Solpadeine

Leaflet accompanying the packaging: information for the user

SOLPADEINE

500 mg + 8 mg + 30 mg, capsules
Paracetamol + Codeine phosphate + Caffeine

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 used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Solpadeine and what is it used for

Solpadeine contains three active substances: paracetamol, codeine, and caffeine. Its therapeutic effect is the result of the combined action of the active substances.
Paracetamol has analgesic and antipyretic effects.
Caffeine has a stimulating effect on the central nervous system and enhances the analgesic effect of paracetamol.
Codeine has analgesic and antitussive effects. Codeine belongs to a group of medicines called opioid analgesics, which relieve pain. It can be used alone or in combination with other analgesics, such as paracetamol.
The onset of action of the medicine occurs within 30 to 60 minutes after administration, and the total duration of action is up to 4 hours.
If after 3 days there is no improvement or the patient feels worse, they should consult their doctor.

Indications for use of Solpadeine:

Headaches, migraines, painful menstruation, toothaches, neuralgia, rheumatic pains, sore throats, flu and cold symptoms, fever.
Solpadeine, due to the presence of codeine, can be used in adolescents over 12 years of age for short-term relief of moderate pain that has not responded to other analgesics, such as paracetamol or ibuprofen used alone (see also "When not to use Solpadeine" in section 2).

2. Important information before taking Solpadeine

When not to use Solpadeine

• if the patient is allergic to paracetamol, caffeine, codeine, other opioid analgesics, or any of the other ingredients of this medicine (listed in section 6),
• in people with alcoholism,
• in people with severe liver or kidney failure,
• in people with respiratory failure and depression,
• in people with asthma,
• in people 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 apnea syndrome,
• in people who are ultra-rapid metabolizers of codeine to morphine,
• in pregnant women
• if the patient is breastfeeding,
• in patients taking MAO inhibitors and for up to 2 weeks after their discontinuation,
• in patients addicted to opioids.

Warnings and precautions

The medicine contains codeine, which can cause dependence (see section 4 of the leaflet).
The medicine should be used in the lowest effective dose and for the shortest possible duration necessary to relieve symptoms. Patients who feel the need to continuously use the medicine should contact their doctor as soon as possible.
If symptoms persist or worsen, medical advice should be sought.
During treatment with this product, other products containing paracetamol or codeine should not be used.
Before starting treatment with Solpadeine, the patient should discuss it with their doctor or pharmacist in the following cases:

• hypotension,
• liver or kidney failure,
• Gilbert's syndrome (familial non-hemolytic jaundice),
• concomitant use of other medicines affecting liver function,
• hemolytic anemia,
• dehydration,
• chronic malnutrition,
• in patients with asthma and concomitantly using acetylsalicylic acid (cross-reactions have been observed),
• in elderly patients, adults, and adolescents with a body weight below 50 kg,
• using medicines that depress the central nervous system,
• respiratory function disorders,
• head injuries and increased intracranial pressure,
• prostatic hypertrophy or difficulty urinating,
• hypothyroidism,
• adrenal insufficiency,
• acute abdominal symptoms,
• inflammatory or obstructive bowel disease,
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
• bile duct diseases (cholelithiasis) and after surgical procedures in the bile ducts,
• glutathione deficiency
• if the patient is or has ever been addicted to opioids, alcohol, prescription drugs, or illegal substances

Taking codeine (an active substance in 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 used for longer than necessary. It should not be given to other people.
Long-term use of different types of painkillers for headaches can only make the headache worse. If such a situation occurs or is suspected, medical advice should be sought and treatment stopped. The diagnosis of drug abuse in headaches should be suspected in patients suffering from frequent or daily headaches despite regular use (or due to such use) of painkillers.
In patients after cholecystectomy (removal of the gallbladder), codeine may cause acute abdominal pain related to the bile ducts or pancreas, usually accompanied by laboratory abnormalities.
Codeine is converted to morphine in the liver with the participation of an enzyme. Morphine is the substance that determines the action of codeine and relieves pain and cough. In some people, there is a variation of this enzyme, which can cause different effects. In some people, morphine is not produced or is produced in very small amounts, and therefore will not have a sufficient analgesic or antitussive effect. In other people, it is more likely to occur severe side effects due to the large amounts of morphine produced. If the patient experiences any of the following side effects, they should stop using this medicine and seek medical attention immediately: slow or shallow breathing, disorientation, drowsiness, pupil constriction, nausea or vomiting, constipation, loss of appetite.
Lab tests
Taking paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).
During treatment with Solpadeine, the doctor should be informed immediately if the patient has severe diseases, including severe kidney or septicemia (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients taking paracetamol regularly for a longer period or taking paracetamol with flucloxacillin have been reported to develop a severe 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(see also "When not to use Solpadeine" and section 3)
Adolescents over 12 years of age
It is not recommended to use Solpadeine in adolescents with respiratory function disorders for the treatment of colds.

Solpadeine and other medicines

The patient should consult their doctor when taking the following medicines:

• metoclopramide, domperidone (used against nausea and vomiting),
• cholestyramine (used to reduce high cholesterol levels in the blood),
• anticoagulant medicines (e.g., warfarin) in case of necessary long-term
• use of painkillers,
• sedatives, such as benzodiazepines or their derivatives,
• antiepileptic drugs,
• rifampicin (an antitubercular drug),
• MAO inhibitors (used in the treatment of depression),
• probenecid (a diuretic),
• estrogens and progesterone (sex hormones),
• lithium salts (used, among other things, in depression, mania),
• disulfiram (used, among other things, in the treatment of alcoholism),
• nonsteroidal anti-inflammatory drugs (including acetylsalicylic acid)

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).

Although there is no significant clinical evidence, it should be considered that paracetamol may affect the action of chloramphenicol if both medicines are administered simultaneously, especially in malnourished patients.
Codeine enhances the inhibitory effect on the respiratory center of other opioid analgesics.
Concomitant use with certain medicines that cause dry mouth or blurred vision (cholinolytic agents, such as atropine) may cause paralytic ileus.
Concomitant use of Solpadeine and sedative medicines, such as benzodiazepines or their derivatives, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of these medicines should only be considered if there are no other treatment options.
However, if the doctor prescribes Solpadeine together with sedative medicines, the dose and duration of concomitant 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 instructions regarding the dose. It may be helpful to inform friends or family about the above symptoms. If these symptoms occur, the patient should contact their doctor immediately.
Caffeine may reduce the effect of sedative and sleep-inducing medicines.

Using Solpadeine with food, drink, and alcohol

During treatment with the medicine, the patient should avoid excessive consumption of caffeine (e.g., contained in coffee, tea, or some drinks).
Excessive consumption of coffee or tea during treatment with the medicine may cause a feeling of tension and irritability.
During treatment with the medicine, the patient should not drink alcohol due to the increased risk of liver damage and enhanced codeine effect. There is a particular risk of liver damage in patients who are fasting and regularly drink alcohol.

Pregnancy, breastfeeding, and fertility

The medicine is contraindicated in pregnant women due to the presence of codeine and caffeine.
The medicine 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

The medicine may cause dizziness and drowsiness. If such symptoms occur, the patient should not drive vehicles or operate machines.

The medicine contains colorants: erythrosine (E127), patent blue V (E131), and quinoline yellow (E104)

May cause allergic reactions.

3. How to take Solpadeine

This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine should be used in the lowest effective dose and 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.
The medicine should not be used for more than 3 days. If the pain does not improve after 3 days, the patient should consult their doctor.
Do not use other medicines containing paracetamol, codeine, or caffeine at the same time.
Dosage:
For oral use only.
Adults:
Orally, 1-2 capsules, up to a maximum of 4 times a day. Do not take a dose of the medicine more often than every 4-6 hours or use more than 8 capsules in 24 hours.
Adolescents 16-18 years old
Use 1-2 capsules every 6 hours, up to a maximum daily dose of 8 capsules (4000 mg paracetamol, 64 mg codeine, and 240 mg caffeine).
Adolescents 12-15 years old:
Take 1 capsule every 6 hours, up to a maximum daily dose of 4 capsules (2000 mg paracetamol, 32 mg codeine, and 120 mg caffeine).
Children under 12 years of age:
Solpadeine, due to the presence of codeine, 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 the symptomatic treatment of colds due to the risk of severe respiratory disorders.
(see also "When not to use Solpadeine" and "Children and adolescents" in section 2).
Elderly patients:
Elderly patients, especially the weak or immobile, may require a reduced dose of the Solpadeine medicine or a reduced frequency of administration.
Kidney function disorders:
Patients diagnosed with kidney function disorders should consult their doctor before taking the medicine. In the case of paracetamol administration, it is recommended to reduce the dose and increase the minimum interval between each administration to at least 6 hours. The restrictions on the use of paracetamol-containing products in patients with kidney function disorders are mainly due to the paracetamol content in the medicine (see "Warnings and precautions" in section 2).
Liver function disorders:
Patients diagnosed with liver function disorders or Gilbert's syndrome should consult their doctor before taking the medicine. The restrictions on the use of paracetamol-containing products in patients with liver function disorders are mainly due to the paracetamol content in the medicine (see "Warnings and precautions" in section 2).

Using a higher than recommended dose of Solpadeine

In case of taking a higher dose than recommended, the patient should immediately consult their doctor, even if they feel well. Overdose of the medicine can cause irreversible liver damage and respiratory disorders.

4. Possible side effects

Like all medicines, Solpadeine can cause side effects, although not everybody gets them.
The medicine may cause constipation.
The patient should stop using the medicine and consult their doctor immediately if they experience:

• severe abdominal pain, nausea, and vomiting in patients who have had their gallbladder removed, which may be a sign of acute pancreatitis (frequency not known),
• allergic reactions (hypersensitivity) such as: skin rash or itching, sweating, flushing, urticaria, angioedema (swelling of the lips, tongue, throat, or face), difficulty breathing,
• anaphylactic reactions - life-threatening inadequate blood flow in the organs caused by hypersensitivity, manifested by dizziness, disorientation, and fainting,
• agranulocytosis - a significant decrease in the number of white blood cells, which increases the likelihood of life-threatening infections,
• toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, manifested by blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain or large blisters, extensive erosions on the skin, and shedding of large skin plates, accompanied by fever,
• breathing difficulties, in case of similar problems in the past when using acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs,
• bruises or bleeding of unknown cause,
• liver function disorders, manifested by nausea, sudden weight loss, loss of appetite, yellowing of the skin and eyes,
• symptoms of dependence, i.e., anxiety and irritability, and feeling the need to continuously use the medicine and increase the dose after stopping long-term regular use of the medicine (frequency not known).

Taking Solpadeine may cause:
rarely (more often than 1 in 10,000 patients but less often than 1 in 1,000 patients):

• allergies (without angioedema)

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

• urination difficulties
• anaphylaxis
• bronchospasm in patients allergic to aspirin and other NSAIDs
• liver function disorders
• skin hypersensitivity reactions, including skin rash, itching, sweating, flushing, urticaria, and angioedema
• severe skin reactions; toxic epidermal necrolysis, drug-induced dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis
• sterile pyuria (cloudy urine)
• thrombocytopenia

frequency not known (frequency cannot be estimated from the available data):

• nervousness,
• dizziness,
• constipation, nausea, vomiting, indigestion,
• dry mouth,
• acute pancreatitis in patients after cholecystectomy (gallbladder removal) in their medical history,
• worsening of headache in case of prolonged use,
• drowsiness,
• difficulty urinating,
• in case of prolonged use of codeine in higher doses, dependence on the medicine may occur,
• a serious condition that can cause blood acidification (so-called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Consuming coffee or tea while taking the medicine may cause tension, irritability, insomnia, anxiety, headaches, stomach and intestinal disorders, unusual rapid heartbeat or irregular heart rhythm.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Solpadeine

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the "EXP" date.
The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C.
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 contains

• The active substances of the medicine are: paracetamol, codeine, and caffeine. One capsule contains 500 mg of paracetamol, 8 mg of codeine phosphate, and 30 mg of caffeine.
• The other ingredients are: magnesium stearate, cornstarch, lower part of the capsule shell: titanium dioxide, gelatin, upper part of the capsule shell: erythrosine (E127), patent blue V (E131), quinoline yellow (E104), titanium dioxide (E171), gelatin.

What Solpadeine looks like and contents of the packaging

Solpadeine is in the form of capsules.
The packaging contains 12 or 24 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Perrigo Poland Sp. z o.o.
Domaniewska Street 48
02-672 Warsaw
phone: +48 (22) 852 55 51

Manufacturer

Swiss Caps GmbH
Grassingerstrabe 9
83043 Bad Aibling
Germany

Date of last revision of the leaflet: