Package leaflet: Information for the patient

Plactidil 300 mg tablets

picotamide monohydrate
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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Plactidil is and what it is used for

Plactidil contains the active substance picotamide monohydrate, which belongs to a group of medicines called antiplatelet agents. By preventing platelets from sticking together, these medicines reduce the formation of blood clots (a condition known as thrombosis or embolism).
Plactidil is indicated for the treatment of diseases caused by blood clots, known as thrombi or emboli, in which it is beneficial to reduce platelet aggregation and enhance the ability to dissolve these clots.
These disorders include:

myocardial infarction,
venous or arterial thrombosis,
cerebral vascular disorders,
pulmonary emboli,
hardening of the arteries (atherosclerotic states).

2. What you need to know before taking Plactidil

Do not take Plactidil

if you are allergic to picotamide monohydrate or to any of the other ingredients of this medicine (listed in section 6),
if you have a reduced blood clotting ability (haemorrhagic syndromes),
if you have erosions of the stomach lining (peptic ulcer),
if you are pregnant or suspect you may be pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Plactidil.
In case of surgery or dental extractions, it is advisable to stop treatment a few days before the procedure; in any case, inform your surgeon or dentist about your current therapy.

Other medicines and Plactidil
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking aspirin (acetylsalicylic acid) and other antiplatelet or anticoagulant drugs at the same time.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
As a precautionary measure, Plactidil should not be used during pregnancy.
Plactidil contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Plactidil

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 900 to 1200 mg per day, taken orally in three divided doses.
The recommended maintenance therapy dose is 300 to 600 mg per day, taken orally in one or more doses.
If you forget to take Plactidil
Do not take a double dose to make up for the missed dose.
If you stop taking Plactidil
If you have any questions about using 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.
The side effects listed below have been reported with the following frequencies:
Rare: may affect up to 1 in 1,000 people

mild stomach burning

Not known: frequency cannot be estimated from the available data

bleeding (haemorrhage) in various parts of the body (particularly gastrointestinal)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Plactidil

Keep this medicine out of the 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.
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 Plactidil contains

The active substance is picotamide monohydrate. Each tablet contains 315 mg of picotamide monohydrate (equivalent to 300 mg of anhydrous picotamide).
The other ingredients are polyvinylpyrrolidone, maize starch, sodium carboxymethyl starch, magnesium stearate.

Description of the appearance of Plactidil and pack contents
Each pack contains 30 tablets for oral use.
Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia