Package leaflet: information for the user

MuscAdvance 25 mg film-coated tablets

Potassium diclofenac
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

What MuscAdvance is and what it is used for
What you need to know before taking MuscAdvance
How to take MuscAdvance
Possible side effects
How to store MuscAdvance
Package contents and other information

1. What MuscAdvance is and what it is used for

MuscAdvance relieves pain and reduces inflammation. MuscAdvance belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs/anti-rheumatic medicines).
MuscAdvance is used to treat mild to moderate pain, such as headache, toothache, muscle and joint pain, backache, and menstrual pain.
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking MuscAdvance

Do not take MuscAdvance

if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6)
if you have previously experienced an allergic reaction such as asthma, chest pain, sneezing, or skin rash when taking painkillers containing acetylsalicylic acid or other pain/inflammation medicines belonging to the group of NSAIDs
if you have severe liver disease
if you have an increased tendency to bleed
if you have porphyria (a metabolic disorder)
if you currently have or have previously had a stomach or duodenal ulcer
if you currently have or have previously had a stomach or duodenal ulcer related to treatment with diclofenac or similar preparations
if you have severe kidney disease
during the last 3 months of pregnancy and during breastfeeding
if you have established heart disease and/or cerebrovascular disease, e.g., if you have had a heart attack, stroke, mini-stroke (TIA), or blockage of blood vessels supplying the heart or brain, or undergone a procedure to remove or prevent such blockages
if you currently have or have previously had circulation problems (peripheral arterial disease)
if you are under 14 years of age

Warnings and precautions
Undesirable effects can be minimized by using the lowest effective dose for the shortest necessary duration.
Consult your doctor or pharmacist before taking MuscAdvance if you currently have or have previously had any of the following conditions:

stomach or intestinal (duodenal) ulcers
intestinal inflammation (ulcerative colitis or Crohn's disease)
liver disease
heart or kidney disease
nasal mucosal inflammation, asthma, chronic obstructive pulmonary disease (COPD), chronic airway infection, or other allergic reactions such as hives or angioedema (localized swelling that occurs periodically)
systemic lupus erythematosus (a connective tissue disease)
blood disorders or diseases causing increased bleeding tendency.

Before taking diclofenac, ensure your doctor is aware if:

You smoke
You have diabetes
You have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides
You have recently undergone or are about to undergo stomach or intestinal surgery before taking MuscAdvance, as MuscAdvance may occasionally impair wound healing in the intestine following surgery.

It is recommended to avoid using this medicine during chickenpox.
Elderly individuals should be informed about the increased risk of age-related adverse effects.
NSAIDs, including MuscAdvance, may rarely cause gastric ulcers, which can occur at any time during treatment, with or without warning symptoms. If you experience stomach or intestinal pain, especially if you are elderly, contact your doctor.
Like other anti-inflammatory agents, MuscAdvance may mask signs or symptoms of infection.
MuscAdvance may, in rare cases, affect blood cells in a way that weakens your immune system. If you develop an infection with symptoms such as fever and severe fatigue, or fever with localized infection such as sore throat/mouth or urinary tract problems, contact your doctor immediately for blood tests to rule out a deficiency in white blood cells (agranulocytosis). It is important that you inform your doctor about the medicine you are taking.
Stop treatment with MuscAdvance and contact your doctor immediately if you develop swelling of the face, tongue, and/or throat, and/or difficulty breathing or hives accompanied by breathing difficulties (angioedema).
Severe skin reactions have been very rarely reported in association with the use of NSAIDs. Discontinue use of MuscAdvance and contact a doctor if you develop any skin rash or mucosal damage.
Taking MuscAdvance (as with all medicines that inhibit cyclooxygenase and prostaglandin synthesis) may make it more difficult to conceive. Consult your doctor if you are planning a pregnancy or experiencing difficulty becoming pregnant. This effect is temporary and resolves when you stop taking this type of medicine.
Medicines such as MuscAdvance may be associated with a small increased risk of heart attacks ("myocardial infarction") or stroke. Any risk is more likely with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Other medicines and MuscAdvance
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicine.
MuscAdvance may affect or be affected by other medicines containing the following active substances:

blood clotting medications (e.g., warfarin, ticlopidine, acetylsalicylic acid, heparin)
medicines for diabetes, except insulin
lithium or SSRIs (used for various forms of depression)
digoxin (used for heart problems)
tacrolimus (used during organ transplants and for eczema)
cyclosporine (used during transplants, for severe psoriasis, and for rheumatic conditions)
certain medicines for high blood pressure (beta-blockers, angiotensin II receptor antagonists, and ACE inhibitors)
diuretics (agents that stimulate urine production and are used for high blood pressure)
quinolone antibiotics (used to treat urinary tract infections)
corticosteroids (used to treat inflammatory diseases)
colestipol and cholestyramine (used to treat high blood fat levels)
rifampicin (an antibiotic used for tuberculosis)
carbamazepine (used for epilepsy)
St. John’s wort (used for depression)
phenytoin (used for epilepsy)
methotrexate (used for psoriasis, rheumatism, and some cancers).

Never take different types of painkillers simultaneously without a doctor's prescription.

MuscAdvance with food and drinks
The tablets should be swallowed whole with liquid. To achieve the best effect, they should not be taken with a meal or immediately after a meal.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take MuscAdvance during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in the fetus. It could affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take MuscAdvance during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, MuscAdvance may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
MuscAdvance should be avoided by women who are trying to become pregnant or who are pregnant.
Treatment with MuscAdvance during any stage of pregnancy should only occur on a doctor's prescription.
The medicine passes into breast milk, posing a risk of effects on the infant. Therefore, MuscAdvance must not be used during breastfeeding. Consult your doctor before taking any medicine while breastfeeding.

Driving and using machines
In some people, MuscAdvance may cause adverse effects such as visual disturbances, dizziness, and drowsiness.

MuscAdvance contains:

7.2 mg of potassium per dose. This should be taken into account in patients with impaired kidney function or those following low-potassium diets;
mannitol, which may have a mild laxative effect.

MuscAdvance contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take MuscAdvance

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Usual dose in adults and adolescents over 14 years: 25 mg (1 tablet), taken at intervals of at least 4–6 hours between doses, as needed. Do not exceed the maximum recommended daily dose of 75 mg, corresponding to 3 tablets. Do not exceed 3 days of treatment.
The tablets must be swallowed whole with liquid. For optimal effect, they should not be taken with food.
If you have any doubts, consult your doctor or pharmacist. If you think that the effect of MuscAdvance is too strong or too weak, contact your doctor.
If you take more MuscAdvance than you should
If you have taken more MuscAdvance than you should, or if a child has accidentally taken MuscAdvance, contact your doctor or go to hospital to obtain advice on any risks or measures to be taken.

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 MuscAdvance and contact your doctor immediately if you notice:

mild cramps and abdominal tenderness occurring shortly after starting treatment with MuscAdvance, 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. You may develop gastrointestinal problems at the beginning of treatment. These side effects usually disappear within a few days.

Common side effects (occur in more than 1 out of 100 patients): abdominal pain, nausea, vomiting, diarrhoea, digestive problems, decreased appetite, flatulence, headache, dizziness, rash, and increased liver values.
Uncommon side effects (occur in less than 1 out of 100 patients): contraction of the muscles lining the airways, making breathing difficult.
Rare side effects (occur in less than 1 out of 1,000 patients): fatigue, body swelling due to fluid retention, hypersensitivity reactions (urticaria, allergic reaction with a drop in blood pressure), stomach ulcer, stomach bleeding (vomiting blood, blood in faeces, haemorrhagic diarrhoea), problems with the large intestine (constipation, intestinal inflammation), worsening of Crohn's disease and ulcerative colitis, inflammation of the tongue, mouth or oesophagus, pancreatitis, impotence (in this case the association is uncertain), asthma (including difficulty breathing), liver function disorders (liver inflammation, jaundice).
Very rare side effects (occur in less than 1 out of 10,000 patients): effects on vision (blurred vision, double vision) and hearing (hearing loss, tinnitus), difficulty sleeping, nightmares, irritability, anxiety, depression, memory disorders, confusion, distorted sense of reality, disturbances in taste sensation, effects on the heart and blood vessels (such as chest pain, tachycardia, high blood pressure, heart failure, heart attack, inflammation of blood vessels), effects on blood composition (reduced platelet count which may lead to minor skin and mucosal bleeding, reduced white blood cell count (agranulocytosis), which may weaken the immune response, breakdown of red blood cells (anaemia)), eczema, itching, skin redness, severe allergic reactions including Stevens-Johnson syndrome (inflammation of mucous membranes and skin with pustules and fever) and Lyell's syndrome (similar to Stevens-Johnson syndrome but with sudden skin peeling), hair loss, photosensitivity, effects on the kidneys (e.g. reduced or blocked urine production or blood in urine), inflammation of the membranes of the brain or lungs without bacterial cause, stroke, angioedema (e.g. facial swelling, rash, difficulty breathing).
Exceptionally, severe skin infections may occur in case of chickenpox.
Medicines such as MuscAdvance may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of side effects
If you get any side effects, including ones 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 MuscAdvance

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after 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 required. This will help protect the environment.

6. Package contents and other information

What MuscAdvance contains

The active substance is potassium diclofenac. Each tablet contains 25 mg of potassium diclofenac.
The other components are: potassium hydrogen carbonate, mannitol, sodium lauryl sulfate, macrogol, crospovidone, magnesium stearate, hypromellose.

Description of the appearance of MuscAdvance and package contents
The tablets are white, round and biconvex.
Blister pack (25 mg) containing 10 or 20 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy.
Responsible producer for batch release
Laboratorio Farmacologico Milanese S.R.L.
Via Monterosso, 273
21042 Caronno Pertusella (VA)
Italy
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