FALEV 250 mg Film-Coated Tablets

Зміст інструкції

1. FALEV 250 mg film-coated tablets, 500 mg film-coated tablets
   1. WHAT IS FALEV TABLETS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING FALEV
   3. HOW TO TAKE FALEV TABLETS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FALEV COMPRESSES
   6. PACKAGE CONTENTS AND OTHER INFORMATION

FALEV 250 mg film-coated tablets, 500 mg film-coated tablets

Levofloxacin
Generic medicine

Read this leaflet carefully before you start 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• 1. What FALEV is and what it is used for
• 2. What you need to know before you take FALEV tablets
• 3. How to take FALEV tablets
• 4. Possible side effects
• 5. How to store FALEV tablets 6 Contents of the pack and other information

1. WHAT IS FALEV TABLETS AND WHAT IT IS USED FOR

FALEV tablets contains the active substance called levofloxacin. This medicine belongs to a group of medicines called antibiotics. Levofloxacin is a “quinolone” antibiotic.
This medicine works by killing the bacteria responsible for infections in the body.

FALEV is indicated for the treatment of infections of:

• Paranasal sinuses
• Lungs, in subjects with long-standing respiratory problems or with pneumonia
• Urinary tract, including kidneys and bladder
• Prostate gland if there are chronic infections
• Skin and underlying layers, including muscles. These are also called soft tissues. In some special situations, FALEV tablets can be used to reduce the likelihood of contracting a lung disease called anthrax or the worsening of the disease after exposure to the bacterium that causes anthrax.

2. WHAT YOU NEED TO KNOW BEFORE TAKING FALEV

Do not take this medicine and inform your doctor if:

• you are allergic (hypersensitive) to levofloxacin or any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or to any of the other components of this medicine (listed in section 6) The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

medicinal (listed in paragraph 6) The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

• you suffer from epilepsy (a disease that causes loss of consciousness and violent involuntary muscle contractions).
• you have had problems with your tendons (e.g. tendinitis) due to treatment with a “quinolone antibiotic”. Tendons are fibrous structures that connect muscles to the skeleton. FALEV should not be administered to children and adolescents during the growth period. FALEV should not be used during pregnancy and breastfeeding (see “Pregnancy and breastfeeding”) Do not take this medicine if the above applies to you in any way. If you have any doubts, consult your doctor or pharmacist before taking FALEV.

Warnings and precautions
Consult your doctor or pharmacist before taking FALEV if:

• you are elderly;
• you are using corticosteroids, medicines used to treat inflammation (see “FALEV and other medicines”);
• you have had an organ transplant;
• you have had convulsions (sudden, involuntary and uncontrolled muscle movements);
• you suffer from kidney problems;
• you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (a hereditary genetic disorder that can cause the destruction of red blood cells after a recent illness or the use of certain medicines);
• you have or have had mental health problems in the past;
• you have heart problems (if you were born with or have a family history of a prolonged QT interval, an irregular heartbeat);
• you have an imbalance of Salts (especially low levels of potassium or magnesium in the blood);
• you suffer from bradycardia (slowed heartbeat);
• you suffer from heart failure (the heart's inability to provide an adequate amount of blood to the body, causing shortness of breath and swelling of the ankles);
• you have had a heart attack (death of heart cells due to prolonged lack of oxygen supply);
• you have diabetes (a disease characterized by high levels of glucose in the blood due to reduced insulin production by the pancreas);
• you have liver problems;
• you suffer from myasthenia gravis(a muscle disease that causes weakness and fatigue)
• you suffer from peripheral neuropathy (a nerve disease that causes pain, numbness, tingling and weakness);
• you have been diagnosed with an aortic aneurysm or peripheral aneurysm of a large blood vessel (an increase in the size or enlargement of a large blood vessel);
• you have previously had an episode of aortic dissection, a serious condition in which a tear occurs in the wall of the largest artery in the body (the aorta);
• you have been diagnosed with insufficiency of one of the heart valves;
• you have a family history of aneurysm or aortic dissection or congenital heart valve disease or other risk factors or predisposing conditions, such as Marfan syndrome, or Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome (autoimmune inflammatory diseases) or vascular disorders such as Takayasu arteritis, giant cell arteritis and Behçet's disease or high blood pressure or known atherosclerosis (fat buildup in and on the walls of the arteries) or rheumatoid arthritis (an autoimmune disease) or endocarditis (inflammation of the heart);
• you have developed a severe skin reaction or peeling of the skin, blisters and/or mouth sores after taking levofloxacin.

Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of levofloxacin.
SJS and TEN can initially appear on the body as reddish spots or as circular patches often with central blisters. Ulcers of the mouth, throat, nose, genitals and eyes may also occur, and the eyes may become red and swollen. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread skin desquamation and life-threatening or fatal complications.
DRESS initially presents as flu-like symptoms and a skin rash on the face, then a widespread rash with fever, increased levels of liver enzymes in blood tests and eosinophilia and enlarged lymph nodes.
If you develop a severe skin rash or any other of these skin symptoms, stop taking levofloxacin and contact your doctor or seek medical attention immediately.
You should not take antibacterial medicines based on quinolones/fluoroquinolones, including FALEV, if you have previously had any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In this case, inform your doctor as soon as possible.

During the intake of FALEV:

• If you have any doubt that the above may apply to you in any way, consult your doctor or pharmacist before taking FALEV.
• If you experience severe and sudden abdominal, chest or back pain, which may be a symptom of aneurysm and aortic dissection, go to the emergency room immediately. The risk may be greater if you are taking corticosteroids (medicines used to treat inflammation).
• Immediately inform your doctor if you notice a rapid onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (feeling of a rapid or irregular heartbeat). - If sudden spasms, muscle spasms or muscle contractions occur, consult a doctor immediately as they may be signs of myoclonus. The doctor may need to stop treatment with levofloxacin and start appropriate therapy.
• If you experience fatigue, paleness, bruising, uncontrolled bleeding, fever, sore throat and a severe deterioration in your general condition or a feeling that your resistance to infections may be diminished, consult a doctor immediately as they may be signs of blood disorders. The doctor may need to monitor your blood with tests. If changes occur, the doctor may need to stop treatment. Rarely, pain and swelling in the joints and inflammation or rupture of tendons may occur. The risk is greater if you are elderly, if you have had an organ transplant, if you have kidney problems or if you are being treated with corticosteroids (medicines used to treat inflammation). Tendon inflammation and rupture can occur within the first 48 hours of treatment and up to several months after the end of FALEV therapy. At the first signs of pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop taking FALEV, consult your doctor and rest the painful part. Avoid any unnecessary movement, as the risk of tendon rupture may increase. Rarely, symptoms of nerve damage may occur such as pain, burning, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms. In this case, stop taking FALEV and inform your doctor immediately to avoid the development of potentially irreversible neuropathy.

Serious, prolonged, disabling and potentially irreversible side effects
Antibacterial medicines based on fluoroquinolones/quinolones, including FALEV, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling or potentially irreversible. These include pain in the tendons, muscles and joints of arms and legs, difficulty walking, paresthesia (abnormal sensations such as tingling, prickling, itching, numbness or burning), sensory organ disorders such as altered vision, taste, smell and hearing, depression, impaired memory, severe sleep disturbances.
If you experience any of these side effects after taking FALEV, contact your doctor immediately before continuing treatment. The doctor will decide with you whether to continue treatment and will also consider the use of an antibiotic from another class.
If you suspect that any of the above conditions applies to you, talk to your doctor or pharmacist before taking FALEV.

Other medicines and FALEV
Inform your doctor or pharmacist if you are taking or have recently taken or may take any other medicines. This is because FALEV can affect the mechanism of action of other medicines. Also, some medicines can affect the mechanism of action of FALEV.

In particular, inform your doctor if you are taking any of the following medicines. This is because concomitant administration with FALEV may increase the possibility that you experience side effects

• Corticosteroids, used for inflammation. The possibility that you develop inflammation and/or rupture of the tendons is greater.
• Warfarin, used to delay blood clotting. The possibility that you experience bleeding is greater. The doctor may prescribe regular blood tests to check blood clotting.
• Theophylline, used for respiratory problems. The possibility that you have convulsions (sudden, involuntary and uncontrolled muscle movements) is greater if you take theophylline in association with FALEV.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indometacin. The possibility that convulsions occur when taken in association with FALEV is greater.
• Ciclosporin, used after organ transplants. The possibility that you experience the typical side effects of ciclosporin is greater.
• medicines known for their effects on the heartbeat. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), antipsychotics (for mental disorders) and macrolide antibiotics such as erythromycin, azithromycin and clarithromycin used for bacterial infections.
• probenecid, used for gout (a disease that causes pain, swelling and redness of the joints) If you have kidney problems, your doctor may prescribe you a lower dose.
• cimetidine, used for ulcers and heartburn). If you have kidney problems, your doctor may prescribe you a lower dose.

