Talvosilen forte

confidential

Package leaflet: Information for the patient

TALVOSILEN FORTE
500 mg + 30 mg, capsules
Paracetamolum + Codeini phosphas hemihydricus
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm others, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Talvosilen Forte is and what it is used for

Talvosilen Forte is an analgesic medicine 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 may be used alone or in combination with other analgesics such as paracetamol.
Talvosilen Forte may be used in children aged 12 years and older for the short-term relief of moderate pain not relieved by other analgesics used alone, such as paracetamol or ibuprofen.

2. Important information before using Talvosilen Forte

When not to use Talvosilen Forte
1314 PL1clean 1 of 12
confidential

• 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 functional respiratory impairment (respiratory failure) or difficulty breathing (respiratory depression);
• in case of loss of consciousness (coma);
• in case of pneumonia;
• in patients experiencing an acute asthma attack;
• in patients with chronic cough, which may be, for example, a warning sign indicating the onset of bronchial asthma (particular attention should be paid to children);
• as the due date approaches;
• if premature delivery has been diagnosed as a risk;
• in children under 12 years of age;
• 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 is known to metabolise codeine to morphine very rapidly;
• if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Talvosilen Forte, discuss this with your doctor or
pharmacist.
Special caution is required when using Talvosilen Forte in the following cases:

• in patients dependent on opioids (including strong painkillers and sedatives);
• in patients with impaired consciousness;
• in patients with increased intracranial pressure;
• disorders of the respiratory centre and respiratory function;
• concomitant use of monoamine oxidase inhibitors (a group of medicines used to treat depression);
• impaired lung ventilation caused by chronic bronchitis or bronchial asthma;
• post-cholecystectomy state (after gallbladder removal);
• use of high doses in patients with low blood pressure due to fluid deficiency;
• 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), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (a blood and body fluid abnormality) have been reported in patients who take paracetamol regularly in high doses over a long period or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.

1314 PL2clean 2 of 12
confidential
Talvosilen Forte may be taken only at reduced doses or less frequently than indicated
in the dosage description (dose reduction or extended intervals between doses)
in the following cases:

• liver function disorders (e.g. due to chronic alcohol abuse or previous hepatitis);
• liver function disorders (hepatitis, Gilbert-Meulengracht syndrome);
• kidney function disorders (this also applies to dialysed patients);
• diseases that may be associated with reduced glutathione concentration (e.g. dose adjustment may be needed in diabetes, HIV infection, Down syndrome, tumours);
• glucose-6-phosphate dehydrogenase deficiency.

Codeine, one of the components of Talvosilen Forte, is converted into morphine by liver enzymes. Morphine is the substance that relieves pain. Some individuals have a genetically altered enzyme, which may affect them differently. In some people, morphine is not produced or is produced in very small amounts, resulting in inadequate 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, the medicine should be discontinued immediately and the doctor contacted without delay: slow or shallow breathing, disorientation, drowsiness, pinpoint pupils, visual disturbances, nausea or vomiting, constipation, loss of appetite.
Due to the risk of overdose, check whether other medicines currently being taken contain paracetamol and/or codeine.
Headaches may occur with long-term, high-dose use of paracetamol and must not be treated by increasing the dose 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 long-term, due to the risk of withdrawal syndrome. Headaches, fatigue, muscle pain, irritability and autonomic symptoms may occur. Withdrawal symptoms usually resolve spontaneously within a few days. In such cases, do not restart taking painkillers without consulting a doctor.
Because the ability to metabolise codeine contained in Talvosilen Forte varies individually, symptoms of overdose may occur even when taking doses recommended by the doctor. If the patient observes symptoms such as visual disturbances, mental clouding, fatigue, constipation or circulatory problems, they should consult their physician.
At the beginning of treatment, the doctor will assess the patient's individual response to Talvosilen Forte. This is especially important for elderly patients and patients with impaired kidney or
1314 PL3clean 3 of 12
confidential
respiratory function. Severe symptoms of acute hypersensitivity (e.g. anaphylactic shock) have been observed very rarely.
If hypersensitivity reactions occur, discontinue the medicine and contact a doctor immediately.
In patients receiving higher doses and in particularly sensitive individuals, dose-related disturbances in visual fixation (eye-hand coordination) and visual blurring may occur. In addition, respiratory drive depression (respiratory depression) and excessive feelings of well-being (euphoria) may occur.
With long-term use of this medicine, as with other medicines containing codeine, there is a risk of dependence.
Exercise caution when administering the medicine to individuals with a history of opioid dependence.
Talk to your doctor, even if the above warnings relate to conditions that occurred in the past.

Children and adolescents
Use in children and adolescents after surgery
Talvosilen Forte must 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
Use of Talvosilen Forte is not recommended in children with breathing disorders, as symptoms of morphine toxicity may worsen in these children.

Talvosilen Forte and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Concomitant use of Talvosilen Forte 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 no other treatment options are available. However, if your doctor prescribes Talvosilen Forte together with sedative medicines, the dose and duration of concomitant treatment should be limited by the doctor. Inform your doctor about all sedative medicines you are taking and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or family members so they are aware of the above-mentioned symptoms. Contact your doctor if such symptoms occur.
Increased fatigue, mental clouding and breathing disorders may occur when Talvosilen Forte is used concomitantly with the following: sedatives and hypnotics, psychotropic medicines (phenothiazine group, e.g. chlorpromazine, thioridazine, perphenazine), other medicines affecting the central nervous system, antiallergic medicines (antihistamines, e.g. promethazine, meclozine), antihypertensive medicines, as well as other painkillers and alcohol.
Concomitant use of medicines that increase hepatic metabolism, such as certain hypnotics and anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and rifampicin, may cause liver damage, even when recommended doses of paracetamol are used. This also applies to substances toxic to the liver and chronic alcohol abuse.
Taking Talvosilen Forte with food and/or a medicine delaying gastric emptying (e.g. propentheline) may delay the absorption of paracetamol and the onset of therapeutic effect.
Taking Talvosilen Forte with medicines accelerating gastric emptying (e.g. metoclopramide) may enhance the absorption of paracetamol and its therapeutic effect.
Concomitant administration of Talvosilen Forte with AZT (zidovudine) enhances the bone marrow toxicity of zidovudine. Talvosilen Forte should not be used with zidovudine unless specifically recommended by a doctor.
When using medicines for treating elevated uric acid levels (e.g. probenecid) concomitantly with Talvosilen Forte, the dose of paracetamol should be reduced.
Cholestyramine (a medicine used to reduce elevated cholesterol levels) reduces the absorption of paracetamol.
Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic) due to a serious blood and fluid abnormality (called metabolic acidosis), which requires urgent treatment (see section 2).
During treatment with Talvosilen Forte, avoid drinking alcohol, as it strongly affects motor coordination and cognitive processes.
In patients taking certain antidepressants (tricyclic antidepressants) such as imipramine, amitriptyline or opipramol, respiratory centre depression caused by codeine may occur.
Concomitant use of antidepressants (MAO inhibitors) such as tranylcypromine may enhance effects on the central nervous system and other adverse effects to an unpredictable extent. Therefore, Talvosilen Forte should not be started until at least two weeks after discontinuation of therapy with MAO inhibitors.
Concomitant use with other painkillers such as buprenorphine or pentazocine may reduce the effectiveness of the medicine.
1314 PL5clean 5 of 12
confidential
Cimetidine and other medicines affecting hepatic metabolism may enhance the effect of Talvosilen Forte. When cimetidine was administered with morphine, inhibition of morphine metabolism was observed, leading to increased plasma concentrations. A similar reaction cannot be excluded with codeine.
If the patient is taking warfarin or other coumarins (to thin the blood), occasional doses of this medicine may be taken, but prior to regular use, the patient should consult a doctor.

Effect on laboratory test results
Paracetamol contained in Talvosilen Forte may affect laboratory test results for serum uric acid and blood glucose levels.

Use of Talvosilen Forte with food, drink and alcohol
During treatment with Talvosilen Forte, alcohol consumption should be avoided (see section 2.3).

Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult your doctor before using this medicine.

Pregnancy
Pregnant women may take Talvosilen Forte only on the explicit recommendation of their doctor, as adverse effects on the unborn child cannot be ruled out.
In the period immediately before delivery and in cases of risk of premature delivery, Talvosilen Forte must not be taken, as codeine crosses the placenta and may suppress respiratory function in the newborn.
With long-term use of codeine, fetal opioid dependence may develop. Cases of withdrawal symptoms in newborns have been reported following repeated use of codeine in the third trimester of pregnancy.

Breastfeeding
Do not take Talvosilen Forte during breastfeeding.
Paracetamol and codeine, as well as morphine, its metabolite, pass into breast milk.

Driving and operating machinery
Talvosilen Forte may impair the ability to drive and operate machinery, even when taken as directed by a doctor.
Do not drive or operate machinery while taking this medicine.

3. How to use Talvosilen Forte

1314 PL6clean 6 of 12
confidential
Talvosilen Forte should always be used as directed by the physician. If in doubt,
consult your doctor.
The medicine is taken orally.
Dosage:
Adults and adolescents over 12 years of age: orally, 1 to 2 capsules at a time; if necessary, the dose may be repeated every 6 to 8 hours, no more than 4 times per day.
The paracetamol dose depends on the patient's body weight and age (usually the single dose is 10 to 15 mg per kg of body weight). The total daily dose should not exceed 60 mg/kg body weight.
Maximum daily dose:

• Paracetamol: 4000 mg;
• Codeine: 240 mg; equivalent to 8 capsules.

The appropriate intervals between doses depend on symptoms and the total maximum daily dose. These intervals should not be shorter than 6 hours.
Maximum daily dose
Single dose
(24 hours)
Body weight (appropriate dose of
paracetamol and codeine
phosphate hemihydrate)
Body weight (appropriate dose of
paracetamol and codeine
phosphate hemihydrate)
1 or 2 capsules
from 43 kg to 8 capsules
(equivalent to 500 or 1000
(children over (equivalent to max. 4000 mg
mg paracetamol and 30 or 60

12 years, adolescents and adults)
mg codeine phosphate hemihydrate)
mg codeine phosphate hemihydrate)

The maximum daily dose indicated in the table must never be exceeded.
Talvosilen Forte should not be used in children under 12 years of age due to the risk of severe respiratory disturbances.
Method of administration
The capsules should be taken whole, with sufficient liquid, between meals. Taking the medicine after meals may delay its effect.
Do not take the capsules while lying down.
Duration of treatment
1314 PL7clean 7 of 12
confidential
The duration of treatment is determined by the physician supervising the therapy.
Talvosilen Forte should not be used for longer than 3 days. If pain persists after 3 days, medical advice should be sought.
Special patient groups
Hepatic impairment and mild renal impairment
In patients with impaired liver or kidney function or with Gilbert-Meulengracht syndrome, the dose should be reduced or the intervals between doses extended.
Severe renal impairment
In cases of severe renal impairment (GFR < 30 ml/min), intervals of at least 8 hours between doses should be maintained.
Children and adolescents under 12 years of age
Use of Talvosilen Forte capsules is not recommended in children under 12 years of age or those weighing less than 43 kg, as the dose is not appropriate for this patient group.
If the effect of Talvosilen Forte is too strong or too weak, please consult your doctor.
Taking more than the recommended dose of Talvosilen Forte
To avoid the risk of overdose, ensure that other medicines taken concurrently do not contain paracetamol and (or) codeine.
Paracetamol overdose may cause severe liver damage.
Symptoms of such overdose include vomiting, nausea, pallor, and abdominal pain.
A characteristic feature of codeine overdose is severe respiratory depression.
Symptoms largely resemble acute morphine poisoning, with extreme drowsiness progressing to loss of consciousness. Typically, pinpoint pupils, vomiting, headache, urinary retention, and constipation also occur. Hypoxia (cyanosis, hypoxia), cold skin, increased smooth muscle tone (with single doses of codeine exceeding 60 mg), loss of reflexes, bradycardia, and hypotension may also occur. Seizures may occur, especially in children.
In case of overdose with Talvosilen Forte, seek immediate medical help. The doctor will decide on appropriate further management.
Missing a dose of Talvosilen Forte
Do not take a double dose to make up for a missed dose.
1314 PL8clean 8 of 12
confidential
If a dose of Talvosilen Forte is missed, it may be taken as soon as remembered, but at least a 6-hour interval must be maintained between this dose and the next.
Stopping Talvosilen Forte
When Talvosilen Forte is used as intended, no special precautions are required.
If the medicine has been taken in high doses over a long period, abrupt discontinuation may cause headache, fatigue, muscle pain, nervousness, and autonomic symptoms. Withdrawal symptoms usually resolve spontaneously within a few days. Do not start taking other painkillers without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If hypersensitivity reactions occur, such as facial swelling, difficulty breathing, profuse sweating, nausea, low blood pressure, including shock, treatment must be discontinued and immediate contact with a doctor is required.

The frequency of adverse 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 of the skin
• allergic rash

1314 PL9clean 9 of 12
confidential

• urticaria
• shallow breathing
• tinnitus

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

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

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

• bronchospasm with breathing difficulties (analgesic-induced asthma)
• accumulation of fluid in the lungs (pulmonary edema may occur with high doses, especially in patients with pre-existing lung dysfunction)
• decreased number or absence of granulocytes
• decreased number of all blood-forming cells
• hypersensitivity reactions such as angioedema, dyspnea, increased sweating, nausea, rapid drop in blood pressure leading to shock

Frequency not known: cannot be estimated based on available data:

• serious condition causing the blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the national reporting system.
Poland
Department for Monitoring of Adverse Drug Reactions
Office for Registration 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: [email protected]
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Talvosilen Forte

Keep the medicine out of the sight and reach of children.
1314 PL10clean 10 of 12
confidential
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 stated month.
Storage conditions:
No special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Talvosilen Forte contains
The active substances in this medicinal product are: paracetamol and codeine phosphate hemihydrate.
Each capsule contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
Excipients:
Talc; capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Talvosilen Forte 500 mg/30 mg looks like and contents of the pack
Talvosilen Forte is in the form of capsules with a white, opaque lower part and an orange upper part.
Talvosilen Forte is available in packs containing 10 capsules (1 blister with 10 units).

Marketing Authorisation Holder and Manufacturer:
bene-Arzneimittel GmbH
Herterichstraße 1
D-81479 Munich
Germany
Tel. +49 89/74987-0
e-mail: [email protected]

For further information, please contact the local representative of the Marketing Authorisation Holder:
Poland
Miralex Sp. z o.o.
ul. Św. Szczepana 25
PL - 61-465 Poznań
1314 PL11clean 11 of 12
confidential
Tel. +48 61 832 90 74
e-mail: [email protected]
1314 PL12clean 12 of 12