SEVITREX 20 mg/5 mg /12.5 Mg Film-Coated Tablets

Зміст інструкції

1. SEVITREX 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
   1. What is Sevitrex and what it is used for
   2. What you need to know before taking Sevitrex
   3. How to take Sevitrex
   4. Possible side effects
   5. How to store Sevitrex
   6. Package Contents and Other Information
2. Sevitrex 40 mg/10 mg/12.5 mg film-coated tablets: 9.5 mm round film-coated tablets
3. Sevitrex 40 mg/5 mg/25 mg film-coated tablets: 15 x 7 mm film-coated tablets
4. Sevitrex 40 mg/10 mg/25 mg film-coated tablets: 15 x 7 mm film-coated tablets

SEVITREX 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)

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Sevitrex and what it is used for

Sevitrex contains three substances called olmesartan medoxomil, amlodipine (as
amlodipine besylate) and hydrochlorothiazide. All of them are used to control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists” which lower blood pressure by relaxing the blood vessels.
• Amlodipine belongs to a group of substances called “calcium antagonists”. Amlodipine also lowers blood pressure by relaxing the blood vessels.
• Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics” (medicines to stimulate diuresis). It lowers blood pressure by helping the body to eliminate excess water by causing the kidneys to produce more urine.

The action of these substances helps to reduce blood pressure.
Sevitrex is used to treat high blood pressure:

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

2. What you need to know before taking Sevitrex

Do not take Sevitrex if:

• you are allergic to olmesartan medoxomil, amlodipine or a particular group of calcium antagonists (dihydropyridines), to hydrochlorothiazide or to substances similar to hydrochlorothiazide (called sulfonamides), or to any of the excipients of this medicine listed in section 6. If you think you may be allergic, talk to your doctor before taking Sevitrex.
• you have severe kidney problems.
• you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• you have low levels of potassium or sodium, or if you have high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood that do not improve after treatment.
• you are pregnant for more than three months (it is best to avoid taking Sevitrex even in the early stages of pregnancy - see section “Pregnancy and breastfeeding”).
• you suffer from severe liver problems, if bile secretion is impaired or the flow of bile is blocked (for example by gallstones), or if you have jaundice (yellowing of the skin and eyes).
• you suffer from reduced blood flow to the tissues with symptoms such as low blood pressure, weak pulse, rapid heartbeat or shock (including cardiogenic shock, which means shock due to serious heart problems).
• you have very low blood pressure.
• the blood flow from your heart is slow or obstructed. This happens if the blood vessels or valves that carry blood out of the heart narrow (aortic stenosis).
• you suffer from reduced cardiac output due to a heart attack (acute myocardial infarction). A reduction in cardiac output manifests with difficulty breathing or swelling of the feet and ankles.

If you think you are in any of the conditions described above, do not take Sevitrex.

Warnings and precautions
Consult your doctor or pharmacist,before taking Sevitrex.
Consult your doctorif you are taking any of the following medicines used to treat high blood pressure:

• an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• Aliskiren

The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated under “Do not take Sevitrex if”

Tell your doctorif you also have any of the following health problems:

• Kidney problems or kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of diuretics, or if you are on a low-salt diet.
• Increased levels of potassium in the blood.
• Problems with the adrenal glands (glands that produce hormones, located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergies or asthma.
• Skin reactions such as sunburn or rash after exposure to the sun or sunlamps.
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV radiation while taking Sevitrex. if you have had breathing problems or lung problems (including inflammation or fluid in the lungs) following the intake of hydrochlorothiazide in the past. If shortness of breath or severe difficulty breathing occurs after taking Sevitrex, consult a doctor immediately.

Tell your doctorif any of the following symptoms occur:

• severe and prolonged diarrhea with significant weight loss. Your doctor will assess the symptoms and decide whether to continue this antihypertensive treatment;
• decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eye and can occur within hours or weeks of taking Sevitrex. This increase, if left untreated, can lead to permanent visual impairment.

As with any medicine that lowers blood pressure, an excessive reduction in pressure in patients with circulatory disorders of the heart or brain could lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
Sevitrex may cause an increase in fats and uric acid (causing gout - painful swelling of the joints) in the blood. Your doctor will probably want to perform periodic blood tests to assess these conditions.
The levels of some substances, called electrolytes, in the blood may change. Your doctor will probably want to perform periodic blood tests to assess these conditions.
Signs of electrolyte disturbances are: thirst, dry mouth, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), feeling weak, sluggishness, fatigue, drowsiness or lack of rest, nausea, vomiting, reduced need to urinate, rapid heart rate. Tell your doctor if these symptoms occur.
If you are to undergo tests of parathyroid function, stop taking Sevitrex before the tests are performed.
You must tell your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Sevitrex is not recommended in early pregnancy and must not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years of age)
Sevitrex is not recommended in children and adolescents under 18 years of age.

Other medicines and Sevitrex
Tell 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 they may increase the effect of Sevitrex.
• The doctor may need to adjust the dose and/or take other precautions: if you are taking an ACE inhibitor or aliskiren (see also “Do not take Sevitrex if” and “Warnings and precautions”).
• Lithium(a medicine used to treat mood swings and some types of depression) used together with Sevitrex may increase the toxicity of lithium. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Diltiazem, verapamil,drugs used for heart rhythm problems and high blood pressure.
• Rifampicin, erythromycin, clarithromycin,tetracyclines or sparfloxacin,antibiotics used for tuberculosis and other infections.
• St John's Wort(Hypericum perforatum), a herbal remedy for the treatment of depression.
• Cisapride,used to speed up the passage of food in the stomach and intestines.
• Difemanil,used to treat a slow heartbeat or reduce sweating.
• Alofantrina,used for malaria.
• Vincamine e.v.,used to improve circulation in the nervous system.
• Amantadine,used for Parkinson's disease.
• Potassium supplements, salt substitutes containing potassium, diuretics orheparin(to thin the blood and prevent thrombosis), ACE inhibitors (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a drug used to treat mouth and stomach ulcers), benzylpenicillin sodium (also called penicillin G sodium, an antibiotic), certain

pain relievers such as acetylsalicylic acid (aspirin) or salicylates. Taking these medicines together with Sevitrex may alter the levels of potassium in the blood.

• Non-steroidal anti-inflammatory drugs(NSAIDs, medicines used to reduce pain, swelling and other symptoms of inflammation, including arthritis) used together with Sevitrex may increase the risk of kidney failure. The effectiveness of Sevitrex may be reduced by NSAIDs. In case of taking high doses of salicylate, the toxic effects on the central nervous system may be increased.
• Sleeping pills, sedatives and antidepressants,used together with Sevitrex may cause a sudden drop in blood pressure when getting up.
• Colesevelam hydrochloride,a medicine that reduces cholesterol levels in the blood, which may decrease the effect of Sevitrex. Your doctor may advise you to take Sevitrex at least 4 hours before colesevelam hydrochloride.
• Some antacids(used for indigestion or heartburn) may slightly reduce the effectiveness of Sevitrex.
• Some muscle relaxants,such as baclofen and tubocurarine.
• Anticholinergic drugs,such as atropine and biperidene.
• Calcium supplements.
• Dantrolene(infusion for severe body temperature alterations).
• Simvastatina,a substance used to reduce cholesterol and fat (triglyceride) levels in the blood.
• Medicines used to control the immune response of your body(such as tacrolimus, sirolimus, temsirolimus, everolimus and cyclosporine) that allow your body to accept transplanted organs.

In addition, tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines for:

• Treating some mental disorderssuch as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol.
• Treating hypoglycemia(such as diazoxide) or hypertension(beta-blockers, methyldopa), as Sevitrex may affect the action of these drugs.
• Treating heart rhythm disturbancessuch as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or injectable erythromycin.
• Treating HIV/AIDS(for example ritonavir, indinavir, nelfinavir).
• Treating fungal infections(for example ketoconazole, itraconazole, amphotericin).
• Treating heart conditionssuch as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil or digitalis.
• Treating tumorssuch as amifostine, cyclophosphamide or methotrexate.
• Increasing blood pressureand slowing the heart ratesuch as norepinephrine.
• Treating goutsuch as probenecid, sulfinpyrazone and allopurinol.
• Reducing blood fat levelssuch as colestyramine and colestipol.
• Reducing blood sugar levelssuch as metformin or insulin.

Tell your doctor or pharmacist if you are taking, have recently taken or will take any other medicine.

Sevitrex with food and drink
Sevitrex can be taken with or without food.
People taking Sevitrex should not consume grapefruit and grapefruit juice as grapefruit and its juice can cause an increase in the levels of the active ingredient amlodipine in the blood, and this may lead to an unpredictable increase in the hypotensive effect of Sevitrex.
Be careful to drink alcohol while taking Sevitrex, as some people may feel faint or confused. If this happens to you, do not drink alcohol.

Elderly
If you are over 65 years of age, your doctor will regularly check your blood pressure with each dose increase, to avoid it dropping too much.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). As a rule, your doctor will advise you to stop taking Sevitrex before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Sevitrex. Sevitrex is not recommended during pregnancy and must not be taken if you are pregnant for more than three months as it can cause serious harm to the baby if taken after the third month of pregnancy.
If you become pregnant while taking Sevitrex, inform and see your doctor immediately.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts. Sevitrex is not recommended for women who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
You may feel drowsy, confused, dizzy or have a headache during treatment for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared.
Ask your doctor for advice.

3. How to take Sevitrex

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

• The recommended dose of Sevitrex is one tablet a day.
• The tablet can be taken with or without food. Swallow the tablet with some liquid (such as a glass of water). The tablets must not be chewed. Do not take it with grapefruit juice.
• If possible, take your daily dose every day at the same time, for example with breakfast.

If you take more Sevitrex than you should
If you take more tablets than you should, you may experience a reduction in blood pressure with symptoms such as dizziness, acceleration or slowing of the heartbeat.
If you take more tablets than you should or if a child accidentally swallows any, go immediately to your doctor or the nearest emergency room bringing with you the packaging of the medicine or this leaflet.
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath which may develop up to 24-48 hours after taking it.

If you forget to take Sevitrex
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 Sevitrex
It is important to continue taking Sevitrex unless your doctor tells you to stop.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If they do occur, they are usually mild and do not require discontinuation of treatment.

Although they do not appear in all people, the following side effects may be serious:
During treatment with Sevitrex, allergic reactions may occur with swelling of the face, mouth and/or
larynx (the site of the vocal cords), associated with itching and skin rash. If this happens, stop
taking Sevitrex and contact your doctor immediately.
Sevitrex may cause excessive reductions in blood pressure in sensitive individuals. This may cause
severe dizziness or fainting. If this happens, stop taking Sevitrex, contact your doctor
immediately and remain lying down.
Frequency not known: if you experience yellowing of the whites of your eyes, dark urine, skin
itching, even if you have been taking Sevitrex for a long time, contact your doctor
immediatelywho will assess the symptoms and decide how to proceed with therapy for
high blood pressure.
Sevitrex is a combination of three active substances. The following information first reports the
other side effects reported so far with the Sevitrex combination (in addition to those already
mentioned above) and, secondly, those side effects known for each of the three separate substances
or when two substances are administered together.
To give you an idea of how many patients have experienced these side effects, they have been listed
as common, uncommon, rare and very rare.

These are the other side effects known with Sevitrex so far:
If they do occur, they are usually mild and do not require discontinuation of treatment.
Common (may affect up to 1 in 10 people):
Upper respiratory tract infection; sore throat and nose inflammation; urinary tract infection; dizziness;
headache; palpitations; low blood pressure; nausea; diarrhea; constipation; cramps; joint swelling;
feeling of urgency to urinate; weakness; ankle swelling; fatigue; laboratory value abnormalities.

Uncommon (may affect up to 1 in 100 people):
Dizziness when assuming an upright position; vertigo; fast heartbeat; feeling of weakness; redness
and feeling of warmth in the face; cough; dry mouth; muscle weakness; inability to obtain or
maintain an erection.

These are the side effects known for each of the components taken alone or for two
components taken together:
They may be side effects of Sevitrex even if they have not been observed so far with Sevitrex.

Very common (may affect more than 1 in 10 people):
Edema (fluid retention).

Common (may affect up to 1 in 10 people):
Bronchitis; stomach and intestinal infection; vomiting; increased blood sugar; glucose in the urine;
confusion; drowsiness; vision disorders (including double and blurred vision); runny or stuffy nose;
sore throat inflammation; difficulty breathing; cough; abdominal pain; heartburn; stomach
disorders; flatulence; joint or bone pain; lower back pain; skeletal pain; blood in the urine;
flu-like symptoms; chest pain; pain.

Uncommon (may affect up to 1 in 100 people):
Reduction of a type of blood cell called platelets, which can cause easy bruising or prolonged
bleeding time; anaphylactic reactions; abnormal decrease in appetite (anorexia); difficulty falling
asleep; irritability; mood changes including anxiety; feeling of depression; chills; sleep
disorders; changes in taste; loss of consciousness; reduced tactile sensitivity; tingling; worsening
of near vision; ringing in the ears (tinnitus); angina (chest pain or discomfort, known as angina
pectoris); irregular heartbeat; rash; hair loss; allergic skin inflammation; skin redness; small red
spots on the skin due to minor bleeding (purpura); skin discoloration; itchy red welts (urticaria);
excessive sweating; itching; skin rash; skin reactions to light such as sunburn or rash; muscle pain;
difficulty urinating; feeling of urgency to urinate at night; breast enlargement in men; decreased
sexual desire; facial swelling; feeling unwell; weight gain or loss; exhaustion.

Rare (may affect up to 1 in 1000 people):
Swelling 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 (anemia); bone marrow
damage; lack of rest; lack of interest (apathy); convulsions; seeing yellow objects; dry eyes;
blood clots (thrombosis or embolism); fluid accumulation in the lungs; pneumonia; inflammation
of the 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, joint pain and cold fingers and hands; severe skin reactions including intense rash, urticaria,
redness of the skin over the entire body surface, severe itching, blisters, peeling and swelling of
the skin, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal
necrosis); impaired movement; acute kidney failure; non-infectious kidney inflammation; reduced
kidney function; fever.

Very rare (may affect up to 1 in 10,000 people):
Muscle hypertonia; numbness of the hands or feet; heart attack; inflammation of the stomach;
thickening of the gums; intestinal blockage; inflammation of the liver.
Acute respiratory distress (signs include severe shortness of breath, fever, weakness and
confusion).

Not known (frequency cannot be estimated based on available data):
Decreased 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 face, slow movements and an unbalanced, shuffling gait.
Skin and lip cancer (non-melanoma skin cancer).

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

5. How to store Sevitrex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after
“EXP”, on the bottle and on the blister after EXP. The expiry date refers to the last day of
that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Sevitrex contains
The active ingredients are olmesartan medoxomil, amlodipine (as amlodipine besylate) and
hydrochlorothiazide.
Each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of
amlodipine (as besylate) and 12.5 mg of hydrochlorothiazide.
Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of
amlodipine (as besylate) and 12.5 mg of hydrochlorothiazide.
Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of
amlodipine (as besylate) and 12.5 mg of hydrochlorothiazide.
Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of
amlodipine (as besylate) and 25 mg of hydrochlorothiazide.
Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of
amlodipine (as besylate) and 25 mg of hydrochlorothiazide.
The other ingredients are:

Tablet core:pregelatinized corn starch, silicified microcrystalline cellulose
(microcrystalline cellulose and anhydrous colloidal silica), croscarmellose sodium, magnesium
stearate.

Coating:polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), iron (III)
yellow oxide (E172), iron (III) red oxide (E172) (only Sevitrex film-coated tablets
20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg and 40 mg/10 mg/25 mg), iron (II, III)
black oxide (E172) (only Sevitrex film-coated tablets 20 mg/5 mg/12.5 mg).
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated
tablet, i.e. it is essentially sodium-free.

Description of the appearance of Sevitrex and contents of the pack
Sevitrex 20 mg/5 mg/12.5 mg film-coated tablets: 8 mm tablets, film-coated,
light orange in colour, round in shape with the letters C51 imprinted on one side.
Sevitrex 40 mg/5 mg/12.5 mg film-coated tablets: 9.5 mm tablets, film-coated,
light yellow in colour, round in shape with the letters C53 imprinted on one side.

Sevitrex 40 mg/10 mg/12.5 mg film-coated tablets: 9.5 mm round film-coated tablets

with a greyish-red film coating, round in shape with the letters C55 imprinted on one side.

Sevitrex 40 mg/5 mg/25 mg film-coated tablets: 15 x 7 mm film-coated tablets

with a light yellow film coating, oval in shape with the letters C54 imprinted on one side.

Sevitrex 40 mg/10 mg/25 mg film-coated tablets: 15 x 7 mm film-coated tablets

with a greyish-red film coating, oval in shape with the letters C57 imprinted on one side.
Sevitrex film-coated tablets are available:

• in packs of 14, 28, 30, 56, 84, 90, 98, 10x28 and 10x30 film-coated tablets in blisters
• in packs of 10, 50 and 500 film-coated tablets with a divisible blister for unit dosage
• in HDPE bottles containing 7, 30 and 90 film-coated tablets.

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
Daiichi Sankyo Italia SpA
Via Paolo di Dono, 73
00142 Rome
Italy

Manufacturers
Daiichi Sankyo Europe GmbH
Luitpoldstrasse,1
85276 Pfaffenhofen (Germany)
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin (Germany)
Menarini – Von Heyden GmbH
Leipziger Strasse 7-13
01097 Dresden (Germany)
This medicinal product is authorised in the Member States of the European Economic Area with the
following designations:
Austria, Germany, Greece, Netherlands, United Kingdom, Romania, Spain:
Sevikar HCT 20 mg/5 mg/12.5 mg
Sevikar HCT 40 mg/5 mg/12.5 mg
Sevikar HCT 40 mg/10 mg/12.5 mg
Sevikar HCT 40 mg/5 mg/25 mg
Sevikar HCT 40 mg/10 mg/25 mg
Belgium and Luxembourg:
Sevikar/HCT 20 mg/5 mg/12.5 mg
Sevikar/HCT 40 mg/5 mg/12.5 mg
Sevikar/HCT 40 mg/10 mg/12.5 mg
Sevikar/HCT 40 mg/5 mg/25 mg
Sevikar/HCT 40 mg/10 mg/25 mg
Denmark, Iceland:
Sevikar Comp 20 mg/5 mg/12.5 mg
Sevikar Comp 40 mg/5 mg/12.5 mg
Sevikar Comp 40 mg/10 mg/12.5 mg
Sevikar Comp 40 mg/5 mg/25 mg
Sevikar Comp 40 mg/10 mg/25 mg
Ireland:
Sevikar Plus 20 mg/5 mg/12.5 mg
Sevikar Plus 40 mg/5 mg/12.5 mg
Sevikar Plus 40 mg/10 mg/12.5 mg
Sevikar Plus 40 mg/5 mg/25 mg
Sevikar Plus 40 mg/10 mg/25 mg
Italy
Sevitrex 20 mg/5 mg/12.5 mg
Sevitrex 40 mg/5 mg/12.5 mg
Sevitrex 40 mg/10 mg/12.5 mg
Sevitrex 40 mg/5 mg/25 mg
Sevitrex 40 mg/10 mg/25 mg

Doping
For athletes: the use of the drug without therapeutic need constitutes
doping and may still result in a positive doping test.