Morniflu: detailed information

Package leaflet: Information for the patient

MORNIFLU 700 mg tablets, 350 mg granules for oral suspension

morniflumate
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 they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MORNIFLU is and what it is used for

This medicinal product contains the active substance morniflumate and belongs to a class of medicines 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 inflammatory conditions of:
- the ear (otitis), nasal cavities as a whole (sinusitis), tonsils (tonsillitis), mouth and throat (pharyngitis, laryngitis);
- the trachea (tracheitis), bronchi (bronchitis);
- the bladder (cystitis), urethra (urethritis), vagina (vaginitis), prostate (prostatitis), ovaries and fallopian tubes (adnexitis);
- bones and joints (musculoskeletal system);
in CHILDREN to reduce pain associated with inflammatory conditions of the ear (otitis), nasal cavities as a whole (sinusitis), tonsils (tonsillitis), mouth and throat.

2. What you need to know before taking MORNIFLU

Do not take MORNIFLU:

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 had an allergic reaction or asthma after taking other NSAIDs such as acetylsalicylic acid (aspirin);
if you have a stomach and/or duodenal (gastroduodenal) ulcer;
if you have had two or more separate episodes of stomach or intestinal ulcer or bleeding (including blood in vomit or during bowel movements, or black, tarry stools);
if you have ever experienced a single episode of ulcer, perforation, or gastrointestinal bleeding caused by taking medications;
if you have severe liver, kidney, or heart problems;
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 ulceration.
Do not take MORNIFLU oral suspension granules if you have 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 disorders, such as ulcers or bleeding, hiatal hernia, Crohn’s disease, or ulcerative colitis;
you are taking medicines that may increase the risk of ulcers and bleeding (see section “Other medicines and MORNIFLU”);
you are elderly, feel very weak (debilitated), or have low body weight, as you may be more likely to experience adverse effects;
you have asthma associated with chronic inflammation of the nose or nasal sinuses (sinusitis) and/or nasal polyps;
you have chickenpox, as NSAIDs may worsen the severity of skin lesions caused by it;
you are undergoing urine tests detecting drugs such as marijuana and hashish, since this medicine may yield 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 involving significant blood loss;
you have liver problems;
you have or have had heart or circulatory 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, elevated cholesterol or triglycerides, or smoke), since medicines like MORNIFLU may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. IN ALL THESE CASES, YOUR DOCTOR WILL EVALUATE WHETHER REGULAR MONITORING TESTS ARE NEEDED.

BE CAREFUL, because during treatment with all NSAIDs:

at any time, with or without warning symptoms, even in patients without previous serious gastrointestinal problems, cases of gastrointestinal bleeding, ulceration, or perforation of the stomach or intestine have been reported, which may be fatal (see section 4.8);
very rarely, severe skin reactions have been reported, some of which have been fatal, manifesting as redness, blistering, and skin peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). During the initial stages of therapy, patients appear to be at higher risk: such reactions usually occur within the first month of treatment (see section 4.8);
signs of infection may be masked.

The risk of adverse effects increases with higher doses and prolonged treatment. Do not exceed the recommended dose
of MORNIFLU and do not take it for long periods; always follow your doctor’s instructions carefully.
STOP TREATMENT AND CONTACT YOUR DOCTOR IMMEDIATELY IF:

you notice any gastrointestinal symptoms, especially bleeding;
a skin 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).

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

corticosteroids (steroidal anti-inflammatory drugs);
blood-thinning medicines (anticoagulants and antiplatelet agents), e.g., warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (aspirin), other NSAIDs, tirofiban, eptifibatide, abciximab, iloprost, heparin;
diuretics and medicines for high blood pressure (hypertension), such as: ACE inhibitors, beta-blockers, angiotensin II antagonists;
medicines known as 'selective serotonin reuptake inhibitors' (SSRIs), used as antidepressants;
lithium, used in depression;
methotrexate, used in cancer treatment and certain immune system disorders, e.g., rheumatoid arthritis;
cyclosporine and tacrolimus, medicines that suppress the immune system;
trimethoprim, an antibiotic;
potassium salts.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Do not take MORNIFLU during the last three months of pregnancy, as it may harm the fetus or cause complications
during delivery. It may cause heart, lung, or kidney problems in the fetus. It may also affect your and your baby’s tendency to bleed and delay or prolong labor beyond normal duration.
You should not take MORNIFLU during the first six months of pregnancy unless absolutely necessary and under
medical advice.
If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible time should be used.
From the 20th week of pregnancy, MORNIFLU may cause kidney problems in the fetus if taken for more than
a few days, thereby reducing amniotic fluid levels surrounding the baby (oligohydramnios), or cause 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, discontinue breastfeeding as a precautionary measure during MORNIFLU treatment.
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 reduced reflexes. Be cautious
before driving vehicles or operating machinery.

MORNIFLU tablets contain lactose: if your doctor has diagnosed you with an intolerance to certain
sugars, contact him/her before taking this medicine.

MORNIFLU granules contain:

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

3. How to take MORNIFLU

Take this medicine exactly as instructed by your doctor, who will determine the correct dose according to your condition and the duration of treatment. If you have any doubts, consult your doctor or pharmacist.
Adults
1 tablet of MORNIFLU 700 mg, twice daily
or
2 sachets of MORNIFLU 350 mg, twice daily.
Elderly (over 65 years of age)
Half a 700 mg tablet or 1 sachet of MORNIFLU 350 mg, 2-3 times daily, unless otherwise indicated by the doctor.
Your doctor will determine whether 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, once daily.
Children from 4 to 8 years of age (15-25 kg)
Half a sachet of MORNIFLU 350 mg, twice daily.
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, twice daily.
Since the dose of MORNIFLU in children depends on body weight, your doctor may prescribe doses different from those indicated above.
Method of administration
Take MORNIFLU by mouth (oral administration) with food.
MORNIFLU tablets have a score line to facilitate splitting into two equal halves. The MORNIFLU granular sachet is divided:

to take the full dose, open the sachet along the line marked “full dose”;
to take ½ dose, open the sachet along the line marked “half dose”.

If you take more MORNIFLU than you should
You may experience abdominal pain (gastrointestinal irritation), drowsiness, headache.
If you take excessive amounts of MORNIFLU, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be required (e.g. activated charcoal, gastric lavage).
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 you experience any of the following conditions:

severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, throat with breathing difficulties, sudden drop in blood pressure (anaphylactic shock);
severe breathing difficulties (asthma attacks);
severe stomach problems, burning sensation or abdominal pain due to stomach or duodenal (peptic) ulcer or abdominal ulcer;
sudden, severe pain in the upper abdomen (perforation of the ulcer);
vomiting blood (haematemesis) or black stools (melena), associated with bleeding in the stomach or intestine (gastrointestinal), or unusual fatigue with reduced urine output (due to non-visible bleeding);
severe skin rashes with redness, blistering and skin peeling (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects with unknown frequency (frequency cannot be estimated from the available data)

worsening of skin infections caused by chickenpox;
decrease in platelets (thrombocytopenia), decrease in white blood cells (leucopenia);
headache and dizziness;
heart attack (myocardial infarction) or stroke, swelling (oedema), high blood pressure (hypertension), inability of the heart to supply sufficient blood to the body (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
nausea, vomiting, diarrhoea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain, inflammation of the mouth mucosa with ulcers (ulcerative stomatitis), worsening of inflammation of the colon (colitis) and Crohn's disease, gastritis;
more or less sudden appearance of skin lesions, even after exposure to sunlight (photosensitivity dermatitis), such as discolouration in spots or widespread (skin rashes, purpura, erythema multiforme and dermatitis), urticaria, itching;
changes in kidney function (renal failure) which may cause swelling (oedema), loss of protein in urine, decreased protein levels in blood (nephrotic syndrome), inflammation of the kidney (interstitial nephritis), presence of blood in urine (haematuria);
changes in liver function tests;
interference with drug screening tests (false positive results) for substances such as marijuana and hashish;
fluoride poisoning (fluorosis), especially if MORNIFLU is taken at high doses and for several years.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website: “http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
Reporting side effects helps 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 stated on the packaging after the word EXP. The expiry
date refers to the last day of that month. This date applies to the product in its original, unopened
packaging, properly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MORNIFLU contains
The active substance is morniflumate.
Each MORNIFLU 700 mg tablet contains 700 mg of morniflumate.
Each sachet of MORNIFLU granules 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 glycyrrhizinate, xanthan gum, polysorbate 20, sodium lauryl sulfate, orange yellow 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 bipartite 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

Patient information leaflet

MORNIFLU ADULTS 700 mg suppositories

morniflumate
Please 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, consult 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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What MORNIFLU is and what it is used for
What you need to know before taking MORNIFLU
How to take MORNIFLU
Possible side effects
How to store MORNIFLU
Package contents and other information

1. What MORNIFLU is and what it is used for

This medicinal product contains the active substance morniflumate and belongs to a class of medicines known as 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 the following inflammatory conditions:

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

2. What you should know before taking MORNIFLU

Do not take MORNIFLU:

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 had an allergic reaction 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 experienced two or more separate episodes of stomach or intestinal ulceration or bleeding (including blood in vomit or during bowel movements, or black, tarry stools);
if you have ever had a single episode of stomach or intestinal ulcer, perforation, or bleeding caused by taking medications;
if you have severe problems with your 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
Consult your doctor or pharmacist before taking MORNIFLU if:

you are taking other NSAIDs;
you are taking medicines that may increase the risk of ulcers and bleeding (see section “Other medicines and MORNIFLU”);
you have had stomach or intestinal disorders, such as ulcers or bleeding, hiatal hernia, Crohn’s disease, or ulcerative colitis;
you are elderly, feel very weak (debilitated), or have low body weight, as you are more likely to develop side effects;
you have asthma associated with chronic inflammation of the nose or nasal cavities (sinusitis) and/or nasal polyps;
you have chickenpox, since NSAIDs may worsen the severity of skin lesions caused by it;
you are undergoing urine tests that detect 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 carefully if:

you have reduced kidney function;
you have recently undergone surgery resulting in significant blood loss;
you have liver problems;
you have or have had heart or blood vessel 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), since medicines like MORNIFLU may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. IN ALL THESE CASES, YOUR DOCTOR WILL EVALUATE WHETHER REGULAR CHECK-UPS ARE NECESSARY.

BE CAREFUL, because during treatment with all NSAIDs:

at any time, with or without warning symptoms, even in patients without previous serious gastrointestinal problems, cases of gastrointestinal bleeding, ulceration, or perforation of the stomach or intestine have been reported, which may be fatal (see section 4.8);
very rarely, severe skin reactions, some of which have been fatal, have been reported, manifesting as redness, blistering, and skin peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). During the initial stages of therapy, patients appear to be at higher risk: such reactions occur mostly within the first month of treatment (see section 4.8);
signs of infection may be masked.

The risk of experiencing side effects increases with higher doses and prolonged treatment. Do not exceed the recommended dose of MORNIFLU or take it for extended periods; always follow your doctor's instructions carefully.
DISCONTINUE treatment and contact your doctor if:

you notice any gastrointestinal symptoms, especially if they involve bleeding;
a skin 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
MORNIFLU ADULTS 700 mg suppositories are not suitable for children. If necessary, consult your doctor or pharmacist, as lower-dose formulations of MORNIFLU are available specifically for these patients.

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

corticosteroids (steroidal anti-inflammatory drugs);
blood-thinning medicines (anticoagulants and antiplatelet agents), e.g., warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (aspirin), other NSAIDs, tirofiban, eptifibatide, abciximab, iloprost, heparin;
diuretics and medicines for high blood pressure (hypertension), such as ACE inhibitors, beta-blockers, angiotensin II antagonists;
medicines known as 'selective serotonin reuptake inhibitors' (SSRIs), used as antidepressants;
lithium, used in depression;
methotrexate, used in cancer treatment and certain immune system disorders, such as rheumatoid arthritis;
cyclosporine and tacrolimus, medicines that suppress the immune system;
trimethoprim, an antibiotic;
potassium salts.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take MORNIFLU during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause problems with the baby’s heart, lungs, or kidneys. It may affect bleeding tendencies in both you and the baby and delay or prolong labor beyond normal duration.
You should not take MORNIFLU during the first six months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible time should be used.
From the 20th week of pregnancy, MORNIFLU may cause kidney problems in the fetus if taken for more than a few days, leading to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or causing constriction 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 breastfeeding, discontinue breastfeeding as a precautionary measure during treatment with MORNIFLU.
This medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and use of machinery
Like other NSAIDs, this medicine may cause dizziness, fatigue, and reduced reflexes. Exercise caution before driving vehicles or operating machinery.

3. How to take MORNIFLU

Take this medicine exactly as your doctor has instructed. Your doctor will determine the correct dose for you, based on your condition, and the duration of treatment. If you have any doubts, consult your doctor or pharmacist.
Adults
2 MORNIFLU ADULT suppositories per day, 0ne in the morning and one in the evening.
Elderly (over 65 years)
Your doctor will decide whether a dose reduction is necessary.
If you take more MORNIFLU than you should
You may experience problems affecting the rectum.
If you have taken or ingested a large dose of MORNIFLU, inform your doctor immediately or go to the nearest hospital, as appropriate measures may be required.
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 everyone experiences them.
Stop taking MORNIFLU immediately and contact your doctor if you experience any of the following conditions:

severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, or throat with breathing difficulties, sudden drop in blood pressure (anaphylactic shock);
severe breathing difficulties (asthma attacks);
severe stomach problems, burning sensation or abdominal pain due to stomach or duodenal (peptic) ulcer or abdominal ulcer;
sudden, severe pain in the upper abdomen (perforation of the ulcer);
vomiting blood (haematemesis) or black stools (melena), associated with bleeding in the stomach or intestines (gastrointestinal), or unusual fatigue accompanied by reduced urine output (due to non-visible bleeding);
severe skin rashes with redness, blistering, and skin peeling (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects with unknown frequency (frequency cannot be estimated from the available data)

rectal reactions, especially if treatment is prolonged, frequent, or involves high doses;
worsening of skin infections caused by chickenpox;
reduced platelet count (thrombocytopenia), reduced white blood cell count (leucopenia);
headache and dizziness;
heart attack (myocardial infarction) or stroke, swelling (edema), high blood pressure (hypertension), inability of the heart to supply adequate blood to the body (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
nausea, vomiting, diarrhoea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain, inflammation of the mouth mucosa with ulcers (ulcerative stomatitis), worsening of colon inflammation (colitis) and Crohn's disease, gastritis;
more or less sudden appearance of skin lesions, even after sun exposure (photosensitivity dermatitis), such as patchy or widespread skin discoloration (skin rashes, purpura, erythema multiforme, and dermatitis), urticaria, itching;
changes in kidney function (renal failure) which may cause swelling (edema), loss of protein in urine, reduced protein levels in blood (nephrotic syndrome), kidney inflammation (interstitial nephritis), presence of blood in urine (haematuria);
changes in liver function tests;
interference with drug screening tests (false positive results) for substances such as marijuana and hashish;
fluoride poisoning (fluorosis), particularly if MORNIFLU is taken at high doses and for several years.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the packaging after the word "EXP". The expiry date refers to the last day of that month. This date applies to the product in its original, unopened packaging stored under the recommended conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MORNIFLU contains
The active substance is morniflumate.
Each MORNIFLU ADULT 700 mg suppository contains: 700 mg of morniflumate.
The other components are: solid semisynthetic glycerides.

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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).

Patient information leaflet: information for the patient

MORNIFLU CHILDREN 400 mg suppositories

morniflumate
Please read this leaflet carefully before using 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, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What MORNIFLU is and what it is used for
What you need to know before using MORNIFLU
How to use MORNIFLU
Possible side effects
How to store MORNIFLU
Contents of the pack and other information

1. What MORNIFLU is and what it is used for

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

2. What you need to know before using MORNIFLU

Do not use MORNIFLU:

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 had an allergic reaction 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 separate episodes of stomach or intestinal ulcer or bleeding (including blood in vomit or during bowel movements, or black, tarry stools);
if you have ever had a single episode of stomach or intestinal ulcer, perforation, or bleeding caused by taking medications;
if you have severe problems with your 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 disorders, such as ulcers or bleeding, hiatal hernia, Crohn's disease, ulcerative colitis;
you are taking medicines that may increase the risk of ulcers and bleeding (see section “Other medicines and MORNIFLU”);
you are elderly, feel very weak (debilitated), or have low body weight, as you are more likely to develop side effects;
you have asthma associated with chronic inflammation of the nose or nasal cavities (sinusitis) and/or nasal polyps;
you have chickenpox, since NSAIDs may worsen the severity of skin lesions caused by it;
you need to undergo urine tests detecting 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 resulting in significant blood loss;
you have liver problems;
you have or have had heart or circulatory 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, elevated cholesterol or triglycerides, or smoke), since medicines like MORNIFLU may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. IN ALL THESE CASES, YOUR DOCTOR WILL EVALUATE WHETHER MONITORING TESTS ARE NECESSARY.

BE CAREFUL, because during treatment with all NSAIDs:

at any time, with or without warning symptoms, even in patients without previous serious gastrointestinal problems, gastrointestinal bleeding, ulceration, or perforation of the stomach or intestine have been reported, which may be fatal (see section 4.8);
very rarely, severe skin reactions, some of which have been fatal, have been reported, manifesting as redness, blistering, and skin peeling (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis). During the initial 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);
signs of infection may be masked.

you notice any gastrointestinal symptoms, especially bleeding;
a skin 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 strictly necessary and under direct medical supervision, as children and adolescents are more likely to develop side effects from this medicine. In particular, children between 6 and 12 months of age are at high risk of serious skin-related adverse effects.
Other medicines and MORNIFLU
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as some drugs may interact with MORNIFLU or increase the risk of adverse events, even serious ones.
In particular, you must inform your doctor if you are taking:

corticosteroids (steroidal anti-inflammatory drugs);
blood-thinning medicines (anticoagulants and antiplatelet agents), e.g., warfarin, ticlopidine, clopidogrel, acetylsalicylic acid (known as aspirin), other NSAIDs, tirofiban, eptifibatide, abciximab, iloprost, heparin;
diuretics and medicines for high blood pressure (hypertension), such as ACE inhibitors, beta-blockers, angiotensin II receptor antagonists;
medicines called 'selective serotonin reuptake inhibitors' (SSRIs), used as antidepressants;
lithium, used in depression;
methotrexate, used in cancer treatment and certain immune system disorders, such as rheumatoid arthritis;
cyclosporine and tacrolimus, medicines that suppress the immune system;
trimethoprim, an antibiotic;
potassium salts.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take MORNIFLU during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause problems with the baby’s heart, lungs, or kidneys. It may affect your and your baby’s tendency to bleed and may delay or prolong labor more than expected.
You should not take MORNIFLU during the first six months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used.
From the 20th week of pregnancy, MORNIFLU may cause kidney problems in the fetus if taken for more than a few days, reducing amniotic fluid levels 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, discontinue breastfeeding as a precautionary measure during MORNIFLU use.
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 reduced reflexes. Be cautious before driving or operating machinery.

3. How to use MORNIFLU

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Children from 6 to 12 months of age: 1 suppository of MORNIFLU CHILDREN per day.
Children over 1 year of age: 1 to 3 suppositories of MORNIFLU CHILDREN per day, depending on weight and age.
Since the dose of MORNIFLU in children depends on body weight and age, your doctor will indicate the dosage to be administered.
In children, the duration of treatment with MORNIFLU must not exceed 4–5 days.
If you use more MORNIFLU than you should
You may experience problems at the rectal level.
In case of ingestion/absorption of high doses of MORNIFLU, contact your doctor immediately 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 everyone experiences them.
Stop taking MORNIFLU immediately and contact your doctor if you experience any of the following conditions:

severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, or throat with breathing difficulties, sudden drop in blood pressure (anaphylactic shock);
severe breathing difficulties (asthma attacks);
serious stomach problems, burning sensation or abdominal pain due to stomach or duodenal (peptic) ulcers or abdominal ulcers;
sudden, severe pain in the upper abdomen (perforation of the ulcer);
vomiting blood (haematemesis) or black stools (melena), associated with bleeding in the stomach or intestine (gastrointestinal), or unusual fatigue with reduced urine output (due to non-visible bleeding);
severe skin rashes with redness, blistering, and skin peeling (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis).
Other side effects with unknown frequency (frequency cannot be estimated from the available data)
rectal reactions, especially if treatment is prolonged, frequent, or involves high doses;
worsening of skin infections caused by chickenpox;
decrease in platelets (thrombocytopenia), decrease in white blood cells (leucopenia);
headache and dizziness;
heart attack (myocardial infarction) or stroke, swelling (edema), high blood pressure (hypertension), inability of the heart to adequately supply blood to the body (heart failure), low blood pressure (hypotension), inflammation of blood vessels (vasculitis);
nausea, vomiting, diarrhoea, intestinal gas (flatulence), constipation, indigestion (dyspepsia), abdominal pain, inflammation of the mouth mucosa with ulcers (ulcerative stomatitis), worsening of colitis and Crohn's disease, gastritis;
more or less sudden appearance of skin lesions, even after sun exposure (photosensitivity dermatitis), such as discoloured spots or widespread skin changes (rashes, purpura, erythema multiforme, and dermatitis), urticaria, itching;
changes in kidney function (renal impairment) which may cause swelling (oedema), loss of protein in urine, decreased blood protein levels (nephrotic syndrome), kidney inflammation (interstitial nephritis), presence of blood in urine (haematuria);
changes in liver function tests;
interference with drug screening tests (false positive) for substances such as marijuana and hashish;
fluoride poisoning (fluorosis), especially if MORNIFLU is taken at high doses and for several years.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at: “http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
Reporting side effects 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 below 30 °C.
Do not use this medicine after the expiry date stated on the packaging after the word EXP. The expiry date refers to the last day of that month. This date applies to the product in its original, unopened packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What MORNIFLU contains
The active substance is morniflumate.
Each MORNIFLU CHILDREN 400 mg suppository contains: 400 mg of morniflumate.
The other components are: solid semisynthetic glycerides.
Description of the appearance of MORNIFLU and contents of the pack
MORNIFLU CHILDREN 400 mg suppositories are available in packs of 10 suppositories.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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).