Femmedol

Package leaflet: Information for the patient

FEMMEDOL 220 mg film-coated tablets

Sodium naproxen
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you notice no improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What FEMMEDOL is and what it is used for

FEMMEDOL contains the active substance naproxen sodium, which belongs to a group of medicines called non-steroidal anti-inflammatory and anti-rheumatic drugs that work by relieving pain and symptoms of inflammation.
FEMMEDOL is indicated for short-term treatment of:

• symptoms of mild to moderate pain, such as muscle pain, joint pain, headache, toothache, and pain associated with menstrual periods;
• fever.

Consult your doctor if you do not feel better or if you feel worse after 7 days of treatment for pain or 3 days for fever (See section “How to take FEMMEDOL”).

2. What you should know before taking FEMMEDOL

Do not take FEMMEDOL:

• if you are allergic to naproxen or to any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic reactions (e.g. asthma, urticaria, runny nose (rhinitis), nasal polyps, swelling of the skin and mucous membranes (angioedema)) to other similar medicines such as acetylsalicylic acid, other non-steroidal anti-inflammatory drugs (NSAIDs), antipyretics, or anti-rheumatic agents;
• if you have stomach or intestinal lesions or inflammation (active peptic ulcer and gastrointestinal inflammations);
• if you have previously experienced episodes (two or more) of bleeding or injury to the stomach or intestine, or have developed these problems after taking medicines for inflammation (non-steroidal anti-inflammatory drugs);
• if you suffer from severe liver problems (severe hepatic insufficiency), kidney problems (severe renal insufficiency with creatinine clearance < 30 ml/min), or heart problems (severe heart failure);
• if you experience swelling of the face, lips, mouth, tongue, or throat due to fluid accumulation (angioedema);
• if you are being treated with medicines called diuretics, used to promote urine elimination and lower blood pressure, or medicines used to thin the blood (anticoagulants);
• if you have active bleeding or are a person at risk;
• if you are in the last months (third trimester) of pregnancy or if you are breastfeeding (See section “Pregnancy and breastfeeding”);
• if the person taking this medicine is under 12 years of age (See section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking FEMMEDOL.
The use of FEMMEDOL should be avoided together with other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (See section “Other medicines and FEMMEDOL”).
Inform your doctor and take this medicine with caution in the following cases:

• if you are predisposed to allergic reactions, FEMMEDOL may increase the risk of anaphylactic or anaphylactoid reactions;
• if you currently suffer or have previously suffered from asthma or allergic reactions, as you may experience severe breathing difficulties (bronchospasm);
• if you are elderly or have previously suffered from stomach or intestinal lesions (gastrointestinal pathology), especially if associated with bleeding or perforations. FEMMEDOL, particularly when taken at high doses and for prolonged periods, may increase the risk of gastrointestinal bleeding, lesions, or perforations, which can be fatal (gastrointestinal hemorrhage, ulceration, or perforation) (See section “Possible side effects”). In such cases, treatment should be initiated with the lowest effective dose, and it may be beneficial to take a medicine that protects the stomach (misoprostol, proton pump inhibitors) (See section “Other medicines and FEMMEDOL”). Inform your doctor if you experience any unusual symptoms affecting the stomach or intestine, particularly bleeding (gastrointestinal hemorrhage), especially during the initial stages of treatment;
• if you are taking the following medicines, as they may increase the risk of stomach and/or intestinal injury and bleeding:
  • medicines used to treat allergies and inflammation (oral corticosteroids);
  • medicines used to thin the blood (anticoagulants and antiplatelet agents such as heparin, warfarin, and aspirin);
  • medicines used to treat depression (selective serotonin reuptake inhibitors, SSRIs);
• if you suffer from intestinal disorders (ulcerative colitis, Crohn’s disease), as FEMMEDOL administration may worsen disease symptoms (See section “Possible side effects”);
• if you suffer from high blood pressure (hypertension) or have heart problems (mild to moderate congestive heart failure). In this case, your doctor should perform periodic checks, as FEMMEDOL may reduce fluid elimination and cause swelling (edema);
• if you have bleeding disorders (coagulation disorders). Your doctor must closely monitor you if you are taking medicines that may affect blood coagulation;
• if you have impaired kidney or liver function (impaired renal and hepatic function). In these cases, especially if you are elderly, your doctor should monitor you closely during FEMMEDOL therapy (See sections “Use in patients with kidney or liver problems”). FEMMEDOL may alter the results of certain laboratory tests for liver function (liver function tests);
• if you suspect you have an infection, as this medicine may mask or worsen symptoms of certain infectious diseases (e.g. development of necrotizing fasciitis);
• if you are planning pregnancy, have fertility problems, or are undergoing fertility assessments (See section “Pregnancy, breastfeeding, and fertility”).

FEMMEDOL, particularly at high doses and for prolonged periods, may increase the risk of heart attack or stroke; therefore, before taking it, ensure your doctor is fully aware of your health status.
In particular, inform your doctor if:

• you have heart problems (congestive heart failure, confirmed ischemic heart disease) or blood vessel problems (peripheral arterial disease, cerebrovascular disease);
• you have high blood pressure (hypertension);
• you have high cholesterol or triglyceride levels in the blood (hyperlipidemia);
• you have diabetes;
• you smoke.

Stop treatment with FEMMEDOL and inform your doctor if, especially at the beginning of treatment, you experience the following symptoms:

• bleeding or lesions in the stomach or intestine, particularly if you are elderly or have previously had similar problems;
• skin irritation (rash), mucosal lesions, or any other skin reaction due to severe skin reactions, which may even be fatal (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)).

Side effects can be minimized by using the lowest effective dose for the shortest necessary duration.
Children and adolescents
This medicine must not be administered to children under 12 years of age (See section “Do not take FEMMEDOL”). FEMMEDOL may be taken by adolescents aged 12 to 15 years only after consulting a doctor.
Elderly
If you are elderly, you are at increased risk of gastrointestinal bleeding and perforation, which may be fatal (See section “Use in the elderly”).
Other medicines and FEMMEDOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking:

• medicines used to treat epilepsy (hydantoins, barbiturates);
• warfarin and other medicines used to thin the blood (anticoagulants and antiplatelet agents);
• medicines used to treat certain bacterial infections (sulfonamides);
• medicines used to treat high blood pressure and certain heart conditions (beta-blockers such as propranolol);
• lithium, a medicine used to treat certain mental disorders;
• probenecid, a medicine used to treat gout;
• methotrexate, a medicine used to treat certain cancers and skin or joint diseases (e.g. psoriasis, rheumatoid arthritis);
• medicines used to treat allergies and inflammation (corticosteroids);
• medicines used to treat depression (selective serotonin reuptake inhibitors, SSRIs);
• medicines used to treat high blood pressure (diuretics, ACE inhibitors, and angiotensin II antagonists).

Laboratory tests
FEMMEDOL may alter the results of certain blood and urine tests (for adrenal gland function and urinary 5-hydroxyindoleacetic acid measurement). Therefore, inform your doctor if you are scheduled for laboratory tests, as it may be necessary to discontinue naproxen treatment 48 hours before the tests.
FEMMEDOL and alcohol
Take this medicine with caution and inform your doctor if you regularly consume large amounts of alcohol.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take FEMMEDOL during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney or heart problems in the fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labor beyond the expected time. You should not take FEMMEDOL 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, FEMMEDOL may cause kidney problems in the fetus if taken for more than a few days, reducing the level of amniotic fluid surrounding the baby (oligo-hydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Avoid taking FEMMEDOL if you are breastfeeding, as this medicine passes into breast milk.
Fertility
The use of sodium naproxen may affect female fertility and is not recommended in women wishing to conceive. Discontinue use of this medicine if you have difficulty conceiving or are undergoing fertility assessments.
Driving and using machines
The effects of this medicine on the ability to drive or use machinery are unknown.
FEMMEDOL contains lactose and sodium
FEMMEDOL contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., essentially “sodium-free”.

3. How to take FEMMEDOL

Take FEMMEDOL exactly as described in this leaflet or as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take this medicine preferably after meals. Swallow the tablet whole with a little water.

Adults and adolescents over 16 years of age:
The recommended dose is 1 tablet every 8–12 hours.
If necessary, on the first day you may take 2 tablets, followed by 1 tablet after 8–12 hours.
Do not take more than 3 tablets per day.
Do not use this medicine for longer than 7 days for pain treatment or for more than 3 days for fever treatment.
Consult your doctor if you do not feel better or if you notice worsening of symptoms.

Use in elderly patients
Elderly patients should start treatment with the lowest possible dose. In particular, the maximum recommended dose is 2 tablets per day.

Use in patients with kidney or liver problems
If you have kidney problems, do not take more than 2 tablets of FEMMEDOL per day. Before and during treatment with FEMMEDOL, your doctor will carefully monitor your kidney function through specific tests (serum creatinine and/or creatinine clearance).
If you have liver problems, take this medicine with great caution and at the lowest effective dose.

If you take more FEMMEDOL than you should
If you take high doses of this medicine, symptoms such as drowsiness, heartburn, digestive problems (dyspepsia), nausea, and vomiting may occur.
In case of accidental ingestion/overdose of FEMMEDOL, contact your doctor immediately or go to the nearest hospital.

If you forget to take FEMMEDOL
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Common (may affect up to 1 in 10 people):
feeling of thirst; increased awareness of heartbeats (palpitations).
Rare (may affect up to 1 in 1,000 people):

• severe allergic (anaphylactic) reactions, which usually present as:
  • severe and sudden drop in blood pressure (severe and sudden hypotension);
  • acceleration or slowing of the heartbeat;
  • unusual tiredness or weakness;
  • anxiety, restlessness;
  • dizziness;
  • loss of consciousness;
  • difficulty breathing or swallowing (due to laryngeal obstruction or bronchospasm);
  • generalized itching (especially on the soles of the feet or palms of the hands);
  • skin irritation (urticaria), sometimes accompanied by swelling of the face, lips, throat and/or tongue (angioedema);
  • skin redness (especially around the ears);
  • bluish discoloration of the skin due to lack of oxygen (cyanosis);
  • excessive sweating;
  • nausea, vomiting, abdominal cramps, diarrhea;
  • fever.
• mouth mucosa lesions (ulcerative stomatitis);
• inflammation of the pancreas (pancreatitis);
• hair loss (alopecia), light sensitivity (photosensitivity dermatitis, pseudoporphyria), severe skin reactions characterized by lesions and blisters (toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, nodular erythema, bullous epidermolysis), skin damage (cutaneous necrosis), widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• abnormal liver function test results and jaundice;
• depression, feeling of malaise, inflammation of the membranes covering the brain (aseptic meningitis);
• attention, memory, perception and reasoning disorders (cognitive disorders);
• heart problems (congestive heart failure), increased heart rate (tachycardia), inflammation of blood vessels (vasculitis);
• lung inflammation (eosinophilic pneumonia, alveolitis), airway obstruction (bronchospasm), swelling of the larynx (laryngeal edema), breathing difficulties (asthma);
• increased or decreased blood sugar levels (hyperglycemia, hypoglycemia).

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

• severe liver inflammation (hepatitis);

The following side effects have also been reported:

• sensation of ringing in the ears (tinnitus);
• nausea, vomiting, constipation, flatulence, abdominal pain, heartburn, indigestion (dyspepsia), inflammation of the esophagus (esophagitis) and of the mouth mucosa (stomatitis), diarrhea, epigastric abdominal pain, stomach and intestinal lesions and bleeding (peptic ulcer, perforation and hemorrhages), colon inflammation (colitis), presence of blood in the stool (melena) and in vomit (hematemesis), worsening of certain intestinal diseases (colitis, Crohn's disease), stomach inflammation (gastritis);
• increased risk of thrombotic events (e.g., heart attack or stroke);
• increased blood pressure (hypertension);
• heart problems (heart failure);
• difficulty breathing;
• skin rash, urticaria, bruising, sweating, skin redness due to blood accumulation (purpura);
• kidney problems (nephrotoxicity, hepatotoxicity, glomerular nephritis, interstitial nephritis, nephrotic syndrome, papillary necrosis, renal failure), presence of blood in urine (hematuria), fluid retention, increased potassium levels in blood (hyperkalemia);
• headache, sensation of emptiness in the head, drowsiness, insomnia, seizures, difficulty concentrating, confusion and dizziness;
• muscle pain and weakness (myalgia);
• vision and hearing disturbances;
• swelling due to fluid accumulation (edema, peripheral edema).

Frequency not known (frequency cannot be estimated from the available data):
a distinctive skin allergic reaction known as drug-induced fixed eruption, which usually recurs at the same site or sites upon re-exposure to the medicine and may appear as round or oval patches with skin redness and swelling, skin rash with blisters (urticaria), itching sensation.
Rarely, the following may occur:
reduction in the number of white blood cells (agranulocytosis, leukopenia, granulocytopenia), platelets (thrombocytopenia), and red blood cells (aplastic anemia and hemolytic anemia), increase in the number of a type of white blood cells (eosinophilia) in the blood.

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 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 FEMMEDOL

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 "Exp".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of this 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 FEMMEDOL contains

• The active substance is sodium naproxen. Each tablet contains 220 mg of sodium naproxen.
• The other components are: monohydrate lactose, pregelatinized starch, microcrystalline cellulose, povidone K30, sodium carboxymethylstarch, anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose, macrogol 400, titanium dioxide, talc.

Description of the appearance of FEMMEDOL and the contents of the pack
Carton pack containing 12 or 24 film-coated tablets.
Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Roma
Manufacturer
FINE FOODS & PHARMACEUTICAL NTM S.p.A. - Via Grignano, 43 - 24041 Brembate (Bg)

Package leaflet: information for the patient

FEMMEDOL 220 mg granules for oral solution

Sodium naproxen
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

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

1. What FEMMEDOL is and what it is used for

FEMMEDOL contains the active substance naproxen sodium, which belongs to a group of
medicines called non-steroidal anti-inflammatory and anti-rheumatic drugs that work by relieving pain
and symptoms of inflammation.
FEMMEDOL is indicated for short-term treatment of:

• symptoms of mild or moderate pain, such as muscle pain, joint pain, headache, toothache, and pain occurring during menstruation;
• fever.

Consult your doctor if you do not feel better or if you feel worse after 7 days of treatment for pain and 3 days for fever (See section “How to take FEMMEDOL”).

2. What you need to know before taking FEMMEDOL

Do not take FEMMEDOL:

• if you are allergic to naproxen or to any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic reactions (e.g. asthma, urticaria, runny nose (rhinitis), nasal polyps, swelling of the skin and mucous membranes (angioedema)) to other similar medicines such as acetylsalicylic acid, other non-steroidal anti-inflammatory drugs (NSAIDs), antipyretics, or anti-rheumatic drugs;
• if you have stomach or intestinal lesions or inflammation (active peptic ulcer and gastrointestinal inflammations);
• if you have previously experienced episodes (two or more) of bleeding or lesions in the stomach or intestine, or have developed these problems after taking medicines used to treat inflammation (non-steroidal anti-inflammatory drugs);
• if you suffer from severe liver problems (severe hepatic insufficiency), kidney problems (severe renal insufficiency with creatinine clearance < 30 ml/min), or heart problems (severe heart failure);
• if you experience swelling of the face, lips, mouth, tongue, or throat due to fluid accumulation (angioedema);
• if you are being treated with medicines called diuretics, used to promote urine elimination and lower blood pressure, or medicines used to thin the blood (anticoagulants);
• if you have active bleeding or are a person at risk;
• if you are in the last months (third trimester) of pregnancy or are breastfeeding (See section “Pregnancy and breastfeeding”);
• if the person taking this medicine is under 12 years of age (See section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking FEMMEDOL.
The use of FEMMEDOL should be avoided together with other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (See section “Other medicines and FEMMEDOL”).
Inform your doctor and take this medicine with caution in the following cases:

• if you are prone to allergic reactions, FEMMEDOL may increase the risk of allergic reactions (anaphylactic and anaphylactoid reactions);
• if you suffer or have previously suffered from asthma or allergic reactions, as you may experience severe breathing difficulties (bronchospasm);
• if you are elderly or have previously suffered from gastrointestinal lesions (past gastrointestinal disease) of the stomach or intestine, especially if associated with bleeding and perforations. FEMMEDOL, particularly when taken at high doses and for long periods, may increase the risk of gastrointestinal bleeding, lesions, or perforations, which can be fatal (gastrointestinal hemorrhage, ulceration, or perforation) (See section “Possible side effects”). In such cases, treatment should begin with the lowest effective dose, and it may be helpful to take a medicine that protects the stomach (misoprostol, proton pump inhibitors) (See section “Other medicines and FEMMEDOL”). Inform your doctor if you experience any unusual symptoms affecting the stomach or intestine, especially bleeding (gastrointestinal hemorrhage), particularly during the initial stages of treatment;
• if you are being treated with the following medicines, as they may increase the risk of stomach and/or intestinal damage and bleeding:
  • medicines used to treat allergies and inflammation (oral corticosteroids);
  • medicines used to thin the blood (anticoagulants and antiplatelet agents such as heparin, warfarin, and aspirin);
  • medicines used to treat depression (selective serotonin reuptake inhibitors, SSRIs).
• if you suffer from intestinal disorders (ulcerative colitis, Crohn’s disease), as administration of FEMMEDOL may worsen disease symptoms (See section “Possible side effects”);
• if you suffer from high blood pressure (arterial hypertension) or have heart problems (mild to moderate congestive heart failure). In this case, your doctor should perform regular checks, as FEMMEDOL may reduce fluid elimination and cause swelling (edema);
• if you have bleeding disorders (coagulation disorders). Your doctor must closely monitor you if you are taking medicines that may affect blood coagulation;
• if you have impaired kidney or liver function (impaired renal and hepatic function). In these cases, especially if you are elderly, your doctor must monitor you closely during FEMMEDOL therapy (See sections “Use in patients with kidney or liver problems”). FEMMEDOL may alter the results of certain laboratory tests for liver function (liver function tests);
• if you suspect you have an infection, as this medicine may mask or worsen symptoms of certain infectious diseases (e.g. development of necrotizing fasciitis);
• if you are planning to become pregnant, have fertility problems, or are undergoing fertility investigations (See section “Pregnancy, breastfeeding, and fertility”).

FEMMEDOL, especially at high doses and for prolonged periods, may increase the risk of heart attack or stroke; therefore, before taking it, ensure your doctor is fully aware of your health status.
In particular, inform your doctor if:

• you have heart problems (congestive heart failure, confirmed ischemic heart disease) or blood vessel problems (peripheral arterial disease, cerebrovascular disease);
• you suffer from high blood pressure (hypertension);
• you have high levels of cholesterol or triglycerides in the blood (hyperlipidemia);
• you suffer from diabetes;
• you smoke.

Stop treatment with FEMMEDOL and inform your doctor immediately if, especially at the beginning of treatment, you experience the following symptoms:

• bleeding or lesions in the stomach or intestine, particularly if you are elderly or have previously experienced similar problems;
• skin irritation (cutaneous rash), mucosal lesions, or any other skin reaction due to severe skin reactions that may even be fatal (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)).

Side effects can be minimized by using the lowest effective dose for the shortest duration necessary.
Children and adolescents
This medicine must not be given to children under 12 years of age (See section “Do not take FEMMEDOL”). FEMMEDOL may be taken by adolescents aged 12 to 15 years only after consulting a doctor.
Elderly
If you are elderly, you are at higher risk of gastrointestinal bleeding and perforation, which may be fatal (See section “Use in the elderly”).
Other medicines and FEMMEDOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking:

• medicines used to treat epilepsy (hydantoins, barbiturates);
• warfarin and other medicines used to thin the blood (anticoagulants and antiplatelet agents);
• medicines used to treat certain bacterial infections (sulfonamides);
• medicines used to treat high blood pressure and certain heart conditions (beta-blockers such as propranolol);
• lithium, a medicine used to treat certain mental disorders;
• probenecid, a medicine used to treat gout;
• methotrexate, a medicine used to treat certain cancers and certain skin or joint diseases (e.g. psoriasis, rheumatoid arthritis);
• medicines used to treat allergies and inflammation (corticosteroids);
• medicines used to treat depression (selective serotonin reuptake inhibitors, SSRIs);
• medicines used to treat high blood pressure (diuretics, ACE inhibitors, and angiotensin II antagonists).

Laboratory tests
FEMMEDOL may alter the results of certain blood and urine tests (for adrenal gland function and urinary 5-hydroxyindoleacetic acid testing). Therefore, inform your doctor if you need to undergo laboratory tests, as it may be necessary to stop treatment with naproxen 48 hours before the tests.
FEMMEDOL and alcohol
Take this medicine with caution and inform your doctor if you regularly consume large amounts of alcohol.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take FEMMEDOL during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney or heart problems in the fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labor beyond the expected time. You should not take FEMMEDOL 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 week 20 of pregnancy, FEMMEDOL may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.
Breastfeeding
Avoid taking FEMMEDOL if you are breastfeeding, as this medicine passes into breast milk.
Fertility
The use of sodium naproxen may affect female fertility and is not recommended in women wishing to conceive. Discontinue use of this medicine if you experience difficulty conceiving or are undergoing fertility investigations.
Driving and using machines
The effects of this medicine on the ability to drive vehicles or operate machinery are unknown.
FEMMEDOL contains aspartame, sucrose, potassium, and sodium
This medicine contains 40 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation because the body cannot properly eliminate it.
FEMMEDOL contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 2.1 mmol (82 mg) of potassium per sachet. This should be taken into account in patients with reduced kidney function or those on a low-potassium diet.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., essentially “sodium-free”.

3. How to take FEMMEDOL

Take FEMMEDOL exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Take this medicine preferably after meals.

Adults and adolescents over 16 years of age:
The recommended dose is 1 sachet every 8–12 hours.
If necessary, on the first day you may take 2 sachets, followed by 1 sachet after 8–12 hours.
Do not take more than 3 sachets per day.
Do not use this medicine for longer than 7 days for pain treatment or for more than 3 days for fever treatment.
Consult your doctor if you do not feel better or if you notice worsening of symptoms.

Use in the elderly
Elderly patients should start treatment with the lowest possible dose. In particular, the maximum recommended dose is 2 sachets per day.

Use in patients with kidney or liver problems
If you have kidney problems, do not take more than 2 sachets of FEMMEDOL per day. Before and during treatment with FEMMEDOL, your doctor will carefully monitor your kidney function through specific tests (serum creatinine and/or creatinine clearance).
If you have liver problems, take this medicine with great caution and at the lowest effective dose.

If you take more FEMMEDOL than you should
If you take high doses of this medicine, symptoms such as drowsiness, stomach burning, digestive problems (dyspepsia), nausea, and vomiting may occur.
In case of accidental ingestion or overdose of FEMMEDOL, contact your doctor immediately or go to the nearest hospital.

If you forget to take FEMMEDOL
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Common (may affect up to 1 in 10 people):
feeling thirsty; increased awareness of heartbeat (palpitations).
Rare (may affect up to 1 in 1,000 people):

• severe allergic (anaphylactic) reactions, which usually present as:
  • severe and sudden drop in blood pressure (severe and sudden hypotension);
  • accelerated or slowed heartbeat;
  • unusual fatigue or weakness;
  • anxiety, restlessness;
  • dizziness;
  • loss of consciousness;
  • difficulty breathing or swallowing (due to laryngeal obstruction or bronchospasm);
  • generalized itching (especially on the soles of the feet or palms of the hands);
  • skin irritation (urticaria), sometimes accompanied by swelling of the face, lips, throat and/or tongue (angioedema);
  • skin redness (especially around the ears);
  • bluish discoloration of the skin due to lack of oxygen (cyanosis);
  • excessive sweating;
  • nausea, vomiting, abdominal cramps, diarrhoea;
  • fever.
• mouth mucosa lesions (ulcerative stomatitis);
• inflammation of the pancreas (pancreatitis);
• hair loss (alopecia), light sensitivity (photosensitivity dermatitis, pseudoporphyria), severe skin reactions characterized by lesions and blisters (toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, erythema nodosum, epidermolysis bullosa), skin damage (cutaneous necrosis), widespread rash, elevated body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• changes in liver function tests and jaundice;
• depression, feeling unwell, inflammation of the membranes covering the brain (aseptic meningitis);
• disturbances in attention, memory, perception and reasoning (cognitive disorders);
• heart problems (congestive heart failure), increased heart rate (tachycardia), inflammation of blood vessels (vasculitis);
• lung inflammation (eosinophilic pneumonia, alveolitis), airway obstruction (bronchospasm), swelling of the larynx (laryngeal edema), difficulty breathing (asthma);
• increase or decrease in blood sugar levels (hyperglycaemia, hypoglycaemia).

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

• severe liver inflammation (hepatitis);

The following side effects have also been reported:

• sensation of ringing in the ears (tinnitus);
• nausea, vomiting, constipation, flatulence, abdominal pain, heartburn, indigestion (dyspepsia), inflammation of the oesophagus (oesophagitis) and mouth mucosa (stomatitis), diarrhoea, epigastric abdominal pain, stomach and intestinal lesions and bleeding (peptic ulcer, perforation and haemorrhages), colon inflammation (colitis), presence of blood in stools (melena) and in vomit (haematemesis), worsening of certain intestinal diseases (colitis, Crohn's disease), stomach inflammation (gastritis);
• increased risk of thrombotic events (e.g. heart attack or stroke);
• increased blood pressure (hypertension);
• heart problems (heart failure);
• difficulty breathing;
• skin rash, urticaria, bruising, sweating, skin redness due to blood accumulation (purpura);
• kidney problems (nephrotoxicity, hepatotoxicity, glomerulonephritis, interstitial nephritis, nephrotic syndrome, papillary necrosis, renal failure), presence of blood in urine (haematuria), fluid retention, increased potassium levels in blood (hyperkalaemia);
• headache, sensation of emptiness in the head, drowsiness, insomnia, seizures, difficulty concentrating, confusion and dizziness;
• muscle pain and weakness (myalgia);
• visual and hearing disturbances;
• swelling due to fluid accumulation (oedema, peripheral oedema).

Frequency not known (frequency cannot be estimated from the available data):
a distinct skin allergic reaction known as fixed drug eruption, which usually recurs at the same site or sites upon re-exposure to the medicine and may appear as round or oval patches with skin redness and swelling, skin rash with blisters (urticaria), itching sensation.
Rarely, the following may occur:
reduction in the number of white blood cells (agranulocytosis, leucopenia, granulocytopenia), platelets (thrombocytopenia), and red blood cells (aplastic anaemia and haemolytic anaemia), increase in the number of a type of white blood cells (eosinophilia) in the blood.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 FEMMEDOL

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of medicines 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 FEMMEDOL contains

• The active substance is sodium naproxen. Each sachet contains 220 mg of sodium naproxen.
• The other components are: sucrose, potassium bicarbonate, mannitol, mint/liquorice flavouring, aspartame, acesulfame K, polysorbate 20, simethicone.

Description of the appearance of FEMMEDOL and package contents
Carton containing 12 sachets.
Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
Manufacturer
E-Pharma Trento S.p.A. – Ravina hamlet - Via Provina, 2 – 38123 Trento (TN) - Italy