you are allergic to naproxen, naproxen sodium or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to acetylsalicylic acid (aspirin), other NSAIDs (such as ibuprofen or diclofenac) or any other pain relief medicine, or if you have asthma, rhinitis, nasal polyps or urticaria.
• If you have or have had nasal polyps, sneeze or have a runny nose frequently, have a stuffy nose or feel itchy (rhinitis).
• If you have asthma or allergies (such as hay fever) or have ever had swelling of 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 had a stomach bleed or perforation while taking non-steroidal anti-inflammatory drugs (NSAIDs).
• If you have severe liver, kidney or heart failure.
• If you are in the third trimester of pregnancy.

Do not take this medicine if you are in any of the above situations. If you are not sure, 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 diseases (for example, if you have high blood pressure, diabetes or high cholesterol or smoke), you should consult your doctor or pharmacist before taking this medicine.

Consult your doctor or pharmacist before starting to take this medicine if any of the following apply to you:

• If you have asthma or allergic disorders (such as rhinitis or nasal polyps), or have had swelling of the face, lips, eyes or tongue in the past.
• If you have a feeling of weakness (perhaps due to an illness) or you are an elderly person.
• If you have nasal polyps or if you sneeze frequently or have a runny nose, or itchy or congested nose (rhinitis).
• If you have kidney or liver problems.
• If you have blood clotting problems.
• If you have problems with blood vessels (arteries) in any part of your body.
• If you have too much fat (lipids) in the blood (hyperlipidemia).
• If you have an autoimmune condition, 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).

Medicines like Lidet may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. At higher doses and longer treatments, there is a greater risk of this happening. Do not exceed the recommended dose or treatment duration.

There have been reports of severe skin reactions, including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (Lyell's syndrome), and drug reaction with eosinophilia and systemic symptoms (DRESS), in association with naproxen. Stop taking naproxen and consult your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.

There have been reports of photosensitivity reactions (including cases where the skin resembles late cutaneous porphyria, "pseudoporphyria"). If skin fragility, blisters or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

If you are in any of the above situations, or if you are not sure, consult your doctor or pharmacist before taking this medicine.

Children and adolescents

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

Other medicines and Lidet

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines bought without a prescription or herbal remedies.

It is especially important that you tell your doctor if you are taking any of the following medicines:

• Other pain medicines such as aspirin, ibuprofen, diclofenac and paracetamol.
• Medicines to prevent blood clotting such as aspirin/acetylsalicylic acid, warfarin, heparin and clopidogrel.
• Hydantoins (medicines for epilepsy), such as phenytoin.
• Sulphonamide medicines, such as hydrochlorothiazide, acetazolamide, indapamide including sulphonamide antibiotics (for infections).
• Sulphonylureas (medicines for diabetes), for example glimepiride or glipizide.
• "ACE inhibitors" or any other medicine for high blood pressure such as cilazapril, enalapril or propranolol.
• Angiotensin II receptor antagonists, such as candesartan, eprosartan or losartan.
• Diuretics (medicines for high blood pressure) such as furosemide.
• "Cardiac glycosides" (for heart problems) such as digoxin.
• Steroids (medicines for swelling and inflammation) such as hydrocortisone, prednisolone and dexamethasone.
• "Quinolone antibiotics" (medicines for infections) such as ciprofloxacin or moxifloxacin.
• Certain medicines for mental health problems such as lithium or "SSRIs" such as fluoxetine or citalopram.
• Probenecid (medicine for gout).
• Methotrexate (used to treat skin problems, arthritis or cancer).
• Ciclosporin or tacrolimus (for skin problems or after an organ transplant).
• Zidovudine (used to treat AIDS and HIV infections).
• Mifepristone (used to terminate pregnancy or to induce labor if the baby is dead).

If you are in any of the above situations, or if you are not sure, consult your doctor or pharmacist before taking this medicine.

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 possible time.
• From the 20th week of pregnancy, Lidet may cause kidney problems in your fetus if taken for more than a few days, which can 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 more than a few days, your doctor may recommend additional checks.
• Do not take naproxen if you are breastfeeding (or plan to).
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Lidet may make it harder to become pregnant. You should tell your doctor if you are planning to become pregnant or if you are having trouble becoming pregnant.

Driving and using machines

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

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

3. How to take Lidet

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

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

Arthritis and ankylosing spondylitis

• The usual dose is between 500 mg and 1000 mg in two divided doses, every 12 hours.

When you need a daily dose of 1000 mg, you can take one 500 mg tablet twice a day, or two 500 mg tablets in one dose (morning or evening).

Some patients may take a higher dose of between 750 mg and 1000 mg per day to control pain. This would be in the case of patients with:

• severe pain at night/morning stiffness.
• if they have recently been changed to a higher dose for another pain treatment.
• osteoarthritis, in which pain is the main symptom.

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

The usual initial dose is 500 mg, followed by 250 mg every 6-8 hours as needed. Do not take more than 1250 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 for other adults.

Use in children and adolescents

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

Method of administration:

This medicine is taken orally.

