In this leaflet:

1. What Dadosel 2% suspensión oral is and what it is used for
2. Before you take Dadosel 2% suspensión oral
3. How to take Dadosel 2% suspensión oral
4. Possible side effects
5. Storing Dadosel 2% suspensión oral

Dadosel 2% suspensión oral
Ibuprofen

The active substance is ibuprofen. Each 5 ml of oral suspension contains 100 mg of ibuprofen.
The other ingredients (excipients) are: sodium benzoate (E-211), citric acid anhydride, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, maltitol syrup, glycerol (E-422), strawberry aroma, azorubine colourant (E-122), purified water.

Marketing authorisation holder:
FARMA-LEPORI, S.A.
C. Osi, 7 - 08034 Barcelona

Manufacturer:
LABIANA PHARMACEUTICALS, S.L.
Gorcs i Lladó, 188 - Pol. Ind. “Can Salvatella” 08210 - Barberà del Vallès (Barcelona)

1. WHAT Dadosel 2% suspensión oral IS AND WHAT IT IS USED FOR

Dadosel is a pink, strawberry-flavoured, oral suspension. It is presented in containers of 200 ml.
Ibuprofen belongs to the group of medicines called non-steroidal antiinflammatories (NSAIDs).
This medicine is indicated in the symptomatic treatment of mild or moderate pain and fever.

2. BEFORE YOU TAKE Dadosel 2% suspensión oral

Do not take Dadosel:
• If you are allergic to ibuprofen or any of the ingredients of this medicine.
• If you have had asthma-, rhinitis- or urticaria-type allergic reactions on taking aspirin or other medicines of the group of the non-steroidal antiinflammatories.
• If you have a blood coagulation disorder.
• If you have or have had gastrointestinal ulcer.
• During the last quarter of pregnancy (see "Pregnancy” section)

Be particularly careful with Dadosel if:
• You suffer from porphyria.
• You have systemic lupus erythematosus or any mixed disease of the conjunctive tissue.
• You have an inflammatory bowel disease, such as ulcerative colitis or Crohn's disease. If on taking this medicine you notice burning or stomach pain, stop the treatment and see your doctor.
• You present hypertension or heart failure.
• You have altered hepatic or renal function.
• You suffer bronchial asthma or an allergic disease.

See your doctor, even if any of the above circumstances have only happened once.

Taking Dadosel with food and drink
You may take it alone or with food. Generally speaking, it should be taken during meals or immediately after them to reduce the possibility of stomach complaint.

Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
Ibuprofen should not be taken during pregnancy, particularly during the third quarter, since it could be dangerous for the unborn child.

Lactation
Ask your doctor or pharmacist for advice before taking any medicine.
Lactation need not be interrupted for the short-term treatment of mild to moderate pain and fever at the recommended dose.

Driving and using machines
If you feel dizziness, vertigo, sight alterations or other symptoms while taking this medicine, do not drive or use machinery. If you only take one dose of ibuprofen or for a short period, you do not need to take special precautions.

Important information about some of the ingredients of Dadosel
This medicine, which contains glycerol as ingredient, may be harmful at high doses. It may cause headache, stomach complaint and diarrhoea.
As it contains sodium benzoate it may slightly irritate the eyes, skin and mucosas. It may also increase the risk of jaundice in new-borns.
This medicine contains azorubine as excipient. It may cause allergic-type reactions, including asthma, particularly in patients allergic to acetyl salicylic acid.

Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Do not take Dadosel with other analgesics without consulting your doctor.
Patients on continuous treatment with other medicines (anticoagulants and platelet antiaggregants, methotrexate, lithium, antihypertensives and diuretics, probenecid, sulfinpyrazone, oral antidiabetics) must consult their doctor before taking this or any other analgesic.

3. HOW TO TAKE Dadosel 2% suspensión oral

Follow these instructions unless told to do otherwise by your doctor.
Remember to take your medicine.
Your doctor will tell you the duration of your treatment with Dadosel . Do not interrupt the treatment before that, since it may eliminate the effect expected.

Dadosel is a suspension for oral administration.
For exact dosage, the containers carry a graduated oral syringe of 5 ml. The syringe must be cleaned and dried after each use.
If you have a sensitive stomach, take the medicine with meals.

Children: The dose of ibuprofen given depends on the age and the weight of the child. For children between 3 months and 12 years, the recommended daily dose is from 20 to 30 mg/kg of weight in three or four individual doses (see table).

Adults and children over 12 years: The recommended dose is 20 ml, 3 to 4 times a day (equivalent to 1200-1600 mg of Ibuprofen/day), as long as the symptoms last.

The elderly: No special dose titrations are required.

Patients with renal impairment: Your doctor will titrate the dose.

If you have the impression that the effect of Dadosel is too strong or too weak, talk to your doctor or pharmacist.

If you take more Dadosel than you should:
If you take more Dadosel than you should, see your doctor or pharmacist immediately.
The most frequent symptoms in case of overdose are: nausea, vomiting, abdominal pain, headache, vertigo, dizziness, drowsiness, involuntary eye movement, blurred vision, whistling in the ears, sometimes a fall in blood pressure and fainting.
In the event of overdose or accidental intake go to a medical centre immediately or call the Toxicology Information Service on 91562 04 20, indicating the medicine and the amount taken.

If you forgot to take Dadosel:
Do not take a double dose to make up for the doses you forgot to take.

4. POSSIBLE SIDE EFFECTS

As occurs with all medicines, Dadosel may have adverse effects.

The following adverse effects have been observed:

Gastrointestinal tract:
Rather infrequent (0.1% to 1%): Gastrointestinal disorders, such as alterations of digestion, abdominal pain, nausea.
Rare (0.01% to 0.1%): Diarrhoea, vomiting, flatulence and constipation.
Very rare (up to 0.01%): Gastrointestinal ulcers, sometimes with haemorrhage and perforation. If you have serious pains at the top of your stomach, vomit blood, have blood in stools or dark stools, stop taking Dadosel and inform your doctor immediately.

Nervous system:
Rather infrequent (0.1% to 1%): Headache

Liver:
Very rare (up to 0.01%): Hepatic disorder, particularly with long-term treatment.

Kidney:
Very rare (up to 0.01%): Fall in urine excretion and water retention in the tissues (oedema). Acute renal impairment. Damage to the renal tissue (papillary necrosis), particularly with long-term treatment. Increased urea blood concentration.

Blood:
Very rare (up to 0.01%): Alterations in blood cells. The first symptoms may be: fever, sore throat, ulcers in the mouth, flu-like symptoms, excessive tiredness, nasal and skin haemorrhages. If you observe these symptoms, stop taking Dadosel and see your doctor immediately.

Skin:
Very rare (up to 0.01%): Serious skin reactions, such as rash with redness and blister formation.

Immune system:
Very rare (up to 0.01%): In patients with a disease of the immune system (such as systemic lupus erythematosus and mixed disease of the connective tissue), symptoms of aseptic meningitis may be observed, such as headaches, nausea, vomiting, fever, stiff neck or disorientation.

Allergic reactions:
Rather infrequent (0.1% to 1%): Allergic reactions with rash and irritation, urticaria and itch.
Very rare (up to 0.01%): Serious allergic reactions, whose symptoms may include: swelling of the face, tongue and throat, difficulty to swallow and/or breathe, increased heart rate and fall in blood pressure or serious shock. If any of these symptoms occur, medical care should be sought immediately. Worsening of asthma.

If you observe any other reaction not described in this leaflet, please inform your doctor or pharmacist.

5. STORING Dadosel 2% oral suspension

Keep Dadosel out of the reach and sight of children.

No special storage conditions are required.

Expiry
Do not use Dadosel after the expiry date indicated on the container.

This leaflet was approved in June 2004.

Farma-Lepori
C. Osi, 7 - 08034 Barcelona

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