Clarema

Package leaflet: Information for the user

CLAREMA 1% cream

Heparan sulfate
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• 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 any improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. WHAT CLAREMA IS AND WHAT IT IS USED FOR

CLAREMA contains the active substance eparan sulfate and is a medicine with anti-varicose (preventing the formation of varicose veins) and vasoprotective (protective action on blood vessels) properties.
CLAREMA is used for the local treatment of:

• Phlebitis with thrombosis (presence of blood clots within veins).
• Thrombophlebitis (inflammation of veins associated with blood clot formation).
• Venous ectasia (dilation of veins) of the lower limbs.
• Skin conditions of vascular origin, such as superficial periphlebitis (inflammation of the connective tissue surrounding veins), inflammatory edema (fluid accumulation due to inflammation), and stasis dermatitis (superficial skin inflammation).
• Traumatic hematomas (collections of blood in an organ or tissue following trauma).
• Post-thrombotic limb disorders (a set of late clinical manifestations following a thrombotic process affecting the deep venous system of a limb).

2. WHAT YOU NEED TO KNOW BEFORE USING CLAREMA

Do not use CLAREMA

• If you are allergic to the active substance (heparan sulfate) or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to heparin or heparinoids (anticoagulant drugs).
• In case of bleeding, on open wounds and mucous membranes, as well as on sites of infection with suppurative processes (inflammations with pus formation).

Warnings and precautions
Talk to your doctor or pharmacist before using CLAREMA.
The use of CLAREMA in the presence of hemorrhagic phenomena (bleeding from blood vessels) must be carefully evaluated.
Immediately discontinue treatment if sensitization reactions (abnormal reactivity to the product) occur.
The use, especially if prolonged, of any topical (local) products may lead to such reactions (see section 4 “Possible side effects”).
Keep this medicine out of the sight and reach of children.

Other medicines and CLAREMA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Interaction studies have not been conducted. No interactions or incompatibilities with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use CLAREMA only if clearly needed and under direct medical supervision.
There is insufficient information regarding the excretion of Heparan sulfate in breast milk.
The risk to newborns/infants cannot be excluded.
If you are breastfeeding, use CLAREMA only if clearly necessary and under direct medical supervision.

Driving and using machines
CLAREMA cream does not affect or affects negligibly the ability to drive and use machinery.

CLAREMA contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which may cause allergic reactions (including delayed-type reactions).

3. HOW TO USE CLAREMA

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
To open the tube for the first time, pierce the protective membrane of the tube using the perforator located in the top part of the cap.
Apply an appropriate amount of cream to the affected skin area and surrounding regions, gently massaging until completely absorbed.
Repeat the application 2–3 times daily.
If you use more CLAREMA than you should
Cases of overdose have not been reported.
In case of accidental ingestion/absorption of an excessive dose of CLAREMA, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of CLAREMA, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
During treatment with CLAREMA, skin rashes and urticaria may occur. The frequency of such effects cannot be estimated because sufficient data are not available.
The use, especially if prolonged, of topical products may lead to irritative and sensitization phenomena; in such cases, discontinue treatment and initiate appropriate therapy (see "Warnings and precautions").
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide further information on the safety of this medicine.

5. HOW TO STORE CLAREMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of
that month and to the product kept unopened and correctly stored.
No special storage precautions are required.
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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What CLAREMA contains
100 g of cream contain:
Active substance: heparan sulfate 1 g.
Excipients: ethylene glycol palmitostearate and polyethylene glycol; polyoxyethylene saturated glycerides; mineral oil;
methyl p-hydroxybenzoate; propyl p-hydroxybenzoate; purified water.
Description of the appearance of CLAREMA and contents of the pack
White cream, contained in a 30 g aluminium tube with screw cap.
Marketing Authorization Holder and Manufacturer
FARMACEUTICI DAMOR S.p.A.
Via E. Scaglione, 27 - 80145 Naples.