Terbinafine 250mg Tablets
Package leaflet: Information for the user Terbinafine 250 mg tablets
terbinafine hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. Y ou 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 Terbinafine 250 mg is and what it is used for
2. What you need to know before you take Terbinafine 250 mg
3. How to take Terbinafine 250 mg
4. Possible side effects
5. How to store Terbinafine 250 mg
6. Contents of the pack and other information
1. What Terbinafine 250 mg is and what it is used for
Terbinafine 250 mg is a broad spectrum antifungal that has a fungicidal effect.
Terbinafine 250 mg is used for the treatment of fungal infections
- of the skin such as athlete's foot (caused by Tinea pedis), groin rash (caused by Tinea cruris) ringworm (caused by Tinea corporis)
- of the nails
2. What you need to know before you take Terbinafine 250 mg
Do not take Terbinafine 250 mg:
- if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Terbinafine 250 mg.
Take special care with Terbinafine 250 mg if
- you develop a skin rash during treatment with Terbinafine 250 mg, you should immediately tell your doctor, who can decide upon any further measures which may be necessary. In very rare cases, Terbinafine 250 mg can cause severe skin reactions with the formation of blisters and detachment of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- you have reduced kidney function
- you have psoriasis (a chronic skin disease)
- you have cutaneous or systemic lupus erythematosus, an autoimmune disorder.
In very rare cases, Terbinafine 250 mg can cause certain blood disorders (neutropenia, thrombocytopenia, agranylocytosis and pancytopenia; these are reductions in the number of different types of blood cells).
Children
Terbinafine 250 mg is not recommended for use in children.
Liver
You should contact your doctor in case of liver problems. After 4-6 weeks of treatment, your doctor should investigate your liver function. One or more of the following symptoms may occur such as unexplained persistent nausea, decreased appetite, tiredness, vomiting, stomach pain in the upper right side, or jaundice, dark urine, pale faeces, loose stools or itching (due to bile products that are deposited in the skin).
Terbinafine 250 mg is not recommended for patients with chronic or active liver disease.
Other medicines and Terbinafine 250 mg
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
There are some medicines that may interact with Terbinafine 250 mg:
- rifampicin (an antibiotic)
- cimetidine (a medicine for stomach ulcers)
- medicines used to treat fungal infections (e.g. fluconazole, ketoconazole)
- medicines against depression (called tricyclic antidepressants e.g. desipramine, selective serotonin re-uptake inbibitors [SSRI] and monoamine oxidase inhibitors [MAO inhibitor])
- medicines for the treatment of heart rhythm disorders and/or cardiovascular disturbance [(antiarrhythmics including class 1A, 1B, 1C and amiodarone), beta blockers]
- warfarin (a medicine used to thin your blood)
- ciclosporin (a medicine used to control your body’s immune system in order to prevent rejection of transplanted organs)
- oral contraceptives (“the pill”), irregular periods or breakthrough bleeding can occur
- caffeine
Terbinafine 250 mg with food and drink
You may take Terbinafine 250 mg with food and drink.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should not take Terbinafine 250 mg if you are pregnant unless it is strictly necessary and only after consulting your doctor.
Breast-feeding
You must not take Terbinafine 250 mg if you are breast-feeding, as terbinafine is secreted in breast milk.
Driving and using machines
Some people have reported feeling dizzy or giddy while they are taking Terbinafine 250 mg. If you feel like this you should not drive or operate machinery.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults
The recommended dose is 1 tablet Terbinafine 250 mg (= 250 mg terbinafine) once a day.
The length of treatment depends on the location of the infection.
Recommended lengths of treatment:
Skin infections
2-6 weeks
2-4 weeks 4 weeks
Athlete's foot (Tinea pedis interdigital, plantar/moccasin type)
Infections of the groin (Tinea cruris):
Infections of the body (Tinea corporis):
Nail infections
The duration of treatment for most patients is between 6 weeks and 3 months.
Fungal infection in the fingernails: less than 3 months
Fungal infection in the toenails: 3 months (if it is required: up to 6 months)
Patients with impaired liver function
Terbinafine 250 mg are not recommended for patients with chronic or active liver disease (see section 2 “Warnings and precautions”).
Patients with impaired kidney function
The use of Terbinafine 250 mg has not been adequately studied in patients with renal impairment and is therefore not recommended in this population (see section 2 “Warnings and precautions”).
Elderly
There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients. The possibility of impairment of liver or kidney function should be considered in this age group (see section 2 “Warnings and precautions”).
If you have the impression that the effect of Terbinafine 250 mg is too strong or too weak, talk to your doctor or pharmacist.
If you take more Terbinafine 250 mg than you should
Contact the doctor, emergency department or pharmacy if you have taken more Terbinafine 250 mg than is stated in this information, or more than the doctor has prescribed.
Symptoms of overdose may be headache, nausea, stomach pain and dizziness.
If you forget to take Terbinafine 250 mg
Do not take a double dose to make up for a forgotten dose. Continue taking your tablets as you normally would.
If you stop taking Terbinafine 250 mg
Y ou should stop treatment only in consultation with the doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the tablets and tell your doctor immediately if you notice any of the following
symptoms:
Rare (may affect up to 1 in 1,000 users):
• reduced liver function or liver failure including in isolated cases yellowing of the skin or whites of the eyes (jaundice), inflammation of the liver (hepatitis) and blocked bile flow (cholestasis). Symptoms include itching, constantly feeling sick, loss of appetite, tiredness, vomiting, fatigue, stomach pain in the upper right side, dark urine or loose stools and pale stools (see section 2 “Warnings and precautions”).
Very rare (may affect up to 1 in 10,000 users):
• an allergic reaction with swelling of the face, lips, tongue or throat, difficulty breathing or swallowing or skin reactions such as a rash or pale or red irregular raised patches with severe itching (hives)
• skin reactions such as a severe form of skin rash (Erythema multiforme) with flushing, fever, blisters or ulcers (Stevens- Johnson syndrome), severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis), and isolated cases of sensitivity to sunlight or artificial light (e.g. sun beds).
• reductions in the number of some blood cells. Y ou may notice that you seem to bleed or bruise more easily than normal, or you may catch infections easily and these might be more severe than usual (see section 2 “Warnings and precautions”)
Not known (frequency cannot be estimated from the available data):
• unexplained muscle weakness or pain, or dark (red-brown) urine (possible signs of muscle breakdown)
• severe upper stomach pain which spreads to the back (possible signs of pancreas inflammation) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body
• symptoms such as rash, fever, itching, tiredness or if you notice appearance of purplish spots under the skin surface (signs of blood vessel inflammation).
Other possible side effects
Very common (may affect more than 1 in 10 users):
• stomach problems such as feeling of fullness, decreased or lack of appetite, indigestion, feeling bloated and sick (nausea), stomach pain and diarrhoea
• non-serious forms of skin reactions [rash, urticaria (reddening of the skin with itching)]
• muscle and joint pain.
Common (may affect up to 1 in 10 users):
• headache.
Uncommon (may affect up to 1 in 100 users):
• taste disorders, including temporary loss of the sense of taste, in isolated cases of prolonged taste disturbance - sometimes leading to a decrease of food intake and significant weight loss.
Rare (may affect up to 1 in 1,000 users):
• general feeling of being unwell
• increased liver enzymes.
Very rare (may affect up to 1 in 10,000 users):
• dizziness
• sensation of spinning or whirling motion (vertigo)
• numbness and tingling (“pins and needles”)
• decreased touch-sensitiveness
• onset or worsening of a condition called lupus (a long-term illness with symptoms including skin rash and pain in the muscles and joints) ( see section 2 “Warnings and precautions”)
• psori asis like skin erupti ons, or worseni ng of any psori asi s (see section 2 “Warnings and precautions”)
• hair loss (alopecia)
• breakthrough bleeding and/or irregular menstruation
• feeling tired.
Not known (frequency cannot be estimated from the available data):
• low number of red blood cells (anaemia)
• psychiatric disturbances (anxiety, depression)
• loss of the sense of smell
• hearing impaired, hearing loss, numbness, a ringing or buzzing noise in the ear (tinnitus)
• sensitivity to light
• flu like illness, fever
• increase of a muscle enzyme called creatine phosphokinase in the blood (may be found on a blood test)
• weight decreased.
Some side effects may need treatment.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Terbinafine 250 mg
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 and blister after EXP. The expiry date refers to the last day of that month.
Keep the blister in the outer carton.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
The active substance is terbinafine hydrochloride.
Each tablet contains 250 mg terbinafine (as hydrochloride).
The other ingredients are Cellulose microcrystalline, Hypromellose, Sodium starch glycolate, Silica colloidal hydrated, Magnesium stearate.
What Terbinafine 250 mg looks like and contents of the pack
Each tablet is a white to off white capsule shaped biconvex tablet scored on one side and debossed “T” on each side of the score.
Your tablets are available in blister packs of 8, 14, 28, 30, 42, 50, 56 and 98.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
ratiopharm GmbH, Graf-Arco-Strasse 3,
D-89079 Ulm, Germany.
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom: Terbinafine 250 mg tablets Finland: Terbinafin ratiopharm 250 mg tabletit
Germany: Terbinafin-ratiopharm 250 mg Tabletten
Norway Terbinafin ratiopharm 250 mg tabletter
Portugal: Terbinafina ratiopharm 250 mg tablets
This leaflet was last revised in February 2016
PL 15773/0548
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