DOLIPRANE VITAMIN C 16 EFFERVESCENT TABLETS

Doliprane Vitamin C is an analgesic (pain reliever) and antipyretic (fever reducer). The active ingredients of this medicine are paracetamol and vitamin C. It is used to treat pain and/or fever, e.g. headaches, flu, toothache, aches and pains, painful periods.

This presentation is reserved for adults and children weighing more than 27 kg. For children weighing less than 27 kg, there are other presentations of paracetamol: ask your doctor or pharmacist for advice.

The active ingredients are:

Paracetamol ....................................................................................... 500.00 mg

Ascorbic acid ............................................................................... 150.00 mg

for one effervescent tablet

The other ingredients are : Citric acid anhydrous, sodium bicarbonate, sodium carbonate anhydrous, saccharin sodium, povidone K90, leucine, mannitol, orange colour PB-23074 (iron oxide red (El 72), quinoline yellow aluminium lake (E104), mannitol (E421 )), orange flavouring (orange essential oil, concentrated orange juice, maltodextrin, gum arabic).

Dosage

• The dose of paracetamol depends on the child's weight. Ages are given for information only.
• If you do not know the child's weight, you should weigh the child in order to give the most appropriate dose.
• Paracetamol is available in many dosages, allowing the treatment to be adapted to each child's weight.
• The recommended daily dose of paracetamol is about 60 mg/kg/day, to be divided into 4 or 6 doses, i.e. about 15 mg/kg every 6 hours or 10 mg/kg every 4 hours (please also refer to the paragraphs below according to your weight).

Children from 27 to 40 kg (about 8 to 13 years)

The usual dose is 1 effervescent tablet per dose, to be repeated if necessary after 6 hours, not exceeding 4 tablets per day.

Children from 41 to 50 kg (about 12 to 15 years)

The usual dose is 1 effervescent tablet per dose, to be repeated if necessary after 4 hours, but not exceeding 6 tablets per day.

Adults and children from 50 kg (about 15 years of age)

The usual dose is 1 to 2 effervescent tablets per dose, depending on the intensity of the pain, to be repeated if necessary after at least 4 hours.

Dose of paracetamol never to be exceeded

In an adult or a child weighing more than 50 kg:

It is generally not necessary to exceed 3 grams of paracetamol per day (i.e. 6 tablets per day). However, if you have more severe pain, and only on the advice of your doctor, the total dose may be increased to 4 grams of paracetamol per day (8 tablets per day).

NEVER TAKE MORE THAN 4 GRAMS OF PARACETAMOL PER DAY (taking into account all medications containing paracetamol in their formula).

Special situations:

The maximum daily dose should not exceed 60 mg/kg/day (not to exceed 3 g/day) in the following situations:

• if you are an adult weighing less than 50 kg,
• if you have liver disease or severe kidney disease,
• if you frequently drink alcohol or have recently stopped drinking alcohol,
• if you suffer from dehydration,
• If you suffer from chronic malnutrition, if you are fasting, if you have recently lost a lot of weight, if you are over 75 years of age or if you are over 65 years of age and have long-standing urea diseases, if you have AIDS or chronic viral hepatitis, if you have cystic fibrosis (a genetic and hereditary disease characterized in particular by severe respiratory infections), or if you have Gilbert's disease (a hereditary disease associated with increased levels of bilirubin in the blood).

How it is taken

This medicine is used orally. You should dissolve the tablets in a glass of water. Wait for complete dissolution before drinking immediately after the contents of the glass

Frequency of administration

You must take your effervescent tablets regularly to prevent pain or fever from returning. The tablets should be taken at regular intervals, including at night, preferably 6 hours apart and at least 4 hours apart (see Dosage section).

If you have severe kidney disease, you should wait at least 8 hours between each tablet.

Duration of treatment

The duration of treatment is limited without medical advice:

• 5 days in case of pain,
• 3 days in case of fever.

Stop the treatment and consult your doctor immediately:

• if the pain persists for more than 5 days or the fever lasts for more than 3 days,
• if the pain or fever gets worse,
• or if new symptoms appear.

If you have taken more DOLIPRANETABS than you should have

See your doctor or emergency room immediately.

Overdose may result in liver disease (liver failure), brain disease (encephalopathy), coma, and even death, especially in high-risk populations such as young children, the elderly, and in certain situations (liver disease, alcoholism, chronic malnutrition).

In the first 24 hours, the main symptoms of intoxication are: nausea, vomiting, loss of appetite, abdominal pain, paleness.

Overdose can also lead to: pancreatic damage (pancreatitis), hyperamylasemia (increased blood amylase levels) and kidney disease (acute renal failure).

Vitamin C overdose:

At doses above 1g/day of vitamin C, possibility of:

• digestive disorders (heartburn, diarrhea),
• urinary disorders (formation of kidney stones).

At doses higher than 2g/day of vitamin C, vitamin C may interfere with the following biological tests: creatinine and blood and urine glucose dosage (control of diabetes by glucose-oxidase test).

At doses higher than 3g/day of vitamin C, risk of haemolysis (destruction of red blood cells) in people suffering from lack of glucose 6 phosphate dehydrogenase (specific enzyme of red blood cells).

If you forget to take DOLIPRANVITAMIN C:Do not take a double dose to make up for the one you forgot to take.

Never take DOLIPRANEVITAMIN C

• if you are allergic to any of the active ingredients (paracetamol or vitamin C) or to any of the other ingredients in DOLIPRANEVITAMIN C
• if you have severe liver disease,
• if you have kidney stones.

Be careful with DOLIPRANEVITAMIN C:

If pain persists for more than 5 days, or fever for more than 3 days, or in case of insufficient efficacy or occurrence of any other signs, do not continue the treatment in the advice of your doctor

Because of a slightly stimulating effect due to the presence of vitamin C, it is advisable not to take this medicine at the end of the day

Taking paracetamol can cause liver problems.

You should seek the advice of your doctor before taking this medicine:

• If you are an adult weighing less than 50 kg,
• If you have liver disease or severe kidney disease,
• If you frequently drink alcohol or have recently stopped drinking alcohol,
• If you suffer from dehydration,
• If you suffer from chronic malnutrition, if you are fasting, if you have recently lost a lot of weight, if you are over 75 years of age or if you are over 65 years of age and have long-term illnesses, if you have AIDS or chronic viral hepatitis, if you suffer from cystic fibrosis (a genetic and hereditary disease characterized in particular by serious respiratory infections), or if you have Gilbert's disease (a hereditary disease associated with increased levels of bilirubin in the blood).

The consumption of alcoholic beverages during treatment is not recommended. In case of recent withdrawal from chronic alcoholism, the risk of liver damage is increased.

When administered to children, the dose depends on their weight (see "How to take DOLIPRANEVITAMINE C 1000 mg").

In case of acute viral hepatitis, stop your treatment and consult your doctor.

Blood tests

Tell your doctor if you are taking DOLIPRANEVITAMIN C and need to have a blood test as this medicine may affect your uric acid and blood sugar (glucose) levels. IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Taking or using other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or may take any other medicines, including medicines available without a prescription. Before starting treatment with this medicine, check that you are not taking any other medicines containing paracetamol.

If you are taking an oral anticoagulant treatment, taking DOLIPRANEVITAMINE C 1000 mg at the maximum dose (4 g/day) for more than 4 days requires reinforced monitoring of the INR. In this case, consult your doctor.

Pregnancy and breastfeeding

Under normal conditions of use, this medicine can be used during pregnancy and while breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of DOLIPRANEVITAMIN C

This medicine contains 390 mg of sodium per tablet. This should be taken into account if you are controlling your dietary intake of sodium.