Package leaflet: Information for the patient

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

nimesulide
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet:

What DOMES is and what it is used for
What you need to know before taking DOMES
How to take DOMES
Possible side effects
How to store DOMES
Contents of the pack and other information

1. What DOMES is and what it is 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, your doctor will evaluate the potential benefits this medicine may provide you against the risk of occurrence of adverse effects.

2. What you need to know before taking DOMES

Do not use DOMES

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 previously experienced any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs):
wheezing, tightness in the chest, shortness of breath (asthma)
nasal congestion due to mucus secretion from the nasal mucosa (nasal polyps)
itchy skin rashes (urticaria)
sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may cause breathing difficulties (angioedema)
if you have previously had reactions following treatment with NSAIDs such as:
gastrointestinal or intestinal bleeding
gastric or intestinal ulcers (perforations)
if you have recently had, or have previously had, gastric or duodenal ulcer or bleeding;

(at least two episodes of ulcer or bleeding);

if you have had cerebral haemorrhage (stroke);
if you have any other bleeding disorder or a blood coagulation disorder;
if you suffer from hepatic insufficiency;
if you are taking other medicines known to affect the liver, e.g. paracetamol or any other analgesic or treatment with NSAIDs;
if you are taking drugs or have developed drug or substance dependence;
if you are a heavy, regular drinker (of alcohol);
if you have previously had a liver-related reaction to nimesulide;
if you suffer from severe renal insufficiency not requiring dialysis;
if you suffer from severe heart failure;
if you have fever or influenza (general 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 inform your doctor before taking DOMES, if you have previously developed
drug-induced fixed eruption (round or oval patches with redness and swelling of the skin, skin rash with blisters, urticaria and itching sensation) after taking nimesulide.
Medicines such as DOMES may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
The risk is higher with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
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, high cholesterol or if you smoke), you should discuss your treatment with your doctor or pharmacist.
If severe allergic reactions occur during treatment, stop taking DOMES and inform your doctor at the first sign of skin rash, lesions of soft tissues (mucous membranes), or any other allergy symptoms.
Immediately discontinue treatment with DOMES if gastrointestinal bleeding (black stools) or ulcer in the digestive tract (causing abdominal pain) occurs.
Exercise particular caution with DOMES
If symptoms indicating liver disorder occur during treatment with nimesulide, stop taking nimesulide and contact your doctor immediately. Symptoms indicating liver disorder include loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue, and dark urine.
If you have previously suffered from peptic ulcers, gastric or intestinal bleeding, or inflammatory bowel diseases such as ulcerative colitis or Crohn’s disease, inform your doctor before taking DOMES.
If fever and/or flu-like symptoms (general malaise, discomfort, chills or tremors) occur during treatment with DOMES, stop taking the product and inform your doctor.
If you suffer from mild heart disorders, high blood pressure, circulatory or kidney problems, inform your doctor before taking DOMES.
If you are elderly, your doctor may carry out regular checks to ensure that DOMES does not cause problems to your stomach, kidneys, heart or liver.
If you plan to become pregnant, inform 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 (medicines used to treat inflammatory conditions)
blood-thinning medicines (anticoagulants, e.g. warfarin or antiplatelet agents such as aspirin or other salicylates)
antihypertensives or diuretics (medicines to control blood pressure or heart conditions)
lithium, used to treat depression and similar disorders
selective serotonin reuptake inhibitors (medicines used to treat depression)
methotrexate (a medicine used to treat rheumatoid arthritis and cancer)
cyclosporine (a medicine used after organ transplantation or to treat immune system disorders), make sure your doctor or pharmacist knows you are taking these medicines before starting DOMES.

Other medicines and DOMES
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.
Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking DOMES or any other medicine.
DOMES must not be used during the last trimester of pregnancy. It may cause problems for the baby and for delivery.
If you are planning a pregnancy, inform your doctor because DOMES may reduce fertility.
If you are in the first or second trimester of pregnancy, do not exceed the dose or duration of treatment prescribed by your doctor.
Do not take nimesulide during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labour beyond expectations. You should not take nimesulide during the first 6 months of pregnancy unless absolutely necessary and under medical advice. When treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible time should be used. From week 20 of pregnancy, DOMES may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause 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.
DOMES must not be used during breastfeeding.
Driving and using machines
Do not drive or operate machinery if DOMES causes you dizziness or drowsiness.
DOMES oral suspension granules contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
DOMES orodispersible tablets contain sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take DOMES

Take this medicine exactly as your doctor has told you. If you are in doubt, consult your doctor or pharmacist.
To reduce unwanted effects, the lowest effective dose for the shortest time necessary to control symptoms should be used.
The recommended dose is one 100 mg tablet or one 100 mg sachet of granules for oral suspension, taken twice daily after meals.
Use DOMES for the shortest possible duration and for no longer than 15 days in a single treatment cycle.
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 any remaining medicine with you. In case of overdose, you may experience one of the following symptoms: drowsiness, nausea, stomach pain, gastric ulcer, breathing difficulties.
If you forget to take DOMES
Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, DOMES may cause side effects, although not everybody experiences them.
If any of the following symptoms occur, stop taking the medicine and inform your doctor immediately, as they could indicate a rare but serious side effect requiring urgent medical attention.
The side effects that may occur with DOMES are:

Stomach discomfort or pain, loss of appetite, nausea (feeling unwell), vomiting, gastrointestinal bleeding, or black stools;
Uncommon: bleeding from the stomach or intestine; duodenal or gastric ulcers, 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 colour of urine;
Swelling of the face, feet or legs;
Persistent fatigue.

General side effects of non-steroidal anti-inflammatory drugs (NSAIDs)
The use of some NSAIDs may be associated with a small increased risk of arterial thrombosis (blockage of blood vessels), for example heart attack (myocardial infarction) or stroke (cerebrovascular accident), particularly at high doses and with long-term treatment.
Fluid retention (oedema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID therapy.
The most commonly observed side effects with NSAIDs involve the gastrointestinal tract (gastrointestinal effects)

Gastric and duodenal ulcers;
Perforation of the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

Other side effects of non-steroidal anti-inflammatory drugs (NSAIDs) include:
Common (may affect more than 1 in 100 patients): diarrhoea, nausea, vomiting, slight changes in blood test values indicating liver function abnormalities.
Uncommon (may affect up to 1 in 100 patients): shortness of breath, dizziness, increased blood pressure, constipation, flatulence, stomach burning (gastritis), itching, skin rashes, increased sweating, swelling (oedema).
Rare (may affect up to 1 in 1,000 patients): anaemia, reduced white blood cells in the blood, increased levels of certain white blood cells (eosinophils) in the blood, changes in blood pressure, bleeding, pain during urination or urinary retention, blood in the urine, increased potassium levels in the blood, feelings of anxiety or restlessness, nightmares, blurred vision, increased heart rate, hot flushes, 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) causing skin rashes and severe malaise; kidney failure or inflammation (nephritis); disturbances in brain function (encephalopathy); reduced platelet count in the blood, leading to bleeding under the skin or in other parts of the body, black stools due to bleeding, gastrointestinal bleeding, duodenal or gastric ulcers, perforated ulcers; liver inflammation (hepatitis), sometimes severe, causing jaundice and blockage of bile flow; allergic reactions, including severe reactions with collapse and breathing difficulties, asthma, reduced body temperature, dizziness, headache, insomnia, stomach pain; indigestion, mouth burning, itching (urticaria); swelling of the face and surrounding areas, visual disturbances.
Not known (frequency cannot be estimated from available data): drug-induced fixed eruption (may appear as round or oval patches with redness and swelling of the skin), skin rash with blisters (urticaria), sensation of itching.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 DOMES
DOMES does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use DOMES after the expiry date stated on the carton after "Exp".
The expiry date refers to the last day of the month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What DOMES contains
DOMES 100 mg orodispersible tablets
The active substance is: nimesulide 100 mg.
Excipients: magnesium trisilicate, crospovidone, sodium stearyl fumarate, sodium saccharin, peppermint flavour.
DOMES 100 mg granules for oral suspension
The active substance is: nimesulide 100 mg.
Excipients: polyoxyl 35 castor oil, citric acid, lemon flavour, sucrose.

Description of the appearance of DOMES and pack contents
DOMES 100 mg orodispersible tablets: yellowish cream, round tablet.
One pack contains 30 tablets.
DOMES 100 mg granules for oral suspension: sachet containing a yellowish or yellowish cream 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

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