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

You should make sure you have enough to drink (stay well-hydrated) when taking naproxen. This is especially important for people who have 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 especially 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 a hospital. Take the medicine package with you.

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

If you forget to take Lidet

If you miss a dose, do not take the missed dose. Wait to take your next normal dose.

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

If you stop taking Lidet

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

4. Possible Adverse Effects

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

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

Important Adverse Effects to Identify:

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

Severe stomach or intestine problems (with a frequency of uncommon or rare – may affect up to 1 in 100 people or up to 1 in 1,000 people),symptoms include:

• Stomach bleeding, seen as vomiting blood or coffee-ground-like fragments.
• Rectal bleeding (anus), seen as black, tarry stools or bloody diarrhea.
• Ulcers or holes in your stomach or intestine. Symptoms include stomach discomfort, stomach pain, fever, nausea, or vomiting.
• Pancreas problems. 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 (with a frequency of rare – may affect up to 1 in 1,000 people),symptoms include:

• Sudden swelling of your throat, face, hands, or feet.
• Difficulty breathing, chest tightness.
• Skin rash, blisters, or itching.

Severe Skin Reactions,symptoms include:

• A severe rash that develops rapidly, with blisters or peeling of the skin and possibly blisters in the mouth, throat, and eyes. Fever, headache, cough, and body aches may also occur. The frequency is unknown and cannot be estimated from the available data.
• Appearance of blisters on the skin when exposed to light (porphyria cutanea tarda) mainly on arms, face, and hands. The frequency is not common – may affect up to 1 in 100 people.
• Widespread skin rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). The frequency is unknown and cannot be estimated from the available data.
• A distinctive allergic skin reaction known as fixed drug eruption, which usually recurs in the same location upon re-exposure to the medicine and may appear as round or oval patches of redness and swelling of the skin, blisters (hives), itching. The frequency is unknown and cannot be estimated from the available data.

Liver Problems (with a frequency of rare – may affect up to 1 in 1,000 people),symptoms include:

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

Heart Attack (with a frequency of rare – may affect up to 1 in 1,000 people),symptoms include:

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

Stroke (with a frequency of rare – may affect up to 1 in 1,000 people),symptoms include:

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

Meningitis (with a frequency not known – cannot be estimated from the available data),symptoms include:

• Fever, nausea or vomiting, neck stiffness, 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 Lidet and tell your doctor immediately.

Other Possible Adverse Effects:

Frequent (may affect up to 1 in 10 people)

• Heartburn

• Diarrhea,
• Constipation,
• Abdominal discomfort,
• Stomatitis,
• Indigestion,
• Bruising,
• Itching,
• Sweating,
• Headache,
• Feeling dizzy, drowsy, or disoriented
• Vision problems,
• Ringing in the ears (tinnitus),

• Feeling or being sick

Uncommon (may affect up to 1 in 100 people)

• Feeling of fluttering in the heart (palpitations),
• Dyspepsia, asthma
• Difficulty with memory or concentration, feeling drowsy,
• Insomnia,
• Hearing loss,
• Skin more sensitive to the sun,
• Skin rashes that include redness,
• Kidney problems;

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

• Blood problems, such as anemia or alterations in the number of white blood cells,
• Swelling of hands, feet, or legs (edema). This may be accompanied by chest pain, tiredness, or difficulty breathing (heart failure),
• Hypercalcemia,
• Problems with the way the heart pumps blood through the body or damage to blood vessels. Signs may include tiredness, difficulty breathing, feeling faint, general pain,
• Slow heart rate,
• Hypertension,
• Damaged blood vessels (vasculitis), signs may include fever, headache, tiredness, weight loss, and pain
• Pneumonia or inflammation of the lungs,
• Blood in the urine,
• Difficulty sleeping or changes in sleep patterns,
• Depression,
• Confusion or seeing and possibly hearing things that do not exist (hallucinations),
• Difficulty with memory or concentration

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

• Eye pain, vision changes, the clear surface of the eye becomes scarred,
• Hearing changes, including deficiencies,
• Dizziness that causes balance problems,

• Hives, boils, and blisters on the body and face,

• Thirst, fever, feeling tired or unwell,
• Muscle pain or weakness,
• Systemic lupus erythematosus (SLE). Symptoms include fever, skin rash,
• Kidney problems

Frequency Not Known (cannot be estimated from the available data)

• Seizures or convulsions, or drowsiness,
• Inflammation of the optic nerve that causes pain with blurred vision and other symptoms,
• Numbness or tingling of hands and feet,
• Problems for women when trying to become pregnant

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lidet

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

Store below 25 ºC. Store in the original package to protect it from light.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your 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 of Lidet

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

Appearance of the Product and Package Contents

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 pack contains 10 gastro-resistant tablets.

Package sizes: 20, 40, and 60 gastro-resistant tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Jozefa Pilsudskiego 5

95-200 Pabianice, Poland

Phone number: 22 732 77 00

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

{Poland} {Anapran EC}

{Spain} {Lidet 500 mg gastro-resistant tablets EFG}

Date of the Last Revision of this Leaflet:April 2025

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