Solpadeine

Leaflet accompanying the packaging: information for the user

SOLPADEINE

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

Read the leaflet carefully before taking the medicine, as it contains

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

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should consult a 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 as monotherapy 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 there is no improvement after 3 days or if the patient feels worse, they should consult a 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 as monotherapy (see also "Contraindications" in section 2).

2. Important information before taking Solpadeine

Contraindications

• 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 patients with alcoholism,
• in patients with severe liver or kidney failure,
• in patients with respiratory failure and depression,
• in patients with asthma,
• in patients with chronic constipation,
• in children under 12 years of age,
• in children and adolescents (under 18 years of age) after tonsillectomy or adenoidectomy due to the risk of obstructive sleep apnea syndrome,
• in patients 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 taken in the lowest effective dose and for the shortest possible duration necessary to relieve symptoms. Patients who feel the need to take the medicine continuously should consult their doctor as soon as possible.
In case of persistent or worsening symptoms, medical advice should be sought.
During treatment with this product, other products containing paracetamol or codeine should not be taken.
Before starting treatment with Solpadeine, the patient should discuss it with their doctor or pharmacist in case of:

• hypotension,
• liver or kidney failure,
• Gilbert's syndrome (familial non-hemolytic jaundice),
• concomitant use of other medicines that affect liver function,
• hemolytic anemia,
• dehydration,
• chronic malnutrition,
• asthma and concomitant use of acetylsalicylic acid (cross-reactions have been observed),
• elderly patients, adults, and adolescents with a body weight below 50 kg,
• use of 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 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 taken for longer than necessary. It should not be given to others.
Long-term use of different types of painkillers for headaches can only worsen the condition. If such a situation occurs or is suspected, medical advice should be sought and treatment discontinued. The diagnosis of drug abuse in headaches should be suspected in patients who suffer from frequent or daily headaches despite regular use (or due to such use) of painkillers.
In patients after cholecystectomy, 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 variant of this enzyme, which can cause different effects. In some people, morphine is not produced or is produced in very small amounts, and therefore, it will not have a sufficient analgesic or antitussive effect. In others, it is more likely to cause severe side effects due to the large amounts of morphine produced. If the patient experiences any of the following side effects, they should stop taking the medicine and seek medical advice 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 disorders or sepsis (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 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 "Contraindications" 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 in case of taking the following medicines:

• metoclopramide, domperidone (used against nausea and vomiting),
• cholestyramine (used to reduce high cholesterol levels in the blood),
• anticoagulants (e.g., warfarin) in case of long-term use of painkillers,
• sedatives, such as sleeping pills, tranquilizers, tricyclic antidepressants, antipsychotic phenothiazines, alcohol,
• 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 risk of severe blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Although there is no evidence of clinically significant effects, 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 depressant effect on the respiratory center of other opioid analgesics.
Concomitant use with certain medicines that cause dryness in the mouth or blurred vision (cholinolytic agents, such as atropine) may cause 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 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 sedatives, the dose and duration of concomitant treatment should be limited by the doctor.
The patient should inform their doctor about all sedatives they are taking and strictly follow the doctor's instructions regarding the dose. It may be helpful to inform friends or family members about the above symptoms. In case of their occurrence, medical advice should be sought immediately.
Caffeine may reduce the effect of sedatives and tranquilizers.

Using Solpadeine with food, drinks, and alcohol

During treatment with the medicine, excessive consumption of caffeine (e.g., contained in coffee, tea, or some drinks) should be avoided.
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 "Contraindications" in section 2).

Driving and using machines

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

3. How to take Solpadeine

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine should be taken in the lowest effective dose and for the shortest possible duration necessary to relieve symptoms. The recommended daily dose should not be exceeded, nor should the prescribed number of doses be exceeded.
A higher dose than recommended should not be taken.
The medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, the patient should consult their doctor.
Other medicines containing paracetamol, codeine, or caffeine should not be taken concomitantly.
Dosage:
Oral use only.
Adults:
Orally, 1-2 tablets, up to a maximum of 4 times a day. The medicine should not be taken more frequently than every 4-6 hours, nor should more than 8 tablets be taken in 24 hours.
Adolescents 16-18 years of age:
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 12-15 years of age:
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 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 "Contraindications" 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 with kidney function disorders should consult their doctor before taking the medicine. In 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 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).

Taking a higher dose of Solpadeine than recommended

In case of taking a higher dose than recommended, the patient should seek medical advice immediately, 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 taking the medicine and consult their doctor immediately if they experience:

• acute 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 reaction - a life-threatening insufficient blood flow in the organs caused by an allergic reaction, 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 patches, as well as fever, acute generalized exanthematous pustulosis,
• breathing difficulties, in case of similar problems in the past when taking 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, such as restlessness and irritability, and the feeling of needing to take the medicine continuously and increasing the dose after long-term regular use (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
• urination difficulties
• in case of prolonged use of codeine in higher doses, dependence on the medicine may occur
• a serious condition that can cause acidification of the blood (metabolic acidosis), in patients with severe diseases taking paracetamol (see section 2).

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

Reporting side effects

If side effects occur, including those not listed in the leaflet, the patient should inform 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.
The medicine should not be used after the expiry date stated on the packaging after the "EXP" date. The expiry date refers to the last day of the month.
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 tablet contains 500 mg of paracetamol, 8 mg of codeine phosphate, and 30 mg of caffeine.
• The other ingredients are magnesium stearate, corn starch, gelatinized starch, potassium sorbate, povidone, talc, microcrystalline cellulose, stearic acid.

What Solpadeine looks like and contents of the packaging

Solpadeine is a white, elongated tablet.
The packaging contains 12 or 24 tablets.

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

GlaxoSmithKline Dungarvan Ltd.
Knockbrack
Dungarvan
Co. Waterford
Ireland
Swiss Caps GmbH
Grassingerstrabe 9
83043 Bad Aibling
Germany

Date of last revision of the leaflet: