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Flexistad Junior 40 mg/ml oral suspension

What is Flexistad Junior and what it is used for

Flexistad Junior belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to treat the symptoms of pain and fever.

Flexistad Junior is used for:

Short-term symptomatic treatment of:

  • Mild to moderate pain, such as headache, toothache, painful menstruation;
  • Fever.

Flexistad Junior is intended for use in children with a body weight of 10 kg and over (age over 1 year), for adolescents and adults.

Warnings and precautions

Talk to your doctor or pharmacist before taking Flexistad Junior.

Side effects can be minimized by using the lowest effective dose for the shortest period of time needed to control symptoms.

Skin reactions

Serious skin reactions with redness and blistering of the skin, sometimes fatal, have been reported very rarely with NSAID use (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis / Lyle's syndrome; see section 4). The risk of such reactions is higher at the beginning of treatment, and these reactions usually occur within the first month of starting treatment.

At the first sign of a skin rash, mucosal lesions (mucosal disorders) or other signs of a hypersensitivity reaction, you should stop taking Flexistad Junior immediately and consult your doctor.

You should not take Flexistad Junior during chickenpox.

other information

Careful monitoring is required when:

  • impairment of renal or hepatic function;
  • if you are dehydrated (dehydrated);
  • recently after major surgery;
  • if you have allergies (for example, skin reactions associated with the use of other drugs, asthma, hives), chronic swelling of the nasal mucosa (nasal polyps), COPD (chronic obstructive airways disease).

Severe hypersensitivity reactions (eg anaphylactic shock) have been reported very rarely.

At the first sign of a severe hypersensitivity reaction after taking Flexistad Junior, treatment should be stopped. Depending on the severity of the symptoms, treatment should be undertaken by a specialist.

Ibuprofen, the active substance in Flexistad Jr., may reduce blood platelet aggregation (blood clotting). Patients with coagulation disorders should be closely monitored.

Prolonged treatment with Flexistad Junior requires regular monitoring of liver and kidney function, as well as blood counts.

Talk to your doctor or dentist if you have taken Flexistad Junior before surgery.

Prolonged use of any type of painkiller can make it worse. If such a situation has occurred before or can be foreseen, medical advice should be sought and treatment discontinued. A diagnosis of overdose headache should be made in patients who have frequent or daily headaches, regardless of (or due to) regular use of headache medications.

Regular use of painkillers, especially a combination of several painkillers, can lead to permanent kidney damage with a risk of kidney failure (analgesic-induced nephropathy).

NSAIDs, to which ibuprofen belongs, may mask symptoms of infection or fever.

Flexistad Junior contains liquid maltitol (E965), sodium methyl 4-hydroxybenzoate (E219), sodium propyl 4-hydroxybenzoate (E217).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Sodium methyl 4-hydroxybenzoate (E219) and sodium propyl 4-hydroxybenzoate (E217) may cause a delayed type allergic reaction.

How to take Flexistad Junior

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. If you are not sure, talk to your doctor or pharmacist.

Unless otherwise prescribed by a doctor, the recommended dose is:

Body weight (age) Single dose Maximum dose

10 kg - 15 kg (1 to 3 years) 100 mg ibuprofen (equivalent to 2.5 ml) 300 mg ibuprofen (equivalent to 7.5 ml)

16 kg - 19 kg (4 to 5 years) 100 mg ibuprofen (equivalent to 2.5 ml) 400 mg ibuprofen (equivalent to 10 ml)

20 kg - 29 kg (6 to 9 years) 200 mg ibuprofen (equivalent to 5 ml) 600 mg ibuprofen (equivalent to 15 ml)

30 kg - 39 kg (10 to 11 years) 200 mg ibuprofen (equivalent to 5 ml) 800 mg ibuprofen (equivalent to 20 ml)

> 40 kg (children and adolescents 12 years of age and older) 200 mg - 400 mg ibuprofen (equivalent to 5 - 10 ml) 1200 mg ibuprofen (equivalent to 30 ml)

In children and adolescents, the dose of Flexistad Junior is determined by body weight, usually from 7 to 10 mg / kg body weight, as a single dose, up to a maximum total daily dose of 30 mg / kg.

The interval of individual receptions should not be shorter than 6 hours.

The recommended dose should not be exceeded.

FLEXISTAD JUNIOR syrup Application method

Oral administration.

In patients with a sensitive stomach, it is recommended to take with food.

For accurate dosing, the package contains a dosing syringe (graduated to: 1.25 ml, 2.5 ml, 3.75 ml and 5 ml):

1. Shake the bottle before use!

2. To open the bottle, press down on the cap and turn it counterclockwise.

3. Insert the dosing syringe tightly into the stopper hole at the neck of the bottle.

4. Shake the bottle.

5. To fill the syringe, turn the bottle upside down. Holding the syringe, gently pull the plunger down to withdraw the required amount of suspension marked on the mark on the syringe.

6. Turn the bottle over and remove the dosing syringe by turning it carefully.

7. Put the end of the syringe in the child's mouth. Slowly push the plunger down to pour out the suspension, depending on how fast your child is able to swallow.

This medicine can be taken directly from the dosing syringe or with water or juice.

Disassemble the syringe after use (disassemble the plunger from the syringe). The dosing syringe must be thoroughly washed with warm water and dried before each use.

Duration of treatment

For short use only.

Flexistad Jr. should not be used in children and adolescents for more than 3 days, or if symptoms worsen, a doctor should be consulted.

In adults, Flexistad Junior should not be used for more than 3 days in high fever and more than 4 days in the treatment of pain, or if symptoms worsen, a doctor should be consulted.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common side effects are gastrointestinal. Gastric / duodenal ulcers (peptic ulcers), perforation or gastrointestinal bleeding may occur, sometimes fatal, especially in the elderly (see section 2). Nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry, vomiting of blood, inflammation of the oral mucosa with ulceration (ulcerative stomatitis), exacerbation of colitis and Crohn's disease have been reported following the use of ibuprofen. point 2). Inflammation of the lining of the stomach (gastritis) is less common.

The risk of gastrointestinal bleeding usually depends on the dose and duration of treatment.

Swelling, high blood pressure and heart failure have been reported with NSAIDs.

If you experience severe upper abdominal pain or vomiting, blood in your stools or black stools, you should stop taking Flexistad Junior and consult your doctor immediately.

How to store Flexistad Jr.

This medicinal product does not require any special storage conditions.

Shelf life after first opening: 1 year.

FLEXISTAD JUNIOR syrup Composition:

What Flexistad Jr. contains

The active substance is ibuprofen.

1 ml of oral suspension contains 40 mg of ibuprofen.

The other ingredients are: Citric acid monohydrate, glycerol, liquid maltitol (E965), sodium methyl 4-hydroxybenzoate (E219), sodium propyl 4-hydroxybenzoate (E217), polysorbate 80, saccharin sodium, purified water, xanthate cherry.