TERBINAFINE MOBERG PHARMA 98 mg/mL CUTANEOUS SOLUTION

2. What you need to know before starting to use Terbinafine Moberg Pharma

Do not useTerbinafine Moberg Pharma

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Terbinafine Moberg Pharma if:

• the part of the nail closest to the cuticle is affected
• you have diabetes
• you have a disease that affects the immune system or are taking medication that may affect the immune system
• you have poor circulation, swelling, or ulcers on the legs or feet (peripheral vascular disease)
• you have damaged, painful, or severely damaged nails
• you have psoriasis, which causes itching and scaly patches on the skin, or any other chronic skin disease
• you have yellow nails with swelling and breathing difficulties (yellow nail syndrome)

Terbinafine Moberg Pharma is for use on nails only. Avoid contact with the eyes and mucous membranes. In case of contact with the eyes or mucous membranes, rinse thoroughly with running water.

Children and adolescents

Terbinafine Moberg Pharma should not be used in children and adolescents under 18 years of age, due to lack of experience in this age group.

Other medications and Terbinafine Moberg Pharma

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

It is unlikely that Terbinafine Moberg Pharma will interact with or be affected by other medications you are using, as it only acts locally on the nail.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. The use of Terbinafine Moberg Pharma during pregnancy and breastfeeding may be considered if your doctor thinks it is necessary. Do not allow infants to come into contact with treated areas. Make sure infants do not suck on treated nails.

Driving and using machines

Terbinafine Moberg Pharma does not affect your ability to drive or use machines.

Terbinafine Moberg Pharma contains propylene glycol

This medication contains 0.7 g of propylene glycol per milliliter of solution.

3. How to use Terbinafine Moberg Pharma

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

For use on fingernails and toenails only.

Before applying Terbinafine Moberg Pharma, remove any nail polish or other cosmetic products from the nails and surrounding skin.

Dosage Adults- Apply a thin layer once a dayto the entire surface of the affected nails and under the free edge of the nail, using the tip of the tube. - Do not apply to the surrounding skin. - Wait about 5 minutes until the solution has dried completely. - The treated nails should not be washed or moistened for at least 8 hours. Therefore, it is recommended to apply at night before bedtime and after showering or bathing. Do not apply Terbinafine Moberg Pharma to the nail bed if the affected nail or parts of the affected nail have detached from the underlying nail bed.

Treatment duration should continue until each treated nail is clean or has improved significantly, and a new, healthy nail has grown. In general, the treatment duration for fingernails is about 6 months, while for toenails it is 9 to 12 months. You may experience some improvement after 12 weeks, but the nail takes longer to heal completely.

If you use more Terbinafine Moberg Pharma than you should

Due to the way this medication is used, it is very unlikely that an overdose will occur. If you or anyone else accidentally ingests the solution, contact your doctor or hospital immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to use Terbinafine Moberg Pharma

If you miss an application, apply the solution as soon as possible on the same day. Then, continue treatment as before.

Do not take a double dose to make up for missed doses.

If you stop using Terbinafine Moberg Pharma

Do not stop using Terbinafine Moberg Pharma before the infected nails are free of visible disease, or before your doctor or pharmacist advises you to do so.

Fungal nail infections can recur if you do not use the solution regularly or if you stop treatment too soon.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects may occur with the following frequencies:

Common (may affect up to 1 in 10 people)

• white or yellowish discoloration of the nail
• detachment of the nail from the nail bed
• separation of a part of the nail that may cause the free edge of the nail to detach
• inflammation of the nail fold or cuticle, with or without bacterial infection
• red rash with itching as a reaction to the medication
• redness of the skin

Uncommon (may affect up to 1 in 100 people)

• nail disorders and skin reactions around the treated nails: skin irritation, skin inflammation, skin itching

Some side effects, such as nail discoloration and nail detachment, can also be caused by the fungal infection.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es.

5. Storage of Terbinafine Moberg Pharma

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

Do not use this medication after the expiration date stated on the tube and carton. The expiration date is the last day of the month indicated.

Store below 25°C. Do not freeze.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Terbinafine Moberg Pharma

• The active ingredient is terbinafine. One milliliter of solution contains terbinafine hydrochloride equivalent to 98 mg of terbinafine.

• The other ingredients are propylene glycol (E 1520), urea, lactic acid, disodium edetate (EDTA), sodium hydroxide (for pH adjustment), and purified water.

Appearance and package contents

Terbinafine Moberg Pharma is a clear, colorless cutaneous solution packaged in plastic tubes with a silicone tip applicator and closed with a plastic cap.

Package sizes: 5 ml, 10 ml

Not all package sizes may be marketed.

Marketing authorization holder

Moberg Pharma AB

Gustavslundsvägen 42

167 51 Bromma

Sweden

Manufacturer

C.P.M. Contract Pharma GmbH

Fruehlingstrasse 7

83620 Feldkirchen-Westerham

Germany

Date of last revision of this leaflet:June 2023

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