Prisma

Package leaflet: Information for the patient

Prisma 24 mg hard capsules, 50 mg hard capsules

Mesoglycan
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 taking 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 Prisma is and what it is used for

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

2. What you need to know before taking Prisma

Do not take Prisma if:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Prisma.
Stop taking Prisma immediately and contact your doctor if you experience:
skin rashes or other serious allergic reactions (hypersensitivity reactions), as
in such cases your doctor will initiate appropriate treatment.
Other medicines and Prisma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking anticoagulant medicines, as concomitant use with Prisma may enhance their effect; in such cases, your doctor will perform periodic monitoring of your blood coagulation parameters.
The use of Prisma together with other medicines affecting blood coagulation should be done with caution.
Children and adolescents
The safety and efficacy of Prisma have not been established in children and adolescents under 18 years of age.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist 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 on the ability to drive or operate machinery have been conducted.
Prisma contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Prisma

Take this medicine exactly as directed by 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 daily.
Your doctor may decide to adjust this dose.
Prisma 50 mg hard capsules
The recommended dose is 1 capsule once or twice daily.
Your doctor may decide to adjust this dose.
Use in children and adolescents
The safety and efficacy of Prisma have not been established in children and adolescents under
18 years of age.
If you take more Prisma than you should
There are no known cases of overdose with Prisma.
In case of accidental ingestion or intake of an excessive dose of Prisma, inform your doctor immediately or go to the nearest hospital. In hospital, you will receive standard treatment procedures (e.g., gastric lavage) and will be kept under close medical supervision; supportive therapy will be administered if necessary.
If you forget to take Prisma
Do not take a double dose to make up for the missed dose.
If you stop taking Prisma
If you have any questions 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 everyone experiences them.
Stop treatment with Prisma and consult your doctor immediately if you experience any of the
following during treatment:

• symptoms of angioedema, such as swelling of the hands, feet, ankles, or even the face, lips, tongue, and/or throat, leading to difficulty in swallowing or breathing (frequency cannot be determined from available data).

The following are side effects reported with the use of Prisma:
Common (may affect up to 1 in 10 people)

• abdominal pain, upper abdominal pain, difficulty in digestion (dyspepsia).

Uncommon (may affect up to 1 in 100 people)

• headache;
• sensation of pounding heartbeat (palpitations);
• low blood pressure (hypotension), symptoms preceding loss of consciousness (pre-syncope);
• feeling unwell (nausea), diarrhoea;
• itching, raised itchy rash (urticaria), skin rash, skin irritation (erythema);
• general malaise.

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

• sensation of dizziness (vertigo);
• skin disease causing red spots of varying size (purpura);
• abnormal, heavy and prolonged uterine bleeding between two consecutive menstrual cycles (metrorrhagia).

Not known (frequency cannot be determined from available data):

• fluid accumulation in the eyelids (periorbital oedema);
• numbness or tingling of limbs, arms and legs (paraesthesia);
• nosebleed (epistaxis);
• pain in arms and legs;
• fluid accumulation (oedema).

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.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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
The stated expiry date applies to the medicine stored in its original intact packaging and kept under the recommended storage conditions.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Prisma contains

• The active substance 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: monohydrate lactose, maize starch, sodium croscarmellose, magnesium stearate, gelatin, titanium dioxide, erythrosine.

Description of the appearance of Prisma and contents of the pack
Prisma is available as 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.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEOPHARMED GENTILI S.P.A.
Via San Giuseppe Cottolengo, 15
20143 Milan

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

Patient Information Leaflet

Prisma 30 mg/ml injectable solution for intramuscular use

Mesoglycan
Please read this leaflet carefully before using this medicine, as 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 others, even if their symptoms are the same as yours, as 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 Prisma is and what it is used for
2. What you need to know before using Prisma
3. How to use Prisma
4. Possible side effects
5. How to store Prisma
6. Package contents and other information

1. What Prisma is and what it is used for

Prisma contains the active substance mesoglycan and belongs to a class of medicines known as "antithrombotic agents", used in the prevention and treatment of blood clots (thrombi) that may form within blood vessels.
Prisma is indicated for the treatment of chronic venous ulcers, i.e. tissue lesions that do not heal through the normal phases of regeneration and healing, and which occur in association with venous disease.

2. What you need to know before taking Prisma

Do not take Prisma if:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Prisma.
Stop taking Prisma immediately and contact your doctor if you experience:
skin rashes or other severe allergic reactions (hypersensitivity reactions), as in such cases your doctor will start you on appropriate treatment.

Other medicines and Prisma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking anticoagulant medicines, as concomitant use with Prisma may enhance their effect; in such cases, your doctor will perform periodic checks of your blood coagulation parameters.
The use of Prisma together with other medicines affecting blood coagulation should be done with caution.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of mesoglycan during pregnancy has not been established; therefore, the use of Prisma during pregnancy is not recommended.
It is not known whether mesoglycan is excreted in breast milk; therefore, the use of Prisma during breastfeeding is not recommended.

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

Prisma contains:
chlorocresol. Chlorocresol is a substance that may 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 exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 ampoules daily for intramuscular use. Your doctor may decide to adjust this dose.
Use in children and adolescents
The efficacy and safety of Prisma have not been established in children and adolescents under 18 years of age.
If you take more Prisma than you should
There are no known cases of overdose with Prisma.
In case of accidental ingestion/overdose of Prisma, inform your doctor immediately or go to the nearest hospital. In the hospital, standard medical procedures (e.g., gastric lavage) will be performed and you will be kept under close medical supervision; supportive therapy will be administered if necessary.
If you forget to take Prisma
Do not take a double dose to make up for the missed dose.
If you stop using Prisma
If you have any questions 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 you experience :

• symptoms of angioedema, such as swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat, leading to difficulty in swallowing or breathing (frequency cannot be estimated from the available data).

The following side effects have been reported with the use of Prisma:
Common (may affect up to 1 in 10 people)

• abdominal pain, upper abdominal pain, difficulty in digestion (dyspepsia).
  Uncommon (may affect up to 1 in 100 people)

• headache (cephalalgia);

• sensation of heart beating in the throat (palpitations);

• low blood pressure (hypotension), symptoms preceding loss of consciousness (pre-syncope);

• feeling of discomfort (nausea), diarrhoea;

• itching, nodular skin rash (urticaria), skin rash, skin irritation (erythema);

• general malaise.

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

• sensation of dizziness (vertigo);
• skin disorder causing the appearance of red spots of variable size (purpura);
• abnormal, heavy and prolonged uterine bleeding between two consecutive menstrual cycles (metrorrhagia).

Not known (frequency cannot be estimated from the available data):

• fluid accumulation in the eyelids (periorbital edema);
• numbness or tingling of limbs, arms and legs (paraesthesia);
• nosebleed (epistaxis);
• pain in arms and legs;
• fluid accumulation (edema);
• pain at the injection site, bruising at the injection site.

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.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 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.
The expiry date stated applies to the medicine kept in its original intact packaging and stored correctly.
This medicine requires no special storage conditions.
Do not dispose of any medicine via 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 substance is mesoglycan (sodium salt). Each 1 ml vial contains 30 mg of mesoglycan (sodium salt).
• The other components are: sodium chloride, chlorocresol, water for injections.

Description of the appearance of Prisma and contents of the pack
Prisma is a clear, colourless or 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 Milan
Manufacturer
Mediolanum Farmaceutici S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan
Biologici Italia Laboratories S.r.l.
Via F. Serpero, 2
20060 Masate (Milan)