Solpadeine forte tabs

Package leaflet: Information for the user

Solpadeine FORTE TABS
500 mg + 12.8 mg, coated tablets
Paracetamolum + Codeini phosphas hemihydricus

• This medicine is intended for the short-term treatment of moderate acute pain when other painkillers have not been effective.
• This medicine should be taken for no more than 3 consecutive days. If continued use beyond 3 days is required, consult a doctor or pharmacist.
• This medicine contains codeine, which may lead to dependence if used continuously for more than 3 days. Withdrawal symptoms may then occur after stopping the medicine.
• If this medicine is used to treat headache for more than 3 days, the headache may worsen.

Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a
doctor or pharmacist.

• Keep this leaflet so that you can read it again if needed.
• If you need advice or further information, consult your pharmacist.
• If any adverse effects occur, consult a doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If your condition does not improve or worsens, contact your doctor.

Contents of the leaflet

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

1. What Solpadeine FORTE TABS is and what it is used for

Solpadeine FORTE TABS may be used in patients over 12 years of age for the short-term relief of moderate pain requiring stronger analgesic action than that achieved with other painkillers such as paracetamol, ibuprofen or acetylsalicylic acid used alone.
It may be used to treat headache, migraine with or without aura, toothache (including pain after extraction), painful menstruation, back pain, muscle pain, neuralgia, bone and joint pain associated with arthritis and rheumatism, pain due to overexertion injuries and sprains, and sciatica.
The tablets contain two active substances: paracetamol and codeine. Codeine and paracetamol are analgesics. Codeine belongs to a group of medicines called opioid analgesics, which relieve pain. It can be used alone or in combination with other painkillers.
Thanks to the dual mechanism of action of its components, moderate pain can be rapidly relieved.

2. Important information before taking Solpadeine FORTE Tabs

• This medicine contains codeine, which may cause dependence if used continuously for more than 3 days. Withdrawal symptoms may then occur after stopping the medicine.
• If a painkiller is used to relieve headache for more than 3 days, the headache may worsen.

When not to take Solpadeine FORTE Tabs:

• if the patient has ever had an allergic reaction to paracetamol, codeine, or other opioid painkillers, or to any of the ingredients of this medicine (listed in section 6)
• if the patient is taking other medicines containing paracetamol or codeine
• if the patient is breastfeeding
• if breathing difficulties occur
• if the patient has chronic constipation
• for pain relief in children and adolescents (aged 0–18 years) after surgical removal of palatine or pharyngeal tonsils due to obstructive sleep apnoea
• if it is known that the patient metabolises codeine to morphine very rapidly.

Before taking the medicine, consult a doctor:

• if the patient has liver or kidney disease, including alcoholic liver disease
• if the patient is taking medicines affecting the liver
• if the patient has intestinal problems, including intestinal obstruction
• if the patient has undergone surgery to remove the gallbladder
• if the patient has asthma and aspirin allergy
• if the patient has Gilbert's syndrome (familial non-haemolytic jaundice)
• if the patient has been informed by a doctor about intolerance to certain sugars, glucose-6-phosphate dehydrogenase deficiency, or glutathione deficiency
• if the patient has chronic malnutrition and dehydration
• if the patient is elderly, an adult, or an adolescent with body weight below 50 kg
• if the patient has hypotension, hypothyroidism, head injury, or increased intracranial pressure.

Warnings and precautions
Codeine is converted into morphine by a specific liver enzyme. Morphine is the substance that relieves pain. Some individuals have a modified version of this enzyme, which may affect them differently. In some people, morphine is not produced or is produced only 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, stop taking the medicine immediately and contact a doctor without delay: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
Before starting treatment with Solpadeine FORTE Tabs, discuss the following with a doctor or pharmacist:

• if the patient is or has ever been dependent on opioids, alcohol, prescription medicines, or illegal substances

Regular and prolonged use of codeine (the active substance in this medicine) may lead to dependence and misuse, which in turn may result in overdose and (or) death. Do not use this medicine longer than necessary. Do not give this medicine to other people.
Before use, consult a doctor if the patient has liver or kidney problems, is underweight (<50 kg), is malnourished, or regularly drinks alcohol, as this may increase the risk of liver damage. It may be necessary to reduce the dose of paracetamol or avoid using this product altogether.
During treatment with Solpadeine FORTE Tabs, inform the doctor immediately if the patient develops serious conditions, including severe kidney dysfunction 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). In such cases, patients have developed a serious condition called metabolic acidosis (an abnormality in blood and body fluids) when taking paracetamol regularly over a long period or when taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children and adolescents
Do not give this medicine to children under 12 years of age.
Use in children and adolescents after surgery:
Codeine must not be used for pain relief in children and adolescents after surgical removal of palatine or pharyngeal tonsils due to obstructive sleep apnoea.
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.

Solpadeine FORTE Tabs and other medicines
Talk to a doctor or pharmacist before taking these tablets if the patient is taking prescription medicines, especially the following: metoclopramide or domperidone (used to treat nausea and vomiting); cholestyramine (used to lower blood cholesterol levels); monoamine oxidase inhibitors (MAOIs) prescribed for depression within the last 2 weeks, or medicines causing drowsiness (e.g. sedatives, antidepressants, or alcohol).
If the patient is taking anticoagulant medicines (blood thinners such as warfarin and coumarin derivatives) and needs to take a painkiller daily, they should discuss the risk of bleeding with a doctor, but may still take occasional doses of Solpadeine FORTE Tabs together with anticoagulants. If the patient is taking probenecid, they should talk to a doctor, as a dose reduction of Solpadeine FORTE Tabs may be necessary.

Paracetamol and other medicines
Inform the doctor or pharmacist if the patient is taking:

• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2).

Concomitant use of Solpadeine FORTE Tabs and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), or coma, which may be life-threatening. Therefore, combined treatment should only be considered when no other treatment options are available.
If Solpadeine FORTE Tabs is used together with other sedative medicines, the doctor should limit the dose and duration of concomitant use.
The patient should inform the doctor about all sedative medicines they are taking and strictly follow the prescribed dosage. It may be helpful to inform a relative or close friend about the possibility of the above-mentioned symptoms occurring. If any of the described symptoms occur, consult a doctor immediately.

Pregnancy and breastfeeding
Unless otherwise advised by a doctor, avoid using Solpadeine FORTE Tabs during pregnancy.
Do not take Solpadeine FORTE Tabs during breastfeeding. Codeine and morphine pass into breast milk.

Driving and operating machinery
If the patient experiences dizziness or excessive drowsiness while taking Solpadeine FORTE Tabs, they should not drive or operate machinery.

Solpadeine FORTE Tabs contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

Solpadeine FORTE Tabs contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Solpadeine Forte TABS

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults:
Take 2 tablets with water. Take the medicine every 4 to 6 hours as needed.

• Do not take more frequently than every 4 to 6 hours.
• Do not exceed 8 tablets in 24 hours (this corresponds to 4 g of paracetamol and 102.4 mg of codeine phosphate hemihydrate).

Elderly patients:
Dosage reduction may be necessary in elderly, debilitated, and immobilized patients.
Renal impairment:
For patients with renal impairment, when administering paracetamol, it is recommended to reduce the dose and extend the minimum interval between doses to at least 6 hours.
Adults:

Liver function disorders:
In patients with impaired liver function or Gilbert's syndrome, the dose should be reduced or the interval between doses prolonged.

Adolescents aged 16–18 years:
Take 2 tablets with water. The medicine should be taken every 6 hours as needed.

• Do not take more frequently than every 6 hours.
• Do not take more than 8 tablets within 24 hours (equivalent to 4 g of paracetamol and 102.4 mg of codeine phosphate hemihydrate).
• Do not exceed the recommended dose.

Adolescents aged 12–15 years:
Take 1 tablet with water every 6 hours as needed.

• Do not take more frequently than every 6 hours.
• Do not take more than 4 tablets within 24 hours (equivalent to 2 g of paracetamol and 51.2 mg of codeine phosphate hemihydrate).
• Do not exceed the recommended dose.

In the following cases, the maximum dose of paracetamol should not exceed 2 g within 24 hours unless otherwise directed by a physician:

• If the patient is elderly or an adult or adolescent with body weight below 50 kg
• If the patient has mild or moderate liver or kidney disease
• If the patient has Gilbert's syndrome (familial non-hemolytic jaundice)
• If the patient suffers from chronic alcoholism, malnutrition, or dehydration

This medicine should not be used for longer than 3 days. If pain has not decreased after 3 days, consult a doctor.
In case of doubt, consult a physician.

Use in children and adolescents under 12 years of age
Solpadeine FORTE Tabs is not recommended for treatment of patients under 12 years of age due to the risk of severe breathing problems.

Possible withdrawal effects
This medicine contains codeine and may lead to dependence if used continuously for more than 3 days. Withdrawal symptoms may occur after discontinuation of the medicine.
If symptoms persist or headache does not resolve, contact a physician.

Accidental overdose of Solpadeine FORTE Tabs
Seek immediate medical advice from a doctor if an excessive dose of this medicine has been taken, even if the patient feels well. This is because an excessive dose of paracetamol may cause delayed but severe liver damage.

Missed dose of Solpadeine FORTE Tabs
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
You should stop taking the medicine and immediately inform your doctor if any of the following symptoms occur:

• dryness in the mouth, nausea and vomiting following recent gallbladder removal surgery
• acute pancreatitis (inflammation of the pancreas), which may cause severe stomach pain
• allergic reactions, which may be severe and may present as skin rash or mouth ulcers, sometimes with flu-like symptoms or itching, sometimes with swelling of the lips or face or shortness of breath, or skin peeling
• breathing difficulties. These symptoms are more likely if the patient has previously experienced them when taking other painkillers such as ibuprofen and acetylsalicylic acid
• unexplained bruising or bleeding
• nausea, sudden weight loss, loss of appetite, and yellowing of the eyes and skin
• difficulty in passing urine
• cloudy urine

Other adverse effects:

• constipation

Very rare cases of severe skin reactions have been reported.
Frequency of occurrence: "frequency unknown" (cannot be estimated from available data).
A serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

How can I know if I am addicted?
When taking the medicine as directed on the package, the likelihood of becoming addicted to the medicine is very low. However, it is important to speak with your doctor in the following situations:

• if the patient needs to take the medicine for a prolonged period
• if the patient needs to take a dose higher than recommended
• if the patient feels unwell after stopping the medicine, but feels better again upon resuming it.

Reporting of adverse effects
If any adverse effects occur, consult your doctor or pharmacist.
This applies to all possible adverse effects not listed in this leaflet.
Adverse effects may also be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Solpadeine Forte TABS

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

What Solpadeine FORTE Tabs contains

• The active substances are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol and 12.8 mg of codeine phosphate hemihydrate.
• Other components of the medicine:
• Tablet core: pregelatinized starch, corn; povidone K25, corn starch, talc, magnesium stearate, stearic acid, microcrystalline cellulose, sodium croscarmellose;
  Coating (Opadry II Pink): lactose monohydrate, hypromellose, macrogol 4000, quinoline yellow (E 104), erythrosine (E 127), and titanium dioxide (E 171).

What Solpadeine FORTE Tabs looks like and contents of the pack
Solpadeine FORTE Tabs are red, capsule-shaped coated tablets, 15.8 mm x 8.4 mm in size, packed in PVC/aluminum blisters within a cardboard box.
Pack sizes: 6, 10, 12, 16 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
tel.: +48 (22) 852 55 51
Manufacturer
Swiss Caps GmbH
Grassingerstrasse 9
83043 Bad Aibling (Bavaria)
Germany
This medicinal product is authorised in the European Economic Area under the following names: