RUSCOROID

Package leaflet: Information for the patient

Ruscoroid 10 mg/g + 10 mg/g rectal cream

ruscogenin + tetracaine hydrochloride
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 instructed.

• 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, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What Ruscoroid is and what it is used for

Ruscoroid contains two active substances: ruscogenin, which reduces inflammation, protects blood vessels and relieves congestion; and tetracaine, which reduces pain.
Ruscoroid belongs to a class of medicines called "anti-haemorrhoidals" (for the treatment of haemorrhoids and anal fissures) for topical use.
Ruscoroid is used to treat disorders associated with haemorrhoids, anal fissures and inflammation of the rectum (proctitis), such as itching, pain and a feeling of heaviness.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Ruscoroid

Do not use Ruscoroid

• if you are allergic to ruscogenin, tetracaine, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Ruscoroid.
Use this medicine only after consulting your doctor in the following cases:

• if you are under 12 years of age (see "Children");
• if you are pregnant or breastfeeding (see "Pregnancy, breastfeeding and fertility").

Do not use the medicine for prolonged treatments. If there is no noticeable improvement after a short period of treatment, consult your doctor.
The use, especially if prolonged, of topical products applied to the skin may lead to skin allergies (local irritation), worsening symptoms, or the appearance of generalized skin redness and itching. In such cases, discontinue treatment and consult your doctor, who will prescribe an appropriate therapy.

Children
Ruscoroid should be used in children under 12 years of age only when strictly necessary and under direct medical supervision.

Other medicines and Ruscoroid
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No disturbances (interactions) related to the concomitant use of Ruscoroid with other medicines have been reported.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, use Ruscoroid only after consulting your doctor.

Driving and using machines
Ruscoroid has no known negative effects on the ability to drive vehicles or operate machinery.

Ruscoroid 10 mg/g + 10 mg/g contains cetyl alcohol.
It may cause localized skin reactions (e.g. contact dermatitis).

Ruscoroid 10 mg/g + 10 mg/g contains methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate.
These may cause allergic reactions (including delayed reactions).

Ruscoroid 10 mg/g + 10 mg/g cream contains fragrance Rosemary 7144.
This medicine contains a fragrance (Rosemary 7144), which itself contains allergens that may cause allergic reactions. For the complete list of allergens, see section 6.

3. How to use Ruscoroid

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years: 1 - 2 applications per day.
Apply directly or using the special applicator that screws onto the tube.
Warning: Do not exceed the recommended doses without medical advice.
Use only for short-term treatment.
Consult your doctor if symptoms recur or if you notice any recent changes in their characteristics.
Use in children under 12 years of age
Ruscoroid should only be used on medical advice.
If you use more Ruscoroid than you should
Cases of overdose are not known.
In the event of accidental ingestion/overdose of Ruscoroid, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not
everyone experiences them.
Rare cases of allergic reactions (sensitization) have been reported, such as localised and generalised skin redness (erythema) associated with itching.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet,
please contact your doctor or pharmacist. You may also report adverse reactions directly
via the national reporting system at the following website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Ruscoroid

Keep this medicine out of the sight and reach of children.
Store below 25°C.
The shelf life after first opening is 6 months.
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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ruscoroid contains

• The active substances are ruscogenin and tetracaine. 100 g of cream contain 1 g of ruscogenin and 1 g of tetracaine hydrochloride.
• The other components are: cetyl alcohol, polysorbate 80, macrogol 400, macrogol 4000, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, Rosemary 7144* fragrance, purified water. *Fragrance Rosemary 7144 contains the following allergens: amyl cinnamal, cinnamyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, geraniol, hexyl cinnamal, hydroxycitronellal, d-limonene, linalool (see section 2).

Description of the appearance of Ruscoroid and contents of the pack
Ruscoroid is a cream for rectal use.
Pack contents: one 40 g tube.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen (Netherlands)
Manufacturer
Sanofi Winthrop Industrie - Amilly (France)