Diclomax

Leaflet attached to the packaging: information for the user

Diclomax, 25 mg, coated tablets

Diclofenac potassium

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

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section
• 4.
• If after 5 days there is no improvement or you feel worse, consult a doctor.

Table of contents of the leaflet:

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

1. What is Diclomax and what is it used for

Diclomax belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). It has anti-inflammatory, analgesic, and antipyretic effects.
Diclomax is used for the symptomatic treatment of mild to moderate acute pain.

2. Important information before taking Diclomax

When not to take Diclomax

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• if you have or have had stomach or duodenal ulcers
• if you have or have had bleeding or perforation of the digestive tract or gastrointestinal bleeding associated with previous NSAID use
• if you have an increased tendency to bleed
• if you have severe liver dysfunction
• if you have porphyria (a metabolic disorder)
• if you have heart or cerebrovascular disease, e.g., after a heart attack, stroke, transient cerebral ischaemia (mini-stroke), or thrombotic events of the heart or brain, or after a revascularization procedure or bypass grafting
• if you have circulatory disorders (peripheral arterial disease)
• if you have severe kidney disease
• in the last 3 months of pregnancy
• if you think you may be allergic to diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other ingredients of Diclomax (listed at the end of this leaflet). Hypersensitivity symptoms include facial and lip swelling (angioedema), difficulty breathing, chest pain, runny nose, rash, or any other allergic reactions

Warnings and precautions

The risk of side effects can be minimized by using the lowest effective dose for the shortest duration necessary. Taking higher doses than recommended is associated with an increased risk of side effects. This also means avoiding the use of different NSAIDs at the same time.
Consult a doctor or pharmacist if you have or have had the following conditions:

• inflammatory bowel disease (ulcerative colitis, Crohn's disease)
• asthma, heart disease, liver or kidney disease
• chronic obstructive pulmonary disease or chronic respiratory infections (diseases leading to narrowing of the airways and limitation of oxygen flow causing shortness of breath)
• nasal mucositis
• systemic lupus erythematosus (SLE) (connective tissue disease)
• urticaria or angioedema (local swelling occurring periodically)
• diseases resulting in an increased tendency to bleed
• porphyria (metabolic disorder)

Before taking diclofenac, inform your doctor or pharmacist

• if you smoke
• if you have diabetes
• if you have angina, thrombosis, high blood pressure, high cholesterol, or high triglycerides

Elderly patients are at increased risk of experiencing side effects related to increasing age.
Severe skin reactions associated with NSAID use are very rare. You should stop taking Diclomax if you experience any skin rash or mucosal lesions and consult a doctor.
During chickenpox, you should avoid taking this medicine.
You should immediately stop taking Diclomax and consult a doctor if you experience any of the following symptoms (angioedema): facial swelling, tongue or throat swelling, swallowing difficulties, urticaria, and breathing difficulties.
Taking medicines like Diclomax may increase the risk of heart attack or stroke. This increased risk is more likely during high-dose and long-term therapy. Do not exceed the recommended dose or treatment duration.
Gastrointestinal bleeding may occur at any time during therapy with or without warning symptoms. These cause more serious consequences in elderly patients. If you experience gastrointestinal problems or signs of gastrointestinal bleeding, such as blood in the stool, black stools, or vomiting blood, stop taking Diclomax and consult a doctor.
Before taking Diclomax, tell your doctor if you have recently undergone or are scheduled for stomach or gastrointestinal surgery, as Diclomax may sometimes impair the healing of intestinal wounds after surgery.
Long-term use of various types of painkillers for headache may cause its worsening. If such a case has occurred or is suspected, you should stop treatment with this medicine.
Like other anti-inflammatory drugs, Diclomax may mask the symptoms and signs of infection.
Diclomax may cause a decrease in white blood cell count, reducing resistance to infections. If you experience infections with symptoms such as fever and severe deterioration of general health or fever with symptoms of local infection, such as throat soreness or oral cavity problems or urinary tract problems, consult a doctor immediately. The doctor will recommend blood tests to monitor possible decreases in white blood cell count (agranulocytosis).
It is essential to inform your doctor about taking this medicine.

Diclomax 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.
The following medicines may interact with Diclomax, for example:

• blood anticoagulants (warfarin, ticlopidine, acetylsalicylic acid, heparin, etc.)
• methotrexate (anticancer and immunosuppressive medicine)
• medicines used to treat diabetes, except insulin
• lithium (used to treat manic-depressive psychosis)
• selective serotonin reuptake inhibitors (used in depression)
• digoxin (used to treat heart conditions)
• tacrolimus (used in transplantation and treatment of eczema)
• cyclosporin (used during the transplantation process, in the treatment of acute psoriasis, and rheumatism)
• medicines for high blood pressure (beta-adrenergic blockers, angiotensin II receptor antagonists, ACE inhibitors)
• diuretics (medicines that stimulate urine production and are used to lower blood pressure)
• quinolone antibiotics (used to treat urinary tract infections)
• zidovudine (used to treat HIV infections)
• corticosteroids (used to treat inflammatory diseases)
• colestipol and cholestyramine (used to lower high fat levels in the blood). These medicines can be taken with Diclomax, provided they are taken with a few hours' interval.
• fluconazole (used to treat fungal infections)
• rifampicin (antibiotics used in tuberculosis)
• carbamazepine (used in epilepsy)
• barbiturates (sleeping pills)
• diazepam (a sedative)
• pentoxifylline (a vasodilator)
• phenytoin (used in the treatment of epilepsy)

