ADOLORIN® Ibuforte DIRECT 400 mg Oral Suspension

Product Details & Mandatory Information

For the short-term symptomatic treatment of mild to moderate pain and fever associated with common colds and flu-like infections.

Pharmaceutical Service

Package leaflet

Further Product Information

ADOLORIN® Ibuforte DIRECT 400 mg

Product Details & Mandatory Information

For the short-term symptomatic treatment of mild to moderate pain and fever associated with common colds and flu-like infections.

Pharmaceutical Service

Package leaflet

Further Product Information

ADOLORIN® Ibuforte DIRECT 400 mg Oral Suspension

ADOLORIN® Ibuforte DIRECT contains the active ingredient ibuprofen. Ibuprofen belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) and has pain-relieving, anti-inflammatory, and fever-reducing effects.

The ready-to-use suspension is suitable for the treatment of pain and fever in adults and adolescents aged 12 and over.

Indications

For the short-term symptomatic treatment of:

• Headaches

• Toothaches

• Back pain

• Muscle pain

• Joint pain

• Menstrual pain

• Nerve pain

• Pain associated with colds

• Fever associated with colds

• Fever associated with flu-like infections

Suitable for:

• Adolescents aged 12 years and over, weighing at least 40 kg

• Adults

If symptoms worsen or persist longer than recommended, a doctor should be consulted.

Dosage and Administration

The lowest effective dose should be used for the shortest duration necessary for treatment.

Adolescents aged 12 years and adults (weighing at least 40 kg)

• Initial dose: 1 sachet (400 mg ibuprofen)

• If necessary, another sachet every 6 to 8 hours

Maximum daily dose

• 3 sachets daily

• Corresponding to 1200 mg ibuprofen per day

Children under 12 years

Due to the dosage, ADOLORIN® Ibuforte DIRECT 400 mg must not be administered to children under 12 years of age and adolescents weighing less than 40 kg.

Method of Administration

• Oral use.

• Place the content of one sachet directly into the mouth.

• Drink water afterwards if necessary.

• For sensitive stomachs, it is recommended to take it with meals.

Duration of Use

• Adolescents: maximum 3 days without medical consultation

• Adults with fever: maximum 3 days

• Adults with pain: maximum 4 days

If symptoms persist or worsen, a doctor should be consulted.

Ingredients

Active ingredient

Each sachet contains:

• 400 mg ibuprofen in 10 ml oral suspension

Other ingredients

• Maltitol solution (E965)

• Sodium benzoate (E211)

• Citric acid, anhydrous (E330)

• Sodium citrate (E331)

• Sodium saccharin (E954)

• Sodium chloride

• Hypromellose type 2910 (E464)

• Xanthan gum

• Glycerol 99.8% (E422)

• Strawberry flavour

• Corn maltodextrin

• Triethyl citrate (E1505)

• Propylene glycol (E1520)

• Benzyl alcohol

• Thaumatin (E957)

• Purified water

Side effects

Like all medicines, ADOLORIN® Ibuforte DIRECT 400 mg can have side effects, although not everyone gets them.

Common

• Abdominal pain

• Nausea

• Indigestion

• Heartburn

• Diarrhoea

• Vomiting

Uncommon

• Headaches

• Dizziness

• Fatigue

• Skin rash

• Itching

Rare to severe

• Stomach or intestinal ulcers

• Gastrointestinal bleeding

• Liver dysfunction

• Kidney dysfunction

• Severe skin reactions

• Severe allergic reactions with shortness of breath or swelling

Overdose

If larger quantities are taken, the following may occur:

• Nausea

• Stomach pain

• Vomiting

• Headaches

• Tinnitus

• Confusion

• Nystagmus (involuntary eye movement)

• Drowsiness

• Palpitations

• Convulsions

• Dizziness

• Breathing difficulties

• Blood in urine

• Circulatory problems

In case of suspected overdose, medical help should be sought immediately.

In case of shortness of breath, swelling of the face or throat, blood in the stool, black stool or severe stomach pain, stop taking the medicine immediately and seek medical advice without delay.

ADOLORIN® Ibuforte DIRECT contains the active ingredient ibuprofen. Ibuprofen belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) and has pain-relieving, anti-inflammatory, and fever-reducing effects.

The ready-to-use suspension is suitable for the treatment of pain and fever in adults and adolescents aged 12 and over.

Indications

For the short-term symptomatic treatment of:

• Headaches

• Toothaches

• Back pain

• Muscle pain

• Joint pain

• Menstrual pain

• Nerve pain

• Pain associated with colds

• Fever associated with colds

• Fever associated with flu-like infections

Suitable for:

• Adolescents aged 12 years and over, weighing at least 40 kg

• Adults

If symptoms worsen or persist longer than recommended, a doctor should be consulted.

Dosage and Administration

The lowest effective dose should be used for the shortest duration necessary for treatment.

Adolescents aged 12 years and adults (weighing at least 40 kg)

• Initial dose: 1 sachet (400 mg ibuprofen)

• If necessary, another sachet every 6 to 8 hours

Maximum daily dose

• 3 sachets daily

• Corresponding to 1200 mg ibuprofen per day

Children under 12 years

Due to the dosage, ADOLORIN® Ibuforte DIRECT 400 mg must not be administered to children under 12 years of age and adolescents weighing less than 40 kg.

Method of Administration

• Oral use.

• Place the content of one sachet directly into the mouth.

• Drink water afterwards if necessary.

• For sensitive stomachs, it is recommended to take it with meals.

Duration of Use

• Adolescents: maximum 3 days without medical consultation

• Adults with fever: maximum 3 days

• Adults with pain: maximum 4 days

If symptoms persist or worsen, a doctor should be consulted.

Ingredients

Active ingredient

Each sachet contains:

• 400 mg ibuprofen in 10 ml oral suspension

Other ingredients

• Maltitol solution (E965)

• Sodium benzoate (E211)

• Citric acid, anhydrous (E330)

• Sodium citrate (E331)

• Sodium saccharin (E954)

• Sodium chloride

• Hypromellose type 2910 (E464)

• Xanthan gum

• Glycerol 99.8% (E422)

• Strawberry flavour

• Corn maltodextrin

• Triethyl citrate (E1505)

• Propylene glycol (E1520)

• Benzyl alcohol

• Thaumatin (E957)

• Purified water

Side effects

Like all medicines, ADOLORIN® Ibuforte DIRECT 400 mg can have side effects, although not everyone gets them.

Common side effects include

• Abdominal pain

• Nausea

• Indigestion

• Heartburn

• Diarrhoea

• Vomiting

Uncommon side effects include

• Headaches

• Dizziness

• Fatigue

• Skin rashes

• Itching

Rare to severe side effects include

• Stomach or intestinal ulcers

• Gastrointestinal bleeding

• Impairment of liver function

• Impairment of kidney function

• Severe skin reactions

• Severe allergic reactions with shortness of breath or swelling

Overdose

If too much is taken, the following symptoms may occur:

• Nausea

• Stomach pain

• Vomiting

• Headaches

• Tinnitus

• Confusion

• Nystagmus (involuntary eye movement)

• Drowsiness

• Palpitations

• Convulsions

• Dizziness

• Breathing difficulties

• Blood in the urine

• Circulatory problems

In case of suspected overdose, a doctor should be consulted immediately.

In case of shortness of breath, swelling of the face or throat, blood in the stool, black stool or severe stomach pain, stop taking the medicine immediately and seek medical advice without delay.