20 mg / ml shampoo
Ketoconazole

1. What Fungoral is and what it is used for

Fungoral is a shampoo used for dandruff. It can also be prescribed by a doctor for dandruff. Dandruff is caused by the fungus Malassezia which normally occurs in the scalp. In most cases, it does not cause any problems, but sometimes the skin can react. When this happens, dandruff and symptoms such as itching and flaking occur.

Ketoconazole contained in Fungoral may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Fungoral

Do not use Fungoral

  • if you are allergic to ketoconazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Avoid getting shampoo in your eyes. If this happens, rinse immediately with plenty of water.

Stop taking Fungoral and contact a doctor immediately if you get any of the following symptoms ( angioedema )

Pregnancy and breastfeeding

Pregnancy

Fungoral shampoo can be used during pregnancy.

Breast-feeding

Fungoral shampoo can be used by women who are breastfeeding.

Driving and using machines

Fungoral does not affect the ability to drive and use machines.

3. How to use Fungoral

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

Teens and Adults:

For dandruff: Wet hair and scalp and massage the shampoo thoroughly into the scalp. Let it work for 3-5 minutes before rinsing. Usually, about 5 ml (a teaspoon) of shampoo is enough. You can wash your hair with your regular shampoo either before or after the treatment. Treat your hair twice a week for 2-4 weeks to get rid of the symptoms. You can then use Fungoral once a week or as needed to prevent a recurrence.

You must contact a doctor if the symptoms worsen or do not improve within 1 month.

Use for children

Fungoral should not be used by children under 12 years of age.

If you use more Fungoral than you should

Fungoral is a shampoo that should be rinsed out after treatment.

If you or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

4. Possible side effects

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

Uncommon (affects less than 1 user in 100): Local reactions such as redness, irritation, and itching. Inflamed hair follicles, burning sensation in the skin, dry skin, rash, hair loss or altered hair quality, increased tear flow.

Rare (affects less than 1 in 1,000 people): Local reactions such as blistering and hypersensitivity. Hypersensitivity reactions, altered taste perception, eye irritation, acne, contact dermatitis, skin flaking.

Has been reported (occurs in unknown numbers of users): hives, altered hair color, allergic reactions with swelling of the face and mouth ( angioedema ).

5. How to store Fungoral

Do not store above 25 ° C.

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

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is ketoconazole . 1 ml of shampoo contains 20 mg of ketoconazole .
  • The other ingredients are sodium lauryl ether sulfate, disodium monolauryl ether sulphosuccinate, coconut fatty acid diethanolamide, lauridimonium hydrolyzed animal collagen, Macrogol 120 methyl glucose dioleate, hydrochloric acid, sodium hydroxide, sodium chloride, preservatives (dyes), and water.

What the medicine looks like and the contents of the pack

The shampoo has a reddish color.

Fungoral shampoo is available in packs of 60 ml and 120 ml.

Marketing Authorisation Holder

Trimb Healthcare AB

Box 16184

103 24 Stockholm

Tel: 08-12135200

Email: medical@trimb.se

Manufacturer

Lusomedicamenta – Sociedade Técnica Pharmacêutica,

SA, Estrada Consiglieri Pedroso 69 B,

Queluz de Baixo, 2730-055 Barcarena, Portugal

Muhammad Nadeem

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