DOMES 100 mg Granulki Do Sporządzania Zawiesiny Doustnej

Treść ulotki

1. DOMES 100 mg orodispersible tablets, 100 mg granules for oral suspension
   1. What is DOMES and what is it used for
   2. What you need to know before you take DOMES
   3. How to take DOMES
   4. Possible side effects
   5. Contents of the pack and other information

DOMES 100 mg orodispersible tablets, 100 mg granules for oral suspension

nimesulide
Generic Equivalent

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What is DOMES and what is it used for

DOMES is a non-steroidal anti-inflammatory drug (“NSAID”), with analgesic properties .It
is used for the treatment of acute pain and menstrual pain.
Before prescribing DOMES, the doctor will assess the potential benefits this medicine can
give you compared to the risk of side effects.

2. What you need to know before you take DOMES

Do not use DOMES

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in paragraph 6)
• if you have had any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs:
• wheezing, tightness in the chest, shortness of breath (asthma)
• nasal congestion due to secretion of the internal nasal mucosa (nasal polyps)
• skin rashes/itchy skin (urticaria)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which can cause difficulty breathing (angioedema)
• if you have had reactions in the past following treatment with NSAIDs such as:
• gastric or intestinal bleeding
• ulcers (perforations) in the stomach or intestine
• if you have recently had a stomach or duodenal ulcer or have had them in the past

(at least two episodes of ulcer or bleeding);

• if you have had a cerebral haemorrhage (stroke);
• if you have any other bleeding problems or problems due to a blood clotting defect;
• if you suffer from liver failure;
• if you are taking other medicines known to have an effect on the liver, e.g. paracetamol or any other analgesic or NSAID treatment
• if you are taking drugs or have developed a dependence on drugs or other substances;
• if you are a heavy habitual drinker (of alcohol);
• if you have had a reaction to nimesulide in the past that affected the liver;
• if you suffer from severe renal failure that does not require dialysis;
• if you suffer from severe heart failure;
• if you have a fever or flu (general feeling of malaise, discomfort, chills or tremors or high temperature);
• if you are in the last trimester of pregnancy;
• if you are breastfeeding.

Do not give DOMES to a child under 12 years of age.

Warnings and precautions
Do not take DOMES or tell your doctor before taking DOMES if you have developed in the past
a fixed drug eruption (round or oval patches with redness and swelling of the skin,
skin rash with blisters, urticaria and feeling of itching) after taking nimesulide.
Medicines like DOMES may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke.
Any risk is more likely with high doses and prolonged treatments. Do not exceed the dose or
duration of treatment recommended.
If you have heart problems, a history of stroke, or think you may be at risk of these conditions
(e.g. if you have high blood pressure, diabetes or high cholesterol or if you smoke), you should discuss your
therapy with your doctor or pharmacist.
If severe allergic reactions occur during treatment, stop taking
DOMES and tell your doctor at the first sign of skin rashes, soft tissue lesions
(mucous membranes) or any other symptom of allergy.
Immediately stop treatment with DOMES in the presence of bleeding (with black stools) or ulceration of the digestive tract (causing abdominal pain).

Pay particular attention with DOMES
If symptoms indicative of a liver disorder appear during treatment with nimesulide,
you must stop taking nimesulide and immediately inform your doctor. Symptoms indicative of a liver disorder are loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue and dark urine.
If you have suffered from peptic ulcers, gastric or intestinal bleeding, or inflammatory bowel
diseases such as ulcerative colitis or Crohn's disease, you should tell your doctor before
taking DOMES.
If fever and/or flu-like symptoms (general malaise, discomfort, chills or tremors) occur during treatment with DOMES
you should stop taking the product and inform your doctor.
If you suffer from mild heart disorders, high blood pressure, circulatory or kidney problems, you
should tell your doctor before taking DOMES.
If you are elderly, your doctor may subject you to regular checks to ensure that DOMES does not
cause problems with your stomach, kidneys, heart or liver.
If you are planning a pregnancy, tell your doctor because DOMES may reduce
fertility.
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.
If you are taking any of the following medicines, which may interact with DOMES:

• corticosteroids (drugs used to treat inflammatory conditions)
• drugs to thin the blood (anticoagulants, e.g. warfarin or antiplatelet agents aspirin or other salicylates),
• antihypertensives or diuretics (drugs to control blood pressure or heart disorders),
• lithium, used to treat depression and similar disorders,
• selective serotonin reuptake inhibitors (drugs used to treat depression)
• methotrexate (drug used to treat rheumatoid arthritis and cancer treatment)
• cyclosporine (drug used after a transplant or to treat immune system disorders), make sure your doctor or pharmacist knows you are taking these medicines before taking DOMES.

Other medicines and DOMES
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription.

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking DOMES or any other medicine.
DOMES should not be used during the last trimester of pregnancy. It can cause problems
for the baby and childbirth.
If you are planning a pregnancy, tell your doctor as DOMES may decrease fertility.
If you are in the first or second trimester of pregnancy, do not exceed the dose and duration of
treatment prescribed by your doctor.
Do not take nimesulide in the last 3 months of pregnancy, as it may harm the fetus or
cause problems during childbirth. It may cause problems with the kidneys and heart of the fetus. It may
affect your and the baby's tendency to bleed and delay or prolong labour more than
expected. You should not take nimesulide in the first 6 months of pregnancy, unless
absolutely necessary and under the advice of a doctor. Where treatment is necessary in that
period or during attempts to conceive, the minimum dose should be used for the
shortest possible time. From the 20th week of pregnancy, DOMES, can cause kidney problems to
the fetus, if taken for more than a few days, thus reducing the levels of amniotic fluid surrounding
the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in
the baby's heart. Where treatment is necessary for more than a few days, your doctor
may advise additional monitoring.
DOMES should not be used during breastfeeding.

Driving and operating machinery
Do not drive or operate machinery if DOMES causes you dizziness or drowsiness.

DOMES granular for oral suspensioncontains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

DOMES orodispersible tabletscontains sodium
This medicine contains less than 1mmol of sodium (23mg) per tablet, i.e. essentially
“sodium-free”.

3. How to take DOMES

Take this medicine following the instructions of your doctor exactly. If you have any doubts,
consult your doctor or pharmacist.
To reduce undesirable effects, the minimum effective dose must be used for the shortest time
necessary to control the symptoms.
The recommended dose is one 100 mg tablet or one 100 mg sachet of granules for
oral suspension, twice a day after meals.
Use DOMES for the shortest possible period and for no more than 15 days in a single cycle of
treatment.

If you take more DOMES than you should:
If you take or think you have taken more DOMES than prescribed (overdose), contact your
doctor or hospital immediately. Bring all the remaining medicine with you. In case of overdose
you will probably develop one of the following symptoms: drowsiness, nausea, stomach pain, gastric ulcer,
difficulty breathing.

If you forget to take DOMES
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, DOMES can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop taking the medicine and inform your
doctor immediately as it may indicate a rare, serious side effect that
requires urgent medical attention.
The side effects that may occur with DOMES are:

• stomach discomfort or pain, loss of appetite, nausea (feeling unwell), vomiting, gastric or intestinal bleeding, or black stools;
• Uncommon: bleeding of the stomach or intestine; ulcers of the duodenum or stomach and perforated ulcers
• skin reactions such as rashes or redness;
• wheezing or shortness of breath;
• yellowing of the skin or eyes (jaundice);
• unexpected change in the amount or color of urine;
• swelling of the face, feet or legs;
• persistent fatigue.

Side effects of a general nature of non-steroidal anti-inflammatory drugs (NSAIDs)
The use of some NSAIDs may be associated with a modest increase in the risk of blockage of the
arterial vessels (thrombosis), for example, heart attack (myocardial infarction) or stroke,
particularly with high doses and with long-term treatment
In association with treatment with NSAIDs, fluid retention (edema),
high blood pressure (hypertension) and heart failure have been reported.

Side effects most commonly observed with NSAIDs concern the gastrointestinal tract (gastrointestinal effects)

• gastric and duodenal ulcers
• perforation of the intestinal walls or gastric or intestinal bleeding (sometimes fatal, especially in elderly patients).

Other side effects of non-steroidal anti-inflammatory drugs (NSAIDs) are:
Common (may affect more than 1 in 100 patients): diarrhea, nausea, vomiting, mild
changes in liver function blood values.
Uncommon (may affect up to 1 in 100 patients): shortness of breath, dizziness, increased
blood pressure, constipation, flatulence, heartburn (gastritis), itching, skin rashes,
increased sweating, swelling (edema).
Rare (may affect up to 1 in 1,000 patients): anemia, decrease in white blood cells in
the blood, increase in some white blood cells (eosinophils) in the blood, changes in blood
pressure, bleeding, pain during urination or urinary retention, blood in the urine,
increased potassium in the blood, feeling of anxiety or nervousness, nightmares, blurred
vision, increased heart rate, hot flashes, skin redness, skin inflammation
(dermatitis), malaise, fatigue.
Very rare (may affect up to 1 in 10,000 patients): severe skin reactions (known as
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) that cause
skin rashes and severe discomfort; kidney failure or inflammation (nephritis); disorders of
brain functions (encephalopathy); reduction in the number of platelets in the blood, causing
bleeding under the skin or in other parts of the body, black stools due to bleeding,
gastric or intestinal bleeding, duodenal or gastric ulcers, perforating ulcers;
liver inflammation (hepatitis), sometimes very severe, causing jaundice and blockage of the bile flow;
allergies, including severe reactions with collapse and difficulty breathing, asthma, reduction of
body temperature, dizziness, headache, insomnia, stomach pains; indigestion, burning
in the mouth, itching (urticaria); swelling of the face and surrounding areas, visual disturbances.
Not known (frequency cannot be estimated on the basis of available data): fixed drug eruption
(may manifest with round or oval patches with redness and swelling of the skin),
skin rash with blisters (urticaria), sensation of itching.
If any of these side effects gets serious or if you notice any side effect

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through
the national reporting system 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 DOMES
DOMES does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use DOMES after the expiry date which is stated on the pack after “Scad”.
The expiry date refers to the last day of the month.
Do not dispose of any medicine in water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DOMES contains

DOMES 100 mg orodispersible tablets
The active ingredient is: nimesulide 100 mg.
Excipients: magnesium trisilicate, crospovidone, sodium stearate, sodium saccharin, mint flavour

DOMES 100 mg granules for oral suspension
The active ingredient is: nimesulide 100 mg
Excipients :polyethylene glycol monocetyl ether, citric acid, lemon flavour, sucrose.
Description of the appearance of DOMES and contents of the pack

DOMES 100 mg orodispersible tablets: round tablet, of cream yellow colour .
One pack contains 30 tablets.

DOMES 100 mg granules for oral suspension: sachet containing a yellowish
or cream yellow powder.
One pack contains 30 sachets.

MARKETING AUTHORISATION HOLDER
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071, Pomezia (Roma) – Italy

MANUFACTURER
Special Product’s Line S.p.a.
Via Fratta Rotonda Vado Largo, 1
03012, Anagni (FR) – Italy