Olmesartan medoxomil/Amlodipine 20 mg/5 mg film-coated tablets – patient leaflet, side effects, dosage

1. What Olmesartan medoxomil/Amlodipine is and what it is used for

Olmesartan medoxomil/Amlodipine contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). Both of these substances help 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 channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening thereby also reducing blood pressure.

The actions of both these substances contribute to stopping the tightening of blood vessels, so that blood vessels relax and blood pressure decreases.

Olmesartan medoxomil/Amlodipine is used for the treatment of high blood pressure in patients whose blood pressure is not controlled enough with either olmesartan medoxomil or amlodipine alone.

2. What you need to know before you take Olmesartan medoxomil/Amlodipine

Do not take Olmesartan medoxomil/Amlodipine:

• if you are allergic to olmesartan medoxomil or to amlodipine or a special group of calcium channel blockers, the dihydropyridines 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 Olmesartan medoxomil/Amlodipine.

• if you are more than 3 months pregnant (It is also better to avoid Olmesartan medoxomil/Amlodipine in early pregnancy - see section “Pregnancy and breastfeeding”.).
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
• if you have severe liver problems, if bile secretion is impaired or drainage of bile from the gallbladder is blocked (e.g. by gallstones), or if you are experiencing any jaundice (yellowing of the skin and eyes).
• if you have very low blood pressure.
• if you are suffering from insufficient blood supply to your tissues with symptoms like e.g. low blood pressure, low pulse, fast heartbeat (shock, including cardiogenic shock). Cardiogenic shock means shock due to severe heart troubles.
• if the blood flow from your heart is obstructed (e.g. because of the narrowing of the aorta (aortic stenosis)).
• if you suffer from low heart output (resulting in shortness of breath or peripheral swellings) after a heart attack (acute myocardial infarction).

Warnings and precautions

Talk to your doctor or pharmacist before taking Olmesartan medoxomil/Amlodipine.

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.

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

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 Olmesartan medoxomil/Amlodipine”.

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).

Contact your doctor if you experience 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.

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.

You must tell your doctor if you think that you are (or might become) pregnant. Olmesartan medoxomil/Amlodipine 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)

Olmesartan medoxomil/Amlodipine is not recommended for children and adolescents under the age of 18.

Other medicines and Olmesartan medoxomil/Amlodipine

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

• Other blood pressure lowering medicines, as the effect of Olmesartan medoxomil/Amlodipine 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 Olmesartan medoxomil/Amlodipine” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, “water tablets” (diuretics) or heparin (for thinning the blood and prevention of blood clots.). Using these medicines at the same time as Olmesartan medoxomil/Amlodipine may raise the levels of potassium in your blood.
• Lithium (a medicine used to treat mood swings and some types of depression) used at the same time as Olmesartan medoxomil/Amlodipine may increase the toxicity of lithium. If you have to take lithium, your doctor will measure your lithium blood levels.
• 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 Olmesartan medoxomil/Amlodipine may increase the risk of kidney failure. The effect of Olmesartan medoxomil/Amlodipine can be decreased by NSAIDs.
• Colesevelam hydrochloride, a drug that lowers the level of cholesterol in your blood, as the effect of Olmesartan medoxomil/Amlodipine may be decreased. Your doctor may advise you to take Olmesartan medoxomil/Amlodipine at least 4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion or heartburn remedies), as the effect of Olmesartan medoxomil/Amlodipine can be slightly decreased.
• Medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir) or for the treatment of fungal infections (e.g. ketoconazole, itraconazole).
• Diltiazem, verapamil, (agents used for heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin (antibiotics) agents used for tuberculosis or other infections
• St. John’s wort (Hypericum perforatum), a herbal remedy.
• Dantrolene (infusion for severe body temperature abnormalities).
• Simvastatine, an agent used to lower levels of cholesterol and fats (triglycerides) in the blood.
• Tacrolimus, cyclosporine, used to control your body’s immune response, enabling your body to accept the transplanted organ

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

Olmesartan medoxomil/Amlodipine with food and drink

Olmesartan medoxomil/Amlodipine can be taken with or without food. Swallow the tablet with some fluid (such as one glass of water). If possible, take your daily dose at the same time each day, for example at breakfast time.

Grapefruit juice and grapefruit should not be consumed by people who are taking Olmesartan medoxomil/Amlodipine. 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 Olmesartan medoxomil/Amlodipine.

Elderly

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.

Black patients

As with other similar drugs the blood pressure lowering effect of Olmesartan medoxomil/Amlodipine can be somewhat less in black patients.

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 Olmesartan medoxomil/Amlodipine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Olmesartan medoxomil/Amlodipine. Olmesartan medoxomil/Amlodipine 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 Olmesartan medoxomil/Amlodipine, 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 has been shown to pass into breast milk in small amounts. Olmesartan medoxomil/Amlodipine 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. If this happens, do not drive or use machines until the symptoms wear off. Ask your doctor for advice.

Olmesartan medoxomil/Amlodipine contains lactose monohydrate

This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Olmesartan medoxomil/Amlodipine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• The recommended dose of Olmesartan medoxomil/Amlodipine is one tablet per day.
• The tablets can be taken with or without food. Swallow the tablet with some fluid (such as a glass of water). The tablet should not be chewed. Do not take them with grapefruit juice.
• If possible, take your daily dose at the same time each day, for example at breakfast time.

If you take more Olmesartan medoxomil/Amlodipine 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.

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 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 Olmesartan medoxomil/Amlodipine

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

If you stop taking Olmesartan medoxomil/Amlodipine

It is important to continue to take Olmesartan medoxomil/Amlodipine unless your doctor tells you to stop.

If you have any further questions on 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 everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped.

Although not many people may get them, the following side effects can be serious:

Allergic reactions, that may affect the whole body, with swelling of the face, mouth and/or larynx (voice box) together with itching and rash may occur during treatment with Olmesartan medoxomil/Amlodipine. If this happens stop taking Olmesartan medoxomil/Amlodipine and talk to your doctor immediately.

Olmesartan medoxomil/Amlodipine can cause the blood pressure to fall too low in susceptible individuals or as the result of an allergic reaction. This could cause severe light-headedness or fainting. If this happens stop taking Olmesartan medoxomil/Amlodipine, talk to your doctor immediately and lie 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 Olmesartan medoxomil/Amlodipine longer time ago, contact your doctor immediately who will evaluate your symptoms and decide on how to continue your blood pressure medication.

Other possible side effects with Olmesartan medoxomil/Amlodipine:

Common: may affect up to 1 in 10 people

Dizziness; headache; swelling of ankles, feet, legs, hands, or arms; tiredness.

Uncommon: may affect up to 1 in 100 people

Dizziness on standing up; lack of energy; tingling or numbness of hands or feet; vertigo; awareness of heart beat; fast heart beat; low blood pressure with symptoms such as dizziness, light-headedness; difficult breathing; cough; nausea; vomiting; indigestion; diarrhoea; constipation; dry mouth, upper abdominal pain; skin rash; cramps; pain in arms and legs; back pain; feeling more of an urge to pass urine; sexual inactivity; inability to get or maintain an erection; weakness.

Some changes in blood test results have also been seen and include the following:

increased as well as decreased blood potassium levels, increased blood creatinine levels, increased uric acid levels, increases in a test of liver function (gamma glutamyl transferase levels).

Rare: may affect up to 1 in 1,000 people

Drug hypersensitivity; fainting; redness and warm feeling of the face red itchy bumps (hives); swelling of face.

Side effects reported with use of olmesartan medoxomil or amlodipine alone, but not with Olmesartan medoxomil/Amlodipine or in a higher frequency:

Olmesartan medoxomil

Common: may affect up to 1 in 10 people

Bronchitis; sore throat; runny or stuffy nose; cough; abdominal pain; stomach flu; diarrhoea; indigestion; nausea; pain in the joints or bones; back pain; blood in the urine; infection of the urinary tract; chest pain; flu-like symptoms; pain. Changes in blood test results as increased fat levels (hypertriglyceridaemia), blood urea or uric acid increased and increase in tests of liver and muscle function.

Uncommon: may affect up to 1 in 100 people

Reduced number of a type of blood cells, known as platelets, which can result in easily bruising or prolonged bleeding time; quick allergic reactions that may affect the whole body and may cause breathing problems as well as a rapid fall of blood pressure that may even lead to fainting (anaphylactic reactions); angina (pain or uncomfortable feeling in the chest, known as angina pectoris); itching; eruption of the skin; allergic skin rash; rash with hives; swelling of the face; muscular pain; feeling unwell.

Rare: may affect up to 1 in 1,000 people

Swelling of the face, mouth and/or larynx (voice box); acute kidney failure and kidney insufficiency; lethargy.

Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Amlodipine

Very common: may affect more than 1 in 10 people

Oedema (fluid retention)

Common: may affect up to 1 in 10 people

Abdominal pain; nausea; ankle swelling; feeling sleepy; redness and warm feeling of the face, visual disturbance (including double vision and blurred vision), awareness of heartbeat, diarrhoea, constipation, indigestion, cramps, weakness, difficult breathing.

Uncommon: may affect up to 1 in 100 people

Trouble sleeping; sleep disturbances; mood changes including feeling anxious; depression; irritability; shiver; taste changes; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (pain or uncomfortable feeling in the chest); irregular heartbeat; runny or stuffy nose; loss of hair; purplish spots or patches on the skin due to small haemorrhages (purpura); discoloration of the skin; excessive sweating; eruption of the skin; itching; red itchy bumps (hives); pain of joints or muscles; problems to pass urine; urge to pass urine at night; increased need to urinate (pass urine); breast enlargement in men; chest pain; pain, feeling unwell; increase or decrease in weight.

Rare: may affect up to 1 in 1,000 people

Confusion

Very rare: may affect up to 1 in 10,000 people

Reduction in the number of white cells in the blood, which could increase the risk of infections; a reduction in the number of a type of blood cells known as platelets, which can result in easily bruising or prolonged bleeding time; increase in blood glucose; increased tightness of muscles or increased resistance to passive movement (hypertonia); tingling or numbness of hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or the pancreas; inflammation of stomach lining; thickening of gums; elevated liver enzymes; yellowing of the skin and eyes; increased sensitivity of the skin to light; allergic reactions: itching, rash, swelling of the face, mouth and/or larynx (voice box) together with itching and rash, 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.

Not known: frequency cannot be estimated from the available data

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see contact details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

5. How to store Olmesartan medoxomil/Amlodipine

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 carton, blister and label after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

HDPE bottle: use within 90 days after first opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Olmesartan medoxomil/Amlodipine contains

The active substances are olmesartan medoxomil and amlodipine

Olmesartan medoxomil/Amlodipine 20 mg/5 mg: Each film-coated tablet contains 20 mg olmesartan medoxomil and 5 mg amlodipine (as amlodipine besilate).

Olmesartan medoxomil/Amlodipine 40 mg/5 mg: Each film-coated tablet contains 40 mg olmesartan medoxomil and 5 mg amlodipine (as amlodipine besilate).

Olmesartan medoxomil/Amlodipine 40 mg/10 mg: Each film-coated tablet contains 40 mg olmesartan medoxomil and 10 mg amlodipine (as amlodipine besilate).

The other ingredients are:

Tablet core:

Pregelatinised maize starch, Silicified microcrystalline cellulose (microcrystalline cellulose with silica, colloidal anhydrous), Lactose monohydrate, Magnesium stearate, Povidone K-30

Tablet coating:

The Opadry II 85F18422 white coating of Olmesartan medoxomil/Amlodipine 20 mg/5 mg contains:

Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc

The Opadry II 85F520132 yellow coating of Olmesartan medoxomil/Amlodipine 40 mg/5 mg contains:

Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc, Iron oxide yellow (E172)

The Opadry II 85F565114 brown coating of Olmesartan medoxomil/Amlodipine 40 mg/10 mg contains:

Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc, Iron oxide yellow (E172), Iron oxide red (E172)

What Olmesartan medoxomil/Amlodipine looks like and contents of the pack

Olmesartan medoxomil/Amlodipine 20 mg/5 mg is White, round, film-coated tablets, debossed with “OA1” on one side and plain on other side. Dimension: Diameter 6.10 mm ± 0.20 mm

Olmesartan medoxomil/Amlodipine 40 mg/5 mg is White to off-white, round, film-coated tablets debossed with “OA3” on one side and plain on other side. Dimension: Diameter 8.10 mm ± 0.20 mm

Olmesartan medoxomil/Amlodipine 40 mg/10 mg is Brownish-red, round, film-coated tablets debossed with “OA4” on one side and plain on other side. Dimension: Diameter 8.10 mm ± 0.20 mm

OPA/Al/PVC-Al blister:

OPA/Al/PVC-Al blister containing 28, 30, 56, 90 or 98 tablets or in OPA/Al/PVC-Al perforated unit dose blisters containing 28 or 30 tablets.

HDPE Bottle:

White opaque HDPE bottle with a white child resistant polypropylene cap, containing 30 or 90 tablets.

White opaque HDPE bottle with a white continuous thread screw polypropylene cap, containing 500 or 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319, Pinner Road, North Harrow

Middlesex ,HA1 4HF

United Kingdom

Manufacturer

Accord Healthcare Limited

Sage House, 319, Pinner Road, North Harrow

Middlesex ,HA1 4HF

United Kingdom

LABORATORI FUNDACIÓ DAU,

C/ C, 12-14 Pol. Ind. Zona Franca

Barcelona, 08040

Spain

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

The medicinal product is authorized in the Member States of the EEA under the following names:

This leaflet was last revised in 01/2025.