ACTIMAG 400 MG/ML ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

ACTIMAG 400 mg/mL Oral Solution

Magnesium pidolate

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What is Actimag and what is it used for
2. What you need to know before taking Actimag
3. How to take Actimag
4. Possible side effects
5. Storage of Actimag
6. Package Contents and Additional Information

1. What is Actimag and what is it used for

Actimag 400 mg/mL Oral Solution belongs to the group of medicines called magnesium supplements. It is indicated for adults and children over 12 years of age for the prevention and treatment of low magnesium levels in the body.

2. What you need to know before taking Actimag

Do not take Actimag

• If you are allergic to magnesium pidolate, magnesium, or any of the other components of this medicine (listed in section 6).
• If you have abnormally high magnesium levels in your blood.
• If you have had severe kidney problems.
• If you have chronic diarrhea.
• If you have any intestinal problems, consult your doctor before using this medicine.
• If you have muscle weakness and/or fatigue (myasthenia gravis)
• If you have had any part of your intestine removed
• If you have Cushing's disease (excess cortisol)
• If you have had diabetic coma (loss of consciousness due to excessively high or low blood glucose levels)
• If you have had heart diseases such as angina pectoris or myocardial infarction.
• If you have any alterations in calcium metabolism

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Actimag.

• Do not use this medicine continuously without medical supervision. Continuous use of this medicine can cause hypermagnesemia (high magnesium levels in the blood) characterized by nausea, vomiting, respiratory depression (weak breathing), and central nervous system depression (symptoms can range from numbness to coma), hyperreflexia (exaggerated reflexes), muscle weakness, and certain cardiovascular effects such as low blood pressure, decreased heart rate, and cardiac arrest.
• Continuous use of this medicine can cause hypercalcemia (high calcium levels in the blood)
• Use this medicine with caution in case of prolonged treatment, as it may be necessary to regularly monitor magnesium and calcium levels in the blood.
• Taking this medicine on an empty stomach can cause diarrhea.
• Patient with kidney diseases should consult their doctor before starting to take this medicine.

Children and Adolescents

Do not administer to children under 12 years of age unless medically prescribed.

Other Medicines and Actimag

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription.

Note that these instructions may also apply to medicines used before or after.

Magnesium can bind to certain medicines and prevent their complete absorption.

This medicine reduces the absorption of:

• Antibiotics, such as tetracyclines (doxycycline, minocycline, oxytetracycline, tetracycline) and quinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin).
• Bisphosphonates (medicines used in the treatment of osteoporosis, such as alendronate).
• Antifungals (for treating fungal infections) of the azole type (e.g., ketoconazole)

The administration of Actimag and these medicines should be spaced at least 2 hours apart to avoid unwanted interactions.

If you are taking any of the following medicines:

• Sodium polystyrene sulfonate (medicine for treating hyperkalemia)
• Calcium supplements

Ask your doctor or pharmacist how much to space the doses and establish a dosing schedule that makes it easier to take these medicines.

• Taking delavirdine (medicine used as part of antiretroviral therapy for the treatment of HIV-1) simultaneously with Actimag may reduce the effect of this medicine, so the administration of delavirdine with Actimag should be spaced at least 1 hour apart.

Review the information of any medicine or herbal remedy you are taking (such as antacids, laxatives, vitamins) as they may contain magnesium. Additionally, there are other possible interactions of Actimag with other medicines used to treat heart diseases, as well as with alcohol and glucose. Ask your doctor or pharmacist how to safely use these products.

Using Actimag with Food and Drinks

Excessive and prolonged consumption of products containing magnesium and calcium can cause excessive calcium concentrations in the blood. In these situations, calcium intake and foods rich in calcium, such as dairy products, should be monitored.

Taking this medicine with food intake

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

This medicine can be used during pregnancy only in cases where it is strictly necessary.

It is recommended to cover magnesium needs with a diet rich in vegetables, whole grains, and legumes to prevent the consequences of magnesium deficiency during pregnancy.

Breastfeeding

Consult your doctor if you are breastfeeding your baby.

No problems have been reported in breastfed children whose mothers take magnesium at the recommended doses.

Driving and Using Machines

The influence of Actimag on the ability to drive or use machines is negligible.

Actimagcontains sucrose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), amaranth (E-123), propylene glycol (E-1520), and sodium.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medicine may cause allergic reactions because it contains amaranth (E-123). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains 8.66 mg of propylene glycol in each dose unit (10 mL).

This medicine contains less than 23 mg of sodium (1 mmol) per dose unit (5 mL); it is essentially "sodium-free".

3. How to Take Actimag

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medicine is administered orally.

The recommended dose in adults and children over 12 years of age is 5 mL twice a day.

Do not exceed the recommended daily doses.

Method of Administration

It is recommended to take this medicine with food intake, unless your doctor indicates otherwise, in order to reduce gastric discomfort and diarrhea.

Use in Children

This medicine should not be used in children unless medically prescribed.

Use in Elderly

In elderly patients (65 years) with reduced kidney function, the dose and frequency of administration of magnesium salts should be adjusted by the doctor according to the degree of renal function impairment.

If You Take More Actimag Than You Should

If you take an excessive dose of this medicine, the following symptoms may appear: nausea, vomiting, decreased blood pressure, and in severe cases, skin vasodilation, slowed heart rate, and central nervous system depression.

If you observe any of these symptoms, consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Bring this package leaflet with you. You can also call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount taken.

If You Forget to Take Actimag

Remember to take your medicine. If you forget to take a dose, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for forgotten doses.

If You Stop Taking Actimag

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects have been observed, although their frequency cannot be established with precision:

Gastrointestinal disorders:

• Occasionally: gastric discomfort, diarrhea

• Vascular disorders

• Hypotension

In rare cases, a severe allergic reaction may occur. Consult your doctor immediately if you show any of the following symptoms: flushing, itching/swelling (especially of the face, tongue, or throat), dizziness, and/or breathing difficulties.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Actimag

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging, after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Actimag 400 mg/mL Oral Solution

• The active ingredient is magnesium pidolate. Each mL of oral solution contains 400 mg of magnesium pidolate (equivalent to 34.7 mg of magnesium).
• The other ingredients are: sucrose, propylene glycol, sodium saccharin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), raspberry flavor, peppermint flavor, amaranth (E-123) coloring, and water.

Appearance of the Product and Package Contents

Glass bottle with a polypropylene/polyethylene high-density (PP/HDPE) cap with a child-resistant closure, containing 100 mL of oral solution and a measuring dosing device.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the Last Revision of this Package Leaflet:November 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/