Sevikar HCT

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 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.

What is in this leaflet

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

Warnings and precautions

Talk to your doctor or pharmacist before using Sevikar HCT. 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 potassium in your blood.
• Problems with your adrenal glands
• 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.

As with any medicine that reduces blood pressure, an excessive drop in blood pressure may lead to a heart attack or stroke. Your doctor will therefore check your blood pressure carefully.

Sevikar HCT may cause a rise in blood cholesterol and uric acid (the cause of gout – painful swelling of the joints). Your doctor may request blood tests to check.

Sevikar HCT may also affect your body’s salt balance. Your doctor may request blood tests to check. Possible symptoms include thirst, dryness of the mouth, muscle pain or cramps, tired muscles, low blood pressure, 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”).

Children and adolescents (under 18)

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

Other medicines and Sevikar HCT

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

• 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, 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, an antibiotic), certain pain killers such as aspirin or salicylates. Using these medicines at the same time as Sevikar HCT may alter the concentration 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.
• Certain antacids (indigestion or heartburn remedies) as the effect of Sevikar HCT can be slightly decreased.
• Other blood pressure lowering medicines as the effect of Sevikar HCT in lowering blood pressure can be increased.
• 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.

Also, tell your doctor or pharmacist if you are taking or have recently taken 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 (such as noradrenaline) and slow heart rate
• Treat infections such as the antibiotics called tetracyclines or sparfloxacin.
• Treat gout such as probenecid, sulfinpyrazone and allopurinol.
• Lower blood fat levels such as colestyramine and colestipol.
• Stop rejection of organ transplants such as ciclosporin.
• 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.

Taking Sevikar HCT with food and drink

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.

Elderly patients

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 and breast-feeding

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 in early 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. 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, especially if your baby is newborn, or was born prematurely.

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.

Driving and using machines

You may feel sleepy, sick or dizzy or get a headache while being treated for your high blood pressure. Do not drive or use machines whilst you have symptoms. Ask your doctor for advice.

If you take more Sevikar HCT than you should

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.

If you forget to take Sevikar HCT

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.

If you stop taking Sevikar HCT

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

What Sevikar HCT contains

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.

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)

What Sevikar HCT looks like and contents of the pack

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 and Manufacturer

Marketing Authorisation Holder

Manufacturer