LOGIMAX 5 mg/50 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Logimax 5mg/50 mg prolonged-release tablets

felodipine/metoprolol succinate

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. See section 4.

Contents of the pack:

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

1. What is Logimax and what is it used for

Logimax acts through two different mechanisms, as it contains two active substances:

• Felodipine belongs to a class of drugs called calcium antagonists. Felodipine lowers blood pressure by dilating small blood vessels.
• Metoprolol belongs to another class of drugs called beta-blockers. Metoprolol lowers blood pressure by reducing the effect of stress hormones, which leads to a reduction in heart rate.

Logimax is presented in the form of prolonged-release tablets that control the speed at which the drug is released into the body and ensures constant effects throughout the day.

Logimax is indicated for the treatment of high blood pressure (hypertension) in adults.

2. What you need to know before you take Logimax

Do not take Logimax:

• if you are allergic to felodipine, metoprolol or any of the other ingredients of this medicine (listed in section 6). Tell your doctor if you have had allergic reactions to other calcium antagonists or beta-blockers. Therefore, inform your doctor if you have had any unusual reactions to other medicines, always mention other health problems to your doctor, especially if they are related to the heart, blood circulation, lungs, liver, or kidneys. Remember to mention conditions such as allergic reactions to insect bites, foods, or other substances.
• if you have uncompensated heart failure, acute myocardial infarction, or angina pectoris that has lasted continuously for 15 minutes or more or is more severe than usual.
• if you have a heart valve obstruction disorder or a heart outflow obstruction.
• if you are pregnant.

• Also, inform your doctor if you experience symptoms of low blood sugar levels (hypoglycemia) or are taking insulin.
• Do not give Logimax to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Logimax.

Logimax, like other blood pressure-lowering medications, can rarely produce markedly low blood pressure, which in some patients can lead to insufficient blood supply to the heart.

If during treatment with Logimax your heart rate slows down more and more, inform your doctor as soon as possible. Your doctor may reduce the dose of Logimax or gradually withdraw the medication.

If your dentist gives you general anesthesia or you need to be hospitalized for surgery, inform your doctor or dentist that you are taking Logimax.

Inform your doctor if you have had chronic health problems before.

If you forgot to mention any of these conditions to your doctor or have any doubts, consult your doctor or pharmacist before starting treatment with Logimax.

Logimax has been prescribed to you only for the treatment of your current illness. Do not take this medicine for other conditions without your doctor's instruction.

Children

Logimax should not be used in children. See "Do not take Logimax".

Taking Logimax with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including eye drops, injectables, or those purchased without a prescription, homeopathic, herbal, including St. John's Wort, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them. This also includes medications used in the past. Some medications can influence the action of other medications. In particular, inform your doctor if you are using any of the following medications:

• Medications used in cardiac treatments (for heart disease) and blood vessels (such as digitalis/digoxin, calcium antagonists (verapamil, diltiazem), antiarrhythmic agents (quinidine or amiodarone), ganglion-blocking agents, hydralazine).
• Other medications such as protease inhibitors (ritonavir) or reverse transcriptase inhibitors (efavirenz, nevirapine) (for HIV infection treatment), monoamine oxidase inhibitors (MAOIs) (for depression treatment) and other antidepressants (paroxetine, fluoxetine, sertraline), inhaled anesthetics, antibiotics (rifampicin, erythromycin), antifungals (itraconazole, ketoconazole, terbinafine), sleep inducers (barbiturics), anti-ulcer medications (cimetidine), anti-inflammatory medications (indomethacin, celecoxib), antiepileptic medications (phenytoin, carbamazepine), St. John's Wort (for depression treatment), and antipsychotics, antihistamines, beta-blockers in the form of eye drops, and other substances (e.g., alcohol, some hormones) can also influence the effect of treatment with Logimax.
• Treatment with Logimax may affect blood levels of tacrolimus (a medication administered to prevent the body from rejecting a transplanted organ, e.g., kidney or liver). Your doctor may need to adjust the dose.
• If you are taking clonidine and Logimax and need to stop clonidine treatment, you should stop taking Logimax several days before stopping clonidine. To stop treatment with Logimax, see the section "If you stop taking Logimax".
• If you are taking oral antidiabetics (medications to control blood sugar), your doctor may need to adjust the dose.

Taking Logimax with food and drinks:

Logimax can be taken with or without food, but it should not be taken with grapefruit juice or after a fatty meal.

Pregnancy and breastfeeding

Pregnancy

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

If you become pregnant during treatment with Logimax, inform your doctor as soon as possible. Logimax should not be taken during pregnancy.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Before taking Logimax, inform your doctor if you are breastfeeding. The effect of Logimax on the child, if breastfeeding, is insignificant if the mother is treated with the recommended normal doses.

Driving and using machines

Observe your response to the medication because in some cases, dizziness or fatigue have occurred at usual doses. If this happens, do not drive or operate hazardous machinery.

Logimax contains lactose and castor oil

This medication contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medication.

This medication may cause stomach upset and diarrhea because it contains castor oil.

Logimax contains sodium

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

Use in athletes

This medication contains metoprolol, which can produce a positive result in doping tests.

3. How to take Logimax

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Logimax. Do not stop treatment before your doctor tells you to. Do not take more doses than your doctor has indicated.

Treatment usually starts with one Logimax tablet once a day. If necessary, your doctor will increase the dose to two Logimax tablets once a day.

Logimax should be taken in the morning with a little liquid. The tablets should not be divided, crushed, or chewed. The tablets can be taken alone or with a light meal (low in fat and carbohydrates).

Use in children

The use of Logimax is not recommended in children due to limited experience available.

Use in elderly patients

Logimax is also indicated in elderly patients. Lower doses may be sufficient in elderly patients.

If you take more Logimax than you should

If you have taken more Logimax than you should, consult your doctor or pharmacist immediately.

If this overdose is high enough, you may experience poisoning with some of the following symptoms: slow or irregular heart rate, difficulty breathing, swelling of ankles, feeling of palpitations, dizziness, fainting, chest pain, cooling of the skin, weak pulse, mental confusion, anxiety, feeling of oppression in the airways, loss of consciousness/coma, nausea, vomiting, bluish discoloration of the skin. In extreme cases, cardiac arrest may occur. Therefore, it is very important that you do not take more doses than prescribed by your doctor.

If you take alcohol, antihypertensive medications, quinidine, or sleep inducers (barbiturics) along with an overdose of Logimax 5/50 mg, the symptoms may worsen.

The first manifestations of overdose may be observed between 20 minutes and 2 hours after administration of the medication. If you experience any of these symptoms, contact your doctor, pharmacist, or the nearest hospital immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Logimax

Do not take a double dose to make up for forgotten doses. If there are 12 hours left until your next dose, take the forgotten dose immediately, then take the next dose at the usual time.

If you stop taking Logimax

Do not stop treatment before your doctor tells you to. Treatment should not be stopped abruptly. When it is necessary to stop treatment, your doctor may reduce the dose and/or opt for administration of the medication every two days for a period of 10-14 days.

If you have heart failure, your doctor may perform checks during this period because the risk of coronary problems (cardiac) may increase.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

The undesirable effects that may occur are generally mild and disappear when treatment is interrupted. Some side effects appear only at the start of treatment or after a dose increase.

If you experience any of the symptoms described below in a persistent manner, inform your doctor.

Very common (may affect more than 1 in 10 patients)

Fatigue, peripheral edema.

Common (may affect up to 1 in 10 patients)

Redness or flushing, dizziness, headaches, slowing of the heart rate, dizziness when changing position (occasionally with fainting), coolness of hands and feet, nausea, abdominal pain, diarrhea, constipation, feeling of shortness of breath when exerting, palpitations.

Uncommon (may affect up to 1 in 100 patients)

Sensation of burning/stinging/numbness, muscle cramps, symptoms of heart disease such as shortness of breath, fatigue, and swelling of the ankles may worsen temporarily, minor alterations in the electrocardiogram without affecting cardiac function, swelling, chest pain, depression, altered concentration, drowsiness, difficulty falling asleep, nightmares, skin rash or itching, feeling of shortness of breath, vomiting, increased sweating, weight gain, and very low blood pressure (hypotension).

Rare (may affect up to 1 in 1,000 patients)

Fainting, alterations in cardiac conduction in the electrocardiogram, irregular heart rate, nervousness, anxiety, abnormal liver function test results, hair loss, appearance of skin rashes, runny nose or tearing/redness of eyes due to an allergic reaction, vision disorders, dryness and/or irritation of eyes, dry mouth, impotence/sexual dysfunction, muscle pain, joint pain.

Very rare (may affect up to 1 in 10,000 patients)

Worsening of circulatory problems in the limbs in patients with severe circulatory disorders, loss or deterioration of memory, confusion, hallucinations, hypersensitivity reactions such as fever and swelling, skin reaction due to increased sensitivity to sunlight, worsening of psoriasis, ringing in the ears, taste alterations, increased need to urinate, blood alterations (decrease in the number of platelets in the blood), and hepatitis.

As with other calcium antagonists, inflammation of the mouth along with a slight hypertrophy of the gums (gingivitis/periodontitis) has been registered. This hypertrophy can be avoided with careful dental hygiene.

Other side effects may occur. If you observe any annoying or unusual reaction during your treatment with Logimax, consult your doctor or pharmacist immediately.

Reporting of side effects

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

5. Storage of Logimax

Keep the blisters in the original package until the moment of use.

Do not store above 30°C.

Keep this medication out of sight and reach of children.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Logimax

• The active substances of Logimax are: 5 mg of felodipine and 47.5 mg of metoprolol succinate (equivalent to 50 mg of metoprolol tartrate).

• The other ingredients (excipients) are: ethylcellulose, hypromellose, hydroxypropylcellulose, anhydrous lactose, microcrystalline cellulose (E460), hydrogenated castor oil, paraffin, polyethylene glycol, propyl gallate, silicon dioxide, aluminum silicate and sodium, sodium stearyl fumarate, titanium dioxide (E171), yellow iron oxide (E172), red-brown iron oxide (E172).

Appearance of the product and contents of the pack

The Logimax tablet is apricot-colored, round with a diameter of 10 mm, biconvex, with a film coating and with the engraving A/FG on one side.

Each pack contains 30 prolonged-release tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milan

Italy

Manufacturer:

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milan

Italy

or

Savio Industrial S.r.l.

Via Emilia, 21

27100 Pavia

Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Casen Recordati, S.L.

Autovía de Logroño, km 13,300

50180 Utebo - Zaragoza

Spain

Date of the last revision of this leaflet: January 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/