PATIENT INFORMATION LEAFLET

Lopresor 100 mg Film-Coated Tablets

Metoprolol Tartrate

Read this leaflet carefully before you start taking this medicine, because 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, do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Lopresor is used for:

•lowering blood pressure

•treating angina (chest pain)

•treating abnormal heart rhythm

•treating an overactive thyroid gland

•preventing migraine (a type of headache)

How Lopresor works:

Lopresor belongs to a group of medications called beta-blockers. They reduce blood pressure in your veins by dilating blood vessels.

Do not take Lopresor:

-if you are allergic to metoprolol tartrate or any of the other ingredients in this medication (listed in section 6).

-if you have difficulty breathing when lying down or if your feet or legs swell due to a heart condition

-if you have irregular heartbeats

-if you have a very slow pulse

-if you have sudden and oppressive chest pain as a sign of a heart attack

-if you have poor circulation in your extremities (for example, pale and cold hands or feet or pain in the muscles of the legs when walking)

-if you have unusually low blood pressure

-if you have asthma or have had difficulty breathing with wheezing (chest sounds with breathing) or coughing

-if you have an untreated pheochromocytoma (adrenal gland tumor)

-if you experience a condition called cardiogenic shock, characterized by low blood pressure, dizziness, rapid and shallow breathing, and cold and sweaty skin

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Lopresor:

-if you have heart disease

-if you have high blood sugar levels (diabetes)

-if you have liver disease

-if you are at risk of severe allergic reactions

-if you have chest pain when at rest

-if you have poor circulation in your extremities (for example, pale and cold hands or feet or pain in the muscles of the legs when walking)

-if you have a tumor of the adrenal gland (pheochromocytoma)

-if you have been told that you have increased activity of the thyroid gland

-if you are undergoing surgery that requires anesthesia

-if you have a severe condition called ocular-mucocutaneous syndrome, characterized by severe conjunctivitis, skin rash, and ear infections

If you experience any of the above symptoms, tell your doctor as soon as possible.

-If you observe spontaneous bleeding or bruising during treatment with Lopresor

-If you observe that your heartbeats become slow during treatment with Lopresor

-If you notice that your skin and eyes turn yellow, if you have nausea, loss of appetite, dark urine during treatment with Lopresor

-If you notice that your heartbeats become irregular during treatment with Lopresor

-If you experience hallucinations during treatment with Lopresor

Monitoring during your treatment with Lopresor:

•If you have heart disease, your doctor will perform blood tests and monitor your heart function.

•If you have high blood sugar levels (diabetes), your doctor will regularly monitor these levels.

•If you have hyperactivity of the thyroid gland, your doctor will regularly monitor your heart and thyroid functions.

•If you are taking or have recently taken other medications, your doctor may perform blood tests and monitor your heart function.

Other medications and Lopresor:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Other medications may interact with Lopresor, such as:

-other medications to treat high blood pressure (e.g. prazosin, clonidine, verapamil, monoamine oxidase inhibitors (MAOIs), diltiazem, and hydralazine)

-medications to treat chest pain (angina) (e.g. nitroglycerin)

-medications to treat irregular heart rhythms (e.g. amiodarone, propafenone, quinidine, disopyramide, tocainide, procainamide, ajmaline, amiodarone, flecainide, and digitalis glycosides such as digoxin, lidocaine)

-inhaled anesthetics used during surgical procedures

-adrenaline or similar substances found in some nasal sprays or eye drops or in some medications for cough or common cold

-insulin or medications to treat high blood sugar levels (diabetes)

-medications to relieve pain or inflammation (nonsteroidal anti-inflammatory drugs such as COX-2 inhibitors)

-some antibiotics (e.g. rifampicin)

-some antiretrovirals (e.g. ritonavir)

-some medications to treat malaria (e.g. hydroxychloroquine or quinidine)

-some antifungals (e.g. terbinafine)

-some antipsychotics (e.g. thioridazine, chlorpromazine, fluphenazine, haloperidol)

-some antidepressants (e.g. fluoxetine, paroxetine, fluvoxamine, sertraline, clomipramine, desipramine, or bupropion)

-some antihistamines used for hay fever (e.g. diphenhydramine)

-ergot alkaloids, medications used in the prevention and treatment of migraines

-dipyridamole, a medication used to reduce the risk of clot formation

Use in patients with liver problems:

Lopresor should be used with caution in patients with liver problems.

Use in elderly patients:

Elderly patients (over 65 years) can take Lopresor. If you are over 65 years old, you will receive the same dose as the rest of adults, but you will need to be more closely monitored by your doctor.

Use in children:

Lopresor is not recommended for children.

Use in athletes:

It is reported to athletes that this medication contains a component that can produce a positive result in doping control tests.

Taking Lopresor with food, drinks, and alcohol:

Lopresor tablets should be swallowed whole without chewing with the help of a glass of water.

If your doctor recommends taking Lopresor with or without food, you should continue to take it in the same way throughout the treatment period.

Avoid taking alcohol as it can further lower blood pressure and/or increase the risk of dizziness and weakness.

Pregnancy, breastfeeding, and fertility:

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

Lopresor should not be used during pregnancy unless it is clearly necessary. Your doctor should indicate the potential risks of taking Lopresor during pregnancy.

If you are breastfeeding, tell your doctor. Lopresor should be used with caution during breastfeeding.

Driving and operating machinery:

Lopresor can cause dizziness, fatigue, and blurred vision. If this happens, do not drive, operate machinery, or perform any activity that requires concentration while taking the medication.

Lopresor contains macrogolglycerol hydroxystearate (polyoxyl 40 hydrogenated castor oil):

This medication can cause stomach discomfort and diarrhea because it contains macrogolglycerol hydroxystearate.

Lopresor contains sodium:

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults:

Your doctor will indicate the duration of your treatment with Lopresor.

When Lopresor is used to treat high blood pressure and angina, the usual recommended dose is 100 to 200 mg per day, once a day (one tablet in the morning) or divided into two doses (one tablet in the morning and one at night). Your doctor may increase this dose up to 400 mg (four tablets) or prescribe another medication if necessary.

When Lopresor is used to treat an overactive thyroid gland, the usual recommended dose is 150 to 200 mg daily, in three or four divided doses (half a tablet, three or four times a day).

When Lopresor is used to treat heart rhythm disturbances, the usual recommended dose is 100 to 150 mg per day, divided into two or three doses (half a tablet in the morning, and the other half at night, and if necessary, half a tablet at midday). Your doctor may increase this dose up to 300 mg (three tablets) if necessary.

When Lopresor is used to prevent migraines, the usual recommended dose is 100 mg per day, once a day (one tablet in the morning); if necessary, your doctor may increase the daily dose to 200 mg in two divided doses (one tablet in the morning and one at night).

The tablets should be taken orally. The tablets should be swallowed whole without chewing with the help of a glass of water.

Taking the tablets at the same time every day will help you remember when to take them.

Use in children and adolescents:

This medication should not be given to children under 18 years old.

Use in elderly patients:

No dose adjustment is required. However, they may require special care at the start of treatment.

Patients with liver problems:

Special care is needed at the start of treatment in these patients, and the dose should be increased gradually based on the response to treatment.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

If you take more Lopresor than you should:

In case of Lopresor overdose, inform your doctor immediately. You may need medical attention.

Some effects of Lopresor overdose are: slow or irregular pulse, very low blood pressure, difficulty breathing, especially when lying down, swelling of the feet, loss of consciousness, nausea, vomiting, bluish discoloration of the lips, tongue, skin, convulsions, sudden and oppressive chest pain, and death.

In cases of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Lopresor:

If you accidentally forget to take a dose, simply take your regular dose as soon as you remember. However, if it is almost time for your next dose, omit the missed dose and continue with the next one. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Lopresor:

Do not change the dose or interrupt treatment without your doctor's consent. If you need to interrupt treatment, your doctor will indicate how to do it.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some of the following side effects could be serious and require medical attention:

• Frequent side effects(affecting between 1 and 10 in every 100 patients)

-Slowing of heart rate

• Rare side effects(affecting between 1 and 10 in every 10,000 patients)

-Difficulty breathing, especially when lying down, swelling of feet or legs due to heart problems

-Numbness or coldness of fingers as signs of Raynaud's syndrome

-Irregular heartbeats

• Very rare side effects(affecting fewer than 1 in every 10,000 patients)

-Spontaneous bleeding or appearance of hematomas as a sign of low platelet levels in the blood (thrombocytopenia)

-Hallucinations

Consult your doctor immediately if you notice the following symptoms: yellow discoloration of the skin or eyes, nausea, loss of appetite, darker urine as a sign of liver disorder, liver pain, and abnormal curvature of the penis.

Some of the following side effects are frequent:

• Frequent side effects(affecting between 1 and 10 in every 100 patients)

-Dizziness

-Headache

-Dizziness, fainting when standing as a sign of orthostatic hypotension (sometimes with loss of consciousness)

-Difficulty breathing

-Nausea

-Vomiting

-Abdominal pain

-Fatigue

If you notice that some of the symptoms described above are affecting you severely, contact your doctor.

Some of the following side effects are rare:

• Rare side effects(affecting between 1 and 10 in every 10,000 patients)

-Muscle cramps

-Skin rash (in the form of a rash that itches, signs of psoriasis on the skin in thickened and inflamed plaques)

-Diarrhea

-Constipation

-Difficulty breathing, breathing with sounds or coughing

-Swelling

-Palpitations

-Decreased alertness, drowsiness, or insomnia (sleep problems)

-Signs of paresthesia in extremities such as numbness, tingling in the extremities

-Depression

-Nightmares

If you notice any of the symptoms described above, consult your doctor.

Some of the following side effects are very rare:

• Very rare side effects(affecting fewer than 1 in every 10,000 patients)

-Change in personality

-Alterations in vision (e.g. blurred vision)

-Dry or irritated eyes

-Ringing in the ears (e.g. hissing sounds)

-Auditory disorders (e.g. reduced hearing or hearing loss) at doses exceeding the recommended

-Chest pain

-Gangrene in patients with pre-existing peripheral circulatory disorders

-Stuffy nose or runny nose as signs of rhinitis

-Dry mouth

-Increased sensitivity of the skin to the sun

-Abnormal increase in sweating

-Hair loss

-Worsening of psoriasis symptoms such as thickening and inflammation of plaques

-Pain and stiffness as signs of arthritis

-Alteration of sexual desire

-Changes in the ability to achieve or maintain an erection

-Weight gain

-Alterations in liver function test results in blood analysis

-Back pain in the lumbar region of the spine, renal alterations, increased blood pressure, clots as possible signs of fibrous tissue proliferation in a part of the body (called retroperitoneum) contained between the kidneys, aorta, renal tract, and other structures.

-Alteration of cardiac conduction.

-Alteration in the number of blood cells.

If you notice any of the symptoms described above, consult your doctor.

Other reported side effects:

-Confusion

-Abnormal values of triglycerides in the blood

-Abnormal values of cholesterol in the blood

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from humidity.

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

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lopresor

-The active ingredient is metoprolol tartrate. Each film-coated tablet contains 100 mg of metoprolol tartrate.

-The other components are:

Core: anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate, sodium carboxymethylcellulose (type A) (from potato)

Coating: hypromellose, polyoxethylene ricinoleate oil, talc, titanium dioxide (E 171).

Appearance of the product and contents of the packaging

Lopresor is presented in the form of film-coated tablets.

Each package contains 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza)

Spain

Responsible for manufacturing

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali 1. 28148 Milan. Italy.

This leaflet was approved in July 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)