TALVOSILEN 500 mg/20 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. TALVOSILEN
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Talvosilen and what is it used for
4. Important information before taking Talvosilen
   1. When not to take Talvosilen
   2. Warnings and precautions
   3. Children and adolescents
   4. Talvosilen and other medicines
   5. Using Talvosilen with food, drinks, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and operating machinery
5. How to take Talvosilen
   1. Maximum daily dose
   2. Single dose (appropriate dose of paracetamol and codeine phosphate hemihydrate)
   3. Body weight (age)
   4. Taking a higher dose of Talvosilen than recommended
   5. Missing a dose of Talvosilen
   6. Stopping Talvosilen treatment
6. Possible side effects
   1. Reporting side effects
7. How to store Talvosilen
8. Contents of the packaging and other information
   1. What Talvosilen contains
   2. What Talvosilen looks like and what the pack contains?
   3. Marketing authorization holder and manufacturer:
   4. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

TALVOSILEN

500 mg + 20 mg, tablets
Paracetamol + Codeine phosphate hemihydrate

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Talvosilen and what is it used for

Talvosilen is a pain reliever that can be used in children from 12 years of age, adolescents, and adults. This medicine contains paracetamol and codeine. Codeine belongs to a group of medicines called opioid analgesics, which relieve pain. It can be used as monotherapy or in combination with other pain relievers, such as paracetamol.
Talvosilen can be used in children from 12 years of age for short-term relief of moderate pain that is not relieved by other pain relievers, such as paracetamol or ibuprofen used as monotherapy.

2. Important information before taking Talvosilen

When not to take Talvosilen

• 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 respiratory failure (respiratory insufficiency) or breathing difficulties (respiratory depression);
• in case of loss of consciousness
• coma;
• in case of pneumonia;
• in patients who are experiencing an acute asthma attack;
• in patients with a chronic cough, which may be a warning sign of the onset of bronchial asthma (special attention should be paid to this in children);
• if the delivery date is approaching;
• if premature birth is threatened;
• in children under 12 years of age;
• for pain relief in children and adolescents (aged 0 to 18 years) after tonsillectomy or adenoidectomy in connection with obstructive sleep apnea syndrome;
• if the patient knows that they metabolize codeine to morphine very quickly;
• if the patient is breastfeeding.

Warnings and precautions

Before starting to take Talvosilen, discuss it with your doctor or pharmacist.
When taking Talvosilen, special caution should be exercised in the following cases:

• people addicted to opioids (including strong painkillers and sedatives);
• patients with impaired consciousness;
• patients with increased intracranial pressure;
• respiratory center disorders and breathing function disorders;
• concomitant use of monoamine oxidase inhibitors (a group of medicines used to treat depression);
• lung ventilation disorders caused by chronic bronchitis or bronchial asthma;
• gallbladder removal (post-cholecystectomy state);
• use of high doses in people with low blood pressure due to fluid deficiency.

Talvosilen can only be taken in reduced doses or less frequently than specified in the dosage description (dose reduction or prolongation of intervals between doses) in the following cases:

• liver function disorders (e.g., due to long-term alcohol abuse or past hepatitis);
• liver function disorders (hepatitis, Gilbert-Meulengracht syndrome);
• kidney function disorders (also applies to dialyzed patients);
• diseases that may be associated with a decrease in glutathione levels (e.g., diabetes, HIV infection, Down syndrome, cancer);
• glucose-6-phosphate dehydrogenase deficiency.

Codeine, one of the ingredients of Talvosilen, is converted to morphine by liver enzymes. Morphine is a substance that relieves pain. Some people have a changed enzyme and this can affect them in different ways. In some people, morphine is not produced or is produced in very small amounts, which does not provide adequate pain relief. Other people are more prone 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 medicine and contact their doctor immediately: slow or shallow breathing, disorientation, drowsiness, small pupils, vision disturbances, nausea or vomiting, constipation, loss of appetite.
Due to the risk of overdose, check if other medicines taken at the same time do not contain paracetamol and/or codeine.
In the case of long-term use of paracetamol in high doses, headaches may occur, which should not be treated with increased doses of the medicine.
Long-term use of painkillers, especially in combination with anti-inflammatory and antipyretic painkillers, may lead to permanent kidney damage and kidney failure (analgesic nephropathy).
Do not stop treatment abruptly if the medicine has been used for a long time, due to the risk of withdrawal syndrome. Headaches and fatigue, muscle pain, irritability, and vegetative symptoms may occur. Withdrawal symptoms usually resolve on their own within a few days. In such cases, do not start taking painkillers again without consulting a doctor.
Since the ability to break down codeine in Talvosilen is individually variable, overdose symptoms may occur even when taking the prescribed dose. If the patient observes symptoms such as vision disturbances, drowsiness, fatigue, constipation, or circulatory problems, they should consult their doctor.
At the beginning of treatment, the doctor will check the patient's individual reaction to Talvosilen.
Severe symptoms of acute hypersensitivity (e.g., anaphylactic shock) have been observed very rarely.
In case of hypersensitivity reactions, the medicine should be discontinued and the doctor should be contacted immediately.
In patients receiving higher doses and in particularly sensitive individuals, dose-related disturbances of optical fixation of objects (visuomotor coordination) and visual acuity disturbances may occur. Additionally, respiratory function impairment (respiratory depression) and excessive feelings of well-being (euphoria) may occur.
During long-term use of this medicine, as with other codeine-containing medicines, there is a risk of dependence.
Caution should be exercised when taking the medicine in patients with a history of opioid addiction.
Consult a doctor, even if the above warnings refer to past situations.

Children and adolescents

Use in children and adolescents after surgical procedures
Talvosilen should not be used for pain relief in children and adolescents after tonsillectomy or adenoidectomy in connection with obstructive sleep apnea syndrome.
Use in children with respiratory disorders
Talvosilen is not recommended for use in children with respiratory disorders, as symptoms of morphine toxicity may worsen in these children.

Talvosilen and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of Talvosilen and sedatives, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if the doctor prescribes Talvosilen with sedatives, the dose and duration of concomitant treatment should be limited by the doctor.
Inform your doctor about all sedatives you are taking and strictly follow the doctor's recommendations regarding the dose. It may be helpful to inform friends or relatives to be aware of the above symptoms.
Consult a doctor if such symptoms occur.
Increased fatigue, drowsiness, and breathing difficulties may occur when taking Talvosilen with the following agents: sedatives and sleeping pills, psychotropic drugs (from the phenothiazine group, e.g., chlorpromazine, thioridazine, perphenazine), other drugs that impair the function of the central nervous system, anti-allergic drugs (antihistamines, e.g., promethazine, meclozine), blood pressure lowering drugs, painkillers, alcohol.
Concomitant use of drugs that increase liver metabolism, such as some sleeping pills and antiepileptic drugs (e.g., phenobarbital, phenytoin, carbamazepine), and rifampicin, may cause liver damage, even when taking the recommended doses. This also applies to toxic substances for the liver and alcohol abuse.
Taking Talvosilen with food and/or a drug that slows down gastric emptying (e.g., propenteline) may delay the absorption of paracetamol and the onset of the therapeutic effect.
Taking Talvosilen with drugs that accelerate gastric emptying (e.g., metoclopramide) may enhance the absorption of paracetamol and the therapeutic effect.
The medicine should not be taken with zidovudine (AZT), as it may increase the toxic effect of zidovudine on the bone marrow. Talvosilen should not be taken with zidovudine unless prescribed by a doctor.
In the case of concomitant use of drugs for the treatment of elevated uric acid levels (e.g., probenecid) and Talvosilen, the paracetamol dose should be reduced.
Cholestyramine (a drug used to reduce elevated cholesterol levels) reduces the absorption of paracetamol.
During treatment with Talvosilen, avoid drinking alcohol (see section 2.3).

Using Talvosilen with food, drinks, and alcohol

During therapy with Talvosilen, avoid consuming alcohol (see section 2.3).

Pregnancy and breastfeeding

In pregnancy, breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before taking this medicine.
Pregnancy
Women who are pregnant can take Talvosilen only on the explicit recommendation of the attending doctor, as adverse effects on the unborn child cannot be ruled out.
In the period immediately before delivery and in case of threatened premature birth, Talvosilen should not be taken, as codeine passes through the placenta and may inhibit respiratory function in the newborn.
In the case of long-term use of codeine, dependence may develop in the fetus. There are reports of withdrawal symptoms in newborns after repeated use of codeine in the third trimester of pregnancy.
Breastfeeding
Do not take Talvosilen during breastfeeding.
Paracetamol and codeine, as well as morphine, its metabolite, pass into breast milk.

Driving and operating machinery

Talvosilen may impair the ability to drive and operate machinery, even if taken as recommended by the doctor.
Do not drive or operate machinery while taking the medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Talvosilen

Always take Talvosilen as recommended by your doctor. If in doubt, consult your doctor.
The medicine is taken orally.
Dosage:
Adults and adolescents over 12 years of age: orally, once 1 to 2 tablets; if necessary, the dose can be repeated every 6 to 8 hours, but no more than 4 times a day.
The paracetamol dose depends on the patient's weight and age (usually a single dose is 10 to 15 mg per kg of body weight). The total daily dose should not exceed 60 mg/kg of body weight.
Maximum daily dose:

• paracetamol is 4000 mg;
• codeine is 160 mg; which corresponds to 8 tablets.

The appropriate intervals between consecutive doses depend on the symptoms and the total maximum daily dose. They should not be shorter than 6 hours.

Maximum daily dose

Single dose (appropriate dose of paracetamol and codeine phosphate hemihydrate)

fosforanu półwodnego)
(24 hours)
(appropriate dose of paracetamol and codeine phosphate hemihydrate)

Body weight (age)

1 or 2 tablets
(corresponding to 500 or 1000 mg of paracetamol and 20 or 40 mg of codeine phosphate hemihydrate)
from 43 kg
(children over 12 years old, adolescents, and adults)
up to 8 tablets
(corresponding to a maximum of 4000 mg of paracetamol and a maximum of 160 mg of codeine phosphate hemihydrate)
The maximum daily dose specified in the table should not be exceeded under any circumstances.
Talvosilen should not be used in children under 12 years of age due to the risk of severe respiratory disorders.
Method of administration
The dividing line on the tablet only facilitates breaking it to facilitate swallowing, not dividing it into equal doses.
Tablets should be taken whole, with a sufficient amount of liquid, between meals.
Taking the medicine after eating may delay its effect.
Do not take tablets while lying down.
Duration of treatment
The duration of treatment is determined by the attending doctor.
Talvosilen should not be taken for more than 3 days. If the pain does not subside after 3 days, consult a doctor.
Special caution is required for patients:

• with liver and mild kidney failure In the case of patients with liver or kidney function disorders, as well as with Gilbert-Meulengracht syndrome, the dose of the medicine should be reduced, or the intervals between individual doses should be prolonged.
• with severe kidney failure In the case of severe kidney failure (GFR <30 ml min), intervals of at least 8 hours should be maintained between consecutive doses.< li>

Children and adolescents under 12 years of age
Talvosilen tablets are not recommended for use in children under 12 years of age, or with a body weight of less than 43 kg, as the dose is not suitable for this group of patients.
If the effect of Talvosilen is too strong or too weak, consult a doctor.

