Talvosilen Forte

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

Talvosilen forte 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 pain relievers, which relieve pain. It can be used alone or in combination with other pain relievers, such as paracetamol.
Talvosilen forte 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 alone.

2. Important information before taking Talvosilen forte

When not to take Talvosilen forte

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• for pain relief in children and adolescents (from 0 to 18 years of age) after tonsillectomy or adenoidectomy in connection with obstructive sleep apnea syndrome;

Warnings and precautions

Before starting to take Talvosilen forte, you should discuss it with your doctor or pharmacist.
When taking Talvosilen forte, you should be particularly careful in the following cases:

• if you are addicted to opioids (including strong painkillers and sedatives);
• if you have impaired consciousness;
• if you have increased intracranial pressure;
• if you have respiratory center disorders and breathing function disorders;
• if you are taking monoamine oxidase inhibitors (a group of medicines used to treat depression);
• if you have lung ventilation disorders caused by chronic bronchitis or bronchial asthma;
• if you have had your gallbladder removed (post-cholecystectomy state);
• if you are taking high doses and have low blood pressure due to fluid deficiency;
• if you have severe diseases, including severe kidney or liver function disorders, sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). There have been reports of a serious disease called metabolic acidosis (a blood and fluid disorder) in patients who have taken paracetamol regularly for a long time or who have taken paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

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Talvosilen forte can only be taken in reduced doses or less frequently than indicated 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 previous hepatitis);
• liver function disorders (hepatitis, Gilbert-Meulengracht syndrome);
• kidney function disorders (also applies to dialysis patients);
• diseases that may be associated with decreased glutathione levels (e.g. diabetes, HIV infection, Down syndrome, cancer);
• glucose-6-phosphate dehydrogenase deficiency.

Codeine, one of the ingredients of Talvosilen forte, 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 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, you should stop taking this medicine and contact your 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, you should check if other medicines you are taking at the same time 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 pain relievers, especially in combination with pain relievers with anti-inflammatory and antipyretic effects, may lead to permanent kidney damage and kidney failure (analgesic nephropathy).
You should not suddenly stop treatment if the medicine has been used for a long time, due to the risk of withdrawal symptoms. 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, you should not start taking pain relievers again without consulting your doctor.
Since the ability to break down codeine in Talvosilen forte is individually variable, overdose symptoms may occur even when taking the doses recommended by your doctor. If you notice symptoms such as vision disturbances, drowsiness, fatigue, constipation, or circulatory problems, you should consult your doctor.
At the beginning of treatment, your doctor will check your individual reaction to Talvosilen forte. This is especially true for elderly patients and patients with impaired kidney or respiratory function. Severe symptoms of acute hypersensitivity (e.g. anaphylactic shock) have been observed very rarely.
In the event of an allergic reaction, you should discontinue the medicine and contact your doctor immediately.
In patients receiving higher doses and in particularly sensitive individuals, dose-related disorders of optical fixation of objects (visuomotor coordination) and visual acuity disturbances may occur. Additionally, respiratory drive 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.
You should be careful when taking the medicine if you have a history of opioid dependence.
You should talk to your doctor, even if the above warnings refer to past situations.

Children and adolescents

Use in children and adolescents after surgery
Talvosilen forte 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
Talvosilen forte is not recommended for children with respiratory disorders, as symptoms of morphine toxicity may worsen in these children.

Talvosilen forte and other medicines

You should 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.
Taking Talvosilen forte and sedatives, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use should only be considered when other treatment options are not possible. However, if your doctor prescribes Talvosilen forte with sedatives, the dose and duration of concurrent treatment should be limited by your doctor. You should inform your doctor about all sedatives you are taking and strictly follow your doctor's dosage recommendations. It may be helpful to inform your friends or relatives to be aware of the above symptoms.
Contact your doctor if you experience such symptoms.
Increased fatigue, drowsiness, and breathing difficulties may occur when taking Talvosilen forte and the following medicines: sedatives and sleeping pills, psychotropic medicines (from the phenothiazine group, e.g. chlorpromazine, thioridazine, perphenazine), other medicines that impair the function of the central nervous system, medicines used for allergies (antihistamines, e.g. promethazine, meclozine), medicines that lower blood pressure, as well as other pain relievers, alcohol.
Concomitant use of medicines that increase liver metabolism, such as certain sleeping pills and antiepileptic medicines (e.g. phenobarbital, phenytoin, carbamazepine) and rifampicin, may cause liver damage, even when taking recommended doses of paracetamol. This also applies to toxic substances for the liver and alcohol abuse.
Taking Talvosilen forte with food and/or a medicine that slows down stomach emptying (e.g. propenteline) may delay the absorption of paracetamol and the onset of the therapeutic effect.
Taking Talvosilen forte with medicines that accelerate stomach emptying (e.g. metoclopramide) may enhance the absorption of paracetamol and the therapeutic effect.
Talvosilen forte should not be taken with zidovudine (AZT), as it may increase the toxic effect of zidovudine on the bone marrow. Talvosilen forte should not be taken with zidovudine unless recommended by your doctor.
In the case of concomitant use of medicines for elevated uric acid levels (e.g. probenecid) and Talvosilen forte, the paracetamol dose should be reduced.
Cholestyramine (a medicine used to reduce elevated cholesterol levels) reduces the absorption of paracetamol.
You should inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic) due to a serious blood and fluid disorder (metabolic acidosis), which requires emergency treatment (see section 2).
While taking Talvosilen forte, you should avoid drinking alcohol (see section 2.3).

Taking Talvosilen forte with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, you should consult your doctor before taking this medicine.
Pregnancy
Pregnant women may only take Talvosilen forte on the explicit recommendation of their attending physician, as adverse effects on the unborn child cannot be ruled out.
In the period immediately before birth and in the event of threatened premature birth, Talvosilen forte 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 on opioids may develop in the fetus. There have been reports of withdrawal symptoms in newborns after repeated use of codeine in the last trimester of pregnancy.
Breastfeeding
You should not take Talvosilen forte while breastfeeding.
Paracetamol and codeine, as well as morphine, its metabolite, pass into breast milk.

Driving and using machines

Talvosilen forte may impair your ability to drive and use machines, even if taken as recommended by your doctor.
While taking the medicine, you should not drive or operate machines.

3. How to take Talvosilen forte

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Talvosilen forte should always be taken as recommended by your doctor. If you have any doubts, you should consult your doctor.
The medicine is taken orally.
Dosage:
Adults and adolescents over 12 years of age: orally, single dose 1 to 2 capsules; 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 240 mg; which corresponds to 8 capsules.

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 (corresponding dose of paracetamol and codeine phosphate hemihydrate)

fosforanu półwodnego)
(24 hours)
(corresponding dose of paracetamol and codeine
fosforanu półwodnego)

Body weight (age)

1 or 2 capsules
(corresponding to 500 or 1000 mg of paracetamol and 30 or 60 mg of codeine phosphate hemihydrate)
up to 8 capsules
(corresponding to a maximum of 4000 mg of paracetamol and a maximum of 240 mg of codeine phosphate hemihydrate)
from 43 kg
(children over 12 years old, adolescents, and adults)

• 12 years old, adolescents, and adults)

The maximum daily dose specified in the table should not be exceeded under any circumstances.
Talvosilen forte should not be used in children under 12 years of age due to the risk of severe respiratory disorders.
Method of administration
The capsules should be taken whole, with a sufficient amount of liquid, between meals. Taking the medicine after eating may delay its effect.
The capsules should not be taken while lying down.
Duration of treatment
The duration of treatment is determined by your doctor.
Talvosilen forte should not be taken for more than 3 days. If the pain does not subside after 3 days, you should consult your doctor.
Special patient groups
Liver and kidney failure
In the case of patients with liver or kidney function disorders, as well as Gilbert-Meulengracht syndrome, the dose of the medicine should be reduced or the intervals between doses prolonged.
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 the medicine.
Children and adolescents under 12 years of age
Talvosilen forte capsules are not recommended for children under 12 years of age, or with a body weight of less than 43 kg, as the dose is not suitable for this patient group.
If the effect of Talvosilen forte is too strong or too weak, you should consult your doctor.

Taking a higher dose of Talvosilen forte than recommended

To avoid the risk of overdose, you should ensure that other medicines you are taking at the same time do not contain paracetamol and/or codeine.
Overdose of paracetamol may 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 depression. Symptoms are similar to acute morphine poisoning, with severe drowsiness, up to loss of consciousness. Usually, pinpoint pupils, vomiting, headache, and urinary retention also occur. Hypoxia (lack of oxygen), cyanosis (blue discoloration of the skin), and increased muscle tone may also occur, as well as decreased reflexes and slowed heart rate, and decreased blood pressure; in some cases, especially in children, convulsions may occur.
In the event of an overdose of Talvosilen forte, you should immediately contact your doctor, who will decide on the appropriate course of action.

Missing a dose of Talvosilen forte

You should not take a double dose to make up for a missed dose.
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In the event of a missed dose of Talvosilen forte, you can take the dose at any time, but you should maintain an interval of at least 6 hours between the missed dose and the next one.

Stopping treatment with Talvosilen forte

In the case of using Talvosilen forte as intended, no special precautions are required.
In the case of sudden 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. You should not start taking pain relievers again without consulting your doctor.
If you have any further doubts about the use of this medicine, you should consult your doctor.

4. Possible side effects

Like all medicines, Talvosilen forte can cause side effects, although not everybody gets them.
In the event of an allergic reaction, such as facial swelling, breathing difficulties, excessive sweating, nausea, low blood pressure, including shock, you should discontinue treatment and contact your 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

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• hives
• shallow breathing
• ringing in the ears

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

• increased activity of liver enzymes (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 in the entire hematopoietic system
• allergic reactions such as angioedema, dyspnea, increased sweating, nausea, severe drop in blood pressure leading to shock

Frequency not known: cannot be estimated from the available data:

• a serious condition that can make the blood more acidic (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the national reporting system.

Poland

Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Talvosilen forte

The medicine should be stored out of sight and reach of children.
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You should not use this medicine after the expiry date stated on the packaging (blister pack) and carton. The expiry date refers to the last day of the given month.
Storage conditions:
There are no special precautions for storing the medicinal product.
Medicines should not be disposed of via wastewater or household waste. You should 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 forte contains

The active substances of the medicine are: paracetamol and codeine phosphate hemihydrate.
1 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 looks like and contents of the pack

Talvosilen forte is a capsule with a white, opaque lower part and an orange upper part.
Talvosilen forte is available in packs of 10 capsules (1 blister pack of 10).

Marketing authorization holder and manufacturer:

bene-Arzneimittel GmbH
Herterichstraße 1
D-81479 München
Germany
Phone: +49 89 74987-0
e-mail: [email protected]
To obtain more detailed information, you should contact the local representative of the marketing authorization holder:
Poland
Miralex Sp. z o.o.
Św. Szczepana 25
61-465 Poznań
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Phone: +48 61 832 90 74
e-mail: [email protected]
Date of last revision of the leaflet:January 2025
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