Prospect: Patient Information

Bepanmed 500 mg/2 ml injectable solution

Dexpantenol

Read this prospect carefully before starting to use this medication, as it contains important information for you.

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

6. Contents of the container and additional information

Bepanmed 500 mg/2 ml injectable solution contains dexpantenol as its active ingredient, a compound similar to a vitamin of the B group, pantothentic acid.

Bepanmed is indicated for states of pantothentic acid deficiency, which may produce cases such as the following: Peripheral intestinal muscle atonia (intestinal atony) caused after an operation or by intestinal obstruction (paralytic ileus); and in the case of Burning Feet Syndrome (“burning feet”) caused by a deficiency of vitamin B5, pantothentic acid.

Do not use Bepanmed:

• if you are allergic to dexpantenol or to any of the other ingredients 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, use this medication with great caution as it may prolong bleeding time.
• Have your symptoms of the disorder monitored to observe its evolution.

Children

Do not administer Bepanmed to children under 18 years of age, as there is no data available for them.

Other medications and Bepanmed

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

Patients undergoing treatment with succinylcholine (suxamethonium chloride) should not use dexpantenol (this medication) within one hour of succinylcholine administration, as it may prolong muscle relaxation.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend 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.

The doctor will decide whether to discontinue breastfeeding or discontinue treatment after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Fertility

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

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults over 18 years old:

The recommended dose in postoperative intestinal atony is:

· Prevention: between half a vial (250 mg) to 2 vials (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 in Burning Feet Syndrome (“burning feet”) is:

· between half and 1 vial (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 in hypervitaminosis have been reported; 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

The following adverse reactions have been reported:

- Skin allergic reactions such as contact dermatitis, allergic dermatitis, itching, tingling, erythema, rash, urticaria, irritated skin, and blisters on the skin.

- Some cases of gastrointestinal disturbances, such as vomiting and diarrhea, have been reported.

- Reactions at the injection and infusion site.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications: 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.

Do not store at a temperature above 25°C.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the Sigre Point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bepanmed injectable solution

- The active ingredient is dexpantenol. Each 2 ml ampule 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 packaging

Bepanmed is an injectable solution, a colorless to yellowish liquid, presented in 2 ml (glass) ampules.

Each box contains 3 or 6 ampules.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Responsible manufacturer:

DOPPEL FARMACEUTICI, S.R.L.

Via Volturno, 48 Quinto De Stampi

I-20089Rozzano, Milan

Italy

Last review date of this leaflet:October 2017.

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