Do not take FALEV tablets at the same time as the following medicines. This is because the mechanism of action of FALEV tablets may be affected:

• iron salts in tablets (for anemia), zinc supplements, antacids containing magnesium or aluminum (for acidity or heartburn), didanosine or sucralfate (for stomach ulcers). See section 3 “If you are taking iron salts in tablets, zinc supplements, antacids, didanosine or sucralfate”.

Urine test for opioids
In patients taking FALEV, urine tests may give “false-positive” results for strong painkillers called “opioids”. If your doctor deems it necessary to perform urine tests, inform him that you are taking FALEV.

Tuberculosis test
This medicine can cause “false-negative” results in some tests used in the laboratory to search for the bacterium that causes tuberculosis.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with breast milk, ask your doctor or pharmacist before taking this medicine.
This medicine is contraindicated during pregnancy and breastfeeding (See “What you need to know before taking FALEV”).

Driving and using machines
FALEV slightly or moderately impairs the ability to drive vehicles and use machinery.
Some side effects may occur after taking this medicine that include drowsiness, dizziness (feeling of movement, rotation and loss of balance) or visual disturbances.
Some of these side effects may alter the ability to concentrate and the speed of reaction. Do not drive vehicles or perform activities that require a high level of attention.

Important information about some excipients of FALEV tablets
This medicine contains the yellow sunset dye (E110) which may cause allergic reactions.

3. HOW TO TAKE FALEV TABLETS

Always take this medicine exactly as your doctor has instructed.
If you have any doubts, ask your doctor or pharmacist.

Taking this medicine

• Take this medicine by mouth
• Swallow the tablets whole with a glass of water
• The tablets can be taken during meals or at any time between meals

If you are already taking tablets containing iron, zinc, antacids, didanosine or sucralfate
Do not take these medicines at the same time as FALEV tablets. Take the dose of
these medicines at least 2 hours before or after FALEV tablets.

How much to take

• Your doctor will decide how many FALEV tablets you need to take
• The dose will depend on the type of infection you have and the location of the infection
• The length of treatment depends on the severity of the infection
• If you think the medicine is not working well enough or is too strong, do not change the dose yourself, but ask your doctor.

Adults and the elderly:
Sinus infections

• Two FALEV 250 mg tablets in two doses a day
• Or one FALEV 500 mg tablet every day

Lung infections in patients with chronic respiratory problems

• two FALEV 250 mg tablets once a day
• or one FALEV 500 mg tablet once a day

Pneumonia

• Two FALEV 250 mg tablets one or two times a day
• or one FALEV 500 mg tablet once a day

Urinary tract infections including kidneys or bladder

• One or two FALEV 250 mg tablets once a day
• Or half or one FALEV 500 mg tablet once a day

Prostate infections

• Two FALEV 250 mg tablets once a day
• Or one FALEV 500 mg tablet once a day

Skin and subcutaneous tissue infections including muscles

• two FALEV 250 mg tablets one or two times a day
• or one FALEV 500 mg tablet one or two times a day

Adults and elderly with kidney problems:
Your doctor may decide to give you a reduced dose.

Children and adolescents:
This medicine should not be given to children or adolescents during the period of growth.

Protect your skin from sunlight
Do not expose yourself directly to sunlight during treatment with this medicine and
for two days after the end of treatment. This is because your skin becomes more sensitive to
the sun and may develop sunburn, stinging or severe blisters if you do not take the following precautions:

• Make sure you use sun creams with a high protection factor
• Always wear a hat and clothes that cover your arms and legs
• Avoid sunbeds.

If you take more FALEV tablets than you should
If you accidentally take more tablets than you should, contact your doctor immediately or seek other medical assistance. Bring the medicine packaging with you. This will allow
the doctor to know what you have taken. The following side effects may occur: seizures (involuntary, sudden and uncontrolled muscle movements), confusion, dizziness (sensation of movement, rotation and loss of balance), feeling of
fainting, tremor and heart problems – which can lead to irregular heartbeat and a
feeling of unwellness (nausea) or heartburn.

If you forget to take FALEV tablets
If you have forgotten to take a dose, take it as soon as you remember, unless it is
almost time for the next dose. Then continue as before. Never take a double
dose to make up for a missed one.

If you stop taking FALEV tablets
Do not stop taking FALEV just because you feel better. It is important that you complete the course
of tablets prescribed by your doctor. If you stop taking the tablets too early, the
infection may return and your condition may worsen or bacteria
may develop resistance to the medicine.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking FALEV and contact your doctor immediately if you notice any of the following
side effects – you may need to receive urgent medical treatment:
Rare(may affect up to 1 in 1,000)

• you have an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• watery diarrhoea with possible blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious intestinal problem
• pain and inflammation of tendons or ligaments which can sometimes rupture. The Achilles tendon is most commonly affected.
• Convulsions (sudden, involuntary and uncontrolled muscle movements)
• Hallucinations and paranoia (seeing or hearing things that do not exist)
• Feeling of depression, mental problems, agitation (feeling of restlessness), abnormal dreams or nightmares
• Widespread skin rash, fever, increased liver enzymes (which may indicate liver damage), eosinophilia (blood abnormalities), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, see paragraph 2).
• SIADH (Syndrome of inappropriate antidiuretic hormone secretion)
• Hypoglycaemia (low blood sugar) or hypoglycaemic coma (low blood sugar leading to a state of deep unconsciousness). This is important for people who have diabetes. Very rare(may affect up to 1 in 10,000)
• burning, tingling, pain or numbness. These signs may be indicative of a disease called “neuropathy” Not known(frequency cannot be estimated based on available data)
• Severe skin rashes that may include blistering or peeling of the skin including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the body as reddish spots or as circular patches often with central blisters, skin desquamation, ulcers of the mouth, throat, nose, genitals and eyes and may be preceded by fever and flu-like symptoms, see paragraph 2.
• Loss of appetite, yellowing of the skin and eyes, dark urine, itching or a painful abdomen.
• These may be signs of liver problems which can include fatal liver failure. Psychotic reactions (loss of contact with reality) with the risk of having suicidal thoughts or suicidal actions.
• Nausea, general feeling of unwellness, discomfort or pain in the stomach area, or vomiting. These may be signs of inflammation of the pancreas (acute pancreatitis), see paragraph 2. If your vision becomes blurred or if you experience any discomfort in your eyes while taking FALEV, consult an ophthalmologist immediately. Very rare cases of adverse drug reactions, prolonged (lasting months or years) or permanent, such as inflammation of the tendons, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as prickling, tingling, itching, burning, numbness or pain (neuropathy symptoms), depression, fatigue, sleep disorders, impaired memory and altered hearing, vision, taste and smell, have been associated with the use of antibiotics of the quinolone and fluoroquinolone type, in some cases independently of pre-existing risk factors. Cases of aneurysms and dissections (dilation and weakening of the aortic wall or tearing of the aortic wall), with possible rupture that can be life-threatening, as well as cases of heart valve incompetence (backflow of blood through the valves), have been reported in patients treated with fluoroquinolones, see also paragraph 2.

Tell your doctor if any of the following side effects worsen or lasts more than
a few days:
Common:(may affect up to 1 in 10)

• Insomnia (sleep problems that can make it difficult to fall asleep or stay asleep),
• Headache,
• Feeling dizzy (sensation of movement, rotation and loss of balance),
• feeling unwell (nausea, vomiting),
• Diarrhoea,
• Increased levels of liver enzymes in the blood which may indicate liver damage (ALT/AST, alkaline phosphatase, GGT). Uncommon(may affect up to 1 in 100)
• Fungal infection, including Candida, which may require treatment,
• Resistant pathogens (bacteria that are able to survive and even multiply in the presence of an antibiotic),
• Leukopenia and eosinophilia (changes in the number of white blood cells shown in some blood tests),
• Anxiety (feeling of stress),
• Feeling of confusion,
• Feeling nervous,
• Drowsiness,
• Tremor,
• Vertigo (sensation of movement, rotation and loss of balance),
• Dyspnoea (difficulty breathing),
• Dysgeusia (altered taste),
• Abdominal pain,
• Dyspepsia (difficult digestion),
• Flatulence (gas),
• Constipation,
• Itching and skin rash,
• Urticaria (severe itching or skin rash),
• Hyperhidrosis (excessive sweating),
• Joint or muscle pain,
• Increased bilirubin and creatinine (due to problems with the liver or kidneys, respectively),
• General weakness. Rare(may affect up to 1 in 1,000)
• Thrombocytopenia (reduced number of platelets in the blood which can cause bruising and easy bleeding)()
• Neutropenia (low number of white blood cells)
• Hypersensitivity (exaggerated immune response)
• Paresthesia (tingling sensation in the hands and feet)
• Tinnitus (perception of a sound that has no external source, so other people cannot hear it),
• Blurred vision,
• Tachycardia (unusually fast heartbeat),
• Palpitations (perception of the heartbeat),
• Hypotension (low blood pressure),
• Muscle weakness. This is important for patients who suffer from myasthenia gravis (see “Warnings and precautions”),
• Impaired memory,
• Impaired renal function and occasional renal failure which may be caused by an allergic reaction to the kidneys called interstitial nephritis,
• Fever. Not known(frequency cannot be estimated based on available data)
• Bone marrow failure (which can cause fatigue, reduced ability to fight infections and uncontrolled bleeding),
• Aplastic anaemia which can cause (this can lead to paleness or yellowish skin due to damage to red blood cells),
• Pancytopenia (decrease in the number of all types of cells present in the blood),
• Agranulocytosis (decreased number of white blood cells in the blood causing fever, sore throat and a general feeling of unwellness that does not go away),
• Haemolytic anaemia (reduction in the number of red blood cells due to their breakdown),
• Anaphylactic shock (a severe allergic reaction that causes a sudden drop in pressure, lack of breathing due to airway constriction),
• Hyperglycaemia (increased blood sugar levels, this is important for those who suffer from diabetes),
• Parosmia (change in the perception of the smell of things),
• Anosmia and ageusia (reduction and loss of smell)
• Mania (feeling very excited, euphoric, agitated or enthusiastic),
• Dyskinesia (involuntary muscle movements),
• Extrapyramidal disorders (difficulty moving and walking),
• Syncope (sudden, temporary loss of consciousness),
• Temporary loss of vision,
• Uveitis (a form of eye inflammation that can cause pain, redness and blurred vision),
• Worsening or loss of hearing,
• Prolongation of the QT interval (abnormal and accelerated heart rhythm, which can turn into a life-threatening irregular heart rhythm with cardiac arrest),
• Bronchospasm (difficulty breathing or wheezing due to airway constriction),
• Allergic reactions to the lungs,
• Pancreatitis (inflammation of the pancreas),
• Hepatitis (inflammation of the liver),
• Photosensitivity (increased sensitivity of the skin to the sun or ultraviolet rays),
• Vasculitis (inflammation of the blood vessels that carry blood throughout the body due to an allergic reaction),
• Stomatitis (inflammation of the inner tissues of the mouth),
• Rhabdomyolysis (breakdown of muscles and destruction of muscles),
• Arthritis (redness and swelling of the joints),
• Pain, including back pain, chest pain and limb pain,
• Myoclonus (muscle jerks, muscle spasms or sudden, involuntary muscle contractions),
• Porphyria attacks (painful attacks that can last for days or weeks, in people who already have porphyria, a very rare metabolic disease that affects the nervous system and/or the skin),
• Benign intracranial hypertension (persistent headache with or without blurred vision).

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

5. HOW TO STORE FALEV COMPRESSES

Keep this medicine out of the sight and reach of children .
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Keep the blister in the box to protect from light.
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 FALEV tablets contain
FALEV tablets are available in two dosages: 250 mg and 500 mg. The active ingredient is levofloxacin.
Each FALEV 250 mg tablet contains levofloxacin hemihydrate equivalent to 250 mg of levofloxacin.
Each FALEV 500 mg tablet contains levofloxacin hemihydrate equivalent to 500 mg of levofloxacin.
The excipients are:
Tablet core
Microcrystalline cellulose, hydroxypropylcellulose, crospovidone, magnesium stearate.
Film coating
Hypromellose, FD&C Blue 2 indigo carmine - aluminum lake (E132), FD&C Yellow 6 sunset yellow -
aluminum lake (E110), iron oxide red (E172), macrogol 4000, titanium dioxide (E171).
In addition, the 500 mg tablets contain yellow iron oxide.

What FALEV tablets look like and contents of the pack
FALEV 250 mg tablets are pink, oblong, biconvex with a break line.
The tablets can be divided into two equal halves.
FALEV 500 mg tablets are orange, oblong, biconvex with a break line. The tablets can be divided into two equal halves.
FALEV 250 mg film-coated tablets are packaged in blisters and are available in packs of 1, 5 and 10 tablets.
FALEV 500 mg film-coated tablets are packaged in blisters and are available in packs of 1, 5, 7 and 10 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
LANOVA FARMACEUTICI S.r.l.
Via Conca D’Oro, 212
00141 Rome

Manufacturer:
Pharmathen S.A.
6 Dervenekion str.,
153 51 Pallini, Attiki
Greece