Sarkamex

Package leaflet: Information for the user

SARKAMEX 20 mg/5 mg/12.5 mg film-coated tablets, 40 mg/5 mg/12.5 mg film-coated tablets, 40 mg/10 mg/12.5 mg film-coated tablets, 40 mg/5 mg/25 mg film-coated tablets, 40 mg/10 mg/25 mg film-coated tablets

Olmesartan medoxomil/amlodipine/hydrochlorothiazide
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What SARKAMEX is and what it is used for
2. What you need to know before taking SARKAMEX
3. How to take SARKAMEX
4. Possible side effects
5. How to store SARKAMEX
6. Contents of the pack and other information

1. What SARKAMEX is and what it is used for

SARKAMEX contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besilate) and hydrochlorothiazide. All three substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists” which reduce blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of substances called “calcium antagonists”. Amlodipine also reduces blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” (medicines that increase urine production). It reduces blood pressure by helping the body get rid of excess fluid, by making the kidneys produce more urine.

The combined action of these substances helps reduce blood pressure.
SARKAMEX is used for the treatment of high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with a fixed-dose combination of olmesartan medoxomil and amlodipine, or
• in patients who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide plus amlodipine as a single tablet, or a fixed-dose combination of olmesartan medoxomil and amlodipine plus hydrochlorothiazide as a single tablet.

2. What you need to know before taking SARKAMEX

Do not take SARKAMEX:

• if you are allergic to olmesartan medoxomil, amlodipine, or a specific group of calcium channel blockers (the dihydropyridines), hydrochlorothiazide, or substances similar to hydrochlorothiazide (sulfonamides), or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, speak with your doctor before taking SARKAMEX.
• if you have severe kidney problems
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you have low levels of potassium or sodium, or high levels of calcium or uric acid (with symptoms of gout and kidney stones) in your blood that have not improved with treatment
• if you are more than three months pregnant (it is best to avoid taking SARKAMEX even in the early stages of pregnancy – see section “Pregnancy and breastfeeding”)
• if you have severe liver problems, if bile secretion is impaired, or if bile flow from the gallbladder is blocked (e.g., due to gallstones), or if you are experiencing jaundice (yellowing of the skin and eyes)
• if you have poor blood supply to tissues with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, meaning shock due to severe heart problems)
• if you have very low blood pressure
• if blood flow from the heart is slow or obstructed. This may occur if the blood vessel or valve carrying blood out of the heart is narrowed (aortic stenosis)
• if you have reduced cardiac output after a heart attack (acute myocardial infarction). Reduced cardiac output may cause shortness of breath or swelling in the feet and ankles.

Do not take SARKAMEX if any of these conditions apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before using SARKAMEX.
Inform your doctor if you are taking any of the following medicines used to treat high blood pressure:

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.
See also the section “Do not take SARKAMEX”.
Inform your doctor if you have any of the following health conditions:

• Kidney problems or kidney transplant
• Liver disease
• Heart failure or problems with heart valves or heart muscle
• Severe vomiting, diarrhea, treatment with high doses of diuretics, or if you are on a low-salt diet
• Increased potassium levels in the blood
• Adrenal gland problems (hormone-producing glands located above the kidneys)
• Diabetes
• Systemic lupus erythematosus (an autoimmune disease)
• Allergies or asthma
• Skin reactions such as sunburn or rash after sun exposure or use of sunbeds.
• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). While taking SARKAMEX, protect your skin from exposure to sunlight and UV radiation.
• If you have had respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe breathing difficulties after taking SARKAMEX, consult a doctor immediately.

Contact your doctor if you experience any of the following symptoms:

• Severe and prolonged diarrhea with significant weight loss. Your doctor will assess your symptoms and decide whether to continue this treatment for high blood pressure.
• Vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within hours to weeks after taking SARKAMEX. If untreated, this may lead to permanent vision impairment.

