MORNIFLU 700 mg Coated Tablet

Зміст інструкції

1. MORNIFLU 700 mg tablets, 350 mg granules for oral suspension
   1. What is MORNIFLU and what is it used for
   2. What you need to know before taking MORNIFLU
   3. How to take MORNIFLU
   4. Possible side effects
   5. How to store MORNIFLU
   6. Contents of the pack and other information
2. MORNIFLU ADULTI 700 mg suppositories
   1. What is MORNIFLU and what is it used for
   2. What you need to know before taking MORNIFLU
   3. How to take MORNIFLU
   4. Possible side effects
   5. How to store MORNIFLU
   6. Contents of the pack and other information
3. MORNIFLU BAMBINI 400 mg suppositories
   1. What is MORNIFLU and what is it used for?
   2. What you need to know before using MORNIFLU
   3. How to use MORNIFLU
   4. Possible side effects
   5. How to store MORNIFLU
   6. Contents of the pack and other information

MORNIFLU 700 mg tablets, 350 mg granules for oral suspension

morniflumate

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. See section 4.

Contents of this leaflet:

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

1. What is MORNIFLU and what is it used for

This medicine contains the active ingredient morniflumate and belongs to a class of drugs called NSAIDs
(non-steroidal anti-inflammatory drugs) which act against pain, fever and inflammation.
MORNIFLU is used:

• in ADULTSto reduce inflammation, with or without pain and/or fever, in cases of inflammation:
• of the ear (otitis), of the nasal cavities as a whole (sinusitis), of the tonsils (tonsillitis), of the mouth and throat (pharyngitis, laryngitis);
• of the trachea (tracheitis), of the bronchi (bronchitis);
• of the bladder (cystitis), of the urethra (urethritis), of the vagina (vaginitis), of the prostate (prostatitis), of the ovaries and fallopian tubes (annexitis);
• of the bones and joints (osteo-articular system);
• in CHILDRENto reduce pain associated with inflammation of the ear (otitis), of the nasal cavities as a whole (sinusitis), of the tonsils (tonsillitis), of the mouth and throat.

2. What you need to know before taking MORNIFLU

Do not take MORNIFLU:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have had allergy or asthma after taking other NSAIDs such as acetylsalicylic acid known as aspirin;
• if you have a stomach and/or duodenal ulcer (gastroduodenal);
• if you have had two or more distinct episodes of ulcer or bleeding in the stomach or intestine (including blood in vomit or during bowel movements or black, tarry stools);
• if you have had even one episode of ulcer, perforation or bleeding in the stomach or intestine caused by taking medications;
• if you have serious problems with the liver, kidneys or heart;
• after the sixth month of pregnancy.

MORNIFLU is contraindicated in children under six months of age and in children with a history of
rectal inflammation (rectitis), rectal bleeding or ulcer.
Do not take MORNIFLU oral suspension granules if you suffer from phenylketonuria.

Warnings and precautions
Talk to your doctor or pharmacist before taking MORNIFLU if:

• you are taking other NSAIDs;
• you have had stomach or intestinal problems, such as ulcer or bleeding, hiatal hernia, Crohn's disease, ulcerative colitis;
• you are taking medicines that can increase the risk of ulcers and bleeding (see section “Other medicines and MORNIFLU”);
• you are elderly or feel very weak (debilitated) or have a reduced body weight, as you are more likely to develop unwanted effects;
• you have asthma associated with chronic inflammation of the nose or sinuses and/or nasal polyps;
• you have chickenpox, as NSAIDs may worsen the severity of skin lesions caused by it
• you need to undergo urine tests to detect the presence of drugs such as marijuana and hashish, as this medicine may give positive results even in the absence of these substances.

In particular, consult your doctor cautiously if:

• you have reduced kidney function;
• you have recently undergone surgery that caused you significant blood loss;
• you have liver problems;
• you have or have had problems with the heart or blood circulation, such as stroke, heart attack or heart failure, or are at risk for these conditions (for example if you have high blood pressure, diabetes, high cholesterol or triglyceride levels, or smoke), as medicines like MORNIFLU may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. IN ALL THESE CASES, THE DOCTOR WILL EVALUATE THE NEED TO PERFORM CHECK-UP EXAMS.

BE CAREFUL, as during treatment with all NSAIDs:

• at any time, with or without warning symptoms, even in patients without a history of serious stomach or intestinal problems (gastrointestinal), bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be fatal (see section 4.8);
• although very rarely, severe skin reactions, some of which have been fatal, have been reported, manifesting with redness, blistering and exfoliation (for example, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). In the early stages of therapy, patients appear to be at higher risk: such reactions occur in most cases within the first month of treatment (see section 4.8);
• the signs of an infection can be masked.

The risk of experiencing unwanted effects increases with high doses and prolonged treatments. Do not exceed the dose
of MORNIFLU and do not take it for long periods; always carefully follow your doctor's instructions.
STOP treatment and contact your doctor if:

• you notice any symptoms affecting the stomach and intestines (gastrointestinal), especially if it is bleeding;
• a rash, mucosal lesions or any other sign of an allergic reaction appears (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure).

Children and adolescents
MORNIFLU should be administered only when absolutely necessary and under the direct supervision of a doctor
because children and adolescents are more likely to develop unwanted effects with this
medicine. In particular, children between 6 and 12 months have a high risk of serious skin effects.

Other medicines and MORNIFLU
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, as some drugs can interact with MORNIFLU or increase the risk of adverse
events, even serious.
In particular, tell your doctor if you are taking:

• corticosteroid anti-inflammatory drugs;
• drugs that thin the blood (anticoagulants and antiplatelet agents), for example warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (known as aspirin) and other NSAIDs, tirofiban, eptifibatide, abciximab, iloprost, heparin;
• diuretics and drugs for high blood pressure (hypertension) such as: ACE inhibitors, beta-blockers, angiotensin II receptor antagonists;
• drugs called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• lithium, used in depression;
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cyclosporine and tacrolimus, drugs that reduce immune defenses;
• trimethoprim, an antibiotic drug;
• potassium salts.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Do not take MORNIFLU in the last 3 months of pregnancy, as it may harm the fetus or cause problems
during childbirth. It may cause problems with the heart, lungs or kidneys of the fetus. It may affect the tendency
Yours and your baby's to bleed and delay or prolong labor more than expected.
You should not take MORNIFLU in the first 6 months of pregnancy unless absolutely necessary and under
doctor's advice.
If treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time.
From the 20th week of pregnancy, MORNIFLU can cause kidney problems in the fetus if taken for more than
a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing
narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed
for more than a few days, your doctor may recommend additional monitoring. If you are breastfeeding
with breast milk, discontinue breastfeeding as a precaution while taking Morniflu.
This medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and operating machinery
Like other NSAIDs, this medicine may cause dizziness, fatigue and decreased reflexes. Be
careful before driving vehicles or using machinery.

MORNIFLU tablets contains lactose:if your doctor has diagnosed you with intolerance to some
sugars, contact him before taking this medicine.

MORNIFLU granules contain

• sucrose:if your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine;
• sorbitol: if your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine;
• aspartame: this medicine contains a source of phenylalanine. It may be harmful if you have phenylketonuria;
• Yellow Orange S (E 110): may cause allergic reactions.

3. How to take MORNIFLU

Take this medicine following the instructions of your doctor exactly, who will indicate the correct dose,
based on your condition, and the duration of treatment. If you have any doubts, consult your doctor or pharmacist.

Adults
1 tablet of MORNIFLU 700 mg, 2 times a day

or
2 sachets of MORNIFLU 350 mg, 2 times a day.

Elderly (over 65 years)
Half a 700 mg tablet or 1 sachet of MORNIFLU 350 mg, 2-3 times a day, unless otherwise indicated
by the doctor.
The doctor will determine if a dose reduction is necessary.

Children (over 6 months of age) and adolescents

Children up to 4 years of age (10-15 Kg)
Half a sachet of MORNIFLU 350 mg, 1 time a day.

Children from 4 to 8 years of age (15-25 Kg)
Half a sachet of MORNIFLU 350 mg, 2 times a day.

Children and adolescents from 8 to 14 years of age (25-45 kg)
Half a 700 mg tablet or 1 sachet of MORNIFLU 350 mg, 2 times a day.
Since in children the dose of MORNIFLU depends on body weight, the doctor may prescribe dosages
different from those indicated.

Method of administration
Take MORNIFLU by mouth (orally) and on a full stomach.
The MORNIFLU tablets have a fracture line to facilitate dividing them into two halves. The
MORNIFLU granules sachet is divided into two parts:

• if you need to take the entire dose, open the sachet along the line indicated “entire dose”;
• to take ½ dose, open the sachet along the line indicated “half dose”.

If you take more MORNIFLU than you should
You may experience abdominal pain (gastrointestinal irritation), drowsiness, headache.
In case of taking high doses of MORNIFLU, immediately inform your doctor or go to the nearest
hospital, as appropriate measures may be necessary (e.g. activated charcoal, gastric lavage).

If you forget to take MORNIFLU
Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking MORNIFLU immediately and contact your doctor if any of the following conditions occur:

• severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, throat with difficulty breathing, sudden drop in blood pressure (anaphylactic shock);
• severe breathing difficulties (asthmatic crises);
• severe stomach problems, burning or abdominal pain due to stomach or duodenal (peptic) or abdominal ulcers;
• sudden and severe pain in the epigastrium (perforation of the ulcer);
• vomiting containing blood (hematemesis) or black stools (melena), associated with bleeding from the stomach or intestines (gastrointestinal) or unusual fatigue with reduced urine output (due to non-visible bleeding);
• severe skin rashes with redness, blistering and exfoliation (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects with unknown frequency (frequency cannot be estimated based on available data)

• worsening of skin infections caused by chickenpox;
• decrease in platelets (thrombocytopenia), decrease in white blood cells (leukopenia);
• headache and dizziness;
• heart attack (myocardial infarction) or stroke, swelling (edema), high blood pressure (hypertension), inability of the heart to supply blood in adequate quantity to the body (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
• nausea, vomiting, diarrhea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain, inflammation of the oral mucosa with ulcers (ulcerative stomatitis), worsening of inflammation in the colon (colitis) and Crohn's disease, gastritis;
• more or less sudden appearance of skin lesions, even following exposure to the sun (photosensitization dermatitis), for example, changes in color in patches or widespread (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
• alterations in kidney function (renal failure) which can cause swelling (edema), loss of protein in the urine, decreased protein in the blood (nephrotic syndrome), kidney inflammation (interstitial nephritis), presence of blood in the urine (hematuria);
• alterations in liver tests;
• alterations in tests (false positive) that detect the presence of drugs such as marijuana and hashish;
• fluoride intoxication (fluorosis), especially if MORNIFLU is taken at high doses and for several years.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at “ http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse ”. By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store MORNIFLU

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after the wording EXP. The date
of expiry refers to the last day of that month. This date applies 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 MORNIFLU contains
The active ingredient is morniflumate.
Each MORNIFLU 700 mg tablet contains 700 mg of morniflumate.
Each MORNIFLU granule sachet contains: 350 mg of morniflumate.
The other ingredients are:

• MORNIFLU tablets: lactose, crospovidone, methylhydroxypropylcellulose, magnesium stearate, sodium lauryl sulfate, hydrated colloidal silica.
• MORNIFLU granules: sucrose, sorbitol, banana flavour, maltodextrin, fruit flavour, crospovidone, hypromellose, aspartame, ammonium glycyrrhizate, xanthan gum, polysorbate 20, Sodium lauryl sulfate, Yellow Orange S (E 110).

Description of the appearance of MORNIFLU and contents of the pack
MORNIFLU 700 mg tablets are available in packs of 20 or 30 divisible tablets.
MORNIFLU 350 granules are available in packs of 20 or 30 tearable sachets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
MASTER PHARMA s.r.l. – Via G. Chiesi 1 - Parma

Manufacturer
CHIESI FARMACEUTICI S.p.A., Officine di Parma, Via S. Leonardo 96
FINE FOODS & Pharmaceuticals N.T.M. S.p.A., Via Grignano, n.43 - Brembate - Bergamo

MORNIFLU ADULTI 700 mg suppositories

morniflumate

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. See section 4.

Contents of this leaflet:

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

1. What is MORNIFLU and what is it used for

This medicine contains the active ingredient morniflumate and belongs to a class of drugs called NSAIDs
(non-steroidal anti-inflammatory drugs) which act against pain, fever and inflammation.
MORNIFLU is used in adults to reduce inflammation, with or without pain and/or fever, in cases
of inflammation:

• of the ear (otitis), of the nasal cavities as a whole (sinusitis), of the tonsils (tonsillitis), of the mouth and throat (pharyngitis, laryngitis);
• of the trachea (tracheitis), of the bronchi (bronchitis);
• of the bladder (cystitis), of the urethra (urethritis), of the vagina (vaginitis), of the prostate (prostatitis), of the ovaries and fallopian tubes (annexitis);
• of the bones and joints (musculoskeletal system).

2. What you need to know before taking MORNIFLU

Do not take MORNIFLU:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have had allergy or asthma after taking other NSAIDs such as acetylsalicylic acid known as aspirin;
• if you have a stomach and/or duodenal ulcer (gastroduodenal);
• if you have had two or more distinct episodes of ulcer or bleeding in the stomach or intestine (including blood in vomit or during bowel movements or black, tarry stools);
• if you have had even a single episode of ulcer, perforation or bleeding in the stomach or intestine caused by taking medications;
• if you have severe problems with the liver, kidneys or heart;
• if you suffer from inflammation or bleeding of the rectum (proctitis or rectorrhagia);
• after the sixth month of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking MORNIFLU if:

• you are taking other NSAIDs;
• you are taking medicines that can increase the risk of ulcers and bleeding (see section “Other medicines and MORNIFLU”);
• you have had stomach or intestinal diseases, such as ulcers or bleeding, a hiatal hernia, Crohn's disease, ulcerative colitis;
• you are elderly or feel very weak (debilitated) or have a reduced body weight, as you are more likely to develop unwanted effects;
• you have asthma associated with chronic inflammation of the nose or sinuses or nasal polyps;
• you have chickenpox, as NSAIDs may worsen the severity of skin lesions caused by it;
• you need to undergo urine tests that detect the presence of drugs such as marijuana and hashish, as this medicine can give positive results even in the absence of these substances.

In particular, consult your doctor cautiously if:

• you have reduced kidney function;
• you have recently undergone surgery that caused you a large blood loss;
• you have liver problems;
• you have or have had problems with the heart or blood vessels, such as stroke, heart attack or heart failure or are at risk for these conditions (for example if you have high blood pressure, diabetes, high cholesterol or triglycerides or smoke), as medicines like MORNIFLU may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. IN ALL THESE CASES, THE DOCTOR WILL EVALUATE THE NEED TO PERFORM CHECK-UP EXAMS.

PAY ATTENTION, as during treatment with all NSAIDs:

• at any time, with or without warning symptoms, even in patients without previous serious stomach or intestinal problems (gastrointestinal), bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be fatal (see section 4.8);
• although very rarely, severe skin reactions, some of which have been fatal, have been reported, manifesting with redness, blistering and exfoliation (for example, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). In the early stages of therapy, patients appear to be at higher risk: such reactions occur in most cases within the first month of treatment (see section 4.8);
• the signs of an infection can be masked.

The risk of experiencing unwanted effects increases with high doses and prolonged treatments. Do not exceed the dose
of MORNIFLU and do not take it for long periods; always carefully follow your doctor's instructions.
STOP treatment and contact your doctor if:

• you notice any symptoms affecting the stomach and intestines (gastrointestinal), especially if it is bleeding;
• a skin rash, mucous membrane lesions or any other sign of an allergic reaction appears (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure).

Children
MORNIFLU ADULTS 700 mg suppositories are not suitable for children. If necessary, ask your doctor or
pharmacist for advice, as there are dosages (lower) of MORNIFLU specifically for these patients.

Other medicines and MORNIFLU
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine, as some drugs can interact with MORNIFLU or increase the risk of adverse events, even serious.
In particular, tell your doctor if you are taking:

• corticosteroid anti-inflammatory drugs;
• medicines that thin the blood (anticoagulants and antiplatelet agents), for example warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (known as aspirin) and other NSAIDs, tirofiban, eptifibatide, abciximab, iloprost, heparin;
• diuretics and medicines against high blood pressure (hypertension) such as: ACE inhibitors, beta-blockers, angiotensin II antagonists;
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• lithium, used in depression;
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cyclosporine and tacrolimus, drugs that reduce the immune defenses;
• trimethoprim, an antibiotic drug;
• potassium salts.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.
Do not take MORNIFLU in the last 3 months of pregnancy, as it may harm the fetus or cause problems
during childbirth. It may cause problems with the heart, lungs or kidneys of the fetus. It may affect the tendency
Yours and the baby's to bleed and delay or prolong labor more than expected.
You should not take MORNIFLU in the first 6 months of pregnancy unless absolutely necessary and under
doctor's advice.
If you need treatment during this period or during attempts to conceive, it should be
used the minimum dose for the shortest possible time.
From the 20th week of pregnancy, MORNIFLU can cause kidney problems in the fetus, if taken for more than
a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing
narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment
for more than a few days, your doctor may recommend additional monitoring.
If you are breastfeeding, discontinue breastfeeding as a precaution while taking
MORNIFLU.
This medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and operating machinery
Like other NSAIDs, this medicine may cause dizziness, fatigue and decreased reflexes. Be careful
before driving vehicles or using machinery.

3. How to take MORNIFLU

Take this medicine following the instructions of your doctor exactly, who will indicate the correct dose,
based on your condition, and the duration of treatment. If you have any doubts, consult your doctor or pharmacist.

Adults
2 suppositories of MORNIFLU ADULTI per day, 1 in the morning and 1 in the evening.

Elderly (over 65 years)
The doctor will determine if a dose reduction is necessary.

If you take more MORNIFLU than you should
You may notice problems at the level of the rectum.
In case of ingestion/taking of high doses of MORNIFLU, immediately inform your doctor or go to
the nearest hospital, as appropriate measures may be necessary.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking MORNIFLU immediately and contact your doctor if any of the following conditions occur:

• severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, throat with difficulty breathing, sudden drop in blood pressure (anaphylactic shock);
• severe breathing difficulties (asthmatic crises);
• severe stomach problems, burning or abdominal pain due to stomach or duodenal (peptic) or abdominal ulcers;
• sudden and severe pain in the epigastrium (ulcer perforation);
• vomiting containing blood (hematemesis) or black stools (melena), associated with bleeding from the stomach or intestines (gastrointestinal) or unusual fatigue with reduced urine output (due to non-visible bleeding);
• severe skin rashes with redness, blistering and exfoliation (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects with unknown frequency (frequency cannot be defined based on available data)

• reactions at the rectum level, especially if the therapy is long or frequent or with high doses;
• worsening of skin infections caused by chickenpox;
• decrease in platelets (thrombocytopenia), decrease in white blood cells (leukopenia);
• headache and dizziness;
• heart attack (myocardial infarction) or stroke, swelling (edema), high blood pressure (hypertension), inability of the heart to supply blood in adequate quantities to the body (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
• nausea, vomiting, diarrhea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain, inflammation of the oral mucosa with ulcers (ulcerative stomatitis), worsening of inflammation in the colon (colitis) and Crohn's disease, gastritis;
• more or less sudden appearance of skin lesions, even following exposure to the sun (photosensitization dermatitis), for example, changes in color in patches or widespread (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
• alterations in kidney function (renal insufficiency) which can cause swelling (edema), loss of protein in the urine, decrease in proteins in the blood (nephrotic syndrome), inflammation of the kidney (interstitial nephritis), presence of blood in the urine (hematuria);
• alterations in liver tests;
• alterations in tests (false positive) that detect the presence of drugs such as marijuana and hashish;
• fluoride intoxication (fluorosis), especially if MORNIFLU is taken at high doses and for several years.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at the address “ http://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 MORNIFLU

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 30 °C.
Do not use this medicine after the expiry date which is stated on the pack after the wording EXP. The date
of expiry refers to the last day of that month. This applies 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 MORNIFLU contains
The active ingredient is morniflumate.
Each MORNIFLU ADULTI 700 mg suppository contains: 700 mg of morniflumate.
The other ingredients are: solid semi-synthetic glycerides.

Description of the appearance of MORNIFLU and contents of the pack
MORNIFLU ADULTI 700 mg suppositories are available in packs of 10 suppositories.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
MASTER PHARMA s.r.l. – Via G. Chiesi 1 - Parma

Manufacturer
LAMP SAN PROSPERO S.p.A., Via della Pace 25/A, S. Prospero (MO).

MORNIFLU BAMBINI 400 mg suppositories

morniflumate

Read this leaflet carefully before using 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

This medicine contains the active ingredient morniflumate and belongs to a class of drugs called NSAIDs
(non-steroidal anti-inflammatory drugs) which work against pain, fever and inflammation.
MORNIFLU is used in children to reduce pain associated with ear infections (otitis),
infections of the nasal cavities as a whole (sinusitis), tonsils (tonsillitis), mouth and throat.

2. What you need to know before using MORNIFLU

Do not use MORNIFLU:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergy or asthma after taking other NSAIDs such as acetylsalicylic acid commonly known as aspirin;
• if you have a stomach and/or duodenal ulcer (gastroduodenal);
• if you have had two or more distinct episodes of ulcer or bleeding in the stomach or intestine (including blood in vomit or during bowel movements or black, tarry stools);
• if you have had even one episode of ulcer, perforation or bleeding in the stomach or intestine caused by taking medications;
• if you have serious problems with the liver, kidneys or heart;
• if you suffer from inflammation or bleeding of the rectum (proctitis or rectorrhagia);
• after the sixth month of pregnancy.

MORNIFLU is contraindicated in children under six months of age.

Warnings and precautions
Talk to your doctor or pharmacist before using MORNIFLU if:

• you are taking other NSAIDs;
• you have had stomach or intestinal problems, such as ulcers or bleeding, a stomach hernia (hiatal), Crohn's disease, ulcerative colitis;
• you are taking medicines that can increase the risk of ulcers and bleeding (see section “Other medicines and MORNIFLU”);
• you are elderly or feel very weak (debilitated) or have a reduced body weight, as you are more likely to develop unwanted effects;
• you have asthma associated with chronic inflammation of the nose or nasal cavities (sinusitis) and/or nasal polyps;
• you have chickenpox, as NSAIDs may worsen the severity of skin lesions caused by it;
• you are going to undergo urine tests to detect the presence of drugs such as marijuana and hashish, as this medicine can give positive results even in the absence of these substances.

In particular, consult your doctor cautiously if:

• you have reduced kidney function;
• you have recently undergone surgery that caused you a large blood loss;
• you have liver problems;
• you have or have had heart or blood circulation problems, such as stroke, heart attack or heart failure or are at risk for these conditions (for example if you have high blood pressure, diabetes, high cholesterol or triglycerides or smoke), as medicines like MORNIFLU may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. IN ALL THESE CASES, THE DOCTOR WILL EVALUATE THE NEED TO PERFORM CHECK-UP EXAMS.

BE CAREFUL, as during treatment with all NSAIDs:

• at any time, with or without warning symptoms, even in patients without previous serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be fatal (see section 4.8);
• although very rarely, serious skin reactions, some of which have been fatal, have been reported, which manifest with redness, blistering and exfoliation (for example, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). In the early stages of therapy, patients appear to be at higher risk: such reactions occur in most cases within the first month of treatment (see section 4.8);
• the signs of an infection can be masked.

The risk of having unwanted effects increases with high doses and prolonged treatments. Do not exceed the dose
of MORNIFLU and do not take it for long periods; always carefully follow the doctor's instructions.
STOP treatment and contact your doctor if:

• you notice any symptoms affecting the stomach and intestines (gastrointestinal), especially if it is bleeding;
• a skin rash, mucous membrane lesions or any other sign of an allergic reaction appears (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure).

Children and adolescents
MORNIFLU should be administered only when necessary and under the direct supervision of the doctor
because children and adolescents are more likely to develop unwanted effects with this
medicine. In particular, children between 6 and 12 months have a high risk of serious skin side effects.

Other medicines and MORNIFLU
Tell your doctor or pharmacist if you are taking, have recently taken or may take any
other medicines, as some drugs may interact with MORNIFLU or increase the risk of adverse events,
even serious.
In particular, you should tell your doctor if you are taking:

• corticosteroid anti-inflammatory drugs;
• drugs that thin the blood (anticoagulants and antiplatelet agents), for example warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (commonly known as aspirin) and other NSAIDs, tirofiban, eptifibatide, abciximab, iloprost, heparin;
• diuretics and drugs against high blood pressure (hypertension) such as: ACE inhibitors, beta-blockers, angiotensin II antagonists;
• drugs called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• lithium, used in depression;
• methotrexate, used in the treatment of cancer and for some types of autoimmune diseases, such as rheumatoid arthritis;
• cyclosporine and tacrolimus, drugs that reduce the immune defenses;
• trimethoprim, an antibiotic drug;
• potassium salts.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.
Do not take MORNIFLU in the last 3 months of pregnancy, as it may harm the fetus or cause problems
during childbirth. It may cause problems with the heart, lungs or kidneys of the fetus. It may affect the tendency
Yours and the baby's to bleed and delay or prolong labor longer than expected.
You should not take MORNIFLU in the first 6 months of pregnancy unless absolutely necessary and under
doctor's advice.
If treatment is needed during this period or during attempts to conceive, it should be
used the minimum dose for the shortest possible time.
From the 20th week of pregnancy, MORNIFLU can cause kidney problems in 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. If treatment is needed
for more than a few days, the doctor may recommend additional monitoring.
If you are breastfeeding, discontinue breastfeeding as a precaution while taking
MORNIFLU.
This medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and using machines
Like other NSAIDs, this medicine may cause dizziness, fatigue and decreased reflexes. Be
careful before driving vehicles or using machinery.

3. How to use MORNIFLU

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.

Children from 6 to 12 months of age:1 suppository of MORNIFLU BAMBINI per day.

Children over 1 year of age:from 1 to 3 suppositories of MORNIFLU BAMBINI per day, depending on weight
and age
Because in children the dose of MORNIFLU depends on body weight and age, your doctor will indicate the
dosage to be administered.
In children, the duration of treatment with MORNIFLU should not exceed 4-5 days.

If you use more MORNIFLU than you should
You may notice problems at the level of the rectum.
In case of ingestion/taking of high doses of MORNIFLU, immediately inform your doctor or go to the
nearest hospital, as appropriate measures may be necessary.

If you forget to use MORNIFLU
Do not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking MORNIFLU immediately and contact your doctor if any of the following conditions occur:

• severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, throat with difficulty breathing, sudden drop in blood pressure (anaphylactic shock);
• severe breathing difficulties (asthmatic crises);
• serious stomach problems, burning or abdominal pain due to stomach or duodenal (peptic) or abdominal ulcers;
• severe and sudden pain in the epigastrium (ulcer perforation);
• vomiting containing blood (hematemesis) or black stools (melena), associated with bleeding from the stomach or intestines (gastrointestinal) or unusual fatigue with reduced urine output (due to non-visible bleeding);
• severe skin rashes with redness, blistering and exfoliation (e.g. Stevens-Johnson Syndrome, toxic epidermal necrolysis).
• Other side effects with unknown frequency (frequency cannot be estimated based on available data)
• reactions at the rectum level, especially if the therapy is long or frequent or with high doses;
• worsening of skin infections caused by chickenpox;
• decrease in platelets (thrombocytopenia), decrease in white blood cells (leukopenia);
• headache and dizziness;
• heart attack (myocardial infarction) or stroke, swelling (edema), high blood pressure (hypertension), inability of the heart to supply blood in adequate quantities to the body (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
• nausea, vomiting, diarrhea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain, inflammation of the oral mucosa with ulcers (ulcerative stomatitis), worsening of inflammation in the colon (colitis) and Crohn's disease, gastritis;
• more or less sudden appearance of skin lesions, even after exposure to the sun (photosensitivity dermatitis), for example, changes in color in patches or widespread (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
• alterations in kidney function (renal insufficiency) which can cause swelling (edema), protein loss with urine, decreased proteins in the blood (nephrotic syndrome), inflammation of the kidney (interstitial nephritis), presence of blood in the urine (hematuria);
• alterations in liver tests;
• alterations in tests (false positive) that detect the presence of drugs such as marijuana and hashish;
• fluoride intoxication (fluorosis), especially if MORNIFLU is taken at high doses and for many years.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at “ http://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 MORNIFLU

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30 °C.
Do not use this medicine after the expiry date which is stated on the pack after the wording EXP. The expiry date
refers to the last day of that month. This date applies 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 MORNIFLU contains
The active ingredient is morniflumate.
Each MORNIFLU BAMBINI 400 mg suppository contains: 400 mg of morniflumate.
The other ingredients are: semi-synthetic solid glycerides.

Description of the appearance of MORNIFLU and contents of the pack
MORNIFLU BAMBINI 400 mg suppositories are available in packs of 10 suppositories.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
MASTER PHARMA s.r.l. – Via G. Chiesi 1 - Parma

Manufacturer
LAMP SAN PROSPERO S.p.A., Via della Pace 25/A, S. Prospero (MO).