Majamil prolongatum

Package leaflet: Information for the patient

Majamil prolongatum, 100 mg, prolonged-release tablets
Diclofenacum natricum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Majamil prolongatum contains diclofenac – a substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which has anti-inflammatory, analgesic and antipyretic properties.
It is used in the treatment of the following acute and chronic conditions:

• rheumatoid arthritis,
• ankylosing spondylitis,
• osteoarthritis,
• soft tissue pain syndromes (myositis, ligament inflammation, fasciitis, bursitis, tenosynovitis).

2. Important information before using the medicine Majamil prolongatum

When not to use Majamil prolongatum: if the patient is allergic to sodium diclofenac or any of the other ingredients of this medicine (listed in section 6); allergic reactions include facial and lip swelling (angioedema), difficulty breathing, chest pain, nasal catarrh, rash, or any other allergic-type reactions;

• if the patient has experienced asthma attacks, angioedema, urticaria, or acute inflammation of the nasal mucosa after taking acetylsalicylic acid derivatives or other drugs inhibiting prostaglandin synthesis;
• if the patient currently has or has had in the past active gastric or duodenal ulcer(s) and/or gastrointestinal bleeding or perforation;
• if the patient has ever experienced gastrointestinal bleeding or perforation after using non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has severe liver, kidney, or heart failure;
• if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischemic attack (TIA), or arterial embolism in the heart or brain, or after a procedure to unblock or bypass obstructed blood vessels;
• if the patient has current or past circulatory disorders (peripheral vascular disease);
• during the third trimester of pregnancy.

Warnings and precautions
Before starting treatment with Majamil prolongatum, discuss it with your doctor.
Exercise particular caution when using Majamil prolongatum:

• if the patient currently has or has ever had gastrointestinal disorders or digestive tract diseases (e.g. ulcerative colitis, Crohn's disease), due to the risk of worsening symptoms, including bleeding;
• if the patient currently has or has ever had gastrointestinal ulcers, due to increased risk of bleeding or perforation;
• if the patient has impaired heart, kidney, or liver function;
• in patients with excessive loss of extracellular fluid (e.g. after major surgical procedures);
• in patients with hepatic porphyria, due to the risk of exacerbating symptoms;
• if the patient has blood clotting disorders or abnormal blood test results;
• if the patient currently has or has ever had bronchial asthma, due to the risk of bronchospasm;
• if the patient has systemic lupus erythematosus or connective tissue diseases, due to increased risk of aseptic meningitis.

There is a risk of gastrointestinal bleeding (often presenting as bloody vomiting or black, tarry stools), ulceration, and/or perforation, which may be fatal. These events may occur without warning symptoms or may occur in patients who previously experienced such warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with a history of gastrointestinal disease, especially elderly individuals, should inform their doctor about any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial treatment period.
Patients with asthma, allergic rhinitis, nasal mucosal swelling (e.g. due to nasal polyps), chronic obstructive pulmonary disease (COPD), or chronic respiratory infections are more susceptible to allergic reactions to diclofenac (worsening of asthma symptoms, Quincke's edema, or urticaria). This warning also applies to patients allergic to other substances (e.g. those experiencing skin reactions, itching, or hives). In such patients, the medicine should be administered with particular caution (preferably under medical supervision).
Taking medicines such 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. Do not use higher doses or longer treatment duration than recommended.
Before taking diclofenac, inform your doctor:

• if the patient smokes
• if the patient has diabetes
• if the patient has angina pectoris, thrombosis, hypertension, elevated cholesterol, or elevated triglycerides
• if the patient recently underwent or is scheduled for stomach or gastrointestinal surgery, as Majamil prolongatum may impair intestinal wound healing after surgery
• if the patient ever developed a severe skin rash, skin peeling, blistering, and/or oral mucosal ulcers after taking Majamil prolongatum or other painkillers.

Severe skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and generalized bullous fixed drug eruption, have been very rarely reported in association with diclofenac use. The highest risk of these severe reactions occurs early in treatment, with most cases beginning within the first month of therapy. Contact your doctor and discontinue the medicine at the first sign of skin rash, mucosal lesions, or other hypersensitivity symptoms (see section 4).
If abnormal liver function test results or any symptoms indicating liver disease occur, your doctor may advise discontinuation of the medicine.
If prolonged treatment is necessary (especially in patients over 65 years of age), your doctor may recommend monitoring kidney and liver function and blood tests.
The medicine may mask symptoms of existing infection.
Avoid concomitant use of this medicine with other systemic non-steroidal anti-inflammatory drugs (NSAIDs), due to lack of evidence of benefit from combination use and potential for increased adverse effects.
The medicine may transiently inhibit platelet aggregation.
The occurrence of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary.
Consult your doctor, even if the above warnings refer to conditions experienced in the past.

Children
This medicine should not be used in children.

Elderly patients
Elderly individuals may be more sensitive to the medicine's effects. Follow the instructions in the leaflet, use the lowest effective dose as recommended by your doctor, and report all adverse effects occurring during treatment to your doctor.

Patients with impaired liver and/or kidney function
In patients with impaired liver and/or kidney function, there is an increased risk of adverse effects, so dose adjustment may be necessary depending on the severity of liver and/or kidney impairment.
Majamil prolongatum is contraindicated in cases of severe liver and/or kidney failure.

Majamil prolongatum and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use, especially the following:

• lithium (antidepressant)
• anticoagulants (e.g. acenocoumarol)
• antidiabetic agents
• methotrexate (anticancer drug)
• antibacterial quinolones
• other non-steroidal anti-inflammatory drugs; due to increased risk of adverse effects, concomitant use should be avoided
• corticosteroids (e.g. prednisolone or dexamethasone)
• drugs inhibiting platelet function (e.g. acetylsalicylic acid)
• selective serotonin reuptake inhibitors (SSRIs) (antidepressants, e.g. fluoxetine, sertraline)
• diuretics
• cardiac glycosides, e.g. digoxin (used mainly in heart failure)
• mifepristone (used mainly in the treatment of uterine fibroids)
• antihypertensive drugs, e.g. beta-blockers (e.g. propranolol, bisoprolol), angiotensin-converting enzyme inhibitors (e.g. enalapril, captopril), angiotensin II receptor antagonists (e.g. irbesartan)
• cyclosporine and tacrolimus (used mainly in organ transplant patients)
• phenytoin (used in epilepsy)
• colestipol or cholestyramine (cholesterol-lowering agents)
• sulfinpyrazone (used in the treatment of gout)
• voriconazole (used in the treatment of fungal infections).

Majamil prolongatum with food and drink
Take the medicine during or immediately after a meal, with water.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Do not take Majamil prolongatum during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.
Majamil prolongatum may cause kidney and heart dysfunction in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labor.
During the first six months of pregnancy, do not use Majamil prolongatum unless your doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. Majamil prolongatum taken for longer than a few days starting from week 20 of pregnancy may lead to impaired kidney function in the unborn child, which may result in low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment longer than a few days is required, your doctor may recommend additional monitoring.

Breastfeeding
Diclofenac passes into breast milk in small amounts. Therefore, diclofenac should not be used during breastfeeding to avoid adverse effects in the infant.

Fertility
The medicine may impair fertility. If the patient is planning pregnancy or has difficulty conceiving, she should inform her doctor before starting treatment.

Driving and operating machinery
If the patient experiences dizziness, drowsiness, fatigue, or visual disturbances, he or she should not drive or operate machinery.

Majamil prolongatum contains sunset yellow (E 110) and sodium
The medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Majamil prolongatum

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The medicine should be taken orally, preferably during or immediately after a meal, with a large amount of water.
Do not chew the tablets.
The usual recommended dosage is given below.
Adults
100 mg (1 tablet) once daily.
Using the lowest effective dose for the shortest possible duration reduces the risk of adverse effects.
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.
Taking more Majamil prolongatum than recommended
If you take more than the recommended dose, contact your doctor immediately.
Symptoms of overdose may include: headache, dizziness, nausea, vomiting, abdominal pain, gastrointestinal bleeding, diarrhea, disorientation, agitation, coma, drowsiness, tinnitus, fatigue, seizures. In cases of acute poisoning, liver damage and acute kidney failure may occur.
If you accidentally take more tablets than recommended, contact your doctor or pharmacist immediately or go to a hospital.
If you forget to take 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 adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious.
If any of the symptoms listed below occur, stop taking the medicine immediately and contact your doctor:
abdominal pain, indigestion and epigastric pain;
mild painful abdominal cramps and tenderness occurring soon after starting treatment with Majamil prolongatum, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency unknown – cannot be estimated based on available data);
vomiting blood, black stools or blood in the urine;
skin disorders such as rash and itching;
severe allergic skin reaction which may present as widespread red and (or) dark spots, skin swelling, blisters and itching (generalised bullous fixed drug eruption);
wheezing and shortness of breath;
chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome;
yellowing of the skin or eyes;
persistent sore throat and high fever;
swelling of the face, feet or hands;
severe headache;
chest pain during coughing.

The adverse reactions listed below may occur after administration of the medicine.

Common (affects less than 1 in 10 patients)

• headache and dizziness;
• stomach area pain and other gastrointestinal disorders such as nausea, vomiting, dyspepsia, diarrhoea, bloating, loss of appetite;
• increased liver enzyme activity in blood;
• rash, skin eruptions.

Uncommon (affects less than 1 in 1,000 patients)

• hypersensitivity reactions such as: asthma, pale and clammy skin, restlessness, vasculitis, hypotension, shock;
• drowsiness;
• asthma, including breathlessness;
• gastric mucosal inflammation, vomiting blood, blood in stool, bloody diarrhoea, lower abdominal pain, tarry stools, gastric or intestinal ulceration with possible bleeding or perforation;
• hepatitis, jaundice, liver function disorders;
• urticaria;
• fluid retention (oedema), feeling excessively tired.

Rare (affects less than 1 in 10,000 patients)

• blood disorders associated with increased susceptibility to infections (leucopenia);
• increased tendency to bruising and bleeding (thrombocytopenia), high fever, severe sore throat (agranulocytosis), and anaemia;
• angioedema (including facial or throat swelling, which may cause breathing difficulties);
• disorientation, depression, insomnia, nightmares, irritability, restlessness, hallucinations, anxiety, psychotic reactions;
• sensory disturbances, including tingling, itching or burning sensations without apparent cause, memory impairment, seizures, tremor, taste disturbances and aseptic meningitis, stroke;
• visual disturbances, blurred vision, double vision, optic neuritis;
• hearing disorders, tinnitus;
• palpitations, chest pain, heart failure, myocardial infarction;
• pneumonia;
• increased blood pressure, vasculitis, low blood pressure;
• (ulcerative) enteritis, Crohn's disease, constipation, membranous stricture of the intestine, (ulcerative) stomatitis, glossitis, oesophageal disorders, pancreatitis associated with severe epigastric pain radiating to the back and accompanied by nausea and vomiting;
• fulminant hepatitis, hepatic necrosis, liver failure;
• skin reactions with blister formation, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening skin diseases causing rash, skin peeling and mucosal ulceration), angioedema (including facial swelling);
• skin rash with intense itching and formation of rings, blisters, exanthema, skin eruption with red (moist) irregular patches, hair loss, photosensitivity (sunlight), purpura (allergic), skin redness, itching;
• blood in urine, protein in urine, interstitial nephritis with haematuria, fever and flank pain, acute renal failure (symptoms may include reduced urine output, weakness, oedema), nephrotic syndrome (a condition caused by excessive loss of protein in urine), renal papillary necrosis;
• impotence.

Frequency unknown (frequency cannot be estimated from available data)

• allergic skin reaction which may present as round or oval redness and swelling of the skin, blisters and itching (erythema multiforme). The skin in affected areas may also be darker, which may persist after healing. Upon re-administration of the medicine, erythema multiforme usually reappears in the same locations.

Use of medicines such as diclofenac is associated with a small increased risk of arterial thrombosis (e.g. myocardial infarction or stroke).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Majamil prolongatum

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

6. Contents of the pack and other information

What Majamil prolongatum contains

• The active substance is sodium diclofenac. Each tablet contains 100 mg of sodium diclofenac.
• The other components are: Eudragit RS 30D, Eudragit L 100-55, Eudragit RS PO, powdered cellulose, colloidal anhydrous silica, talc, povidone K-25, magnesium stearate (forming the tablet core), and hypromellose, macrogol 6000, talc, titanium dioxide, sunset yellow, lac (E 110), propylene glycol (forming 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański, Poland
Tel. +48 22 364 61 01