Solpadeine

Leaflet accompanying the packaging: information for the user

SOLPADEINE

500 mg + 8 mg + 30 mg, effervescent 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.

• The 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 alone or in combination with other analgesics, such as paracetamol.
The onset of action of the medicine occurs within 15 to 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, 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 alone (see also "When not to take Solpadeine" in section 2).

2. Important information before taking Solpadeine

When not to take 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 taken in the lowest effective dose and for the shortest possible time 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 the following cases:

• 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,
• in patients with asthma who are also taking acetylsalicylic acid (cross-reactions have been observed),
• in elderly patients, adults, and adolescents with a body weight below 50 kg,
• in patients taking medicines that depress the central nervous system,
• in patients with respiratory function disorders,
• in patients with head injuries and increased intracranial pressure,
• in patients with prostatic hypertrophy or difficulty urinating,
• in patients with hypothyroidism,
• in patients with adrenal insufficiency,
• in patients with acute abdominal symptoms,
• in patients with inflammatory or obstructive bowel disease,
• in patients with a deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
• in patients with biliary tract disease (cholelithiasis) and after surgical procedures in the biliary tract,
• in patients with 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 taken for longer than necessary. It should not be given to other people.
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 stopped. Misuse of painkillers for headaches should be suspected in patients who experience frequent or daily headaches despite regular use (or due to such use) of painkillers.
In patients who have had their gallbladder removed, codeine may cause severe abdominal pain related to the biliary tract or pancreas, usually accompanied by laboratory abnormalities.
Codeine is converted to morphine in the liver with the help 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 that serious side effects will occur due to 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 seek medical advice immediately: slow or shallow breathing, disorientation, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
Laboratory 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 experiences 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, cases of a severe condition called metabolic acidosis (a blood and body fluid disorder) have been reported in patients taking paracetamol regularly for a long time or taking paracetamol with flucloxacillin. 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 take Solpadeine" and section 3)
Adolescents over 12 years of age
Solpadeine should not be used 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 a need for 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),
• non-steroidal anti-inflammatory drugs (e.g., 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, the possibility of paracetamol affecting the action of chloramphenicol should be considered if both medicines are given at the same time, 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 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 members 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.

Taking 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 feelings 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. A particular risk of liver damage exists 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 take Solpadeine" in section 2).

Driving and using machines

The medicine may cause dizziness and drowsiness. If such symptoms occur, the patient should not drive or operate machinery.
The medicine contains 427 mg of sodium(the main component of common salt) in each effervescent tablet. This corresponds to 21% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine contains 50 mg of sorbitol (E 420)in each effervescent tablet, which corresponds to 1.60% of the tablet mass. The additive effect of products containing fructose (or sorbitol) and food containing fructose (or sorbitol) should be taken into account. Sorbitol in the medicinal product may affect the bioavailability of other orally administered medicinal products.

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 doubt, the patient should consult their doctor or pharmacist.
The medicine should be taken in the lowest effective dose and for the shortest possible time necessary to relieve symptoms. The recommended daily dose should not be exceeded, nor should the specified number of doses be exceeded.
A higher dose than recommended should not be taken.
The medicine should not be taken for longer 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 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 a day. The medicine should not be taken more frequently than every 4-6 hours, nor should more than 8 effervescent tablets be taken in 24 hours.
Adolescents 16-18 years of age:
1-2 effervescent tablets every 6 hours, up to a maximum daily dose of 8 effervescent tablets (4000 mg of paracetamol, 64 mg of codeine, and 240 mg of caffeine).
Adolescents 12-15 years of age:
1 effervescent tablet every 6 hours, up to a maximum daily dose of 4 effervescent tablets (2000 mg of paracetamol, 32 mg of codeine, and 120 mg of 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 "When not to take 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 medicinal product or a reduced frequency of administration.
Renal impairment:
Patients with renal impairment should consult their doctor before taking the medicine. 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. The restrictions on the use of products containing paracetamol in patients with renal impairment are mainly due to the paracetamol content in the medicine (see "Warnings and precautions" in section 2).
Hepatic impairment:
Patients with hepatic impairment or Gilbert's syndrome should consult their doctor before taking the medicine. The restrictions on the use of products containing paracetamol in patients with hepatic impairment 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 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 taking 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 organs caused by hypersensitivity, manifested by dizziness, disorientation, and fainting,
• agranulocytosis - a significant decrease in the number of white blood cells, which increases the risk of life-threatening infections,
• toxic epidermal necrolysis, Stevens-Johnson syndrome, characterized 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 fever,
• breathing difficulties, if similar problems have occurred in the past when taking acetylsalicylic acid or other non-steroidal 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 anxiety and irritability, and the feeling of needing to take the medicine continuously and increasing 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 rashes, 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 who have had their gallbladder removed,
• worsening of headache with 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 acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

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

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 Monitoring of Adverse Reactions to Medicinal Products of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to 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 taken after the expiry date stated on the packaging after the expiry date. The expiry date refers to the last day of the specified 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 effervescent tablet contains 500 mg of paracetamol, 8 mg of codeine phosphate, and 30 mg of caffeine.
• The other ingredients are: sorbitol powder, sodium saccharin, sodium bicarbonate, povidone, sodium lauryl sulfate, dimethicone, anhydrous citric acid, anhydrous sodium carbonate.

What Solpadeine looks like and what the packaging contains

Solpadeine is a white, flat tablet with a dividing line on one side.
The packaging contains 12 or 24 effervescent tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Perrigo Poland Sp. z o.o.
ul. Domaniewska 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: