Package Insert: Information for the User

Treclinac 10 mg/g + 0.25 mg/g Gel

clindamicina/tretinoína

Read this package insert carefully before starting to use the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

Treclinac contains clindamycin and tretinoin as active ingredients.

Clindamycin is an antibiotic. It limits the growth of bacteria associated with acne and the inflammation caused by these bacteria.

Tretinoin normalizes the growth of surface skin cells and stimulates the normal elimination of cells that block hair follicles in acne-prone areas. This prevents the accumulation of sebum and the formation of early acne lesions (pimples and blackheads).

These active ingredients are more effective when combined than when used separately.

Treclinacis applied to the skin to treat acne in patients aged 12 years and above.

Do not use Treclinac:

• If you are pregnant.
• If you plan to become pregnant.
• If you are allergic to clindamycin, tretinoin, or any of the other components of this medication (listed in section 6).
• If you are allergic to lincomycin.
• If you have chronic inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis).
• If you have a history of colitis with previous antibiotic use, characterized by significant or abnormal diarrhea, or abdominal pain.
• If you, or a family member, have ever had skin cancer.
• If you have acute eczema, characterized by inflamed, red, dry, and scaly skin.
• If you suffer from rosacea, a skin condition that affects the face and is characterized by redness, pimples, and flaking.
• If you have any other acute inflammatory skin conditions (e.g. folliculitis), especially around the mouth (perioral dermatitis).
• If you have certain forms of acne vulgar characterized by pustular or nodulocystic acne lesions (conglobata and fulminant acne).

If you are in any of the above situations, do not use this medication and consult your doctor.

Warnings and precautions

• Avoid contact of this medication with the mouth, eyes, mucous membranes, and damaged or eczematous skin. Be careful when applying to sensitive skin areas. In case of accidental eye contact, rinse the area with plenty of warm water.
• If you are a fertile woman, do not use Treclinac unless you are using a contraceptive method (see also section "Pregnancy, breastfeeding, and fertility").
• If you experience prolonged or significant diarrhea, or abdominal cramps, discontinue use of this medication and consult your doctor immediately.
• If you have atopic eczema (chronic inflammation and itching of the skin), consult your doctor before using this medication.
• Avoid exposure to natural or artificial light (such as a sunlamp). This is because this medication may make your skin more susceptible to sunburns and other adverse effects of the sun.

Whenever you are outdoors, use a sunscreen with a Sun Protection Factor (SPF) of at least 30, along with protective elements (e.g. a hat).

If, despite these measures, you get a sunburn on your face, discontinue medication until your skin is healed.

• Inform your doctor if you experience an acute skin inflammation when using this medication.
• Treclinac should not be applied at the same time as other products used on the skin, including cosmetics (see also the section "Using Treclinac with other medications").

Using Treclinac with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription or herbal medications. This is because Treclinac may affect the mechanism of action of other medications. Similarly, other medications may affect the way Treclinac works.

If you have used any product containing sulfurs, salicylic acid, benzoyl peroxide, or resorcinol, or any abrasive chemical agents, you need to wait until the effect of these has diminished before starting to use this medication. Your doctor will tell you when to start using Treclinac.

During treatment with Treclinac, do not use cleaners or medicated soap solutions that have a strong drying effect. Be cautious when using the following products that have a drying effect: abrasive soaps, soaps, and cosmetics, and products with high concentrations of alcohol, astringents, spices, or minerals.

Consult your doctor before using this medication with other medications containing erythromycin or metronidazole, aminoglycosides, other antibiotics, or corticosteroids, or if you are receiving neuromuscular blocking medications, such as muscle relaxants used in anesthesia.

Warfarin or similar medications - used to thin the blood- you are more likely to have a hemorrhage. Your doctor may need to perform regular blood tests to check that your blood is clotting properly.

Pregnancy, breastfeeding, and fertility

Do not use Treclinac if you are pregnant or plan to become pregnant. Your doctor may provide you with more information.

Do not use this medication if you are breastfeeding. It is unknown whether Treclinac can pass into breast milk and cause harm to the newborn.

If you are a fertile woman, adopt contraceptive measures while using this medication and for one month after completing treatment.

Driving and operating machinery

It is unlikely that Treclinac will have any effect on your ability to drive or operate machinery.

Treclinac contains parahydroxybenzoic acid methyl ester, parahydroxybenzoic acid propyl ester, butylhydroxytoluene, and polysorbate 80

This medication may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester (E218) and parahydroxybenzoic acid propyl ester (E216).

This medication may cause local skin reactions (such as contact dermatitis), or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene (E321).

This medication may cause allergic reactions because it contains polysorbate 80 (E433).

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Apply a quantity of Treclinac equivalent to the size of a pea daily, at bedtime.

Administration method

Wash your face carefully with a mild soap and warm water, and dry the skin with light touches of a towel. Deposit a quantity of medication equivalent to the size of a pea on the tip of your finger. Apply the gel lightly, depositing it on the forehead, chin, nose, and both cheeks, and then extend it evenly over the entire face.

Do not use more than the amount suggested by your doctor, nor use it more frequently than indicated. Excessive medication may irritate the skin, without providing faster or better results.

Treatment duration

To achieve optimal results with Treclinac, it is necessary to use the product properly and not interrupt its application as soon as you start to see improvement in acne. Normally, it may take several weeks to achieve optimal effect. In some cases, up to 12 weeks may be required. Consult your doctor if symptoms persist for more than 12 weeks, as your doctor will need to reevaluate your treatment.

If you use more Treclinac than you should

You will not get faster or better results if you apply more Treclinac than recommended. If you apply too much, redness, peeling, or discomfort may occur. In these cases, wash your face carefully with a mild soap and warm water. Use of this medication will be interrupteduntil all these symptoms have disappeared.

A overdose may also have as a consequence secondary effects in the stomach and intestine: including stomach pain, nausea, vomiting, and diarrhea.In such cases, discontinue use of this medicationand you should contact your doctor.

Treclinacis indicated only for use on the skin. In case of accidental ingestion, contact your doctor or go to a medical center, or call the Toxicological Information Service. Phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Treclinac

If you forgot to use Treclinac at bedtime, you should apply the next dose at the usual time. Do not apply a double dose to compensate for the missed dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Infrequent: may affect up to 1 in 100 people

• Acne, dry skin, skin redness, increased sebum production, photosensitivity reaction, itching, exanthema, exfoliative exanthema, skin exfoliation, sunburn.
• Reactions at the application site, such as, burning, inflamed skin, dryness, and skin redness.

Rare: may affect up to 1 in 1,000 people

• Hypersensitivity.
• Hypothyroidism (symptoms that may include fatigue, weakness, weight gain, dry hair, rough and pale skin, hair loss, increased sensitivity to cold).
• Headache.
• Eye irritation.
• Gastroenteritis (inflammation of any part of the gastrointestinal tract), nausea.
• Skin inflammation, herpes simplex (fever), macular exanthema (small, flat, red spots), skin hemorrhages, skin burning sensation, skin pigment loss, irritated skin.
• Symptoms at the application site such as irritation, swelling, superficial skin injury, color change, itching, peeling.
• Sensation of heat, pain.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es . By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C. Do not freeze.

Keep the tube perfectly closed.

Do not use this medication after the expiration date that appears on the box and on the tube after “CAD”. The expiration date is the last day of the month indicated.

Expiration after first opening:3 months.

Medicines should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications.This will help protect the environment.

Composition of Treclinac

• The active principles are clindamicina and tretinoína.

1 g of gel contains 10 mg (1%) of clindamicina (as phosphate of clindamicina) and 0.25 mg (0.025%) of tretinoína.

• The other components are: purified water, glycerol, carbomer, methyl parahydroxybenzoate (E 218), polisorbate 80 (E433), disodium edetate, anhydrous citric acid, propyl parahydroxybenzoate (E 216), butylhydroxytoluene (E321), trometamol.

Appearance of Treclinac and contents of the container

This medicine is a yellow translucent gel.

This medicine is available in aluminum tubes containing 30 g or 60 g of gel.

Only some container sizes may be marketed.

Holder of the Marketing Authorization and responsible for manufacturing

Holder of the Marketing Authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

MEDA Pharma GmbH & Co.KG

Benzstrasse, 1

61352 Bad Homburg (Germany)

or

Madaus GmbH

Lütticher Straße 5

53842 Troisdorf

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Last review date of this leaflet:October 2024

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es