CLINDAMICINA 1% Żel

Treść ulotki

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

clindamicina same 1% gel

clindamicina

Read this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is CLINDAMICINA SAME and what is it used for

CLINDAMICINA SAME is a gel to be applied to the skin that contains the active ingredient clindamycin. Clindamycin is an antibiotic with a strong antibacterial effect against the main bacterium responsible for acne (Propionebacterium acnes). CLINDAMICINA SAME is indicated for the local treatment of acne (acne vulgaris).

2. What you need to know before using CLINDAMICINA SAME

Do not use CLINDAMICINA SAME

• if you are allergic to clindamycin or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to lincomycin.
• if you have suffered from inflammatory bowel disorders (enteritis, ulcerative colitis and colitis associated with the use of antibiotics including pseudomembranous colitis).

Warnings and precautions
Talk to your doctor or pharmacist before using CLINDAMICINA SAME.

• Avoid contact of this medicine with the eyes, mouth, nostrils and mucous membranes as it may be irritating. If this happens, wash thoroughly with water.
• Inform your doctor if you experience redness, dryness of the skin, burning sensation.
• If you experience diarrhea, immediately inform your treating doctor, who will perform appropriate investigations to exclude the presence of inflammation of the intestine called pseudomembranous colitis. Your doctor may tell you to stop taking the medicine.
• Use this medicine with caution if you have a predisposition to allergies.
• The use, especially if prolonged, of products to be applied to the skin can give rise to sensitization phenomena (allergy to one or more components) (see section 4 “Possible side effects”).
• Do not exceed the recommended doses.

Children
In early infancy, administer the medicine only if absolutely necessary and under the direct control of the doctor.

Other medicines and CLINDAMICINA SAME
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Following the application of clindamycin to the skin, the appearance of microbial resistance to other related antibiotics such as lincomycin and erythromycin administered systemically is possible. In the case of lincomycin, similar undesirable effects are also possible.
Clindamycin has the property of causing neuromuscular blockade (muscle paralysis) and can increase the effect of medicines specifically used for this purpose (for example: ether, tubocurarine, pancuronium): therefore, it must be used with caution in patients who are using these medicines.
If you are using other medicines for the skin, apply CLINDAMICINA SAME at a different time of the day.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. If you are pregnant, use this medicine only if absolutely necessary and under the direct control of the doctor.
It is not known whether clindamycin after application to the skin can pass into breast milk; however, as this happens with many medicines, do not use the medicine during breastfeeding or stop breastfeeding.

Driving and using machines
CLINDAMICINA SAME does not impair the ability to drive vehicles or operate machinery.

CLINDAMICINA SAME contains propylene glycol, methyl parahydroxybenzoate and propyl
parahydroxybenzoate
This medicine contains 50 mg of propylene glycol per gram.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).

3. How to use CLINDAMICINA SAME

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.

CLINDAMICINA SAME must not be taken orally.
Apply 1-2 times a day, as directed by your doctor, a thin layer of CLINDAMICINA
SAME gel to the affected areas.
Wash and dry the skin before applying the medicine.

If you use more CLINDAMICINA SAME than you should
Clindamycin on the skin can be absorbed in sufficient quantity to produce systemic effects.
Undesirable effects do not depend on the amount of CLINDAMICINA SAME applied, therefore problems
resulting from an overdose are rare.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist .

If you forget to use CLINDAMICINA SAME
Do not use a double dose to make up for a missed dose

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the use of clindamycin on the skin, the following side effects may occur:

• eye irritation
• abdominal pain, stomach and intestinal problems, nausea
• infections caused by bacteria such as inflammation of the hair follicles (folliculitis) due to Gram-negative bacteria
• skin irritation (erythema, erythema multiforme, urticaria), swelling of the face, throat and lips, dry skin or flaking, burning sensation, oily skin, allergic skin reaction (contact dermatitis)
• cases of diarrhea, diarrhea with blood and colitis (including pseudomembranous colitis). In these cases, you should immediately stop this medicine and inform your doctor to initiate appropriate therapy with the administration of antibiotics (vancomycin orally) and fluids and electrolytes (to restore those lost as a result of diarrhea). Symptoms may appear after a few days, weeks or months after starting treatment with clindamycin. It has also been observed that they can appear even a few weeks after stopping clindamycin therapy.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
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 CLINDAMICINA SAME

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.
The expiry date refers to the product in intact packaging, correctly stored.
Store this medicine at a temperature not exceeding 30° C.
Do not dispose of any medicine in 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 pack and other information

What CLINDAMICINA SAME contains

• The active ingredient is clindamycin. 100 g of gel contains 1.188 g of clindamycin phosphate equivalent to 1.000 g of clindamycin.
• The other ingredients are: glycerol, propylene glycol (E1520), carbomer, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate, sodium hydroxide (pH adjuster), purified water.

Description of the appearance of CLINDAMICINA SAME and contents of the pack
CLINDAMICINA SAME is a gel contained in a 30 gram tube.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Savoma Medicinali S.p.A. - Via Baganza, 2/A - 43125 Parma

Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)