Eminocs

PACKAGE LEAFLET: INFORMATION FOR THE USER

EMINOCS 50 mg/ml oral solution

potassium diclofenac
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What EMINOCS 50 mg/ml oral solution is and what it is used for

2. What you need to know before taking EMINOCS 50 mg/ml oral solution

3. How to take EMINOCS 50 mg/ml oral solution

4. Possible side effects

5. How to store EMINOCS 50 mg/ml oral solution

6. Contents of the pack and other information

7. What EMINOCS 50 mg/ml oral solution is and what it is used for
   EMINOCS 50 mg/ml oral solution is an oral solution containing 50 milligrams of potassium diclofenac per millilitre. Potassium diclofenac belongs to the group of prostaglandin synthesis inhibitors which have anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) properties.

EMINOCS 50 mg/ml oral solution is used for short-term treatment of:

• inflammatory pain following trauma, for example sprains;
• inflammatory pain and swelling following orthopedic surgery (procedures involving the musculoskeletal system, i.e. bones, joints, muscles, tendons, and ligaments) or dental surgery;
• menstrual pain.

2. What you need to know before taking EMINOCS 50 mg/ml oral solution

Do not take EMINOCS 50 mg/ml oral solution

• if you currently have a peptic ulcer, gastrointestinal bleeding, or gastrointestinal perforation (blood in stools or black stools)
• if you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs, or a history of recurrent peptic ulcer/bleeding (two or more distinct episodes of proven ulceration or bleeding)
• if you are hypersensitive (allergic) to diclofenac or to other chemically related substances, e.g. acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of the medicine
• if you have experienced asthma attacks, chest pain, urticaria, or inflammatory reactions of the nasal mucosa shortly after taking acetylsalicylic acid or similar medicines
• if you have had cerebral haemorrhages
• if you have or have had abnormal blood cell composition (haematological dyscrasia)
• if your bone marrow function is impaired (bone marrow depression)
• if you have severe liver disease (hepatic cirrhosis) characterized by irreversible liver tissue damage
• if you have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or obstruction of blood vessels supplying the heart or brain, or undergone a procedure to remove or prevent such obstructions
• if you have or have had circulatory problems (peripheral arterial disease), or if your renal function is severely impaired (severe renal failure)
• if you are pregnant: during the third trimester of pregnancy
• if you are under 14 years of age
  Consult your doctor or pharmacist if you are in any of the situations listed above.

Warnings and precautions
Talk to your doctor before taking EMINOCS 50 mg/ml oral solution:

• if you have previously had serious gastrointestinal problems (e.g. due to gastric or intestinal ulcers)
• if you suffer from recurrent (severe) episodes of inflammation of the large intestine accompanied by fever and mucus in the stool, sometimes mixed with pus or blood (ulcerative colitis)
• if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract, as EMINOCS may occasionally impair wound healing in the intestine following surgery
• if you suffer from recurrent (severe) episodes of intestinal inflammation, accompanied by diarrhoea, lower abdominal pain, weight loss, and occasionally fever (Crohn's disease)
• if you have severe impairment of kidney or liver function
• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, elevated cholesterol or elevated triglycerides
• if you have any blood disorders including hepatic porphyria (a type of metabolic disease)
• if you have skin reactions (skin rash, urticaria, mucosal lesions) or allergy symptoms such as itching, swelling of the face, lips and tongue, wheezing/shortness of breath
• if you have pre-existing asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (nasal polyps), chronic obstructive respiratory diseases, or chronic respiratory tract infections (particularly if associated with symptoms of allergic rhinitis)

Consult your doctor if you are or have previously been in any of the above situations.
Medicines such as EMINOCS may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. This risk is more likely with higher doses and prolonged treatment. Undesirable effects can be minimized by using the lowest effective dose for the shortest necessary duration. Do not exceed the recommended doses or duration of treatment.

Other medicines and EMINOCS 50 mg/ml oral solution
Always inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
The following interactions include those observed with diclofenac gastro-resistant tablets and/or other pharmaceutical forms of diclofenac.

Phenytoin: when phenytoin is used together with diclofenac, monitoring of plasma phenytoin concentrations is recommended.
Potent CYP2C9 inhibitors: caution is recommended when prescribing diclofenac together with potent CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole); this could lead to a significant increase in peak plasma concentrations and exposure to diclofenac due to inhibition of its metabolism.

Potassium diclofenac may alter the activity of other medicines, and conversely, the activity of potassium diclofenac may be altered by other medicines.

Potassium diclofenac may increase the effects of the following medicines:

• lithium (a medicine used, among other things, for depression)
• digoxin (a medicine used for certain heart conditions)
• methotrexate and cyclosporine (medicines used, among other things, for certain joint diseases and for a skin condition (psoriasis)).

Potassium diclofenac may reduce the activity of diuretics and antihypertensive agents (e.g. beta-blockers, angiotensin-converting enzyme (ACE) inhibitors).
Diclofenac may alter blood glucose levels, necessitating adjustment of dosage of antidiabetic agents administered during treatment with diclofenac.
Colestyramine and colestipol may cause a delay or reduction in the absorption of diclofenac: it is recommended to administer diclofenac at least one hour before or 4–6 hours after administration of colestipol/colestyramine.

If potassium diclofenac is used concomitantly with any of the following medicines, the following adverse effects may occur:

• some types of diuretics (potassium-sparing diuretics): blood potassium levels may become too high
• adrenocortical hormones (glucocorticoids with anti-inflammatory activity): gastrointestinal adverse effects may be increased
• other medicines similar to diclofenac (inhibitors of prostaglandin synthesis): there is an increased risk of adverse effects
• some types of antibacterial medicines (quinolone antibiotics): in some cases, seizures have been reported
• some types of medicines that reduce blood clotting (anticoagulants – e.g. warfarin) and medicines like aspirin (antiplatelet agents): gastrointestinal adverse effects and bleeding may be increased
• some types of medicines used for depression (SSRIs – serotonin reuptake inhibitors): gastrointestinal adverse effects and bleeding may be increased.

Pregnancy, breastfeeding and fertility
In general, always ask your doctor or pharmacist for advice before taking any medicine.
During the first six months of pregnancy, EMINOCS 50 mg/ml oral solution should not be used unless your doctor considers the potential benefits to the patient to outweigh the risks to the fetus. EMINOCS 50 mg/ml oral solution must not be used during the last three months of pregnancy. Consult your doctor if you are pregnant or planning a pregnancy, during treatment with EMINOCS 50 mg/ml oral solution.
The use of EMINOCS 50 mg/ml oral solution is not recommended during breastfeeding. Potassium diclofenac passes into breast milk in very small amounts.
If you have fertility problems, consider discontinuing the medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
EMINOCS 50 mg/ml oral solution may cause dizziness, fatigue, and reduced visual acuity. If you experience these symptoms, it is advisable to avoid driving vehicles or operating machinery.

EMINOCS 50 mg/ml oral solution contains:

• approximately 300 mg of alcohol in a 1 ml dose (30% weight/volume of ethanol). This is equivalent to 6 ml of beer or 2.5 ml of wine per dose. This alcohol content should be taken into account when administering the medicine to pregnant or breastfeeding women, and in particularly at-risk groups such as patients with liver disease, epileptic patients, or alcoholics.
• potassium (0.4 mmol per ml). This should be considered in patients with impaired renal function or those on low-potassium diets.
• Allura red (E129). May cause allergic reactions.

3. How to take EMINOCS 50 mg/ml oral solution

Take EMINOCS 50 mg/ml oral solution exactly as directed by your
doctor. If you have any doubts, always consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 14 years of age
Initial dose: take 100–150 mg per day (2–3 ml per day).
For mild conditions, 50–100 mg per day (1–2 ml per day) are generally sufficient.
It is recommended to divide the daily dose into 2–3 administrations.
Do not exceed the maximum daily dose of 150 mg (3 ml).
For menstrual pain, take 50–100 mg per day (1–2 ml) at the onset of the first symptoms. If
necessary, continue with doses not exceeding 50 mg (1 ml) three times a day for several days.
If the maximum recommended daily dose of 150 mg (3 ml) proves insufficient for 2 or 3 menstrual
periods, during the following menstrual period a maximum dose of 200 mg (4 ml) may be taken.
Your doctor will advise you on how long you should take EMINOCS 50 mg/ml oral solution. Since
the use of EMINOCS 50 mg/ml oral solution is indicated for conditions of limited duration, it is
recommended to take EMINOCS 50 mg/ml oral solution for short periods (approximately 1 week).
Children under 14 years of age
EMINOCS 50 mg/ml oral solution is not recommended for children under 14 years of age.
Instructions for use

EMINOCS 50 mg/ml oral solution should preferably be taken before meals.

The prescribed milliliters can be measured using the provided pipette. Empty the measured amount into a glass of water and drink immediately. Close the bottle tightly by screwing the cap with the dosing pipette securely.

If you take more EMINOCS 50 mg/ml oral solution than you should
If you take more EMINOCS 50 mg/ml oral solution than prescribed, contact your doctor or pharmacist immediately.

If you forget to take EMINOCS 50 mg/ml oral solution
Do not take a double dose to make up for the missed dose.

If you take EMINOCS 50 mg/ml oral solution twice a day
If the delay is less than 6 hours, you may still take the missed dose. If the delay is more than 6 hours, skip the missed dose. Take the next dose as scheduled.

If you take EMINOCS 50 mg/ml oral solution three times a day
If the delay is less than 3 hours, you may still take the missed dose. If the delay is more than 3 hours, skip the missed dose. Take the next dose as scheduled.

If you have any doubts about the use of EMINOCS 50 mg/ml oral solution, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, EMINOCS 50 mg/ml oral solution can cause side effects, although not everyone experiences them.
The following side effects include those reported with short- or long-term use.
Some side effects may be serious.
Stop taking Eminocs and contact your doctor immediately if you notice:

• mild cramps and abdominal tenderness occurring shortly after starting treatment with Eminocs, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Common side effects (may affect more than 1 in 100 people)

• headache, dizziness, vertigo
• nausea, vomiting, diarrhoea, indigestion, abdominal pain, intestinal gas, loss of appetite
• increased transaminase levels
• rash

Uncommon side effects (may affect less than 1 in 100 people)

• abdominal pain, burping
• swelling of the ankles, feet, or fingers

Rare side effects (may affect less than 1 in 1,000 people)

• abnormal blood test results (increased eosinophil count, reduced haemoglobin, reduced haematocrit)
• hypersensitivity, anaphylactic and anaphylactoid reactions (including low blood pressure and shock)
• drowsiness
• persistent breathing problems (asthma), including shortness of breath
• stomach inflammation, stomach bleeding, vomiting blood, bloody diarrhoea, dark stools, stomach or intestinal ulcer (with or without bleeding or perforation)
• liver inflammation, jaundice, liver disorders
• urticaria, swelling, cysts

Very rare side effects (may affect less than 1 in 10,000 people)

• reduced platelet count, reduced number of white and red blood cells (including abnormal breakdown of red blood cells and inadequate production of new cells by the bone marrow), reduced number of certain types of white blood cells
• giant urticaria (including facial swelling)
• mental confusion (disorientation), depressed mood (depression), insomnia, nightmares, irritability, altered mental state
• pricking pains, memory problems, uncontrolled body tremors (seizures), anxiety, tremors, inflammation of the lining of the skull (meninges)
• taste disturbances
• cerebrovascular accidents
• vision disorders, blurred vision, double vision
• tinnitus, worsening of hearing
• palpitations, chest pain, heart failure, myocardial infarction, increased blood pressure, inflammation of blood vessels
• lung inflammation
• inflammation of the large intestine (colitis, including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, inflammation of the oral cavity (including oral ulcer), inflammation of the tongue, oesophageal disorders, intestinal stenosis
• pancreatitis, blood cell death, rapidly progressive and severe liver disease
• blistering rashes, skin inflammation, skin redness, multiple skin lesions; Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), inflammatory skin peeling, hair loss, skin photosensitivity reaction, allergic-type violet skin discoloration, itching
• acute kidney failure, blood in urine, protein in urine, kidney damage, inflammatory process in the kidneys, death of cells in the renal papillae

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EMINOCS 50 mg/ml oral solution

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not refrigerate or freeze.
Keep in the original packaging.
After opening, the oral solution can be used for 6 months.
Do not use this medicine after the expiry date stated on the packaging after the word “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What EMINOCS 50 mg/ml oral solution contains

• The active substance is potassium diclofenac. Each 1 ml contains 50 mg of potassium diclofenac.
• The other components are ethanol, glycerol, potassium bicarbonate, sucralose, Allura red (E129), brilliant blue (E133), purified water.

Description of the appearance of EMINOCS 50 mg/ml oral solution and package contents
EMINOCS 50 mg/ml oral solution is supplied in 20, 25, 50 or 100 ml brown glass bottles.
A glass graduated pipette is provided with the bottle.
Marketing Authorization Holder
Dymalife Pharmaceutical S.r.l. – Via Bagnulo, 95 - 80063 - Piano di Sorrento (Naples)
Manufacturer
Laboratorio Farmacologico Milanese s.r.l.
Via Monterosso, 273
21042 Caronno Pertusella (VA) - Italy
Alfasigma S.p.A.
Via E. Fermi, 1
65020 - Alanno (PE), Italy