Maiamil Pph

Leaflet attached to the packaging: patient information

Majamil PPH, 25 mg, enteric-coated tablets

Majamil PPH, 50 mg, enteric-coated tablets

Diclofenac sodium

Read the 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Diclofenac sodium (the active substance of Majamil PPH) belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs). Diclofenac has anti-inflammatory, pain-reducing, and antipyretic effects.
Majamil PPH is used in:

• rheumatoid arthritis;
• osteoarthritis, including back pain caused by spinal arthritis;
• painful shoulder stiffness caused by inflammation around the shoulder joint;
• pain caused by inflammation and swelling after surgical or dental procedures;
• acute gout attack;
• severe menstrual pain;
• diseases accompanied by fever, for a short period, together with the medicine used in the infection.

2. Important information before taking Majamil PPH

When not to take Majamil PPH:

as a result of taking painkillers (NSAIDs) (blood in the stool or black stools);

• during the last three months of pregnancy.

Warnings and precautions

Before starting to take Majamil PPH, discuss it with your doctor or pharmacist.
When to be particularly careful when taking Majamil PPH:

• In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), consult your doctor or pharmacist about the treatment method.

Consult a doctor, even if one of the above warnings applies to the patient now or in the past.
If long-term use of the medicine is necessary, the doctor will recommend control tests, even if the patient does not have the above-mentioned diseases.
Before taking Majamil PPH, inform your doctor:

in the intestines after surgery.
The occurrence of side effects can be limited by taking the medicine in the smallest effective dose and not for longer than necessary.

Majamil PPH and other medicines

Tell your doctor or pharmacist about all the medicines the patient is taking now or has taken recently, as well as about the medicines the patient plans to take, especially about taking:

• certain non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid or ibuprofen; there is an increased risk of side effects;
• lithium, digoxin, methotrexate, and cyclosporine; there is an increased risk of side effects;
• anti-diabetic medicines (except insulin); the effect of these medicines may decrease;
• diuretics; potassium levels in the blood should be checked;
• certain medicines that prevent blood clots; the anticoagulant effect may increase and the risk of gastrointestinal bleeding may increase;
• certain steroid anti-inflammatory medicines (corticosteroids); gastrointestinal disorders may worsen;
• certain medicines used to treat infections (quinolone antibacterials);
• certain medicines used to treat depression (selective serotonin reuptake inhibitors); the risk of gastrointestinal bleeding increases;
• phenytoin (used in epilepsy);
• cholestyramine or colestipol (cholesterol-lowering medicines);
• sulfinpyrazone (used in gout treatment);
• voriconazole (used in fungal infection treatment).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Do not take Majamil PPH if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. Majamil PPH may cause kidney and heart problems in the unborn child. It may increase the patient's and child's tendency to bleed and cause delayed or prolonged labor.
During the first six months of pregnancy, do not take Majamil PPH unless the doctor considers it absolutely necessary. If treatment is necessary during this period or while trying to conceive, use the smallest possible dose for the shortest possible time. Majamil PPH taken for more than a few days, starting from the 20th week of pregnancy, may result in kidney function disorders in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. This may lead to low amniotic fluid levels (oligohydramnios). If treatment for more than a few days is necessary, the doctor may recommend additional monitoring.
Diclofenac passes into breast milk in small amounts. Therefore, diclofenac should not be taken during breastfeeding to avoid side effects in the child.

Driving and using machines

Wait and see how the patient reacts to diclofenac before driving or operating machines. Diclofenac may cause dizziness, drowsiness, or vision disturbances. If these side effects occur, do not drive vehicles, operate machines, or perform other activities that require attention.

Majamil PPH contains lactose and sodium

Majamil PPH, 25 mg, enteric-coated tablets: Each tablet contains 50 mg of lactose monohydrate.
Majamil PPH, 50 mg, enteric-coated tablets: Each tablet contains 65 mg of lactose monohydrate.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medicine.
Majamil PPH contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Majamil PPH

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

Usually recommended doses

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Do not exceed the maximum dose of 150 mg per day.
The doctor may recommend taking diclofenac tablets during the day and diclofenac suppositories at night.
Adults
In rheumatoid arthritis, the recommended initial dose is usually 150 mg per day, maintenance dose from 75 mg to 100 mg per day.
In osteoarthritis, the initial dose is usually 100 mg to 150 mg per day, depending on the severity of pain; the maintenance dose is usually 75 mg to 100 mg per day.
In painful shoulder stiffness, the initial dose is usually 150 mg per day. Then the dose is reduced depending on the severity of symptoms.
In painful inflammatory conditions and swelling after surgical procedures, the initial dose is usually 150 mg per day. Then the dose is reduced depending on the severity of symptoms.
In painful menstruation, the initial dose is 50 mg to 100 mg per day. The initial dose should be taken when the first symptoms appear. If necessary, take the maximum dose of 50 mg 3 times a day for a few days. If the maximum daily dose is not sufficient within 2-3 menstrual cycles, the maximum dose of 200 mg per day can be taken during subsequent menstrual cycles.
Elderly patients
Elderly patients are more sensitive to the effects of diclofenac. They should take the smallest effective dose.
Children
Diclofenac should not be taken by children under 1 year of age. Children over 1 year of age should be given 0.5 mg to 2 mg per kilogram of body weight per day in 2 to 3 doses, depending on the severity of the disease.
In the treatment of juvenile rheumatoid arthritis, the dose can be increased to 3 mg per kilogram of body weight, divided into smaller doses throughout the day.
Only 25 mg tablets are suitable for use in children.
50 mg tablets should not be used in children.

How to take the medicine

Tablets should be taken whole with a glass of water (do not crush or chew them), preferably before meals.
The daily dose should be divided into 2-3 portions.

Duration of treatment

The duration of treatment may be from a few days to several weeks or even longer. The doctor determines the duration of treatment. It is very important to follow this. If the patient wants to stop treatment earlier, they should discuss it with their doctor.

Taking a higher dose of Majamil PPH than recommended

If a higher dose of the medicine than recommended is taken, consult a doctor or pharmacist immediately. Try to remember how many tablets were taken and what dose.
Follow the doctor's instructions exactly.

Missing a dose of Majamil PPH

If a dose of the medicine is missed, take the next dose as soon as possible, unless more than half of the time has passed between the two usually administered doses. In this case, do not take the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking Majamil PPH and contact a doctor immediately if the patient notices:

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

If any of the following symptoms occur, stop taking Majamil PPH and contact a doctor immediately:

• abdominal pain, nausea, and epigastric pain;
• vomiting blood, 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 (frequency unknown - cannot be estimated from available data);
• yellowing of the skin or eyes;
• prolonged sore throat and high fever;
• facial swelling, foot or leg swelling;
• severe headache;
• chest pain when coughing.

The following side effects may occur:

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

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

Rare (occurring in 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, vomiting blood, blood in stool, bloody diarrhea, lower abdominal pain;
• hepatitis with or without jaundice, liver function disorders;
• hives;
• fluid retention (edema).

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

• blood disorders associated with increased susceptibility to infections (leukopenia);
• increased tendency to bruising and bleeding (thrombocytopenia), high fever, severe sore throat (agranulocytosis), and anemia;
• disorientation, depression, insomnia, nightmares, irritability, psychotic reactions;
• sensory disturbances, including tingling, itching, or burning without a clear cause, memory problems, seizures, anxiety, tremors, taste disorders, and some types of meningitis;
• vision disturbances, blurred vision, double vision;
• hearing disturbances, tinnitus;
• palpitations, chest pain, heart failure;
• pneumonia;
• high blood pressure, vasculitis;
• (ulcerative) enteritis and Crohn's disease, constipation, oral inflammation, tongue inflammation, esophageal damage, 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 mucous membrane ulcers);
• skin rash with severe itching and blistering, blisters, rashes, skin rash with red (moist) irregular spots, hair loss, photosensitivity (sun), urticaria (allergic), erythema (redness), itching;
• blood in urine, protein in urine, kidney inflammation with blood in urine, fever, and side pain, reduced kidney function.

Taking medicines like diclofenac is associated with a slight increase in the risk of arterial thrombosis (e.g., heart attack or stroke).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 gather more information on the safety of the medicine.

5. How to store Majamil PPH

Store below 25°C. Store in the original packaging.
Keep the medicine out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the specified month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates 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 packaging and other information

What Majamil PPH contains

• The active substance of Majamil PPH is diclofenac sodium. Each 25 mg enteric-coated tablet contains: 25 mg of diclofenac sodium. Each 50 mg enteric-coated tablet contains: 50 mg of diclofenac sodium.
• Other ingredients are: tablet core:corn starch, lactose monohydrate, sodium carboxymethylcellulose (Type A), corn starch, microcrystalline cellulose, magnesium stearate; tablet coating:talc, macrogol 6000, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, silicone emulsion (dimethicone, polysorbate 80, sorbic acid, purified water), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172) (only 50 mg tablets).

What Majamil PPH looks like and contents of the packaging

Majamil PPH 25 mg enteric-coated tablets are yellow film-coated tablets with "D25" engraved.
Majamil PPH 50 mg enteric-coated tablets are brown film-coated tablets with "D50" engraved.
The cardboard box contains 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Dragenopharm Apotheker Püschl GmbH
Göllstrasse 1
84529 Tittmoning
Germany
Date of last revision of the leaflet:November 2022