Cefalgin Migraplus

Package Leaflet: Information for the Patient

Cefalgin Migraplus, 250 mg + 150 mg + 50 mg, Tablets

Paracetamol + Propyphenazone + Caffeine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Patient Information Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Leaflet, so you can Read it Again if you Need to.
• If you Need Advice or More Information, Consult a Pharmacist.
• If you Experience any Side Effects, including those not Listed in this Leaflet, Inform your Doctor or Pharmacist. See Section 4.
• If there is no Improvement after 7 Days or if you Feel Worse, Consult a Doctor.

Table of Contents of the Leaflet:

• 1. What is Cefalgin Migraplus and what is it Used for
• 2. Important Information Before Taking Cefalgin Migraplus
• 3. How to Take Cefalgin Migraplus
• 4. Possible Side Effects
• 5. How to Store Cefalgin Migraplus
• 6. Package Contents and Other Information

1. What is Cefalgin Migraplus and what is it Used for

Cefalgin Migraplus is a Combination Medication Containing Paracetamol and Propyphenazone, which have Analgesic and Antipyretic Effects, and a Small Amount of Caffeine. The Active Substances in the Medication Support each Other's Effects. Caffeine Enhances the Analgesic Effect of Paracetamol.

Indications for Use:

• Pain of Mild or Moderate Intensity: Migraine Headaches, Toothaches, Menstrual Pain, Neuralgia;
• Fever.

2. Important Information Before Taking Cefalgin Migraplus

When not to Take Cefalgin Migraplus:

• If the Patient is Allergic (Hypersensitive) to Paracetamol, Caffeine, or Acetylsalicylic Acid or any of the Other Ingredients of this Medication (Listed in Section 6);
• If the Patient is Allergic to Medications from the Pyrazolone Group or their Derivatives, Contained in Other Medications (Phenazone, Propyphenazone, Aminophenazone, Phenylbutazone, or Metamizole);
• If the Patient has Severe Liver or Kidney Failure;
• If the Patient has Changes in the Blood Count, such as Anemia, Leukopenia (Decreased White Blood Cell Count), Agranulocytosis (Lack of Granulocytes in the Blood);
• If the Patient has a Congenital Deficiency of 6-Phosphodehydrogenase;
• If the Patient has Hypertension;
• If the Patient has Gastric or Duodenal Ulcer Disease;
• If the Patient has Acute Hepatic Porphyria (a Disease in which there is Excessive Production of Porphyry Pigments in the Liver);
• If the Patient has Alcoholism.

Warnings and Precautions

Before Starting to Take Cefalgin Migraplus, Discuss it with a Doctor or Pharmacist.

During the Use of Cefalgin Migraplus, do not Consume Alcohol.

Cefalgin Migraplus Contains Paracetamol. Due to the Risk of Overdose, do not Take Cefalgin Migraplus at the Same Time as Other Medications Containing Paracetamol.

The Medication Should not be Taken for a Long Time or in Higher Doses than Recommended, as it may Cause Liver and Kidney Function Disorders. Stop Taking the Medication and Consult a Doctor in Case of Symptoms of these Organ Disorders.

Cefalgin Migraplus Should be Used with Caution (Reduced Dose or Frequency of Administration) in Patients with Liver or Kidney Failure, Gilbert's Syndrome (Mild Jaundice Caused by a Deficiency of Glucuronyltransferase), and Hemopoietic Disorders (Blood Cell Formation Process).

There is a Particular Risk of Liver Damage in Patients with Alcoholism and Malnutrition.

Cefalgin Migraplus Should be Used with Caution in Patients with Asthma, Chronic Rhinitis, or Chronic Urticaria, Especially in Cases of Allergy to Other Anti-Inflammatory Medications, such as Acetylsalicylic Acid.

Particular Caution is Advised when Taking Medications Containing Paracetamol (e.g., Cefalgin Migraplus) and Zidovudine.

Cefalgin Migraplus Should not be Taken by Patients with Severe Liver or Kidney Function Disorders.

In Elderly Patients, the Medication Should be Used with Caution Due to the Presence of Caffeine.

Children and Adolescents

Cefalgin Migraplus Should not be Taken by Children.

Cefalgin Migraplus and Other Medications

Tell your Doctor or Pharmacist about all Medications you are Currently Taking or have Recently Taken, as well as any Medications you Plan to Take.

Certain Medications Taken at the Same Time as Cefalgin Migraplus may Increase the Risk of Liver Damage (Rifampicin, Chloramphenicol, Certain Sleep Medications, Antiepileptic Medications - Barbiturates, Phenytoin, Carbamazepine) and Kidney Damage (Acetylsalicylic Acid, Salicylates, and Non-Steroidal Anti-Inflammatory Medications).

Paracetamol Enhances the Effect of Anticoagulant Medications from the Coumarin Derivative Group (e.g., Warfarin).

Caffeine Metabolism is Accelerated by Smoking and Barbiturates, while Oral Contraceptives, Cimetidine, and Disulfiram Reduce Caffeine Metabolism.

Cefalgin Migraplus Should be Used with Caution with Zidovudine, Sympathomimetic Medications (e.g., Ephedrine), Thyroxine, Theophylline, and Sedative Medications (Barbiturates and Antihistamines).

When Taking Paracetamol and Flucloxacillin (an Antibiotic) at the Same Time, there is a Risk of a Serious Disorder of Blood and Body Fluids (Metabolic Acidosis with a Large Anion Gap), which Requires Urgent Treatment and may Occur Especially in Patients with Severe Kidney Function Disorders, Sepsis (a Condition in which Bacteria and their Toxins Circulate in the Blood, Leading to Organ Damage), Malnutrition, Chronic Alcoholism, as well as in Patients Taking the Maximum Daily Dose of Paracetamol.

Cefalgin Migraplus with Food, Drink, and Alcohol

Cefalgin Migraplus Should be Taken after Meals, with Plenty of Water.

Alcohol Increases the Toxic Effect of Paracetamol on the Liver.

Pregnancy and Breastfeeding

If you are Pregnant or Breastfeeding, Think you may be Pregnant, or are Planning to have a Child, Consult a Doctor or Pharmacist before Taking this Medication.

Cefalgin Migraplus Should not be Taken during Pregnancy and Breastfeeding.

Driving and Operating Machines

Cefalgin Migraplus Taken in the Recommended Dose does not Affect the Ability to Drive Vehicles and Operate Machines.

Cefalgin Migraplus Contains Sodium

The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, which means it is Considered "Sodium-Free".

3. How to Take Cefalgin Migraplus

This Medication Should Always be Taken Exactly as Described in the Patient Information Leaflet or as Advised by a Doctor or Pharmacist.

In Case of Doubt, Consult a Doctor or Pharmacist.

The Medication is Taken Orally.

Recommended Dose:

Adults: 1 to 2 Tablets at a Time.

If Necessary, the Dose can be Repeated up to 3 Times a Day.

The Tablet Should be Taken with a Large Amount of Water.

The Medication Should not be Taken for Longer than 7 Days without Consulting a Doctor.

If you Feel that the Effect of Cefalgin Migraplus is too Strong or too Weak, Consult a Doctor.

Taking a Higher Dose of Cefalgin Migraplus than Recommended

Accidental or Intentional Overdose may Cause Symptoms such as Nausea, Vomiting, Excessive Sweating, Drowsiness, and General Weakness within a Few to Several Hours.

These Symptoms may Subside the Next Day, despite the Onset of Liver Damage, which will Later Manifest as Abdominal Distension, Return of Nausea, and Jaundice.

In any Case of Taking more than 5 g of Paracetamol at a Time, Induce Vomiting (if it has not been more than an Hour since Ingestion) and Immediately Consult a Doctor.

In Case of Taking a Higher Dose of the Medication than Recommended, Immediately Consult a Doctor or Pharmacist.

Missing a Dose of Cefalgin Migraplus

Do not Take a Double Dose to Make up for a Missed Dose.

4. Possible Side Effects

Like all Medications, Cefalgin Migraplus can Cause Side Effects, although not Everybody will Experience them.

Liver and Biliary Disorders

Long-Term Use may Cause Liver Damage.

Kidney and Urinary Disorders

Prolonged Use may Cause Kidney Function Disorders.

Skin and Subcutaneous Tissue Disorders

Skin Changes in the Form of Redness, Rash, Itching, or Urticaria, which are Symptoms of an Allergic Reaction.

Rarely, Severe Skin Reactions have been Reported.

Gastrointestinal Disorders

Nausea, Abdominal Pain, Vomiting, Heartburn.

Blood and Lymphatic System Disorders

Rarely, Changes in the Blood Count, such as Thrombocytopenia (Decreased Platelet Count), Leukopenia (Decreased White Blood Cell Count), Agranulocytosis (Lack of Granulocytes), Pancytopenia (Deficiency of all Normal Morphological Elements of the Blood, i.e., Red, White Blood Cells, and Platelets), Methemoglobinemia (Increased Amount of Methemoglobin Formed as a Result of Hemoglobin Oxidation).

Immune System Disorders

Angioedema, Dyspnea, Asthma Attacks, which are Symptoms of an Allergic Reaction (Hypersensitivity), Anaphylactic Shock.

Nervous System Disorders

Headaches, Sleep Disorders, Muscle Tremors.

Reporting Side Effects

If you Experience any Side Effects, including those not Listed in this Leaflet, Inform your 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

Tel.: +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 Medication.

5. How to Store Cefalgin Migraplus

Store the Medication in a Place Invisible and Inaccessible to Children.

Store at a Temperature below 25°C.

Do not Use this Medication after the Expiration Date Stated on the Packaging.

The Expiration Date Refers to the Last Day of the Specified Month.

Medications Should not be Disposed of in the Drain or Household Waste Containers.

Ask a Pharmacist how to Dispose of Medications that are no Longer Needed.

This will Help Protect the Environment.

6. Package Contents and Other Information

What Cefalgin Migraplus Contains

The Active Substances of the Medication are: Paracetamol, Propyphenazone, Caffeine.

One Tablet Contains:

Paracetamol

250 mg;

Propyphenazone

150 mg;

Caffeine

50 mg.

The Other Excipients are: Potato Starch, Sodium Lauryl Sulfate, Polyvinyl Alcohol, Gelatin, Silica Colloidal Anhydrous, Magnesium Stearate.

What Cefalgin Migraplus Looks Like and what the Package Contains

Cefalgin Migraplus are White Tablets with a Yellowish Tint, Round, Flat on both Sides, with a Notch and Marking "-" on one Side, Packed in PVC/Aluminum Blisters and Cardboard Boxes.

The Package Contains 10 Tablets.

Marketing Authorization Holder

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Manufacturer

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Date of the Last Update of the Leaflet: