Diclomax

Package leaflet: Information for the user

Diclomax, 25 mg, coated tablets
Diclofenacum kalicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days of treatment, or if your condition worsens, contact your doctor.

Contents of the leaflet:

1. What Diclomax is and what it is 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 Diclomax is and what it is used for

Diclomax belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It has
anti-inflammatory, analgesic and antipyretic properties.
Diclomax is used for 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 to any of the other ingredients of this medicine (listed in section 6)
• if you have or have had a gastric or duodenal ulcer
• if you have or have had gastrointestinal bleeding or perforation related to previous use of pain-relieving medicines (NSAIDs)
• if you have an increased tendency to bleeding
• if you have severe liver function disorders
• if you have porphyria (a metabolic disorder)
• if you have been diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischaemic attack (TIA), or arterial embolism in the heart or brain, or after a procedure to unblock or bypass blocked blood vessels
• if you have circulatory disorders (peripheral vascular disease)
• if you have severe kidney disease
• during the last 3 months of pregnancy
• if you suspect 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). Symptoms of hypersensitivity include facial and lip swelling (angioedema), difficulty breathing, chest pain, nasal congestion, rash or any other allergic-type reactions

Warnings and precautions

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary. Using higher than recommended doses increases the risk of adverse effects. This also means that concomitant use of different NSAIDs should be avoided.

Consult your doctor or pharmacist before taking Diclomax if you have or have had any of 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 tract infections (conditions causing airway narrowing and reduced oxygen flow leading to shortness of breath)
• nasal mucosal inflammation
• systemic lupus erythematosus (SLE) (a connective tissue disease)
• urticaria or angioedema (recurrent localized swelling)
• disorders causing increased tendency to bleeding
• hepatic porphyria (a metabolic disorder)
• if you have ever experienced severe skin rash, skin peeling, blistering or oral ulcers after taking Diclomax or other pain-relieving medicines.

Before taking diclofenac, inform your doctor or pharmacist:

• if you smoke
• if you have diabetes
• if you have angina pectoris, thrombosis, hypertension, elevated cholesterol or elevated triglycerides

Elderly patients are at increased risk of adverse effects associated with advancing age.
Serious skin reactions associated with the use of NSAIDs are very rare. Discontinue Diclomax immediately if any skin rash or mucosal changes occur and contact your doctor.
This medicine should be avoided during chickenpox.
Stop taking Diclomax immediately and consult your doctor if you experience any of the following symptoms (angioedema): swelling of the face, tongue or throat, difficulty swallowing, urticaria or breathing difficulties.
Medicines such as Diclomax may increase the risk of myocardial infarction or stroke. This increased risk is more likely with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
Gastrointestinal bleeding may occur at any time during treatment, with or without warning symptoms. These complications may have more serious consequences in elderly patients. If gastrointestinal problems or signs of gastrointestinal bleeding occur, such as blood in stool, black stools or vomiting blood, stop taking Diclomax and contact your doctor.
Before taking Diclomax, inform your doctor if you have recently undergone or are scheduled for surgery of the stomach or gastrointestinal tract, as Diclomax may impair intestinal wound healing after surgery.
Prolonged use of various types of painkillers for headache may worsen the headache. If this occurs or is suspected, discontinue treatment with this medicine.
Like other anti-inflammatory medicines, Diclomax may mask signs and symptoms of infection.
Diclomax may reduce white blood cell count, thereby reducing resistance to infections. If infections occur with symptoms such as fever and significant deterioration in general health, or fever with local signs of infection such as sore throat or mouth ulcers, or urinary tract problems, consult your doctor immediately. Your doctor may recommend blood tests to monitor for possible reduction in white blood cells (agranulocytosis).
It is important to inform your doctor about the use of this medicine.

Diclomax and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take.

The following medicines may interact with Diclomax, for example:

• anticoagulants (warfarin, ticlopidine, acetylsalicylic acid, heparin, etc.)
• methotrexate (an anticancer and immunosuppressive agent)
• antidiabetic medicines other than insulin
• lithium (used in the treatment of manic-depressive psychosis)
• selective serotonin reuptake inhibitors (used for depression)
• digoxin (used in the treatment of heart diseases)
• tacrolimus (used in transplantation and eczema treatment)
• cyclosporine (used in transplantation, treatment of acute psoriasis and rheumatism)
• antihypertensive medicines (beta-blockers, angiotensin II receptor antagonists, ACE inhibitors)
• diuretics (medicines stimulating urine production and used to lower blood pressure)
• quinolone antibiotics (used to treat urinary tract infections)
• zidovudine (used in the treatment of HIV infections)
• corticosteroids (used to treat inflammatory diseases)
• colestipol and cholestyramine (used to reduce elevated blood lipid levels). These medicines may be used with Diclomax provided they are taken with an interval of several hours.
• fluconazole (used to treat fungal infections)
• rifampicin (antibiotics used in tuberculosis)
• carbamazepine (used in epilepsy)
• barbiturates (sedatives)
• diazepam (a calming medicine)
• pentoxifylline (a vasodilator)
• phenytoin (used in the treatment of epilepsy)

Do not take different pain-relieving medicines simultaneously without prior consultation with your doctor or pharmacist.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before using 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 disorders in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour.

