TARMED 40 MG/G SHAMPOO

Introduction

Package Leaflet: Information for the User

Tarmed 40 mg/g Shampoo

coal tar

Read the package leaflet carefully before starting to use this medicine because it contains important information for you.

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the Package Leaflet

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

1. What is Tarmed Shampoo and what is it used for

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

Tarmed is indicated in scaling disorders of the scalp, such as relief of itching and scaling of the skin in psoriasis (red, often scaly patches), seborrheic dermatitis (inflammatory, scaly eruption), and dandruff.

In particular, Tarmed Shampoo is indicated in:

• Treatment of redness, thickening, and scaling of mild to moderate psoriasis.
• Relief of itching, irritation, scaling, and redness in seborrheic dermatitis and dandruff.
• Maintenance treatment of atopic eczema or atopic dermatitis (itchy skin eruption) under medical supervision.

2. What you need to know before using Tarmed Shampoo

Do not use Tarmed Shampoo

If you are allergic to coal tar or any of the other components of this medicine (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
• photosensitivity
• folliculitis or common acne.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Tarmed.

For cutaneous use only, exclusively on the scalp.

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

Avoid getting the shampoo in contact with the eyes and mucous membranes. If it accidentally comes into contact with the eyes, rinse with plenty of water.

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

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

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

Children

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

Other Medicines and Tarmed Shampoo

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Tarmed may increase the sensitivity of your skin to sunlight. Its simultaneous use with photosensitizing medicines (which produce an allergic reaction to sunlight; e.g., tetracyclines, methoxsalen, or tretinoin, systemic or topical) may produce additive photosensitizing effects:

• thiazides (a diuretic)
• certain antibiotics, including tetracyclines, fluoroquinolones, and sulfonamides.
• phenothiazines (used to treat some mental illnesses).

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is no information on the safety of Tarmed in pregnant women.

Treatment with Tarmed Shampoo is not recommended if you are pregnant, unless the expected benefit to the mother is greater than the risk to the fetus.

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

It is not known whether the ingredients of Tarmed can pass into breast milk.

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

Driving and Using Machines

Not applicable.

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

This medicine contains 150 mg of sodium lauryl ether sulfate 70% per gram of shampoo.

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

This medicine contains 10 mg of benzyl alcohol per gram of shampoo.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

This medicine contains 29 mg of alcohol (ethanol) per gram of shampoo.

Ethanol may cause a burning sensation on damaged skin.

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

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

3. How to use Tarmed Shampoo

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and children over 12 years:

Use Tarmed Shampoo on the scalp one or two times a week.

The usual duration of treatment is 4 weeks, after which improvement should be observed. If longer treatment is needed, it should be done under medical supervision.

How to apply Tarmed Shampoo

For cutaneous use only (exclusively on the scalp).

1. Wet the hair thoroughly.
2. Apply enough shampoo to produce a rich lather. The lather should cover the scalp, hair, and adjacent areas, if also affected.
3. Massage the scalp and adjacent areas, if necessary, with your fingertips.
4. Rinse the hair and scalp with plenty of water.

1. Repeat steps 2-4, leaving the product on for a few minutes before rinsing. Considering the two applications, the shampoo should be in contact with the scalp for about 3-5 minutes.
2. 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 chances of experiencing skin irritation and photosensitivity.

Ingestion of Tarmed may cause nausea and vomiting. In case of accidental ingestion, induce vomiting and administer plenty of water and antacids.

In case of overdose or accidental ingestion, go immediately to a medical center or consult your doctor or pharmacist, or call the Toxicology 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 make up for forgotten doses.

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects(may affect up to 1 in 1,000 people):

• Severe allergic reactions: hypersensitivity; signs may include:
  • raised, itchy rash
  • swelling of the face or mouth (angioedema)
  • difficulty breathing.

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

• Other side 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, itching, or burning sensation
  • skin pain, rash, or inflammation at the application site.

Side effects with unknown frequency:

• folliculitis
• generalized pustular psoriasis
• varicose status alteration.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tarmed Shampoo

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for disposal. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

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 ingredients are: polysorbate 80 (E-433), denatured alcohol (contains ethanol and methanol), sodium lauryl ether sulfate 70%, cocamidopropyl betaine, disodium hydrogen phosphate, citric acid monohydrate, benzyl alcohol, polyethylene glycol (PEG) 150 distearate, hexylene glycol, oleic alcohol, polyquaternium-10, fragrance AF17050 (contains 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, Amyl cinnamaldehyde, Benzyl alcohol, Benzyl salicylate, Citronellol, d-Limonene, Geraniol, Hexyl cinnamaldehyde, Hydroxy citronellal, and Linalool), and purified water.

Appearance of the product and pack contents

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

It is available in 150 ml bottles.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Date of last revision of this package leaflet:October 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.