Solpadeine Max

Leaflet accompanying the packaging: Information for the user

Solpadeine Max, 500 mg + 30 mg + 12.8 mg, effervescent tablets

Paracetamol + Caffeine + Codeine phosphate hemihydrate

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

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

This medicine should always be taken exactly as described in this patient leaflet, or according to the doctor's or pharmacist's instructions.

• You should keep this leaflet, so you can read it again if you need to.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should consult a doctor.

Table of contents of the leaflet

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

1. What is Solpadeine Max and what is it used for

Solpadeine Max can 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 pain relievers, such as those containing paracetamol, ibuprofen, or acetylsalicylic acid alone.

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

The tablets contain three active substances: paracetamol, codeine, and caffeine. Codeine and paracetamol are pain relievers. Codeine belongs to a group of pain relievers called opioids, which can be used alone or in combination with other pain relievers. Caffeine enhances the effectiveness of paracetamol. Due to the triple mechanism of action of the ingredients, it is possible to quickly relieve moderate pain.

2. Important information before taking Solpadeine Max

• This medicine contains codeine, which can cause dependence if used continuously for more than 3 days. Withdrawal symptoms may then occur after stopping the medicine.
• Taking this medicine for headaches for more than 3 days can worsen them.

When not to use Solpadeine Max:

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

Before taking Solpadeine Max, consult a doctor or pharmacist:

intolerance to some sugars, glucose-6-phosphate dehydrogenase deficiency, or glutathione deficiency
• in elderly patients, it may be necessary to reduce the dose. In this case, you should consult a doctor or pharmacist

Warnings and precautions

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

Before using, 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.

Before starting to take Solpadeine Max, discuss it with a doctor or pharmacist:

Children and adolescents

Do not give this medicine to children under 12 years of age.

Use in children and adolescents after surgical procedures: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 worsen in these children.

Solpadeine Max and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, 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 taken in the last 2 weeks or sedating substances (e.g., sedatives, antidepressants, or alcohol).

Concomitant use of Solpadeine Max and sedating medicines (e.g., benzodiazepines or derivatives) increases the risk of drowsiness, breathing difficulties (respiratory depression), or coma, which can be life-threatening. Therefore, combination therapy should only be considered when other treatment options are not available.

If Solpadeine Max is used with other sedating medicines, the doctor should limit the dose and duration of concomitant use.

The patient should tell their doctor about all sedating medicines they are taking and strictly follow the prescribed dose. 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

If the patient is pregnant, they should consult a doctor before taking Solpadeine Max.

Do not take Solpadeine Max while breastfeeding. Codeine and morphine pass into breast milk.

Driving and using machines

Do not drive or operate machinery while taking Solpadeine Max, as it can cause dizziness or excessive drowsiness.

Solpadeine Max contains sodium

The maximum recommended daily dose of this medicinal product (8 tablets) contains 3416 mg of sodium (found in salt). This corresponds to 171% of the recommended maximum daily sodium intake for an adult. Consult a doctor or pharmacist if the patient needs to use Solpadeine Max daily for an extended period, especially if a low-salt diet has been prescribed.

Solpadeine Max contains sorbitol (E420)

This medicine contains 50 mg of sorbitol in each tablet.

Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine or giving it to their child.

3. How to take Solpadeine Max

This medicine should always be taken exactly as described in this patient leaflet, or according to the doctor's or pharmacist's instructions.

In case of doubt, consult a doctor or pharmacist.

Adults:

1 to 2 tablets should be dissolved in at least half a glass of water (200 ml). The medicine should be taken every 4 to 6 hours, if necessary.

• Do not take more frequently than every 4 hours.
• Do not take more than 8 tablets in 24 hours (which is equivalent to 4 g of paracetamol, 102.4 mg of codeine phosphate hemihydrate, and 240 mg of caffeine).

Elderly:

In elderly patients, debilitated, or bedridden patients, it may be necessary to reduce the dose.

Renal impairment:

When administering paracetamol to patients with renal failure, it is recommended to reduce the dose and increase the minimum interval between each administration to at least 6 hours.

Adults:

Hepatic impairment:

In patients with hepatic impairment or Gilbert's syndrome, the dose should be reduced or the interval between doses extended.

Adolescents 16 to 18 years old:

1 or 2 tablets should be dissolved in at least half a glass of water (200 ml). The medicine should be taken every 6 hours, if necessary.

• Do not take more frequently than every 6 hours.
• Do 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 and 240 mg of caffeine).

Adolescents 12 to 15 years old:

1 tablet should be dissolved in at least half a glass of water (200 ml). The medicine should be taken every 6 hours, if necessary.

• Do not take more frequently than every 6 hours.
• Do 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 and 120 mg of caffeine).
• Do not exceed the recommended dose.

In the following cases, the maximum dose of paracetamol should not exceed 2 g in 24 hours, unless otherwise advised by a doctor:

Avoid consuming too much caffeine in beverages such as coffee and tea. High caffeine intake can cause sleep problems, tremors, and discomfort in the chest.

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

Use in children and adolescents under 12 years of age.

Solpadeine Max should not be used in patients under 12 years of age due to the risk of severe breathing difficulties.

Withdrawal effects

This medicine contains codeine and can cause dependence if used continuously for more than 3 days. Withdrawal symptoms may occur after stopping the medicine.

If the symptoms do not resolve or the headache does not go away, consult a doctor.

Taking a higher dose of Solpadeine Max than recommended

Consult a doctor immediately if too much of this medicine has been taken, even if the patient feels well. This is because an overdose of paracetamol can cause delayed, severe liver damage.

Missing a dose of Solpadeine Max

Do not take a double dose to make up for a missed dose.

If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Stop taking the medicine and immediately inform your doctor if you experience any of the following symptoms:

• dry mouth, nausea, and vomiting, if the patient has recently had their gallbladder removed
• 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, or peeling skin
• breathing difficulties. These symptoms are more likely if the patient has previously experienced them when taking other pain relievers, 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

• nervousness and dizziness
• constipation

Very rare cases of severe skin reactions have been reported.

How can the patient know if they are addicted?

If the medicine is taken as directed, the likelihood of addiction is very low. However, in the following situations, it is essential to talk to a doctor.

• If the patient needs to take the medicine for a long time.
• If the patient needs to take a higher dose than recommended.
• If the patient feels unwell after stopping the medicine but feels better after taking it again.

Reporting side effects

If side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel. +48 22 49 21 301, fax: +48 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, you can help provide more information on the safety of this medicine.

5. How to store Solpadeine Max

Keep the medicine out of the sight and reach of children.

Do not store above 25°C.

Store in the original packaging to protect the product from moisture.

Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Solpadeine Max contains

• The active substances of the medicine are paracetamol, caffeine, and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol, 30 mg of caffeine, and 12.8 mg of codeine phosphate hemihydrate
• The other ingredients are: sorbitol (E420), sodium saccharin, sodium bicarbonate, sodium lauryl sulfate, anhydrous citric acid, anhydrous sodium carbonate, povidone K-25, and dimethicone 350

What Solpadeine Max looks like and contents of the pack

Solpadeine Max is available in the form of white tablets with beveled edges

The line on the tablet is not intended for dividing into equal doses.

Package sizes: 8, 10, 12, or 16 tablets.

Not all package sizes may be marketed.

Marketing authorization holder:

Perrigo Poland Sp. z o.o.

Al. Niepodległości 18

02-653 Warszawa

tel. (22) 489 54 51

Manufacturer

GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland

Swiss Caps GmbH, Grassingerstrasse 9, 83043 Bad Aibling, 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: November 2022