PATIENT INFORMATION LEAFLET (PIL)

Read all of this leaflet carefully before you start taking this medicine.• Keep this leaflet. You may need to read it again .• If you have any further questions. ask your doctor. health care provider or pharmacist.• This medicine has been prescribed for you. Do not pass it on to others. It may harm them. even if theirsymptoms are the same as yours.

• If any of the side effects get serious. or if you notice any side effects not listed in this leaflet. please tellyour doctor. health care proviQar 01 plwmacist.

cOVERAM 5 mg 15 mg tabletsperindopril arginine I amlodipine

cOVERAM 10 mg 15 mg tabletsperindopril arginine I amlodipine

In this leaflet:1.WhatCO RAM is and what it is used fOI

2. Before you take COVERAM3. How to take COVERAM4. Possible side effects5. How to store COVERAM6. Further information

1. WHAT COVERAM IS AND WHAT IT IS U R

COVERAM is prescribed for treatment of high bloodpressure (hypertension) and/or treatment of stablecoronary artery disease (a condition where the bloodsupply to the heart is reduced or blocked).Patients already taking perindopril and amlodipinefrom separate tablets may instead receive one tabletof COVERAM which contains both ingredients.COVERAM is a combination of two active ingre-dients. perindopril and amlodipine.Perindopril is an ACE (angiotensin convertingenzyme) inhibitor. Amlodipine is a calcium antago-nist (which belongs to a class 0 medicines calleddihydropyridines). Toge er they work to widen andrelax the blood vessels so that blood passes throughthem more easily and makes it easier for your heartto maintain a good blood flow.

2. BEFORE YOU TAKE COVERAM

a. Do not take COVERAM• if you are allergic (hypersensitive) to pen oprilor any other ACE inhibito • or to amlod' pineother calcium antagonists. or any of the 0 eringredients of COVERAM.

• if you are more than 3 months pregnant (It is alsobetter to avoid COVERAM in early pregnancy - seepregnancy section).

• if you have experienced symptoms such as whee-zing. swelling of the face or tongue. intense itchingor severe skln-m ith previous ACE inhibitortreatment or if you or a ember of your familyhave had these symptoms in any other circums-tances (a condition called angllO'eoemlli~'

• if you have narrowing of the aortic hear •• - .• ~(aortic stenosis) or cardiogenic shock (a conditionwhere your heart is 0 supply enoug bloodo. you have severe low blood pressure (hypotension).

• if you suffer from heart failure after a heart attack.

b. Take special care with COVERAMIf you have any of the following please talk to yourdoctor or health care provider before taking COVERAM:• hypertrophic cardiomyopathy (cardiac musclei disease) or renal artery stenosis (narrowing of the

'" artery which supplies the kidney with blood).;;: • heart failure.§'" • severe increase in blood pressure (hypertensive

crisis).• any other heart problems.• liver problems.

COVE RAM 5 mg 110 mg tabletsperindopril arginine I amlodipine

COVE RAM 10mg/10mg tabletsperindopril arginine I amlodipine

-problems or if you are receiving dialysis.vascular disease (disease of the connec-) such as systemic lupus erythematosuserrna,

dlS.are on a salt restricted d'et or use salt subs-

lr.lJalSwol·ch contain potassium (a well balancedpotaSSium blood level is essential).

• if you are eld and your dose needs to be increased.

You must tell your doctor or health care provider ifyou think you are (or might become) pregnant.COVERAM is not recommended in early pregnancy.and must not be taken if you are more than 3 monthspregnant. as it may cause serious harm to your babyif used at that stage (see pregnancy section).When you are taking COVERAM. you should alsoinform your doctor. health care provider or the medi-cal staff if you:are going to nave a general anaesthetic and/ormajor surgery.

• have recently suffered from diarrhoea or vomiting(being ).

• are to undergo LDL apheresis (the removal ofchOlesterol from your blood by a machine).

• are ~ to havedesensitisation treatment to reducethe effects of an allergy to bee or wasp stings.

COVERAM 's not recommended for use in childrenand adolescents.

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c. a 'ng othe edicines. herba or die arysupplementsPlease tell your doctor. health care provider or phar-macist if you are taking or have recently taken anyother medicines, i1duding medicines obtained withouta prescription.

You should avoid COVERAM with:• lithium (used to treat mania or depression).• estramustine used in cancer therapy).• potassium-sparing diuretics (spironolactone.triamterene potassium supplements or potas-s m-comaining salt substitutes.

Treatme with COVERAM can be affected by othermedicines. Make sure to tell your doctor or healthcare provder if you are taking any of the followingmedicines as special care may be required:• other medicines for high blood pressure. includingdiuretics (medicines which increase the amountof urine produced by the kidneys).

• non-steroidal anti-inflammatory drugs (e.g. ibu-profen) for pain relief or high dose aspirin.

• medicines to tr-eat diabetes (such as insulin).• medicines to treat mental disorders such asdepression. anxiety. schizophrenia etc (e.g. tricy-clic antidepressants. anti psychotics. imipramine-like antidepressants. neuroleptics).

• immunosuppressants (medicines which reducethe defence mechanism of the body) used for the

treatment of auto-immune disorders or fo 0 'ngtransplant surgery (e.g. ciclosporin),

• allopurinol (for the treatment of gout),• procainamide (for the treatment of an irregularheart beat),

• vasodilators including nitrates (products thatwiden the blood vessels),

• heparin (medicines use-Cd,-';-to..••t"hi-.nblood),• ephedrine, noradrenaline or adrenaline (medicinesused to treat low blood pressure, shock or asthma),

• baclofen or dantrolene (Ulfusion) both used to treatmuscle stiffness in diseases such as multiple scle-rosis; dantrolene is also used to treat malignanthyperthermia during anaesthesia (symptoms inclu-ding very high fever and muscle stiffness),

• some antibiotics such as rifampicin, erythromycin,clarithromycin,

• antiepileptic agents such as amaze' e.nobarbital, phenytoin, fosphenytoin, primidone,

• itraconazole, ketoconazole (medicines used fortreatment of fungal infections),

• alpha-blockers used for the treatment of enlargedprostate such as prazosin, alfuzosin, doxazosin,tamsulosin, terazosin,

• amifostine (used to prevent or reo ce side effectscaused by other medicines or radiation therapythat are used to treat cancer),

• corticosteroids (used to treat various conditionsincluding severe asthma and rheumatoid arthritis),

• gold salts, especially . . aYe ous admi is-tration (used to treat symp oms of rheumatoidarthritis),

• ritonavir, indinavir, nelfinavir (so called proteaseinhibitors used to treat HIV).

d. Taking COVERAM with food and drink

COVERAM should be taken before a meal.Grapefruit juice and grapefruit should not be consu-med by people who are taking COVERAM. This isbecause grapefruit and grapefruit juice can lead toan increase in the blood levels ot the active' re-dient amlodipine, which can cause an unpredictableincrease in the blood pressure lowering effect ofCOVERAM.

e. Pregnancy and breast-feeding

Ask your doctor, health care provider or pharmacistfor advice before taking any medicine.

PregnancyYou must tell your doctor or health care provider ifyou think you are (or might become) pregnant. Yourdoctor or health care provider Will normally adviseyou to stop taking COVERAM before you becomepregnant or as soon as you know you are pregnantand will advise you to take another medici e insteadof COVERAM. COVERAM is not recomme ed inearly pregnancy, and must not be taken ethan 3 months pregnant, as it may causeharm to your baby if used after the thirdpregnancy.

BreastfeedingTell your doctor or health care provider if you arebreast-feeding or about to start breast-feeding.COVERAM is not recommended for mothers whoare breast-feeding, and your doctor or health careprovider may choose another treatment for you ifyou wish to breast-feed, especially if your baby isnewborn, or was born prematurely.

f. Oriving and using machines

COVERAM may affect your ability to drive or usemachines. If the tablets make you feel sick, dizzy,weak or tired, or give you a headache, do not driveor use machines and contact yOUrdoctor or healthcare provider immediately.g. Important information about some of the

ingredients of COVERAM

COVERAM contains lactose monohydrate (a type ofsugar). If you have been told by your doctor or health

erance to somecare provider

3. HOW TO TAKE COVERAM

Always take COVERAM exactly as your doctor orhealth care provider has told you. You should checkwith your doctor, health care provider or pharmacistif you are not sure.Swallow your tablet with a glass of water, preferablyat the same time each day, in the morning, beforea meal. Your doctor or health care provider willdecide on the correct dose for you. This will normallybe one tablet per day.COVERAM will usually be prescribed for patientsalready aking perindopril and amlodipine fromseparate tablets.

fa e IIlOIre C:OVlERA.MUllilll .ruu liIJIJUIQ

u take too many tablets, contact your nearest~ dent and emergency department or tell your

tor or health care provider immediately. Thet likely effect in case of overdose is low bloodsure which can make you feel dizzy or faint. Ifhappens, lying down with your legs raised can

p.b. If you forget to take COVERAM

It· important to take your medicine every day asre u r treatment works better. 0 ever. if youforge to take a dose of COVERAM, take the nextdose a the usual time. Do not take a double doseto make up for a forgotten dose.

c. If you stop taking COVERAM

As the eatment with COVERAMis usually life-long,you should discuss with your doctor or health carepro before you stop taking your tablets.If you ve any further Questions on the use of thisproduc ask your doctor, health care provider orpharmaci .-

4. POSSIBLE SIDE EFFECTS

Like all medicines, COVERAM can cause sideeffects, although not everybody gets them.If you expe .ence any of the following, stop takingthe medicinal product at once and tell your doctoror health care provider immediately:• sudden wheeziness, chest pain, shortness ofbreath, or difficulty in breathing,

• swelling of eyelids, face or lips,• swelling of the tongue and throat, which causesgreat difficulty breathing,

• severe skin reactions including intense skin rash,hives, reddening of the skin over your whole body,severe itching, blistering, peeling and swelling ofthe skin, inflammation of mucous membranes(Stevens Johnson Syndrome) or other allergiCreactions,

• severe dizziness or fainting,attac unusual fast or abnormal heart beat.

pancreas which may cause severe abdo-minal and back pain accompanied with feelingvery unwell.

The following co side effects have been repor-ted. If any of these cause you problems or if theylast for more than one week, you should con actyour doctor or health care provider.• Common side effects (occur in less than 1 in 10users but in more than 1 in 100 users): headache,diuiness, sleepiness (especially at the beginningof treatment), vertigo, numbness or tingling sensa-tion in your limbs, vision disturbances (includingdouble vision), tinnitus (sensation of noises in theears), palpitations (awareness of your heartbeat),flushing, light-headedness due to low blood pres-sure, cough, shortness of breath, nausea (feelingsick), vomiting (being sick), abdominal pain, tastedisturbances, dyspepsia or difficulty of digestion,diarrhoea, constipation, allergic reactions (such as

skin rashes, itching), muscle cramps, tiredness,weakness, ankle swelling (oedema).

Other side effects that have been reported includethe following list. If any of these get serious, or ifyou notice any side effects not listed in this leaflet,please tell your doctor, health care provider or phar-macist.• Uncommon side effects (occur in less than 1 in100 users but in more than 1 in 1,000 users): moodswings, anxiety, depression, sleeplessness, sleepdisturbances, trembling, fainting, loss of painsensation, rhinitis (blocked up or runny nose),altered bowel habits, hair loss, red patches onskin, skin discoloration, back pain, muscle or jointpain, chest pain, disorder in passing urine,increased need to urinate at night, increased num-ber of times of passing urine, pain, feeling unwell,bronchospasm (tightening of the chest, wheezingand shortness of breath), dry mouth, angioedema(symptoms such as whee'. . of the faceor tongue), kidney problems, impotence, increasedsweating, di ort or enlargement of thebreasts In men, weight increase or decrease.

• Rareside effects (occur in less than 1 in 1,000 usersbut in more than 1 in 10,000 users): confusion.

• Very rare side effects (occur in less than 1 in 10,000users): cardiovascular disorders (irregular heartbeat, angina, heart attack and stroke), eosinophi-lic pneumonia (a rare type of pneumonia), swellingof eyelids, face or lips, swelling of the tongue andthroat, which causes great difficulty in breathing,severe skin reactions including intense skin rash,hives, reddening of the skin over your whole body,severe itching, blistering, peeling and swelling ofthe skin, inflammation of mucous membranes(Stevens Johnson Syndrome), ery1hema multi-forme (askin rash which often starts with red itchypatches on your face, arms or legs), sensitivity tolight, disorders of the blood, inflamed pancreaswhich may cause severe abdominal and back ainaccompanied with feeling very unwell, abnormalliver function, inflammation of the liver (hepa:" ,yellowing of the skin Oaundice), liver enzymeincrease which may have an effect on some medi-cal tests, abdominal bloating (gastritis), disorderof the nerves which can cause weakness, tinglingor numbness, increased muscle tension, vasculitis(inflammation of blood vessels), swelling of thegums, excess sugar in blood (hyperglycaemia).

• The following side effects have also been reportedby patients taking COVERAM:hypogtycaemia (verylow blood sugar level), disorders combining rigi-dity, tremor, and/or movements disorders.

If any of the side effects get serious, or if you noticeany side effects not listed in this leaflet, please tellyour doctor, health care provider or pharmacist.

5. HOW TO STORE COVERAM

Keep out of the reac ight of children.Store below 30°C.Keep the bottle tightly closed in order to protectfrommoisture. Store in the ori' pa ka e.Do not use COVERAMafter the expiry date ich isstated on the carton G-bottle. The expiry daterefers ay of that month.

---edicines shouldnot bedisposedof viawastewateror household waste. Ask your pharmacist how todispose of medicines no longer required. Thesemeasures will help to protect the environment.

6. FURTHER INFORMATION

a, What COVERAM contains• The active substances are perindopril arginine andamlodipine.

COVERAM 5mg / 5mg: one tablet contains 5 mgperindopril argin' e and 5 mg am e.COVERAM lOmg I Smg: one table: . s 10 mgperindopril ar . . <> and 5 mg :lmlnr-~""'.P.

COVERAM 5mg / 10mg: one tablet contains 5 mgperindopril arginine and 10 mg amlodipine.COVERAM10mg / 10mg: one tablet contains 10 mgperindopril arginine and 10 mg amlodlplne.• The other ingredients in the tablet are: lactosemonohydrate, magnesium stearate (E470B), cel-lulose microcrystalline (E460), colloidal anhydroussilica (E551),

b. What COVERAM looks like and contents ofthe pack

COVERAM5mg / 5mg tablets are white, rod-shapedtablets engraved with 5/5 on one face and ~ onthe other face.COVERAM1Omg/ 5mg tablets are white, triangular-shaped tablets engraved with 10/5 on one face and~ on the other.COVERAM 5mg / 10mg tablets are white, square-shaped tablets engraved with 5/10 on one face and~ on the other.COVERAM 10mg / 10mg tablets are white, roundtablets engraved with 10/10 on one face and ~on eo er.The tab ets are available in containers of 5, 7, 10,14,20,28,30,50,56,60,90, 100, 120 or 500tab ets.o all pack sizes may be available.

c. arXeting Authorisation Holder andManufacturer

Marketing Authorisation Holder*'~ Les Laboratoires Servier~SERVIER France

ManufacturerServier (Ireland) Industries LtdGorey RoadArklow - Co. Wicklow -IrelandFor any information about this medicine, pleasecontact the local representative of the MarketingAuthorisation Holder.

Saudi Arabia Gulf CountriesLes Laboratoires Servier Les Laboratoires ServierScientific Office SCientific OfficeAI-Sulaimaniah, P.O,Box 1586, APIAI-Safwah building Towers Office # 801Riyadh, Saudi Arabia. Sheikh Zayed Road,Tel: +966 (1) 2886813 Dubai, UAEE-mail: fawaz.al-anazi@ Tel: +971 4 3329903sa.netgrs.com E-mail: magdy.abdou@

ae.netgrs.com

d. This leaflet was last approved in 07.2012

e. To report any side effect(s):• Saudi Arabia:- National Pharmacovigilance Center (NPC)Fax: +966-1-205-7662E-mail: npc.drug@sfda.gov.saWebsite: www.sfda.gov.sa/npc

• Other GCCstates:- Please contact the relevant competent authority.

f. Council of Arab Health Ministers:

This is a Medicament

• Medicament is a product which affects yourhe and its consumption contrary to instruc-tions' dangerous for you.

• Follow the doctor's prescription, the method ofuse and the instruction of the pharmacist whosold the medicament.

• The doctor and the pharmacist are the expertsin medicines, their benefits and risks.

• Do not by yourselves interrupt the period oftreatment prescribed for you.

• Do not repeat the same prescription withoutconsulting your doctor.

• Keep all medicaments out of reach of children

Council of Arab Health MinistersUnion of Arab Pharmacists