Solpadeine Control

Leaflet attached to the packaging: Information for the user

Solpadeine Control, 500 mg + 65 mg, effervescent tablets

Paracetamol + Caffeine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised 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 you experience any side effects, you should consult a doctor or pharmacist. This includes all possible side effects not listed in this leaflet. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact a doctor.

Table of contents of the leaflet

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

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

Solpadeine Control contains two active substances. Paracetamol is a pain reliever that also lowers body temperature in case of fever. Caffeine enhances the effectiveness of paracetamol. The dual action of the ingredients provides quick and effective pain relief in case of headache and migraine, with or without warning signs (aura), as well as back pain, joint pain, toothache, painful menstruation, muscle pain, neuralgia, sore throat, and fever and pain in the course of colds and flu.

2. Important information before taking Solpadeine Control

When not to take Solpadeine Control:

Warnings and precautions

Before taking Solpadeine Control, you should consult a doctor or pharmacist:

Children and adolescents

This medicine should not be given to children under 12 years of age.

Solpadeine Control and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, especially metoclopramide or domperidone (used for nausea or vomiting) or cholestyramine (used to lower blood cholesterol levels). If you are taking blood-thinning medicines (anticoagulants, e.g., warfarin and coumarin derivatives) and need to take a pain reliever every day, you should talk to your doctor about the risk of bleeding, but you can still take occasional doses of Solpadeine Control with anticoagulants. If you are taking probenecid, you should talk to your doctor, as you may need to reduce the dose of Solpadeine Control. If you are taking flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and can occur especially in patients with severe kidney dysfunction, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking maximum daily doses of paracetamol.

You should inform your doctor if you are taking sedatives and mucosal constrictors, as Solpadeine Control contains caffeine, which can disrupt or enhance their effects.

Pregnancy and breastfeeding

Due to the caffeine content in this medicine, it should not be used during pregnancy or breastfeeding.

Driving and using machines

Solpadeine Control does not affect the ability to drive or use machines.

Solpadeine Control contains sodium

This medicinal product contains 427 mg of sodium (the main component of common salt) per tablet. This corresponds to 21% of the recommended maximum daily sodium intake for an adult.

Solpadeine Control contains sorbitol

Sorbitol is a source of fructose. If you have been diagnosed with an intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should consult your doctor before taking this medicine or giving it to your child.

3. How to take Solpadeine Control

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.

Adults (including the elderly) and adolescents over 16 years of age:

1 to 2 tablets should be dissolved in at least half a glass of water and taken every 4-6 hours as needed.

• Do not take more frequently than every 4 hours. Do not exceed 4 doses in 24 hours, which corresponds to 8 tablets (4000 mg of paracetamol and 520 mg of caffeine). The maximum dose of paracetamol should not exceed 2g in 24 hours (4 tablets in 24 hours), unless your doctor advises otherwise:

In patients with kidney or liver failure and in patients with Gilbert's syndrome, the dose should be reduced or the interval between doses increased. In such cases, you should consult a doctor.

The elderly: a dose reduction may be recommended for weakened or immobilized patients.

Adolescents 12-15 years of age:

1 tablet should be dissolved in at least half a glass of water and taken every 4-6 hours as needed.

• Do not take more frequently than every 4 hours.
• Do not take more than 4 tablets (2000 mg of paracetamol and 260 mg of caffeine) in 24 hours.

Do not exceed the recommended dose.

• Do not give to children under 12 years of age.
• Avoid consuming too much caffeine found in beverages like coffee and tea.

High caffeine intake can cause sleep problems, tremors, and discomfort in the chest.

Use in children and adolescents under 12 years of age.

Solpadeine Control is not recommended for patients under 12 years of age.

Taking a higher dose of Solpadeine Control than recommended

You should immediately talk to a doctor if you have taken too much of this medicine, even if you feel well. This is because an overdose of paracetamol can cause delayed and severe liver damage.

Missing a dose of Solpadeine Control

Do not take a double dose to make up for a missed dose.

If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Solpadeine Control can cause side effects, although not everybody gets them. Side effects have been reported 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 can be severe, such as skin rash or itching, sometimes with swelling of the mouth or face or shortness of breath
• skin rash or peeling or ulcers in the mouth
• breathing problems. These symptoms are more likely if you have experienced them before when taking other pain relievers, 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 side effects:

• nervousness and dizziness of central origin
• in very rare cases, a decrease in the number of white blood cells (neutropenia and leukopenia) may occur.
• very rare cases of severe skin reactions have been reported.

Reporting side effects

If you experience any side effects, you should consult a doctor or pharmacist. This includes all possible side effects not listed in this leaflet.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02 222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

By reporting side effects, you can help provide more information on the safety of this medicine.

Side effects can also be reported to the marketing authorization holder.

5. How to store Solpadeine Control

The medicine should be stored out of sight and reach of children. Do not store 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 the expiry date (EXP). The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Control contains

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

What Solpadeine Control looks like and what the pack contains

Solpadeine Control is white effervescent tablets with beveled edges and a dividing line (the line on the tablet is not intended for dividing into equal doses) in a soft blister pack.

Package sizes: 4, 6, 12, 16, 18, 24, 30, 48, or 60 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Perrigo Poland Sp. z o.o.

Al. Niepodległości 18

02-653 Warszawa

tel. (22) 489 54 51

Manufacturer

Famar A.V.E. Anthoussa Plant

Anthoussa Avenue 7, Anthoussa Attiki, 15349 Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: