Lidet 500 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Lidet 500 mg gastro-resistant tablets EFG

Naproxen

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

??Keep this leaflet, as you may need to read it again.

??If you have any questions, ask your doctor or pharmacist.

??This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.

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

Leaflet contents:

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

1. What Lidet is and what it is used for

Lidet contains naproxen as the active substance, a compound belonging to a group of medicines known as 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 affecting 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 taking Lidet

Do not take Lidet

• If you are allergic to naproxen, sodium naproxen, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to acetylsalicylic acid (aspirin), other NSAIDs (e.g., ibuprofen or diclofenac), or any other pain-relieving medication, or if they cause you asthma, rhinitis, nasal polyps, or hives.
• If you have or have had nasal polyps, frequently sneeze or have a runny nose, nasal congestion, or itching (rhinitis).
• If you have asthma or allergies (such as hay fever), or have ever experienced swelling of the face, lips, eyes, or tongue.
• If you have or have ever had stomach or intestinal problems such as ulcers or bleeding.
• If you previously experienced stomach bleeding 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 any of the above apply to you. 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 developing such conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or smoke), discuss treatment with your doctor or pharmacist.

Consult your doctor or pharmacist before starting 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 previously had swelling of the face, lips, eyes, or tongue.
• If you feel weak (perhaps due to illness) or if you are elderly.
• If you have nasal polyps, frequently sneeze, have nasal discharge, or experience nasal itching or congestion (rhinitis).
• If you have kidney or liver problems.
• If you have blood clotting disorders.
• If you have blood vessel (arterial) problems anywhere in your body.
• If you have high levels of fat (lipids) in your blood (hyperlipidemia).
• If you have an autoimmune condition such as systemic lupus erythematosus (SLE), which causes joint pain, skin rashes, and fever, or ulcerative colitis or Crohn's disease (conditions causing 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. The risk is greater with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

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

Photosensitivity reactions (including cases resembling porphyria cutanea tarda, known as "pseudoporphyria") have been reported. If skin fragility, blistering, or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

If any of the above conditions apply to you, or if you are unsure whether they do, 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

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

It is important to inform your doctor if you are taking any of the following medicines in particular:

• 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.
• Sulfonamide medicines, such as hydrochlorothiazide, acetazolamide, indapamide, including sulfonamide antibiotics (for infections).
• Sulfonylureas (medicines for diabetes), for example, glimepiride or glipizide.
• “ACE inhibitors” or any other medicines 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” (for infections) such as ciprofloxacin or moxifloxacin.
• Certain medicines for mental health conditions such as lithium or SSRIs (e.g., fluoxetine or citalopram).
• Probenecid (a medicine for gout).
• Methotrexate (used to treat skin conditions, arthritis, or cancer).
• Cyclosporine or tacrolimus (for skin conditions or after organ transplant).
• Zidovudine (used for the treatment of AIDS and HIV infection).
• Mifepristone (used to terminate pregnancy or induce labor if the baby has died).

If any of the above apply to you, or if you are unsure, consult your doctor or pharmacist before taking this medicine.

Pregnancy, breastfeeding, and fertility

• Do not take naproxen 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 unborn baby. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labor beyond expectations.
• You should not take naproxen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest effective dose for the shortest possible time.
• From week 20 of pregnancy, Lidet may cause kidney problems in your fetus if taken for more than a few days, which may 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 treatment is needed for longer than a few days, your doctor may recommend additional monitoring.
• Do not take naproxen if you are breastfeeding (or planning to breastfeed).
• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
• Lidet may make it harder to become pregnant. Inform your doctor if you plan to become pregnant or if you have difficulty becoming pregnant.

Driving and using machines

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

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

3. How to take Lidet

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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 1,000 mg in two divided doses, every 12 hours.

When you require a daily dose of 1,000 mg, you may take one 500 mg tablet twice daily, or two 500 mg tablets as a single dose (morning or evening).

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

• severe night pain/morning stiffness.
• if you have recently had your tablets changed to a higher dose for another pain treatment.
• osteoarthritis, where pain is the main symptom.

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

The usual initial 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 people with liver and kidney problems

Your doctor will decide your dose, which will usually be lower than 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 split or chew the tablets.

You should ensure you drink enough fluids (stay well hydrated) while taking naproxen. This is particularly important for people who have kidney problems. While you are taking Lidet, your doctor will want to see you to verify that you are taking the correct dose for you and to detect any side effects. This is especially important if you are elderly.

If you take more Lidet than you should

If you have taken more Lidet than you should, contact your doctor immediately or go to a hospital. Take the medicine packaging with you.

