BEPANMED 500 mg/2 ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Bepanmed 500 mg/2 ml Solution for Injection

Dexpantenol

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Bepanmed and what is it used for
2. What you need to know before using Bepanmed
3. How to use Bepanmed
4. Possible side effects
5. Storage of Bepanmed

1. Contents of the Pack and Additional Information

1. What is Bepanmed and what is it used for

Bepanmed 500 mg/2 ml Solution for Injection contains the active substance dexpantenol, similar to a vitamin of the B group, pantothenic acid.

Bepanmed is indicated in states of pantothenic acid deficiency, which may produce cases such as the following: Loss of intestinal muscle tone (intestinal atony) caused after an operation or by intestinal obstruction (paralytic ileus); and in cases of Burning Feet Syndrome caused by a deficiency of vitamin B5, pantothenic acid.

2. What you need to know before starting to use Bepanmed

Do not use Bepanmed:

• if you are allergic to dexpantenol or any of the other components of this medication (listed in section 6).
• if you have mechanical intestinal obstruction.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Bepanmed.

• If you have hemophilia, this medication should be used with caution, as it may prolong bleeding time.
• Your symptoms should be monitored to observe the evolution of your condition.

Children

Do not administer Bepanmed to children under 18 years of age, as there are no data available for this age group.

Other Medications and Bepanmed

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Patients being treated with succinylcholine (suxamethonium chloride) should not use dexpantenol (this medication) within one hour after administration of succinylcholine, due to possible prolongation of muscle relaxant effect.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

As a precaution, it is preferable not to use Bepanmed during pregnancy.

Breastfeeding

The risk to newborns/children cannot be excluded, as it is unknown whether dexpantenol passes into breast milk.

Your doctor will decide whether it is necessary to interrupt breastfeeding or treatment, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Fertility

Due to the lack of data, it cannot be determined whether dexpantenol may interfere with fertility.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is negligible or insignificant.

3. How to Use Bepanmed

Follow the administration instructions for this medication exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

Adults over 18 years:

The recommended dose for postoperative intestinal atony is:

• Prevention: between half an ampoule (250 mg) and 2 ampoules (1000 mg dexpantenol) by intravenous or intramuscular route during or after surgery.
• Treatment: the same dose as for prevention by intravenous or intramuscular route, every 6 hours if necessary.

The recommended dose for Burning Feet Syndrome is:

• between half and 1 ampoule (250-500 mg dexpantenol) per day, by intramuscular (or intravenous) route for 2-3 weeks.

If you use more Bepanmed than you should

No cases of disorders due to hypervitaminosis are known; Bepanmed is well tolerated even at high doses.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following adverse reactions have been reported:

• Allergic skin reactions such as contact dermatitis, allergic dermatitis, itching, tingling, erythema, rash, urticaria, irritated skin, and blisters on the skin.
• Some cases of gastrointestinal disorders, such as vomiting and diarrhea, have been reported.
• Reactions at the injection and infusion site.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Bepanmed

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

Do not store above 25°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Pack and Additional Information

Composition of Bepanmed Solution for Injection

• The active substance is dexpantenol. Each 2 ml ampoule contains 500 mg of dexpantenol.
• The other components (excipients) are: DL-lactone, nitrogen, and water for injectable preparations.

Appearance of the Product and Contents of the Pack

Bepanmed is a solution for injection, a colorless to yellowish liquid, presented in 2 ml ampoules (of glass).

Each box contains 3 or 6 ampoules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Manufacturer:

DOPPEL FARMACEUTICI, S.R.L.

Via Volturno, 48 Quinto De Stampi

I-20089 Rozzano, Milan

Italy

Date of the Last Revision of this Package Leaflet:October 2017.

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