Solpadeine

Package leaflet: Information for the user

SOLPADEINE
500 mg + 8 mg + 30 mg, effervescent tablets
Paracetamolum + Codeini phosphas + Coffeinum
Please read the entire leaflet carefully before taking this 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
your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, 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 the patient feels worse, consult a 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 stimulating 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 15 and 30 minutes after administration, and the total duration of action is up to 4 hours.
If there is no improvement after 3 days, or if the patient feels worse, medical advice should be sought.
Indications for Solpadeine:
Headache, migraine, painful menstruation, toothache, neuralgia, rheumatic pain, sore throat, symptoms of influenza and common 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 not relieved by other analgesics such as paracetamol or ibuprofen used as monotherapy (see also "When not to use Solpadeine" in section 2).

2. 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) after tonsillectomy or adenoidectomy due to obstructive sleep apnoea syndrome,
• in patients who are ultra-rapid metabolisers of codeine to morphine,
• in pregnant women,
• in breastfeeding women,
• in patients taking MAO inhibitors and within 2 weeks after their discontinuation,
• in patients dependent on opioids.

Warnings and precautions
This medicine contains codeine, which may cause 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. Patients who feel a continuous need to take the medicine 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 you have:

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

Regular and long-term use of codeine (an active ingredient of 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.
Long-term use of various types of painkillers for headache may worsen headache. If this occurs or is suspected, medical advice should be sought and treatment discontinued. Medication overuse headache should be suspected in patients with frequent or daily headaches despite regular (or due to such) use of analgesics.
In patients after cholecystectomy, codeine may cause acute abdominal pain related to the biliary tract or pancreas, usually accompanied by abnormal laboratory results.
Codeine is metabolised to morphine in the liver by an enzyme. Morphine is the substance responsible for the effect of codeine, 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, large amounts of morphine are produced, increasing the risk of severe adverse effects. If any of the following adverse effects occur, discontinue use of this medicine and seek immediate medical advice: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, 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 you develop serious conditions, including severe kidney dysfunction or sepsis (bacteria and their toxins circulating in the blood leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In these situations, patients taking regular doses of paracetamol for prolonged periods or paracetamol together 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, 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 disorders for the treatment of colds.
Solpadeine with other medicines
Consult your doctor if you are taking any of the following medicines:

• metoclopramide, domperidone (used for nausea and vomiting),
• cholestyramine (used to reduce high blood cholesterol levels),
• anticoagulants (e.g. warfarin) if long-term pain relief is needed,
• sedating medicines such as sleeping tablets, sedatives, tricyclic antidepressants, antipsychotics of the phenothiazine group, alcohol,
• antiepileptic medicines,
• rifampicin (an antituberculosis medicine),
• MAO inhibitors (used in the treatment of depression),
• probenecid (a uricosuric diuretic),
• oestrogens and progesterone (sex hormones),
• lithium salts (used, among others, in depression and mania),
• disulfiram (used, among others, in the treatment of alcoholism),
• non-steroidal anti-inflammatory drugs (including acetylsalicylic acid).

Paracetamol and other medicines
Inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to the 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 analgesics.
Concomitant use with certain medicines causing dry mouth or blurred vision (anticholinergics such as atropine) may lead to paralytic ileus.
Concomitant use of Solpadeine and 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 concomitant treatment should be limited by the doctor.
The patient should inform the doctor about all sedatives being taken and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or family about the symptoms listed above. If these symptoms occur, contact the doctor immediately without delay.
Caffeine may reduce the effect of sleeping tablets and sedatives.
Use of Solpadeine with food, drink and alcohol
Avoid excessive intake of caffeine (e.g. contained in coffee, tea or certain beverages) while taking this medicine.
Excessive consumption of coffee or tea during treatment may cause nervousness and irritability.
Do not drink alcohol while taking this medicine due to increased risk of liver damage and enhanced effect of codeine. The risk of liver damage is particularly high in fasting patients and those who regularly consume alcohol.
Pregnancy, breastfeeding and 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 operating machinery
This medicine may cause dizziness and drowsiness. If such symptoms occur, do not drive or operate machinery.
Each soluble tablet contains 427 mg of sodium (the main component of table salt), equivalent to 21% of the maximum recommended daily dietary intake of sodium for adults.
Each tablet contains 50 mg of sorbitol (E 420), corresponding to 1.60% of the tablet's mass. The additive effect of simultaneously administered products containing fructose (or sorbitol) and food containing fructose (or sorbitol) should be considered. Sorbitol contained in this medicinal product may affect the bioavailability of other medicinal products administered simultaneously by the oral route.

3. How to take Solpadeine

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a
doctor
or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine should be used 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 a doctor.
Do not take other medicines containing paracetamol, codeine or caffeine at the same time.
The tablet should be dissolved in a glass of water.

Dosage:
For oral use only.

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

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

Adolescents aged 12–15 years:
Take 1 effervescent tablet every 6 hours, up to a maximum daily dose of 4 effervescent 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 risk of opioid toxicity associated with the variable and unpredictable metabolism of codeine to morphine.
Solpadeine is contraindicated in children under 12 years of age for symptomatic treatment of cold 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 frail or immobile individuals, may require a reduced dose of Solpadeine effervescent 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 failure, dose reduction and extension of the minimum interval between doses to at least 6 hours are recommended. 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 recommended, seek medical advice immediately, even if you feel well. Overdose can cause irreversible liver damage and respiratory disturbances.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The medicine may cause constipation.
You should stop taking the medicine immediately and consult a doctor if any of the following occur:

• acute abdominal pain, nausea and vomiting in patients who have had their gallbladder removed, which may indicate acute pancreatitis (frequency unknown),
• allergic reactions such as skin rash or itching, sweating, flushing, urticaria, angioedema (swelling of lips, tongue, throat or face), breathing difficulties,
• anaphylactic reaction – a life-threatening inadequate blood flow to organs caused by hypersensitivity, manifesting as dizziness, disorientation and fainting,
• agranulocytosis – a significant decrease in white blood cells, increasing the risk of life-threatening infections,
• toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, presenting 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, shedding of large epidermal sheets, and fever, acute generalized exanthematous pustulosis,
• breathing problems, especially if similar problems occurred previously when using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• bruising or unexplained bleeding,
• liver function disorders, presenting 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 take 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 more than 1 in 1,000 patients):

• allergic reactions (without angioedema)

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

• difficulty in urination
• 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 not known (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 in urination,
• with prolonged use of codeine at higher doses, dependence on the medicine may occur,
• a serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Consuming coffee or tea while taking this medicine may cause tension, irritability,
insomnia, anxiety, headache, gastrointestinal disturbances, unusually rapid heartbeat or irregular heart rhythm.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can 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

Keep the 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Solpadeine contains

• The active substances in this medicine are: paracetamol, codeine, and caffeine. One effervescent tablet contains 500 mg paracetamol, 8 mg codeine phosphate, and 30 mg caffeine.
• Other ingredients are: sorbitol powder, sodium saccharin, sodium hydrogen carbonate, povidone, sodium lauryl sulfate, dimethicone, anhydrous citric acid, anhydrous sodium carbonate.

What Solpadeine looks like and contents of the pack
Solpadeine is a white, flat tablet with a break line on one side.
Pack sizes contain 12 or 24 effervescent 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