Sevikar HCT

• 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.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• you are allergic to olmesartan medoxomil, to amlodipine or a special group of calcium channel blockers (the dihydropyridines) to hydrochlorothiazide or to 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 talk to your doctor before taking Sevikar HCT.
• you have severe kidney problems.
• you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
• you have low potassium, low sodium, high calcium or high uric acid (with symptoms of gout or kidney stones) levels in your blood that have not got better when treated.
• you are more than 3 months pregnant. (It is also better to avoid Sevikar HCT in early pregnancy - see section “Pregnancy and breast-feeding”.)
• you have severe liver problems, if bile secretion is impaired or drainage of bile from the gall bladder is blocked (e. g. by gallstones), or if you are jaundiced (yellowing of the skin and eyes).
• you have a poor blood supply to your tissues with symptoms such as low blood pressure, low pulse, fast heartbeat or shock (including cardiogenic shock, which means shock due to severe heart troubles).
• you have very low blood pressure.
• the blood flow from your heart is slow or blocked. This may happen if the blood vessel or valve that takes blood away from your heart becomes narrow (aortic stenosis).
• you have a low heart output after a heart attack (acute myocardial infarction). Low heart output may make you feel short of breath or have swelling in your feet and ankles.

Do not take Sevikar HCT if any of the above applies to you.

Talk to your doctor or pharmacist before using Sevikar HCT.

Tell your doctor if you are taking any of the following medicines used to treat high blood pressure:

• an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems,
• aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Sevikar HCT if:”

Tell your doctor if you have any of the following health problems:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with your heart valves or heart muscle.
• Severe vomiting, diarrhoea, treatment with high doses of “water tablets” (diuretics) or if you are on a low salt diet.
• Increased levels of potassium in your blood.
• Problems with your adrenal glands (hormone-producing glands on top of the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergies or asthma.
• Skin reactions such as sunburn or rash after being in the sun or using a sunbed.
• If you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Sevikar HCT.
• If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Sevikar HCT, seek medical attention immediately.

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

• diarrhoea that is severe, persistent and causes substantial weight loss. Your doctor may evaluate your symptoms and decide on how to continue your blood pressure medication.
• decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking Sevikar HCT. This can lead to permanent vision impairment, if not treated.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Sevikar HCT. Your doctor will decide on further treatment. Do not stop taking Sevikar HCT on your own.

As with any medicine, which reduces blood pressure, an excessive drop in blood pressure in patients with blood flow disturbances of the heart or brain could lead to a heart attack or stroke. Your doctor will therefore check your blood pressure carefully.

Sevikar HCT may cause a rise in blood fat levels and uric acid levels (the cause of gout – painful swelling of the joints). Your doctor will probably want to do a blood test from time to time to check these.

It may change the levels of certain chemicals in your blood called electrolytes. Your doctor will probably want to do a blood test from time to time to check these. Signs of electrolyte changes are: thirst, dryness of the mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, sleepy or restless, nausea, vomiting, less need to pass urine, a rapid heart rate. Tell your doctor if you notice these symptoms.

If you are due to have tests for parathyroid function you should stop taking Sevikar HCT before these tests are carried out.

You must tell your doctor if you think that you are (or might become) pregnant. Sevikar HCT is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see section “Pregnancy and breast-feeding”).

Sevikar HCT is not recommended for children and adolescents under the age of 18.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following:

• Other blood pressure lowering medicines, as the effect of Sevikar HCT can be increased. Your doctor may need to change your dose and/or to take other precautions:
  If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Sevikar HCT if:” and “Warnings and precautions”).
• Lithium (a medicine used to treat mood swings and some types of depression), used at the same time as Sevikar HCT may increase the toxicity of lithium. If you have to take lithium your doctor will measure your lithium blood levels.
• Diltiazem, verapamil, 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 treatment of depression.
• Cisapride, used to increase food movement in the stomach and gut.
• Diphemanil, used to treat a slow heartbeat or reduce sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve circulation to the nervous system.
• Amantadine, used for Parkinson’s disease.
• Potassium supplements, salt substitutes containing potassium, “water tablets” (diuretics), heparin (for thinning the blood and prevention of blood clots), ACE inhibitors (for blood pressure lowering), laxatives, steroids, adrenocorticotrophic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), penicillin G sodium (also called benzylpenicillin sodium, an antibiotic), certain pain killers such as acetylsalicylic acid (“aspirin”) or salicylates. Using these medicines at the same time as Sevikar HCT may alter the levels of potassium in your blood.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis), used at the same time as Sevikar HCT may increase the risk of kidney failure. The effect of Sevikar HCT can be decreased by NSAIDs. In case of high dosages of salicylate the toxic effect on central nervous system may be increased.
• Sleeping tablets, sedatives and anti-depressant medicines as using these medicines together with Sevikar HCT may cause a sudden drop in blood pressure when standing up.
• Colesevelam hydrochloride, a drug that lowers the level of cholesterol in your blood, as the effect of Sevikar HCT may be decreased. Your doctor may advise you to take Sevikar HCT at least 4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion or heartburn remedies) as the effect of Sevikar HCT can be slightly decreased.
• Certain muscle relaxing medicines such as baclofen and tubocurarine.
• Anticholinergic agents such as atropine and biperiden.
• Calcium supplements.
• Dantrolene (infusion for severe body temperature abnormalities).
• Simvastatin, used to lower levels of cholesterol and fats (triglycerides) in the blood.
• Medicines used to control your body’s immune response (such as tacrolimus, sirolimus, temsirolimus, everolimus and cyclosporine), enabling your body to accept the transplanted organ.

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

• Treat certain mental health problems such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol.
• Treat low blood sugar (e. g. diazoxide) or high blood pressure (e. g. beta-blockers, methyldopa) as Sevikar HCT can affect how these drugs work.
• Treat heart rhythm problems such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or erythromycin injections.
• Treat HIV/AIDS (e. g. ritonavir, indinavir, nelfinavir)
• Treat fungal infections (e. g. ketoconazole, itraconazole, amphotericin).
• Treat heart problems such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil or digitalis.
• Treat cancers such as amifostine, cyclophosphamide or methotrexate.
• Increase blood pressure and slow heart rate such as noradrenaline.
• Treat gout such as probenecid, sulfinpyrazone and allopurinol.
• Lower blood fat levels such as colestyramine and colestipol.
• Lower blood sugar such as metformin or insulin.

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

Sevikar HCT can be taken with or without food.

Grapefruit juice and grapefruit should not be consumed by people who are taking Sevikar HCT. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Sevikar HCT.

Take care when drinking alcohol while you are taking Sevikar HCT as some people feel faint or dizzy. If this happens to you, do not drink any alcohol.

If you are over 65 years of age your doctor will regularly check your blood pressure at any dose increase, to make sure that your blood pressure does not become too low.

Pregnancy

You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Sevikar HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Sevikar HCT. Sevikar HCT is not recommended during pregnancy, and must not be taken when more than 3 months pregnant as it may cause serious harm to your baby if used after the third month of pregnancy.

If you become pregnant during therapy with Sevikar HCT please inform and see your physician without delay.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Amlodipine and hydrochlorothiazide have been shown to pass into breast milk in small amounts. Sevikar HCT is not recommended for mothers, who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You may feel sleepy, sick or dizzy or get a headache while being treated for your high blood pressure. If this happens do not drive or use machines until the symptoms wear off. Ask your doctor for advice.

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

If you take more tablets than you should you may experience low blood pressure with symptoms such as dizziness, fast or slow heart beat.

If you take more tablets than you should or if a child accidentally swallows some go to your doctor or nearest emergency department immediately and take your medicine pack or this leaflet with you.

Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24-48 hours after intake.

If you forget to take a dose take your normal dose the following day as usual. Do not take a double dose to make up for a forgotten dose.

It is important to continue to take Sevikar HCT unless your doctor tells you to stop.

Allergic reactions with swelling of the face, mouth and/or larynx (voice box) together with itching and rash may occur during treatment with Sevikar HCT. If this happens stop taking Sevikar HCT and contact your doctor immediately.

Severe light-headedness or fainting because Sevikar HCT can cause the blood pressure to fall too low in susceptible individuals. If this happens stop taking Sevikar HCT, contact your doctor immediately and lay down flat.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started therapy with Sevikar HCT longer time ago, contact your doctor immediately who will evaluate your symptoms and decide on how to continue your blood pressure medication.

Sevikar HCT is a combination of three active substances. The following information firstly gives the other side effects reported so far with the combination Sevikar HCT (besides those already mentioned above) and, secondly, those side effects, which are known for each of the separate substances or when two substances are given together.

To give you an idea of how many patients might get side effects, they have been listed as common, uncommon, rare and very rare.

If these side effects occur they are often mild and you do not need to stop your treatment.

Common

(may affect less than 1 in 10 people)

Upper respiratory tract infection; sore throat and nose; urinary tract infection; dizziness; headache; awareness of heartbeat; low blood pressure; nausea; diarrhoea; constipation; cramps; joint swelling; feeling more of an urge to pass urine; weakness; ankle swelling; tiredness; abnormal laboratory values.

Uncommon

(may affect less than 1 in 100 people)

Dizziness on standing up; vertigo; fast heartbeat; feeling faint; redness and warm feeling of the face; cough; dry mouth; muscular weakness; inability to get or maintain an erection.

They may be side effects for Sevikar HCT, even if they have not been seen so far with Sevikar HCT.

Very common

(may affect more than 1 in 10 people)

Oedema (fluid retention)

Common

(may affect less than 1 in 10 people)

Bronchitis; stomach and gut infection; vomiting; increased blood sugar; sugar in urine; confusion; feeling sleepy; visual disturbance (including double vision and blurred vision); runny or stuffy nose; sore throat; difficult breathing; cough; abdominal pain; heartburn; stomach discomfort; flatulence; pain in the joints or bones; back pain; skeletal pain; blood in the urine; flu-like symptoms; chest pain; pain.

Uncommon

(may affect less than 1 in 100 people)

Reduced number of a type of blood cells known as platelets, which can result in bruising easily or a prolonged bleeding time; anaphylactic reactions; abnormally reduced appetite (anorexia); problems sleeping; irritability; mood changes including feeling anxious; feeling “down” or depressed; shiver; sleep disturbances; distorted sense of taste; loss of consciousness; reduced sense of touch; tingling sensations; worsening of shortsightedness; ringing in the ears (tinnitus); angina (pain or uncomfortable feeling in the chest, known as angina pectoris); irregular heart beat; rash; loss of hair; allergic inflammation of the skin; redness of skin; purplish spots or patches on the skin due to small haemorrhages (purpura); discolouration of the skin; red itchy bumps (hives); increased sweating; itching; eruption of the skin; skin reactions to light such as sunburn or rash; muscle pain; problems to pass urine; feeling urge to pass urine at night; breast enlargement in men; decreased sexual desire; swelling of the face; feeling unwell; weight increase or decrease; exhaustion.

Rare

(may affect less than 1 in 1,000 people)

Swollen and sore salivary glands; reduced number of white cells in the blood, which could increase the risk of infections; low red blood cell count (anaemia); bone marrow damage; restlessness; feeling uninterested (apathy); fits (convulsions); objects you look at appearing yellow; 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 gall bladder; symptoms of lupus erythematosus such as rash, joint pains and cold hands and fingers; severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome, toxic epidermal necrolysis), sometimes life-threatening; impaired movement; acute kidney failure; non-infectious kidney inflammation; poor kidney function; fever; intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Very Rare

(may affect less than 1 in 10,000 people)

High muscle tension; numbness of hands or feet; heart attack; inflammation of the stomach; thickening of the gums; blockage in the gut; inflammation of the liver.

Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

Not Known

(frequency cannot be estimated from the available data)

Decrease in vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk.

Skin and lip cancer (Non-melanoma skin cancer).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substances are olmesartan medoxomil, amlodipine (as amlodipine besilate) and hydrochlorothiazide.
  Each film-coated tablet contains 20 mg olmesartan medoxomil, 5 mg amlodipine (as amlodipine besilate) and 12.5 mg hydrochlorothiazide.
  Each film-coated tablet contains 40 mg olmesartan medoxomil, 5 mg amlodipine (as amlodipine besilate) and 12.5 mg hydrochlorothiazide.
  Each film-coated tablet contains 40 mg olmesartan medoxomil, 10 mg amlodipine (as amlodipine besilate) and 12.5 mg hydrochlorothiazide.
  Each film-coated tablet contains 40 mg olmesartan medoxomil, 5 mg amlodipine (as amlodipine besilate) and 25 mg hydrochlorothiazide.
  Each film-coated tablet contains 40 mg olmesartan medoxomil, 10 mg amlodipine (as amlodipine besilate) and 25 mg hydrochlorothiazide.
• The other ingredients are:
  Tablet core: pregelatinized maize starch, silicified microcrystalline cellulose (microcrystalline cellulose and silica colloidal anhydrous), croscarmellose sodium, magnesium stearate
  Film coat: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), iron (III) oxide yellow (E 172), iron (III) oxide red (E 172) (20 mg/5 mg/12.5mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25mg film coated tablets only), iron (II, III) oxide black (E°172) (20 mg/5 mg/12.5 mg film coated tablets only)

Sevikar HCT 20 mg/5 mg/12.5 mg film-coated tablets of 8 mm are light orange, round with C51 debossed on one side.

Sevikar HCT 40 mg/5 mg/12.5 mg film-coated tablets of 9.5 mm are light yellow, round with C53 debossed on one side.

Sevikar HCT 40 mg/10 mg/12.5 mg film-coated tablets of 9.5 mm are greyish red, round with C55 debossed on one side.

Sevikar HCT 40 mg/5 mg/25 mg film-coated tablets of 15 x 7 mm are light yellow, oval with C54 debossed on one side.

Sevikar HCT 40 mg/10 mg/25 mg film-coated tablets of 15 x 7 mm are greyish red, oval with C57 debossed on one side.

Sevikar HCT film-coated tablets are available:

• in blister packs of 14, 28, 30, 56, 84, 90, 98 and 10 x 28, 10 x 30 film-coated tablets
• in packs with perforated unit dose blisters of 10, 50 and 500 film-coated tablets.
• Sevikar HCT in HDPE-bottles in packs of 7, 30 and 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer