Olmesartan medoxomil 10 mg Film-coated Tablets

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

• if you are allergic to olmesartan medoxomil or any of the other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (It is also better to avoid Olmesartan medoxomil in early pregnancy – see pregnancy section.)
• if you suffer from yellowing of the skin and eyes (jaundice) or problems with drainage of the bile from the gallbladder (biliary obstruction e.g. gallstones)
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Talk to your doctor or pharmacist before taking Olmesartan medoxomil:

• 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 Olmesartan medoxomil”.

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

• Kidney problems
• 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.

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 you are (or might become) pregnant. Olmesartan medoxomil 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 pregnancy section).

Olmesartan medoxomil has been studied in children and adolescents. For more information, talk to your doctor. Olmesartan medoxomil is not recommended for children from 1 year to less than 6 years and should not be used in children under the age of 1 year as no experience is available.

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

• Other blood pressure lowering medicines, as the effect of Olmesartan medoxomil 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” and “Warnings and precautions”).
• Potassium supplements, a salt substitute which contains potassium, water tablets (diuretics) or heparin (for thinning the blood). Using these medicines at the same time as Olmesartan medoxomil 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 may increase the toxicity of lithium. If you have to take lithium, your doctor will measure your lithium blood levels.
• Non-Steroidal Anti-Inflammatory (NSAIDs) medicines (medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis) used at the same time as Olmesartan medoxomil may increase the risk of kidney failure and the effect of Olmesartan medoxomil can be decreased by NSAIDs.
• Colesevelam hydrochloride, a drug that lowers the level of cholesterol in your blood, as the effect of Olmesartan medoxomil may be decreased. Your doctor may advise you to take Olmesartan medoxomil at least 4 hours before colesevelam hydrochloride.Certain antacids (indigestion remedies), as the effect of Olmesartan medoxomil can be slightly decreased.

If you are over 65 years of age and your doctor decides to increase your dose of Olmesartan medoxomil to 40 mg daily, then you need to have your blood pressure regularly checked by your doctor to make sure that your blood pressure does not become too low.

As with other similar drugs the blood pressure lowering effect of Olmesartan medoxomil is somewhat less in black patients.

Olmesartan medoxomil can be taken with or without food.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Olmesartan medoxomil 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. Olmesartan medoxomil 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.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Olmesartan medoxomil 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. Ask your doctor or pharmacist for advice before taking any medicine.

You may feel sleepy or dizzy 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 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 medicinal product.

The recommended starting dose is one 10 mg tablet once a day. However, if your blood pressure is not controlled, your doctor may decide to change your dose up to 20 or 40 mg once a day, or prescribe additional medicines.

In patients with mild to moderate kidney disease, your dose will not be higher than 20 mg once a day.

The tablets can be taken with or without food. Swallow the tablets with a sufficient amount of water (e.g. one glass). If possible, take your daily dose at the same time each day, for example at breakfast time.

Children and adolescents from 6 to less than 18 years of age:

The recommended starting dose is 10 mg once daily. If the patient’s blood pressure is not adequately controlled, the doctor may decide to change the dose up to 20 or 40 mg once a day. In children who weigh less than 35 kg, the dose will not be higher than 20 mg once a day.

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 with you.

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

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

In children, side effects are similar to those reported in adults. However, dizziness and headache are seen more often in children, and nose bleeding is a common side effect seen in children only.

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 substance is olmesartan medoxomil
• Each tablet contains 10 mg, 20 mg or 40 mg olmesartan medoxomil.
• The other ingredient are cellulose microcrystalline, low substituted hydroxypropyl cellulose, lactose monohydrate, hydrogenated castor oil, magnesium Stearate, hypromellose, hydroxypropyl cellulose, Titanium Dioxide and talc

Olmesartan medoxomil 10 mg tablets are white to off white, round film-coated tablets, debossed with 476 on one side and plain on the other side with a characteristic odour, approx. 6.3 mm in diameter.

Olmesartan medoxomil 20 mg tablets are white to off white, round film-coated tablets, debossed with 437 on one side and plain on the other side with a characteristic odour, approx. 8.6 mm in diameter.

Olmesartan medoxomil 40 mg tablets are white to off white, oval-shaped film-coated tablets debossed with 438 on one side and plain on the other side with a characteristic odour approx.15.3 mm in length and 7.2 mm in breadth.

Olmesartan medoxomil tablets are available in packs of 28, 30, 56, 90 and 98 film-coated tablets and packed in PVC/Alu/OPA – Alu blister packs.

Not all pack sizes may be marketed.

This medicinal product is authorised in the Member States of the EEA under the following names:

Netherlands Olmesartan medoxomil Glenmark 10 mg/20mg/40mg filmomhulde tabletten

Spain Olmesartan Viso Farmacéutica 10mg/20mg/40mg comprimidos recubiertos con película EFG

Germany Olmesartan Glenmark 10 mg/20mg/40mg Filmtablette

United Kingdom Olmesartan medoxomil 10 mg/20mg/40mg Film-coated Tablets