Package leaflet: Information for the patient

FLAMINASE 30 mg gastro-resistant tablets

Seaprose S
Please read this leaflet carefully before taking 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 yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What FLAMINASE is and what it is used for

Flaminase contains the active substance seaprose S, which is an anti-inflammatory agent.
Flaminase is used in acute and chronic respiratory diseases to help liquefy mucus (secretolytic effect).
The medicine is used to treat inflammation and swelling caused by fluid accumulation (oedema and tumescence) in various conditions:

Bone fractures, oedema and bruising (haematomas) following surgery
Inflammation with pus accumulation around the teeth and gums (abscess), following tooth extraction, delayed, difficult or irregular tooth eruption
Acute and chronic inflammation of the nasal and ear mucosa
Inflammation of the veins (thrombophlebitis)
Breast swelling with increased pressure (mammary engorgement), surgical incision to assist childbirth (episiotomy)
Bladder inflammation (cystitis)

2. What you should know before taking FLAMINASE

Do not take Flaminase

if you are allergic to seaprose S or to any of the other ingredients of this medicine (listed in section 6)
if you have haemophilia or a tendency to excessive bleeding (haemorrhagic diathesis)
if you have severe kidney disease or liver disease
if you suffer from peptic ulcer.

Warnings and precautions
Talk to your doctor or pharmacist before using Flaminase.
Other medicines and Flaminase
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
This medicine should be administered only if clearly needed and under direct medical supervision.
Driving and using machines
Flaminase does not affect the ability to drive or operate machinery.
Flaminase contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take FLAMINASE

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults
The recommended daily dose for adults is 1 to 3 tablets, taken in two or more divided doses, or as
advised by the doctor.
Use in children and adolescents
The recommended daily dose for children is 0.5–2 mg/kg body weight, taken in two or more divided
doses, or as advised by the doctor.
Always swallow Flaminase gastro-resistant tablets whole, without splitting or chewing, with an
adequate amount of liquid.
If you take more Flaminase than you should
If you or someone else has taken more Flaminase tablets than prescribed, contact a doctor or go to
the nearest hospital immediately, taking the packaging with you if possible.
If you forget to take Flaminase
Do not take a double dose to make up for the missed tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Allergic skin reactions may occur in predisposed individuals.
The side effects are:

Mild gastrointestinal disturbances such as anoressia (loss of appetite), stomach ache, heartburn, nausea, vomiting and diarrhoea
Allergic skin reactions may occur in predisposed individuals.

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:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FLAMINASE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP:.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Flaminase contains

The active substance is seaprose S. One tablet contains 30 mg of seaprose S.
The other components are: maltose, carboxymethylcellulose calcium, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, sodium hydroxide.

Description of the appearance of Flaminase and package contents
Gastro-resistant tablets
20 tablets of 30 mg in PVC/PE/PVDC and aluminium blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GRÜNENTHAL ITALIA S.r.l.
Via Vittor Pisani 16 - 20124 Milan
Manufacturer
FARMACEUTICI FORMENTI S.p.A.
Production site: Origgio (VA)
Via Di Vittorio 2, Italy
Laboratorio Farmacologico Milanese S.r.l.
Via Monterosso, 273 – Caronno P. (VA)
Quality control: FARMACEUTICI FORMENTI S.p.A.
Production facility: Origgio (VA) – Via Di Vittorio, 2