PRISMA 30 mg /Ml Injectable Solution

Зміст інструкції

1. Prisma 24 mg hard capsules, 50 mg hard capsules
   1. What is Prisma and what is it for
   2. What you need to know before taking Prisma
   3. How to take Prisma
   4. Possible side effects
   5. How to store Prisma
   6. Contents of the pack and other information
2. Prisma 30 mg/ml injectable solution for intramuscular use
   1. What is Prisma and what is it for
   2. What you need to know before taking Prisma
   3. How to take Prisma
   4. Possible side effects
   5. How to store Prisma
   6. Contents of the pack and other information

Prisma 24 mg hard capsules, 50 mg hard capsules

Mesoglican

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Prisma is and what it is used for
• 2. What you need to know before you take Prisma
• 3. How to take Prisma
• 4. Possible side effects
• 5. How to store Prisma
• 6. Contents of the pack and other information

1. What is Prisma and what is it for

Prisma contains the active substance mesoglycan and belongs to the class of medicines called
"antithrombotics", used in the prevention and treatment of blood clots (thrombi) that
can form inside blood vessels.
Prisma is indicated in the treatment of chronic venous ulcers, i.e. tissue lesions that do not
heal through normal regeneration and cicatrization phases, and which occur in
association with a venous pathology.

2. What you need to know before taking Prisma

Do not take Prisma if:

• you are allergic to mesoglycan or any of the other ingredients of this medicine (listed in section 6);
• you are allergic to heparin or other medicines with an anticoagulant action similar to that of heparin (heparinoids);
• you have a predisposition to or suffer from diseases that cause bleeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Prisma.

Stop taking Prisma immediately and contact your doctor if you experience:
the appearance of skin rashes or other serious allergic reactions (hypersensitivity reactions), as
in such cases your doctor will subject you to appropriate therapy.

Other medicines and Prisma
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are taking anticoagulant medicines, as taking them
concurrently with Prisma may enhance their effect; in such cases your doctor will
subject you to periodic checks of your blood coagulation parameters.
The use of Prisma with other medicines with effects on coagulation must be carried out with caution.

Children and adolescents
The safety and efficacy of Prisma have not been established in children and adolescents under the age of
18 years.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The safety of using mesoglycan during pregnancy has not been established, therefore
the use of Prisma during pregnancy is not recommended.
It has not been established whether mesoglycan is excreted in breast milk, therefore
the use of Prisma during breastfeeding is not recommended.

Driving and using machines
No studies have been performed on the ability to drive vehicles and use machines.

Prisma contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

3. How to take Prisma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

Prisma 24 mg hard capsules
The recommended dose is 1 capsule, twice a day.
The doctor may decide to modify this dosage.

Prisma 50 mg hard capsules
The recommended dose is 1 capsule, one or two times a day.
The doctor may decide to modify this dosage.

Use in children and adolescents
The safety and efficacy of Prisma have not been established in children and adolescents under the age of
18 years.

If you take more Prisma than you should
No cases of Prisma overdose are known.
In case of accidental ingestion/intake of an excessive dose of Prisma, immediately
inform your doctor or go to the nearest hospital. In hospital, you will be subjected to normal intervention protocols (e.g. gastric lavage) and will be kept under strict medical supervision, receiving
supportive therapy if necessary.

If you forget to take Prisma
Do not take a double dose to make up for a missed dose.

If you stop taking Prisma
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.

Stop treatment with Prisma and consult your doctor immediately if during treatment you experience:

• symptoms of angioedema, such as swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat with resulting difficulty swallowing or breathing (frequency cannot be defined based on available data).

Below are listed the side effects found with the use of Prisma:

Common (may affect up to 1 in 10 people)

• abdominal pain, pain in the upper abdomen, indigestion (dyspepsia).

Uncommon (may affect up to 1 in 100 people)

• headache (cephalalgia);
• heart racing sensation (palpitations);
• low blood pressure (hypotension), symptoms preceding loss of consciousness (pre-syncope);
• feeling unwell (nausea), diarrhea;
• itching, nodular rash (urticaria), rash, skin irritation (erythema);
• general malaise.

Rare (may affect up to 1 in 1,000 people)

• feeling dizzy (vertigo);
• skin disease causing the formation of red spots of varying sizes (purpura);
• abnormal, heavy and prolonged uterine bleeding between two consecutive menstrual cycles (metrorrhagia).

Not known (frequency cannot be defined based on available data):

• fluid accumulation in the eyelids (palpebral edema);
• numbness or tingling of the limbs, arms and legs (paresthesia);
• nosebleed (epistaxis);
• arm and leg pain;
• fluid retention (edema).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Prisma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after “Exp.”. The
expiry date refers to the last day of that month.
The expiry date indicated refers to the medicine in intact packaging, correctly
stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Prisma contains

• The active ingredient is mesoglycan (sodium salt). Each 24 mg hard capsule contains 24 mg of mesoglycan (sodium salt). Each 50 mg hard capsule contains 50 mg of mesoglycan (sodium salt).
• The other ingredients are: lactose monohydrate, corn starch, sodium croscarmellose, magnesium stearate, gelatin, titanium dioxide, erythrosine.

Description of the appearance of Prisma and contents of the pack
Prisma is presented in the form of hard capsules contained in blisters.
Prisma 24 mg hard capsules are available in packs of 50 capsules.
Prisma 50 mg hard capsules are available in packs of 30 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
NEOPHARMED GENTILI S.P.A.
Via San Giuseppe Cottolengo, 15
20143 Milano

Manufacturer
Mediolanum Farmaceutici S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milano
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto dè Stampi, Rozzano (MI)
VAMFARMA S.r.l.,
Via Kennedy 5
26833 Comazzo (Lodi)

Prisma 30 mg/ml injectable solution for intramuscular use

Mesoglycan

Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Prisma is and what it is used for
• 2. What you need to know before you use Prisma
• 3. How to use Prisma
• 4. Possible side effects
• 5. How to store Prisma
• 6. Contents of the pack and other information

1. What is Prisma and what is it for

Prisma contains the active ingredient mesoglycan and belongs to the class of medicines called
"antithrombotics", used in the prevention and treatment of blood clots (thrombi) that
can form inside blood vessels.
Prisma is indicated in the treatment of chronic venous ulcers, i.e. tissue lesions that do not
heal through normal regeneration and cicatrization phases, and which occur in
association with a venous pathology.

2. What you need to know before taking Prisma

Do not take Prisma if:

• you are allergic to mesoglycan or any of the other ingredients of this medicine (listed in section 6);
• you are allergic to heparin or other medicines with an anticoagulant action similar to that of heparin (heparinoids);
• you have a predisposition to or suffer from diseases that cause bleeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Prisma.

Stop taking Prisma immediately and contact your doctor if you experience:
the appearance of skin rashes or other serious allergic reactions (hypersensitivity reactions), because
in such cases the doctor will subject you to appropriate therapy.

Other medicines and Prisma
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are taking anticoagulant medicines, as taking them
concurrently with Prisma may enhance their effect; in such cases, your doctor will
subject you to periodic checks of your blood coagulation parameters.
The use of Prisma with other medicines with effects on coagulation must be carried out with caution.

Children and adolescents
The safety and efficacy of Prisma have not been established in children and adolescents under the age of
18 years.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The safety of mesoglycan use during pregnancy has not been established, therefore
the use of Prisma during pregnancy is not recommended.
It has not been established whether mesoglycan is excreted in breast milk, therefore
the use of Prisma during breastfeeding is not recommended.

Driving and using machines
No studies have been conducted on the ability to drive vehicles and use machines.

Prisma contains:
chlorocresol. Chlorocresol is a substance that can cause allergic reactions ;
sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically
"sodium-free".

3. How to take Prisma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 vials per day for intramuscular use. The doctor may decide to
modify this dosage.

Use in children and adolescents
The efficacy and safety of Prisma have not been established in children and adolescents under the age of
18 years.

If you take more Prisma than you should
No cases of Prisma overdose are known.
In case of accidental ingestion/administration of an excessive dose of Prisma, immediately
inform your doctor or go to the nearest hospital. In hospital, you will be subjected to normal
intervention protocols (e.g., gastric lavage) and will be kept under strict medical supervision, receiving
supportive therapy if necessary.

If you forget to take Prisma
Do not take a double dose to make up for a missed dose.

If you stop taking Prisma
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.
li manifestino.

Stop treatment with Prisma and consult your doctor immediately if during the
treatment you experience:

• symptoms of angioedema, such as swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat with resulting difficulty swallowing or breathing (frequency cannot be defined based on available data).

Below are listed the side effects observed with the use of Prisma:

Common (may affect up to 1 in 10 people)

• abdominal pain, pain in the upper abdomen, difficulty in digestion (dyspepsia). Uncommon (may affect up to 1 in 100 people)
• headache;
• heart palpitations;
• low blood pressure (hypotension), symptoms preceding loss of consciousness (pre-syncope);
• feeling unwell (nausea), diarrhea;
• itching, nodular rash (urticaria), rash, skin irritation (erythema);
• general malaise.

Rare (may affect up to 1 in 1,000 people)

• feeling of dizziness;
• skin disease that causes the formation of patches of varying sizes of red color (purpura);
• abnormal, heavy and prolonged uterine bleeding between two consecutive menstrual cycles (metrorrhagia).

Not known (frequency cannot be defined based on available data):

• fluid accumulation in the eyelids (palpebral edema);
• numbness or tingling of the limbs, arms and legs (paresthesia);
• nosebleeds (epistaxis);
• pain in arms and legs;
• fluid retention (edema).
• pain at the injection site of the medicine, hematoma at the injection site.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.it/it/responsabili .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Prisma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”. The
expiry date refers to the last day of that month.
The expiry date indicated refers to the medicine in intact packaging, correctly
stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

7. Contents of the pack and other information

What Prisma contains

• The active ingredient is mesoglycan (sodium salt). Each 1 ml vial contains 30 mg of mesoglycan (sodium salt).
• The other ingredients are: sodium chloride, chlorocresol, water for injections.

Description of the appearance of Prisma and contents of the pack
Prisma is a clear, colorless to straw-yellow injectable solution contained in dark glass vials.
Each pack contains 10 vials.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
NEOPHARMED GENTILI S.P.A.
Via San Giuseppe Cottolengo, 15
20143 Milano

Manufacturer
Mediolanum Farmaceutici S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milano
Biologici Italia Laboratories S.r.l.
Via F. Serpero, 2
20060 Masate (Milano)