ULTRACOD 500 mg/30 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. ULTRACOD
3. 500 mg + 30 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the package leaflet:
4. What is Ultracod and what is it used for
5. Important information before taking Ultracod
   1. When not to take Ultracod
   2. Warnings and precautions
   3. Taking higher than recommended doses of Ultracod may be associated with a risk of severe liver damage.
   4. Children and adolescents
   5. Ultracod and other medicines
   6. Ultracod with food, drink, and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Ultracod contains sodium
6. How to take Ultracod
   1. What to do if you take more Ultracod than you should
   2. What to do if you miss a dose of Ultracod
   3. What to do if you stop taking Ultracod
7. Possible side effects
   1. Stop taking the medicine and seek medical help immediately if you experience any of the following very rare but serious side effects:
8. How to store Ultracod
9. Contents of the pack and other information
   1. What Ultracod contains
   2. What Ultracod looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturers:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

ULTRACOD

500 mg + 30 mg, tablets

Paracetamol + Codeine phosphate hemihydrate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.

Contents of the package leaflet:

• 1. What is Ultracod and what is it 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 is Ultracod and what is it used for

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

2. Important information before taking Ultracod

When not to take Ultracod

if you are allergic to paracetamol, codeine, or any of the other ingredients of this medicine (listed in section 6);
if you have severe asthma attacks or serious breathing problems or a condition where you breathe more slowly or weakly than expected (respiratory depression);
if you have a head injury and if you have increased intracranial pressure (e.g., due to bleeding into the brain or a brain tumor);
if you have acute liver failure and severe liver dysfunction;
if you have recently undergone liver, gallbladder, or bile duct surgery;
if you are taking medicines for depression called MAOIs (monoamine oxidase inhibitors) or if you have taken these medicines in the last 2 weeks;
if you have paralytic ileus (a condition where the muscles of the intestine prevent the movement of food, resulting in bowel obstruction);
for pain relief in children and adolescents (0 to 18 years) after tonsillectomy or adenoidectomy in connection with obstructive sleep apnea syndrome;
if you know that you metabolize codeine to morphine very quickly;
if you are breastfeeding;
in case of impending delivery or risk of premature delivery.
The medicine should not be used in children under 12 years of age.

Warnings and precautions

Before starting treatment with Ultracod, you should discuss it with your doctor or pharmacist if you:
have acute liver disease;
have severe kidney disease;
are addicted to alcohol (or have recently stopped drinking alcohol) or drugs and psychoactive substances or are addicted to opioids (morphine, codeine). In alcohol-dependent patients, concomitant use of Ultracod may lead to liver damage;
have impaired consciousness;
are allergic to acetylsalicylic acid and/or other non-steroidal anti-inflammatory drugs;
are taking other medicines that affect the liver;
have difficulty breathing due to chronic obstructive pulmonary disease, spinal deformity, severe obesity;
are taking medicines that inhibit the central nervous system (e.g., sedatives) (see section 2 "Ultracod and other medicines").

Caution should be exercised:
if you have chronic constipation;
if you have liver disease;
if you have a condition called Gilbert's syndrome, which causes higher than normal bilirubin levels in the blood;
if you have inflammatory bowel disease or bowel obstruction;
if you have low blood volume (hypovolemia); this may be due to severe bleeding (external or internal bleeding), severe burns, excessive sweating, severe diarrhea, or vomiting;
if you have an irregular heartbeat or heart dysfunction;
if you have myasthenia gravis (an autoimmune disease that causes muscle weakness);
if you have gallstones or have had your gallbladder removed;
if you are elderly;
if you have prostate problems (prostate enlargement);
if you have acute abdominal pain (acute abdomen), which may be accompanied by vomiting, dizziness, or fever;
if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase;
if you have a low red blood cell count (hemolytic anemia);
if you have a low glutathione reserve (a condition associated with infections, inadequate diet, or chronic alcoholism);
if you have a narrowed urethra;
if you have abnormal adrenal function (adrenal insufficiency), e.g., Addison's disease;
if you have hypothyroidism;
if you have multiple sclerosis;
if you have epilepsy.

During treatment with Ultracod, you should immediately inform your doctor if:
you have severe illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or when you are also taking flucloxacillin (an antibiotic).
There have been reports of a serious condition called metabolic acidosis (a blood and fluid disorder) in patients who take paracetamol regularly for a long time or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling sick (nausea) and vomiting.
Ultracod should not be taken with other medicines that contain paracetamol and codeine.
In case of long-term use of Ultracod, it is necessary to monitor liver enzyme activity.
In case of long-term use of high doses of Ultracod, contrary to the doctor's recommendations, headaches may occur. In this case, do not increase the dose of the medicine. Stop taking the medicine and consult a doctor for advice.

Taking higher than recommended doses of Ultracod may be associated with a risk of severe liver damage.

Long-term use of Ultracod tablets may lead to dependence. This may mean that you feel like you need to take the medicine more often or in higher doses to get the same pain relief. You should inform your doctor as soon as possibleif you suspect this is happening. Do not change the dose of Ultracod or the frequency of taking it without consulting your doctor first.
Codeine is converted to morphine by liver enzymes. Morphine is a substance that relieves pain. Some people have altered these enzymes, which can affect them differently.
In some people, morphine is not produced or is produced in very small amounts, which may not provide adequate pain relief. Other people are more likely to experience severe side effects caused by the production of very large amounts of morphine. If you experience any of the following side effects, stop taking this medicine and contact your doctor immediately: slow or shallow breathing, disorientation, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.

Children and adolescents

Use in children and adolescents after surgical removal of tonsils
Codeine should not be used to relieve pain in children and adolescents after tonsillectomy or adenoidectomy 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 be exacerbated in these children.

Ultracod and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or recently, and about any medicines you plan to take.

• Do not take Ultracod with medicines used to treat depression called MAOIs (monoamine oxidase inhibitors) or if you have taken these medicines in the last two weeks (see section 2 "When not to take Ultracod").
• Ultracod may enhance the effects of medicines that affect the central nervous system, such as sedatives, anxiolytics, antihistamines, antidepressants (e.g., imipramine and amitriptyline), antihypertensives, antitussives, or other analgesics.
• Concomitant use of Ultracod and sedatives such as benzodiazepines or similar medicines increases the risk of sedation, respiratory depression, coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible. If your doctor prescribes Ultracod in combination with sedatives, they should limit the dose and duration of treatment. You should inform your doctor about all sedatives you are taking and strictly follow the doctor's dosage recommendations.

During treatment with Ultracod, you should inform your doctor or pharmacist about all sedatives you are taking and strictly follow the doctor's dosage recommendations. You should also inform your friends and family about the symptoms mentioned above. If you experience such symptoms, you should contact your doctor.

• Concomitant use of Ultracod and certain sedatives, antiepileptics, or rifampicin (an antibiotic) may cause liver damage.
• When Ultracod is used concomitantly with lamotrigine (an antiepileptic), the effectiveness of lamotrigine may be reduced.
• Concomitant use of Ultracod and chloramphenicol (an antibiotic) may lead to accumulation of the antibiotic in the body and enhance its side effects.
• The onset of action of Ultracod may be delayed when taken with substances that reduce gastric emptying (e.g., propantheline) or substances that lower cholesterol levels (cholestyramine). The action of Ultracod may be accelerated when taken with medicines that accelerate gastric emptying (e.g., metoclopramide or domperidone).
• Flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (called metabolic acidosis), which requires emergency treatment.
• Oral contraceptives may reduce the effectiveness of paracetamol.
• Concomitant use of codeine and cough medicines (e.g., ambroxol) should be avoided, as codeine may inhibit the cough reflex.
• Concomitant use of paracetamol and zidovudine (an antiviral) may lead to a decrease in white blood cell count and liver damage.
• In case of long-term use of high doses of Ultracod (more than 4 tablets per day) concomitantly with certain medicines that reduce blood clotting (warfarin or other vitamin K antagonists), an increased risk of bleeding has been observed. Therefore, during concomitant use of these medicines, blood clotting should be monitored more frequently.
• Concomitant use of antidiarrheal 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 action of codeine.

Ultracod with food, drink, and alcohol

The medicine should be taken before or during a meal. Taking it after a meal may delay the onset of action.
Do not drink alcoholic beverages while taking this medicine. Combining alcohol with Ultracod may lead to liver damage. The greatest risk of liver damage occurs in patients who chronically abuse alcohol if they take Ultracod after a short period of abstinence (about 12 hours).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ultracod may be used during the first and second trimester of pregnancy only if clearly necessary, after a careful analysis of the benefits and risks by the doctor.
If your doctor has recommended that you take this medicine during the first 6 months of pregnancy, you should take the lowest possible dose that relieves pain, for the shortest possible time.
You should contact your doctor if the pain does not subside or if you need to take this medicine more frequently.
Do not use the medicine during the third trimester of pregnancy or during delivery.
Do not take Ultracod while breastfeeding. Codeine and morphine pass into breast milk and may cause respiratory depression in breastfed infants.

Driving and using machines

While taking Ultracod, you may feel drowsy, less alert, and react more slowly than usual. Ultracod may impair your ability to drive or operate machines, reducing your reaction speed, especially when taken with factors that act depressingly on the central nervous system (e.g., sedatives or alcohol).
Do not drive or operate machines if you feel tired, until it is established that taking Ultracod does not affect your ability to perform these activities.

Ultracod contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Ultracod

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Adults and adolescents over 12 years of age
Take 1-2 tablets up to four times a day (if necessary), with intervals of at least 6 hours between doses.
The dose of the medicine depends on body weight; only individuals weighing 60 kg or more can take 2 tablets at a time. Do not take more than 8 tablets in 24 hours.
Do not take this medicine for more than 3 days. If the pain does not subside after 3 days, consult your doctor.
Children
Ultracod should not be used in children under 12 years of age due to the risk of severe respiratory disorders.

What to do if you take more Ultracod than you should

In case of overdose or accidental ingestion by a child, contact your doctor immediately, even if you feel well.
Overdose may cause initial excitement, anxiety, insomnia, seizures, dry mouth, gastrointestinal disorders, hypersensitivity, respiratory depression, followed by drowsiness, brief loss of consciousness, visual disturbances, constricted pupils, nausea, vomiting (vomit may contain blood or dark particles resembling coffee grounds), headaches, impaired motor function, urinary retention, and constipation, black or tarry stools, blue discoloration of the skin and mucous membranes, cool and clammy skin, sweating, jaundice, irregular heartbeat, and changes in blood pressure.
Severe poisoning can lead to respiratory arrest, circulatory collapse, cardiac arrest, and even death.

What to do if you miss a dose of Ultracod

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

What to do if you stop taking Ultracod

In case of sudden cessation of long-term treatment with higher than recommended doses of Ultracod, headaches and fatigue, muscle pain, nervousness, and gastrointestinal disorders have been observed. These symptoms subside within a few days after stopping treatment. In the future, the medicine can only be used if prescribed by a doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking the medicine and seek medical help immediately if you experience any of the following very rare but serious side effects:

• 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 swelling of the throat, difficulty breathing, sweating, nausea, low blood pressure, and shock,
• severe skin reactions including redness, blistering, and peeling of the skin.

During treatment with paracetamol and codeine (the active substances in Ultracod), the following side effects have been observed (according to frequency of occurrence).
Common(may affect up to 1 in 10 people):

• fatigue, fainting (temporary loss of consciousness when taking high doses), dizziness, mild headaches, low blood pressure, constipation, and especially at the beginning of treatment, nausea and vomiting.

Uncommon(may affect up to 1 in 100 people):

• sleep disorders, itching, skin redness, hives.

Rare(may affect up to 1 in 1,000 people):

• ringing and buzzing in the ears, shortness of breath, dry mouth, allergic rash, visual disturbances or constricted pupils (when taking high doses).

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

• decreased white and red blood cell count and platelet count, bronchospasm (asthma),
• respiratory depression (when taking high doses or in patients with increased intracranial pressure or head injury), feelings of excessive happiness or sadness (euphoria or depressed mood when taking high doses), impaired coordination and visual acuity (when taking high doses),
• lung edema (when taking high doses, especially in patients with respiratory dysfunction).

Unknown(frequency cannot be estimated from available data):

• liver inflammation (which may cause abdominal pain, loss of appetite, nausea, or vomiting), which can lead to liver failure,
• seizures,
• confusion, drowsiness, or severe sedation,
• difficulty urinating (urinary retention),
• risk of developing dependence (during long-term use),
• a serious condition that can make the blood more acidic (metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Reporting side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system (see below). By reporting side effects, you can help provide more information on the safety of this 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 carton. The expiry date refers to the last day of that month.
There are no special storage requirements.
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 of Ultracod 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, maize starch, croscarmellose sodium, povidone K-30, stearic acid, anhydrous colloidal silica.

What Ultracod looks like and contents of the pack

Ultracod is a white, oval, biconvex tablet.
The pack contains 10, 20, 30, 60, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Zentiva k.s., U kabelovny 130, Dolní Mĕcholupy, 102 37 Prague 10, Czech Republic.

Manufacturers:

Zentiva k.s., U kabelovny 130, Dolní Mĕcholupy, 102 37 Prague 10, Czech Republic.
Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovak Republic.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic, Latvia, Lithuania, Poland, Romania:
Ultracod
Estonia:
Algocalm
Date of last revision of the package leaflet:April 2025