Tarmed 40 mg/g shampoo

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tarmed 40 mg/g Shampoo

coal tar

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

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

Leaflet Contents

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

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

Tarmed is a medicinal shampoo containing coal tar as the active ingredient, which helps reduce excessive scaling of the scalp.

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

Specifically, Tarmed shampoo is indicated for:

• Treatment of redness, thickening, and scaling in mild to moderate psoriasis.
• Relief of itching, irritation, scaling, and redness in seborrheic dermatitis and dandruff.
• Maintenance treatment of controlled chronic atopic eczema or atopic dermatitis (itchy skin rash) (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 (coal tar) or to any of the other ingredients of this medicine (listed in section 6).

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

• active and inflamed psoriasis or exudative eczema (with fluid leakage)
• acute or painful pustular psoriasis (with pus-filled blisters)
• sensitivity to sunlight (photosensitivity)
• inflammation of the hair follicles (folliculitis) or vulgar acne.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Tarmed.

For topical use only on the scalp.

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

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

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

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

Tarmed may cause allergic reactions to sunlight (photosensitivity) if shampoo residues remain on the scalp. Therefore, it is recommended to rinse the hair thoroughly to completely remove the shampoo after washing. In addition, caution should be taken when exposing the treated area to sunlight (even on cloudy days) or to UVA lamps.

Children

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

Other medicines and Tarmed shampoo

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Tarmed may increase your skin's sensitivity to sunlight. Concurrent use with photosensitizing medicines (which cause an allergic reaction to sunlight; for example: tetracyclines, methoxsalen, or topical or systemic retinoids) may produce additive photosensitizing effects:

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 during pregnancy, unless the expected benefit to the mother outweighs the potential risk to the fetus.

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

It is unknown whether the ingredients of Tarmed pass into breast milk.

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

Driving and use of machines

Not applicable.

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

This medicine contains 150 mg of sodium laureth sulfate 70% in each gram of shampoo.

Sodium laureth 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 in each gram of shampoo.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

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

Ethanol may cause a burning sensation on damaged skin.

This medicine contains fragrances composed of 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, Hydroxycitronellal, 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, Hydroxycitronellal, and Linalool may cause allergic reactions.

3. How to use Tarmed shampoo

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and children aged 12 years and older:

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

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

How to apply Tarmed shampoo

For topical use (exclusively on the scalp).

1. Thoroughly wet the hair.

2. Apply a sufficient amount of shampoo to produce abundant lather. The lather should cover the scalp, hair, and adjacent areas if also affected.

3. Gently massage the scalp and adjacent areas, if necessary, using the fingertips.

4. Rinse hair and scalp thoroughly with plenty of water.

5. Repeat steps 2 to 4, leaving the product to act for a few minutes before rinsing. Taking into account the two applications, the total time that the shampoo should remain in contact with the scalp should be about 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 recommended, the risk of skin irritation and photosensitivity may increase.

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

In case of overdose or accidental ingestion, seek immediate medical attention at a healthcare facility, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 missed doses.

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

Rare adverse 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 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 colour
  • abnormal hair texture
  • sensitivity to sunlight
  • skin irritation, possibly with dryness, redness, itching, or even a burning sensation
  • pain, rash, or inflammation at the application site.

Adverse effects with unknown frequency:

• inflammation of hair follicles (folliculitis)
• generalized pustular psoriasis
• worsening of varicose condition.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaRAM.es. By reporting adverse 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the package and other information

Composition of Tarmed 40 mg/g shampoo

• The active substance is coal tar solution. Each gram contains 40 mg of coal tar solution (4%).
• The other components are: polysorbate 80 (E-433), denatured alcohol (containing 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, Amylcinnamaldehyde, Benzyl alcohol, Benzyl salicylate, Citronellol, d-Limonene, Geraniol, Hexyl cinnamaldehyde, Hydroxycitronellal and Linalool) and purified water.

Appearance of the product and contents of the container

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

It is supplied in 150 ml bottles.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Billev Pharma ApS

Slotsmarken 10

2970 Hørsholm

Denmark

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Local representative

UMIP Limited

Landscape House

Baldonnell Business Park

Dublin 22

D22 P3K7

Ireland

Contact: [email protected]

Date of the latest revision of this leaflet: October 2023

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