Label: information for the user

Tarmed 40 mg/g shampoo

coal tar

Read this label carefully before starting to use this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if it worsens or does not improve after 15 days.

1. What it isTarmed shampooand what it is used for

2. What you need to know before starting to useTarmed shampoo

3. How to useTarmed shampoo

4. Possible adverse effects

5. Storage ofTarmed shampoo

6. Contents of the package and additional information

It is a medicinal shampoothat contains coal tar as its active ingredient, which helps to reduce excessive scaling of the scalp.

Tarmed is indicated for scaling alterationsof the scalp, such as relief from itching and scaling of the skin in psoriasis (a red condition, often with silvery scales), seborrheic dermatitis (inflammation and scaling) and dandruff.

In particular, Tarmed shampoo is indicated for:

- Treatment of mild to moderate psoriasis redness, thickening, and scaling.

- Relief of itching, irritation, scaling, and redness in seborrheic dermatitis and dandruff.

- Maintenance treatment of chronic atopic eczema or atopic dermatitis (chronic skin eruption with itching) under medical supervision.

No use Tarmedshampoo

If you are allergic to coal tar (coal tar) or any of the other components of this medication (listed in section 6).

Do not use Tarmed if you have any of the following skin problems:

• Active and inflamed psoriasis or exudative eczema
• Acute or painful pustular psoriasis
• Sunlight sensitivity
• Folliculitis or common acne

Warnings and precautions

Consult your doctor or pharmacist before starting to use Tarmed.

Topical use, exclusively on the scalp.

If irritation occurs, stop using Tarmed and consult your doctor.

Avoid contact with the eyes and mucous membranes. If accidental contact with the eyes occurs, rinse with plenty of water.

Do not apply the shampoo to open wounds or skin infections, except under medical supervision.

Tarmed may temporarily stain light hair, skin, and clothing.

Tarmed may cause sun allergy reactions if shampoo residue remains on the scalp. Therefore, thoroughly rinse the hair to completely remove the shampoo after washing. Additionally, exercise caution when exposing the treated area to the sun (even on cloudy days) or UVA lamps.

Children

Do not use Tarmed in children under 12 years, as its efficacy and safety have not been established.

Other medications and Tarmed shampoo

Inform your doctor or pharmacistif you are using, have used recently, or may need to use any other medication.

Tarmed may increase your skin's sensitivity to sunlight. Concurrent use with photosensitizing medications (which produce an allergic reaction to sunlight; e.g., tetracyclines, methoxsalen, or tretinoin, systemic or topical) may produce additive photosensitizing effects:

• Thiazides (a diuretic)
• Some antibiotics, including tetracyclines, fluoroquinolones, and sulfonamides.
• Phenothiazines (used to treat certain mental disorders).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

No information is available on the safety of Tarmedin pregnant women.

Do not use Tarmedshampoo if you are pregnant, unless the expected benefit to the mother outweighs the risk to the fetus.

Do not use Tarmed shampoo during the first trimester of pregnancy.

The ingredients in Tarmed may pass into breast milk.

If used during breastfeeding, ensure the breast is thoroughly rinsed to remove any remaining product before breastfeeding.

Driving and operating machinery

Not applicable.

Tarmed shampoo contains sodium lauryl sulfate 70%, benzyl alcohol, ethanol, and fragrance

This medication contains 150 mg of sodium lauryl sulfate 70% in each gram of shampoo.

Sodium lauryl sulfate may cause local skin reactions (such as itching or burning sensation) or increase reactions to other medications when applied to the same area.

This medication contains 10 mg of benzyl alcohol in each gram of shampoo.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

This medication contains 29 mg of ethanol in each gram of shampoo.

Ethanol may cause a burning sensation on damaged skin.

This medication contains fragrances with 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, Amilcinamaldehyde, Benzyl alcohol, Benzyl salicylate, Citronellol, d-Limonene, Geraniol, Hexyl cinnamaldehyde, Hydroxycitronellal, and Linalool.

3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, Amilcinamaldehyde, Benzyl alcohol, Benzyl salicylate, Citronellol, d-Limonene, Geraniol, Hexyl cinnamaldehyde, Hydroxycitronellal, and Linalool may cause allergic reactions.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

- Adults and children 12 years of age and older:

Use Tarmed shampoo on the scalp once or twice a week.

The usual duration of treatment is 4 weeks, at the end of which you should observe improvement. If you need a longer treatment, it should be done under medical supervision.

How to apply Tarmed shampoo

Cutaneous use (exclusively on the scalp).

1. Moisten the hair well.
2. Apply a sufficient amount of shampoo to produce abundant foam. The foam should cover the scalp, hair, and adjacent areas, if they are also affected.
3. Massage the scalp and adjacent areas, if necessary, with the fingertips.
4. Rinse the hair and scalp thoroughly with abundant water.

5. Repeat steps 2 to 4, allowing the product to act for a few minutes before rinsing.Considering the two applications, the time the shampoo should be in contact with the scalp should be around 3-5 minutes.

6. Rinse thoroughly.

Use in children and adolescents

Do not use this shampoo in children under 12 years of age (see section 2).

If you use more Tarmed than you should

If you use more Tarmed than you should, you may increase the risk of skin irritation and photosensitivity.

The ingestion of Tarmed may cause nausea and vomiting. In case of accidental ingestion, induce vomiting and administer abundant amounts of water and antacids.

In case of overdose or accidental ingestiongo immediately to a medical center orconsult immediately with your doctor or pharmacist, orcall the Toxicological Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

If you forget to use Tarmed

Do not apply a double dose to compensate for the missed doses.

If you forget to use Tarmed, apply the next dose the following day.

If you have any other questions about the use of thismedication, ask your doctor or pharmacist.

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

Rare Adverse Effects(may affect up to 1 in 1,000 people):

-Severe Allergic Reactions:hypersensitivity; symptoms may include:

• raised, itchy rash
• swelling of the face or mouth (angioedema)
• difficulty breathing.

• If you experience these symptoms,contact a doctor immediately. Stop using Tarmed immediately.

- Other Adverse Effects:

• eye irritation
• unusual hair loss or thinning
• itchy skin rash (dermatitis)
• changes in hair color
• abnormal hair texture
• sensitivity to sunlight
• skin irritation, with possible dryness, redness, itchiness, or burning sensation in the skin
• skin pain, rash, or inflammation at the application site.

Adverse Effects of Unknown Frequency:

• inflammation of hair follicles (foliculitis)
• generalized pustular psoriasis
• alteration of varicose vein status.

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 for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about 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 use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tarmed 40 mg/g shampoo

• The active ingredient is coal tar solution. Each gram contains 40 mg of coal tar solution (4%).
• The other components are: polisorbate 80 (E-433), denatured alcohol (contains ethanol and methanol), lauril ether sodium sulfate 70%, cocamidopropyl betaïne, dihydrogen phosphate, citric acid monohydrate, benzyl alcohol, polyethylene glycol (PEG) 150 diestearate, hexylene glycol, oleic alcohol, poliquaternium-10, fragrance AF17050 (contains 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, Amilcinamaldehyde, Benzyl alcohol, Benzyl salicylate, Citronellol, d-Limonene, Geraniol, Hexyl cinnamaldehyde, Hydroxycitronellal, and Linalol) and purified water.

Appearance of the product and contents of the packaging

Tarmed is a shampoo; it is viscous, homogeneous, and brown in color.

It is presented in 150 ml bottles.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2- 18

61118 Bad Vilbel

Germany

Last review date of this leaflet: October 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.