Package Insert: Information for the User

ACTIMAG 400 mg/mL Oral Solution

Magnesium pidolate

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

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

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

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

Do not take Actimag

• If you are allergic to magnesium pidolate, magnesium, or any of the other components of this medication (listed in section 6).
• If you have abnormally high levels of magnesium 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 medication.
• If you have myasthenia gravis (muscle weakness and/or fatigue).
• If you have had any part of your intestine removed.
• If you have Cushing's disease (excess cortisol).
• If you have or have had diabetic coma (loss of consciousness due to extremely high or low blood glucose levels).
• If you have or have had heart diseases such as angina or myocardial infarction.
• If you have any calcium metabolism disorders.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Actimag.

• Do not use this medication continuously without medical control. Prolonged use of this medication may cause hypermagnesemia (high magnesium levels in the blood) characterized by nausea, vomiting, respiratory depression (weak breathing), and central nervous system depression (symptoms may 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.
• Prolonged use of this medication may cause hypercalcemia (high calcium levels in the blood).
• Use this medication with caution in cases of prolonged treatment, as it may be necessary to regularly monitor magnesium and calcium levels in the blood.
• Consuming this medication on an empty stomach may cause diarrhea.
• Patients with kidney disease should consult their doctor before starting to take this medication.

Children and adolescents

Do not administer to children under 12 years old, except on medical advice.

Other medications and Actimag

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

Be aware that these instructions may also apply to medications that have been used before or may be used afterwards.

Magnesium may bind to certain medications and prevent their complete absorption.

This medication reduces the absorption of:

• Antibiotics, such as tetracyclines (doxycycline, minocycline, oxytetracycline, tetracycline) and quinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin).
• Bisphosphonates (medications used to treat osteoporosis, such as alendronate).
• Azole antifungals (to treat fungal infections) such as ketoconazole.

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

If you take any of the following medications:

• Polystyrene sulfonate sodium (medication to treat hyperkalemia).
• Calcium supplements.

Ask your doctor or pharmacist how much to space the doses and establish a dosing schedule that makes it easy for you to take these medications.

• The simultaneous administration of delavirdine (medication used as part of antiretroviral therapy for the treatment of HIV type 1) with Actimag may reduce the action of this medication, so you should space the administration of delavirdine with Actimag at least 1 hour apart.

Review the information on any medication or medicinal plant you are taking (such as antacids, laxatives, vitamins) as they may contain magnesium. Additionally, there may be other possible interactions between Actimag and medications used to treat heart diseases, as well as with alcohol and glucose.Ask your doctor or pharmacist how to use these products safely.

Use of Actimag with food and beverages

Excessive and prolonged consumption of products containing magnesium and calcium may cause excessive calcium levels in the blood. In these situations, you should monitor calcium intake and foods rich in calcium, such as dairy products.

Taking this medication with food intake.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

This medication may 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 adverse effects have been described in infants whose mothers take magnesium at the recommended doses.

Driving and operating machinery

The influence of Actimag on the ability to drive or operate machinery is negligible or insignificant.

Actimag contains saccharose, parahydroxybenzoate of methyl (E-218), parahydroxybenzoate of propyl (E-216), amaranth (E-123), propylene glycol (E-1520), and sodium.

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

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

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

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

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medication is administered orally.

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

Do not exceed the recommended daily doses.

Administration Form

It is recommended to take this medication with food intake unless your doctor tells you otherwise, in order to reduce gastrointestinal discomfort and diarrhea.

Use in Children

This medication should not be used in children unless prescribed by a doctor.

Use in Older Adults

In older adults (65 years) with kidney function decline, the dose and administration frequency of magnesium salts should be adjusted by the doctor according to the degree of renal function decline.

If You Take More Actimag Than You Should

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

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

If You Forget to Take Actimag

Remember to take your medication. If you forget to take a dose, take it as soon as possible unless it is almost time to take the next dose. Do not take a double dose to compensate for the missed dose.

If You Interrupt Treatment with Actimag

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

Gastrointestinal Disorders:

• Occasionally: stomach discomfort, diarrhea

• Vascular Disorders

• Hypotension

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Actimag 400 mg/mL oral solution

• The active ingredient is magnesium pidolate. Each mL of oral solution contains400 mg of magnesium pidolate (equivalent to 34.7 mg of magnesium).
• The other components are: sucrose, propylene glycol, sodium saccharin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), raspberry flavor, peppermint oil, amaranth dye (E-123), and water.

Appearance of the product and content of the packaging

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

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Last review date of this leaflet:November 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/