Paracofdal (20 tablets)

Do not take Paracofdal

• if you are allergic (hypersensitive) to the active substances or to any of the other ingredients of Paracofdal.
• if you suffer from kidney and liver diseases; heart rhythm disorders and slow heart rate, diseases of the hematopoietic system; peptic ulcer, glaucoma, insomnia, hypertension, severe headache with vomiting, headache as a result of head injury; decreased thyroid function; elderly or impaired patients; Addison’s disease; enlargement of the prostate or narrowing of the urethra; drug habituation data, chronic alcoholism, porphyria, glucose-6-phosphate dehydrogenase enzyme deficiency; pregnancy and lactation, children under 14 years.

Take special care with Paracofdal

Paracofdal should be taken with caution in the following cases:

• Due to the existing risk of developing drug dependence on Paracofdal associated with the presence of the narcotic analgesic in its composition — its rebate should be avoided in persons with evidence of drug addiction, and the duration of treatment with the product should not exceed 3-5 days.
• Paracofdal should be used with caution in food allergies and asthmatics.
• Its use in acute infections can erase the symptoms (fever, pain) and complicate the diagnosis.
• When performing laboratory tests, it is recommended to stop taking Paracofdal 3-4 days before the test.

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 treat increased stomach acidity (antacids) may delay the absorption of Paracofdal.
• Chronic alcohol use may increase Paracofdal’s hepatic toxicity.
• Cimetidine may increase the hepatic toxicity of Paracofdal.
• Paracofdal should not be taken with alcohol and drugs that depress the central nervous system (narcotic analgesics, general anesthetics, sedatives and hypnotics), due to the enhancement of this effect.
• Metamizole in the medicine may reduce the therapeutic effect of oral anticoagulants (medicines that affect blood clotting).
• Chloramphenicol and other hematopoietic agents increase the toxic effects of metamizole on leukopoiesis (white blood cell formation).

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. All Paracofdal components cross the placental barrier. Taken in high doses and immediately before birth, it can cause suppression of fetal respiration due to the presence of paracofdal components secreted with milk in low concentrations, but their effect on infants has not been studied.

Paracofdal is not recommended during pregnancy and lactation, or breast-feeding should be discontinued if treatment is required.

Driving and using machines

Paracofdal may cause dizziness and drowsiness, and in some individuals anxiety and agitation, which is why it is not recommended for drivers and people working with machines.

Side effects:

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

The following side effects are possible with the use of Paracofdal: abdominal pain, nausea and vomiting, kidney problems, abnormal blood counts, skin rash and itching, constipation or diarrhea, dizziness, respiratory depression and bronchospasm, hypotension (marked decrease in blood pressure). ), increased heart rate, insomnia and increased nervous excitability, discoloration of the skin, easy fatigue, fever, fever and sore throat after starting treatment.

If any of these symptoms occur, stop taking Paracofdal immediately and seek professional 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.

PARACOFDAL tablets * 20 SOPHARMA

Package leaflet: information for the user

Paracofdal® tablets

metamizole sodium/paracetamol/caffeine/codeine phosphate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may have to read it again.
• If you need further information or advice, ask your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist.
• This includes any possible side effects not listed in this leaflet. See section 4.
• If after 3 days you do not feel better or your condition worsens, you should seek medical attention.

What is in this leaflet

1. What Paracofdal is and what it is used for
2. What you need to know before you take Paracofdal
3. How to take Paracofdal
4. Possible side effects
5. How to store Paracofdal
6. Contents of the pack and other information

1. What Paracofdal is and what it is used for

Paracofdal is a combined medicinal product with analgesic, temperature-lowering and antitussive action. Paracofdal contains codeine, which belongs to a group of medicines called narcotic analgesics that work to relieve pain.

Paracofdal is used to treat mild to moderate pain (headache, postoperative conditions, toothache, neuralgia and neuritis, painful menstruation), to lower fever and soothe dry cough.

