Maiamil prolongatum

Package Leaflet: Information for the Patient

Majamil Prolongatum 100 mg, prolonged-release tablets
Diclofenac Sodium

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Majamil Prolongatum and what is it used for
• 2. Important information before taking Majamil Prolongatum
• 3. How to take Majamil Prolongatum
• 4. Possible side effects
• 5. How to store Majamil Prolongatum
• 6. Contents of the pack and other information

1. What is Majamil Prolongatum and what is it used for

Majamil Prolongatum contains diclofenac, a non-steroidal anti-inflammatory substance with anti-inflammatory, analgesic, and antipyretic effects.
It is used to treat the following acute and chronic conditions:

• rheumatoid arthritis,
• ankylosing spondylitis,
• osteoarthritis,
• soft tissue pain syndromes (muscle inflammation, tendonitis, bursitis, synovial cysts).

2. Important information before taking Majamil Prolongatum

When not to take Majamil Prolongatum:

if you are allergic to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6); hypersensitivity symptoms include facial and lip swelling (angioedema), difficulty breathing, chest pain, runny nose, rash, or any other allergic reactions;

• if you have experienced asthma attacks, angioedema, urticaria, or acute rhinitis after taking acetylsalicylic acid or other prostaglandin synthesis inhibitors;
• if you have or have had active stomach or duodenal ulcers, bleeding from the gastrointestinal tract, or perforation;
• if you have ever had bleeding from the gastrointestinal tract or perforation after taking non-steroidal anti-inflammatory drugs;
• if you have severe liver, kidney, or heart failure;
• if you have had heart disease and/or cerebrovascular disease, such as a heart attack, stroke, transient ischemic attack (mini-stroke), or vascular surgery;
• if you have or have had circulatory disorders (peripheral vascular disease);
• in the last trimester of pregnancy.

Warnings and precautions

Before starting treatment with Majamil Prolongatum, discuss it with your doctor.
Be particularly cautious when taking Majamil Prolongatum:

• if you have or have had gastrointestinal disorders or diseases (e.g., ulcerative colitis, Crohn's disease), as this may worsen symptoms, including bleeding;
• if you have or have had gastrointestinal ulcers, as this increases the risk of bleeding or perforation;
• if you have heart, kidney, or liver function disorders;
• in patients with excessive fluid loss (e.g., after major surgery);
• in patients with porphyria, as this may worsen symptoms;
• if you have bleeding disorders or abnormal blood test results;
• if you have asthma, as this may cause bronchospasm;
• if you have systemic lupus erythematosus or connective tissue diseases, as this may increase the risk of aseptic meningitis.

There is a risk of gastrointestinal bleeding (often manifested as bloody vomiting and black stools), ulcers, and/or perforation, which can be fatal and may not be preceded by warning signs or may occur in patients who have had such warning signs.
If gastrointestinal bleeding or ulcers occur, the medicine should be discontinued immediately.
Patient with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.
Patients with asthma, allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease, or chronic respiratory infections are more likely to experience an allergic reaction to diclofenac (asthma exacerbation, angioedema, or urticaria).
This warning also applies to patients allergic to other substances (e.g., those who experience skin reactions, itching, or urticaria).
In these patients, the medicine should be administered with caution (preferably under medical supervision).
Taking such medicines as diclofenac may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
This risk increases with long-term use of high doses of the medicine.
Do not exceed the recommended dose and duration of treatment.
Before taking diclofenac, inform your doctor:

• if you smoke
• if you have diabetes
• if you have angina pectoris, blood clots, high blood pressure, high cholesterol, or high triglycerides
• if you have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Majamil Prolongatum may sometimes impair the healing process of intestinal wounds after surgery.

Severe skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been rarely reported in association with the use of non-steroidal anti-inflammatory drugs.
The greatest risk of these severe reactions occurs at the beginning of treatment, in most cases within the first month of taking the medicine.
Consult your doctor and discontinue the medicine if you experience the first symptoms of a skin rash, mucosal lesions, or other hypersensitivity symptoms (see section 4).
If you experience abnormal liver function test results or any symptoms indicating liver disease, your doctor may recommend discontinuing the medicine.
If long-term use of the medicine is necessary (especially in people over 65 years of age), your doctor will recommend tests to assess kidney and liver function and blood tests.
The medicine may mask symptoms of an existing infection.
Avoid concomitant use of this medicinal product with other systemic non-steroidal anti-inflammatory drugs (NSAIDs), as there is no evidence of benefits from concomitant use and a potential increase in adverse reactions.
The medicine may transiently inhibit platelet aggregation.
Limiting the use of the medicine to the smallest effective dose and the shortest possible duration reduces the risk of adverse reactions.
Consult your doctor, even if the above warnings refer to past situations.
Children
The medicine should not be used in children.
Elderly patients
Elderly people may be more sensitive to the effects of the medicine.
Follow the recommendations in the leaflet, take the medicine as directed by your doctor, use the smallest effective dose, and report any adverse reactions that occur during treatment to your doctor.
Patient with liver or kidney function disorders
In patients with liver or kidney function disorders, there is a risk of increased adverse reactions to the medicine, so dose adjustment may be necessary depending on the severity of liver or kidney failure.
The medicine is contraindicated in severe liver or kidney failure.

Majamil Prolongatum and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, especially:

• lithium (antidepressant)
• anticoagulants (e.g., acenocoumarol)
• antidiabetic medicines
• methotrexate (anticancer medicine)
• quinolone antibacterials
• other non-steroidal anti-inflammatory drugs; due to the increased risk of adverse reactions, avoid concomitant use of these medicines
• corticosteroids (e.g., prednisolone or dexamethasone)
• platelet aggregation inhibitors (e.g., acetylsalicylic acid)
• selective serotonin reuptake inhibitors (antidepressants, e.g., fluoxetine, sertraline)
• diuretics
• cardiac glycosides, e.g., digoxin (mainly used in heart failure)
• mifepristone (mainly used in the treatment of uterine fibroids)
• antihypertensive medicines, e.g., beta-blockers (e.g., propranolol, bisoprolol), ACE inhibitors (e.g., enalapril, captopril), angiotensin II antagonists (e.g., irbesartan)
• cyclosporine and tacrolimus (mainly used in organ transplant patients)
• phenytoin (used in epilepsy)
• colestyramine or colestipol (cholesterol-lowering medicines)
• sulfinpyrazone (used in gout treatment)
• voriconazole (used in fungal infection treatment).

Majamil Prolongatum with food and drink

Take the medicine during or immediately after a meal, with a glass of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take Majamil Prolongatum if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery.
Majamil Prolongatum may cause kidney and heart problems in the unborn child.
It may also increase the risk of bleeding in the mother and child and prolong labor.
Do not use Majamil Prolongatum during the first 6 months of pregnancy, unless your doctor considers it absolutely necessary.
If treatment is necessary during this period or when trying to conceive, use the smallest effective dose for the shortest possible time.
Majamil Prolongatum taken for more than a few days, starting from the 20th week of pregnancy, may cause kidney function disorders in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the ductus arteriosus in the child's heart.
This may lead to low amniotic fluid levels (oligohydramnios).
If treatment is necessary for more than a few days, your doctor may recommend additional monitoring.
Diclofenac passes into breast milk in small amounts.
Therefore, diclofenac should not be used during breastfeeding to avoid adverse reactions in the child.
The medicine may make it difficult to conceive.
If you plan to conceive or have difficulty conceiving, tell your doctor before starting treatment with the medicine.

Driving and using machines

If you experience dizziness, drowsiness, fatigue, or vision disturbances, do not drive or operate machinery.

Majamil Prolongatum contains orange yellow S (E110) and sodium

The medicine may cause allergic reactions.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Majamil Prolongatum

Always take this medicine exactly as your doctor has told you.
If you are not sure, consult your doctor or pharmacist.
Take the medicine orally, preferably during or immediately after a meal, with a large amount of water.
Do not chew the tablets.
The recommended dose is presented below.
Adults
100 mg (1 tablet) per day.
Using the smallest effective dose for the shortest possible duration reduces the risk of adverse reactions.
Children and adolescents
The medicine should not be used in children and adolescents under 18 years of age.

Overdose of Majamil Prolongatum

If you have taken more than the recommended dose of the medicine, consult your doctor immediately.
Symptoms that may occur after an overdose include headache, dizziness, nausea, vomiting, abdominal pain, gastrointestinal bleeding, diarrhea, disorientation, agitation, coma, drowsiness, tinnitus, fatigue, seizures.
In the case of acute poisoning, liver damage and acute kidney failure may occur.
If you have accidentally taken more tablets than recommended, contact your doctor, pharmacist, or go to the hospital immediately.

Missed dose of Majamil Prolongatum

If you miss a dose, take the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.

Stop taking Majamil Prolongatum and consult your doctor immediately if you notice:

• mild painful abdominal cramps and tenderness, starting soon after taking Majamil Prolongatum, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain onset (frequency not known - cannot be estimated from available data).

If you experience any of the following symptoms, stop taking the medicine and consult your doctor:

abdominal pain, indigestion, and epigastric pain;
bloody vomiting, black stools, or blood in urine;
skin disorders, such as rash and itching;
wheezing when breathing and shortness of breath;
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
jaundice;
prolonged sore throat and high fever;
swelling of the face, feet, or ankles;
severe headache;
chest pain when coughing.
The following side effects may occur after taking the medicine.

Common (more than 1 in 100 and less than 1 in 10 patients)

• headache and dizziness;
• abdominal pain and other gastrointestinal disorders, such as nausea, vomiting, indigestion, diarrhea, bloating, loss of appetite;
• increased liver enzyme activity in the blood;
• rash, skin eruptions.

Rare (more than 1 in 10,000 and less than 1 in 1,000 patients)

• hypersensitivity reactions, such as: asthma, pale and moist skin, restlessness, vasculitis, low blood pressure, shock;
• drowsiness;
• asthma, including shortness of breath;
• gastritis, bloody vomiting, melena, hematochezia, abdominal pain, black stools, gastrointestinal ulcers with possible bleeding or perforation;
• hepatitis, jaundice, liver function disorders;
• urticaria;
• fluid retention (edema), feeling of excessive tiredness.

Very rare (less than 1 in 10,000 patients)

• blood disorders associated with increased susceptibility to infections (leukopenia);
• increased tendency to bruise and bleed (thrombocytopenia), high fever, severe sore throat (agranulocytosis), and anemia;
• angioedema (including facial or laryngeal edema, which may cause difficulty breathing);
• disorientation, depression, insomnia, nightmares, irritability, restlessness, hallucinations, anxiety, psychotic reactions;
• sensory disturbances, including tingling, itching, or burning without a clear cause, memory disturbances, seizures, tremors, taste disturbances, and aseptic meningitis;
• vision disturbances, blurred vision, double vision, optic neuritis;
• hearing disturbances, tinnitus;
• palpitations, chest pain, heart failure, myocardial infarction;
• pneumonia;
• high blood pressure, vasculitis, low blood pressure;
• (ulcerative) colitis, Crohn's disease, constipation, intestinal obstruction, (ulcerative) stomatitis, glossitis, esophageal disorders, pancreatitis associated with severe abdominal pain radiating to the back and nausea and vomiting;
• fulminant hepatitis, liver necrosis, liver failure;
• skin reactions with blistering, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening skin diseases causing rash, skin peeling, and mucosal ulcers), angioedema (including facial edema);
• skin rash with severe itching and blistering, papules, urticaria, skin eruption with red (moist) irregular patches, hair loss, photosensitivity, lichen planus, erythema, pruritus;
• blood in urine, protein in urine, interstitial nephritis with hematuria, fever, and flank pain, acute kidney failure (which may be manifested by decreased urine output, weakness, edema), nephrotic syndrome (a disease caused by excessive protein loss in the urine), renal papillary necrosis;
• impotence.

Taking medicines like diclofenac is associated with a small increased risk of arterial thrombosis (e.g., myocardial infarction or stroke).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Majamil Prolongatum

Store in a temperature below 25°C.
Store in a dry place, protected from light.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the pack and other information

What Majamil Prolongatum contains

• The active substance of the medicine is diclofenac sodium.
  Each tablet contains 100 mg of diclofenac sodium.
• The other ingredients of the medicine are: Eudragit RS 30D, Eudragit L 100-55, Eudragit RS PO, cellulose powder, silica colloidal anhydrous, talc, povidone K-25, magnesium stearate (constituting the tablet core) and hypromellose, macrogol 6000, talc, titanium dioxide, orange yellow S (E110), propylene glycol (constituting the tablet coating).

What Majamil Prolongatum looks like and contents of the pack

Majamil Prolongatum is an orange, round, biconvex tablet with a slightly rough surface.
The pack contains 20 or 30 tablets.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of last revision of the leaflet: