Bepamedin

Package leaflet: Information for the patient

Bepamedin 500 mg/2 ml injectable solution

dexpanthenol
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Bepamedin is and what it is used for
2. What you need to know before using Bepamedin
3. How to use Bepamedin
4. Possible side effects
5. How to store Bepamedin
6. Package contents and other information

1. What Bepamedin is and what it is used for

Bepamedin belongs to the therapeutic category of vitamin preparations based on dexpanthenol
(precursor of Vitamin B5).
Bepamedin is used in cases of constipation due to intestinal atony (constipation caused by
insufficient intestinal motility) or postoperative paralytic ileus (temporary reduction or paralysis
of intestinal functions and motility following surgical procedures).

2. What you need to know before using Bepamedin

Do not use Bepamedin

• if you are allergic to dexpanthenol or to any of the other ingredients of this medicine (listed in section 6);
• if you have mechanical ileus (intestinal obstruction due to the presence of an obstacle).

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Do not inject Bepamedin within one hour following administration of succinylcholine (a medicine used in anaesthesia as a neuromuscular blocking agent).
Intravenous administration must be performed only by a physician or qualified personnel. The administration of the medicine and handling of needles must be carried out with caution.
Other medicines and Bepamedin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Due to its ability to promote the synthesis of acetylcholine (a substance acting on the nervous system), Bepamedin may enhance the effects of parasympathomimetic drugs (which stimulate the parasympathetic nervous system). It is not certain whether it enhances the effect of succinylcholine (a medicine used in anaesthesia as a neuromuscular blocking agent).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
There are no data available on the use of dexpanthenol in pregnant women.
Use this medicine during pregnancy only if absolutely necessary.
It is unknown whether dexpanthenol and its metabolites are excreted in breast milk.
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from treatment with Bepamedin, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Driving and using machines
Bepamedin does not impair the ability to drive vehicles or operate machinery.

3. How to use Bepamedin

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
The recommended dose is:
Therapy: 2 vials by intravenous (into the vein) or intramuscular (into the muscle) administration, repeated every 6 hours if necessary.
Prophylaxis of postoperative intestinal atony: 2 vials by intravenous (into the vein) administration during or after surgery (possibly added to the intravenous infusion [medical device used for the administration of liquid substances directly into the vein]).

If you use more Bepamedin than you should
Dexpanthenol is well tolerated and non-toxic, even at high doses. No cases of acute or chronic hypervitaminosis (a condition caused by excessive intake of vitamins) due to panthenol have been reported.
In case of accidental ingestion/overdose of Bepamedin, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use Bepamedin, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
The adverse reactions listed below are derived from spontaneous reports and therefore cannot be organized according to frequency categories.
Immune system disorders and skin and subcutaneous tissue disorders
Allergic reactions and skin reactions have been reported, such as contact dermatitis, allergic dermatitis, pruritus, erythema (redness of the skin), eczema (itchy dermatitis), rash, urticaria, skin irritation, and blistering.
Systemic disorders and administration site conditions
Reactions at the injection and infusion site.
Following the instructions provided in the package leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store Bepamedin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in its original, unopened packaging stored correctly.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Bepamedin contains

• The active substance is dexpantenol. One 2 ml vial contains 500 mg dexpantenol.
• The other components are: d,l-pantothenolactone, water for injections, nitrogen.

Description of the appearance of Bepamedin and contents of the pack
Injectable solution
Bepamedin 500 mg/2 ml solution for injection, pack of 3 vials
Bepamedin 500 mg/2 ml solution for injection, pack of 20 vials
Not all pack sizes may be marketed.

Marketing Authorization Holder
Bayer S.p.A. – Viale Certosa 130 - 20156 Milano
Manufacturer
Doppel Farmaceutici S.r.l
Via Volturno 48 – Quinto De’ Stampi
20089 Rozzano (Mi)