What Terbinafine Hexal is and what it is used for
Terbinafine, the active substance in Terbinafine Hexal, is an anti-fungal medicine.
Terbinafine Hexal is used to treat various fungal infections of the skin and nails.
Terbinafine contained in Terbinafine Hexal may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have further questions, and always follow their instructions.
What you need to know before using Terbinafine Hexal
Do not use Terbinafine Hexal
- if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6)
- if you have severely impaired liver function.
Warnings and precautions
Talk to your doctor before taking Terbinafine Hexal if any of the following apply to you:
- you have problems with your kidneys or liver
- you have psoriasis
- you have lupus erythematosus (an autoimmune disease).
Your doctor should check your liver function before you start using Terbinafine Hexal and every four to six weeks during treatment.
Children and young people
Use of Terbinafine Hexal in children is not recommended.
Other medicines and Terbinafine Hexal
Some medicines can affect your treatment. Tell your doctor if you are taking any of the following:
- rifampicin against infection
- cimetidine for stomach problems, e.g. indigestion or stomach ulcers
- certain antidepressants, including tricyclic antidepressants such as desipramine, SSRI preparations (selective serotonin reuptake inhibitors), or certain MAO inhibitors ( monoamine oxidase inhibitors type B)
- certain medicines for fungal infections (eg fluconazole, ketoconazole )
- dextromethorphan for cough
- Birth control pills (irregular periods, breakthrough bleeding, bleeding between periods, and missed periods may occur in some female patients)
- certain beta- blockers (medicines for certain cardiovascular diseases with active substances whose names end in “-lol”, e.g. metoprolol ) or medicines for heart rhythm disorders, e.g. propafenone or amiodarone
- caffeine
- ciclosporin to suppress the immune system
- warfarin (a blood-thinning medicine).
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
As the experience of use in pregnant women is very limited, Terbinafine Hexal should not be used during pregnancy, unless specifically prescribed by the doctor.
Terbinafine Hexal should not be used during breastfeeding, as the active substance terbinafine passes into breast milk and can harm the baby.
Driving ability and use of machinery
Some patients have reported dizziness when taking Terbinafine Hexal. If you feel dizzy, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Terbinafine Hexal contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use Terbinafine Hexal
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults, including elderly patients, is 1 tablet once a day.
- In the case of skin infections, treatment continues for 2–6 weeks.
- In the case of nail infections, the treatment normally lasts between 6 weeks and 3 months, but some patients with infection in the toenails may need to be treated for 6 months or longer.
How to take the medicine
Swallow the tablets whole with a glass of water, preferably at the same time every day.
The tablets can be taken before or after a meal.
If you have taken too much Terbinafine Hexal
If you take too many Terbinafine Hexal tablets at one time, you may get headaches, nausea, upper stomach pain, and dizziness. Always contact a doctor or hospital emergency department immediately. Take the medicine packaging with you so the staff can see what you have taken.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, pharmacy, or hospital for an assessment of the risk and advice.
If you forget to take Terbinafine Hexal
If you forget to take a Terbinafine Hexal tablet, you do not need to worry. Take it as soon as you remember. However, if it is almost time for the next dose, you should wait and take the next tablet at the usual time. Then continue as before. Do not take a double dose to make up for a missed tablet.
If you stop taking Terbinafine Hexal
Do not stop taking the tablets without consulting your doctor. If this is not possible, you should tell the doctor as soon as possible that you have stopped the treatment so that he or she can decide on further measures together with you.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
Tell your doctor immediately if you notice any of the following rare or very rare symptoms:
- Yellowing of the skin or whites of the eyes, unusually dark urine or light stools, unexplained persistent nausea, stomach problems, pain in the upper right side of the abdomen, loss of appetite, unusual tiredness or weakness (may indicate liver problems).
- Severe skin reactions with rashes, photosensitivity, blisters, peeling skin, or rash.
- Symptoms such as facial rash, fever, feeling unwell or tired, and joint or muscle pain (may be signs of lupus erythematosus, an autoimmune disease).
- The severe allergic reaction that can cause breathing difficulties, dizziness, flushing, stomach cramps, stiffness, skin rash, swelling mainly of the face and throat, fever, or swollen/enlarged lymph nodes.
- Unusual bleeding, bruising, abnormally pale skin, unusual tiredness or weakness or shortness of breath on exertion, sore throat with fever and chills, or frequent infection (may be a sign of a blood disorder).
- Symptoms such as skin rash, fever, itching, tiredness, or purple-red spots under the skin (may be signs of inflammation of the blood vessels).
- Severe pain in the upper abdomen that radiates to the back (may be a sign of inflammation of the pancreas).
- Unexplained muscle weakness and pain, or dark (reddish-brown) urine (may be signs of muscle breakdown).
The following side effects have been reported with terbinafine tablets
Very common (may affect more than 1 in 10 users):
- headache
- indigestion
- nausea
- stomach pains
- diarrhea
- feeling of bloating
- loss of appetite
- itching, rash, or swelling
- joint and muscle pain
Common (may affect up to 1 in 10 users):
- Depression
- taste disturbances and loss of taste these usually disappear slowly within several weeks when you stop taking the medicine. In very rare cases, taste disturbances or loss of taste may persist for a longer period.
- visual disturbances
- dizziness or fatigue
Uncommon (may affect up to 1 in 100 users):
- decreased number of red blood cells
- anxiety (with symptoms such as sleep disturbances, fatigue, weakness, or reduced ability to think or concentrate)
- numbness or tingling
- ringing or buzzing in the ears
- increased sensitivity to sunlight
- fever
- weight loss due to taste disturbances
Rare (may affect up to 1 in 1,000 users):
- liver problems such as liver failure, inflammation of the liver, yellowing of the skin or the whites of the eyes, and increased levels of liver enzymes in the blood
Very rare (may affect up to 1 in 10,000 users):
- reduced number of certain blood cells
- lupus erythematosus (an autoimmune disease)
- serious skin reactions
- allergic reactions
- hair loss
- skin disease in which skin cells grow too quickly, leading to thick, white, silvery, or red patches on the skin (psoriasis-like rash, worsening of psoriasis )
- liver failure, leading to liver transplantation or death. In most of these cases, the patients had serious underlying diseases.
Has been reported (occurring in an unknown number of users):
- severe allergic reactions (anaphylactic reactions, reactions similar to serum sickness)
- impaired hearing
- blurred vision reduced visual acuity
- inflammation of the blood vessels
- effect on the sense of smell, including permanent loss of the sense of smell
- symptoms of depression (e.g. depressed mood) due to taste disturbances
- inflammation of the pancreas
- drug-induced rash with an increase in certain blood cells ( eosinophilia ) and inflammation in internal organs, which is called “drug-induced rash with eosinophilia and systemic symptoms” (DRESS)
- a condition that causes severe muscle cell damage leading to cell death (muscle necrosis) called rhabdomyolysis or increased amount of muscle enzyme (creatine phosphokinase) in the blood
- flu-like symptoms such as fatigue, chills, sore throat, joint or muscle pain
How to store Terbinafine Hexal
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister pack/tablet container after Ex.date. or EXP. The expiration date is the last day of the specified month.
Blister pack: Store the blister pack in the outer carton. Light sensitive.
Tablet jar: Store in the original packaging. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is terbinafineEach tablet contains 250 mg of terbinafine as terbinafine hydrochloride.
- Other ingredients are sodium starch glycolate (type A), hypromellose, anhydrous colloidal silicon dioxide, potato starch, and magnesium stearate.
Appearance and package sizes of the medicine
White or almost white, round, convex tablets with a score on both sides and the code “TER 250” on one side. The tablets are packed in blisters or tablet jars.
Package sizes:
8, 10, 14, 20, 28, 30, 42, 56, 98 and 100 tablets.
The tablet can be divided into two equal doses.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
HEXAL A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany
or
Rowa Pharmaceuticals Ltd. Bantry, Co. Cork, Ireland
or
Lek SA, Ul. Domaniewska 50 C, PL-02-672 Warsaw, Poland
or
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia (valid for tablet containers only)
or
Lek Pharmaceuticals dd Trimlini 2D, Lendava, 9220, Slovenia (valid for blister packs only)