ARFEN 500 mg Tablet

Зміст інструкції

1. ARFEN 400 mg/3 ml injectable solution for intramuscular use
   1. What is ARFEN and what is it used for
   2. What you need to know before you take ARFEN
   3. How to take ARFEN
   4. Possible side effects
   5. How to store ARFEN
   6. Contents of the pack and other information
2. ARFEN 10 mg/ml Vaginal Solution
   1. What is ARFEN and what is it used for
   2. What you need to know before using ARFEN
   3. How to use ARFEN
   4. Possible side effects
   5. How to store ARFEN
   6. Contents of the pack and other information

ARFEN 400 mg/3 ml injectable solution for intramuscular use

Ibuprofen Lysine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ARFEN and what is it used for

ARFEN contains a substance called ibuprofen lysine, which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine works by reducing inflammation and relieving pain, swelling and
stiffness of the joints and muscles.
ARFEN is used in the treatment of acute pain in patients with inflammatory diseases of the
joints and muscles.

2. What you need to know before you take ARFEN

Do not take ARFEN

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have had angioedema (a serious allergic reaction that causes swelling of the hands, feet or ankles, face and lips);
• if you have, or have had in the past, a stomach or intestinal ulcer or bleeding;
• if you have severe liver or kidney failure;
• if you have had stomach or intestinal bleeding after taking ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have a disease that increases your tendency to bleed (haemorrhagic diathesis);
• if you have severe heart failure;
• if you are taking diuretics (i.e. medicines that help to increase urine) or medicines that prevent blood clotting;
• if you are pregnant or breastfeeding;
• if you are under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking ARFEN.
This medicine must be taken under strict medical supervision.
Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop taking ARFEN immediately and contact your doctor or
emergency medical service immediately if you notice any of these signs.
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS),
acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment.
Stop using ARFEN and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions
described in section 4.
See your pharmacist or nurse if you have an infection - see section «Infections» below.
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a
modest increase in the risk of heart attack or stroke, especially if administered in high
doses.
Infections
ARFEN can mask the symptoms of infections such as fever and pain. It is therefore possible that
ARFEN may delay adequate treatment of the infection, which could increase
the risk of complications. This has been observed in pneumonia caused by bacteria and in
bacterial skin infections related to varicella. If you take this medicine while you
have an infection and the symptoms of the infection persist or worsen, contact your
doctor immediately.

Do not exceed the recommended dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking ARFEN if:

• you have heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including ‘mini-stroke’ or transient ischemic attack (TIA));
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;
• you suffer from asthma. This medicine can cause bronchospasm (symptoms including shortness of breath and difficulty breathing), shock and other allergic reactions;
• you have experienced bronchospasm in the past during treatment with aspirin or other NSAIDs;
• you have liver or kidney problems;
• you have bleeding or blood clotting problems;
• you have had episodes of toxicity to the stomach or intestines in the past;
• you have an inflammatory bowel disease (such as ulcerative colitis or Crohn's disease);
• you are an elderly person. Elderly people are more prone to side effects associated with ARFEN.

Other medicines and ARFEN
Tell your doctor or pharmacistif you are taking, have recently taken or might
take any other medicines.
ARFEN can influence or be influenced by other medicines. For example:

• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• other painkillers (such as aspirin or other NSAIDs). Combining them with these medicines may lead, although very rarely, to the onset of serious skin reactions, some of which are fatal (such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). They may also increase the risk of stomach or intestinal ulcer or bleeding;
• corticosteroids (hormones used to treat inflammation and allergies) may increase the risk of stomach or intestinal ulcer or bleeding;
• medicines that prevent blood clots (antiplatelet agents) or medicines known as selective serotonin reuptake inhibitors (SSRIs), used to treat depression. These medicines may increase the risk of bleeding in the stomach and intestines;
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Some other medicines may also influence or be influenced by treatment with
ARFEN. Therefore, always consult your doctor or pharmacistbefore using ARFEN with
other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Do not take ARFEN if you are pregnant, as it may harm the fetus or cause problems
during childbirth. It may 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.
From the 20th week of pregnancy, ARFEN 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 narrowing a blood vessel (ductus arteriosus) in the baby's
heart.
This medicine must notbe used during pregnancy or breastfeeding.

Driving and using machines
There are no data available to assess the effect of this medicine on the ability to drive
vehicles or use machines.

ARFEN contains Sodium Metabisulphite
This medicine contains Sodium Metabisulphite: it can rarely cause serious hypersensitivity
reactions and bronchospasm.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially
“sodium-free”.

3. How to take ARFEN

Take this medicine following strictly the doctor's instructions. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is 1-2 vials of 400 mg per day, as directed by your doctor.
ARFEN is administered intramuscularly.

Do not exceedthe maximum daily dose of 2,500 mg.
The doctor may decide to vary the dosage based on the severity of your symptoms, or at the beginning
of treatment or based on your response to treatment.
The lowest effective dose should be used for the shortest period necessary to relieve the
symptoms. If you have an infection, consult your doctor immediately if symptoms (such as
fever and pain) persist or worsen (see paragraph 2).
In elderly patients, the doctor may prescribe a lower dose of the medicine compared to
that for adults.

If you take more ARFEN than you should
If you take an excessive dosage (overdose) of ibuprofen, you may experience more
commonly the following symptoms: nausea, vomiting, stomach pain, a state of deep sleep with
reduced response to normal stimuli (lethargy), drowsiness, headache, ringing in the ears
(tinnitus), dizziness, uncontrolled body movements (convulsions) and loss of consciousness.
The symptoms of an overdose may appear within 4-6 hours of taking
ibuprofen.
Rarely, it may present uncontrolled eye movements (nystagmus), lowering of
body temperature (hypothermia), effects on the kidney, bleeding from the stomach and
intestines, profound loss of consciousness, temporary cessation of breathing (apnea),
diarrhea, reduced activity of the nervous system (depression of the Central Nervous System)
and respiratory activity (depression of the respiratory system).
In addition, it may also manifest disorientation, a state of excitement, fainting,
lowering of blood pressure, decreased or increased heart rate
(bradycardia or tachycardia).
It may also have an increase in acids in the blood (metabolic acidosis). In the latter case
symptoms may include nausea, stomach pain, vomiting (possibly with
traces of blood), headache, ringing in the ears, confusion and uncontrolled
eye movements. At high doses, drowsiness, chest pain, palpitations, have been reported
loss of consciousness, convulsions (especially in children), weakness and dizziness, blood in
urine, low levels of potassium in the blood, feeling of coldness to the body and breathing problems.
If you take significantly high doses of ibuprofen, you may experience serious damage to the
kidneys and liver.
If you have taken more ARFEN than you should or if your child has taken this medicine by
mistake, always contact a doctor or the nearest hospital to obtain an opinion on
the risk and advice on the actions to be taken.
If you have any doubts about the use of ARFEN, consult your doctor or pharmacist.

If you forget to take ARFEN
Do nottake a double dose to make up for a missed dose.
If you have any doubts 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.

Stop using ibuprofene and consult your doctor immediately if you notice any of the following symptoms:

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• if you experience any unusual symptoms in the stomach or intestines (such as vomiting with blood, dark brown vomit, black and sticky stools or diarrhoea with traces of blood);
• if you develop symptoms such as skin rash, lesions to the mucous membranes (e.g. of the oral cavity) or other symptoms of an allergic reaction;
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• widespread rash, high body temperature and swollen lymph nodes and increased eosinophils (a type of white blood cells) (DRESS syndrome);
• widespread, red and scaly rash with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The most common side effects are:

• indigestion,
• pain in the upper abdomen,
• heartburn,
• flatulence,
• skin rash.

Other side effects:

• discomfort (nausea, vomiting),
• presence of hard and dry stools (constipation),
• frequent need to evacuate, with soft and watery stools (diarrhoea),
• bleeding of the stomach (with traces of blood in the vomit, or dark brown vomit) or intestines (with black and sticky stools or diarrhoea with blood), sometimes fatal,
• formation of ulcers or perforations in the stomach or intestines,
• inflammation and ulceration in the oral cavity (ulcerative stomatitis),
• inflammation of the stomach (gastritis),
• worsening of inflammation of the intestines (colitis and Crohn's disease),
• problems at the blood level, such as anaemia, decrease in platelets (thrombocytopenia) or changes in the number of white blood cells (leukopenia, neutropenia, agranulocytosis),
• problems at the nervous system level (depression, disorientation),
• swelling (oedema),
• blistering skin conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis,
• high blood pressure (hypertension),
• heart failure,
• heart attack (myocardial infarction),
• stroke,
• the skin becomes sensitive to light - frequency not known.

If side effects become severe, or if you experience any side effect

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

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
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. Contents of the pack and other information

What ARFEN contains

• the active ingredient is lysine ibuprofen. One vial (3ml) contains 400 mg of lysine ibuprofen.
• the other ingredients of the medicine are sodium metabisulfite and water for injectable preparations.

Description of the appearance of ARFEN and contents of the pack
Arfen 400 mg/3 ml injectable solution for intramuscular use is presented in a box
containing 6 vials.

Marketing Authorisation Holder
Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A.
Via Licinio, 11
22036 ERBA (CO) – Italy

Manufacturer and final control
Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A.
Via Licinio, 11
22036 ERBA (CO) – Italy

ARFEN 10 mg/ml Vaginal Solution

Ibuprofen Lysine

Read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ARFEN and what is it used for

ARFEN contains an active substance called ibuprofen, which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
ARFEN is used in the treatment of inflammatory diseases of the female genital tract
(vaginitis, vulvitis and cervico-vaginitis) and in the prevention during gynecological surgery
before and after surgical procedures.
It works by reducing inflammation and relieving pain.

2. What you need to know before using ARFEN

Do not use ARFEN

• If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have a stomach or intestinal ulcer or bleeding, or if you have had repeated episodes of ulcer or bleeding in the past;
• if you have had stomach or intestinal bleeding after taking ibuprofen, acetylsalicylic acid (e.g. aspirin) or other similar non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have severe heart failure;
• if you are in the last 3 months of pregnancy.

Warnings and precautions
Consult your doctor or pharmacist before using ARFEN.
Solution for external use only.

Pay particular attention if

• you are already taking other non-steroidal anti-inflammatory drugs (NSAIDs);
• you are taking medicines that prevent blood clotting (such as warfarin);
• you have high blood pressure (hypertension) or heart problems;
• you have bleeding or blood clotting problems, if you have an inflammatory bowel disease (such as ulcerative colitis or Crohn's disease);
• you are pregnant or breastfeeding;
• you are an elderly person. Elderly people are more prone to side effects associated with ARFEN.

Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with treatment with ibuprofen.
Stop using ARFEN and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Other medicines and ARFEN
Tell your doctor or pharmacistif you are taking, have recently taken or might take any other medicines.
No negative interactions with other medicines commonly used in the treatment of the conditions for which this medicine is used are known.
ARFEN can influence or be influenced by other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• anticoagulants (medicines that make the blood more fluid, such as warfarin). ARFEN may increase the effect of these medicines.
• other painkillers (such as aspirin or other NSAIDs).
• corticosteroids (hormones used to treat inflammation and allergies) may increase the risk of ulcer or bleeding of the stomach or intestine.
• antiplatelet agents (which prevent blood clots) or medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the treatment of depression. These medicines may increase the risk of bleeding in the stomach and intestines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use ARFEN if you are in the last 3 months of pregnancy. ARFEN should not be used in the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is necessary during this period, the lowest possible dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of ARFEN can cause adverse effects in the newborn. It is not known whether the same risk occurs with ARFEN when used on the skin.
The use of this medicine is not recommendedduring pregnancy and during breastfeeding.

Driving and using machines
ARFEN does not impair the ability to drive vehicles and operate machinery.

3. How to use ARFEN

Use this medicine following exactly the doctor's instructions. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one or two vaginal suppositories per day, as directed by your doctor.
The solution can be used at room temperature or lukewarm, by placing the bottle
under a stream of warm water.

Instructions for use

• 1- Remove the warranty seal and closure by pushing it sideways;
• 2- Extract the cannula from the protective sheath, inserting it into the bottle until it is securely positioned;
• 3- Position yourself so that the solution can perform its cleansing and therapeutic action, remaining for a few moments at the level of the affected mucous membranes (supine position is ideal). Carefully insert the cannula into the vaginal canal as deeply as possible. Completely compress the bottle to allow the entire quantity of solution to escape.

If you use more ARFEN than you should
If you take an excessive dose (overdose) of ibuprofen, you may experience more
commonly the following symptoms: nausea, vomiting, stomach pain, a state of deep sleep with
reduced response to normal stimuli (lethargy), drowsiness, headache, ringing in the ears
(tinnitus), dizziness, uncontrolled body movements (convulsions) and loss of consciousness.
The symptoms of an overdose may appear within 4-6 hours of taking
ibuprofen.
Rarely, it may present uncontrolled eye movements (nystagmus), increased acids
in the blood (metabolic acidosis), lowering of body temperature (hypothermia), effects
on the kidney, bleeding of the stomach and intestines, profound loss of consciousness
(coma), temporary interruption of breathing (apnea), diarrhea, reduction of the activity of
the nervous system (depression of the Central Nervous System) and respiratory activity
(depression of the respiratory system).
Furthermore, it may also manifest disorientation, a state of excitement, fainting,
lowering of blood pressure (hypotension), decrease or increase of heartbeats (bradycardia or tachycardia).
If you take significantly high doses of ibuprofen, you may experience serious damage to
the kidneys and liver.
In case of accidental ingestion/taking of an excessive dose of ARFEN, immediately notify
your doctor or go to the nearest hospital.
If you have any doubts about the use of ARFEN, consult your doctor or pharmacist.

If you forget to use ARFEN
Do notuse a double dose to make up for a missed dose.
If you have any doubts 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.
Use, especially if prolonged, of the product may lead to sensitization phenomena. In such
cases it is necessary to stop treatment and consult your doctor.

Stop using ibuprofene and consult your doctor immediately if you notice any of the
following symptoms:

• if you experience any unusual symptoms in the stomach or intestines (such as vomiting with blood, dark brown vomit, black and tarry stools, or diarrhea with traces of blood);
• if you develop symptoms such as skin rash, lesions of the mucous membranes (e.g. of the oral cavity) or other symptoms of an allergic reaction;
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome);
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The most common side effects are:

• nausea
• vomiting
• frequent need to evacuate, with soft and watery stools (diarrhea)
• flatulence
• presence of hard and dry stools (constipation)
• heartburn (dyspepsia)
• pain in the upper abdomen
• black stools due to the presence of blood (melena)
• bleeding of the stomach with traces of blood in the vomit (hematemesis)
• inflammation and ulceration in the oral cavity (ulcerative stomatitis)
• worsening of inflammation of the intestine (colitis and Crohn's disease).
• formation of ulcers or perforations in the stomach or intestine, especially in the elderly, sometimes fatal

Other side effects:

• inflammation of the stomach (gastritis)
• swelling (edema)
• high blood pressure (hypertension)
• heart failure
• mild and temporary burning at the site of administration, in sporadic cases
• severe blistering skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, very rarely
• the skin becomes sensitive to light - frequency not known

If you experience any of the aforementioned side effects, if the side effects
become serious, or if you experience any side effects not listed in this

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

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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. Contents of the pack and other information

What ARFEN contains

• the active ingredient is lysine ibuprofen. Each 140 ml bottle contains 1.4 g of lysine ibuprofen.
• the other ingredients of the medicine are phenylethyl alcohol, rose red fragrance and purified water.

Description of the appearance of ARFEN and contents of the pack
ARFEN 10 mg/ml vaginal solution is presented in a pack containing 5 bottles of
140 ml and 5 single-dose cannulae.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A.
Via Licinio, 11
22036 ERBA (CO) – Italy

Manufacturer
Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A.
Via Licinio, 11
22036 ERBA (CO) – Italy