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IE Package leaflet: Information for the patient 75078157

Abacavir/ Mylan Pharma 75078157 600 mg/300 mg Film-coated Tablets /lamivudine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 75078157 - 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. 75078157 - If you get any , talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IMPORTANT — Hypersensitivity reactions Abacavir/Lamivudine Mylan Pharma contains abacavir. Some people who take abacavir (or any other medicine containing abacavir) may develop a hypersensitivity reaction (a serious allergic reaction), which can be life-threatening if they continue to take abacavir containing products. You must carefully read all the information under ‘Hypersensitivity reactions’ in the panel in Section 4. The Abacavir/Lamivudine Mylan Pharma pack includes an Alert Card, to remind you and medical staff about abacavir hypersensitivity. Remove this card and keep it with you at all times.

What is in this leaflet 1. What Abacavir/Lamivudine Mylan Pharma is 4. Possible side effects and what it is used for 5. How to store Abacavir/Lamivudine Mylan 2. What you need to know before you take Pharma Abacavir/Lamivudine Mylan Pharma 6. Contents of the pack and other information 3. How to take Abacavir/Lamivudine Mylan Pharma

Breast-feeding 1. What Abacavir/Lamivudine Mylan Women who are HIV-positive must not Pharma is and what it is used for breast‑feed, because HIV infection can be passed on to the baby in breast milk. A small Abacavir/lamivudine is used to treat HIV amount of the ingredients in this medicine can (human immunodeficiency ) infection in also pass into your breast milk. adults, adolescents and in children weighing If you are breast-feeding, or thinking about at least 25 kg. breast-feeding: This medicine contains two active ingredients Talk to your doctor immediately. that are used to treat HIV infection: abacavir and Driving and using machines lamivudine. These belong to a group of anti- Abacavir/Lamivudine Mylan Pharma may cause retroviral medicines called side effects which could affect your ability to inhibitors (NRTIs). drive or use machines. It does not completely cure HIV infection; it Talk to your doctor about your ability to drive or reduces the amount of virus in your body, and operate machines while taking this medicine. keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are 3. How to take Abacavir/Lamivudine a type of white blood cells that are important in Mylan Pharma helping your body to fight infection. Not everyone responds to treatment with this Always take this medicine exactly as your medicine in the same way. Your doctor will doctor has told you. Check with your doctor or monitor the effectiveness of your treatment. pharmacist if you are not sure. 2. What you need to know before The recommended dose of Abacavir/ Lamivudine Mylan Pharma for adults, you take Abacavir/Lamivudine adolescents and children weighing 25 kg or Mylan Pharma more is one tablet once a day. Do not take Abacavir/Lamivudine Mylan Pharma: Swallow the tablets whole, with some water. This • if you are allergic (hypersensitive) to abacavir medicine can be taken with or without food. (or any other medicine containing abacavir — Stay in regular contact with your doctor (e.g. abacavir/lamivudine, abacavir/lamivudine/ Abacavir/Lamivudine Mylan Pharma helps to , abacavir//lamivudine), control your condition. You need to keep taking it lamivudine or any of the other ingredients of every day to stop your illness getting worse. You this medicine (listed in section 6) may still develop other infections and illnesses Carefully read all the information about linked to HIV infection. hypersensitivity reactions in Section 4. Check Keep in touch with your doctor, and do not stop with your doctor if you think this applies to you. taking this medicine without your doctor’s advice. Do not take this medicine. If you take more Abacavir/Lamivudine Mylan Warnings and precautions Pharma than you should Take special care with Abacavir/Lamivudine If you accidentally take too much Abacavir/ Mylan Pharma Lamivudine Mylan Pharma, tell your doctor or your pharmacist, or contact your nearest hospital Some people taking abacavir/lamivudine or other emergency department for further advice. combination treatments for HIV are more at risk of serious side effects. You need to be aware of If you forget to take Abacavir/Lamivudine the extra risks: Mylan Pharma • if you have moderate or severe disease If you forget to take a dose, take it as soon as you • if you have ever had , including remember. Then continue your treatment as before. B or C (if you have hepatitis Do not take a double dose to make up for B infection, do not stop this medicine without a forgotten dose. your doctor’s advice, as your hepatitis may It is important to take this medicine regularly, come back) because if you take it at irregular intervals, you may • if you are seriously overweight (especially if be more likely to have a hypersensitivity reaction. you are a woman) If you have stopped taking Abacavir/ • if you have a problem Lamivudine Mylan Pharma Talk to your doctor if any of these apply If you have stopped taking this medicine for any to you before taking Abacavir/Lamivudine reason - especially because you think you are Mylan Pharma. You may need extra check‑ups, having side effects, or because you have other including blood tests, while you are taking your illness: medicine. See Section 4 for more information. Talk to your doctor before you start taking Abacavir hypersensitivity reactions it again. Your doctor will check whether your Even patients who do not have the HLA‑B*5701 symptoms were related to a hypersensitivity gene may still develop a hypersensitivity reaction. If the doctor thinks they may have been reaction (a serious allergic reaction) related, you will be told never again to take this Carefully read all the information about medicine, or any other medicine containing hypersensitivity reactions in Section 4 of this abacavir (e.g. abacavir/lamivudine, abacavir/ leaflet. lamivudine/zidovudine, abacavir/dolutegravir/ Risk of heart attack lamivudine). It is important that you follow this It cannot be excluded that abacavir may increase advice. the risk of having a heart attack. If your doctor advises that you can start taking Tell your doctor if you have heart problems, if you abacavir/lamivudine again, you may be asked smoke, or have other illnesses that may increase to take your first doses in a place where you will your risk of heart disease such as high blood have ready access to medical care if you need it. pressure, or diabetes. Do not stop taking this If you have any further questions on the use of medicine unless your doctor advises you to do so. this medicine, ask your doctor or pharmacist. Look out for important symptoms Some people taking medicines for HIV infection 4. Possible side effects develop other conditions, which can be serious. You need to know about important signs and Like all medicines, this medicine can cause side symptoms to look out for while you are taking effects, although not everybody gets them. Abacavir/Lamivudine Mylan Pharma. During HIV therapy there may be an increase in Read the information ‘Other possible side weight and in levels of blood lipids and glucose. effects of combination therapy for HIV’ in This is partly linked to restored health and life Section 4 of this leaflet. style, and in the case of blood lipids sometimes Protect other people to the HIV medicines themselves. Your doctor HIV infection is spread by sexual contact with will test for these changes. someone who has the infection, or by transfer of When you are being treated for HIV, it can be infected blood (for example, by sharing injection hard to tell whether a symptom is a side effect of needles). You can still pass on HIV when taking abacavir/lamivudine or other medicines you are this medicine, although the risk is lowered by taking, or an effect of the HIV disease itself. So it effective antiretroviral therapy. Discuss with your is very important to talk to your doctor about doctor the precautions needed to avoid infecting any changes in your health. other people. Even patients who do not have the HLA‑B*5701 Children gene may still develop a hypersensitivity reaction Abacavir/lamivudine should not be given to (a serious allergic reaction), described in this leaflet children who weigh less than 25 kg. in the panel headed ‘Hypersensitivity reactions’. Other medicines and Abacavir/Lamivudine It is very important that you read and understand Mylan Pharma the information about this serious reaction. Tell your doctor or pharmacist if you are taking As well as the side effects listed below for any other medicines, or if you have taken any abacavir/lamivudine, other conditions can recently, including herbal medicines or other develop during combination therapy for HIV. medicines you bought without a prescription. It is important to read the information later in Remember to tell your doctor or pharmacist if this section under ‘Other possible side effects of you begin taking a new medicine while you are combination therapy for HIV’. taking Abacavir/Lamivudine Mylan Pharma. STOP taking your medicine and contact These medicines should not be used with a doctor immediately if you experience any of Abacavir/Lamivudine Mylan Pharma: the following side effects: • , to treat HIV infection Common (may affect up to 1 in 10 people): other medicinal products containing lamivudine, • hypersensitivity (allergic) reactions. Please see used to treat HIV infection or the ‘Hypersensitivity reactions’ box below for infection important information about these symptoms • high doses of trimethoprim/ sulfamethoxazole, an antibiotic Hypersensitivity reactions • cladribine, used to treat hairy cell leukaemia

Tell your doctor if you are being treated with any Abacavir/Lamivudine Mylan Pharma of these. contains abacavir (which is also an active substance in medicines such as abacavir/ Some medicines interact with Abacavir/ Lamivudine Mylan Pharma lamivudine, abacavir/lamivudine/zidovudine, These include: abacavir/dolutegravir/lamivudine). Abacavir • phenytoin, for treating epilepsy. can cause a serious allergic reaction known as a Tell your doctor if you are taking phenytoin. Your hypersensitivity reaction. These hypersensitivity doctor may need to monitor you while you are reactions have been seen more frequently in taking abacavir/lamivudine. people taking medicines that contain abacavir. • , used as a heroin substitute. Who gets these reactions? Abacavir increases the rate at which Anyone taking Abacavir/Lamivudine Mylan methadone is removed from the body. If you Pharma could develop a hypersensitivity reaction are taking methadone, you will be checked for to abacavir, which could be life threatening if any withdrawal symptoms. Your methadone dose may need to be changed. they continue to take this medicine. Tell your doctor if you are taking methadone. You are more likely to develop this reaction if • medicines (usually liquids) containing sorbitol you have a gene called HLA-B*5701 (but you and other sugar alcohols (such as xylitol, can get a reaction even if you do not have mannitol, lactitol or maltitol), if taken regularly. this gene). You should have been tested for Tell your doctor or pharmacist if you are taking this gene before Abacavir/Lamivudine Mylan any of these. Pharma was prescribed for you. If you know you have this gene, tell your doctor before Abacavir/Lamivudine Mylan Pharma is not you take this medicine. recommended for use during pregnancy. This medicine may cause side effects in unborn About 3 to 4 in every 100 patients treated with babies. If you have taken abacavir/lamivudine abacavir in a who did not have the during your pregnancy, your doctor may request HLA- B*5701 gene developed a hypersensitivity regular blood tests and other diagnostic tests reaction. to monitor the development of your child. In What are the symptoms? children whose mothers took NRTIs during pregnancy, the benefit from the protection The most common symptoms are: against HIV outweighed the risk of side effects. •  (high temperature) and skin rash.

Page Mylan Date of Final dd / mm / yy Date of Issue dd / mm / yy Count 1 of 2 Date/Time of Creation 23/01/21 11:44 Track-Wise PR No. 2366340 Client Market Ireland Software / Ver. No. Adobe InDesign 9.0 Vendor Job No. 586095 Affiliate New Code 2366340 Product Description LIT(B/F) ABA/LAMI MYL PH TABS 600/300MG IE Artwork Proof No. 1 Superseded Code NA Pharma Code NA Barcode Information NA New Material Code Actual A/w Size 160 x 640 mm (Open) 75078157 Product Render ID No. NA MA Number PA0577/216/001 ITF Barcode Other Sizes (if any) 160 x 40 mm (Folded) Main Font Type - 1 Helvetica Neue LT Pro SAP or SPC Code 400559782 Superseded Code NIL Pitch After Every NA Mylan Laboratories Ltd Main Font Type - 2 NA Packaging Site (Aurangabad - IN) Component Type Printed Literature Eye / Sensor Mark NA Min. Font Size 9 pt Mfg. Lic. No. / Code No. NA No. of Printed Colors 1 ITF Barcode Size NA New Component Printed Colors Reason for CMYK / Pantones BLACK Revision / Issuance Color Bridge Coated Non Printed Colors Die Line

New Component Equivalent with CMYK Artwork (Pantones Ref. Code) NA Implementation Immediately (Stock of supperseded component to be destroyed, if applicable) Schedule, () After Consumption of Existing (supperseded) stock Material of 30 gsm ITC Tribeni Paper whichever is Others (specify) Construction applicable Design & Style Supply in Folded form as Proposed Size LABEL CONTROL / BUSINESS DEVELOPMENT / REGULATORY / MARKETING Prepared By Checked By Approved By Packaging Technical Services Production Regulatory Affairs Quality Assurance

Digital Signature Digital Signature Digital Signature Digital Signature Name Name Name Name Name Sign Sign Sign Sign Sign

Sign Offs dd/mm/yy dd/mm/yy dd/mm/yy dd/mm/yy dd/mm/yy y r Date / Remarks

o 18/01/21-New Component Date / Remarks Date / Remarks is t H

Date / Remarks Date / Remarks Date / Remarks Date / Remarks n o Date / Remarks Date / Remarks Date / Remarks Date / Remarks vis i e R Date / Remarks Date / Remarks Date / Remarks Format No.: SOP-000485364_FORM-000525810_Version-4.0 Other common symptoms are: In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue • (feeling sick), (being sick), (autoimmune disorders). The symptoms of diarrhoea, abdominal (stomach) pain, autoimmune disorders may develop many , , severe tiredness, months after you start taking medicine to treat generally feeling ill, , pains in the your HIV infection. Symptoms may include: muscles. • palpitations (rapid or irregular heartbeat) or Other symptoms include: tremor Pains in the joints, mouth ulcers, sore throat, • hyperactivity (excessive restlessness and chest pains, difficulty breathing (respiratory movement) problems), swelling of arms or legs, swollen • weakness beginning in the hands and feet and glands (neck, arm or groin), low blood pressure, moving up towards the trunk of the body of the eye (conjunctivitis), tingling If you get any symptoms of infection and or numbness of the hands or feet. Signs of inflammation or if you notice any of the liver problems include yellowing of the skin and symptoms above: whites of the eyes, dark urine, light stools and Tell your doctor immediately. Do not take other signs of kidney problems include producing little medicines for the infection without your doctor’s or no urine or lower back pain. Liver and kidney advice. problems can also be seen in blood tests. You may have problems with your bones When do these reactions happen? Some people taking combination therapy for Hypersensitivity reactions can start at any time HIV develop a condition called osteonecrosis. during treatment with this medicine, but are more With this condition, parts of the bone tissue die likely during the first 6 weeks of treatment. because of reduced blood supply to the bone. Contact your doctor immediately: People may be more likely to get this condition: 1 if you get a skin rash, OR • if they have been taking combination therapy 2 if you get symptoms from at least 2 of the for a long time following groups: • if they are also taking anti-inflammatory - fever medicines called corticosteroids - shortness of breath, sore throat or cough • if they drink alcohol - nausea or vomiting, diarrhoea or • if their immune systems are very weak • if they are overweight - severe tiredness or achiness, or generally Signs of osteonecrosis include: feeling ill • stiffness in the joints Your doctor may advise you to stop taking • aches and pains (especially in the hip, knee or Abacavir/Lamivudine Mylan Pharma. shoulder) If you have stopped taking Abacavir/ • difficulty moving Lamivudine Mylan Pharma. If you notice any of these symptoms: If you have stopped taking this medicine Tell your doctor. because of a hypersensitivity reaction, you Reporting of side effects must NEVER AGAIN take it, or any other If you get any side effects, talk to your doctor medicine containing abacavir (e.g. abacavir/ or pharmacist. This includes any possible lamivudine, abacavir/lamivudine/zidovudine, side effects not listed in this leaflet. You can abacavir/dolutegravir/lamivudine). If you do, also report side effects directly via HPRA within hours, your blood pressure could fall Pharmacovigilance. Website: www.hpra.ie. By dangerously low, which could result in death. reporting side effects you can help provide more If you have stopped taking Abacavir/Lamivudine information on the safety of this medicine. Mylan Pharma for any reason - especially because you think you are having side effects, 5. How to store Abacavir/Lamivudine or because you have other illness: Mylan Pharma Talk to your doctor before you start again. Your doctor will check whether your symptoms Keep this medicine out of the sight and reach of were related to a hypersensitivity reaction. If children. the doctor thinks they may have been, you Do not use this medicine after the expiry date will then be told never again to take this which is stated on the carton, bottle label or medicine or any other medicine containing blister after ‘EXP’. The expiry date refers to the abacavir (e.g. abacavir/lamivudine, last day of that month. abacavir/lamivudine/zidovudine, abacavir/ Bottle only: Write the date the bottle was opened dolutegravir/lamivudine). It is important that on the label and/or carton in the space provided. you follow this advice. Do not use this medicine after 90 days of first Occasionally hypersensitivity reactions have opening. developed in people who start taking abacavir This medicine does not require any special containing products again, but who had only temperature storage conditions. Store in the one symptom on the Alert Card before they original package in order to protect from light. stopped taking it. Do not throw away any medicines via wastewater Very rarely patients who have taken medicines or household waste. Ask your pharmacist how to containing abacavir in the past without any throw away medicines you no longer use. These symptoms of hypersensitivity have developed measures will help protect the environment. a hypersensitivity reaction when they start taking these medicines again. 6. Contents of the pack and other If your doctor advises that you can start taking information abacavir/lamivudine again, you may be asked to take your first doses in a place where you will What Abacavir/Lamivudine Mylan Pharma have ready access to medical care if you need it. contains If you are hypersensitive to this medicine, The active substances in each film‑coated tablet return all your unused tablets for safe disposal. are abacavir sulfate equivalent to 600 mg of abacavir and 300 mg of lamivudine. Ask your doctor or pharmacist for advice. The other ingredients in the core of the tablet The Abacavir/Lamivudine Mylan Pharma pack are microcrystalline cellulose, crospovidone, includes an Alert Card, to remind you and magnesium stearate, colloidal anhydrous medical staff about hypersensitivity reactions. silica and talc. The tablet coating contains Remove this card and keep it with you at all hypromellose, titanium dioxide (E171), macrogol times. and polysorbate 80. What Abacavir/Lamivudine Mylan Pharma Rare (may affect up to 1 in 1,000 people): looks like and contents of the pack • swelling of the eyelids, face, lips, mouth, A white, oblong, biconvex, film‑coated tablet, tongue or throat, which may cause difficulty in marked with ‘AL12’ on one side and ‘M’ on the swallowing or breathing other side. Contact your doctor as soon as possible if you experience any of the following side effects: Abacavir/Lamivudine Mylan Pharma are supplied Uncommon (may affect up to 1 in 100 people): in plastic bottles with white opaque child- • reduced number of white cells, as shown in blood resistant closures containing 30 tablets or blister tests, which increases the risk of infections packs containing 30, 30x1 (perforated unit dose (neutropenia, lymphopenia) blisters) or 90 tablets or in multipacks of 90 tablets • reduced number of platelets, as shown in blood comprising 3 cartons, each containing 30 tablets. tests, which causes unexpected bruising or Not all pack sizes may be marketed. bleeding for longer than normal Marketing Authorisation Holder (thrombocytopenia) McDermott Laboratories Ltd. T/A Gerard Rare (may affect up to 1 in 1000 people): Laboratories, 35/36 Baldoyle Industrial Estate, • liver disorders, such as jaundice, enlarged Grange Road, Dublin 13, Ireland liver or fatty liver, inflammation (hepatitis). You Manufacturers may feel sick, notice yellowing of the skin and whites of the eyes, have pale stools, dark urine Mylan Hungary Kft, Mylan utca 1, Komárom, and severe stomach pain 2900, Hungary • inflammation of the pancreas (pancreatitis). You McDermott Laboratories Limited t/a Gerard may experience severe pain in the stomach that Laboratories t/a Mylan Dublin, 35/36 Baldoyle radiates into the back, have a swollen and tender Industrial Estate, Grange Road, Dublin 13, Ireland stomach and feel sick and generally unwell This medicinal product is authorised in the • breakdown of muscle tissue (rhabdomyolysis). Member States of the EEA under the following You may have muscle pain, especially in the names: shoulders, thighs or lower back, weakness or Austria Abacavir/Lamivudin Mylan trouble moving arms or legs, dark urine and Phamrma 600 mg/300 mg reduced or no urine Filmtabletten Very rare (may affect up to 1 in 10,000 people): Belgium Abacavir/Lamivudine Mylan • deep, rapid, difficult breathing, drowsiness, Pharma 600 mg/300 mg numbness or weakness in the limbs, feeling filmomhulde tabletten sick (nausea), being sick (vomiting) and Bulgaria Abacavir/Lamivudine Mylan stomach pain. These may be signs of excess Pharma 600 mg/300 mg lactic acid in the blood (), as film‑coated tablets shown in blood tests Croatia Abakavir/Lamivudin Mylan • a failure of the bone marrow to produce new red Pharma 600 mg/300 mg blood cells (pure red cell aplasia), as shown in filmom obložene tablete blood tests. You may feel tired, lethargic and Czech Republic Abakavir/Lamivudin Mylan notice abnormal paleness of the skin Pharma • skin rash, which may form blisters and Denmark Abakavir/Lamivudin Mylan looks like small targets (central dark spots Pharma surrounded by a paler area, with a dark ring Estonia Abacavir/Lamivudine Mylan around the edge) (erythema multiforme) Pharma • a widespread rash with blisters and peeling Finland Abakavir/Lamivudin Mylan skin, particularly around the mouth, nose, eyes Pharmae and genitals (Stevens–Johnson syndrome) France ABACAVIR/LAMIVUDINE and a more severe form causing skin peeling MYLAN PHARMA in more than 30% of the body surface (toxic 600 mg/300 mg comprimé epidermal necrolysis pelliculé • numbness, tingly feelings in the skin (pins and Germany Abacavir/Lamivudin Mylan needles) Pharma 600 mg/300 mg Filmtabletten Other possible side effects: Greece Abacavir+/Lamivudine/ Mylan Common (may affect up to 1 in 10 people): Pharma 600 mg/300 mg • film‑coated tablets • being sick (vomiting) Ireland Abacavir/Lamivudine Mylan • feeling sick (nausea) Pharma 600 mg/300 mg • diarrhoea Film‑coated Tablets • stomach pains Italy Abacavir e Lamivudina Mylan • loss of appetite Pharma 600 mg/300 mg • tiredness, lack of energy Latvia Abacavir/Lamivudine Mylan • fever (high temperature) Pharma 600 mg/300 mg • general feeling of being unwell apvalkotās tabletes • difficulty in sleeping () Lithuania Abacavir/Lamivudine Mylan • muscle pain and discomfort Pharma 600 mg/300 mg • joint pain plėvele dengtos tabletės • cough Luxembourg Abacavir/Lamivudine Mylan • irritated or runny nose Pharma 600 mg/300 mg • skin rash comprimés pelliculés • hair loss Norway Abakavir/Lamivudin Mylan Uncommon (may affect up to 1 in 100 people): Pharma • a low red blood cell count (anaemia), as shown Poland Abacawir + Lamivudine Mylan in blood tests Pharma • an increase in the level of liver enzymes, as Portugal Abacavir/Lamivudina Mylan shown in blood tests Pharma 600 mg/300 mg comprimidos revestidos por Rare (may affect up to 1 in 1,000 people): película • increase in an enzyme called amylase, as Romania Abacavir/Lamivudină Mylan shown in blood tests Pharma 600 mg/300 mg If you get side effects comprimate filmate Tell your doctor or pharmacist if any of the Slovak Republic Abakavir/Lamivudín Mylan side effects gets severe or troublesome, or if you Pharma 600 mg/300 mg, notice any side effects not listed in this leaflet. filmom obalené tablety Other possible side effects of combination Slovenia Abakavir/Lamivudin Mylan therapy for HIV Pharma 600 mg/300 mg Combination therapy such as abacavir/ filmsko obložene tablete lamivudine may cause other conditions to Spain Abacavir/Lamivudina Mylan develop during HIV treatment. Pharma 600 mg/300 mg comprimidos Symptoms of infection and inflammation Sweden Abakavir/Lamivudin Mylan Old infections may flare up Pharma People with advanced HIV infection (AIDS) have The Netherlands Abacavir/Lamivudine Mylan weak immune systems, and are more likely Pharma 600 mg/300 mg to develop serious infections (opportunistic filmomhulde tabletten infections). Such infections may have been United Kingdom Abacavir/Lamivudine Mylan ‘silent’ and not detected by the weak immune Pharma 600 mg/300 mg system before treatment was started. After Film‑coated Tablets starting treatment, the immune system becomes stronger, and may attack the infections, This leaflet was last revised in November 2020. which can cause symptoms of infection or inflammation. Symptoms usually include fever, plus some of the following: • headache • stomach ache 2366340 • difficulty breathing 75078157

Page Mylan Date of Final dd / mm / yy Date of Issue dd / mm / yy Count 2 of 2 Date/Time of Creation 23/01/21 11:44 Track-Wise PR No. 2366340 Client Market Ireland Software / Ver. No. Adobe InDesign 9.0 Vendor Job No. 586095 Affiliate New Code 2366340 Product Description LIT(B/F) ABA/LAMI MYL PH TABS 600/300MG IE Artwork Proof No. 1 Superseded Code NA Pharma Code NA Barcode Information NA New Material Code Actual A/w Size 160 x 640 mm (Open) 75078157 Product Render ID No. NA MA Number PA0577/216/001 ITF Barcode Other Sizes (if any) 160 x 40 mm (Folded) Main Font Type - 1 Helvetica Neue LT Pro SAP or SPC Code 400559782 Superseded Code NIL Pitch After Every NA Mylan Laboratories Ltd Main Font Type - 2 NA Packaging Site (Aurangabad - IN) Component Type Printed Literature Eye / Sensor Mark NA Min. Font Size 9 pt Mfg. Lic. No. / Code No. NA No. of Printed Colors 1 ITF Barcode Size NA New Component Printed Colors Reason for CMYK / Pantones BLACK Revision / Issuance Color Bridge Coated Non Printed Colors Die Line

New Component Equivalent with CMYK Artwork (Pantones Ref. Code) NA Implementation Immediately (Stock of supperseded component to be destroyed, if applicable) Schedule, () After Consumption of Existing (supperseded) stock Material of 30 gsm ITC Tribeni Paper whichever is Others (specify) Construction applicable Design & Style Supply in Folded form as Proposed Size LABEL CONTROL / BUSINESS DEVELOPMENT / REGULATORY / MARKETING Prepared By Checked By Approved By Packaging Technical Services Production Regulatory Affairs Quality Assurance

Digital Signature Digital Signature Digital Signature Digital Signature Name Name Name Name Name Sign Sign Sign Sign Sign

Sign Offs dd/mm/yy dd/mm/yy dd/mm/yy dd/mm/yy dd/mm/yy y r Date / Remarks

o 18/01/21-New Component Date / Remarks Date / Remarks is t H

Date / Remarks Date / Remarks Date / Remarks Date / Remarks n o Date / Remarks Date / Remarks Date / Remarks Date / Remarks vis i e R Date / Remarks Date / Remarks Date / Remarks Format No.: SOP-000485364_FORM-000525810_Version-4.0