As with any medicine that lowers blood pressure, excessive reduction in blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
SARKAMEX may increase blood levels of fats and uric acid (the cause of gout – painful joint swelling). Your doctor may want to perform occasional blood tests to check these values.
This medicine may alter blood levels of certain chemicals called electrolytes. Your doctor may want to perform occasional blood tests to monitor these values. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), feeling weak, lethargic, tired, drowsy, or restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Inform your doctor if
you notice these symptoms.
If you are scheduled for tests assessing parathyroid function, you must stop taking SARKAMEX before undergoing these tests.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). SARKAMEX is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section “Pregnancy and breastfeeding”).
Contact your doctor if, after taking SARKAMEX, you experience abdominal pain, nausea, vomiting, or diarrhea. Your doctor will decide whether to continue treatment. Do not stop taking SARKAMEX on your own.
Children and adolescents
SARKAMEX is not recommended for children and adolescents under 18 years of age.
Other medicines and SARKAMEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

• Other medicines that lower blood pressure, as the effect of SARKAMEX may be increased. Your doctor may need to adjust the dose and/or take other precautions:
• If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take SARKAMEX” and “Warnings and precautions”).
• Lithium (a medicine used to treat mood swings and certain types of depression) taken together with SARKAMEX may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Diltiazem, verapamil used for heart rhythm problems and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, tetracyclines, and sparfloxacin, antibiotics used for tuberculosis or other infections.
• St. John’s wort (Hypericum perforatum), a herbal remedy for depression.
• Cisapride, used to increase gastrointestinal motility.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Halofantrine, used for malaria.
• Intravenous vincamine, used to improve circulation to the nervous system.
• Amantadine, used for Parkinson’s disease.
• Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (to thin the blood and prevent blood clots), ACE inhibitors (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), sodium penicillin G (also known as benzylpenicillin sodium, an antibiotic), some painkillers such as acetylsalicylic acid (“aspirin”) or salicylates. Taking these medicines together with SARKAMEX may alter potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis) taken together with SARKAMEX may increase the risk of kidney failure. The effect of SARKAMEX

may be reduced by NSAIDs. With high doses of salicylates, the central nervous system toxicity may be increased.

• Sedatives, sleeping pills, and antidepressants, as using these with SARKAMEX may cause a sudden drop in blood pressure when standing up.
• Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, as the effect of SARKAMEX may be reduced. Your doctor may advise you to take SARKAMEX at least 4 hours before colesevelam hydrochloride.
• Some antacids (remedies for indigestion or heartburn), as the effect of SARKAMEX may be slightly reduced.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Anticholinergic agents such as atropine and biperiden.
• Calcium supplements.
• Dantrolene (infusion for severe disturbances in body temperature).
• Simvastatin, used to reduce cholesterol and fat (triglyceride) levels in the blood.
• Medicines used to control the body’s immune response (tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), allowing the body to accept a transplanted organ.

You should also inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

• for treating certain mental health conditions such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• for treating low blood sugar levels (e.g., diazoxide) or high blood pressure (e.g., beta-blockers, methyldopa), as SARKAMEX may affect the action of these medicines.
• for treating heart rhythm disorders such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin.
• for treating HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir).
• for treating fungal infections (e.g., ketoconazole, itraconazole, amphotericin).
• for treating heart problems such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis.
• for treating cancers such as amifostine, cyclophosphamide, or methotrexate.
• to increase blood pressure and slow heart rate such as noradrenaline.
• for treating gout such as probenecid, sulfinpyrazone, and allopurinol.
• to reduce fat levels in the blood such as cholestyramine and colestipol.
• to reduce blood sugar levels such as metformin or insulin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
SARKAMEX with food and drinks
SARKAMEX can be taken with or without food.
Grapefruit and grapefruit juice must not be consumed by people taking SARKAMEX. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of SARKAMEX.
Be cautious when drinking alcohol during treatment with SARKAMEX, as some people may feel faint or dizzy. If this happens to you, do not drink alcohol.
Elderly
If you are over 65 years old, your doctor will regularly monitor your blood pressure with each dose increase to prevent your blood pressure from becoming too low.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Normally, your doctor will advise you to stop taking SARKAMEX before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine.
SARKAMEX is not recommended during pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
If you become pregnant while taking SARKAMEX, inform and see your doctor immediately.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. SARKAMEX is not recommended for breastfeeding women, and your doctor may choose an alternative treatment if you wish to breastfeed.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
You may experience drowsiness, discomfort, dizziness, or headache during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor.
SARKAMEX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.
SARKAMEX contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
For athletes:
Using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take SARKAMEX

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of SARKAMEX is one tablet daily.
The tablets can be taken with or without food. Swallow the tablet with some liquid (such as a glass of water). The tablet must not be chewed. Do not take it with grapefruit juice.
If possible, take your daily dose at the same time each day, for example with breakfast.

If you take more SARKAMEX than you should
If you take more tablets than you should, you may experience a drop in blood pressure with symptoms such as dizziness, fast or slow heartbeat.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop up to 24–48 hours after ingestion.
If you take more tablets than prescribed or if a child accidentally swallows any, go immediately to a doctor or the nearest emergency department, taking the medicine pack or this leaflet with you.

If you forget to take SARKAMEX
If you forget to take a dose, take your normal dose the next day. DO NOT take a double dose to make up for the missed dose.

If you stop taking SARKAMEX
It is important to continue taking SARKAMEX unless your doctor tells you to stop.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If they occur, they are mostly mild and do not require stopping treatment.
However, the following two side effects may be serious, even if they do not occur in all patients:

• During treatment with SARKAMEX, allergic reactions may occur, with swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash. If this happens, stop taking SARKAMEX and contact your doctor immediately.
• Severe dizziness or fainting due to excessive lowering of blood pressure in sensitive individuals caused by SARKAMEX. If this happens, stop taking SARKAMEX, contact your doctor immediately and remain lying down.
• Frequency not known: if you develop yellowing of the whites of the eyes, dark urine, or skin itching, even if you started therapy with SARKAMEX a long time ago, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your high blood pressure treatment.

SARKAMEX is a combination of three active substances. The following information first lists other side effects reported so far with SARKAMEX (in addition to those already mentioned above), and secondly, the side effects known for each of the individual active substances when taken alone or for combinations of two active substances.

To give you an idea of how many patients experience side effects, they have been categorized as common, uncommon, rare, and very rare.
These are the other side effects known so far with SARKAMEX:
If they occur, they are mostly mild and do not require stopping treatment.
Common (may affect up to 1 in 10 people):

• upper respiratory tract infection
• sore throat and painful nose
• urinary tract infection
• dizziness; headache
• awareness of heartbeat (palpitations)
• low blood pressure
• nausea
• diarrhoea
• constipation
• cramps
• joint swelling
• feeling a greater need to urinate
• weakness
• swelling of the ankles
• fatigue
• abnormal laboratory test results.

Uncommon (may affect up to 1 in 100 people):

• dizziness when standing up
• vertigo
• rapid heartbeat
• feeling faint
• facial flushing and sensation of warmth
• cough
• dry mouth
• muscle weakness
• inability to achieve or maintain erection.

These are the side effects known for each of the active substances taken alone or for two active substances taken together:
These may be side effects of SARKAMEX, even though they have not been observed so far with the fixed-dose combination of olmesartan medoxomil/amlodipine/hydrochlorothiazide.
Very common (may affect more than 1 in 10 people):

• oedema (fluid retention).

Common (may affect up to 1 in 10 people):

• bronchitis
• stomach and intestinal infection
• vomiting, increased blood sugar levels
• sugar in urine
• confusion; drowsiness
• vision disturbances (including double vision and blurred vision)
• nasal congestion or runny nose
• sore throat
• difficulty breathing
• cough
• abdominal pain
• heartburn
• stomach discomfort
• flatulence
• joint or bone pain
• back pain
• skeletal pain
• blood in urine
• flu-like symptoms
• chest pain
• pain.

Uncommon (may affect up to 1 in 100 people):

• reduction in the number of a type of blood cells called platelets, which may lead to easier bruising or prolonged bleeding time
• anaphylactic reactions
• abnormally reduced appetite (anorexia)
• sleep problems; irritability
• mood changes including anxiety
• feeling low or depressed
• chills; sleep disorders
• distorted sense of taste
• loss of consciousness
• reduced sense of touch
• tingling sensation
• worsening of myopia
• ringing in the ears (tinnitus)
• angina (chest pain or discomfort, known as angina pectoris)
• irregular heartbeat; rash (skin eruption)
• hair loss; allergic skin inflammation
• skin redness
• purple spots or patches on the skin due to small haemorrhages (purpura)
• change in skin colour
• red, itchy welts (urticaria)
• increased sweating
• itching
• skin rash
• skin reactions to light such as sunburn or rash (skin eruption)
• muscle pain
• problems urinating
• need to urinate at night
• breast enlargement in men
• reduced sexual desire
• facial swelling
• feeling unwell
• weight gain or loss
• exhaustion.

Rare (may affect up to 1 in 1000 people):

• enlargement and pain of the salivary glands
• reduction in the number of white blood cells in the blood, which may increase the risk of infections
• low number of red blood cells (anaemia)
• bone marrow damage
• restlessness
• feeling of indifference (apathy)
• epileptic seizures (convulsions)
• seeing yellow objects
• dry eyes
• blood clots (thrombosis, embolism)
• fluid accumulation in the lungs
• pneumonia
• inflammation of blood vessels and small blood vessels in the skin
• inflammation of the pancreas
• yellowing of the skin and eyes
• acute inflammation of the gallbladder
• symptoms of lupus erythematosus such as rash (skin eruption), joint pain, cold hands and fingers
• severe skin reactions including severe rash, urticaria, skin redness over the entire body, severe itching, blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening
• impaired movements
• acute kidney failure
• non-infectious inflammation of the kidneys
• poor kidney function
• fever
• intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Very rare (may affect up to 10 in 10,000 people):

• increased muscle tension
• numbness of hands or feet
• heart attack
• inflammation of the stomach
• gum thickening
• intestinal obstruction
• liver inflammation
• acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated from the available data):

• reduced vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• tremor, rigid posture, mask-like facial expression, slowed movements, shuffling and unbalanced gait
• skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SARKAMEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What SARKAMEX contains
SARKAMEX 20 mg/5 mg/12.5 mg film-coated tablets
The active substances in SARKAMEX are olmesartan medoxomil 20 mg, amlodipine (as besylate)
5 mg and hydrochlorothiazide 12.5 mg.
SARKAMEX 40 mg/5 mg/12.5 mg film-coated tablets
The active substances in SARKAMEX are olmesartan medoxomil 40 mg, amlodipine (as besylate)
5 mg and hydrochlorothiazide 12.5 mg.
SARKAMEX 40 mg/10 mg/12.5 mg film-coated tablets
The active substances in SARKAMEX are olmesartan medoxomil 40 mg, amlodipine (as besylate)
10 mg and hydrochlorothiazide 12.5 mg.
SARKAMEX 40 mg/5 mg/25 mg film-coated tablets
The active substances in SARKAMEX are olmesartan medoxomil 40 mg, amlodipine (as besylate)
5 mg and hydrochlorothiazide 25 mg.
SARKAMEX 40 mg/10 mg/25 mg film-coated tablets
The active substances in SARKAMEX are olmesartan medoxomil 40 mg, amlodipine (as besylate)
10 mg and hydrochlorothiazide 25 mg.

The other components are:
Tablet core: microcrystalline cellulose, lactose monohydrate, povidone,
crospovidone, sodium starch glycolate, hydrated colloidal silica, magnesium stearate
Coating:
SARKAMEX 20 mg/5 mg/12.5 mg:
White coating Opadry II 85F18378: partially hydrolysed polyvinyl alcohol (E1203),
titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
SARKAMEX 40 mg/5 mg/12.5 mg and 40 mg/5 mg/25 mg:
Yellow coating Opadry II 85F22055: partially hydrolysed polyvinyl alcohol (E1203),
titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172)
SARKAMEX 40 mg/10 mg/12.5 mg and 40 mg/10 mg/25 mg:
Pink coating Opadry II 85F94526: partially hydrolysed polyvinyl alcohol (E1203),
titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), red iron oxide (E172)

Description of the appearance of SARKAMEX and contents of the pack
SARKAMEX 20 mg/5 mg/12.5 mg: White, round, bevelled-edge tablets, marked “OA” on one side and “05” on the other side.
SARKAMEX 40 mg/5 mg/12.5 mg: Yellow, round, bevelled-edge tablets, marked “OA” on one side and “06” on the other side.
SARKAMEX 40 mg/10 mg/12.5 mg: Pink, round, bevelled-edge tablets, marked “OA” on one side and “03” on the other side.
SARKAMEX 40 mg/5 mg/25 mg: Yellow, capsule-shaped, bevelled-edge tablets, marked “OA” on one side and “04” on the other side.
SARKAMEX 40 mg/10 mg/25 mg: Pink, capsule-shaped, bevelled-edge tablets, marked “OA” on one side and “02” on the other side.
SARKAMEX is available in blisters of 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adamed S.r.l.
Via G. Mazzini 20
20123 Milan
Italy
Manufacturers
Teva Operations Poland Sp. z.o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria

This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy: SARKAMEX