MOMENDOL 5% Żel

Treść ulotki

1. MOMENDOL 220 mg soft capsules
   1. What is Momendol and what is it used for
   2. What you need to know before taking Momendol
   3. How to take Momendol
   4. Possible side effects
   5. How to store Momendol
   6. Package contents and other information
2. MOMENDOL 220 mg film-coated tablets
   1. WHAT MOMENDOL IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING MOMENDOL
   3. HOW TO TAKE MOMENDOL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MOMENDOL
   6. PACKAGE CONTENTS AND OTHER INFORMATION
3. MOMENDOL 10% gel
   1. What is MOMENDOL GEL and what is it used for
   2. What you need to know before using MOMENDOL GEL
   3. How to use MOMENDOL GEL
   4. How to store MOMENDOL GEL
   5. Contents of the pack and other information
4. MOMENDOL 5 % gel
   1. What is MOMENDOL GEL and what is it used for
   2. What you need to know before using MOMENDOL GEL
   3. How to use MOMENDOL GEL
   4. How to store MOMENDOL GEL
   5. Contents of the pack and other information

MOMENDOL 220 mg soft capsules

naproxen sodium
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 want 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 7 days of treatment for pain and 3 days of treatment for fever.

Contents of this leaflet

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

1. What is Momendol and what is it used for

Momendol contains naproxen, a medicine that belongs to the class of analgesic-anti-inflammatory drugs,
that is, drugs that fight pain and inflammation.
Momendol is used, in adultsand adolescents starting from 16 years of age, for the short-term treatment of:
mild to moderate pain such as headache, joint and muscle pain (e.g. back pain,
neck pain), toothache and menstrual pain;
fever.
See a doctor if you do not feel better or if you feel worse.
Do not prolong the treatment with Momendol for:
more than 7 days for pain;
more than 3 days for fever.

2. What you need to know before taking Momendol

Do not take Momendol
if you are allergic to naproxen or any of the other ingredients of this medicine (listed in
section 6);
if you are allergic to substances closely related to naproxen from a chemical point of view;
if you suffer from allergic diseases, such as asthma, urticaria, runny nose (rhinitis), nasal polyps,
swelling of the skin and mucous membranes (angioedema);
if you have had allergic reactions caused by acetylsalicylic acid, painkillers, anti-inflammatory drugs or drugs
used for the treatment of rheumatism;
if you have suffered from gastrointestinal or other bleeding, for example cerebrovascular;
if you have previously had bleeding or perforation of the stomach or intestine following the administration
of drugs;
if you have previously had two or more distinct episodes of stomach ulcers or bleeding;
if you have suffered from inflammation of the stomach lining (e.g., congestive gastropathy, atrophic gastritis);
if you have an active stomach or duodenal ulcer;
if you suffer from inflammatory bowel diseases (e.g., ulcerative colitis and Crohn's disease);
if you are under 16 years of age;
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
if you have serious heart disease;
if you have severe liver or kidney disease;
if you are taking diuretics (medicines to treat high blood pressure) at high doses (see
section “Other medicines and Momendol”);
if you have ongoing bleeding or are taking anticoagulant drugs (drugs that thin the
blood) and are at risk of bleeding.

Warnings and precautions
In general, undesirable effects can be reduced by using the lowest effective dose, and for the
shortest possible duration of treatment necessary to control symptoms, especially in elderly patients.

Talk to your doctor or pharmacist before taking Momendol:
if you are taking other anti-inflammatory medicines (including selective COX-2 inhibitors and some NSAIDs)
because they may cause a modest increase in the risk of heart attack (myocardial infarction) or
stroke (cerebral blood flow disruption) (see section “Other medicines and Momendol”).;
if you suffer from high blood pressure and/or have non-serious heart disease, as fluid retention, increased blood pressure and swelling have been found following treatment with NSAIDs;
if you suspect you have an infection;
if you are elderly, know you have non-serious kidney, liver or heart problems or are taking a prolonged
anti-inflammatory medicine; in these cases, the doctor may advise you to start treatment with the lowest dose and possibly the simultaneous use of drugs that protect the stomach;
if you habitually drink high doses of alcohol;
if you want to take Momendol because you have stomach pain;
if you have previously suffered from non-serious stomach and/or intestinal problems due to a medicine;
if you are taking drugs against inflammation (corticosteroids by mouth), drugs that thin the
blood (anticoagulants such as warfarin) or drugs against depression (selective serotonin reuptake inhibitors)
if you are taking Aspirin/acetylsalicylic acid to prevent blood clot formation.

• Severe skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Momendol. If you notice any of the symptoms relating to these severe skin reactions, described in section 4, stop treatment with Momendol and consult your doctor immediately.

Stop taking Momendol and talk to your doctor or pharmacist if during the administration
of Momendol:
vision disturbances occur;
you have an infection or notice a worsening of an infection;
in the event of a wound you notice a prolongation of the time to stop the bleeding;
you experience sudden and severe abdominal pain;
in particular in the first days of treatment, you experience any unusual symptoms in the stomach and/or
intestines (especially bleeding);
in particular in the first month of treatment, you experience changes in the skin or mucous membranes or any
other sign of hypersensitivity that could be signals of severe allergic reactions (exfoliative dermatitis,
Stevens-Johnson syndrome, toxic epidermal necrolysis).
The doctor will monitor your kidney function:

• if you are elderly;
• if you suffer from diseases that impair kidney function and diuresis (the process that allows the formation of urine);
• if you are taking diuretics (medicines used to treat high blood pressure and that increase the amount of urine);
• if you have recently undergone surgery involving hypovolemia (decreased blood volume).
• During treatment with Momendol, the doctor will monitor you carefully:
• if you have diseases that alter blood coagulation;
• if you are taking drugs that can alter blood coagulation.

Children and adolescents
Momendol can be used in adolescents starting from 16 years of age.

Other medicines and Momendol
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines.

Do not combinenaproxen with:
lithium, a medicine used to treat mental disorders;
anti-inflammatory medicines such as corticosteroids (e.g. cortisone) and NSAIDs;
anticoagulants (such as warfarin or dicoumarol) or antiplatelet agents (such as acetylsalicylic acid or
ticlopidine), medicines used to make the blood more fluid
antidepressants (serotonin inhibitors);
as they may increase the risk of injury or bleeding. The doctor may therefore prescribe a
medicine to protect your stomach.

Do not combinenaproxen also with cyclosporine, tacrolimus (medicines administered after an organ
transplant) and methotrexate (medicine for treating tumors) because the toxicity of these drugs could be
increased.

Combine with cautionnaproxen with:
hydantoin derivatives (medicines used to treat epilepsy) or sulfonamides (medicines for treating
infections);
sulfonylureas (medicines for treating diabetes);
loop diuretics and thiazide diuretics (medicines used to treat high blood pressure);
beta-blockers (medicines used for the treatment of high blood pressure);
ACE inhibitors and angiotensin II antagonists (medicines used to treat high blood
pressure);
probenecid (medicine used to treat gout);
digoxin (medicine used to treat heart failure).
Laboratory tests
Momendol can alter the results of blood and urine tests. Tell your doctor or laboratory technician that you are taking Momendol before undergoing these tests as it may be necessary
to interrupt treatment with naproxen 72 hours before performing the tests.

Pregnancy, breastfeeding and fertility

Pregnancy
Do not take Momendol 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 the narrowing of a blood vessel (ductus arteriosus) in
the baby's heart.

Breastfeeding
Do not take Momendol if you are breastfeeding.

Fertility
Stop using Momendol if you have fertility problems or are undergoing fertility investigations. If you suspect or
are planning a pregnancy, ask your doctor or pharmacist for advice before taking this
medicine.

Driving and using machines
Due to the possible occurrence of drowsiness, dizziness, vertigo or insomnia, Momendol may impair
the ability to drive and use machines.
Avoid these activities or others that require particular vigilance in such cases.

Momendol contains
Sorbitol: Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to
certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which
patients cannot transform fructose, talk to your doctor before you (or your child) take this
medicine.
Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially “sodium-free”.

3. How to take Momendol

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much
Adults and adolescents over 16 years:the recommended dose is 1 capsule every 8-12 hours.
To achieve a better effect, you can start treatment with 2 capsules on the first day, and continue with 1
capsule after 8-12 hours.
Do not exceed 3 capsules in 24 hours.
If you are elderly or suffer from kidney disease (mild and moderate renal impairment) do not exceed 2 capsules
in 24 hours.

Do not exceed the indicated doses without consulting your doctor.

When and for how long
Take the medicine preferably on a full stomach (after breakfast, lunch or dinner). Do not use Momendol for
more than 7 days for pain and more than 3 days for fever.

Consult your doctor if the pain or fever persists or worsens.

How
Swallow the capsule whole with water or another beverage.

If you take more Momendol than you should

In case of ingestion/accidental intake of an excessive dose of Momendol, immediately notify your
You may experience a state of stupor, heartburn, diarrhea, nausea, vomiting, drowsiness, increased
levels of sodium in the blood, increased acids in the blood, convulsions, abdominal pain, dizziness,
disorientation, gastric bleeding, alterations in liver function, coagulation defects
(hypoprothrombinemia), kidney malfunction, difficulty breathing (apnea).

Note for healthcare professional: in case of overdose, prompt administration of an adequate
amount of activated charcoal and gastric lavage is indicated.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The use of Momendol may cause side effects that are generally mild or moderate (nausea, vomiting, diarrhea,
flatulence, constipation, dyspepsia (difficulty digesting food), abdominal pain, or more serious reactions,
of an allergic type.
If you develop an ulcer, or bleeding from the stomach occurs with melena (emission of black stools),
hematemesis (vomiting blood) and/or of the intestine or skin and/or mucous membrane lesions, you should
discontinue treatment with Momendol and consult your doctor.
Also, if you experience any of the following symptoms, IMMEDIATELY STOPusing Momendol and
consult a doctor or the nearest hospital where you will be subjected to appropriate and specific treatment:
skin rashes or lesions
mucous membrane lesions
signs of an allergic reaction (erythema, itching, urticaria)
skin that is peeling
severe skin rash or skin exfoliation (toxic epidermal necrolysis, Stevens–
Johnson syndrome)
bleeding, ulceration and perforation of the stomach and intestines, which can be fatal, especially
in the elderly
visual disturbances
edema, hypertension and heart failure.
The risk of experiencing these symptoms is higher in the early stages of therapy. In most cases the
reaction occurs within the first month of treatment.
Side effects can be minimized by using the lowest effective dose, for the shortest possible duration needed to control the symptoms.
You may also experience further side effects, listed below according to frequency:

Common (may affect up to 1 in 10 people)
nausea
difficulty digesting food (dyspepsia)
vomiting
heartburn (pyrosis)
stomach pain (gastralgia)
gas emission (flatulence)
headache (cephalalgia)
drowsiness
dizziness
lightheadedness

Uncommon (may affect up to 1 in 100 people)
diarrhea
constipation
sleep disorders, insomnia and lethargy
excitement
vision disorders
ringing in the ears (tinnitus)
hearing disorders
allergic reactions with swelling and angioedema
chills
skin rash
itching
swelling (edema)
bruising (ecchymosis)
reduced kidney function

Rare (may affect up to 1 in 1,000 people)
stomach or intestinal ulcer
bleeding from the stomach or intestine
perforation of the stomach or intestine
blood in vomit (hematemesis)
lesions inside the mouth (ulcerative stomatitis)
worsening of colitis
worsening of a chronic inflammatory bowel disease (Crohn's disease)
kidney inflammation (glomerulonephritis)
muscle weakness and pain (myalgia)
fever
increase and decrease in blood glucose

Very rare (may affect up to 1 in 10,000 people)
inflammation inside the mouth (stomatitis), aphthous ulcers
inflammatory disease of the colon and intestine (colitis), of the pancreas (pancreatitis) and of the esophagus
(esophagitis)
yellowing of the skin (jaundice)
liver inflammation (hepatitis)
reduced liver function
decrease in hemoglobin, a substance that carries oxygen in the blood (aplastic or hemolytic anemia)
reduction in the number of platelets in the blood (thrombocytopenia)
decreased number of white blood cells (granulocytopenia, leukopenia) up to complete absence
(agranulocytosis)
increase in cells of the blood called eosinophils (eosinophilia)
difficulty breathing (dyspnea, asthma), eosinophilic pneumonia, alveolitis
sensitivity to light (photosensitivity)
hair and hair loss (alopecia)
skin rash with blisters (vesicular rash) or with nodules, pustules or reddish spots
target-shaped red patches on the skin (erythema multiforme)
redness and blisters (fixed erythema)
inflammatory reaction with the formation of small purple papules (lichen planus)
sweating
systemic lupus erythematosus (chronic autoimmune disease)
fast heartbeat (tachycardia)
swelling (edema) and inflammation of the vessels (vasculitis)
high blood pressure (hypertension)
heart failure (serious heart disease)
kidney failure
inflammation or damage at the kidney level with loss of protein and blood in the urine
increased potassium in the blood
increased creatinine in the blood
symptoms such as fever, drowsiness, headache, sensitivity to light in patients with diseases of the
immune system (meningitis-like symptoms) and convulsions
cognitive disorders
thirst and malaise
depression and difficulty concentrating and thinking
inflammation of the front part of the optic nerve (papillitis)
inflammation of the back part of the optic nerve (retrobulbar optic neuritis)
swelling of the papilla in the back of the eye (papilledema)
hearing loss.
Not known: frequency cannot be estimated based on available data
Stop taking Momendol and contact your doctor immediately if you notice the appearance of any of the
following side effects:

• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also paragraph 2.
• A distinctive allergic skin reaction known as fixed drug eruption, which usually recurs in the same location or locations upon re-exposure to the medicine and may appear as round or oval patches with redness and skin swelling, rash with blisters (urticaria), sensation of itching.

inflammation of the stomach (gastritis)
Other side effects that have been reported with other medicines similar to Momendol and which therefore may
be potential side effects of Momendol as well:
allergic reactions, even serious.
The characteristic symptoms of a serious allergic reaction are: severe and sudden low blood pressure, acceleration
or slowing of the heartbeat, unusual fatigue or weakness, anxiety, agitation, loss of consciousness,
difficulty breathing or swallowing, itching, urticaria with or without skin swelling,
redness of the skin, nausea, vomiting, abdominal pain with cramps, diarrhea.
Medicines similar to Momendol may be associated with a modest increase in the risk of heart attack
(“myocardial infarction”) or stroke.

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

5. How to store Momendol

Do not store at a temperature above 25°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
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. Package contents and other information

What Momendol contains
The active ingredient is naproxen. Each capsule contains 220 mg of naproxen sodium corresponding to 200 mg
of naproxen
The other ingredients are macrogol 600, lactic acid, gelatin, sorbitol/special glycerol (see
section “Momendol contains sorbitol”), brilliant blue (E133), lecithin, medium chain triglycerides, purified
water.

Description of the appearance of Momendol and package contents
Momendol is presented in blue soft capsules, with a filling ranging from transparent to slightly blue.
It is available in packs of 10, 12, 20, 24 or 30 soft capsules.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome
Catalent Italy S.p.A. - Via Nettunense km 20, 100 - 04011 Aprilia (LT)
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131
Ancona

INDICATIONS
There are different types of pain, which with greater or lesser frequency and intensity, we all face, particularly headaches, joint and muscle pain, toothache and menstrual pain.
One of the most common pains is certainly headache(or cephalalgia) which can sometimes be a symptom of other
diseases, such as in the case of headache from cervicalgia. If you suffer from headaches, it is important to identify the
factors that can trigger it and try to prevent them (incorrect eating habits, certain foods, smoking,
alcohol, stress, too intense physical exertion, excessive exposure to the sun, loud noises, strong
perfumes, etc.).
Menstrual pain(or dysmenorrhea) is a very common disorder, which is generally accompanied by changes
in mood (sadness, easy irritability), breast tension, a feeling of general fatigue. Menstrual pain, sometimes even of considerable intensity, can be combated with painkillers that work
by reducing the amount of prostaglandins, substances produced by the uterus and considered the main responsible for
the disorder.

MOMENDOL 220 mg film-coated tablets

naproxen sodium
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 want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed inthis leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsenafter 7 days of treatment for pain and after 3 days of treatment for fever.

Contents of this leaflet:

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

1. WHAT MOMENDOL IS AND WHAT IT IS USED FOR

Momendol belongs to the class of non-steroidal analgesic-anti-inflammatory-rheumatic drugs,
that is, medicines that fight pain, inflammation, fever and are useful in the symptomatic treatment
of rheumatic diseases.
Momendol is used for the symptomatic treatment of short-term mild to moderate pain, such as muscle
and joint pain (for example, back pain, stiff neck), headache, toothache and
menstrual pain.
Momendol can also be used for the treatment of fever.
See your doctor if you do not feel better or if you feel worse after 7 days of treatment for
pain, and after 3 days of treatment for fever.

2. WHAT YOU NEED TO KNOW BEFORE TAKING MOMENDOL

Do not take MOMENDOL

• If you are allergic to naproxen sodium or any of the other ingredients of this medicine (listed in section 6), or to other substances chemically related to it.
• If you suffer from allergic manifestations, such as asthma, urticaria, rhinitis, nasal polyps, angioedema and allergic reactions induced by acetylsalicylic acid, analgesics, anti-inflammatory and/or rheumatic drugs.
• If you have had previous gastrointestinal bleeding or perforation, recurrent peptic ulcerin an active or previous phase, chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease), severe hepatic insufficiency, severe heart failure, severe renal insufficiency(creatinine clearance <30 ml/min), angioedema, during intensive therapy with diuretics, in

subjects with ongoing bleeding and at risk of bleeding during therapy with anticoagulants (See

“Other medicines and MOMENDOL” and “Warnings and precautions”).

• During pregnancy, from the third trimester and during breastfeeding (See “Pregnancy, breastfeeding and fertility”).
• The medicine must not be administered to children under 12 years of age.
• When MOMENDOL is used in hypertensive patients and/or patients with reduced cardiac and/or renal function. During treatment with MOMENDOL, diuresis and renal function should be carefully monitored, particularly in the elderly, patients with heart failure or chronic renal insufficiency and patients undergoing treatment with diuretics, following major surgery involving significant blood loss.
• If you have heart problems, or a history of stroke or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or if you smoke) you should discuss your therapy with your doctor or pharmacist.
• When MOMENDOL is used in patients with severe heart failure, a worsening of the condition may occur.
• When MOMENDOL is used in patients with a history of gastrointestinal diseases or hepatic insufficiency and in patients with ongoing or previous allergic manifestations, as in these subjects the product may determine bronchospasm, asthma, or other allergic phenomena. Particular caution is advised in these cases.
• MOMENDOL should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of allergy and/or hypersensitivity.
• If visual disturbances occur, treatment with MOMENDOL should be discontinued.
• Because naproxen, like any other anti-inflammatory drug, can mask the symptoms of concomitant infectious diseases.
• Because in isolated cases, an aggravation of inflammation of an infectious basis has been reported in temporal connection with the use of anti-inflammatory drugs.
• If used in elderly patients, who generally present some degree of impairment of renal, hepatic and cardiac functions, since this group of patients is more exposed to the risk of adverse effects related to the use of anti-inflammatory drugs. Prolonged use of anti-inflammatory drugs in the elderly is not recommended.
• Because naproxen inhibits platelet aggregation and can prolong bleeding time. Patients with coagulation disorders or undergoing therapy with medicines that interfere with coagulation should be carefully monitored during the intake of MOMENDOL.
• When MOMENDOL is used by habitual consumers of high daily doses of alcohol there is a high risk of stomach bleeding.
• The use of the product should be avoided in cases of pain of gastrointestinal origin. It is in fact known that in patients taking anti-inflammatory drugs, bleeding in the stomach or intestine can occur.
• In asthmatic patients, the product is generally contraindicated.
• When MOMENDOL is used in association with other drugs that require caution, see “Other medicines and MOMENDOL”.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Momendol. If you notice any of the symptoms relating to

these severe skin reactions, described in section 4, stop treatment with
Momendol and seek immediate medical attention.

Children and adolescents
Under 16 years of age, it is advisable to contact a doctor.

Other medicines and MOMENDOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines:
Aspirin/acetylsalicylic acid to prevent blood clot formation.

The administration of naproxen with other anti-inflammatory drugs or corticosteroids is not recommended
as it increases the risk of ulcers and gastro-duodenal bleeding.
Naproxen increases the anticoagulant effect of coumarin-type anticoagulants (e.g. warfarin,
dicoumarol) because it prolongs prothrombin time and reduces platelet aggregation.

The combination of naproxen and lithium should be avoided; when necessary, closer monitoring of plasma lithium levels and dosage adjustment are recommended.
Due to the high binding of naproxen to plasma proteins, caution is advised in
concomitant treatment with hydantoins or sulfonamides.
Particular caution should also be exercised in patients treated with cyclosporines,
tacrolimus, sulfonylureas, loop diuretics, methotrexate, beta-blockers, ACE inhibitors, probenecid,
thiazide diuretics and digoxin.
Naproxen can alter bleeding time (which may be increased up to 4 days
after discontinuation of therapy), creatinine clearance (may decrease), azotemia and blood levels
of creatinine and potassium (may increase), liver function tests (an increase in transaminases may occur).
Naproxen can induce false positives in the determination of urinary 17-ketosteroid values and
can interfere with urinary determinations of 5-hydroxyindoleacetic acid.
Therapy with naproxen should be discontinued at least 72 hours before performing
cortico-surrenal function tests.

MOMENDOL with food and drink
MOMENDOL should preferably be taken after a meal.

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.
Pregnancy
Do not take Momendol in the last 3 months of pregnancy as it may harm the fetus or cause
problems during childbirth.
It can cause problems with the kidneys and heart of the fetus. It may affect your and your baby's
tendency to bleed and delay or prolong labor more than expected. During the first six months of
pregnancy, MOMENDOL should not be administered unless absolutely necessary and after
consulting a doctor and evaluating the risk/benefit ratio of your case with him.
If treatment is needed during this period or during attempts to conceive, the lowest dose should be used
for the shortest possible time. From the 20th week of
pregnancy, MOMENDOL 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
the 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.
Consult your doctor if you suspect you are pregnant or wish to plan a
pregnancy.
MOMENDOL, like other anti-inflammatory drugs, is contraindicated during the third trimester of
pregnancy.
Breastfeeding
Since NSAIDs are excreted in breast milk, as a precaution their use is contraindicated
during breastfeeding.
Fertility
MOMENDOL belongs to a class of drugs (NSAIDs, anti-inflammatory drugs) that may
cause fertility problems in women. This effect is reversible with discontinuation of
treatment.

Driving and using machines
Normally, taking the product does not alter or negligibly alters the ability to drive and
use other machinery. However, those who perform an activity requiring vigilance should use caution
if they notice drowsiness, dizziness, depression during therapy.

MOMENDOL contains:

• lactose: if your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine.
• sodium: This medicine contains 23 mg of sodium (the main component of table salt) per tablet. This is equivalent to 1.15% of the recommended maximum daily intake with the diet of an adult.

3. HOW TO TAKE MOMENDOL

Take this medicine following exactly the instructions in this leaflet, or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 16 years of age: 1 film-coated tablet every 8-12 hours.
If necessary, a better effect can be obtained by starting, on the first day, with 2 film-coated tablets
followed by 1 film-coated tablet after 8-12 hours.
Elderly patients and patients with mild or moderate renal impairment should not exceed 2
film-coated tablets within 24 hours.

Use in children and adolescents
Under the age of 16, it is recommended to contact your doctor.
Momendol is contraindicated in children under 12 years of age.
Swallow the film-coated tablets whole with water.
Momendol should preferably be taken after a meal.
Do not take the medicine for more than 7 days for pain, and for more than 3 days for fever.
Consult your doctor if the fever or pain persists or worsens.

If you take more MOMENDOL than you should
Signs of overdose include a state of stupor, heartburn, diarrhea, nausea,
vomiting, drowsiness, increased blood sodium levels, metabolic acidosis, convulsions.
In case of accidental or intentional overdose of the product, you should contact
your doctor to implement the usual measures required in these cases. Bring this leaflet
with you.
Gastric emptying and usual supportive measures are recommended.
Prompt administration of an adequate amount of activated charcoal (activated charcoal is a medicine;
ask your pharmacist for it if necessary) can reduce the absorption of the medicine.

If you forget to take MOMENDOL
Do not take a double dose to make up for a missed tablet.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most commonly observed side effects are of a gastrointestinal nature.
The following side effects have been reported with NSAIDs and with naproxen:

Common (may affect up to 1 in 10 people):

• Headache, drowsiness, dizziness
• Nausea, dyspepsia, vomiting, pyrosis, gastralgia, flatulence.

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

• Allergic reaction (including facial edema and angioedema)
• Sleep disturbances, excitement
• Visual disturbances
• Tinnitus, hearing disturbances
• Bruising
• Diarrhea, constipation
• Skin rash/pruritus
• Abnormal kidney function
• Chills, edema (including peripheral edema).

Rare (may affect up to 1 in 1000 people):

• Peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal, may occur especially in elderly patients, hematemesis, ulcerative stomatitis, aggravated colitis and aggravated Crohn's disease.

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

• Hemolytic or aplastic anemia, thrombocytopenia, granulocytopenia
• Meningitis-like reaction
• In association with treatment with NSAIDs, tachycardia, edema, hypertension and heart failure have been observed
• Dyspnea, asthma
• Colitis, stomatitis. Gastritis has been observed less frequently
• Jaundice, hepatitis, reduced liver function
• Photosensitivity, alopecia, bullous disorder including Stevens-Johnson syndrome and toxic epidermal necrolysis
• Increased blood pressure.

Stop taking Momendol and contact your doctor immediately if you notice the appearance of
any of the following side effects:

Not known:frequency cannot be estimated based on the available data

• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• A distinctive skin allergic reaction known as fixed drug eruption, which usually reappears in the same location or locations upon re-exposure to the medicine and may appear as round or oval patches with redness and skin swelling, rash with blisters (urticaria), sensation of itching. As with other anti-inflammatory drugs, anaphylactic or anaphylactoid reactions may occur in patients with or without previous exposure to drugs of the same class.

The characteristic symptoms of an anaphylactic reaction are: severe and sudden hypotension,
acceleration or slowing of the heartbeat, unusual fatigue or weakness, anxiety,
agitation, loss of consciousness, difficulty breathing or swallowing, itching, urticaria
with or without angioedema, flushing of the skin, nausea, vomiting, cramp-like abdominal pain,
diarrhea.
Medicines like MOMENDOL may be associated with a modest increase in the risk of
heart attack (“myocardial infarction”) or stroke.

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 reported at the address https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE MOMENDOL

Keep this medicine out of the sight and reach of children.
Do not use MOMENDOL after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Store in the original package to protect it from light and moisture.
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. PACKAGE CONTENTS AND OTHER INFORMATION

What MOMENDOL contains
The active ingredient is naproxen 200 mg (equivalent to naproxen sodium 220 mg).
The other ingredients are: Tablet core: lactose monohydrate, corn starch, microcrystalline
cellulose, povidone (K25), sodium carboxymethylamide, hydrated colloidal silica, magnesium
stearate. Film coating: hypromellose, macrogol 400, titanium dioxide (E 171), talc.

Description of the appearance of MOMENDOL and contents of the pack
MOMENDOL is presented as a film-coated tablet, white, round and biconvex.
Aluminum/PVC blisters containing 12 or 24 film-coated tablets (1-2 blisters each containing 12
film-coated tablets).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Angelini Pharma S.p.A.
Viale Amelia 70,
00181 Rome
Italy
Tel +39 06 780531
Fax +39 06 78053291
Manufacturer and final control :
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.

Via Vecchia del Pinocchio, 22 – 60131 Ancona, Italy
Tel +39 071 8091
Fax +39 071 809440
Manufacturer and final control:
Famar Italia S.p.A.
Via Zambeletti, 25
20021 Baranzate di Bollate (MI)
Italy

This medicinal product is authorised in the Member States of the EEA with the following names:
GERMANYMOMENDOL 220 mg Filmtabletten

ITALYMOMENDOL 220 mg film-coated tablets

PORTUGALMOMENDOL 220 mg comprimido revestido por pelìcula

This leaflet was last approved on
By scanning the QR Code on the package or visiting http://leaflet.angelini.it/L08 you can read the

MOMENDOL 10% gel

naproxene
Read this leaflet carefully before using this medicinebecause it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor
or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need further information or advice.
• If any side effects occur, including those not listed inthis leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

• 7. What MOMENDOL GEL is and what it is used for
• 8. What you need to know before using MOMENDOL GEL
• 9. How to use MOMENDOL GEL
• 10. Possible side effects
• 11. How to store MOMENDOL GEL
• 12. Contents of the pack and other information

2. What is MOMENDOL GEL and what is it used for

Momendol gel belongs to the class of non-steroidal anti-inflammatory analgesics for topical use.
Momendol gel is used for the local treatment of muscular and joint pain, such as: muscle pain (myalgia), lower back pain, stiff neck, inflammation of a synovial bursa near a joint or tendon (bursitis), tendon inflammation (tendinitis), inflammation of the synovial sheath surrounding the tendons (tenosynovitis), inflammation of the tissues around a joint (periarthritis), muscle strains, bruises and hematomas.
Momendol gel can also be used as an adjunct in rehabilitation following trauma and/or orthopedic surgery.
See your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using MOMENDOL GEL

Do not use MOMENDOL GEL

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6),
• during the third trimester of pregnancy (see “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using Momendol gel

• if you have allergic reactions such as asthma, urticaria, rhinitis, nasal polyps, angioedema, and anaphylactic reactions induced by acetylsalicylic acid and/or other non-steroidal anti-inflammatory drugs,
• if you are using other medicines that require caution, see the following section “Other medicines and Momendol gel”. The product should not be applied to eyes, mucous membranes, wounds and/or skin lesions.

To avoid any phenomena of hypersensitivity or photosensitization, do not expose yourself to
direct sunlight, including solariums and lamps or tanning beds, during treatment and for the
two weeks following (see “Possible side effects”).
Stop treatment in case of skin rash or skin irritation.
This medicine contains a fragrance with D-Limonene. D-Limonene may cause allergic
reactions.

Other medicines and MOMENDOL GEL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any

other medicine.

MOMENDOL GEL with food, drinks and alcohol
No influence.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
The risk of harmful effects on the fetus and/or the infant cannot be excluded. Therefore, during
breastfeeding, Momendol gel should be used at the doctor's discretion and only when strictly
necessary. Momendol gel should not be used in the third trimester of pregnancy.
Oral forms (e.g. tablets) of Momendol can cause adverse effects in the fetus. It is not
known whether the same risk applies to Momendol gel when used on the skin.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not use Momendol gel if you are in the last 3 months of pregnancy. Do not use Momendol gel in
the first 6 months of pregnancy, unless clearly necessary and recommended by your doctor.
If you need treatment during this period, you should use the lowest dose for the shortest
possible time.

Driving and using machines
Momendol gel does not impair the ability to drive vehicles or operate machinery.

3. How to use MOMENDOL GEL

Always use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Apply Momendol gel to the site of pain twice a day, massaging gently until fully absorbed.
The use of Momendol gel is not recommended in children under 12 years of age due to the lack of safety and efficacy data in children.
Do not use the medicine for more than 7 days. Do not exceed the recommended doses.
Consult your doctor or pharmacist if the pain persists or worsens.

If you use more MOMENDOL GEL than you should
No cases of overdose have been reported.
Contact your doctor or pharmacist if you have used the medicine more times than recommended or
in case of accidental ingestion.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

• 4.Possible side effectsLike all medicines, Momendol gel can cause side effects, although not everyone gets them. Frequency not known (frequency cannot be estimated based on available data):
• redness of the skin (erythema),
• itching,
• skin irritation,
• feeling of heat or burning,
• skin rash in the area of gel application (contact dermatitis),
• blister formation (bullous eruption),
• photosensitivity reaction,
• hypersensitivity reaction,
• heat at the application site.

Prolonged use of topical medicines can cause sensitization phenomena. In
this case, stop treatment, see your doctor and report what happened.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects, you can help provide more information
about the safety of this medicine.

5. How to store MOMENDOL GEL

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original packaging with the cap closed to protect the medicine from light and
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 MOMENDOL GEL contains
The active ingredient is naproxen at a concentration of 10% (1 g of product contains 100 mg of
naproxen).
The other components are: isopropyl alcohol, trolamine, glycerol, hydroxyethylcellulose, sodium
hydroxide, fragrance containing menthol and eucalyptus oil, purified water.

Description of the appearance of MOMENDOL GEL and contents of the pack
Momendol gel is presented as a transparent, homogeneous gel, from colorless to slightly
yellow, slightly scented.
Each pack contains a tube of gel of 50 g or 100 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Angelini Pharma S.p.A.
Tel +39 06 780531
Viale Amelia, 70 - 00181 Rome (Italy)
Fax +39 06 78053291
Manufacturer:
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.

Via Vecchia del Pinocchio, 22 - 60131 Ancona (Italy)
Tel +39 071 8091
Fax +39 071 809440

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
PORTUGAL: MOMENDOL 100 mg/g (10%) GEL
By scanning the QR Code on the package or at the address http://leaflet.angelini.it/L09 you can read the

MOMENDOL 5 % gel

naproxene
Read this leaflet carefully before using this medicinebecause it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor
or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need further information or advice.
• If any side effects occur, including those not listed inthis leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

• 13. What MOMENDOL GEL is and what it is used for
• 14. What you need to know before using MOMENDOL GEL
• 15. How to use MOMENDOL GEL
• 16. Possible side effects
• 17. How to store MOMENDOL GEL
• 18. Contents of the pack and other information

3. What is MOMENDOL GEL and what is it used for

Momendol 5% gel is a non-steroidal drug with analgesic, anti-inflammatory and
rheumatic action, which combats pain and inflammation of muscles and joints. The presence
in the gel of glucuronil glucosaminoglycan facilitates the reabsorption of any bruises and
hematomas.
Momendol 5% gel is available in the form of a tube containing gel for external use. Each tube contains
50 g of gel. Momendol 5% gel is used locally to combat pain due to trauma such as
for example: contusions, sprains and muscle tears, dislocations, bruises, hematomas, localized edema
and traumatic infiltrates, etc; or to inflammatory phenomena such as for example: torticollis,
lumbago, fibromyositis, tendinitis, bursitis, tenosynovitis, periarthritis, phlebitis etc.
Momendol 5% gel can be used as an adjunct in arthrorheumatic therapy (osteoarthritis, rheumatoid arthritis,
ankylosing spondylitis)
See your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using MOMENDOL GEL

Do not use MOMENDOL GEL

• If you have hypersensitivity to the components or to other substances closely related from a chemical point of view: (e.g. acetylsalicylic acid, etc.)
• In patients undergoing therapy with coumarin-type anticoagulants (warfarin, dicoumarol etc.).
• If you are in the last 3 months of pregnancy.

Warnings and precautions
Consult your doctor or pharmacist before using Momendol gel.

• The product should not be applied to wounds or skin lesions.
• In paediatric age, Momendol 5% gel should only be used after consulting a doctor and evaluating the risk/benefit ratio in your specific case with him. The application of the product does not alter

the ability to drive and use other machinery. To avoid any phenomena of hypersensitivity or
photosensitization, avoid exposure to direct sunlight, including solariums, during the
treatment and for the following two weeks

Other medicines and MOMENDOL GEL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any

other medicine. Do not use Momendol 5% gel if you are following a therapy based on coumarin-type

anticoagulants (warfarin, dicoumarol etc.).

MOMENDOL GEL with food, drinks and alcohol
No influence.

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Oral forms (e.g. tablets) of Momendol can cause adverse effects in the fetus. It is not
known whether the same risk applies to Momendol 5% gel when used on the skin.
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.
Do not use Momendol 5% gel if you are in the last 3 months of pregnancy. You should not use Momendol 5% gel
in the first 6 months of pregnancy, unless it is clearly necessary and recommended by your doctor.
If you need treatment during this period, you should use the lowest dose for the shortest
possible time.

Driving and operating machinery
Momendol gel does not alter the ability to drive vehicles or operate machinery.

3. How to use MOMENDOL GEL

Always use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use 2-3 applications per day. Spread the gel on the painful area and massage gently until completely absorbed. Apply the medicine as needed, at any time of the day.
Caution: use only for short periods of treatment. Do not exceed three applications per day unless specifically directed by your doctor.
Consult your doctor if the discomfort recurs or if you have noticed any recent change in its characteristics.

If you use more MOMENDOL GEL than you should
No cases of overdose have been reported.
Contact your doctor or pharmacist if you have used the medicine more times than recommended or in case of accidental ingestion. In such cases, immediately notify your doctor or go to the nearest hospital. Bring this leaflet with you.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

• 4.Possible side effectsLike all medicines, Momendol 5% gel can cause side effects, although not everyone experiences them. With some non-steroidal anti-inflammatory drugs for topical cutaneous or transdermal use, derivatives of propionic acid, cutaneous adverse reactions such as erythema, itching, irritation, a sensation of heat or burning, and contact dermatitis have been reported. Some cases of blistering rashes of varying severity have also been reported. Photosensitivity reactions are possible. In such cases, discontinue the

risk of side effects.
These side effects are generally transient. However, when they occur, it is advisable to consult your doctor or pharmacist. It is important to inform your doctor or pharmacist of the appearance
Prolonged use of topical medicines can cause sensitization phenomena. In this event, discontinue treatment, see your doctor and report what happened.

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

5. How to store MOMENDOL GEL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original packaging with the cap closed to protect the medicine from light and
evaporation.
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 MOMENDOL GEL contains
The active ingredient is naproxen sodium g 5.482 (equivalent to naproxen g 4.983) and glucuronil
glucosaminoglycan gr 0.200 (anticoagulant activity compared to Heparin 20-40 IU/mg). The other
ingredients are: Isopropyl alcohol; Glycerol; Hydroxyethylcellulose; Menthol fragrance; Demineralized
water.

Description of the appearance of MOMENDOL GEL and contents of the pack
Momendol 5% gel is presented in the form of a tube containing gel for external use.
Each pack contains a tube of 50 g of gel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome (Italy)
Manufacturer:
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.

Via Vecchia del Pinocchio, 22 - 60131 Ancona (Italy)