Paracofdal 20 tablets

WHAT PARACOFDAL IS AND WHAT IT IS USED

Paracetamol 200 mg
Metamizole sodium 300 mg
Codeine phosphate 20 mg
Caffeine 30 mg

Paracofdal is a combined medicinal product with pain relieving, temperature-limiting and anti-coughing action.

It is used to treat weak and moderate pain (headaches, post-operative conditions, toothache, neuralgia and neuritis, painful menstruation); lowering fever and coughing.

2. BEFORE YOU TAKE PARACOFDAL

Do not take PARACOFDAL

• if you are allergic (hypersensitive) to the active substances or any of the other ingredients of Paracophal.

• if you suffer from kidney and liver disease; heart rhythm disturbances and delayed heart rate, diseases of the haemorrhagic system; ulcerative disease, glaucoma, insomnia, hypertonic disease, severe headache with vomiting, headache resulting from head trauma; decreased thyroid function; elderly or impaired consciousness; Addison's disease; increased prostate or narrowing of the urethra; drug addiction, chronic alcoholism, porphyria, glucose-6-phosphatodehydrogenase enzyme deficiency; pregnancy and lactation, children under 14 years of age.

Take special care with PARACOFDAL

PARACOFDAL should be taken with caution in the following cases:

• Because of the potential risk of developing drug dependence on Parakofad due to the presence of narcotic analgesic codeine in its composition, its use should be avoided in persons with evidence of drug use and the duration of treatment with the product should not be longer, longer than 3-5 days.

• Paracophage should be used with particular care in the presence of food allergy and asthmatics.

• Using it for acute infections can wipe out the symptoms (temperature, pain) and make it difficult to diagnose.

• It is recommended to stop taking Paracophal 3-4 days prior to testing if laboratory tests are performed.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

• Medicines to respond to increased gastric acidity (antacids) may delay the absorption of Paracophal.

• Chronic alcohol use may increase the liver toxicity of Paracophal.

• Cimetidine may increase the liver toxicity of Paracophal.

• Paracophal should not be taken with alcohol and drugs that suppress the central nervous system (narcotic analgesics, general anesthetics, sedative and hypnotic), because of this effect.

• Metamizole found in the drug can reduce the therapeutic effect of oral anticoagulants (medicines that affect blood clotting).

• Chloramphenicol and other blood-suppressing agents enhance the toxic effects of metamizole on leukopoesis (white blood cell formation).

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine. All the ingredients of Paracophal pass through the placental barrier. Taken in high doses and just before birth, it can cause suppression of the fetus due to the presence of codeine. All Paracophal ingredients are secreted with milk at low concentrations, but their effect on infants has not been studied.

Paracophage is not recommended during pregnancy and lactation, or breast-feeding should be discontinued if necessary.

Driving and using machines

Paracophal can cause dizziness and drowsiness and, in some individuals, anxiety and agitation, which is why it is not recommended to take it by drivers and people using machines.

Important information about some of the ingredients of PARACOFDAL

The product contains lactose monohydrate (excipient). If you have been told by a doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine. Wheat starch (an adjuvant in the medicinal product) may contain only traces of gluten and is considered safe in people with celiac disease. Patients with wheat allergy (other than celiac disease) should not take this product.

3. HOW TO TAKE PARACOFDAL

Always take PARACOFDAL as directed.

If you are not sure, ask your doctor or pharmacist. The tablets are taken with water after a meal.

The usual dose is:

♦ PARACOFDAL tablets on prescription:

Adults and children over 14 years of age

1 tablet 1 to 3 times a day, but no more than 6 tablets a day.

♦ PARACOFDAL tablets without prescription:

Adults and children over 14 years of age

1 tablet 3 times a day.

The maximum daily dose is 3 tablets.

The medicine should not be taken for more than 2-3 consecutive days.

Children under 14 years of age

The safety and efficacy of Paracophal in children has not been studied, so its use in children under 14 years of age is not recommended.

If you take morePARACOFDAL than you should

Ask immediately
If you forget to take PARACOFDAL
If you miss a dose, take it as soon as possible. If it's almost time for the next dose, take it as usual. Do not take a double dose to make up for the missed dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, PARACOFDAL can cause side effects, although not everyone gets them.

The following side effects are possible with Paracophal: abdominal pain, nausea and vomiting, kidney problems, abnormal blood counts, skin rashes and itching, constipation or diarrhea, dizziness, respiratory depression and bronchospasm, hypotension (marked decrease in blood pressure ), rapid heart rate, insomnia and increased nervous excitability, change in skin color, slight tiredness, fever, fever and sore throat after initiation of treatment.

If you experience any of these symptoms, immediately stop taking Paracophal and seek specialist medical attention.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE PARACOFDAL

♦ Keep out of the reach and sight of children.

♦ Store in the original package in a dry and shielded place at temperature
below 25 ° C.

Do not use PARACOFDAL after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.

♦ Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of your unnecessary medicines.
These measures will help to protect the environment.

6. ADDITIONAL INFORMATION

What PARACOFDAL contains

♦ The active substances are: paracetamol, metamizole sodium, codeine phosphate and caffeine.

♦ The other ingredients are: lactose monohydrate, povidone, wheat starch, sodium carboxymethyl starch, magnesium stearate; cellulose, microcrystalline; talc.

What PARACOFDAL looks like and what the package contains

10 tablets are packed in a PVC / aluminum foil blister. 1 or 2 blisters in a cardboard box.