Taking a higher dose of Talvosilen than recommended

To avoid the risk of overdose, make sure that other medicines taken at the same time do not contain paracetamol and/or codeine.
Paracetamol overdose can cause severe liver damage.
Symptoms of such an overdose are: vomiting, nausea, pallor, and abdominal pain.
A characteristic feature of codeine overdose is severe respiratory reflex disturbance.
Symptoms are largely similar to acute morphine poisoning, with severe drowsiness up to loss of consciousness. Usually, at the same time, there is a narrowing of the pupils, vomiting, headaches, and urinary and fecal retention. Hypoxia (cyanosis, hypoxia), skin cooling, increased muscle tone (at single doses of codeine above 60 mg), as well as abolition of reflexes and slowing of heart rate and blood pressure decrease, may also occur; sometimes, especially in children, convulsions occur.
In case of taking too high a dose of Talvosilen, immediately call a doctor, who will decide on further action.

Missing a dose of Talvosilen

Do not take a double dose to make up for a missed dose.
If a dose of Talvosilen is missed, it can be taken at any time, but maintain at least a 6-hour interval between the missed dose and the next one.

Stopping Talvosilen treatment

In case of taking Talvosilen as intended, no special precautions are required.
In case of abrupt discontinuation of the medicine after long-term use in high doses, headaches and fatigue, muscle pain, irritability, and vegetative symptoms may occur. Withdrawal symptoms usually resolve on their own within a few days. Do not start taking painkillers again without consulting a doctor.
If you have any further doubts about taking this medicine, consult a doctor.

4. Possible side effects

Like all medicines, Talvosilen can cause side effects, although not everybody gets them.
In case of hypersensitivity reactions, such as facial swelling, breathing difficulties, excessive sweating, nausea, low blood pressure, including shock, stop treatment and contact a doctor immediately.
The frequency of side effects is defined as follows:
Very common: may affect more than 1 in 10 people:

• nausea
• vomiting
• constipation
• fatigue
• mild headache

Common: may affect up to 1 in 10 people:

• mild drowsiness
• low blood pressure and fainting (in patients receiving high doses)

Uncommon: may affect up to 1 in 100 people:

• dry mouth
• sleep disturbances
• itching
• redness
• allergic rash
• hives
• shallow breathing
• tinnitus

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

• increased activity of liver transaminases (liver enzymes)
• severe allergic reactions (including Stevens-Johnson syndrome)
• decreased platelet count and white blood cell count

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

• bronchial spasm with breathing difficulties (asthma caused by analgesics)
• fluid accumulation in the lungs (pulmonary edema may occur at high doses, especially in patients with pre-existing lung function disorders)
• decreased granulocyte count
• decreased count of cells of the entire hematopoietic system
• hypersensitivity reactions such as angioedema, dyspnea, increased sweating, nausea, sudden drop in blood pressure leading to shock

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Talvosilen

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (blister) and on the carton. The expiry date refers to the last day of the given month.
Storage conditions:
No special precautions are required for storing the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Talvosilen contains

The active substances of the medicine are: paracetamol and codeine phosphate hemihydrate.
1 tablet contains 500 mg of paracetamol and 20 mg of codeine phosphate hemihydrate.
Excipients:
cornstarch, talc, stearic acid, anhydrous colloidal silica, sodium carboxymethylcellulose (type A), povidone

What Talvosilen looks like and what the pack contains?

Talvosilen is a white, round, biconvex, faceted tablet with a notch on one side and an embossed inscription "Talvosilen" on the other side.
Talvosilen is available in packs of 20 tablets (2 blisters of 10 tablets each).

Marketing authorization holder and manufacturer:

bene-Arzneimittel GmbH
Herterichstraße 1
D-81479 Munich
Germany
Tel.+ 49 89/74987-0
e-mail: [email protected]
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
Poland
Miralex Sp. z o.o.
ul. Św. Szczepana 25
PL - 61-465 Poznań
Tel. + 48 61 832 90 74
e-mail: [email protected]

Date of last revision of the leaflet: