Patient Information Leaflet

DOLZAN 400 mg film-coated tablets

Ibuprofen
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What DOLZAN is and what it is used for
What you need to know before taking DOLZAN
How to take DOLZAN
Possible side effects
How to store DOLZAN
Contents of the pack and other information

1. What DOLZAN is and what it is used for

DOLZAN belongs to a group of medicines known as "non-steroidal anti-inflammatory drugs" or
NSAIDs.
DOLZAN is used for:

symptomatic treatment of mild to moderate pain and/or fever
symptomatic treatment of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis), and painful swelling and inflammation following soft tissue injuries.

2. What you need to know before taking DOLZAN

Do not take DOLZAN:

If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
If you have ever experienced breathlessness, asthma, runny nose, swelling, or hives after taking acetylsalicylic acid or other similar painkillers (NSAIDs).
If you suffer from severe renal, hepatic, or cardiac insufficiency.
If you have unexplained blood formation disorders.
- If you have cerebral hemorrhage (cerebrovascular hemorrhage) or any other active bleeding.
If you have previously had gastrointestinal bleeding or perforation while taking NSAIDs.
If you currently have active ulcers or have had recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding in the past (at least two separate episodes of ulcer or bleeding).
If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
If you are in the last three months of pregnancy.
If the patient is a child under 12 years of age or weighing less than 40 kg.

Warnings and precautions
Consult your doctor or pharmacist before taking DOLZAN.
Unwanted effects can be minimized by using the lowest effective dose for the shortest duration needed to control symptoms.
Anti-inflammatory/pain-relieving medicines such as DOLZAN may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
What you need to know before taking DOLZAN
With DOLZAN, signs of an allergic reaction to this medicine have been reported, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain.
Stop taking DOLZAN immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
You should discuss treatment with your doctor or pharmacist before taking DOLZAN if:

you have recently undergone major surgery
you suffer or have suffered from asthma or an allergic condition, as breathing difficulties may occur.
you have heart problems
you have a history of gastrointestinal diseases (such as ulcerative colitis, Crohn's disease)
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 certain inherited blood formation disorders (e.g., acute intermittent porphyria)
you have blood clotting disorders
you are taking other NSAIDs. Concomitant use with other NSAIDs, including specific cyclooxygenase-2 (COX-2) inhibitors, increases the risk of adverse reactions (see section “Other medicines and DOLZAN”).
you have chickenpox, it is advisable to avoid using DOLZAN
you suffer from systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (an autoimmune disease affecting connective tissue)
you suffer from an inherited blood formation disorder (e.g., acute intermittent porphyria).
you have impaired liver or kidney function
you have recently undergone major surgery
you are sensitive (allergic) to other substances
you suffer from hay fever, nasal polyps, or chronic obstructive respiratory disorders, as you are at higher risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), rapid swelling (Quincke's edema), or hives.
you have an infection – see section “Infections” below.

Infections
DOLZAN may mask symptoms of infections such as fever and pain. Therefore, DOLZAN could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
Gastrointestinal safety
Avoid using DOLZAN together with other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called cyclooxygenase-2 (COX-2) inhibitors.
Elderly:
In elderly patients, certain side effects occur more frequently after NSAID use. In particular, gastrointestinal bleeding and perforation, which in some cases may be potentially fatal.
Gastrointestinal bleeding, ulceration, and perforation:
Gastrointestinal bleeding, ulceration, or perforation, sometimes fatal, have been reported during treatment with all NSAIDs. These effects may occur at any time during therapy, with or without warning symptoms or previous clinical history of serious gastrointestinal events.
The risk of developing gastrointestinal bleeding, ulcers, and perforation is higher with increasing doses of NSAIDs and is greater in patients with a clinical history of ulcers, especially with complications such as bleeding or perforation (see section 2: "Do not take DOLZAN") and in elderly patients. These patients should be treated with the lowest possible dose. For these patients, as well as for those requiring additional therapy with low-dose acetylsalicylic acid or other medicines that may increase gastrointestinal risk, combination therapy with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered.
If you have a clinical history of gastrointestinal adverse effects, especially if you are elderly, report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially in the early stages of therapy.
Caution is advised if you are taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (blood thinners) like warfarin, selective serotonin reuptake inhibitors (used to treat psychiatric disorders including depression), or platelet aggregation inhibitors such as acetylsalicylic acid (see section 2: "Other medicines and DOLZAN").
Treatment should be discontinued and a doctor consulted if you develop gastrointestinal bleeding or ulcers during treatment with DOLZAN.
NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may worsen (see section 4).
Severe cutaneous adverse reactions (SCAR)
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 ibuprofen treatment. Stop using DOLZAN and contact your doctor immediately if you notice any symptoms related to these severe skin reactions described in section 4.
During chickenpox, it is advisable to avoid using DOLZAN.
Other notes
Severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed very rarely. Immediately discontinue treatment at the first signs of hypersensitivity reaction after taking DOLZAN and inform your doctor immediately.
Ibuprofen may temporarily inhibit platelet function (aggregation). Therefore, patients with coagulation disorders should be closely monitored.
Regular monitoring of liver values, renal function, and blood counts is required during prolonged administration of DOLZAN.
While taking DOLZAN, consult/inform your doctor or dentist before undergoing any surgical procedure.
Prolonged use of any type of painkiller for headache may worsen it. If this occurs or is suspected, seek medical advice and discontinue treatment. Medication-overuse headache (MOH) should be suspected in patients with frequent or daily headaches despite regular use of headache medications (or because of them).
In general, habitual use of painkillers, particularly combinations of various pain-relieving substances, may lead to permanent kidney damage with risk of renal failure (analgesic nephropathy). This risk may be increased under physical stress associated with salt loss and dehydration. Therefore, it should be avoided.
The risk of renal failure is increased in dehydrated patients, elderly patients, and those taking diuretics and ACE inhibitors.
Ibuprofen may mask signs of infections.
Patients reporting eye disturbances during treatment with ibuprofen should discontinue therapy and undergo an eye examination.
Other medicines and DOLZAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
DOLZAN may affect or be affected by other medicines. For example:

Medicines with an anticoagulant effect (i.e., substances that thin the blood/prevent clot formation, e.g., acetylsalicylic acid, warfarin, ticlopidine)
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)

Also, some other medicines may affect or be affected by treatment with DOLZAN.
Therefore, always consult your doctor or pharmacist before using DOLZAN with other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

Other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (e.g., celecoxib) or glucocorticoids, as they may increase the risk of gastrointestinal ulcers and bleeding due to cumulative effects.
Diuretics (medicines for urination) and medicines for high blood pressure (antihypertensives), as NSAIDs may reduce the effectiveness of these medicines and increase the risk of kidney problems. Additionally, use of potassium-sparing diuretics (some diuretics) may lead to increased potassium levels in the blood. Therefore, monitoring of serum potassium levels is recommended.
DOLZAN may reduce the effects of ACE inhibitors (used to treat heart failure and high blood pressure). Furthermore, when used together, there may be an increased risk of renal dysfunction.
Digoxin (used to treat heart failure), phenytoin (used to treat epilepsy), or lithium (used to treat depression), as their blood levels may increase when taken with ibuprofen. Monitoring of lithium levels is required. Monitoring of serum digoxin and serum phenytoin levels is recommended.
Methotrexate (used to treat certain types of cancer or rheumatism), as its effect may be increased.
Anticoagulants (blood thinners). NSAIDs may enhance the effects of these medicines.
Platelet aggregation inhibitors such as acetylsalicylic acid and certain antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of stomach and intestinal bleeding.
Medicines containing probenecid and sulfinpyrazone (used to treat gout) may slow down the excretion of ibuprofen.
Immunosuppressive medicines such as cyclosporine and tacrolimus, as kidney damage may occur.
Cholestyramine (a medicine used to lower cholesterol), as it may reduce the absorption of ibuprofen in the gastrointestinal tract. However, the clinical relevance of this interaction is unknown.
Sulfonylureas (medicines used to treat diabetes) such as glibenclamide. Blood glucose monitoring is recommended when these medicines are used together.
Antibiotics known as quinolones, such as ciprofloxacin, due to an increased risk of developing seizures.
Voriconazole or fluconazole (CYP2C9 inhibitors) used to treat fungal infections, as they may increase ibuprofen blood levels. Dose reduction of ibuprofen should be considered, especially when high-dose ibuprofen is used with voriconazole or fluconazole.
Zidovudine (an antiviral drug used to treat HIV infections), due to increased risk of blood accumulation in joints (hemarthrosis) and bruising in HIV-positive hemophiliacs.
Aminoglycosides (a type of antibiotic). NSAIDs may increase the excretion of aminoglycosides.
Ginkgo biloba (a herbal medicine) may increase the risk of bleeding.

