Solpadeine Forte Tabs

Leaflet attached to the packaging: Information for the user

Solpadeine FORTE Tabs

500 mg + 12.8 mg, coated tablets

Paracetamol + Codeine phosphate hemihydrate

• This medicine is intended for short-term treatment of moderate acute pain in cases where other painkillers have not been effective.
• This medicine should be taken for a maximum of 3 days in a row. If it is necessary to use this medicine continuously for more than 3 days, you should consult a doctor or pharmacist.
• This medicine contains codeine, which can cause dependence if taken continuously for more than 3 days. Withdrawal symptoms may then occur after stopping the medicine.
• If this medicine is used to relieve headache pain for more than 3 days, the headache may worsen.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet so that you can read it again if necessary.
• If advice or additional information is needed, you should consult a pharmacist.
• If any side effects occur, you should consult a doctor or pharmacist. This applies to all possible side effects not listed in this leaflet. See section 4.
• If there is no improvement or the patient feels worse, you should consult a doctor.

Table of contents of the leaflet

• 1. What is Solpadeine FORTE Tabs and what is it 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 packaging and other information

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

Solpadeine FORTE Tabs may be used in patients over 12 years of age for the short-term relief of moderate pain that requires a stronger analgesic effect than observed with other painkillers, such as those containing paracetamol, ibuprofen, or acetylsalicylic acid alone.

It may be used to treat headache, migraine with or without aura, toothache (including pain after tooth extraction), painful menstruation, back pain, muscle pain, neuralgia, bone and joint pain associated with arthritis and rheumatism, pain associated with injuries due to overexertion and sprains, and sciatica.

The tablets contain two active ingredients: paracetamol and codeine. Codeine and paracetamol are painkillers. 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 the ingredients, it is possible to quickly relieve moderate pain.

2. Important information before taking Solpadeine FORTE Tabs

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

When not to use Solpadeine FORTE Tabs:

• for pain relief in children and adolescents (0-18 years) after tonsillectomy or adenoidectomy performed due to obstructive sleep apnea

Before taking the medicine, you should consult a doctor:

Warnings and precautions

Codeine is converted to morphine by a certain liver enzyme. 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 consult a doctor immediately: slow or shallow breathing, disorientation, drowsiness, small pupils, nausea or vomiting, constipation, loss of appetite.

Taking codeine (the active substance of this medicine) regularly and for a long time can lead to dependence and misuse, which can cause overdose and/or death. This medicine should not be taken for longer than necessary. It should not be given to other people.

Before using, you should consult a doctor if the patient has liver or kidney problems, is underweight (<50kg), is malnourished, or regularly drinks alcohol, as this may increase the risk of liver damage. It may be necessary to reduce the amount of paracetamol taken or completely avoid using this product.

If the patient experiences severe illnesses, including severe kidney problems or sepsis (when bacteria and their toxins are in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or is taking flucloxacillin (an antibiotic), they should consult a doctor. In these situations, patients taking paracetamol regularly for a long time or taking paracetamol with flucloxacillin have reported a serious condition called metabolic acidosis (a blood and body fluid disorder), which must be treated urgently (see section 2). Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling sick (nausea) and vomiting.

Children and adolescents

This medicine should not be given to children under 12 years of age.

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 due to obstructive sleep apnea.

Use in children with breathing difficulties:

Codeine is not recommended for children with breathing difficulties, as symptoms of morphine toxicity may be exacerbated in these children.

Solpadeine FORTE Tabs and other medicines

You should 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 that cause drowsiness (e.g., sedatives, antidepressants, or alcohol).

If the patient is taking blood-thinning medicines (e.g., warfarin and coumarin derivatives) and needs to take a painkiller every day, they should talk to a doctor about the risk of bleeding, but may still take occasional doses of Solpadeine FORTE Tabs with blood-thinning medicines. If the patient is taking probenecid, they should talk to a doctor, as it may be necessary to reduce the dose of Solpadeine FORTE Tabs.

Paracetamol and other medicines

The patient should inform their doctor or pharmacist if they are taking:

• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Taking Solpadeine FORTE Tabs and sedative medicines (e.g., benzodiazepines or derivatives) at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), or coma, which can be life-threatening. Therefore, combined treatment should only be considered when other treatment options are not available.

If Solpadeine FORTE Tabs are taken with other sedative medicines, the doctor should limit the dose and duration of concurrent use.

The patient should tell their doctor about all sedative medicines they are taking and strictly follow the dose prescribed by the doctor. It may be helpful to inform a relative or close friend of the patient about the possibility of the above symptoms. If these symptoms occur, the patient should consult a doctor.

