Document: Terbinafin Bluefish tablet ENG PL change

• Terbinafin BMM Pharma tablet PL
• Terbinafin Bluefish tablet ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Terbinafin Bluefish 250 mg tablets

Terbinafine

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

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Terbinafin Bluefish is and what it is used for

2. What you need to know before you take Terbinafin Bluefish

3. How to take Terbinafin Bluefish

4. Possible side effects

6. Content of the pack and other information

Terbinafine belongs to the group of medicines called antifungal agents and is used to treat fungal infections of the skin and nails. When taken by mouth, it reaches the site of infection in concentrations strong enough to kill the fungus or stop it growing.

Terbinafin Bluefish tablets are used to treat fungal infections of the fingernails and toenails.

Terbinafin Bluefish are also used to treat tinea (ringworm) infections of the groin and other areas of the skin, and the feet (athlete’s foot).

Terbinafine tablets are not effective against Pityriasis versicolor (a skin disease caused by the yeast fungus Malassezia ovale).

Do not use Terbinafin Bluefish

• If you are allergic (hypersensitive) to terbinafine or any of the other ingredients of Terbinafin Bluefish

• If you suffer from severely impaired liver or kidney function

Warnings and precautions

Talk to you doctor or pharmacists or nurse before taking Terbinafin Bluefish:

If you have

• Liver or kidney problems

• Psoriasis

Stop taking the tablets and contact your doctor immediately if you:

• Develop any of the following: itching, a feeling of sickness that won't go away, reduced appetite, tiredness, yellowing of the whites of the eyes or skin, being sick, fatigue, stomach pain, nausea, vomiting, dark urine or pale coloured stools (poo).

• Develop a high temperature (fever) or sore throat or serious skin reactions (Stevens-Johnsons syndrome).

Other medicines and Terbinafin Bluefish

Tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without a prescription.

Terbinafin Bluefish can affect or be affected by some medicines which contain the following active ingredients:

• rifampicin (used to treat tuberculosis)

• cimetidine (used to treat stomach ulcers)

• tricyclic antidepressants such as clomipramine or amitriptylin

• antidepressants called serotonin reuptake inhibitors (SSRI) e.g. paroxetine

• certain medicines called monoamine oxidase inhibitors e.g. selegiline used to treat Parkinson´s disease.

• beta receptor blockers (used to treat high blood pressure and some heart conditions)

• antiarrhythmics (medicines used to treat heart irregular heart beat)

• cyclosporine (a medicine used to control your body’s immune system in order to prevent rejection of transplanted organs)

• fluconazole, ketoconazole (medicines used to treat fungal infections)

• amiodarone (medicine to treat heart problems)

• caffeine

If you are taking the oral contraceptive pill while taking Terbinafin Bluefish, break-through bleeding and irregular periods may occur.

Pregnancy, breast-feeding and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

Do not take Terbinafin Bluefish if you are pregnant unless specifically advised by your doctor.

Do not take Terbinafin Bluefish if you are breast-feeding as it passes into breast milk.

Driving and using machines

Terbinafin Bluefish has no or negligible effect on the ability to drive a car or operate machinery.

Always take Terbinafin Bluefish exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage is determined by the doctor who will adjust it to your individual needs.

The usual dose for adults (including the elderly) is one 250mg tablet once daily. The length of your course of treatment will depend on the nature and severity of infection. Usual course lengths are as follows:

Athlete's foot, ringworm, ringworm of the groin

Take for 2-4 weeks. Some types of athlete's foot may require up to 6 weeks treatment. Signs of the infection may not disappear until several weeks after completing the course of treatment.

Nail infection

Fingernails: usually take for 6 weeks.

Toenails: usually take for 12 weeksbut in some cases up to 6 months.

Terbinafine Bluefish is not recommended for children and adolescents (less than 18 years of age).

If you find that Terbinafin Bluefish has too strong or too weak an effect, contact your doctor or pharmacist.

If you take more Terbinafin Bluefish than you should

If you have taken more Terbinafin Bluefish than you should, or if children have been taking medicine by accident, please contact your doctor or the hospital to get an opinion of the risk and advice on action to be taken. If an overdose has been taken there may be signs such as headache, feeling sick, upper chest pain and dizziness.

If you forget to take Terbinafin Bluefish

If you forget to take your tablet(s), take them as soon as you can. Do not take a double dose to make up for a forgotten dose.

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

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

The following side effects have been reported in connection with treatment with Terbinafin Bluefish:

Very common (occur in more than 1 in 10 users): loss of appetite, indigestion, diarrhoea, feeling bloated, stomach ache, feeling sick, allergic skin rashes, itching, joint or muscle pain

Common (occur in more than 1 in 100 users): headache, feeling unwell

Uncommon (occur in fewer than 1 in 100 users): taste loss or taste disturbances

Rare (occur in fewer than 1 in 1000 users): anaphylactic reactions (serious allergic reactions), angioneurotic oedema (swelling of the lips, face, throat or tongue), serious liver problems including severe liver failure, hepatic enzymes increase.

Very rare (occur in fewer than 1 in 10,000 users):worsening of existing psoriasis, serious skin reactions such as Stevens-Johnson syndrome (severe widespread reddening and blistering), toxic epidermal necrolysis (peeling of the surface layer of skin), pustular drug eruption and toxic pustuloderma, hair loss, changes or reduction of numbers and types of certain blood cells (detected through blood tests, bruising or repeated infections such as colds or sore throats), menstrual disturbance (breakthrough bleeding and irregular cycle), cause or worsening of existing skin or systemic lupus erythematosus (large areas of red skin patches, fatigue, dizziness, sensation of tickling, tingling, burning, pricking and partial loss of sensitivity

Not known (cannot be estimated from the available data)

blood creatinine phosphokinase increased, inflammation of the pancreas, hearing impairment, ringing of the ears, inflammation of blood vessels, inability to perceive odor, jaundice (signs include yellowing of the whites of the eyes or skin) or inflammation of the liver, oversensitivity to light, depression, anxiety, influenza like illness and high temperature

You should see your doctor immediately if you experience symptoms of angioedema, such as:

• swollen face, tongue or pharynx

• difficulty to swallow

• hives and difficulties to breath

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE TERBINAFIN BLUEFISH

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

This medical product does not require any special storage conditions.

Do not use Terbinafin Bluefish after the expiry date which is stated on the carton. The expiry date refers to the last day of that 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 PACK AND OTHER INFORMATION

What Terbinafin Bluefish contains

• The active substance is terbinafine. Each tablet contains 250 mg terbinafine (as terbinafine hydrochloride).

• The other ingredients are microcrystalline cellulose, sodium starch glycolate (type A), hypromellose, colloidal andhydrous silica and magnesium stearate.

What Terbinafin Bluefish looks like and contents of the pack

Terbinafin Bluefish 250 mg tablets are white, circular, biconvex tablets with “TF” on one side and a score line on the other side.

Pack sizes: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 98, 100, 112, 250 and 500 tablets in blister pack.

Not all of the pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bluefish Pharmaceuticals AB

Torsgatan 11

111 23 Stockholm

Sweden

This medical product is authorized in the member states of the EEA under the following names:

Denmark: Terbinafin Bluefish

Finland: Terbinafin Bluefish

Iceland: Terbinafin Bluefish

Norway: Terbinafin Bluefish

Sweden: Terbinafin Bluefish

This leaflet was last revisedin 21 May 2015