Do not take different pain-relieving medicines at the same time without consulting a doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Diclomax if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. Diclomax may lead to kidney and heart disease in the unborn child. It may increase the risk of bleeding in you and your child and cause prolongation or delay of labor.
In the first 6 months of pregnancy, do not take Diclomax unless your doctor advises you to do so. If treatment is necessary during this period or during attempts to conceive, use the lowest possible dose for the shortest possible time.
If Diclomax is taken by women at more than 20 weeks of gestation, for more than a few days, it may cause kidney disease in the unborn child, which may lead to low amniotic fluid levels (oligohydramnios) or constriction of the ductus arteriosus in the baby's heart. If you require treatment for a longer period than a few days, additional fetal monitoring should be recommended.
Breastfeeding
Diclofenac passes into breast milk. Therefore, Diclomax should not be taken during breastfeeding to avoid side effects in the baby.
Fertility
Diclofenac may make it harder to conceive. Inform your doctor if you plan to conceive or if you have problems conceiving.

Driving and using machines

If you experience dizziness, drowsiness, fatigue, or vision disturbances while taking Diclomax, you should avoid driving or operating machinery.

3. How to take Diclomax

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Do not take for more than 5 days in the treatment of pain without consulting a doctor.
Mild and moderate pain
Adults (over 18 years and elderly): One coated tablet (25 mg) every 4 to 6 hours. The maximum daily dose is 3 tablets.
Tablets should be taken with a drink. Tablets should not be taken during meals or immediately after meals. Tablets can be divided into equal doses.
If you have doubts about dosing, consult a doctor or pharmacist. Do not take more than the recommended dose.
Diclomax should not be taken by children and adolescents under 18 years.

Take more Diclomax than recommended

In case of overdose, contact a doctor or go to the hospital immediately to get advice on the risk and the necessary actions to be taken.
Symptoms of overdose are nausea, vomiting, abdominal pain, gastrointestinal bleeding, diarrhea, dizziness, drowsiness, headache, tinnitus, restlessness, hallucinations, seizures in children (including myoclonic seizures), loss of consciousness, effects on the kidneys and liver, possibility of excessive acid production by the body (metabolic acidosis), and tendency to edema.
Additionally, low blood pressure, respiratory depression, and blue discoloration of the skin and lips may occur.

Forget to take Diclomax

Do not take a double dose to make up for a forgotten dose.
In case of further doubts about taking this medicine, consult a doctor or pharmacist.

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 Diclomax and tell your doctor immediately if you experience any of the following side effects:

• agranulocytosis (symptoms: fever, sore throat, painful mouth ulcers, anal ulcers, decreased immune response, tendency to bacterial infections).
• Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening skin diseases that cause rash, psoriasis, and mucosal lesions).
• hypersensitivity reactions (narrowing and obstruction of airways, urticaria, anaphylactic shock with blood pressure drop).
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.
• stop taking Diclomax and consult a doctor immediately if you experience symptoms of angioedema, such as facial swelling, tongue or throat swelling, swallowing difficulties, urticaria, and breathing difficulties.
• mild painful abdominal cramps and tenderness, starting soon after taking Diclomax, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain onset (frequency not known - cannot be estimated from available data).

Other side effects that may occur:

• abdominal pain
• nausea
• vomiting
• diarrhea
• digestive problems
• decreased appetite
• excess gas
• headache
• dizziness
• rash
• increased liver enzyme values.

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

• eczema, erythema
• hypersensitivity reactions (narrowing and obstruction of airways, urticaria, anaphylactic shock with blood pressure drop)
• gastritis, gastrointestinal bleeding or ulcers (may cause blood in the stool or vomit)
• liver dysfunction (including hepatitis with or without jaundice)
• fatigue
• asthma (shortness of breath, difficulty breathing)
• body swelling due to fluid retention.

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

• blisters on the skin
• reduction in the number of certain blood cells (red blood cells, platelets, and neutrophils)
• sudden severe swelling of the skin and mucous membranes (angioedema)
• disorientation, depression, insomnia, nightmares, irritability, disturbances of sense of reality
• burning or prickling sensation of the skin without visible physical effects (paresthesia), memory disturbances, seizures, restlessness, uncontrolled muscle movements (tremor), taste disturbances, stroke
• vision and hearing disturbances (blurred vision, double vision) and hearing (reduced hearing, tinnitus)
• effects on the heart and blood vessels (such as palpitations, chest pain, heart failure, heart attack)
• high blood pressure
• vasculitis
• pneumonitis
• colitis, constipation, inflammation of the tongue, mouth, or esophagus
• pancreatitis
• meningitis (inflammation of the meninges)
• acute liver failure
• hair loss
• photosensitivity
• acute kidney failure
• effects on the kidneys (which may lead to decreased or stopped urine production and blood in the urine).

Severe skin infections may occur in the case of chickenpox.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the 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
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Diclomax

Do not store above 25°C. Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Diclomax contains

The active substance is 25 mg of diclofenac potassium.
The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, maize starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, macrogol, talc, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).
Diclomax, 25 mg also contains black iron oxide (E 172).

What Diclomax looks like and contents of the pack

What Diclomax tablets look like:
The tablets are light pink, round, biconvex, with a dividing line on one side. The diameter is 8 mm.
The tablet can be divided into equal doses.
Pack sizes:
10 or 20 tablets.

Marketing authorization holder and manufacturer

Vitabalans Oy
Varastokatu 8
FI-13500 Hämeenlinna
FINLAND
Phone: +358 3 615 600
Fax: +358 3 618 3130

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

Dicuno 25 mg (CZ, DK, EE, FI, LT, LV, NO, SE, SI, SK)
Diclotin 25 mg (DE)
Diclomax 25 mg (PL)

Date of leaflet approval 30-01-2023