Ibufast forte

Package leaflet: Information for the user

IBUFAST Forte, 400 mg, coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days (in case of fever) or 5 days (in case of pain), or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What IBUFAST Forte is and what it is used for

This medicine is intended for short-term symptomatic treatment of:

• mild to moderate pain such as rheumatic and muscular pain, back pain, neuralgia, primary dysmenorrhoea, toothache, migraine, headache,
• symptoms of flu and cold,
• fever lasting less than 3 days.

In adult patients, if there is no improvement after 3 days (in case of fever) or 5 days (in case of pain), or if symptoms worsen, medical advice should be sought.
In adolescents, if there is a need to use this medicine for more than 3 days, or if symptoms worsen, consult a doctor.

2. Important information before taking IBUFAST Forte

When not to take IBUFAST Forte
Do not take IBUFAST Forte:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• in patients with hypersensitivity (allergy) to other non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients currently suffering or with a history of:
• asthma, urticaria or allergic-type reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• increased tendency to bleeding or active bleeding,
• gastrointestinal bleeding or perforation related to previous treatment with NSAIDs,
• ulcerative colitis, Crohn's disease, peptic ulcer or recurrent gastrointestinal bleeding (defined as two or more distinct episodes of confirmed ulceration or bleeding),
• severe heart, kidney or liver failure,
• congenital metabolic disorders of porphyrin (e.g. acute intermittent porphyria),
• chronic alcoholism (14 to 20 drinks per week or more),
• blood cell production disorders of unknown origin.

The use of ibuprofen is contraindicated during the third trimester of pregnancy (last 3 months of pregnancy). The use of ibuprofen is not recommended during breastfeeding. During the first and second trimester of pregnancy (first 6 months of pregnancy), this medicine should not be used except under clear medical indication.

Warnings and precautions
IBUFAST Forte should not be used in the following situations unless clearly recommended by a doctor:

• in uncontrolled hypertension,
• in congestive heart failure,
• in diagnosed ischaemic heart disease,
• in peripheral arterial disease and/or cerebrovascular disease,
• in significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake),
• in systemic lupus erythematosus or other autoimmune diseases,
• in children.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration needed to relieve symptoms (see "How to take IBUFAST Forte").
As with other NSAIDs, ibuprofen may mask symptoms of infection.
With prolonged use of any painkiller, headache may occur, which should not be treated with higher doses of the medicine.
When alcohol is consumed concurrently with NSAIDs, adverse effects related to the active substance, especially those affecting the gastrointestinal tract or central nervous system, may intensify.

Effects on the cardiovascular and cerebrovascular system
Exercise caution (consult a doctor or pharmacist) before starting treatment if you have a history of high blood pressure or heart failure, e.g. fluid retention and oedema associated with NSAID treatment.
Before taking IBUFAST Forte, talk to your doctor or pharmacist about treatment if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including mini-stroke or transient ischaemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Respiratory disorders
Special precautions should be taken in patients with asthma or bronchial asthma, chronic rhinitis or respiratory disorders in medical history, as ibuprofen may cause bronchospasm, urticaria or angioedema in these patients.

Allergic reactions
Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are rare. Treatment with IBUFAST Forte should be discontinued immediately upon the first signs of hypersensitivity reactions. Medical professionals must initiate appropriate management according to the symptoms present.
Exercise caution in patients who have experienced allergic-type reactions or hypersensitivity to other substances, as they may have an increased risk of hypersensitivity reactions to ibuprofen.
Caution is advised in patients suffering from hay fever, nasal polyps or chronic obstructive respiratory diseases, as they have an increased risk of allergic reactions. These may develop as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema or urticaria.
During treatment with ibuprofen, symptoms of allergic reaction to this medicine have occurred, including difficulty breathing, swelling of the face and neck (angioedema), chest pain.
If any of these symptoms occur, discontinue IBUFAST Forte immediately and contact a doctor or emergency medical services without delay.

Heart, kidney or liver disorders
Caution is advised in patients with heart, kidney or liver disorders, as the use of NSAIDs may worsen kidney function. Concurrent regular use of multiple painkillers further increases this risk. In such cases, the dose should be as low as possible and used for the shortest possible duration (see section "When not to take IBUFAST Forte").

Effects on the kidneys
At the beginning of treatment, ibuprofen, like other NSAIDs, should be used cautiously in patients with significant dehydration. There is a risk of kidney function disorders, especially in children, adolescents and dehydrated elderly individuals.
As with other NSAIDs, prolonged use of ibuprofen has led to renal papillary necrosis and other pathological kidney changes. Cases of nephrotoxic effects have also been observed in patients in whom prostaglandins play a compensatory role in maintaining renal perfusion. In these patients, administration of NSAIDs may cause dose-dependent reduction in prostaglandin production and, secondarily, renal blood flow, potentially leading to significant renal decompensation. Patients at increased risk of this reaction include those with kidney dysfunction, heart failure, liver dysfunction, patients treated with diuretics and ACE inhibitors, and elderly patients. After discontinuation of NSAID treatment, recovery to the pre-treatment state usually occurs.

Aseptic meningitis
In rare cases, aseptic meningitis has been observed in patients treated with ibuprofen. Although it is more likely to occur in patients with systemic lupus erythematosus and connective tissue diseases, aseptic meningitis has been reported in patients without underlying chronic disease.

Haematological effects
Ibuprofen, like other NSAIDs, may inhibit platelet aggregation and may prolong bleeding time in healthy patients.

Skin reactions
Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have occurred with the use of ibuprofen. If any of the symptoms associated with these serious skin reactions described in section 4 occur, IBUFAST Forte should be discontinued immediately and medical help sought.

In exceptional cases, severe complications of skin and soft tissue infections may be caused by chickenpox. Currently, the contribution of NSAIDs to the worsening of these infections cannot be excluded. Therefore, it is advisable to avoid using IBUFAST Forte in case of chickenpox.

Elderly patients
In elderly patients, a higher frequency of adverse effects after NSAID use is observed, particularly gastrointestinal bleeding and perforation, which may lead to death.

Gastrointestinal bleeding, ulceration and perforation
Ibuprofen should be used cautiously in patients with a history of peptic ulcer or other gastrointestinal disorders, as these conditions may worsen.
Cases of gastrointestinal bleeding, ulceration and gastrointestinal perforation, including fatal outcomes, have been reported with all NSAIDs, at any time during treatment, both with and without preceding warning symptoms, or with a history of severe gastrointestinal incidents.
The risk of gastrointestinal bleeding, ulceration or perforation is higher at higher doses of ibuprofen, in patients with a history of peptic ulcer, especially if associated with bleeding or perforation, and in elderly patients.
In these patients, treatment should be initiated with the lowest effective dose. In these patients, as well as in those who must simultaneously take low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk, concomitant administration of protective drugs (e.g. misoprostol or proton pump inhibitors) should be considered.
Caution is advised in patients who must simultaneously take other drugs increasing the risk of gastrointestinal ulceration or gastrointestinal bleeding, e.g. oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors or antiplatelet drugs, e.g. acetylsalicylic acid.
If gastrointestinal bleeding or ulceration occurs in patients treated with IBUFAST Forte, treatment must be discontinued immediately.
Concomitant administration of IBUFAST Forte with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to the increased risk of gastrointestinal ulceration or gastrointestinal bleeding.

Patients with a history of gastrointestinal disorders, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding) at the early stages of treatment.

Children and adolescents
IBUFAST Forte should not be used in children under 12 years of age.

IBUFAST Forte and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take.
Exercise caution in patients treated with any of the following medicines due to reported interactions:

Lithium
NSAIDs may reduce lithium excretion.

Methotrexate
NSAIDs may reduce methotrexate excretion and consequently increase its plasma concentration.

Cardiac glycosides
NSAIDs may exacerbate heart failure, reduce glomerular filtration rate and increase plasma concentration of cardiac glycosides.

Cholestyramine
Concomitant administration of ibuprofen and cholestyramine may reduce ibuprofen absorption in the gastrointestinal tract. However, the clinical significance of this interaction is unknown.

Cyclosporine
Administration of NSAIDs and cyclosporine increases the risk of nephrotoxicity.

Antihypertensive drugs, beta-blockers and diuretics
NSAIDs may reduce the effectiveness of these drugs. Diuretics may increase the risk of NSAID nephrotoxicity. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function), concomitant administration of an ACE inhibitor, beta-blocker or angiotensin II antagonist and cyclooxygenase inhibitors may lead to further worsening of kidney function, including acute renal failure, which is usually reversible. Therefore, this combination of drugs should be used with caution, especially in elderly patients. Patients should maintain adequate hydration, and periodic monitoring of kidney function after initiation of combination therapy should be considered.

Other NSAIDs, including selective cyclooxygenase-2 inhibitors
Concomitant use of IBUFAST Forte with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to the possibility of additive effects.

Corticosteroids
When used concomitantly with NSAIDs, corticosteroids increase the risk of gastrointestinal ulceration or gastrointestinal bleeding.

Anticoagulants
NSAIDs may enhance the effects of anticoagulants, e.g. warfarin.

Acetylsalicylic acid
As with other NSAIDs, concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the possibility of increased adverse effects.

Antiplatelet drugs (e.g. clopidogrel and ticlopidine), selective serotonin reuptake inhibitors (SSRIs)
The risk of gastrointestinal bleeding increases when used concomitantly with NSAIDs.

Aminoglycosides
NSAIDs may reduce aminoglycoside excretion.

Ginkgo biloba
May increase the risk of bleeding when used in combination with NSAIDs.

Mifepristone
NSAIDs may weaken the effect of mifepristone.

Quinolone antibiotics
Patients taking NSAIDs and quinolones may have an increased risk of seizures.

Tacrolimus
There is an increased risk of nephrotoxicity when NSAIDs are used concomitantly with tacrolimus.

Zidovudine
There is an increased risk of haematological toxicity when NSAIDs are used concomitantly with zidovudine.

Sulfonylurea derivatives
NSAIDs may enhance the effect of drugs containing sulfonylurea (rare cases of hypoglycaemia have been reported in patients receiving sulfonylurea derivatives and ibuprofen concomitantly).

CYP2C9 inhibitors
Concomitant administration of ibuprofen with CYP2C9 inhibitors may lead to increased exposure to ibuprofen (a CYP2C9 substrate). Consideration should be given to reducing the ibuprofen dose, especially when high doses of ibuprofen are administered concomitantly with voriconazole or fluconazole.

Probenecid and sulfinpyrazone
Drugs containing probenecid or sulfinpyrazone may delay ibuprofen excretion.

Phenytoin
Concomitant use of IBUFAST Forte with phenytoin may increase plasma concentrations of both drugs.

IBUFAST Forte with food, drink and alcohol
To achieve a faster maximum effect, IBUFAST Forte should be taken on an empty stomach. In patients with sensitive stomachs, it is recommended to take IBUFAST Forte with food.
Alcohol should not be consumed during treatment.

Pregnancy, breastfeeding and effects on fertility
If you are pregnant, breastfeeding, suspect you may be pregnant or plan to become pregnant, you should consult your doctor or pharmacist before using IBUFAST Forte.

Pregnancy
Do not take IBUFAST Forte if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both you and your child and may delay or prolong labour. During the first 6 months of pregnancy, IBUFAST Forte should not be used unless your doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible duration should be used. From the 20th week of pregnancy, IBUFAST Forte may cause narrowing of the blood vessel (ductus arteriosus) in the baby's heart or kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is required for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding
The use of IBUFAST Forte is not recommended in breastfeeding women.

Fertility
There is evidence that substances inhibiting prostaglandin/cyclooxygenase synthesis may reduce female fertility by affecting ovulation. This effect is reversible upon discontinuation of treatment.

Driving and operating machinery
IBUFAST Forte has a minor influence on the ability to drive and operate machinery. Therefore, increased caution is advised when driving or operating machinery. This is particularly important when ibuprofen is used in combination with alcohol.

IBUFAST Forte contains lactose monohydrate and sodium

Lactose monohydrate
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and adolescents over 12 years of age (with body weight ≥40 kg)
This medicine is intended for oral use only and short-term use.
The dose of ibuprofen depends on the patient's age and body weight. In adults and adolescents, the maximum single dose of ibuprofen should not exceed 400 mg.
Taking more than 400 mg of ibuprofen in a single dose does not provide better pain relief.
There should be a minimum interval of 4 hours between doses.
The total daily dose of ibuprofen should not exceed 1200 mg within 24 hours.
The recommended dose is 400 mg of ibuprofen (1 tablet) up to 3 times a day, at intervals of 4 to 6 hours. Do not exceed a daily dose of 1200 mg of ibuprofen (3 tablets).

Adult patients should consult a physician if symptoms persist or worsen, or if it becomes necessary to use this medicine for longer than 3 days for fever or 5 days for pain.
If adolescents require treatment with this medicine for more than 3 days, or if symptoms worsen, medical advice should be sought.
Children
Forte medicine is contraindicated in children under 12 years of age.
Elderly patients
In elderly patients, dose adjustment is not required unless severe renal or hepatic impairment is present. In such cases, the dose should be adjusted according to individual needs. Greater caution is recommended in this population.
Renal function disorders
There is no need to reduce the dose in patients with mild or moderate renal impairment (patients with severe renal failure, see section 2).
Hepatic function disorders
There is no need to reduce the dose in patients with mild or moderate hepatic function disorders (patients with severe hepatic dysfunction, see section 2).
Method of administration
For oral use.
Ibuprofen tablets should be taken with plenty of fluid.
The tablet should be swallowed whole. It must not be chewed, broken, crushed, or sucked to avoid oral discomfort or throat irritation.
Average duration of treatment
The average duration of treatment depends on the patient's clinical condition.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
Do not take higher doses than recommended. Do not use the medicine for more than 3 days for fever, unless otherwise directed by a physician.
In case of pain, do not use the medicine for longer than 5 days in adults, unless otherwise advised by a physician, as intense and prolonged pain may require medical evaluation and treatment.
Overdose of Forte medicine
If a patient has taken a higher than recommended dose of Forte medicine, or if a child has accidentally ingested the medicine, medical advice must always be sought from a physician or the nearest hospital to assess potential health risks and receive guidance on appropriate actions.
Symptoms may include nausea, abdominal pain, vomiting (possibly containing blood), headache, tinnitus, disorientation, and nystagmus. Following large overdoses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, feeling cold, and respiratory disturbances have been reported.
In case of overdose, gastric lavage should be performed, followed by supportive measures. There is no specific antidote for ibuprofen.
Missed dose of Forte medicine
If one or more doses are missed, continue taking the next dose as usual.
Do not take a double dose to make up for a missed tablet.
If you have any further questions concerning use of this medicine, consult your physician, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following symptoms occur in a patient, ibuprofen use must be stopped immediately and
medical help should be sought:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the centre, peeling skin, ulcers in the mouth, throat, nose, genital organs 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).
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Adverse effects observed with ibuprofen are similar to those seen with other NSAIDs:
Gastrointestinal disorders
The most commonly observed adverse effects are gastrointestinal in nature. After administration of these
medicines, nausea, dyspepsia, vomiting, haematemesis, bloating, abdominal pain, diarrhoea,
constipation, tarry stools, aphthous stomatitis, gastrointestinal bleeding, exacerbation of colitis and
Crohn's disease have been reported. Cases of gastritis, duodenal and gastric ulcers, and gastrointestinal perforation have been observed less frequently.
Immune system disorders
Hypersensitivity reactions have been reported following ibuprofen treatment. These may include non-specific allergic reactions and anaphylaxis, respiratory tract reactivity, including asthma, aggravated asthma, bronchospasm or dyspnoea, or skin disorders, including various types of skin rashes, pruritus, urticaria, purpura, angioedema, and very rarely exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme.
Infections and parasitic infections
Exacerbations of inflammatory conditions associated with skin infections (e.g. necrotising fasciitis) have been described in connection with NSAID use. If signs of infection occur or worsen during ibuprofen treatment, the patient should consult a doctor immediately.
Skin and subcutaneous tissue disorders
In exceptional cases, severe skin infections and soft tissue complications may occur during chickenpox infection (see also "Infections and parasitic infections").
Cardiac and vascular disorders
Clinical studies indicate that the use of ibuprofen, especially at high doses (2400 mg per day) and over a prolonged period, may be associated with a small increase in the risk of arterial thrombotic events (e.g. myocardial infarction or CVA) (see section 2).
The following adverse effects, probably associated with ibuprofen use, are listed below in decreasing order of frequency. Frequency of occurrence is defined as follows: very common (more than 1 in 10 people), common (not more than 1 in 10 people), uncommon (not more than 1 in 100 people), rare (not more than 1 in 1,000 people), very rare (not more than 1 in 10,000 people), and frequency not known (frequency cannot be determined from available data).
Common:

• dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, bloating, constipation, tarry stools, haematemesis and gastrointestinal bleeding;
• headache and dizziness;
• skin rash;
• fatigue.

Uncommon:

• gastritis, duodenal ulcer, gastric ulcer, oral ulceration and gastrointestinal perforation;
• nephrotoxicity, including tubulointerstitial nephritis, nephrotic syndrome and renal failure;
• asthma, bronchospasm and dyspnoea;
• hepatitis, jaundice and liver function abnormalities;
• hypersensitivity reactions;
• urticaria, pruritus, purpura, angioedema and photosensitivity reaction;
• insomnia, restlessness and depression;
• hearing impairment, dizziness and tinnitus;
• paraesthesia and somnolence;
• visual disturbances;
• rhinitis.

Rare:

• anaphylactic reactions; symptoms may include: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock);
• aseptic meningitis;
• leucopenia, thrombocytopenia, aplastic anaemia, neutropenia, agranulocytosis and haemolytic anaemia; initial symptoms include: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, unexplained bleeding and bruising;
• toxic optic neuropathy;
• optic neuritis;
• oedema;
• disorientation.

Very rare:

• heart failure and myocardial infarction;
• red, flat, target-like or circular spots on the trunk, often with blisters in the centre, peeling skin, ulcers in the mouth, throat, nose, genital organs 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);
• liver failure;
• pancreatitis;
• hypertension.

Frequency not known:

• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome;
• red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis);
• exacerbation of inflammatory bowel disease and Crohn's disease.

A severe skin reaction known as DRESS (drug reaction with eosinophilia and systemic symptoms) may occur. Symptoms of DRESS include widespread rash, high body temperature and swollen lymph nodes.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store IBUFAST Forte

Do not store above 30°C.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister after:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What the medicine contains Forte

• The active substance is ibuprofen – one coated tablet contains 400 mg of ibuprofen.
• Other ingredients are: tablet core: hypromellose (2910), pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate; coating: hypromellose (2910), propylene glycol (E 1520), talc, titanium dioxide (E 171).

What Forte looks like and contents of the pack
White, elongated, biconvex coated tablets.
Forte is available in blisters made of PVC/PVDC/Aluminium, containing 20 or 50 coated tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fortis Pharmaceuticals Sp. z o.o.
ul. Mickiewicza 29
40-085 Katowice
e-mail: [email protected]
tel.: +48 32 726 66 67

Manufacturer:
PHARMEX ADVANCED LABORATORIES, S.L.
Ctra. A-431 Km.19
14720 Almodóvar del Río (Córdoba)
Spain