Package leaflet: Information for the patient

PAF 500 mg/ml Concentrate for cutaneous solution

Bisbutilcarboetilene
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

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, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after 7 days.

Contents of this leaflet:

What PAF is and what it is used for
What you need to know before using PAF
How to use PAF
Possible side effects
How to store PAF
Contents of the pack and other information

1. What PAF is and what it is used for

PAF contains the active substance bisbutilcarboetilene, which belongs to a group of medicines called
antiscabietic ectoparasiticides.
This medicine is indicated for the treatment of skin infestations caused by parasites (parasitic dermatoses), and in particular the infestation caused by Sarcoptes scabiei (S. hominis).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using PAF

Do not use PAF

if you are allergic to bisbutilcarboetilene or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using PAF.
If someone in your family or community has a parasitic infestation (parasitic infestation), it may spread to other members. In such cases, it is advisable that all members of the group undergo treatment with this medicine.
Do not allow this medicine to come into contact with plastic materials: dilute the solution using only glass containers, not plastic ones. Do not use plastic spoons to stir the liquid.
Apply this medicine only to the skin. PAF may be applied to the entire body except the head. Do not apply PAF to mucous membranes.
Do not ingest, inhale, or inject this medicine.
Thoroughly change underclothing, bed linen, and clothing worn in the days prior to treatment with PAF.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction (sensitization phenomena) following the use of this medicine.
Children
This medicine may also be applied to children's skin.
Other medicines and PAF
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between PAF and other medicines are known.
Interaction studies have not been conducted.
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 using this medicine.
Pregnancy
PAF must not be used during pregnancy unless recommended by your doctor.
Breastfeeding
PAF must not be used unless your doctor decides that the benefits outweigh the potential risks to the newborn (see section "Do not use PAF").
Driving and using machines
PAF does not affect or affects negligibly the ability to drive vehicles and use machinery.
PAF contains Polysorbate
This medicine contains Polysorbate 80. Polysorbates may cause allergic reactions.

3. How to use PAF

Use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
Apply this medicine to the skin only.
Pour the contents of the bottle into a glass container with 150 ml of water and stir for a few minutes with a spoon (not plastic) until a homogeneous, milky-looking liquid is obtained. Use only glass containers and not plastic ones for this procedure.
Do not use plastic spoons to stir the liquid.

First application:
For the first application, use half of the freshly prepared liquid.
Using a cotton ball, evenly spread the freshly prepared liquid over the entire body with gentle massage, avoiding the head. Pay particular attention to the areas of skin most affected, and allow it to dry in the air.

Second application:
12 hours after the first application, shake the remaining liquid well and repeat the application following the same procedure as the first application.

PAF may also be used without bathing, as it is equally effective and leaves no residue on the skin and/or clothing.
A single treatment (two applications 12 hours apart) may be sufficient to relieve symptoms of infestation.

Consult your doctor if you do not notice any improvement, if symptoms worsen, if symptoms recur repeatedly, or if they change.

Use in children
This medicine can also be used in children.

If you use more PAF than you should
There are no known cases of overdose.
In case of accidental ingestion/ingestion of PAF, contact your doctor immediately or go to the nearest hospital.

If you forget to use PAF
Do not use a double dose to make up for the missed application.
If you have any doubts 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 following side effects may occur:

burning sensation with skin redness;
itching;
skin inflammation (dermatitis);
allergic reactions (sensitization phenomena) with prolonged and/or repeated use. In such cases, stop treatment and inform your doctor, who will prescribe appropriate therapy.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store PAF

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.
Store in the original packaging to protect the medicine from light.
The prepared solution for application, if properly stored, must be used within 24 hours.
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 PAF contains

The active substance is bisbutilcarboetilene. 1 ml of concentrate for cutaneous solution contains 500 mg of bisbutilcarboetilene.
The other components are: chlorobutanol, polysorbate 80.

Description of the appearance of PAF and contents of the pack
5 ml glass bottle of solution.
Marketing Authorization Holder
Lofarma S.p.A., Viale Cassala, 40, 20143 Milan – Italy
Manufacturer
Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A., Via Licinio 11, 22036 Erba (CO) – Italy