Solpadeine

Package leaflet: Information for the user

SOLPADEINE
500 mg + 8 mg + 30 mg, tablets
Paracetamolum + Codeini phosphas + Coffeinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What Solpadeine is and what it is used for

Solpadeine contains three active substances: paracetamol, codeine phosphate, and caffeine. Its therapeutic effect results from the combined action of these active ingredients.
Paracetamol has analgesic and antipyretic properties.
Caffeine has a stimulant effect on the central nervous system and enhances the analgesic effect of paracetamol.
Codeine has analgesic and antitussive properties. 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.
The onset of action occurs between 30 and 60 minutes after ingestion, and the total duration of action lasts up to 4 hours.
If there is no improvement after 3 days, or if you feel worse, you should consult your doctor.
Indications for Solpadeine:
Headache, migraine, painful menstruation, toothache, neuralgia, rheumatic pain, sore throat, symptoms of influenza and cold, fever.
Due to its codeine content, Solpadeine may be used in adolescents aged 12 years and older for short-term relief of moderate pain that has not responded to other analgesics such as paracetamol or ibuprofen used as monotherapy (see also "When not to take Solpadeine" in section 2).

2. Important information before using Solpadeine

When not to use Solpadeine

• if the patient is allergic to paracetamol, caffeine, codeine, other opioid painkillers, or any of the other ingredients of this medicine (listed in section 6),
• in patients with alcoholism,
• in patients with severe liver or kidney impairment,
• in patients with respiratory insufficiency or respiratory depression,
• in patients with bronchial asthma,
• in patients suffering from chronic constipation,
• in children under 12 years of age,
• in children and adolescents (under 18 years of age) following tonsillectomy or adenoidectomy due to obstructive sleep apnoea syndrome,
• in patients who are ultra-rapid metabolisers of codeine to morphine,
• in pregnant women,
• if the patient is breastfeeding,
• in patients taking MAO inhibitors or within 2 weeks of discontinuing them,
• in opioid-dependent patients.

Warnings and precautions
This medicine contains codeine, which may lead to dependence (see section 4 of the leaflet).
The medicine should be used at the lowest effective dose and for the shortest duration necessary to relieve symptoms.
If the patient feels the need to use the medicine continuously, they should contact their doctor as soon as possible.
If symptoms persist or worsen, medical advice should be sought.
Do not use other products containing paracetamol or codeine while taking this product.
Before starting Solpadeine, discuss with your doctor or pharmacist if the patient has:

• hypotension,
• liver or kidney impairment,
• Gilbert's syndrome (familial non-haemolytic jaundice),
• concomitant use of other medicines affecting liver function,
• haemolytic anaemia,
• dehydration,
• chronic malnutrition,
• asthma and is also taking acetylsalicylic acid (cross-reactions have been observed),
• elderly, adult, or adolescent patients with body weight below 50 kg,
• use of central nervous system depressants,
• respiratory function disorders,
• head injury or increased intracranial pressure,
• benign prostatic hyperplasia or urinary retention,
• hypothyroidism,
• adrenal insufficiency,
• acute abdominal symptoms,
• inflammatory or obstructive intestinal disorders,
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
• biliary tract diseases (gallstones) or following biliary tract surgery,
• glutathione deficiency,
• if the patient is or has ever been dependent on opioids, alcohol, prescription medicines, or illegal substances.

Regular and long-term use of codeine (an active ingredient in this medicine) may lead to dependence and misuse, which may result in overdose and/or death. Do not use this medicine longer than necessary. Do not pass this medicine on to others.
Long-term use of various types of painkillers for headache may worsen headache. If this occurs or is suspected, seek medical advice and discontinue treatment. Medication-overuse headache should be suspected in patients with frequent or daily headaches despite regular (or because of regular) use of painkillers.
In patients who have undergone cholecystectomy, codeine may cause acute abdominal pain related to the biliary tract or pancreas, usually accompanied by abnormal laboratory test results.
Codeine is metabolised to morphine in the liver by an enzyme. Morphine is the substance responsible for codeine's effect, relieving pain and cough. Some individuals have a variant of this enzyme, leading to different responses. In some people, morphine is not formed or is formed in very small amounts, resulting in insufficient analgesic or antitussive effect. In others, high levels of morphine may form, increasing the risk of severe adverse reactions. If any of the following adverse effects occur, stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.
Laboratory tests
Paracetamol use may cause false results in certain laboratory tests (e.g. blood glucose measurement).
During treatment with Solpadeine, inform your doctor immediately if the patient has severe medical conditions, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or is also taking flucloxacillin (an antibiotic). In these situations, patients taking paracetamol regularly for a prolonged period or taking paracetamol with flucloxacillin have developed a serious condition called metabolic acidosis (abnormality in blood and body fluids). Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Children and adolescents (see also "When not to use Solpadeine" and section 3)
Adolescents over 12 years of age
Solpadeine is not recommended in adolescents with respiratory function disorders for the treatment of cold symptoms.
Solpadeine and other medicines
Consult your doctor if taking the following medicines:

• metoclopramide, domperidone (used against nausea and vomiting),
• cholestyramine (used to reduce high blood cholesterol levels),
• anticoagulants (e.g. warfarin) if long-term painkiller use is required,
• sedatives such as sleeping pills, tranquilisers, tricyclic antidepressants, antipsychotics (phenothiazines), alcohol,
• antiepileptic medicines,
• rifampicin (an antituberculosis medicine),
• MAO inhibitors (used in depression treatment),
• probenecid (a diuretic),
• oestrogens and progesterone (sex hormones),
• lithium salts (used, among others, in depression and mania),
• disulfiram (used, among others, in alcoholism treatment),
• non-steroidal anti-inflammatory drugs (including acetylsalicylic acid).

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

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

Although there is no clinically significant evidence, consider the possibility of paracetamol affecting the action of chloramphenicol when both medicines are administered simultaneously, especially in malnourished patients.
Codeine enhances the respiratory depressant effect of other opioid painkillers.
Concomitant use with medicines causing dry mouth or blurred vision (anticholinergic drugs such as atropine) may lead to paralytic ileus.
Concomitant use of Solpadeine with sedatives such as benzodiazepines or their derivatives increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered if no other treatment options are available.
Nevertheless, if your doctor prescribes Solpadeine together with sedatives, the dose and duration of combined treatment should be limited by the doctor.
The patient should inform their doctor about all sedative medicines they are taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family about the symptoms listed above. If these symptoms occur, contact a doctor immediately.
Caffeine may reduce the effect of sleeping pills and tranquilisers.
Use of Solpadeine with food, drink, and alcohol
Avoid excessive intake of caffeine (e.g. in coffee, tea, or certain drinks) while taking this medicine.
Excessive consumption of coffee or tea during treatment may cause feelings of tension and irritability.
Do not drink alcohol while taking this medicine due to increased risk of liver damage and enhanced effects of codeine. The risk of liver damage is particularly high in fasting patients and those who regularly consume alcohol.
Pregnancy, breastfeeding, and effects on fertility
Solpadeine is contraindicated in pregnant women due to its content of codeine and caffeine.
Solpadeine is contraindicated during breastfeeding. Codeine and morphine pass into breast milk.
There are no available data on the effect of Solpadeine on female fertility (see also "When not to use Solpadeine" in section 2).
Driving and using machines
This medicine may cause dizziness and drowsiness. If these symptoms occur, do not drive or operate machinery.

3. How to take Solpadeine

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine should be taken at the lowest effective dose for the shortest possible duration. Do not exceed the recommended daily dose or the specified number of doses.
Do not take a higher dose than recommended.
Do not take this medicine for longer than 3 days. If pain persists after 3 days, consult your doctor.
Do not take other medicines containing paracetamol, codeine, or caffeine at the same time.

Dosage:
For oral use only.

Adults:
Orally, 1–2 tablets, up to 4 times daily. Do not take the medicine more frequently than every 4–6 hours, or take more than 8 tablets in 24 hours.

Adolescents aged 16–18 years:
Take 1–2 tablets every 6 hours, up to a maximum daily dose of 8 tablets (4000 mg paracetamol, 64 mg codeine, and 240 mg caffeine).

Adolescents aged 12–15 years:
Take 1 tablet every 6 hours, up to a maximum daily dose of 4 tablets (2000 mg paracetamol, 32 mg codeine, and 120 mg caffeine).

Children under 12 years of age:
Solpadeine should not be used in children under 12 years of age due to the presence of codeine, because of the risk of opioid toxicity related to variable and unpredictable metabolism of codeine to morphine.
Solpadeine is contraindicated in children under 12 years of age for symptomatic treatment of cold and flu due to the risk of severe respiratory depression.
(see also “When not to take Solpadeine” and “Children and adolescents” in section 2).

Elderly patients:
Elderly patients, especially those who are frail or immobile, may require a reduced dose of Solpadeine tablets or less frequent dosing.

Renal impairment:
Patients with diagnosed renal impairment should seek medical advice before taking this medicine. When administering paracetamol to patients with renal impairment, it is recommended to reduce the dose and extend the minimum interval between doses to at least 6 hours. Restrictions on the use of paracetamol-containing products in patients with renal impairment are primarily due to the paracetamol content of the medicine (see “Warnings and precautions” in section 2).

Hepatic impairment:
Patients with diagnosed hepatic impairment or Gilbert’s syndrome should seek medical advice before taking this medicine. Restrictions on the use of paracetamol-containing products in patients with hepatic impairment are primarily due to the paracetamol content of the medicine (see “Warnings and precautions” in section 2).

Taking more Solpadeine than recommended
If you take more Solpadeine than you should, seek medical advice immediately, even if you feel well. Overdose can cause irreversible liver damage and respiratory depression.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The medicine may cause constipation.
You should immediately stop using the medicine and consult a doctor if any of the following occur:

• acute abdominal pain, nausea and vomiting in people who have had their gallbladder removed, which may be a sign of acute pancreatitis (frequency unknown),
• allergic reaction (hypersensitivity) such as: skin rash or itching, sweating, redness, urticaria, angioedema (swelling of lips, tongue, throat or face), difficulty breathing,
• anaphylactic reaction – life-threatening inadequate blood flow to organs due to hypersensitivity, manifesting as dizziness, disorientation and fainting,
• agranulocytosis – significant decrease in white blood cell count, increasing the risk of life-threatening infections,
• toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, manifesting as blisters and erosions on the skin, in the mouth, eyes and genital organs, fever and joint pain, or rupturing large blisters, extensive skin erosions, peeling of large skin sheets, and fever, acute generalized exanthematous pustulosis,
• breathing difficulties, especially if similar problems occurred previously during use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• bruises or unexplained bleeding,
• liver function disorders manifesting as nausea, sudden weight loss, loss of appetite, jaundice (yellowing of the skin and whites of the eyes),
• signs of dependence such as anxiety and irritability, feeling the need to continuously use the medicine and increasing the dose after prolonged regular use (frequency unknown).

Use of Solpadeine may cause the following:
Rarely (more than 1 in 10,000 patients but not less than 1 in 1,000 patients):

• allergy (without angioedema)

Very rarely (less than 1 in 10,000 patients):

• difficulty urinating
• anaphylaxis
• bronchospasm in patients hypersensitive to aspirin and other NSAIDs
• liver function disorders
• skin hypersensitivity reactions including skin rashes, itching, sweating, purpura, urticaria and angioedema; cases of serious skin reactions; toxic epidermal necrolysis, drug-induced skin inflammation, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis
• sterile pyuria (cloudy urine)
• thrombocytopenia

Frequency unknown (frequency cannot be estimated from available data):

• nervousness
• dizziness
• constipation, nausea, vomiting, dyspepsia
• dry mouth
• acute pancreatitis in patients with a history of cholecystectomy (gallbladder removal)
• worsening of headache with prolonged use
• drowsiness
• difficulty urinating
• with prolonged use of higher doses of codeine, drug dependence may occur
• serious condition which may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Consumption of coffee or tea while taking this medicine may cause tension, irritability,
insomnia, anxiety, headache, stomach and intestinal disturbances, unusually rapid or irregular
heartbeat.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Solpadeine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Solpadeine contains

• The active substances in Solpadeine are: paracetamol, codeine and caffeine. Each tablet contains 500 mg of paracetamol, 8 mg of codeine phosphate and 30 mg of caffeine.
• Other ingredients: magnesium stearate, maize starch, pregelatinized starch, potassium sorbate, povidone, talc, microcrystalline cellulose, stearic acid.

What Solpadeine looks like and contents of the pack
Solpadeine is a white, elongated tablet.
The pack contains 12 or 24 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
tel.: +48 (22) 852 55 51
Manufacturer
GlaxoSmithKline Dungarvan Ltd.
Knockbrack
Dungarvan
Co. Waterford
Ireland
Swiss Caps GmbH
Grassingerstrabe 9
83043 Bad Aibling
Germany