Atolme 40 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Atolme 10 mg film-coated tablets EFG

Atolme 20 mg film-coated tablets EFG

Atolme 40 mg film-coated tablets EFG

Olmesartan medoxomil

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Atolme is and what it is used for

Atolme belongs to a group of medicines known as angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

Atolme is used to treat high blood pressure (also known as hypertension) in adults, and in children and adolescents aged 6 to less than 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this may lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually produces no symptoms. It is important to monitor your blood pressure to prevent organ damage.

High blood pressure can be managed with medications such as Atolme tablets. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and decreasing the amount of salt in your diet). Your doctor may also recommend that you exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Atolme

Do not take Atolme

• If you are allergic to olmesartan medoxomilo or to any of the other components of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (It is also advisable to avoid Atolme tablets at the beginning of pregnancy – see Pregnancy section.)
• If you have yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• Atolme contains soya lecithin. It should not be used if you are allergic to peanuts or soya.

Warnings and precautions

Talk to your doctor before starting to take Atolme.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Atolme. Your doctor will decide whether to continue treatment. Do not stop taking Atolme used as monotherapy.

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

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Atolme”.

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

• Kidney problems.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhoea, treatment with high doses of medicines that increase urine output (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands.

Contact your doctor if you develop severe, persistent diarrhoea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

As with any other medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You should inform your doctor if you are pregnant or think you might be pregnant. The use of Atolme is not recommended at the beginning of pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken during this stage (see Pregnancy section).

Children and adolescents

Atolme has been studied in children and adolescents. For further information, consult your doctor. Atolme is not recommended for children aged 1 year to less than 6 years, and should not be used in children under 1 year of age, as there is no experience available.

Taking Atolme with other medicines

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

In particular, inform your doctor or pharmacist about any of the following medicines:

• Other blood pressure-lowering medicines, as they may increase the effect of Atolme. Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Atolme” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine output (diuretics), or heparin (to thin the blood). Taking these medicines together with Atolme may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression), as it may increase lithium toxicity when taken together with Atolme. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as they may increase the risk of kidney failure and reduce the effect of Atolme when taken together.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Atolme. Your doctor may advise you to take Atolme at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of Atolme.

Elderly patients

If you are over 65 years old and your doctor decides to increase the dose of olmesartan medoxomil to 40 mg daily, your doctor will monitor your blood pressure regularly to ensure it does not drop too low.

Black patients

As with other similar medicines, the blood pressure-lowering effect of Atolme is somewhat reduced in black patients.

Taking Atolme with food and drink

Atolme can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Atolme before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of Atolme is not recommended at the beginning of pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Atolme is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

You may feel drowsy or dizzy during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Atolme contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Atolme

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 1 tablet of 10 mg daily. If blood pressure is not adequately controlled, your doctor may increase the dose up to 20 mg or 40 mg daily, or prescribe additional treatment.

In patients with mild to moderate renal impairment, the maximum dose is 20 mg once daily.

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

Children and adolescents aged 6 to less than 18 years

The recommended initial dose is 10 mg daily. If the patient's blood pressure is not adequately controlled, the doctor may decide to adjust the dose up to 20 mg or 40 mg once daily. In children weighing less than 35 kg, the dose will not exceed 20 mg once daily.

If you take more Atolme than you should

If you take more tablets than you should, or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency department immediately and bring the medicine pack with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Atolme

If you forget to take a dose, take your usual dose the next day.

Do not take a double dose to make up for forgotten doses.

If you stop taking Atolme

It is important to continue taking Atolme unless your doctor tells you to stop.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If they do occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects may be serious:

In rare cases (may affect up to 1 in 1,000 people), the following allergic reactions have been reported, which may affect the whole body:

swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Atolme and consult your doctor immediately.

Rarely (but slightly more frequently in elderly patients), Atolme may cause a marked drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This may lead to fainting or severe dizziness. If this happens to you, stop taking Atolme, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency not known: If you experience yellowish discoloration of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Atolme some time ago, contact your doctor immediately. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

The following are other adverse effects known so far with Atolme:

Frequent adverse effects (may affect up to 1 in 10 people):

Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, gastroenteritis, fatigue, sore throat, nasal congestion and discharge, bronchitis, flu-like symptoms, cough, pain, chest pain, back pain, bone pain, joint pain, urinary tract infection, swelling of ankles, feet, legs, hands, arms, blood in urine.

Also observed were some changes in the results of certain blood tests:

increase in fat levels (hypertriglyceridemia), increase in uric acid levels (hyperuricemia), increase in blood urea, increases in liver and muscle function test values.

Uncommon adverse effects (may affect up to 1 in 100 people):

Rapid allergic reactions that may affect the whole body and may cause breathing difficulties, as well as a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), vertigo, vomiting, weakness, feeling of malaise, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives), angina pectoris (chest pain or discomfort).

In blood tests, a decrease in the number of a type of blood cells called platelets (thrombocytopenia) has been observed.

Rare adverse effects (may affect up to 1 in 1,000 people):

Lack of energy, muscle cramps, worsening of kidney function, kidney failure.

Some changes in certain blood test results have been observed. These include increased levels of potassium in the blood (hyperkalaemia) and increased levels of components related to kidney function.

Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Other adverse effects in children and adolescents:

Adverse effects similar to those reported in adults have been observed in children. However, dizziness and headache have been observed more frequently in children, and nosebleeds are a frequent adverse effect observed only in children.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atolme

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atolme

• The active substance is olmesartan medoxomilo.

Each film-coated tablet contains 10 mg, 20 mg or 40 mg of olmesartan medoxomilo.

• The other components are:

lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropylcellulose, calcium stearate, maize starch, talc (E553b), mannitol (E421), soya lecithin (E322) and titanium dioxide (E171). (See section 2 “Atolme contains lactose” and “Atolme contains soya lecithin”).

Nature of the product and pack contents

Atolme 10 mg is presented as white, round, biconvex film-coated tablets, 6 mm in diameter, smooth on both sides.

Atolme 10 mg is available in blister packs containing 14, 28 or 56 tablets.

Atolme 20 mg is presented as white, round, biconvex film-coated tablets, 8 mm in diameter, with a score on one side and smooth on the other. The score is not intended to divide the tablet into equal doses.

Atolme 20 mg is available in blister packs containing 14, 28 or 56 tablets.

Atolme 40 mg is presented as white, round, biconvex film-coated tablets, 11 mm in diameter, smooth on both sides.

Atolme 40 mg is available in blister packs containing 14, 28 or 56 tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain Atolme 10 mg / 20 mg / 40 mg film-coated tablets EFG

Portugal Olmesartan medoxomilo Atolme 10 mg / 20 mg / 40 mg film-coated tablets MG

Date of the latest revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.