SARIDON 10 mg Coated Tablet

Зміст інструкції

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

Saridon tablets

paracetamol 250 mg, propyphenazone 150 mg and caffeine 25 mg

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after three days.

Contents of this leaflet:

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

1. What is Saridon and what is it used for?

Saridon belongs to the therapeutic category of analgesics-antipyretics (medicines used for the reduction of pain and fever).
Saridon is used for the symptomatic treatment of acute painful conditions (i.e. of short duration, such as headache, toothache, neuralgia, menstrual pains) and febrile states.
Do not take the product for more than 3 consecutive days without consulting your doctor.

2. What you need to know before taking Saridon

Do not take Saridon

• if you are allergic to paracetamol, propyphenazone or caffeine or to any of the other components of this medicine (listed in paragraph 6);
• if you are allergic to other substances closely related from a chemical point of view;
• if you have a history of gastrointestinal bleeding (stomach and intestines) or perforation related to previous active treatments or a history of recurrent peptic ulcer (on the inner lining of the stomach, duodenum or esophagus) (two or more distinct episodes of demonstrated ulceration or bleeding);
• if you suffer from blood disorders (hematopathies) such as granulocytopenia (low number of granulocytes, a particular type of white blood cells, in the blood) and intermittent porphyria (deficiency of an enzyme known as PGB deaminase);
• if you suffer from glucose-6-phosphate dehydrogenase deficiency (disease commonly called favism);
• if you suffer from severe hemolytic anemia (anemia determined by the destruction of red blood cells);
• if you suffer from severe hepatocelluar insufficiency (insufficient function of liver cells), renal or cardiac (the heart's inability to pump the adequate amount of blood needed by the body);
• if you are pregnant or if you are breastfeeding (see “Pregnancy and breastfeeding”). Saridon should not be administered to children under 12 years of age due to the presence of caffeine. P a g . 1 | 7

Warnings and precautions
Consult your doctor or pharmacist before taking Saridon:

• if you suffer from or have suffered from gastric or duodenal ulcers; in this case, the use of Saridon must be carefully monitored by a doctor. NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) must be administered with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. If you have suffered from gastrointestinal toxicity, you should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) in particular in the early stages of treatment;
• if you suffer from renal (reduced kidney function) or hepatic (reduced liver function) insufficiency, Gilbert's syndrome (a benign liver disease that manifests with excessive and uncontrolled increase in bilirubin) or hematopoietic disorders (of the formation of cellular components of the blood);
• if you are taking any other medicine that contains the same active ingredient (paracetamol), as if paracetamol is taken in high doses, serious adverse reactions can occur (see also “Other medicines and Saridon”);
• if you suffer from asthma, chronic rhinitis or chronic urticaria, as isolated cases of asthma attacks and anaphylactic shock associated with the intake of medicines containing propyphenazone and paracetamol have been reported;
• if you have heart problems or a history of stroke (cerebrovascular accident) or think you may be at risk for these conditions (for example if you have high blood pressure, high cholesterol levels, diabetes or if you smoke) because the use of some NSAIDs (especially at high doses and for long-term treatments) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke);
• if you have a history of hypertension (high blood pressure) and/or heart failure (the heart's inability to pump the adequate amount of blood needed by the body), as fluid retention, hypertension and edema (swelling caused by an excessive accumulation of fluid in cells or tissues) have been found in association with treatment with NSAIDs (Non-Steroidal Anti-Inflammatory Drugs);
• if you suffer from hyperthyroidism: in this case, the use of Saridon must be carefully monitored by a doctor.

Children and adolescents
Saridon should not be taken by children under 12 years of age.

Other medicines and Saridon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription. The use of Saridon should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors.
Be particularly careful if you are taking:

• Medicines that slow down gastric emptying (e.g. propantheline), as they may slow down the absorption of paracetamol with a consequent delay in the onset of activity;
• Corticosteroids (contain cortisol, a hormone produced by the adrenal glands), as concurrent use increases the risk of ulceration or gastrointestinal bleeding;
• Oral anticoagulants (medicines that prevent blood clotting), such as warfarin: NSAIDs may increase the effects of anticoagulants; also paracetamol can increase the effects of anticoagulants, therefore, it should not be taken for long periods without medical control; in case of oral anticoagulant therapy, it is advisable to reduce the doses;
• Antiplatelet agents (medicines that prevent blood clotting) and selective serotonin reuptake inhibitors (SSRIs, antidepressants), as the risk of gastrointestinal bleeding increases;
• Diuretics (medicines that increase urine production), ACE inhibitors and angiotensin II antagonists (medicines used to treat high blood pressure), as NSAIDs may reduce the effect of diuretics and other antihypertensive medicines. In case of P a g . 2 | 7

administration on the same day, take particular care, especially if you have impaired renal (in particular if you are elderly or dehydrated) function; after starting concomitant therapy, you should hydrate adequately and your doctor should consider monitoring renal function;

• Hypoglycemic agents (medicines used in the treatment of diabetes), such as acetamide, chlorpropamide, tolbutamide;
• Probenecid (medicine used to treat gout and hyperuricemia [high concentration of uric acid in the blood]): in case of concomitant treatment, your doctor should consider a reduction in the dosage of paracetamol;
• Medicines that increase the rate of gastric emptying (e.g. metoclopramide, domperidone), as they lead to an increase in the rate of absorption of paracetamol;
• Cholestyramine (medicine used to reduce cholesterol levels in the blood) as it reduces the rate and degree of absorption of paracetamol;
• Chloramphenicol (antibiotic), as paracetamol may increase its half-life (the time it takes to reduce by half the amount of a medicine in plasma or blood) and therefore, potentially, increase its toxicity;
• AZT (zidovudine - antiretroviral, against the attack of some viruses); the concomitant use of paracetamol and AZT increases the tendency to a reduction in the count of leukocytes or white blood cells (neutropenia). The product, therefore, should not be taken in association with AZT (zidovudine) except on medical prescription;
• Anti-inflammatory (NSAIDs) and analgesic (opioid) medicines, as the simultaneous administration with Saridon potentiates the analgesic effect. It is not advisable to use Saridon if you are being treated with anti-inflammatory drugs;
• Lamotrigine (antiepileptic): paracetamol may reduce the effectiveness of lamotrigine;
• Protective agents (misoprostol or proton pump inhibitors): the concomitant use of protective agents should be considered in elderly patients and also in patients who take low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events;
• Tropisetron and granisetron (antiemetics, medicines used against nausea and vomiting): these medicines can completely inhibit the analgesic effect of paracetamol.

If you are being treated with rifampicin (antibiotic), cimetidine (medicine against stomach acidity) or with antiepileptic medicines (phenytoin, glutethimide, phenobarbital, carbamazepine) use paracetamol with extreme caution and only under strict medical control.
The administration of paracetamol may interfere with the determination of uricemia (by the phosphotungstic acid method) and with that of glycemia (by the glucose-oxidase-peroxidase method). If you are to undergo blood tests such as those indicated above, inform your doctor.
Tell your doctor or pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a serious risk of alterations in blood and fluids (metabolic acidosis with elevated anion gap) that must be treated urgently and that can occur in particular in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism and if the maximum daily doses of paracetamol are used.

Saridon with alcohol
The product may interact with alcohol; moderate alcohol consumption in conjunction with the intake of paracetamol, even at low doses, may increase the risk of liver damage (to the liver).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
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Pregnancy
Do not take Saridon if you are pregnant, as it may harm the fetus or cause problems during delivery.
NSAIDs can cause problems with the kidneys and heart of the fetus. They may affect the tendency of the mother and child to bleed and delay or prolong labor more than expected.
From the 20th week of pregnancy, NSAIDs can cause kidney problems in the fetus, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing constriction of a blood vessel (ductus arteriosus) in the baby's heart.
Avoid using the medicine even if you suspect a state of pregnancy or wish to plan a pregnancy
Breastfeeding
Saridon should not be used during breastfeeding.

Driving and using machines
Due to the possible occurrence of dizziness or drowsiness, Saridon may impair the ability to drive vehicles and use machinery.

3. How to take Saridon

Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take Saridon with a full stomach.
Swallow the medicine with plenty of water.

Recommended doses are:
Adults: 1-2 tablets, up to a maximum of 4 tablets in 24 hours.

Use in elderly patients and patients with a history of ulcer:elderly patients should adhere to the
minimum dosages indicated above.
Caution: do not exceed the indicated doses without your doctor's advice.

Do not take for more than 3 consecutive days without consulting your doctor.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change
in its characteristics.

If you take more Saridon than you should
If you accidentally ingest/take an excessive dose of Saridon, inform your doctor immediately
or go to the nearest hospital. Prompt medical intervention is important even if there are no
evident signs or symptoms.
The symptoms of acute paracetamol poisoning are: nausea, vomiting, abdominal pain,
sweating and general malaise. Liver damage has been described due to the progressive necrosis of
liver cells and kidney damage resulting from tubular necrosis (destruction of renal tubular cells). Due to the presence of caffeine, and with high doses, hyperstimulation may occur
resulting in excitement, insomnia, muscle tremors, nausea, vomiting, increased urine output, increased heart rate, palpitations.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
When gastrointestinal bleeding or ulceration occurs in patients taking Saridon, treatment should be stopped.

Serious side effects:
If fever returns or sore throat appears during treatment, stop therapy and consult your doctor.
Severe skin reactions, some of which have been fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). The highest risk appears to be in the early stages of therapy, as the onset of the reaction in most cases occurs within the first month of treatment.
Stop treatment with Saridon at the first appearance of skin rash, mucosal lesions or any other sign of allergy.
The adverse reactions listed below are derived from spontaneous reports and therefore it is not possible to organize them by frequency categories.

Skin (skin) and subcutaneous tissue disorders:
Skin reactions of varying types and severity have been reported, including:

• skin rash;
• itching;
• urticaria;
• allergic edema and angioedema (areas of skin that are swollen and itchy, located more frequently on the extremities, external genitalia and face, especially in the region of the eyes and lips);
• acute generalized pustulosis (eruption of small, superficial pustules);
• fixed erythema (erythematous patches of reddish-purple color);
• erythema multiforme (skin lesions of bright red color caused by inflammation of blood vessels);
• bullous reactions including Stevens-Johnson syndrome and epidermal necrolysis (very rarely) (two serious skin diseases with a possible fatal outcome).

Immune system disorders:

• hypersensitivity reactions (allergic reactions) such as cyanosis (bluish discoloration of the skin and mucous membranes), sweating, nausea, hypotension (low blood pressure), dyspnea (difficulty breathing), asthma, laryngeal edema (swelling of the larynx often accompanied by difficulty breathing), anaphylactoid reaction, anaphylactic reaction, anaphylactic shock (possible symptoms of an anaphylactic reaction are: a severe and sudden drop in blood pressure, acceleration or slowing of the heartbeat, unusual fatigue or weakness, anxiety, agitation, dizziness, loss of consciousness, difficulty breathing [due to laryngeal obstruction or bronchospasm] or swallowing).

Hematopoietic system disorders (blood diseases):

• alterations in blood cell counts (revealed in blood tests), such as thrombocytopenia (low number of platelets in the blood), thrombocytopenic purpura (blood clotting disorder), leukopenia (low number of white blood cells in the blood), anemia (low number of red blood cells in the blood), agranulocytosis (low number of granulocytes, a type of white blood cells, in the blood), pancytopenia (low number of all cells present in the blood).

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During the administration of therapeutic doses of paracetamol, an elevation of serum alanine-aminotransferase (ALT) may occur.

Nervous system disorders:

• dizziness;
• drowsiness.

Hepatobiliary disorders (liver, gallbladder and bile ducts):

• impaired liver function;
• hepatitis;
• dose-dependent liver failure, hepatic necrosis (destruction of liver cells) potentially fatal (see “Warnings and precautions” and “If you take more Saridon than you should”).

Renal and urinary disorders:

• acute renal failure (rapid decrease in kidney function);
• interstitial nephritis (inflammation of the kidneys);
• hematuria (presence of blood in the urine);
• anuria (absence of urine output).

Gastrointestinal disorders
The most commonly observed adverse events are of a gastrointestinal nature:

• peptic ulcers (lesion of the stomach mucosa), perforation or gastrointestinal bleeding, sometimes fatal, especially in the elderly, can occur in association with the use of non-steroidal anti-inflammatory drugs (see “Warnings and precautions”). In the elderly and patients with a history of ulcers, especially if complicated by bleeding or perforation (see paragraph 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. In this case, treatment should be started with the lowest available dose;
• nausea;
• vomiting;
• diarrhea;
• flatulence (gas in the intestine);
• constipation;
• dyspepsia (difficulty digesting);
• abdominal pain;
• melena (presence of blood in the stool: the stool is dark in color);
• hematemesis (vomiting blood);
• ulcerative stomatitis (inflammation of the oral mucosa);
• exacerbation of colitis;
• Crohn's disease (a severe inflammation of the intestine; see “Warnings and precautions”);
• gastritis (less frequently).

Thoracic and mediastinal disorders:

• bronchospasm and asthma (breathing difficulties), including analgesic-induced asthma syndrome.

Edema (swelling caused by an excessive accumulation of fluid in cells or tissues), hypertension (high blood pressure) and heart failure (the inability of the heart to pump the adequate amount of blood needed by the body) have been reported in association with the treatment with NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
Medicines like Saridon may be associated with a modest increase in the risk of arterial thrombotic events such as heart attack (“myocardial infarction”) or stroke (cerebrovascular accident).
Continuous use of paracetamol, especially in association with other analgesics, can lead to permanent kidney damage and renal failure (analgesic nephropathy).
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High or prolonged doses of the product can cause a high-risk hepatopathy and alterations in blood count even serious.
Side effects can be minimized by using the lowest effective dose for the shortest duration possible of treatment needed to control the symptoms.
These side effects are generally transient. When they occur, however, it is advisable to consult your doctor or pharmacist.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Saridon

Keep this medicine out of sight and reach of children.
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Do not dispose of any medicine in wastewater 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 Saridon contains

• The active ingredients are: paracetamol, propyphenazone and caffeine. 1 tablet contains: paracetamol 250 mg, propyphenazone 150 mg, caffeine 25 mg.
• The other ingredients are: microcrystalline cellulose, povidone, corn starch, hypromellose, talc, magnesium stearate, precipitated silica.

Description of the appearance of Saridon and contents of the pack
Saridon is available as oral tablets.
The pack contains 5, 10 or 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bayer S.p.A. Viale Certosa 130, 20156 Milan.
Sales concessionaire
Bruno Farmaceutici S.p.A
Via delle Ande, 15
00144 Rome

Manufacturer
Delpharm Gaillard- Gaillard plant (France).
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