DOLZAN with alcohol
If you consume alcohol, you may be more likely to experience adverse reactions such as gastrointestinal and central nervous system disturbances.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you become pregnant while taking DOLZAN.
During the first and second trimesters of pregnancy, your doctor will prescribe ibuprofen only if clearly necessary. In such cases, the dose should be kept as low as possible and the duration of treatment as short as possible.
During the last three months of pregnancy, you must not take DOLZAN, as it may affect the fetus or cause problems during childbirth. It may cause kidney and heart problems in the baby. It may affect your and your baby's tendency to bleed and may lead to delayed or prolonged labor. You should not take DOLZAN during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while planning pregnancy, the dose and duration of treatment should be as low and as short as possible. If taken for more than a few days from the 20th week of pregnancy onwards, DOLZAN may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is necessary, your doctor may recommend additional monitoring.
Breastfeeding
This medicine passes into breast milk but may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration.
Fertility
Ibuprofen may make it more difficult to conceive. You should inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.
Driving and using machines
Ibuprofen does not affect, or affects only negligibly, the ability to drive vehicles or operate machinery. However, since at higher doses adverse effects on the central nervous system such as fatigue and dizziness may occur, reaction ability and the capacity to actively participate in road traffic and use machinery may be impaired in individual cases. This is particularly important when combined with alcohol.
DOLZAN contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
DOLZAN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take DOLZAN

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The dose should be adjusted according to the patient's age or body weight.
The recommended dose is:
Pain and/or fever
Adults and adolescents aged 12 years and older (≥ 40 kg body weight):
The initial dose should be 400 mg of ibuprofen. Additional doses of 400 mg ibuprofen may be taken if needed. The dosing interval should be based on symptom severity and the recommended maximum daily dose. The interval must not be less than 6 hours.
A total daily dose of 1200 mg of ibuprofen must not be exceeded.
Rheumatic diseases
Adults
The recommended dose is 1200–1800 mg per day in divided doses. Some patients may be maintained on 600–1200 mg per day. In acute or severe conditions, it may be helpful to increase the dose until the acute phase is under control, provided that the total daily dose does not exceed 2400 mg in divided doses.
Age Single dose Maximum
daily dose
400–800 mg 1200–2400 mg
Adults
ibuprofen ibuprofen
(1–2 tablets) (3–6 tablets)
Adolescents aged 15 to 17 years
The recommended dose should be adjusted according to body weight: 20–40 mg/kg per day (maximum 2400 mg per day) in 3–4 divided doses.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
Special populations
Elderly:
No specific dose adjustment is required. Due to the possible adverse effect profile, elderly patients should be monitored with particular care.
Renal impairment:
No dose adjustment is required in patients with mild to moderate renal function impairment (for patients with severe renal impairment, see section 2: "Do not take DOLZAN").
Hepatic impairment:
No dose adjustment is required in patients with mild to moderate hepatic function impairment (for patients with severe hepatic impairment, see section 2: "Do not take DOLZAN").
Children and adolescents
DOLZAN 400 mg film-coated tablets are contraindicated in children under 12 years of age and in adolescents weighing less than 40 kg.
Method of administration
DOLZAN should be taken orally. The tablets should be swallowed whole with a glass of water.
Patients with a sensitive stomach are advised to take DOLZAN with food.
Duration of treatment
Your treating doctor will determine the duration of treatment.
In rheumatic diseases, DOLZAN may need to be used for a longer period.
If you take more DOLZAN than you should:
If you suspect an overdose of DOLZAN, seek immediate medical attention.
Possible problems include headache, dizziness, drowsiness, and loss of consciousness (including myoclonic seizures in children), as well as abdominal pain, nausea and vomiting, gastrointestinal bleeding, liver and kidney dysfunction. In addition, low blood pressure, reduced breathing (respiratory depression), and bluish discoloration of the skin and mucous membranes (cyanosis) may occur.
If you have taken more DOLZAN than prescribed, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and actions to take.
Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, feeling cold, and breathing difficulties may occur.
There is no specific antidote for ibuprofen overdose.
If you forget to take DOLZAN
Do not take a double dose to make up for a missed tablet.
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 everyone gets them.
The following side effects should be considered as largely dose-dependent and may vary from patient to patient.
Stop taking ibuprofen and consult your doctor immediately if you notice any of the following symptoms:

Flat, reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These serious 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).
Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized pustular eruption, acute generalized exanthematous pustulosis).

The most commonly observed side effects affect the digestive tract. Gastric/duodenal ulcers (peptic ulcers), perforation, or bleeding, sometimes fatal, may occur, particularly in elderly patients (see section 2: "Warnings and precautions"). After use, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting blood, mouth and throat sores (ulcerative stomatitis), worsening of colitis or Crohn's disease have been reported (see section 2: "Warnings and precautions"). Less commonly, inflammation of the inner stomach lining (gastritis) has been observed. In particular, the risk of gastrointestinal bleeding depends on the dose level and duration of treatment.
Fluid accumulation in tissues (edema), high blood pressure, and heart failure have been reported in association with NSAID treatment.
Medicines such as DOLZAN may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Very common side effects (may affect more than 1 in 10 people):

Gastrointestinal disorders such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and minor bleeding in the stomach and intestine, which in rare cases may lead to anemia. Stop taking DOLZAN and inform your doctor immediately if you experience relatively severe upper abdominal pain, vomiting blood, or bloody and/or black stools.

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

Central nervous system disorders such as dizziness, spinning sensation, headache, drowsiness, difficulty sleeping, restlessness, irritability, or fatigue.
Stomach or intestinal ulcer, potentially with bleeding and perforation (a hole in the wall of the digestive tract). Ulcerative stomatitis, worsening of colitis or Crohn's disease (inflammation of the colon).

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

Visual disturbances.
Fluid accumulation in tissues (edema), particularly in patients with high blood pressure (hypertension) or kidney problems, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute kidney failure (renal failure). Therefore, kidney function should be monitored regularly.
Inflammation of the inner lining of the stomach (gastritis).
Allergic reactions such as skin rash and itching, as well as asthma attacks (even with drop in blood pressure). If you experience any of these symptoms, inform your doctor immediately.

Rare side effects (may affect up to 1 in 1,000 people):

Ringing or buzzing in the ears (tinnitus).
Hearing difficulties (hearing loss).
Kidney tissue damage (papillary necrosis), elevated levels of uric acid in the blood, elevated levels of urea in the blood.

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

Blood cell formation disorders, such as reduced number of red blood cells or hemoglobin (anemia), white blood cells (leukopenia), or platelet count (thrombocytopenia); and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anemia, or hemolytic anemia). Initial symptoms may include fever, sore throat, mouth sores, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. Blood counts should be monitored regularly during long-term therapy.
Severe generalized allergic reactions (hypersensitivity). These may present as: facial swelling, tongue swelling, laryngeal swelling with airway constriction, breathing difficulties, rapid heartbeat, and drop in blood pressure up to potentially fatal shock. If you experience any of these symptoms, seek immediate medical attention.
Low blood sugar levels (hypoglycemia).
Low sodium levels in the blood (hyponatremia).
Palpitations (fast heartbeat), heart failure, myocardial infarction.
Hypertension (high blood pressure).
Inflammation of blood vessels (vasculitis).
Worsening of infection-related inflammation (e.g., necrotizing fasciitis) has been reported with the use of certain painkillers (NSAIDs). If signs of infection occur or worsen during DOLZAN use, seek medical attention immediately. Your doctor will assess whether antibiotic therapy is needed.
Symptoms of aseptic meningitis, including neck stiffness, headache, nausea, vomiting, fever, or altered consciousness, have been observed during ibuprofen treatment. Patients with autoimmune diseases (SLE, mixed connective tissue disease) appear to be more susceptible.
Inflammation of the esophagus or pancreas, intestinal obstruction (intestine diaphragm-like stenosis).
Psychotic reactions, hallucinations, confusion, depression, and anxiety.
Asthma, breathing difficulties (dyspnea), bronchospasm.
Yellowing of the eyes and/or skin (jaundice), liver dysfunction, liver damage—particularly during long-term therapy—acute hepatitis (liver inflammation).
Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome); erythema multiforme; during chickenpox infection, severe skin infections and soft tissue complications may occur; alopecia (hair loss), red or purple spots on the skin (purpura).

Frequency not known (frequency cannot be estimated from the available data):

Inflammation of the nasal mucosa (rhinitis).
Tingling (paresthesia) and inflammation of the optic nerve (optic neuritis).
Kidney malfunction.
A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell).
A widespread, red, scaly rash with pustules under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking DOLZAN if you develop these symptoms and contact your doctor immediately. See also section 2.
Skin becomes sensitive to light.
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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 DOLZAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after
Exp. The expiry date refers to the last day of that month.
DOLZAN 400 mg film-coated tablets:
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DOLZAN contains

The active substance is ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen.
The other components are:
Tablet core: Hypromellose (E464), sodium croscarmellose, monohydrate lactose, microcrystalline cellulose, pregelatinized starch (maize), anhydrous colloidal silicon dioxide and magnesium stearate (E572)
Film coating: Hypromellose (E464), titanium dioxide (E171), talc (E553b) and propylene glycol (E1520)

Description of the appearance of DOLZAN and pack contents
Film-coated tablet.
White, oblong, biconvex film-coated tablets, engraved on both sides. The score line is not intended to facilitate breaking the tablet.
DOLZAN 400 mg film-coated tablets are available in packs of 20, 30 and 60 tablets in Al-PVC/PVDC blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LABORATORI ALTER S.r.l.,
Via Egadi, 7
20144 Milan, Italy

Manufacturers:
ROVI PHARMA INDUSTRIAL SERVICES, S.A.
Vía Complutense, 140, Alcalá de Henares,
28805 Madrid, Spain
FARMALIDER, S.A
C/Aragoneses, 2
Alcobendas 28108
Madrid, Spain
TOLL MANUFACTURING SERVICES S.L.
C/ Aragoneses Nº 2,
28108 Alcobendas
Madrid, Spain

Dolzan