Solpadeine control

Patient Information Leaflet

Solpadeine Control, 500 mg + 65 mg, effervescent tablets
Paracetamolum + Coffeinum
Please read this leaflet carefully before taking this 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.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If any adverse reactions occur, please consult your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If there is no improvement or if symptoms worsen after 3 days, consult your doctor.

Table of Contents

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

1. What Solpadeine Control is and what it is used for

Solpadeine Control contains two active substances. Paracetamol is an analgesic which also reduces body temperature in fever. Caffeine enhances the effectiveness of paracetamol. The dual action of these components provides fast and effective pain relief for headaches and migraine, with or without aura. This medicine also relieves back pain, joint pain, toothache, painful menstruation, muscle pain, neuralgia, sore throat, as well as fever and pain associated with colds and influenza.

2. Important information before taking Solpadeine Control

When not to use Solpadeine Control:

• if the patient has ever had an allergic reaction to paracetamol, caffeine, or any of the other ingredients of this medicine (listed in section 6)
• if the patient is taking other medicines containing paracetamol.

Warnings and precautions
Before starting to take Solpadeine Control, consult a doctor or pharmacist:

• if the patient has liver or kidney disease, including alcoholic liver disease
• if the patient suffers from asthma and is allergic to acetylsalicylic acid
• if the patient has Gilbert's syndrome (familial non-haemolytic jaundice)
• if the patient is taking medicines that affect liver function (e.g. carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John's wort)
• if the patient has been informed by a doctor of intolerance to certain sugars, glucose-6-phosphate dehydrogenase deficiency, or glutathione deficiency
• if the patient has haemolytic anaemia, chronic malnutrition, or dehydration
• if the adult or adolescent weighs less than 50 kg
• if the patient is on a sodium-restricted diet.

During treatment with Solpadeine Control, inform a doctor immediately if the patient develops severe illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
Cases of a serious condition called metabolic acidosis (an abnormality in blood and body fluids) have been reported in patients who take paracetamol regularly for a prolonged period or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children and adolescents
Solpadeine Control must not be given to children under 12 years of age.

Solpadeine Control and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken by the patient, especially: metoclopramide or domperidone (used for nausea or vomiting), or colestyramine (used to lower blood cholesterol levels). If the patient is taking anticoagulant medicines (blood thinners such as warfarin and coumarin derivatives) and needs to take a painkiller daily, they should discuss the risk of bleeding with their doctor, but may still take occasional doses of Solpadeine Control together with anticoagulant medicines. If the patient is taking probenecid, they should speak to their doctor, as it may be necessary to reduce the dose of Solpadeine Control. If the patient is taking flucloxacillin (an antibiotic), there is a serious risk of a blood and body fluid disorder (called high anion gap metabolic acidosis), which requires urgent treatment (see section 2).

The patient should inform the doctor if they are taking sedatives and anticholinergic medicines, as Solpadeine Control contains caffeine, which may interfere with or enhance their effects.

Pregnancy and breastfeeding
Due to the presence of caffeine in this medicine, it should not be used during pregnancy or breastfeeding.

Driving and operating machinery
Solpadeine Control has no effect on the ability to drive or operate machinery.

Solpadeine Control contains sodium
This medicinal product contains 427 mg of sodium (the main component of table salt) in one tablet. This corresponds to 21% of the recommended maximum daily intake of sodium for an adult.

Solpadeine Control contains sorbitol
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a doctor before taking this medicine or giving it to their child.

3. How to take Solpadeine Control

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults (including elderly) and adolescents aged 16 years and above:
Dissolve 1 to 2 tablets in at least half a glass of water and take every 4 to 6 hours as needed.

• Do not take more frequently than every 4 hours. Do not exceed 4 doses per day, equivalent to 8 tablets (4000 mg paracetamol and 520 mg caffeine). The maximum daily dose of paracetamol should not exceed 2 g per day (4 tablets within 24 hours), unless otherwise advised by a doctor:
  • if the patient has liver or kidney disease
  • if the patient has Gilbert's syndrome
  • if the patient suffers from chronic alcoholism, malnutrition, or dehydration
  • if the patient weighs less than 50 kg.

For patients with impaired kidney or liver function, and for patients with Gilbert's syndrome, the dose should be reduced or the interval between doses increased. In such cases, consult a doctor.

Elderly patients: dose reduction may be recommended for debilitated or immobile patients.

Adolescents aged 12–15 years:
Dissolve 1 tablet in at least half a glass of water and take every 4 to 6 hours as needed.

• Do not take more frequently than every 4 hours.
• Do not exceed 4 tablets (2000 mg paracetamol and 260 mg caffeine) per day.

Do not use a higher than recommended dose.

• Do not give to children under 12 years of age.
• Avoid consuming excessive amounts of caffeine found in drinks such as coffee and tea.

High caffeine intake may cause sleep disturbances, tremors, and chest discomfort.

Use in children and adolescents under 12 years of age
Solpadeine Control is not recommended for patients under 12 years of age.

Accidental overdose of Solpadeine Control
Seek immediate medical advice if an overdose is taken, even if feeling well. This is because an overdose of paracetamol may cause delayed but severe liver damage.

Missed dose of Solpadeine Control
Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them. Adverse reactions have been observed in a small number of people. You should stop taking the medicine and immediately inform your doctor if you experience any of the following symptoms:

• allergic reactions, which may be severe, such as skin rash or itching, sometimes with swelling of the lips or face or shortness of breath
• skin rash or skin peeling or oral mucosal ulcers
• breathing problems. These symptoms are more likely if they have occurred previously in the patient during treatment with other painkillers, such as ibuprofen and acetylsalicylic acid
• unexplained bruising or bleeding
• nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin
• cloudy urine

Other adverse reactions:

• central nervous system-related nervousness and dizziness
• in very rare cases, a decrease in white blood cell count (neutropenia and leukopenia) may occur
• very rare cases of severe skin reactions have been reported

Frequency of occurrence: "frequency unknown" (cannot be estimated based on available data)
A serious condition which may cause the blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, consult your doctor or pharmacist. This applies to all possible adverse reactions not listed in this leaflet.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309,
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Solpadeine Control

Keep this medicine out of sight and reach of children. Do not store at temperatures above 25°C.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Solpadeine Control contains

• The active substances are paracetamol and caffeine. Each tablet contains 500 mg of paracetamol and 65 mg of caffeine.
• Other ingredients: sodium hydrogen carbonate, sorbitol (E420), sodium saccharin, sodium lauryl sulfate, anhydrous citric acid, anhydrous sodium carbonate, povidone K25, and dimethicone 315/385.

What Solpadeine Control looks like and contents of the pack
Solpadeine Control is white effervescent tablets with bevelled edges and a division line (the line on the tablet
is not intended for dividing into equal doses), packed in soft blisters.
Pack sizes: 4, 6, 12, 16, 18, 24, 30, 48 or 60 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warszawa
tel.: +48 (22) 852 55 51
Manufacturer
Famar A.V.E. Anthoussa Plant
Anthoussa Avenue 7, Anthoussa Attiki, 15349 Greece
This medicinal product is authorised in the European Economic Area countries under the following names:

January 2025