Artwork No. - Colours Used Customer Accord (BST to ONE) Pantone Black Description Terbinafine Market UK Language English Size 170 x 550 (PIL) Min. Font Size 10 Version No. 1 (Page 1 of 2) Keyline Date 09_09_20 (Terbinafine (ACC-UK) PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance

Rare (may affect up to 1 in 1,000 people) • Feeling unwell, dizzy • Numbness or tingling Package leaflet: Information for the user Very rare (may affect up to 1 in 10,000 people) Terbinafine 250mg tablets • Feeling tired • Decrease in the number of some blood cells. Read all of this leaflet carefully before giddy while they are taking Terbinafine tablets. If You may notice that you seem to bleed or you start taking this medicine because it you feel like this you should not drive or operate bruise more easily than normal, or you may contains important information for you. machinery. catch infections easily and these might be • Keep this leaflet. You may need to read it more severe than usual • like skin eruptions, or worsening of again. 3 How to take Terbinafine tablets any psoriasis including a or eruption of • If you have any further questions, ask small pus containing blisters your doctor or pharmacist. Always take this medicine exactly as your doctor • Vertigo • This medicine has been prescribed for or pharmacist has told you. Check with your • loss you only. Do not pass it on to others. It doctor or pharmacist if you are not sure. • Onset or worsening of a condition called lupus (a long-term illness with symptoms including may harm them, even if their signs of Swallow the tablets with water. skin rash and pain in the muscles and joints) illness are the same as yours. • If you get any side effects, talk to your The usual dose for adults, including the Not known (frequency cannot be estimated doctor or pharmacist. This includes any elderly, is 250 mg once a day. from the available data) possible side effects not listed in this • For skin infections continue taking the tablets • Signs of blood disorders: weakness, unusual bleeding, bruising or frequent infections leaflet. See section 4. for 2 to 6 weeks. • For infections treatment usually lasts for • and depressive symptoms. between 6 weeks and 3 months, although • Disorders of sense of smell which may be What is in this leaflet: some patients with toenail infections may permanent, impaired hearing, hissing and/or 1 What Terbinafine tablets are and need to be treated for 6 months or longer. ringing in the ears, flu like symptoms, increase what they are used for • If your kidneys are not working very well, your in blood of a muscle enzyme called creatine phosphokinase (may be found on a blood test), 2 What you need to know before you doctor may reduce the dose of Terbinafine tablets you take. reduced or blurred vision. take Terbinafine tablets • Swallow the tablets whole with a glass of 3 How to take Terbinafine tablets water. Reporting of side e ects 4 Possible side e ects If you get any side effects, talk to your doctor, 5 How to store Terbinafine tablets Complete healing of the infection may not occur pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also 6 Contents of the pack and other until several weeks after completing the course of treatment. A healthy nail may take several report side effects directly via the Yellow Card information months to grow back. Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play If you take more Terbinafine tablets than you or Apple App Store. 1 What Terbinafine tablets are and should By reporting side effects you can help provide what they are used for If you (or someone else) swallow a lot of tablets more information on the safety of this medicine. at the same time, or you think a child may have Terbinafine belongs to a group of medicines swallowed any, contact your nearest hospital called drugs. Terbinafine tablets are casualty department or tell your doctor 5 How to store Terbinafine tablets used for the treatment of fungal infections of: immediately. Symptoms of an overdose include • The groin area. , feeling sick, pain in the upper part of Keep this medicine out of the sight and reach of • The skin (ring worm). the stomach (epigastric pain) and . children. • Toe and finger nails (yellow, opaque and This medicine does not require any special thickened nails). If you forget to take Terbinafine tablets storage conditions. • The feet (athlete’s foot). Do not take a double dose to make up for a Do not use this medicine after the expiry date forgotten dose. If you forget to take a dose, take which is stated on the label/carton/bottle. The it as soon as you remember it and then take the expiry date refers to the last day of that month. 2 What you need to know before you next dose at the right time. Do not throw away any medicines via take Terbinafine tablets wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer require. These measures will help Do not take Terbinafine tablets if you: 4 Possible side e ects protect the environment. • are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6). Like all medicines, this medicine can cause side • have or have had any liver problems. effects, although not everybody gets them. • are breast-feeding. 6 Contents of the pack and other Some side e ects can be serious information Warnings and precautions Stop taking the tablets and tell your doctor Talk to your doctor or pharmacist before immediately if you notice any of the What Terbinafine tablets contain taking Terbinafine tablets if you: following rare symptoms: • The active substance is terbinafine as • are pregnant or trying to become pregnant. • Yellowing of your skin or eyes. terbinafine hydrochloride. Each • have any problems with your kidneys or liver. Unusually dark urine or pale faeces, contains 250mg of the active substance. • have psoriasis (scaling skin disease) unexplained persistent , • The other ingredients are microcrystalline • have systemic (SLE) stomach problems, loss of appetite cellulose, croscarmellose sodium, (auto-immune disorder, affecting the skin, or unusual tiredness or weakness anhydrous colloidal silica, hypromellose joints, kidneys & brain), as it may worsen whilst (this may indicate liver problems), and magnesium stearate. you are taking Terbinafine tablets. increase in liver enzymes which may be noted • have a rash due to a high level of a specific on a blood test result What Terbinafine tablets look like and type of white blood cells. • Severe skin reactions including rash, light contents of the pack sensitivity, blistering or wheals Terbinafine tablets are white, round, flat tablets, Children and adolescents • Weakness, unusual bleeding, bruising, scored on both sides with side scores and Use in children is not recommended. abnormal pale skin, unusual tiredness, or marked with ‘T’ above and ‘1’ below the score on weakness or breathlessness on exertion or one side. Other medicines and Terbinafine tablets frequent infections (this may be a sign of blood Pack sizes for blister packs: 7, 14, 20, 28, 30, 42, Tell your doctor or pharmacist if you are disorders) 50, 60, 84, 90, 98, 100, 50 x 1 (unit dose) tablets. taking, have recently taken or might take any • Difficulty breathing, dizziness, swelling mainly other medicines. It is especially important to tell of the face and throat, flushing, crampy Not all pack sizes may be marketed. your doctor about the following: abdominal pain, stiffness, rash, fever or • Rifampicin (an antibiotic). swollen/enlarged lymph nodes (possible signs Marketing Authorisation Holder • Cimetidine (used to treat stomach ulcers). of severe allergic reactions) Accord, Barnstaple, EX32 8NS, UK. • Antidepressants including tricyclic • Symptoms such as rash, fever, itching, antidepressants, SSRIs (selective serotonin tiredness or if you notice appearance of Manufacturer: reuptake inhibitors) or MAOIs (monoamine purplish spots under the skin surface (signs of Actavis Ltd, BLB 015-016 Bulebel Industrial oxidase inhibitors) (medicines for depression). blood vessel ) Estate, Zejtun ZTN 3000, Malta. • Oral contraceptives (as irregular periods and • Severe upper stomach pain which spreads to breakthrough bleeding may occur in some the back (possible signs of pancreas Accord Healthcare Limited female patients). inflammation) Sage House, 319 Pinner Road, North Harrow, • Beta blockers or antiarrhythmics (for heart • Unexplained muscle weakness or pain, or dark Middlesex, HA1 4HF, United Kingdom. problems). (red-brown) urine (possible signs of muscle • Warfarin, a medicine used to thin your blood. breakdown) Accord, Barnstaple, EX32 8NS, UK. • Medicines to treat heart problems (eg propafenone, amiodarone). Other side e ects This leaflet was last revised in December 2020. • Ciclosporin (a medicine used to control your Tell your doctor if you notice any of the body’s immune system in order to prevent following side e ects or any other e ects not rejection of transplanted organs). listed: • Medicines used to treat fungal infections (e.g. , ) Very common (may affect more than 1 in 10 • Medicines used to treat cough (e.g. people) dextromethorphan) • Stomach problems such as loss of appetite, • Caffeine ache, , feeling bloated or sick • Diarrhoea You should have blood tests before and during • Itching, rash or swelling treatment with Terbinafine tablets to monitor • Pains in the muscles and joints your liver function. Common (may affect up to 1 in 10 people) and breast-feeding • Headache If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, Uncommon (may affect up to 1 in 100 people) ask your doctor or pharmacist for advice before • Taste loss and taste disturbance. This usually taking this medicine disappears within several weeks after you stop taking the medicine. However, a very small If you are breast-feeding, you should not take number of people, (less than 1 in 10,000), have Terbinafine tablets. If you are pregnant or reported that the taste disturbance lasts for planning to become pregnant, you should not some time and, as a result, they go off their take Terbinafine tablets unless your doctor food and lose weight.There have also been decides it is necessary. You must only take reports of some people experiencing anxiety Terbinafine tablets according to your doctor’s or symptoms of depression as a result of these instructions. taste disturbances.

Driving and using machines Some people have reported feeling dizzy or

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(6004461) Date: 03_10_20, 31_10_20, 03_12_20, 18_12_20, 21_12_20 Artwork No. - Colours Used Customer Accord (BST to ONE) Pantone Black Description Terbinafine Market UK Language English Size 170 x 550 (PIL) Min. Font Size 10 Version No. 1 (Page 2 of 2) Keyline Date 09_09_20 (Terbinafine (ACC-UK) PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance

Rare (may affect up to 1 in 1,000 people) • Feeling unwell, dizzy • Numbness or tingling

Very rare (may affect up to 1 in 10,000 people) • Feeling tired • Decrease in the number of some blood cells. Read all of this leaflet carefully before giddy while they are taking Terbinafine tablets. If You may notice that you seem to bleed or you start taking this medicine because it you feel like this you should not drive or operate bruise more easily than normal, or you may contains important information for you. machinery. catch infections easily and these might be • Keep this leaflet. You may need to read it more severe than usual • Psoriasis like skin eruptions, or worsening of again. 3 How to take Terbinafine tablets any psoriasis including a rash or eruption of • If you have any further questions, ask small pus containing blisters your doctor or pharmacist. Always take this medicine exactly as your doctor • Vertigo • This medicine has been prescribed for or pharmacist has told you. Check with your • you only. Do not pass it on to others. It doctor or pharmacist if you are not sure. • Onset or worsening of a condition called lupus (a long-term illness with symptoms including may harm them, even if their signs of Swallow the tablets with water. skin rash and pain in the muscles and joints) illness are the same as yours. • If you get any side effects, talk to your The usual dose for adults, including the Not known (frequency cannot be estimated doctor or pharmacist. This includes any elderly, is 250 mg once a day. from the available data) possible side effects not listed in this • For skin infections continue taking the tablets • Signs of blood disorders: weakness, unusual bleeding, bruising or frequent infections leaflet. See section 4. for 2 to 6 weeks. • For nail infections treatment usually lasts for • Anxiety and depressive symptoms. between 6 weeks and 3 months, although • Disorders of sense of smell which may be What is in this leaflet: some patients with toenail infections may permanent, impaired hearing, hissing and/or 1 What Terbinafine tablets are and need to be treated for 6 months or longer. ringing in the ears, flu like symptoms, increase what they are used for • If your kidneys are not working very well, your in blood of a muscle enzyme called creatine phosphokinase (may be found on a blood test), 2 What you need to know before you doctor may reduce the dose of Terbinafine tablets you take. reduced or blurred vision. take Terbinafine tablets • Swallow the tablets whole with a glass of 3 How to take Terbinafine tablets water. Reporting of side e ects 4 Possible side e ects If you get any side effects, talk to your doctor, 5 How to store Terbinafine tablets Complete healing of the infection may not occur pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also 6 Contents of the pack and other until several weeks after completing the course of treatment. A healthy nail may take several report side effects directly via the Yellow Card information months to grow back. Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play If you take more Terbinafine tablets than you or Apple App Store. 1 What Terbinafine tablets are and should By reporting side effects you can help provide what they are used for If you (or someone else) swallow a lot of tablets more information on the safety of this medicine. at the same time, or you think a child may have Terbinafine belongs to a group of medicines swallowed any, contact your nearest hospital called antifungal drugs. Terbinafine tablets are casualty department or tell your doctor 5 How to store Terbinafine tablets used for the treatment of fungal infections of: immediately. Symptoms of an overdose include • The groin area. headache, feeling sick, pain in the upper part of Keep this medicine out of the sight and reach of • The skin (ring worm). the stomach (epigastric pain) and dizziness. children. • Toe and finger nails (yellow, opaque and This medicine does not require any special thickened nails). If you forget to take Terbinafine tablets storage conditions. • The feet (athlete’s foot). Do not take a double dose to make up for a Do not use this medicine after the expiry date forgotten dose. If you forget to take a dose, take which is stated on the label/carton/bottle. The it as soon as you remember it and then take the expiry date refers to the last day of that month. 2 What you need to know before you next dose at the right time. Do not throw away any medicines via take Terbinafine tablets wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer require. These measures will help Do not take Terbinafine tablets if you: 4 Possible side e ects protect the environment. • are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6). Like all medicines, this medicine can cause side • have or have had any liver problems. effects, although not everybody gets them. • are breast-feeding. 6 Contents of the pack and other Some side e ects can be serious information Warnings and precautions Stop taking the tablets and tell your doctor Talk to your doctor or pharmacist before immediately if you notice any of the What Terbinafine tablets contain taking Terbinafine tablets if you: following rare symptoms: • The active substance is terbinafine as • are pregnant or trying to become pregnant. • Yellowing of your skin or eyes. terbinafine hydrochloride. Each tablet • have any problems with your kidneys or liver. Unusually dark urine or pale faeces, contains 250mg of the active substance. • have psoriasis (scaling skin disease) unexplained persistent nausea, • The other ingredients are microcrystalline • have systemic lupus erythematosus (SLE) stomach problems, loss of appetite cellulose, croscarmellose sodium, (auto-immune disorder, affecting the skin, or unusual tiredness or weakness anhydrous colloidal silica, hypromellose joints, kidneys & brain), as it may worsen whilst (this may indicate liver problems), and magnesium stearate. you are taking Terbinafine tablets. increase in liver enzymes which may be noted • have a rash due to a high level of a specific on a blood test result What Terbinafine tablets look like and type of white blood cells. • Severe skin reactions including rash, light contents of the pack sensitivity, blistering or wheals Terbinafine tablets are white, round, flat tablets, Children and adolescents • Weakness, unusual bleeding, bruising, scored on both sides with side scores and Use in children is not recommended. abnormal pale skin, unusual tiredness, or marked with ‘T’ above and ‘1’ below the score on weakness or breathlessness on exertion or one side. Other medicines and Terbinafine tablets frequent infections (this may be a sign of blood Pack sizes for blister packs: 7, 14, 20, 28, 30, 42, Tell your doctor or pharmacist if you are disorders) 50, 60, 84, 90, 98, 100, 50 x 1 (unit dose) tablets. taking, have recently taken or might take any • Difficulty breathing, dizziness, swelling mainly other medicines. It is especially important to tell of the face and throat, flushing, crampy Not all pack sizes may be marketed. your doctor about the following: abdominal pain, stiffness, rash, fever or • Rifampicin (an antibiotic). swollen/enlarged lymph nodes (possible signs Marketing Authorisation Holder • Cimetidine (used to treat stomach ulcers). of severe allergic reactions) Accord, Barnstaple, EX32 8NS, UK. • Antidepressants including tricyclic • Symptoms such as rash, fever, itching, antidepressants, SSRIs (selective serotonin tiredness or if you notice appearance of Manufacturer: reuptake inhibitors) or MAOIs (monoamine purplish spots under the skin surface (signs of Actavis Ltd, BLB 015-016 Bulebel Industrial oxidase inhibitors) (medicines for depression). blood vessel inflammation) Estate, Zejtun ZTN 3000, Malta. • Oral contraceptives (as irregular periods and • Severe upper stomach pain which spreads to breakthrough bleeding may occur in some the back (possible signs of pancreas Accord Healthcare Limited female patients). inflammation) Sage House, 319 Pinner Road, North Harrow, • Beta blockers or antiarrhythmics (for heart • Unexplained muscle weakness or pain, or dark Middlesex, HA1 4HF, United Kingdom. problems). (red-brown) urine (possible signs of muscle • Warfarin, a medicine used to thin your blood. breakdown) Accord, Barnstaple, EX32 8NS, UK. • Medicines to treat heart problems (eg propafenone, amiodarone). Other side e ects This leaflet was last revised in December 2020. • Ciclosporin (a medicine used to control your Tell your doctor if you notice any of the body’s immune system in order to prevent following side e ects or any other e ects not rejection of transplanted organs). listed: • Medicines used to treat fungal infections (e.g. fluconazole, ketoconazole) Very common (may affect more than 1 in 10 • Medicines used to treat cough (e.g. people) dextromethorphan) • Stomach problems such as loss of appetite, • Caffeine ache, indigestion, feeling bloated or sick • Diarrhoea You should have blood tests before and during • Itching, rash or swelling treatment with Terbinafine tablets to monitor • Pains in the muscles and joints your liver function. Common (may affect up to 1 in 10 people) Pregnancy and breast-feeding • Headache If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, Uncommon (may affect up to 1 in 100 people) ask your doctor or pharmacist for advice before • Taste loss and taste disturbance. This usually taking this medicine disappears within several weeks after you stop taking the medicine. However, a very small If you are breast-feeding, you should not take number of people, (less than 1 in 10,000), have Terbinafine tablets. If you are pregnant or reported that the taste disturbance lasts for planning to become pregnant, you should not some time and, as a result, they go off their take Terbinafine tablets unless your doctor food and lose weight.There have also been decides it is necessary. You must only take reports of some people experiencing anxiety Terbinafine tablets according to your doctor’s or symptoms of depression as a result of these instructions. taste disturbances.

Driving and using machines INP113 Some people have reported feeling dizzy or 10 4755 0 6004461

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(6004461) Date: 03_10_20, 31_10_20, 03_12_20, 18_12_20, 21_12_20