Due to its codeine content, Paracofdal can be used as a painkiller in children over the age of 14 years for short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.

2. What you need to know before you take Paracofdal

Do not take Paracofdal

• if you are allergic (hypersensitive) to the active substances or any of the other ingredients of Paracofdal (listed in section 6);
• if you suffer from severe kidney and/or liver disease; if you have heart rhythm disturbances;
• if you have diseases of the hematopoietic system;
• if you suffer from peptic ulcer disease of the stomach and duodenum;
• if you have a severe headache with vomiting;
• if you are aware that you have acute liver porphyria (an inherited disease with impaired red blood cell formation) or congenital glucose-6-phosphatedehydrogenase deficiency (an inherited disease with a deficiency of this enzyme);
• if you know that you metabolize codeine into morphine very quickly;
• to relieve pain in children and adolescents (aged 0-18 years) after removal of the tonsils or adenoid vegetation (third tonsil), due to obstructive sleep apnea syndrome (cessation of breathing during sleep);
• during pregnancy and lactation;
• children under 14 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracofdal.

• Paracofdal contains codeine, which may cause drug dependence when used in high doses for a long time. Its use should be avoided in persons with evidence of drug dependence, and the duration of continuous treatment should not exceed 2-3 days. Its constant use for a long period of time can lead to the appearance of such symptoms as anxiety and irritability, when stopping taking the drug.
• Codeine is converted to morphine in the liver by a certain enzyme. Morphine is the substance that leads to pain relief. In some people, this enzyme is different, and it can affect people in different ways. In some people, morphine is not produced or produced in very small amounts and will not provide enough pain relief. Other people are more likely to experience serious side effects because a very large amount of morphine is produced. If you notice any of the following side effects, you should stop taking this medicine and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, contracted pupils, nausea, constipation, lack of appetite.
• Use in children and adolescents after surgery. Codeine should not be used to relieve pain in children and adolescents after removing the tonsils or in adenoid vegetation due to obstructive sleep apnea syndrome.
• Use in children with respiratory problems. Codeine is not recommended in children with respiratory problems, as symptoms of morphine toxicity may be more severe in such children.
• This medicine contains caffeine. Avoid taking large amounts of tea, coffee or caffeinated beverages while taking Paracofdal. Increased caffeine intake can make you irritable and tense, have trouble sleeping, or experience an unpleasant feeling of tightness and heaviness in your chest.
• Paracetamol is included in the composition of the drug. Other combined drugs may also contain this active substance. Do not combine such drugs, so as not to exceed the recommended daily dose of paracetamol.
• Paracofdal should be used with particular caution in the presence of allergy to food, medication and asthmatics.
• In patients with abdominal pain, taking the drug can blur the clinical picture of an acute abdomen.
• Its use in acute infections caused by bacteria can suppress such symptoms as fever and pain, make diagnosis difficult and delay treatment.
• Paracofdal should be used with caution in elderly and debilitated patients.
• It should be used with caution in chronic alcoholism.

It is necessary to tell a doctor:

• If you have had a serious head injury or increased intracranial pressure.
• If you have low thyroid function.
• If you have an over-kidney gland disease called Addison’s disease.
• If you have problems urinating (enlargement of the prostate or narrowing of the urethra.
• When medical laboratory tests are to be carried out, it is recommended to stop taking Paracofdal 3-4 days before testing.

Liver problems

Inflammation of the liver has been reported in patients taking metamizole and symptoms develop within a few days to several months of starting treatment.

Stop using Paracofdal and contact a doctor if you have symptoms of liver problems such as nausea or vomiting, fever, feeling tired, loss of appetite, darkening of urine, light stools, yellowing of the skin or whites of the eyes, itching, rash or pain in the upper abdomen. Your doctor will check your liver function.

You should not take Paracoughdal if you have previously taken a medicine containing metamizole and have had liver problems.

Serious skin reactions Serious skin reactions
including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with methamisole treatment. Stop using metamizole and seek medical advice immediately if you notice any of the symptoms associated with these serious skin reactions described in section 4.

If you have ever developed severe skin reactions, you should never restart treatment with Paracofdal (see section 4).

Other medicines and Paracofdal

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Consult a doctor if you are taking the following medications:

• medicines to affect increased gastric acidity (antacids);
• anti-vomiting drugs (metoclopramide, domperidone);
• coumarin anticoagulants (medicines that reduce blood clotting);
• ciclosporin (a medicine used after organ transplantation and to treat tumour diseases);
• chlorpromazine (a medicine for the treatment of mental illness);
• drugs that suppress the central nervous system (narcotic analgesics, general anesthetics, sedative and sleeping pills);
• chloramphenicol and other myelotoxic products (medicines that damage the blood-sacrifuging) increase the risk of adverse effects on the hematopoietic system when given together with Paracofdal ;
• such drugs as phenytoin, carbamazepine, phenobarbital, sulfinpyrazone, rifampicin, isoniazid can enhance the toxic action of paracetamol on the liver;
• Anticholinergic drugs (to affect spasms of the gastrointestinal tract) taken concomitantly with codeine may lead to an increase in the suppressive effect of codeine on intestinal peristalsis.

Metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and blood clot) when taken at the same time. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection (prevention).
Metamizole should be used with caution with the following medicines, as it may reduce their effect:

• bupropion, a medicine used to treat depression or as an aid in stopping smoking;
• efavirenz, a medicine used to treat HIV/AIDS;
• methadone, a medicine that is used to treat dependence on illicit substances, e.g. opioids);
• valproate, a medicine used to treat epilepsy or bipolar disorder;
• tacrolimus, a medicine used to prevent organ rejection in transplanted patients;
• sertraline, a medicine used to treat depression.

Paracofdal with food, drink and alcohol

During treatment with Paracofdal, alcohol use is not recommended due to an increased risk of hepatic impairment.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of the product during pregnancy is contraindicated.

Metamizole

Available data on the use of metamizole during the first three months of pregnancy are limited, but do not indicate harmful effects for the embryo. In certain cases, where there are no other treatment options, it is possible to accept the administration of single doses of metamizole in the first and second trimesters after consulting a doctor or pharmacist and after careful consideration of the benefits and risks of using metamizole. In general, however, the use of metamizole in the first and second trimesters is not recommended.
During the last three months of pregnancy, you should not take Paracofdal because of an increased risk of complications for the mother and child (bleeding, premature closure of an important blood vessel, the so-called Bottali ductus, in the unborn, which closes naturally only after birth).

Paracetamol

If necessary, paracetamol can be administered during pregnancy. You should use the lowest possible dose that reduces pain and/or lowers the temperature in the shortest possible time. Contact your doctor if your pain and/or fever has not decreased or if you need to take the medicine more often.

Lactation

Do not take codeine while breastfeeding. Codeine and morphine pass into breast milk. In cases of imperative use, breast-feeding should be discontinued.

Metamizole

Metamizole degradation products pass into breast milk in significant quantities and a risk to the infant cannot be excluded. Therefore, repeated use of metamizole during breast-feeding should be avoided. In the case of a single administration of metamizole, mothers are advised to collect and dispose of breast milk for 48 hours after dosing.

Driving and using machines

Paracofdal can cause dizziness and drowsiness, and in individuals anxiety and agitation, therefore it is not recommended to take it by drivers and persons operating machines.

Paracofdal contains lactose monohydrate

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

Paracofdal contains wheat starch

The wheat starch in this medicine contains only very small amounts of gluten, is considered gluten-free, and is unlikely to cause problems if you have celiac disease (gluten intolerance). One tablet contains no more than 2.48 micrograms of gluten. If you have an allergy to wheat (a condition other than celiac disease), you should not take this medicine.

Paracofdal contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it can be said to be practically sodium free.

3. How to take Paracofdal

Always take Paracofdal exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Tablets are taken with water after a meal.

Adults and children over 14 years of age

1 tablet 3 times a day. The maximum daily dose is 3 tablets.
This medicine should not be taken for longer than 3 consecutive days. If the pain does not subside after 3 days, ask a doctor’s advice.

Children under 14 years of age

The safety and effectiveness of Paracofdal in children have not been studied, therefore its use in children under 14 years of age is not recommended.

Paracofdal should not be taken by children under the age of 14 years due to the risk of severe respiratory problems.

Elderly and patients with poor general health/renal impairment

The dose should be reduced in elderly patients, in debilitated patients and in patients with reduced renal function, as the excretion of metamizole degradation products may be delayed.

Patients with impaired renal or hepatic function

Since the rate of excretion is reduced in patients with impaired renal or hepatic function, repeated high doses should be avoided. No dose reduction is required only with short-term use. There is no experience available from long-term use.

If you take more Paracofdal than you should

Ask your doctor immediately or contact the nearest health facility in this case!

If you forget to take Paracofdal

If you miss a dose, take it as soon as possible. If it’s almost time for your next dose, take it as usual. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, Paracofdal can cause side effects, although not everybody gets them. As a rule, the drug is well tolerated.

Stop using Paracofdal and contact a doctor immediately if you experience any of the following symptoms:

Nausea or vomiting, fever, feeling tired, loss of appetite, darkening of urine, light stools, yellowing of the skin or whites of the eyes, itching, rash or pain in the upper abdomen. These symptoms may be signs of liver damage. See also section 2 “Warnings and precautions”.

Serious skin reactions

Stop using Paracofdal and seek medical advice immediately if you notice any of the following serious side effects:

• reddish, flat, target-like or round patches on the torso, often with centrally located blisters, peeling of the skin, ulcers of the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The following side effects are possible with the use of Paracofdal: hypersensitivity reactions, which may include skin rashes and itching, swelling (generalised or local), respiratory depression and bronchospasm, asthma attack (in patients with analgesic asthma), allergic shock (severe life-threatening allergic condition), blood abnormalities, abdominal pain, dry mouth, nausea and vomiting, constipation or diarrhoea in rare cases with prolonged administration, ulceration and bleeding from the gastrointestinal tract, inflammation of the liver, yellowing of the skin and the white part of the eyes, increase in the level of liver enzymes in the blood, renal disorders when high doses are administered for a long time, redness of the skin, sweating, abnormalities in blood indicators, dizziness, hypotension (marked decrease in blood pressure), heart rate, insomnia and increased nervous excitability, • drowsiness, aggravation of headaches with prolonged use, discolouration of the skin, easy tiredness, fever, fever and sore throat after starting treatment, drug dependence with prolonged use of high doses. Not known: serious skin reactions.

If any of these symptoms occur, stop taking Paracofdal immediately and seek specialist medical attention.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Paracofdal

Store below 25°C.Store in the original package in order to protect from light and moisture.

Keep out of the reach of children.

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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Paracofdal contains

• The active substances are: paracetamol, metamizole sodium, codeine phosphate and caffeine. Each tablet contains metamizole sodium 300 mg, paracetamol 200 mg, caffeine 30 mg, codeine phosphate 20 mg.
• The other ingredients are: lactose monohydrate, povidone, wheat starch, sodium starch glycolate, magnesium stearate, cellulose microcrystalline, talc.

What Paracofdal looks like and contents of the pack

Round, flat tablets, with veneer and line on one side, diameter 13 mm, white to almost white in color. The score line is only to facilitate breakage for ease of ingestion, not to divide into equal doses.

10 tablets in PVC/aluminum foil blister. 1 or 2 blisters in a cardboard box, together with a leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD, Bulgaria