During the first 6 months of pregnancy, Diclomax should not be used unless strictly prescribed by your doctor. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.

If Diclomax is taken by women beyond the 20th week of pregnancy for more than a few days, it may cause kidney disorders in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the ductus arteriosus in the baby's heart. If prolonged treatment is required, additional fetal monitoring should be recommended.

Breastfeeding

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

Fertility

Diclofenac may impair fertility. Inform your doctor if you are planning to become pregnant or if you have difficulty becoming pregnant.

Driving and operating machinery

If you experience dizziness, drowsiness, fatigue or visual disturbances while taking Diclomax, you should refrain from driving and operating machinery.

3. How to take Diclomax

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Do not use for longer than 5 days for pain treatment without consulting a doctor.
Mild and moderate pain
Adults (>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 liquid. Tablets should not be taken during meals or immediately after meals. Tablets may be divided into equal doses.
If the patient has any doubts about dosing, they should consult their doctor or pharmacist. Do not exceed the recommended dose.
Diclomax should not be used in children and adolescents under 18 years of age.
Taking more Diclomax than recommended
If you take more Diclomax than recommended, or if a child takes the medicine by mistake, contact a doctor immediately or go to hospital for advice on the risks involved and what actions should be taken.
Symptoms of overdose include nausea, vomiting, abdominal pain, gastrointestinal bleeding, diarrhoea, dizziness, drowsiness, headache, tinnitus, restlessness, hallucinations, convulsions in children (including myoclonic convulsions), loss of consciousness, effects on kidneys and liver, possible overproduction of acid in the body (metabolic acidosis), and tendency to develop oedema.
Additionally, low blood pressure, respiratory depression and blue discoloration of the skin and lips may occur.
Missed dose of Diclomax
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious.
You must immediately stop taking Diclomax and inform your doctor if any of the following adverse reactions occur:

• agranulocytosis (symptoms: fever, sore throat, painful oral ulcers, anal ulceration, reduced immune response, susceptibility to bacterial infections).

• Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening skin diseases causing rash, desquamation, and ulceration of mucous membranes).

• hypersensitivity reactions (airway constriction and obstruction, urticaria, anaphylactic shock with low blood pressure).

• chest pain, which may indicate a potentially severe allergic reaction known as Kounis syndrome.

• discontinue Diclomax and seek immediate medical advice if symptoms of angioedema occur, such as swelling of the face, tongue or throat, difficulty swallowing, urticaria, and breathing difficulties.

• mild abdominal cramps and tenderness occurring soon after starting Diclomax treatment, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency unknown – cannot be estimated from available data).

• Severe allergic skin reaction, which may manifest as extensive red and/or dark spots, skin swelling, blisters and itching (generalized bullous fixed drug eruption).

Other possible adverse reactions include:
Common (may affect up to 1 in 10 people):

• abdominal pain
• nausea
• vomiting
• diarrhoea
• digestive problems
• decreased appetite
• excess gas
• headache
• dizziness
• rash
• elevated liver enzyme levels.

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

• eczema, erythema
• hypersensitivity reactions (airway constriction and obstruction, urticaria, anaphylactic shock with low blood pressure)
• gastritis, gastrointestinal bleeding or ulcers (blood in stools or vomit may occur)
• liver function disorders (including hepatitis with or without jaundice)
• fatigue
• asthma (shortness of breath, dyspnoea)
• fluid retention leading to body swelling (oedema).

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

• skin blisters
• reduction in certain blood cells (red blood cells, platelets, and neutrophils)
• sudden swelling of the skin and mucous membranes (angioedema)
• disorientation, depression, insomnia, nightmares, irritability, disturbances in perception of reality
• skin burning or prickling sensation without visible physical effects (paraesthesia), memory impairment, seizures, restlessness, uncontrolled muscle movements (tremor), taste disturbances, stroke
• vision disturbances (blurred vision, double vision) and hearing disturbances (reduced hearing, tinnitus)
• effects on the heart and blood vessels (such as palpitations, chest pain, heart failure, myocardial infarction)
• high blood pressure
• vasculitis
• pneumonia
• bowel disorders, constipation, glossitis, stomatitis, or oesophagitis
• pancreatitis
• meningitis (inflammation of the meninges)
• acute liver failure
• hair loss
• photosensitivity
• acute kidney failure
• effects on the kidneys (which may lead to reduced or stopped urine production and blood in urine).

Particular serious skin infections may occur in cases of chickenpox.
Frequency not known (cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may 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 Diclomax

Do not store above 25°C. Keep in a place invisible and
inaccessible to 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist what to do with medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Diclomax contains
The active substance is 25 mg of potassium diclofenac.
The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, maize gelatinised 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 the Diclomax tablet looks like:
The tablets are light pink, round, convex, with a division line on one side. Diameter is 8 mm.
The tablet can be divided into equal doses.

Pack sizes:
10 or 20 tablets.

Marketing Authorisation Holder and Manufacturer
Vitabalans Oy
Varastokatu 8
FI-13500 Hämeenlinna
FINLAND
Tel.: +358 3 615 600
Fax.: +358 3 618 3130

This medicinal product is authorised in 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)