Paramax-cod

Package Leaflet: Information for the User

Paramax-Cod, 500 mg + 30 mg, Tablets

Paracetamol + Codeine Phosphate Hemihydrate

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Paramax-Cod and what is it used for
• 2. Important information before taking Paramax-Cod
• 3. How to take Paramax-Cod
• 4. Possible side effects
• 5. How to store Paramax-Cod
• 6. Contents of the pack and other information

1. What is Paramax-Cod and what is it used for

Paramax-Cod contains paracetamol and codeine. Paracetamol acts as an analgesic and antipyretic. A medication containing paracetamol and codeine causes longer and stronger analgesic action compared to the action of each component separately. The medication is used for short-term treatment of moderate pain. This medication contains codeine. Codeine belongs to a group of medications called opioid analgesics, which relieve pain. It can be used alone (monotherapy) or in combination with other analgesics, such as paracetamol. Codeine can be used in children over 12 years old for short-term relief of moderate pain that is not relieved by other analgesics, such as paracetamol or ibuprofen, used in monotherapy.

2. Important information before taking the medication

When not to take Paramax-Cod

• if the patient has been diagnosed with hypersensitivity (allergy) to paracetamol, codeine, or any other component of Paramax-Cod;
• if the patient has severe kidney failure;
• if the patient has liver failure;
• if the patient has an alcohol-related disease;
• if the patient has asthma or respiratory failure;
• during the first three months of pregnancy;
• if the patient is breastfeeding;
• if the patient has a deficiency of the enzyme - glucose-6-phosphate dehydrogenase;
• if the patient is taking MAO inhibitors (medications used, among others, in the treatment of depression) and for 14 days after the end of treatment with medications from this group;
• for pain relief in children and adolescents (aged 0 to 18) after surgical removal of tonsils or adenoids in connection with obstructive sleep apnea syndrome;
• if the patient knows that they metabolize codeine to morphine very quickly.

The medication should not be used in children under 12 years old.

Warnings and precautions

The medication contains paracetamol.Do not take other medications containing paracetamol (including some medications used to relieve symptoms of colds and flu) due to the risk of overdose and potentially life-threatening liver damage. It is not recommended to use the medication for a long time or frequently. Do not exceed the recommended daily dose. In case of overdose, contact a doctor immediately, even if the patient feels well. See also section 3 "Taking a higher dose of Paramax-Cod than recommended."

• While taking the medication, do not drink alcohol or take medications containing alcohol, due to the increased risk of toxic liver damage and enhanced codeine effect. Particular risk of toxic liver damage exists in malnourished individuals and those who regularly consume alcohol.
• Caution should be exercised in patients with respiratory, liver, or kidney failure.
• Caution should be exercised in patients taking medications that cause central nervous system depression, such as benzodiazepines, antipsychotics, or anesthetics.
• Long-term use of high doses of codeine may lead to dependence. When using high doses of codeine, tolerance, psychological dependence, and constipation may occur.
• Codeine may cause a gallbladder attack in patients with gallstones.
• Codeine may cause a kidney stone attack in patients with kidney stones.
• Codeine may cause urinary retention in patients with prostate enlargement.
• Codeine may increase intracranial pressure and should be used with caution in patients with head injuries.
• In patients with kidney failure, the interval between doses should be at least 8 hours.
• Codeine is converted to morphine by liver enzymes. Morphine is a substance that relieves pain. Some individuals have altered these enzymes, which can affect the medication's action in different ways. In some individuals, morphine is not produced or is produced in very small amounts, which does not ensure adequate pain relief. Other individuals are more susceptible to severe side effects caused by the production of very large amounts of morphine. If the patient experiences any of the following side effects, they should stop taking the medication and contact their doctor immediately: slow or shallow breathing, disorientation, drowsiness, small pupils, nausea or vomiting, constipation, loss of appetite.

During treatment with Paramax-Cod, the doctor should be informed immediately

• if the patient has severe diseases, including severe kidney or liver disorders, sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe condition called metabolic acidosis (a blood and fluid disorder) when taking paracetamol in regular doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.

Children and adolescents

This medication should not be given to children under 12 years old. Use in children and adolescents after surgical removal of tonsils or adenoids Codeine should not be used to relieve pain in children and adolescents after surgical removal of tonsils or adenoids in connection with obstructive sleep apnea syndrome. Use in children with respiratory disorders Codeine is not recommended for use in children with respiratory disorders, as symptoms of morphine toxicity may worsen.

Paramax-Cod and other medications

Tell the doctor about all medications taken recently, including those available without a prescription. Due to the risk of overdose, check if other medications contain paracetamol or codeine. Paracetamol Concomitant use of this medication with MAO inhibitors and for 2 weeks after the end of treatment with medications from this group is contraindicated due to the possibility of excitement and high fever. While taking paracetamol, do not drink alcohol due to the risk of toxic liver damage. Medications such as isoniazid or rifampicin (anti-tuberculosis medications), carbamazepine, phenytoin, and phenobarbital (medications used in, among others, epilepsy) accelerate the metabolism of paracetamol. This may lead to liver damage even when using recommended doses of paracetamol. Probenecid (a medication used in, among others, gout) delays the elimination of paracetamol metabolites and may increase liver toxicity of paracetamol. Concomitant use of paracetamol with zidovudine (AZT, an antiviral medication used in HIV infection) may enhance the toxic effect of zidovudine on the bone marrow. Paracetamol may enhance the effect of anticoagulant medications (coumarin derivatives). Concomitant use of paracetamol and non-steroidal anti-inflammatory medications increases the risk of kidney function disorders. The rate of paracetamol absorption may be increased by metoclopramide or domperidone (medications used in nausea and vomiting), while decreased by cholestyramine (a medication that lowers excessive cholesterol levels in the blood). Salicylamide (a medication with analgesic and antipyretic effects) prolongs the elimination time of paracetamol. Flucloxacillin (an antibiotic), due to the serious risk of blood and fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2). Codeine Concomitant use of this medication with other analgesics containing buprenorphine, pentazocine, or nalbuphine is contraindicated, as the effect of codeine may be weakened, and the risk of withdrawal syndrome after treatment cessation may be increased. Alcohol enhances the effect of codeine. Barbiturates, benzodiazepines, morphine derivatives (analgesics and antitussives), methadone (an opioid analgesic) used concomitantly with codeine increase the risk of respiratory depression, which may lead to death in case of overdose of these medications. Other medications with a central nervous system depressant effect (sedating antidepressants, barbiturates, clonidine and its derivatives, sleeping medications, neuroleptics, anxiolytics) enhance the depressant effect of codeine on the central nervous system. Concomitant use of codeine and cholinolytic medications may cause paralytic ileus.

Paramax-Cod with food and drink

The medication can be taken during or outside of meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medication. PregnancyThe medication is contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the medication should be used only after consulting a doctor. BreastfeedingParacetamol and codeine pass into breast milk. Codeine should not be taken during breastfeeding.

Driving and using machines

Due to the content of codeine, Paramax-Cod may impair the ability to drive and use machines.

3. How to take Paramax-Cod

This medication should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor. The usual dose of Paramax-Cod is: Adults: 1 to 2 tablets every 6 hours. The maximum daily dose is 6 tablets. Children over 12 years old: the recommended dose of codeine is 1 to 2 tablets every 6 hours, if necessary, up to a maximum dose of 180 mg per day. Paramax-Cod should not be used in children under 12 years old due to the risk of severe respiratory disorders. Patients with kidney failure: the interval between doses should be at least 8 hours. The duration of treatment should be limited to 3 days, and if effective pain relief is not achieved, the patient or caregiver should consult a doctor. Method of administration The tablets should be swallowed with a glass of water.

Taking a higher dose of Paramax-Cod than recommended

In case of taking a higher dose of the medication than recommended, contact a doctor immediately, even if the patient feels well. SymptomsParacetamol: accidental or intentional overdose of paracetamol may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few hours. These symptoms may resolve the next day, despite the fact that liver damage has begun, which will then manifest as abdominal distension, return of nausea, and jaundice. Death may occur. Codeine: accidental or intentional overdose of codeine in adults may cause respiratory depression (cyanosis, respiratory failure, shallow breathing), low blood pressure, slow heart rate, drowsiness, vomiting, rash, itching, ataxia, pulmonary edema (rare), and miosis. Symptoms of overdose in children: respiratory depression, miosis, seizures, symptoms of histamine release - sudden flushing and swelling of the face, urticaria, urinary retention. ProcedureIn any case of taking a higher dose of the medication than recommended, or if a child has accidentally ingested even one tablet, induce vomiting if it has been less than 1 hour since ingestion, and contact the emergency department of the nearest hospital immediately.

Missing a dose of Paramax-Cod

Do not take a double dose to make up for a missed tablet; take the tablet as soon as possible and then continue taking the medication according to the recommendations. In case of doubts related to the use of the medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Paramax-Cod can cause side effects, although not everybody gets them. If a hypersensitivity reaction or other severe side effects occur, the medication should be discontinued, and a doctor or the emergency department of the nearest hospital should be contacted immediately. Frequent(may affect up to 1 in 10 people): constipation, nausea, vomiting, renal colic, necrosis, and renal papillitis, acute kidney failure Rare(may affect up to 1 in 1,000 people):

• cases of hypersensitivity reactions, such as skin redness, rash, flushing, or urticaria, excessive sweating, low blood pressure to the point of shock symptoms,
• drowsiness, dizziness

Very rare(may affect up to 1 in 10,000 people):

• cases of hypersensitivity reactions, such as angioedema (a clearly defined, localized swelling involving the deeper skin layers, including the subcutaneous tissue), dyspnea, bronchospasm.
• decreased white blood cell or platelet count
• granulocytopenia.
• respiratory depression, apnea.
• severe skin reactions.

Frequency not known(cannot be estimated from the available data): a serious condition that can cause acidosis of the blood (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2). During long-term use of the medication, there is a risk of dependence and withdrawal syndrome in patients who suddenly stop taking the medication, as well as in newborns whose mothers took the medication in the third trimester of pregnancy.

Reporting side effects

If any side effects occur, including any not listed in the leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Paramax-Cod

Store the medication out of sight and reach of children. Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Paramax-Cod contains

• The active substances of the medication are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
• Other ingredients of the medication are: microcrystalline cellulose, povidone, stearic acid, magnesium stearate.

What Paramax-Cod looks like and contents of the pack

White capsule-shaped tablets with a score line, 18 mm long and 7.5 mm wide. A plastic container with a LDPE closure, in a cardboard box, contains 10, 20, 30, 50, or 100 tablets.

Marketing authorization holder

Vitabalans Oy, Varastokatu 8, 13500 Hämeenlinna, Finland

Manufacturer

Vitabalans Oy, Varastokatu 8, FI-13500 Hämeenlinna, Finland To obtain more detailed information, contact the representative of the marketing authorization holder: Vitabalans Sp. z o.o., ul. Narbutta 5, lok. 1, 02-564 Warsaw, Phone: (0-48) 22 646 6035

Date of leaflet approval: