Package leaflet: Information for the patient

Indusil

30 mg powder and solvent for oral solution
Cobamamide
Read this entire leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

What Indusil is and what it is used for
What you need to know before taking Indusil
How to take Indusil
Possible side effects
How to store Indusil
Contents of the pack and other information

1. What Indusil is and what it is used for

Indusil contains the active substance cobamamide.
Cobamamide is an active form of vitamin B which, by stimulating protein synthesis,
promotes an increase in muscle mass (strong anabolic effect).
Indusil is used in all cases of vitamin B deficiency due to increased demand or reduced
dietary intake.
Consult your doctor if you do not feel better or if you feel worse after a short period of
treatment.

2. What you need to know before taking Indusil

Do not take Indusil

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if you are allergic to other substances with a chemical structure similar to cobamide, particularly cyanocobalamin, hydroxocobalamin, or etio-cobalamin.

Warnings and precautions
Talk to your doctor or pharmacist before taking Indusil:

if you have previously suffered or currently suffer from anaemia, a condition characterized by a reduced amount of haemoglobin in the blood. In such cases, treatment should be carried out under medical supervision; your doctor will carry out tests to determine the exact nature of the anaemia and will evaluate the risks and benefits of treatment in your specific case.

Cobamamide is a particularly unstable active ingredient and is sensitive to light; therefore,
any solution of the product in liquids or its mixing with other foods must be carried out
immediately before administration.
Other medicines and Indusil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Indusil and beverages
Indusil may be added to water, milk, or other liquids (see section "How to take Indusil").
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy, you may take Indusil only at the usual therapeutic doses and only after consulting your doctor, who will assess the necessity of treatment.
Driving and using machines
No effects on the ability to drive or use machinery are known.

3. How to take Indusil

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults: 10-20 drops 2-3 times daily.
Use in children:
10 drops 2-3 times daily.
Caution: Do not exceed the recommended doses without medical advice.
When and for how long
Caution: Use only for short-term treatment.
Consult your doctor if symptoms occur repeatedly or if you notice any recent changes in their characteristics.
The drops may optionally be added to water, milk or other liquid immediately before administration, without altering its taste.

INSTRUCTIONS FOR USE OF INDUSIL DROPS

Black and white drawing showing two hands pouring a liquid from a bottle with a nozzle into another open container with the cap placed beside it

Open two containers and pour the entire contents of the vial with solvent into the vial
containing the powder.

Black and white drawing showing two hands rotating a medical device with gray arrows indicating the rotational movement

Press the dropper firmly into the vial.
Shake gently to obtain the solution.

A hand holds an inverted bottle to pour its contents into a transparent glass held by another hand

At the time of use: remove the cap from the dropper and press to release the drops.
If you take more Indusil than you should
In case of accidental ingestion/overdose of Indusil, contact your doctor immediately or go to the nearest hospital.
If you forget to take Indusil
Do not take a double dose to make up for the forgotten dose.
If you stop using Indusil
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of Indusil, general allergic-type reactions (hypersensitivity reactions) may rarely occur, such as:

fever
lowering of blood pressure (hypotension)
skin rashes
severe and rapid generalized allergic reaction (anaphylaxis).

Some of these side effects are generally temporary. However, if they occur, you should consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Indusil

Store the reconstituted solution (solution prepared by mixing powder and solvent) at a temperature below 25°C in the original packaging to protect the medicine from light.
The shelf life of the reconstituted solution is 30 days.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry". The expiry date refers to the last day of that month.
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 Indusil contains

The active substance is cobamamide. One vial of powder contains 30 mg of cobamamide (after reconstitution, 10 drops contain 1 mg of cobamamide).
The other components are:
- in the powder: mannitol
- in the solvent: benzalkonium chloride, purified water.

Description of the appearance of Indusil and package contents
Indusil is presented as a powder and solvent for oral solution.
The package contains 1 vial of powder, 1 plastic vial of 15 ml of solvent, and a dropper.

Marketing Authorization Holder and Manufacturer
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via M. Civitali, 1 – 20148 Milan, Italy.