Ultracod

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Ultracod, 500 mg + 30 mg, tablets
Paracetamolum + Codeini phosphas hemihydricus
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What Ultracod is and what it is used for

This medicine contains codeine and paracetamol. Codeine belongs to a group of medicines called opioid analgesics and, in combination with paracetamol, an analgesic, relieves pain.
Ultracod is indicated for the treatment of moderate to severe pain and may be used in adults for various types of pain, such as headaches, toothaches, musculoskeletal pain, or painful menstruation.
Ultracod may be used in adolescents over 12 years of age for short-term relief of moderate pain not relieved by other analgesics such as paracetamol or ibuprofen used as monotherapy.

2. Important information before taking Ultracod

When not to take Ultracod

• if the patient is allergic to paracetamol, codeine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe asthma attacks or serious breathing problems or a condition in which the patient breathes slower or weaker than expected (respiratory depression);
• if the patient has a head injury or increased intracranial pressure (e.g. due to brain haemorrhage or tumour);
• if the patient has acute liver failure or severe liver function disorders;
• if the patient has recently undergone surgery of the liver, gallbladder or bile ducts (biliary tract);
• if the patient is currently taking medicines used to treat depression belonging to the group of MAO inhibitors (monoamine oxidase inhibitors) or if the patient has taken these medicines within the last 2 weeks;
• if the patient suffers from paralytic ileus (a condition in which intestinal muscles prevent movement of food, leading to intestinal blockage);
• for pain relief in children and adolescents (aged 0 to 18 years) following tonsillectomy or adenoidectomy due to obstructive sleep apnoea syndrome;
• if the patient knows they metabolise codeine to morphine very rapidly;
• if the patient is breastfeeding;
• during imminent delivery or risk of premature birth.

Ultracod must not be used in children under 12 years of age.
Warnings and precautions
Before starting to take Ultracod, consult your doctor or pharmacist if the patient:

• has acute liver disease;
• has severe kidney disease;
• is alcohol-dependent (or recently stopped drinking alcohol) or dependent on drugs and psychoactive substances, or is opioid-dependent (morphine, codeine). In patients dependent on alcohol, liver damage may occur when taking Ultracod concomitantly;
• has impaired consciousness;
• is allergic to acetylsalicylic acid and (or) other non-steroidal anti-inflammatory drugs;
• is taking other medicines affecting the liver;
• has breathing difficulties due to chronic obstructive pulmonary disease, spinal deformity, or severe obesity;
• is taking other medicines that depress the central nervous system (e.g. sedatives) (see section 2 "Ultracod and other medicines").

Exercise caution:

• if the patient suffers from chronic constipation;
• if the patient has liver disease;
• if the patient has a disorder called Gilbert's syndrome causing higher than normal blood bilirubin levels;
• if the patient has inflammatory bowel disease or intestinal obstruction;
• if the patient has low blood volume (hypovolemia); this may be caused by severe bleeding (external or internal), severe burns, excessive sweating, severe diarrhoea or vomiting;
• if the patient has irregular heart rhythm or heart function disorders;
• if the patient has myasthenia gravis (an autoimmune disease causing muscle weakness);
• if the patient has gallstones or has had the gallbladder removed;
• if the patient is elderly;
• if the patient has prostate problems (prostatic hypertrophy);
• if the patient has acute abdominal pain (acute abdomen) possibly accompanied by vomiting, dizziness or fever;
• if the patient has been diagnosed with glucose-6-phosphate dehydrogenase enzyme deficiency;
• if the patient has low red blood cell count (haemolytic anaemia);
• if the patient has been found to have low glutathione reserves (a condition associated with infections, poor diet or chronic alcoholism);
• if the patient has a narrowed urethra;
• if the patient has adrenal dysfunction (adrenal glands do not function properly, which may manifest as weakness, weight loss, dizziness, nausea or vomiting), e.g. Addison's disease;
• if the patient has hypothyroidism;
• if the patient has multiple sclerosis;
• if the patient has seizures (epilepsy).

During treatment with Ultracod, contact your doctor immediately if:
If the patient has severe illnesses, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism or if the patient is also taking flucloxacillin (an antibiotic).
Severe metabolic acidosis (a blood and body fluid disorder) has been reported in patients taking paracetamol regularly for a prolonged period or when paracetamol is taken with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.
Ultracod should not be taken simultaneously with other medicines containing paracetamol and codeine.
If long-term treatment with Ultracod is necessary, liver enzyme activity should be monitored.
Long-term use of high doses of Ultracod not in accordance with medical advice may cause headaches. In such cases, do not increase the dose. Discontinue the medicine and contact your doctor for advice.
Taking higher than recommended doses of the medicine may lead to a risk of severe liver damage.
Long-term use of Ultracod tablets may lead to dependence. This may mean that the patient feels the need to take Ultracod more frequently or in higher doses to achieve the same pain relief. Contact your doctor as soon as possible if the patient suspects this is happening. Do not change the dose or frequency of taking Ultracod without first consulting your doctor.
Codeine is converted to morphine by liver enzymes. Morphine is the substance that relieves pain. Some people have altered enzymes, which may affect them differently. In some individuals, morphine is not produced or is produced in very small amounts, which may not provide adequate pain relief. Other individuals are at higher risk of severe adverse effects due to the production of very large amounts of morphine. If the patient experiences any of the following adverse effects, discontinue taking this medicine and contact your doctor immediately: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
Children and adolescents
Use in children and adolescents after surgery
Codeine should not be used for pain relief in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnoea syndrome.
Use in children with breathing disorders
Codeine is not recommended in children with breathing disorders, as symptoms of morphine toxicity may be intensified in these children.
Ultracod and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• Do not take Ultracod with medicines used to treat depression called MAO inhibitors (monoamine oxidase inhibitors) or if the patient has taken these medicines within the last two weeks (see section 2 "When not to take Ultracod").
• Ultracod may enhance the effects of medicines that depress the central nervous system, such as sleeping pills, sedatives, anxiolytics, antihistamines, antidepressants (e.g. imipramine and amitriptyline), medicines used to treat high blood pressure, cough suppressants or other painkillers.
• Concomitant use of Ultracod and sedatives such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, concomitant use should only be considered if other treatment options are not possible. If your doctor prescribes Ultracod in combination with sedatives, they should limit the dose and duration of treatment.

Inform your doctor about all sedative medicines being taken and strictly follow the doctor's dosage recommendations. Inform friends and family about the objective and subjective symptoms listed above. If the patient experiences such symptoms, contact the treating doctor.

• Concomitant use of Ultracod and certain sleeping pills, antiepileptic medicines or rifampicin (an antibiotic) may cause liver damage.
• Concomitant use of Ultracod and lamotrigine (an antiepileptic medicine) may reduce the effectiveness of lamotrigine.
• Concomitant use of Ultracod and chloramphenicol (an antibiotic) may lead to accumulation of the antibiotic in the body and intensification of its adverse effects.
• The onset of action of Ultracod may be delayed when taken concomitantly with substances that reduce gastric emptying rate (e.g. propantheline) or substances that lower cholesterol levels (cholestyramine). The effect of Ultracod may be accelerated when taken concomitantly with medicines that accelerate gastric emptying (e.g. metoclopramide or domperidone).
• Flucloxacillin (an antibiotic), due to the serious risk of a blood and body fluid disorder (called metabolic acidosis), which requires urgent treatment.
• Oral contraceptives may reduce the effectiveness of paracetamol.
• Avoid concomitant use of codeine and expectorants (e.g. ambroxol), as codeine may suppress the cough reflex.
• Concomitant use of paracetamol and zidovudine (an antiviral medicine) may lead to reduced white blood cell count and liver damage.
• With long-term use of higher doses of Ultracod (more than 4 tablets per day) concomitantly with certain medicines that reduce blood clotting (warfarin or other vitamin K antagonists), increased bleeding has been observed. Therefore, during concomitant use of these medicines, blood clotting should be monitored more frequently.
• Concomitant use of antidiarrhoeal medicines may increase the risk of severe constipation or central nervous system depression.
• Concomitant use of a partial morphine agonist (buprenorphine) or antagonist (naltrexone) may accelerate or delay the effect of codeine.

Ultracod with food, drink and alcohol
Take the medicine before or during a meal. Taking it after a meal may delay the onset of action.
Do not consume alcoholic beverages while taking this medicine. Combining alcohol with Ultracod may lead to liver damage. The highest risk of liver damage occurs in patients with chronic alcohol abuse who take Ultracod after a short period of abstinence (about 12 hours).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Ultracod may be used during the first and second trimesters of pregnancy only if clearly necessary, after careful assessment by the doctor of benefits versus risks.
If your doctor has advised the patient to take this medicine during the first 6 months of pregnancy, take the lowest possible dose that relieves pain, for the shortest possible time. Contact your doctor if pain does not subside or if more frequent dosing is needed.
Avoid using the medicine during the third trimester of pregnancy and during delivery.
Do not take Ultracod during breastfeeding. Codeine and morphine pass into breast milk and may cause respiratory depression in breastfed infants.
Driving and operating machinery
While taking Ultracod, the patient may feel drowsy, less alert and significantly slower to react than usual. Ultracod may adversely affect the ability to drive or operate machinery by reducing reaction speed, especially when taken concomitantly with substances that depress the central nervous system (e.g. sleeping pills or alcohol).
Do not drive or operate machinery if the patient feels tired, until it has been proven that taking Ultracod does not affect the ability to perform these activities.
Ultracod contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Ultracod

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.

Adults and adolescents over 12 years of age
Take 1-2 tablets up to four times daily (if necessary), with intervals between doses of at least 6 hours.
The dose depends on body weight; only individuals weighing 60 kg or more may take 2 tablets
at the same time. Do not exceed 8 tablets within 24 hours.
Do not take this medicine for longer than 3 days. If pain persists after 3 days, consult a doctor.

Children
Ultracod must not be used in children under 12 years of age due to the risk of severe
respiratory disorders.

Elderly patients
Same as for adult patients; however, the doctor will decide whether a dose reduction is necessary.

Patients with impaired liver and/or kidney function
Dosage should be determined by a doctor. In these patients, the dose usually needs to be reduced
or the interval between doses extended. In case of kidney dysfunction, a maximum of 1 tablet should be
administered every 6–8 hours after the previous dose.
Tablets should be swallowed whole and taken with sufficient fluid.

Taking more Ultracod than recommended
In case of overdose or accidental ingestion by a child, contact a doctor immediately, even if the patient feels well.
Overdose may cause initial excitement, anxiety, insomnia, convulsions, dry mouth, gastrointestinal disturbances,
hypersensitivity, respiratory depression, followed by drowsiness, brief loss of consciousness, visual disturbances,
pupil constriction, nausea, vomiting (vomit may contain blood or dark particles resembling coffee grounds),
headache, impaired motor function, urinary and fecal retention, black or tarry stools,
bluish discoloration of the skin and mucous membranes, cold and clammy skin, sweating, jaundice,
irregular heartbeat, and changes in blood pressure.
Severe poisoning may lead to respiratory arrest, circulatory collapse, cardiac arrest, and even death.

Missing a dose of Ultracod
If a dose is missed, take it as soon as remembered. However, if it is nearly time for the next dose,
skip the missed dose and take the next dose at the usual time. Always maintain an interval of at least
4 hours between doses.
Do not take a double dose to make up for a missed dose.

Stopping Ultracod treatment
In cases of abrupt discontinuation after prolonged treatment with doses higher than recommended,
headache, fatigue, muscle pain, nervousness, and gastrointestinal disturbances have been observed.
These symptoms resolve within a few days after stopping treatment. In subsequent periods, the medicine
should be used only if prescribed by a doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must immediately stop using the medicine and seek medical help without delay if any of the following very rare adverse reactions occur:

• sudden high fever, sore throat, and mouth ulcers – these are symptoms of a very serious blood disorder (low white blood cell count),
• severe allergic reactions with laryngeal swelling, shortness of breath, profuse sweating, nausea, low blood pressure, and even shock,
• severe skin reactions including redness, blistering, and peeling of the skin.

The following adverse reactions have been observed during the use of paracetamol and codeine (the active substances in Ultracod), according to frequency of occurrence.
Common (may occur in fewer than 1 in 10 people):

• fatigue, fainting (transient loss of consciousness when high doses are used), dizziness, mild headaches, low blood pressure, constipation, and particularly at the beginning of treatment, nausea and vomiting.

Uncommon (may occur in fewer than 1 in 100 people):

• sleep disturbances, itching, skin redness, urticaria (hives).

Rare (may occur in fewer than 1 in 1,000 people):

• ringing and noises in the ears, shortness of breath, dry mouth, allergic rash, visual disturbances or pinpoint pupils (when high doses are used).

Very rare (may occur in fewer than 1 in 10,000 people):

• decreased number of white and red blood cells and platelets, bronchoconstriction (asthma),
• respiratory depression (when high doses are used or in patients with increased intracranial pressure or head injury), feelings of excessive happiness or sadness (euphoria or depressed mood when high doses are used), disturbances in visual-motor coordination and visual acuity (when high doses are used),
• pulmonary edema (when high doses are used, especially in patients with impaired lung function).

Not known (frequency cannot be estimated from available data):

• hepatitis (symptoms may include abdominal pain, loss of appetite, nausea or vomiting), which may lead to liver failure,
• seizures,
• confusion, drowsiness, or marked sedation,
• difficulty in passing urine (urinary retention),
• risk of developing dependence (with long-term use),
• a serious condition that may cause the blood to become more acidic (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ultracod

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ultracod contains
The active substances in this medicine are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
The other ingredients are: microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, povidone K 30, stearic acid, anhydrous colloidal silicon dioxide.

What Ultracod looks like and contents of the pack
Ultracod is white, oblong, biconvex tablets.
Packs contain 10, 20, 30, 60 or 100 tablets.

For further information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Romania, country of export:
Zentiva, k.s.
U kabelovny 130, Dolní Měcholupy, 102 37, Prague 10, Czech Republic

Manufacturer:
Saneca Pharmaceuticals, a.s.
Nitrianská 100, 920 27 Hlohovec, Slovakia

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation numbers in Romania, country of export:
4561/2012/01
4561/2012/02
4561/2012/03
4561/2012/04
4561/2012/05

Parallel Import Authorisation number: 82/26

This medicinal product is authorised for sale in the European Economic Area (EEA) under the following names:
Czech Republic, Latvia, Lithuania, Poland, Romania: Ultracod
Estonia: Algocalm