Package leaflet: Information for the user

ALGOLIDER 100 mg granules for oral suspension

Nimesulide
Generic medicine
Please read all of 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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ALGOLIDER is and what it is used for

ALGOLIDER contains the active substance nimesulide, which 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 ALGOLIDER, your doctor will evaluate the potential benefits this medicine may provide you against the risk of developing adverse effects.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking ALGOLIDER

Do not take ALGOLIDER

If you are allergic to nimesulide or to any of the other ingredients of this medicine (listed in section 6).
If you have previously experienced allergic reactions (e.g. shortness of breath, runny nose, nasal congestion, nasal polyps, hives) after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs);
If you have previously had a liver-related reaction to nimesulide;
If you are currently taking other medicines known to affect the liver, for example paracetamol or any other analgesic, or undergoing treatment with non-steroidal anti-inflammatory drugs;
If you are using drugs or have developed a dependency on drugs or other substances;
If you are a heavy, regular drinker (alcohol);
If you have liver disease or elevated liver enzymes;
If you currently have or have previously had peptic ulcer (gastric or duodenal ulcer);
If you have previously experienced stomach or intestinal bleeding or perforation;
If you have previously had a cerebral haemorrhage (stroke);
If you have any other bleeding disorder or blood coagulation defect;
If you have heart problems (heart failure);
If you have severe renal insufficiency (poor kidney function);
If you have hepatic insufficiency (poor liver function);
If you have fever or influenza (generalized aching, malaise, chills or shivering, or high temperature);
If you are in the last trimester of pregnancy;
If you are breastfeeding.

Do not give ALGOLIDER to a child under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking ALGOLIDER.

If during treatment with nimesulide you develop symptoms indicating liver disorder, you must stop taking nimesulide and contact your doctor immediately. These symptoms include loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue, dark urine, and abnormal liver function tests (see also section “Possible side effects”).
If you have previously suffered from peptic ulcers, gastrointestinal bleeding, ulcerative colitis, or Crohn’s disease, inform your doctor before taking ALGOLIDER; your condition may worsen with treatment with ALGOLIDER.
If during treatment with ALGOLIDER you develop fever and/or flu-like symptoms (generalized aching, malaise, chills or shivering), you must stop taking the medicine and inform your doctor.
If you suffer from heart or kidney disease, inform your doctor before taking ALGOLIDER; kidney function may worsen with treatment with ALGOLIDER.
If you are elderly, your doctor may carry out regular checks to ensure that ALGOLIDER does not cause problems with your stomach, kidneys, heart, or liver.
If you are taking any of the following medicines, which may increase the risk of ulceration and bleeding (see also section “Other medicines and ALGOLIDER”):
Corticosteroids (medicines used to treat inflammatory conditions)
Anticoagulants, e.g. Warfarin, or antiplatelet agents such as Aspirin (medicines that prevent blood clots)
Selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat depression) Make sure your doctor or pharmacist knows that you are taking these medicines before taking ALGOLIDER.
If during treatment you develop a severe, potentially life-threatening skin reaction (exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis), you must stop taking ALGOLIDER at the first sign of skin rash, skin peeling, blisters, or bleeding from lips, eyes, mouth, nose, or genitals, or any other symptom of an allergic reaction. Do not take ALGOLIDER, or consult your doctor before taking ALGOLIDER, if you have previously developed fixed drug eruption (round or oval patches with redness and swelling of the skin, skin rash with blisters, hives, or itching) after taking nimesulide (see also section “Possible side effects”).
If gastrointestinal symptoms such as stomach pain, gastric bleeding, or black stools develop, stop treatment immediately and consult your doctor.
If you do not notice any benefit, inform your doctor.
If you are planning to start a pregnancy, inform your doctor because ALGOLIDER may reduce fertility. Medicines such as ALGOLIDER may be associated with an increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely 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 (for example, if you have high blood pressure, diabetes, high cholesterol, or if you smoke), discuss your treatment with your doctor or pharmacist.

Children and adolescents
ALGOLIDER must not be administered to children under 12 years of age.
Other medicines and ALGOLIDER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, if you are taking any of the following medicines, which may interact with ALGOLIDER, ensure that your doctor or pharmacist knows you are taking them before starting ALGOLIDER:

Other non-steroidal anti-inflammatory drugs (NSAIDs)
Corticosteroids (used to treat inflammatory conditions)
Anticoagulants, e.g. warfarin or similar agents, antiplatelet medicines such as acetylsalicylic acid (medicines used to thin the blood)
Selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat depression)
Antihypertensives or diuretics (used to control blood pressure or cardiac disorders)
Lithium (used to treat depression and similar disorders)
Methotrexate (a medicine used to treat rheumatoid arthritis and cancer)
Cyclosporine (a medicine used after organ transplantation or to treat immune system disorders)

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take ALGOLIDER during the last trimester of pregnancy. It may cause problems for the baby and delivery. It may cause kidney and heart problems in the unborn child. It may affect your and your baby’s tendency to bleed and may lead to delayed or prolonged labour.
You should not take ALGOLIDER during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while planning a pregnancy, 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, ALGOLIDER may cause kidney problems in your unborn child, which may lead 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 for more than a few days is needed, your doctor may recommend additional monitoring.
If you are in the first or second trimester of pregnancy, do not take ALGOLIDER unless your doctor considers it strictly necessary.
Breastfeeding
Do not take ALGOLIDER while breastfeeding.
Fertility
If you are planning a pregnancy, inform your doctor, as ALGOLIDER may reduce fertility.
Driving and using machines
If you experience dizziness or drowsiness after taking ALGOLIDER, you must not drive or operate machinery.
ALGOLIDER 100 mg granules for oral suspension contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take ALGOLIDER.

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one sachet containing 100 mg of granules for oral suspension,
twice daily after meals.
Take ALGOLIDER for the shortest possible duration and for no longer than 15 days.
If you take more ALGOLIDER than you should
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital emergency department. Take any remaining medicine with you.
Symptoms of overdose include: drowsiness, stupor, nausea, vomiting, stomach problems (pain, gastric ulcer, gastrointestinal bleeding), high blood pressure, kidney problems, breathing difficulties, and coma.
If you forget to take ALGOLIDER
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following symptoms, stop taking the medicine and inform your doctor immediately,
as they may indicate a rare but serious side effect requiring urgent medical attention:

Stomach pain or discomfort, loss of appetite, nausea (feeling unwell), vomiting, gastrointestinal bleeding, or black stools;
Skin reactions such as rashes or redness;
Wheezing or shortness of breath;
Yellowing of the skin or eyes (jaundice);
Unexpected changes in the amount or colour of urine;
Swelling of the face, feet or legs;
Persistent tiredness

General side effects associated with non-steroidal anti-inflammatory drugs (NSAIDs): Medicines such as ALGOLIDER may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Common (may affect more than 1 in 100 people):

Diarrhoea;
Nausea;
Vomiting;
Increased blood levels of liver enzymes (indicating liver function). Side effects that may occur with ALGOLIDER include:

Uncommon (may affect up to 1 in 100 people):

Bleeding of the stomach or intestines;
Duodenal or gastric ulcers, and perforated ulcers;
Shortness of breath (dyspnoea);
Dizziness;
Increased blood pressure;
Constipation;
Presence of gas in the intestine (flatulence);
Itching;
Skin rashes;
Increased sweating;
Swelling (oedema);

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

Low haemoglobin levels in the blood (anaemia);
Decreased white blood cells, increased levels of certain white blood cells (eosinophils) in the blood;
Hypersensitivity reactions;
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 nervousness, nightmares, blurred vision;
Increased heart rate;
Hot flushes;
Skin redness (erythema), skin inflammation (dermatitis);
Difficulty urinating, blood in the urine;
Malaise, fatigue.

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

Reduced platelet count in the blood, leading to subcutaneous bleeding or bleeding elsewhere in the body, black stools due to gastrointestinal bleeding, gastric or intestinal bleeding (thrombocytopenia), reduced levels of all blood cells (pancytopenia), purpura (conditions characterised by red skin spots), sudden potentially fatal allergic reaction;
Sudden potentially fatal allergic reaction (anaphylaxis);
Severe skin reactions (known as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) causing skin rashes and severe malaise;
Inability of the bladder to empty (urinary retention), impaired kidney function (renal failure), reduced urine excretion, interstitial nephritis (a kidney disease);
Impairment of brain function (encephalopathy);
Duodenal or gastric ulcers, perforated ulcers;
Inflammation of the liver (hepatitis), sometimes severe, causing jaundice and blockage of bile flow;
Breathing difficulties, asthma, bronchospasm;
Decreased body temperature;
Vertigo;
Headache, drowsiness, Reye's syndrome (a brain disorder);
Stomach pain, indigestion; heartburn, inflammation of the stomach (gastritis);
Burning sensation in the mouth;
Urticaria;
Swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioneurotic oedema), facial swelling;
Visual disturbances.

Not known:

Fixed drug eruption (may present as round or oval patches with redness and swelling of the skin), skin eruption with blisters (urticaria), itching sensation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
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 ALGOLIDER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet. 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 ALGOLIDER contains

The active substance is Nimesulide. Each sachet contains 100 mg of nimesulide.
The other components are: Sucrose, maltodextrins, citric acid, orange flavour.

Description of the appearance of ALGOLIDER and the contents of the pack
ALGOLIDER is a granulate for oral suspension. It is available in packs of 30 sachets of 100 mg.
Marketing Authorization Holder
Siar Pharma Srl, Via Verdi 33 - Bussero (Milan)
Manufacturer
Fine Foods & Pharmaceuticals NTM Spa, Via Grignano 43 – Brembate (Bergamo)