Pregnancy and breastfeeding

Unless otherwise directed by a doctor, Solpadeine FORTE Tabs should be avoided during pregnancy.

Solpadeine FORTE Tabs should not be taken during breastfeeding. Codeine and morphine pass into breast milk.

Driving and using machines

If the patient feels dizzy or excessively drowsy 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 some sugars, they should consult a doctor before taking the medicine.

Solpadeine FORTE Tabs contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means 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 leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult a doctor or pharmacist.

Adults:

2 tablets with water. The medicine should be taken every 4 to 6 hours, as needed.

• The medicine should not be taken more often than every 4 to 6 hours.
• The patient should not take more than 8 tablets in 24 hours (which is equivalent to 4 g of paracetamol and 102.4 mg of codeine phosphate hemihydrate).

Elderly:

In elderly, frail, or bedridden patients, the dose may need to be reduced.

Kidney problems:

When giving paracetamol to patients with kidney failure, the dose should be reduced and the minimum interval between each administration should be at least 6 hours.

Adults:

Liver problems:

In patients with liver problems or Gilbert's syndrome, the dose should be reduced or the interval between doses prolonged.

Adolescents 16-18 years:

2 tablets with water. The medicine should be taken every 6 hours, as needed.

• The medicine should not be taken more often than every 6 hours.
• The patient should not take more than 8 tablets in 24 hours (which is equivalent to 4 g of paracetamol and 102.4 mg of codeine phosphate hemihydrate).

Adolescents 12-15 years:

1 tablet with water and take every 6 hours, as needed.

• The medicine should not be taken more often than every 6 hours.
• The patient should not take more than 4 tablets in 24 hours (which is equivalent to 2 g of paracetamol and 51.2 mg of codeine phosphate hemihydrate).
• The patient should not take a higher dose than recommended.

In the following cases, the maximum dose of paracetamol should not exceed 2 g in

24 hours unless otherwise directed by a doctor:

• If the patient is elderly or an adult or adolescent with a 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 has chronic alcoholism, is malnourished, or dehydrated

This medicine should not be used for longer than 3 days. If the pain does not decrease after 3 days, the patient should consult a doctor.

In case of doubt, the patient should consult a doctor.

Use in children and adolescents under 12 years of age.

Solpadeine FORTE Tabs is not recommended for patients under 12 years of age due to the risk of severe breathing difficulties.

Withdrawal symptoms

This medicine contains codeine and may cause dependence if taken continuously for more than 3 days. After stopping the medicine, withdrawal symptoms may occur.

If the symptoms do not go away or the headache does not improve, the patient should consult a doctor.

Taking a higher dose of Solpadeine FORTE Tabs than recommended

The patient should immediately talk to a doctor if they have taken too much of this medicine, even if they feel well. This is because too much paracetamol can cause delayed and severe liver damage.

Missing a dose of Solpadeine FORTE Tabs

The patient should not take a double dose to make up for a missed dose.

If the patient has any further doubts about the use of this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking the medicine and immediately inform their doctor if they experience any of the following symptoms:

• dry mouth, nausea, and vomiting after recent gallbladder surgery
• acute pancreatitis (inflammation of the pancreas), which can cause severe stomach pain
• allergic reactions, which can be severe and take the form of a skin rash or mouth ulcers, sometimes with flu-like symptoms or itching, sometimes with swelling of the mouth or face or shortness of breath, peeling skin
• 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 urinating
• cloudy urine

Other side effects:

• constipation

Very rare cases of severe skin reactions have been reported.

Frequency of occurrence: "frequency not known" (cannot be estimated from the available data)

A serious condition that can cause acidification of the blood (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

How do I know if I am addicted?

When taking the medicine as directed on the packaging, the risk of dependence on the medicine is very low. However, in the following situations, it is important to talk to a doctor:

Reporting side effects

If the patient experiences any side effects, they should consult a doctor or pharmacist. This applies to all possible side effects not listed in this leaflet.

Side effects can also be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Solpadeine FORTE Tabs

The medicine should be stored 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 carton after EXP. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Solpadeine FORTE Tabs contains

• The active substances of the medicine are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol and 12.8 mg of codeine phosphate hemihydrate.
• Other ingredients of the medicine:
• Core:maize starch, corn starch; 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, film-coated tablets in the shape of capsules, measuring 15.8 mm x 8.4 mm, packaged in a blister pack of PVC/Aluminum, in a cardboard box.

Package sizes: 6, 10, 12, 16 tablets

Not all package sizes may be marketed.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: January 2025