Package Leaflet: Information for the Patient

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1 Package Leaflet: Information for the Patient TERBINAFINE 250mg TABLETS 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. IN THIS LEAFLET 1.What Terbinafine 250mg Tablets are and what they are used for 2. What you need to know before you take Terbinafine 250mg Tablets 3. How to take Terbinafine 250mg Tablets 4. Possible side effects 5. How to store Terbinafine 250mg Tablets 6. Contents of the pack and other information 1. WHAT TERBINAFINE 250mg TABLETS ARE AND WHAT THEY ARE USED FOR The name of this medicine is Terbinafine 250mg Tablets. Terbinafine acts by attacking and killing fungus which causes infection. Your doctor has prescribed the medicine for you to treat fungal infections of the skin and nails or for the treatment of ringworm. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TERBINAFINE 250mg TABLETS Contraindications Do not take Terbinafine 250mg Tablets if you have: Ever had an allergic reaction to terbinafine or to any of the other ingredients listed in section 6, Contents of the pack and other information. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. Severe kidney or liver problems Are breast-feeding Warnings and precautions Talk to your doctor or pharmacist before taking Terbinafine 250mg Tablets if you: Are pregnant or trying to become pregnant Suffer from psoriasis Have liver problems Develop any of the following within two months of starting treatment with this medicine: 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, dark urine or pale coloured stools, high temperature, sore throat Have kidney problems

2 Suffer from an auto-immune condition e.g. lupus erythematosus Other medications and Terbinafine 250mg tablets Check with your doctor or pharmacist if you are taking or have recently taken any other medicines even those not prescribed by a doctor. In particular tell your doctor if you are taking any of the following: Rifampicin for tuberculosis (can make terbinafine less effective) Cimetidine for indigestion or stomach ulcers (can cause terbinafine blood levels to rise) Antidepressants including tricyclic antidepressants (e.g. amitriptyline or desipramine), SSRIs (selective serotonin re-uptake inhibitors, e.g. fluoxetine or paroxetine) or MAOIs (monoamine oxidase inhibitors, e.g. moclobemide) Beta blockers for treating high blood pressure such as atenolol, metoprolol or propranolol (blood levels of these medicines may rise when taken with terbinafine) Oral contraceptives (irregular periods or breakthrough bleeding may occur) Antiarrhythmics to treat abnormal heart rhythms Ciclosporin (used in transplant patients) may be less effective if taken with terbinafine Medicines used to treat fungal infections (e.g. fluconazole, ketoconazole) Medicines used to treat cough (e.g. dextromethorphan) Warfarin for thinning your blood Caffeine Pregnancy and breast-feeding Do not take Terbinafine 250mg Tablets if you are pregnant unless your doctor considers it absolutely necessary. Do not take this medicine whilst breast-feeding. Driving and using machinery Terbinafine 250mg Tablets may make you feel dizzy or fatigued. Make sure you are not affected before you drive or operate machinery. 3. HOW TO TAKE TERBINAFINE 250mg TABLETS Always take this medication exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide what the right dose is for you to take and how long you will need to continue taking the medicine. If you suffer from kidney problems you may be given a different dose to that suggested below. The recommended dose is: Adults (including the elderly) The usual oral dosage is one 250mg tablet once daily. The length of your course of treatment will depend on the nature and severity of infection. Take your tablet with a glass of water. For skin infections the usual dose is 250mg per day for between 2 and 6 weeks depending on the site and severity of the infection. For nail infections the treatment may be for longer between 6 and 12 weeks. With toenail infections the treatment may be for 6 months. If you have kidney problems your doctor may reduce the dose of Terbinafine 250mg Tablets you take. Children Terbinafine 250mg Tablets are not recommended for use in children. If you take more Terbinafine 250mg Tablets than you should

3 If you (or someone else) take too many tablets, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Take this leaflet and any remaining tablets with you to show the doctor. If an overdose has been taken there may be signs such as headache, feeling sick, upper abdominal pains and dizziness. If you forget to take Terbinafine 250mg Tablets If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time. If you stop taking Terbinafine 250mg Tablets Take the tablets for as long as directed by your doctor, it is important that you complete the course of treatment. This is to ensure that the infection is completely cured and lessen the chance of its return after you stop taking the tablets. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them.. Any side effects are usually mild or moderate and don t last for too long. Some side effects can be serious. Stop taking the tablets and tell your doctor immediately if you notice any of the following rare symptoms: Yellowing of your skin or eyes, unusually dark urine or pale faeces, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness or weakness (this may indicate liver problems) Severe skin reactions including rash, light sensitivity, blistering or wheals, rash or eruption of small pus-containing blisters Weakness, unusual bleeding, bruising, frequent infections (e.g. sore throats and fever) these may be signs of blood disorders Allergic reactions signs may include difficulty breathing, dizziness, swelling mainly of the face and throat, flushing, cramping abdominal pain, stiffness, rash, fever or swollen/enlarged lymph nodes Inflammation of blood vessels may cause rash, fever, itching, tiredness or the appearance of purplish spots under the skin surface Severe upper stomach pain which spreads to the back (may be caused by pancreatitis) Muscle damage (symptoms may include muscle weakness and pain or dark coloured urine) The side effects listed below have also been reported. Very common (may affect more than 1 in 10 people) Stomach problems such as ache, indigestion, feeling bloated or sick, Diarrhoea Decreased appetite Itching, rash, hives Pains in the muscles and joints Common (less than 1 in 10 and more than 1 in 100 people)

4 Headache Uncommon (less than 1 in 100 and more than 1 in 1,000 people) Taste loss and taste disturbance. This usually disappears when you stop taking the medicine. However, a very small number of people, (less than 1 in 10,000), have reported that the taste disturbance lasts for some time and, as a result, they go off their food and lose weight. Rare (less than 1 in 1,000 and more than 1 in 10,000 people) Feeling unwell, dizziness Numbness or tingling Very rare (less than 1 in 10,000 people) Alopecia (hair loss) Anxiety or symptoms of depression as a result of taste disturbances Vertigo (spinning motion) Parotid swelling (swelling of one of the salivary glands situated just in front of the ear) Onset or worsening of a condition called lupus (a long-term illness with symptoms including skin rash and pain in the muscles and joints) Unknown frequency (cannot be estimated from the available information) Anaemia (symptoms may include pale skin and feeling tired) Loss of smell Impaired hearing or ringing in the ears Exhaustion/tiredness Fever Flu-like illness Psoriasis-like skin eruptions, or worsening of any psoriasis Increased amount of a muscle enzymes in your blood (creatinine kinase) If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine. Reporting of side effects If you get any side effects, talk to your doctor pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at By reporting side effects you can help provide more information on the safety of medicines. 5. HOW TO STORE TERBINAFINE 250mg TABLETS KEEP OUT OF THE SIGHT AND REACH OF CHILDREN Keep the blister in the outer carton. Do not use after the expiry date stated on the carton. Store in the original package. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need, these measures will help protect the environment.

5 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Terbinafine 250mg Tablets contain The active substance is terbinafine; each tablet contains 250mg terbinafine as terbinafine hydrochloride. The tablets also contain magnesium stearate, silica colloidal anhydrous, croscarmellose sodium, hypromellose and microcrystalline cellulose. What Terbinafine 250mg Tablets look like and contents of the pack The tablets are white, round and flat, scored on both sides and marked T above and 1 below the score on one side. They are supplied in blister packs of 14 and 28 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder: Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland. Distributed by: Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K. Company responsible for release of this medicine: Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K. Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K. Product Licence Number: PL 06453/0060 This leaflet was last revised in December 2015

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