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

If you forget to take Lidet

If you forget to take a dose, do not take the missed dose. Wait and take your next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Lidet

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

4. Possible adverse effects

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

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

Important adverse effects to identify:

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

Serious stomach or intestinal problems (uncommon or rare frequency – may affect up to 1 in 100 or up to 1 in 1,000 people), symptoms include:

• Bleeding from the stomach, seen as blood in vomit or vomit resembling coffee grounds.
• Bleeding from the rectum (anus), seen as black, sticky bowel movements (feces) or bloody diarrhea.
• Ulcers or holes in your stomach or intestine. Symptoms include stomach discomfort, stomach pain, fever, nausea, or vomiting.
• Problems with your pancreas. Symptoms include severe stomach pain spreading to your back.
• Worsening of ulcerative colitis or Crohn's disease, seen as pain, diarrhea, vomiting, and weight loss.

Allergic reactions (rare frequency – 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.

Serious skin reactions, symptoms include:

• 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 general malaise may occur at the same time. Frequency is unknown and cannot be estimated from available data.
• Appearance of blisters on the skin when exposed to light (porphyria cutanea tarda), mainly seen on arms, face, and hands. Frequency is uncommon – may affect up to 1 in 100 people.
• Generalized skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs in the body (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). Frequency is unknown and cannot be estimated from available data.
• A distinct skin allergic reaction known as fixed drug eruption, which usually reappears at the same site upon re-exposure to the medicine and may appear as round or oval patches of redness and swelling of the skin, blisters (urticaria), itching. Frequency is unknown and cannot be estimated from available data.

Liver problems (rare frequency – 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 stools (hepatitis) and abnormalities (including hepatitis), shown in blood tests.

Heart attack (rare frequency – may affect 1 in 1,000 people), symptoms include:

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

Stroke (rare frequency – may affect 1 in 1,000 people), symptoms include:

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

Meningitis (frequency not known – cannot be estimated from 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 notice any of the serious side effects listed above, stop taking Lidet and inform 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 lightheaded

• Vision problems

• Ringing in the ears (tinnitus)

• Feeling or being sick

Uncommon (may affect up to 1 in 100 people)

• Sensation of fluttering in the heart (palpitations)
• Dyspepsia, asthma
• Difficulty with memory or concentration, feeling drowsy
• Insomnia
• Hearing loss
• Skin more sensitive to sunlight
• Skin rashes including redness
• Kidney problems

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

• Blood disorders, such as anemia or changes in white blood cell count
• Swelling of hands, feet, or legs (edema). May be accompanied by chest pain, fatigue, or difficulty breathing (heart failure)
• Hypercalcemia
• Problems with how the heart pumps blood through the body or damage to blood vessels. Signs may include fatigue, difficulty breathing, feeling faint, general pain
• Slow heartbeats
• Hypertension
• Damage to blood vessels (vasculitis), signs may include fever, headache, fatigue, weight loss, and pains
• Pneumonia or lung inflammation
• Blood in the urine
• Difficulty sleeping or changes in sleep patterns
• Depression
• Confusion or seeing and possibly hearing things that are not there (hallucinations)
• Difficulty with memory or concentration

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

• Eye pain, vision disturbances, the clear surface of the eye becomes scarred
• Hearing disturbances, including impairments
• Dizziness causing balance problems
• Hives, spots, and blisters on the body and face
• Thirst, fever, feeling tired or generally unwell
• Muscle pain or weakness
• Systemic lupus erythematosus (SLE). Symptoms include fever, skin rash
• Kidney problems

Frequency not known (cannot be estimated from available data)

• Seizures or convulsions, or drowsiness
• Inflammation of the optic nerve causing pain, lack of sharpness or clarity of vision, and other symptoms
• Tingling or numbness in hands and feet
• Problems for women in becoming pregnant

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at: www.notificaram.es. By reporting adverse effects, you can help provide 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 °C. Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the blister and the carton, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lidet

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

Appearance of the product and contents of the pack

Lidet 500 mg gastro-resistant tablets: round, biconvex, film-coated tablets, white or almost white in colour, with a diameter of approximately 13 mm.

Presented in PVC/aluminum blisters contained in a cardboard outer pack.

Each blister contains 10 gastro-resistant tablets.

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

Only some pack sizes may be commercially available.

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

Telephone number: 22 732 77 00

This medicinal product is authorized in the European Economic Area member states under the following names:

{Poland} {Anapran EC}

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

Date of the most recent review of this leaflet: April 2025

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