Package leaflet: Information for the patient

clindamicina same 1% gel

clindamicina
Read this leaflet carefully before using 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, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

CLINDAMICINA SAME is a topical gel containing the active substance clindamycin.
Clindamycin is an antibiotic with strong antibacterial activity against the main bacterium responsible
for acne (Propionibacterium acnes). CLINDAMICINA SAME is indicated for the local treatment of acne
(acne vulgaris).

2. What you should 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 previously suffered from inflammatory bowel disorders (enteritis, ulcerative colitis, or antibiotic-associated colitis including pseudomembranous colitis).

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

Avoid contact of this medicine with eyes, mouth, nostrils, and mucous membranes, as it may be irritating. If contact occurs, wash thoroughly with water.
Inform your doctor if you experience redness, dry skin, or a burning sensation.
If you develop diarrhoea, inform your doctor immediately. The doctor will carry out appropriate investigations to rule out the presence of an intestinal inflammation called pseudomembranous colitis. The doctor may instruct you to stop taking the medicine.
Use this medicine with caution if you are prone to allergies.
Use of topical products, especially if prolonged, may lead to sensitization reactions (allergy to one or more components) (see section 4 “Possible side effects”).
Do not exceed the recommended doses.

Children
In very early infancy, administer this medicine only when strictly necessary and under direct medical supervision.

Other medicines and CLINDAMICINA SAME
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
After applying clindamycin to the skin, development of microbial resistance to related antibiotics such as lincomycin and erythromycin administered systemically may occur. When lincomycin is used, similar adverse effects may also appear.
Clindamycin has the potential to cause neuromuscular blockade (muscle paralysis) and may enhance the effect of medicines specifically used for this purpose (e.g., ether, tubocurarine, pancuronium); therefore, it should be used with caution in patients receiving these medicines.
If you are using other topical medicines, apply CLINDAMICINA SAME at a different time of day.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine. If you are pregnant, use this medicine only when strictly necessary and under direct medical supervision.
It is not known whether clindamycin passes into breast milk after topical application; however, since this occurs with many medicines, do not use this medicine during breastfeeding or discontinue breastfeeding.

Driving and using machines
CLINDAMICINA SAME does not affect 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 exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
CLINDAMICINA SAME must not be taken orally.
Apply a thin layer of CLINDAMICINA SAME gel to the affected areas 1-2 times daily, as directed by your doctor.
Wash and dry the skin before applying the medicine.
If you use more CLINDAMICINA SAME than you should
Clindamycin applied to the skin may be absorbed in amounts sufficient to produce systemic effects.
However, adverse effects are not directly related to the amount of CLINDAMICINA SAME applied, so problems due to overdose are rare.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you forget to use CLINDAMICINA SAME
Do not use a double dose to make up for the missed dose.

4. Possible side effects

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

eye irritation
abdominal pain, stomach and intestinal problems, nausea
infections caused by bacteria such as inflammation of hair follicles (folliculitis) due to Gram-negative bacteria
skin irritation (erythema, erythema multiforme, urticaria), swelling of the face, throat and lips, dry or peeling skin, burning sensation, oily skin, allergic skin reaction (contact dermatitis)
cases of diarrhoea, bloody diarrhoea and colitis (including pseudomembranous colitis). In such cases, you must immediately stop using this medicine and contact your doctor to initiate appropriate therapy with antibiotics (oral vancomycin) and fluids and electrolytes (to replace those lost due to diarrhoea). Symptoms may appear after a few days, weeks or even months following the start of treatment with clindamycin. It has also been observed that they may occur several weeks after discontinuation of clindamycin therapy. Following the instructions provided in this leaflet helps reduce the risk of side effects.

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 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 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 its original, unopened packaging, correctly stored.
Store this medicine at a temperature not exceeding 30°C.
Do not dispose of any medicine 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 CLINDAMICINA SAME contains

The active substance is clindamycin. 100 g of gel contain 1.188 g of clindamycin phosphate, equivalent to 1.000 g of clindamycin.
The other components are: glycerol, propylene glycol (E1520), carbomer, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate, sodium hydroxide (pH regulator), 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 Authorization Holder and Manufacturer
Marketing Authorization 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)