Bepanmed 500 mg/2 ml, solution for injection
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Bepanmed 500 mg/2 ml injection solution
Dexpanthenol
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
-
What Bepanmed is and what it is used for
-
What you need to know before using Bepanmed
-
How to use Bepanmed
-
Possible side effects
-
How to store Bepanmed
-
Contents of the pack and other information
1. What Bepanmed is and what it is used for
Bepanmed 500 mg/2 ml injectable solution contains as its active substance dexpanthenol, a substance similar to vitamin B group acid, pantothenic acid.
Bepanmed is indicated in states of pantothenic acid deficiency, which may lead to conditions such as: Loss of tone in intestinal musculature (intestinal atony) caused after surgery or due to intestinal obstruction (paralytic ileus); and in cases of Burning Feet Syndrome ("burning feet") caused by vitamin B5 (pantothenic acid) deficiency.
2. What you need to know before using Bepanmed
Do not use Bepanmed:
- if you are allergic to dexpanthenol or to any of the other ingredients of this medicine (listed in section 6).
- if you have mechanical intestinal obstruction.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Bepanmed.
- If you have haemophilia, this medicine should be used with great caution as it may prolong bleeding time.
- Your symptoms should be monitored to observe their progression.
Children
Do not administer Bepanmed to children under 18 years of age, due to lack of data in this population.
Other medicines and Bepanmed
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Patients receiving succinylcholine (suxamethonium chloride) should not use dexpanthenol (this medicine) within one hour after administration of succinylcholine, due to the possible prolongation of the muscle-relaxing effect.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
As a precautionary measure, it is preferable not to use Bepanmed during pregnancy.
Breastfeeding
Risk to newborns/infants cannot be excluded, as it is unknown whether dexpanthenol passes into breast milk.
Your doctor must decide whether to discontinue breastfeeding or to discontinue treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.
Fertility
Due to lack of data, it cannot be determined whether dexpanthenol may interfere with fertility.
Driving and using machines
The effect of this medicine on the ability to drive and use machines is none or negligible.
3. How to use Bepanmed
Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
Adults over 18 years of age:
The recommended dose for postoperative intestinal atony is:
- Prophylaxis: from half an ampoule (250 mg) up to 2 ampoules (1000 mg dexpanthenol) by intravenous or intramuscular route during or after surgery.
- Treatment: the same dose as for prophylaxis by intravenous or intramuscular route, every 6 hours if necessary.
The recommended dose for Burning Feet Syndrome is:
- Between half and one ampoule (250–500 mg dexpanthenol) daily, 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, go to a medical center, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse 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 skin blisters.
- Cases of gastrointestinal disturbances such as vomiting and diarrhea have been reported.
- Reactions at the injection or infusion site.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bepanmed
Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Collection Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bepanmed injectable solution
- The active substance is dexpanthenol. Each 2 ml ampoule contains 500 mg of dexpanthenol.
- The other components (excipients) are: DL-lactone, nitrogen, and water for injections.
Appearance of the product and contents of the pack
Bepanmed is an injectable solution, a colourless to slightly yellow liquid, supplied in 2 ml ampoules (glass).
Each carton contains 3 or 6 ampoules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 most recent revision of this leaflet: October 2017.
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/