Dafalgan Odis Gran 500 mg bag 16 pcs

What is Dafalgan Odis Granulate and when is it used?

Dafalgan Odis Granulate contains the active ingredient paracetamol, which has an analgesic and antipyretic effect.

Dafalgan Odis Granulate is used for the short-term treatment of headaches, toothache, pain in the area of ​​joints and ligaments, back pain, pain during the menstrual period, pain after injuries (e.g. sports injuries), pain with colds and fever.

What should be considered?

Like all fever and painkillers, Dafalgan Odis Granules should not be used for more than 5 days without a doctor's prescription, or for more than 3 days in the case of fever. For children up to 12 years of age, the maximum continuous use without medical consultation is 3 days.

Painkillers should not be taken regularly over a long period of time without medical supervision. Prolonged pain requires medical evaluation.

High fever or a worsening of the condition in children requires early medical consultation.

To prevent the risk of overdose, it should be ensured that other medications administered do not contain paracetamol.

The indicated dosage or that prescribed by the doctor must not be exceeded.

It should also be borne in mind that the long-term use of painkillers in turn contributes to this headaches may persist.

Long-term use of painkillers, especially when several painkillers are combined, can lead to permanent kidney damage with the risk of kidney failure.

When should Dafalgan Odis Granulate not be taken?

Dafalgan Odis Granulate should not be taken in the following cases:

• If you are hypersensitive to the active ingredient paracetamol or any other ingredient (see «What is in Dafalgan Odis Granulate included?"). Such hypersensitivity manifests itself e.g. through asthma, shortness of breath, circulatory problems, swelling of the skin and mucous membranes or skin rashes (urticaria);
• Severe liver diseases;
• In the case of alcohol overconsumption;
• In the case of a hereditary liver disorder (so-called Meulengracht disease).

When is caution required when taking Dafalgan Odis Granules?

In the case of illnesses of the kidneys or the liver as well as in the case of the so-called "glucose-6-phosphate dehydrogenase deficiency" (rare hereditary disease of the red blood cells) you should consult your doctor before taking it.

Also tell your doctor if you are also taking blood-thinning medication or certain medicines for the treatment of tuberculosis (rifampicin, isoniazid), epilepsy (phenytoin, carbamazepine), G ot (Probenecid), increased blood fat levels (cholestyramine) or HIV infections (zidovudine). Caution is also required when using drugs with the active ingredients chloramphenicol, salicylamide or phenobarbital at the same time.

Your doctor must also be informed if you are using an antibiotic with the active ingredient flucloxacillin at the same time, as there is an increased risk of acidification of the blood (metabolic acidosis with increased anion gap). Close medical monitoring is recommended to detect the occurrence of metabolic acidosis.

It is not advisable to take paracetamol and alcohol at the same time. The risk of liver damage increases particularly if there is no food intake at the same time.

In the case of eating disorders such as anorexia, bulimia and very severe emaciation, as well as chronic malnutrition, caution is advised when taking Dafalgan Odis Granules.

In the event of a lack of fluids and reduced amounts of blood, caution is advised when taking Dafalgan Odis Granules. If you have a severe infection (e.g. blood poisoning), you should also be careful when using Dafalgan Odis Granules.

This medicine contains sorbitolol:

• One 250 mg sachet contains 600.6 mg sorbitol.
• One 500 mg sachet (strawberry-vanilla flavor) contains 801.3 mg sorbitol.
• One 500 mg sachet (cappuccino flavor) contains 810.3 mg sorbitol.

One 1,000 mg sachet contains 805, 8 mg sorbitol. Sorbitol is a source of fructose. Talk to your doctor before taking or receiving this medicine if your doctor has told you that you (or your child) have an intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI) - a rare inherited condition in which a person is unable to break down fructose -.

Sorbitol can cause gastrointestinal discomfort and may have a mild laxative effect.

This medicine contains less than 1 mmol sodium (23 mg) per sachet, i.e. it is almost «sodium-free».

Individuals who are hypersensitive to painkillers or rheumatism drugs may also be hypersensitive to paracetamol (see side effects).

Inform your doctor, pharmacist or druggist if you

• suffer from other diseases,
• have allergies or
< li>Take other medicines (including those you bought yourself!) or use them externally!

Can Dafalgan Odis Granulate be taken during pregnancy or while breastfeeding?

As a precautionary measure, you should avoid taking medicines during pregnancy and breastfeeding if possible or ask your doctor, pharmacist or druggist for advice.

If necessary, Dafalgan Odis Granulate can be taken during be used during pregnancy. Based on previous experience, currently with short-term use of the active substance paracetamol in the specified dosage, the risk for the child is considered low. You should use the lowest dose that relieves your pain and/or fever and you should use the medicine for the shortest possible time. If the pain and/or fever does not improve or you need to take the medicine more frequently, contact your doctor, pharmacist or druggist or nurse.

Although the use of paracetamol is considered compatible with breast-feeding, caution should be exercised when using Dafalgan Odis granules during breast-feeding as paracetamol is excreted in breast milk.

How to use Dafalgan Odis granules ?

Put the contents of the sachet directly in your mouth onto your tongue. The granules dissolve in the saliva and should then be swallowed without additional intake of water.

Taking after eating can lead to a delayed onset of action.

Do not administer single doses of the granules more frequently than indicated. The specified maximum daily dose must not be exceeded. Do not use in children under 3 years.

Children from 15-22 kg (3-6 years):

1 sachet of 250 mg paracetamol as a single dose, wait at least 6-8 hours before the next dose. The maximum daily dose is 4 sachets of 250 mg (=1,000 mg paracetamol).

Children from 22-30 kg (6-9 years):

1-2 sachets of 250 mg paracetamol as a single dose, wait at least 6-8 hours before taking the next dose. The maximum daily dose is 6 sachets of 250 mg (= 1,500 mg paracetamol).

Children from 30-40 kg (9-12 years):

2 sachets of 250 mg paracetamol or 1 sachet of 500 mg paracetamol as a single dose, wait at least 6-8 hours before taking the next dose. The maximum daily dose is 8 sachets of 250 mg or 4 sachets of 500 mg (= 2,000 mg paracetamol).

Adults and adolescents over 12 years (over 40 kg):

1-2 sachets of 500 mg paracetamol as a single dose, wait at least 4-8 hours before taking the next dose. The maximum dose per day is 8 sachets of 500 mg each (= 4,000 mg paracetamol).

Adults and adolescents over 12 years (over 50 kg):

1 sachet of 1,000 mg paracetamol as a single dose, wait at least 4-8 hours before taking the next dose. The maximum dose per day is 4 sachets of 1,000 mg each (= 4,000 mg of paracetamol).

Dafalgan Odis granules of 1,000 mg each may only be taken if prescribed by a doctor.

Observe the dosage specified in the package insert or prescribed by the doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Dafalgan Odis Granulate have?

The following side effects can occur when taking Dafalgan Odis Granulate:

In rare cases, hypersensitivity reactions such as itching, swelling of the skin and mucous membranes or skin rashes up to severe skin reactions (very rare) and nausea may occur. Furthermore, shortness of breath or asthma may occur, especially if these side effects have also been observed previously with the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). If signs of a hypersensitivity reaction or bruising/bleeding occur, the drug should be discontinued and the doctor consulted. Very rarely, changes in the blood count have been observed, such as a reduced number of blood platelets (thrombocytopenia) or a severe reduction in certain white blood cells (agranulocytosis).

If you notice any side effects, talk to your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be taken into account?

Dafalgan Odis granules may only be used up to the date marked «EXP» on the container.

Storage instructions

Dafalgan Odis granules should be stored at room temperature (15-25 °C), protected from moisture and out of the reach of children.

Further information

In the event of uncontrolled intake (overdose), a doctor must be consulted immediately. Nausea, vomiting, abdominal pain, loss of appetite and/or a general feeling of illness can be an indication of an overdose, but only occur several hours to a day after ingestion.

An overdose can result in very serious liver damage.

Medicines containing the active ingredient paracetamol must not be administered to children who have accidentally ingested alcohol.

Your doctor, pharmacist or druggist or your doctor or pharmacy can provide you with further information rin or druggist. These people have the detailed technical information.

What does Dafalgan Odis granules contain?

Active ingredients

250 ​​mg, 500 mg or 1,000 mg paracetamol.

Excipients

Strawberry-vanilla flavor: Basic butyl methyl acrylate copolymer, sodium dodecyl sulfate , Stearic Acid, Talc, Titanium Dioxide, Simethicone, Hypromellose, Sorbitol (E420), Carmellose Sodium, Sucralose (E955), Light Magnesium Oxide, Magnesium Stearate, Vanilla Flavor, Strawberry Flavor, Trimethylisopropylbutanamide (500 mg sachet only).

Cappuccino Flavor: Basic Butyl Methacrylate Copolymer, Sodium Lauryl Sulfate, Stearic Acid, Talc, Titanium Dioxide, Simethicone, Hypromellose, Sorbitol (E 420), Carmellose Sodium, Sucralose (E 955), Light Magnesium Oxide, Magnesium Stearate, Cappuccino Flavour, Trimethylisopropylbutanamide.

Authorization number

65339 (Swissmedic).

Where can you get Dafalgan Odis granules? What packs are available?

In pharmacies and drugstores, without a doctor's prescription:

Dafalgan Odis granules 250 mg strawberry-vanilla flavor: box of 16 sachets.

Dafalgan Odis granules 500 mg strawberry-vanilla flavor: box of 16 sachets.

Dafalgan Odis granules 500 mg cappuccino flavor: box of 16 sachets (currently not commercially available).

In pharmacies only with a doctor's prescription:

Dafalgan Odis Granules 250 mg Erdbeer-vanilla flavor: box of 40 sachets (currently not on sale).

Dafalgan Odis granules 500 mg strawberry-vanilla flavor: box of 40 sachets (currently not on sale).

Dafalgan Odis granules 500 mg cappuccino flavor: box of 40 sachets (currently not on sale).

Dafalgan Odis granules 1'000 mg cappuccino flavor : Box with 16, 40 and 100 sachets (currently not on sale).

Authorization holder

Bristol-Myers Squibb SA, Steinhausen.

This package leaflet was last checked by the medicinal products authority (Swissmedic) in September 2020.