DOLZAN 400 mg Film-Coated Tablets

Зміст інструкції

1. DOLZAN 400 mg film-coated tablets
   1. What is DOLZAN and what is it used for
   2. What you need to know before taking DOLZAN
   3. How to take DOLZAN
   4. Possible side effects
   5. How to store DOLZAN
   6. Contents of the pack and other information

DOLZAN 400 mg film-coated tablets

Ibuprofen

Generic medicine
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 they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is DOLZAN and what is it used for

DOLZAN belongs to a group of medicines called "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 rheumatic diseases (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis) and in painful and inflammatory swelling following soft tissue injury.

2. What you need to know before taking DOLZAN

Do not take DOLZAN:

• If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If you have ever suffered from shortness of breath, asthma, runny nose, swelling or hives after using acetylsalicylic acid or other similar pain relievers (NSAIDs).
• If you have severe kidney, liver or heart failure.
• If you suffer from unexplained disorders of blood formation.
• - If you suffer from bleeding in the brain (cerebrovascular hemorrhage) or other active bleeding.
• If you have ever had bleeding or perforation in the stomach or intestine while taking NSAIDs.
• If you have active ulcers or have had recurrent ulcers in the stomach/duodenum (peptic ulcers) in the past or bleeding (at least two different 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
Talk to your doctor or pharmacist before taking DOLZAN.
Adverse effects can be minimized by using the lowest effective dose for the shortest period necessary to control the symptoms.
Anti-inflammatory/pain-relieving drugs such as DOLZAN may be associated with a modest increase in the risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended dose or duration of treatment.
What you need to know before taking DOLZAN
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 DOLZAN. Stop taking DOLZAN immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.
You should discuss the therapy with your doctor or pharmacist before taking DOLZAN if:

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

Infections
DOLZAN can mask the symptoms of infections such as fever and pain. Therefore, DOLZAN may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection 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 the elderly, some effects occur more frequently after the use of NSAIDs. In particular, gastrointestinal bleeding and perforation, which in some cases may be potentially fatal.

Gastrointestinal bleeding, ulceration and perforation:
Bleeding, ulceration or perforation of the gastrointestinal tract, sometimes fatal, have been reported during treatment with all NSAIDs. These effects have occurred at any time during therapy, with or without warning symptoms or a previous history of severe events in the gastrointestinal tract.
The risk of developing gastrointestinal bleeding, ulcers and perforation is greater with increasing doses of NSAIDs and higher in patients with a history of ulcers, especially with complications of 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 patients who require additional therapy with low doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal problems, combined treatment with protective substances (e.g. misoprostol or proton pump inhibitors) should be considered.
If you have a history of adverse effects on the gastrointestinal tract, especially if you are elderly, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the early stages of therapy.
Caution is advised if you are receiving other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (blood thinners) such as 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 should be 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)
Severe 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 the treatment with ibuprofen. Stop using DOLZAN and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
It is advisable to avoid using DOLZAN during chickenpox.

Other notes
Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed very rarely. Discontinue treatment immediately at the first signs of a hypersensitivity reaction after taking DOLZAN and immediately inform your doctor.
Ibuprofen can temporarily inhibit platelet function (aggregation). Patients with blood clotting disorders should therefore be carefully monitored.
Regular monitoring of liver values, kidney function and blood counts is required during prolonged administration of DOLZAN.
While taking DOLZAN, you should consult/inform your doctor or dentist before undergoing any surgical procedure.
Prolonged use of any type of pain reliever for headaches can worsen them. If this occurs or is suspected, medical advice should be obtained and treatment discontinued. The diagnosis of medication-overuse headache (MOH) should be suspected in patients with frequent or daily headaches despite regular use of headache medications (or because of it).
In general, habitual use of pain relievers, especially the combination of various pain-relieving substances, can lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy). This risk may be increased under physical stress associated with salt loss and dehydration. Therefore, this should be avoided.
The risk of kidney failure is increased in dehydrated patients, the elderly and those taking diuretics and ACE inhibitors.
Ibuprofen can mask the signs of infections.
Patients who report eye disorders during treatment with ibuprofen should discontinue therapy and undergo an eye examination.

Other medicines and DOLZAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
DOLZAN can affect or be affected by other medicines. For example:

• Medicines that have an anticoagulant effect (i.e. substances that thin the blood/prevent the formation of clots, for example 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)

Some other medicines can also affect or be affected by treatment with DOLZAN.
Therefore, always consult your doctor or pharmacist before using DOLZAN with other medicines.
In particular, tell 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 a cumulative effect.
• Diuretics (water pills) and medicines for high blood pressure (antihypertensive medicines) as NSAIDs can reduce the effect of these medicines and may increase the risk of kidney problems. In addition, the use of potassium-sparing diuretics (some diuretics) can lead to an increase in blood potassium levels. Therefore, monitoring of serum potassium levels is recommended.
• DOLZAN may decrease the effects of ACE inhibitors (used to treat heart failure and high blood pressure). In addition, if used together, there may be an increased risk of kidney dysfunction.
• Digoxin (used to treat heart failure), phenytoin (used to treat epilepsy) or lithium (used to treat depression), as they may increase their levels in the blood when taken with ibuprofen. Monitoring of lithium levels is required. Monitoring of digoxin and phenytoin serum levels is recommended.
• Methotrexate (used to treat some types of cancer or rheumatism) as the effect of methotrexate may be increased.
• Anticoagulants (blood thinners). NSAIDs can increase the effects of these medicines.
• Platelet aggregation inhibitors such as acetylsalicylic acid and some antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of bleeding in the stomach and intestines.
• Medicines containing probenecid and sulfinpyrazone (used to treat gout) may slow down the excretion of ibuprofen.
• Medicines known as immunosuppressants 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 not known.
• Sulfonylureas (medicines used to treat diabetes) such as glibenclamide. Monitoring of blood glucose levels is recommended when these medicines are used together.
• Antibiotics called quinolones, such as ciprofloxacin, due to an increased risk of developing seizures.
• Voriconazole or fluconazole (CYP2C9 inhibitors) used for the treatment of fungal infections, as they may increase the levels of ibuprofen in the blood. Dose reduction of ibuprofen should be considered, especially when a high dose of ibuprofen is used with voriconazole or fluconazole.
• Zidovudine (an antiviral drug used to treat HIV infections) due to the increased risk of blood accumulation in the joints (hemarthrosis) and bruising in HIV-positive hemophiliacs.
• Aminoglycosides (a type of antibiotic). NSAIDs can increase the excretion of aminoglycosides.
• Gingko biloba (a herbal medicine) may increase the risk of bleeding.

DOLZAN with alcohol
If you drink alcohol, you may be more likely to experience adverse reactions such as gastrointestinal and central nervous system disorders.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you become pregnant while taking DOLZAN.
During the first and second trimester of pregnancy, your doctor will only prescribe ibuprofen if
clearly necessary. In this case, the dose should be kept as low as possible and the duration of
treatment as short as possible.
In the last 3 months of pregnancy, you should not take DOLZAN, as it may have effects on the fetus or
cause problems at the time of delivery. It can cause problems with the kidneys and heart of the baby. It can
affect your and your baby's tendency to bleed and cause labor to be delayed or longer than
expected. You should not take DOLZAN during the first 6 months of pregnancy unless it is
absolutely necessary and recommended by your doctor. If you need treatment during
this period or while planning a pregnancy, the dose and duration of treatment must
be respectively the lowest and the shortest possible. If taken for more than a few days from the
twentieth week of pregnancy onwards, DOLZAN may cause kidney problems in the fetus that
can lead 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 is necessary for
more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
This medicine passes into breast milk but can be used during breastfeeding if used at the
recommended dose and for the shortest possible period.
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 starting a pregnancy.

Driving and operating machinery
Ibuprofen does not alter, or negligibly alters, the ability to drive vehicles or operate
machinery. However, as undesirable effects on the central nervous system, such as fatigue and dizziness, may occur at the highest dose,
reaction ability and the ability to actively participate in road traffic and use machinery may be altered in individual cases. This is
particularly important when combined with alcohol.

DOLZAN contains lactose
If your doctor has diagnosed you with intolerance to some 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 following the instructions of your doctor exactly. If you have any doubts, consult your doctor or pharmacist.
The dose must be modified according to the patient's age or weight.
The recommended dose is:

Pain and/or fever
Adults and adolescents starting from 12 years of age (≥ 40 kg body weight):
The initial dose should be 400 mg of ibuprofen. If necessary, additional doses of ibuprofen 400 mg can be taken. The respective dosing interval should be chosen based on the observed symptoms and the recommended maximum daily dose. It should not be less than 6 hours.
A total dose of 1200 mg of ibuprofen in a 24-hour period 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 brought under control, provided that the total daily dose does not exceed 2400 mg in separate doses.

AgeSingle doseDosemaximum
daily

• 1200 - 2400 mg ibuprofen (3 - 6 tablets)

Adolescents from 15 to 17 years of age
The recommended dose must be modified according to weight: 20-40 mg/kg per day (maximum 2400 mg per day) in 3-4 separate doses.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms.
If you have an infection, see your doctor immediately if symptoms (such as fever and pain) persist or worsen (see paragraph 2).
Adverse effects can be minimized by using the lowest effective dose for the shortest period necessary to control symptoms (see paragraph 4.4).
Special populations
Elderly:
No special dosage adjustments are required. Due to the possible adverse effect profile, it is recommended to monitor the elderly with particular attention.

• 400 - 800 mg ibuprofen (1 - 2 tablets) Adults

Renal insufficiency:
No adjustment is required in patients with mild to moderate impairment of renal function (for patients with severe renal impairment see paragraph 2: "Do not take DOLZAN").
Hepatic insufficiency:
No adjustment is required in patients with mild to moderate impairment of hepatic function (for patients with severe hepatic impairment see paragraph 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 must be taken orally. The tablets must be swallowed whole with a glass of water.
It is recommended that patients with a sensitive stomach take DOLZAN with food.
Duration of treatment
The treating physician decides the duration of treatment.
In rheumatic diseases, the use of DOLZAN may be necessary for a longer period.

If you take more DOLZAN than you should:
If you suspect an overdose with DOLZAN, go to your doctor immediately.
Possible problems include headache, dizziness, drowsiness, and loss of consciousness (including myoclonic seizures in children), as well as abdominal pain, nausea, and vomiting, bleeding in the stomach (gastrointestinal tract), liver and kidney dysfunction. In addition, a drop in blood pressure, reduced breathing (respiratory depression), and bluish discoloration of the skin and mucous membranes (cyanosis) can occur.
If you have taken more DOLZAN than you should or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and recommendations for action.
Symptoms may include nausea, stomach pain, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion, and involuntary eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, and dizziness, blood in the urine, a feeling of coldness, and breathing problems have been reported.
There is no specific antidote for ibuprofen overdose.

If you forget to take DOLZAN
Do not take a double dose to make up for the missed tablet.
If you have any doubts about using 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.
With regard to the following side effects, it should be considered that they are largely dependent
on the dose and vary from patient to patient.
Stop using ibuprofene and consult your doctor immediately if you notice any of the following
symptoms:

• reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes.

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).
• 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 side effects observed most commonly affect the gastrointestinal tract. Ulcers of the stomach/duodenum (peptic ulcers), perforation or bleeding, sometimes fatal, especially
in elderly patients (see section 2: "Warnings and precautions") may occur. Nausea, vomiting, diarrhea, flatulence, constipation, digestive disorders, abdominal pain, tarry stools, vomiting with blood, sores (ulcerations) in the mouth and throat
(ulcerative stomatitis), worsening of colitis and Crohn's disease (see section 2: "Warnings
and precautions") have been reported after use.
Less commonly, inflammation of the stomach lining (gastritis) has been observed. In particular, the risk of developing gastrointestinal bleeding depends on the dose
level and the duration of treatment.
Fluid retention in the tissues (edema), high blood pressure and heart failure have been reported in association with treatment with NSAIDs.
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 intestines which, in exceptional cases, can lead to anemia. Stop taking DOLZAN and tell your doctor immediately if you experience relatively severe pain in the upper abdomen, vomiting blood, black stools and/or black vomit.

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

• Central nervous system disorders such as dizziness, feeling of spinning, headache, drowsiness, inability to sleep, agitation, 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 retention in the tissues (edema), especially in patients with high blood pressure (hypertension) or kidney problems, nephrotic syndrome, interstitial nephritis which may be accompanied by acute renal failure (kidney 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 low blood pressure). If you have any of these symptoms, you should inform your doctor immediately. Rare side effects (may affect up to 1 in 1,000 people):
• Sound, ringing, in the ears (tinnitus).
• Hearing difficulties (hearing loss)
• Kidney tissue damage (papillary necrosis), high levels of uric acid in the blood, high 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 a decrease in the amount of red blood cells or hemoglobin (anemia), white blood cells (leukopenia) or platelets (thrombocytopenia); and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anemia or hemolytic anemia). The first symptoms may be fever, sore throat, superficial wounds in the mouth, flu-like symptoms, severe fatigue, bleeding from the nose and skin. Blood counts should be monitored regularly during long-term therapy.
• Severe general allergic reactions (hypersensitivity). These can manifest as: facial edema, swelling of the tongue, swelling of the larynx with constriction of the airways, difficulty breathing, rapid heartbeat and a drop in blood pressure to potentially life-threatening shock. If you have any of these symptoms, you should go to the doctor immediately.
• 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).
• A worsening of infection-related inflammation (e.g. necrotizing fasciitis) has been described associated with the use of some painkillers (NSAIDs). If signs of infection occur or worsen during the use of DOLZAN, you should see a doctor immediately. The doctor will assess whether you need antibiotic therapy.
• During treatment with ibuprofen, symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or confusion have been observed. Patients with autoimmune diseases (SLE, mixed connective tissue disease) appear to be predisposed.
• Inflammation of the esophagus or pancreas, obstruction of the intestine (intestinal stenosis similar to diaphragm).
• Psychotic reactions, hallucinations, confusion, depression and anxiety.
• Asthma, difficulty breathing (dyspnea), bronchospasm.
• Yellowing of the eyes and/or skin (jaundice), liver dysfunction, liver damage, especially with long-term therapy, acute hepatitis (inflammation of the liver).
• Blistering reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome); erythema multiforme; during a 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 (the 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
• It is possible that a serious skin reaction known as DRESS syndrome may occur. The symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
• A widespread, red and scaly rash, with the formation of pustules under the skin and blisters located mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using DOLZAN if you develop these symptoms and contact your doctor immediately. See also section 2.
• the 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 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 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 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 the packaging after
Exp. The expiry date refers to the last day of that month.
DOLZAN 400 mg film-coated tablets:
Do not store at a temperature above 30°C
Do not dispose of any medicine in waste water 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 DOLZAN contains

• The active ingredient is ibuprofen. Each film-coated tablet contains 400 mg of ibuprofen
• The other ingredients are: Tablet core Hypromellose (E464), croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn), anhydrous colloidal silica and magnesium stearate (E572)

Film coating
Hypromellose (E464), titanium dioxide (E171), talc (E553b) and propylene glycol (E1520)

Description of the appearance of DOLZAN and contents of the pack
Film-coated tablet.
White, oblong, biconvex film-coated tablets with an inscription on both sides. The score line is not intended for 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LABORATORI ALTER S.r.l.,
Via Egadi, 7
20144 Milan

Manufacturer:
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