Package Insert: Information for the Patient

Logimax 5mg/50 mg prolonged-release tablets

felodipine/metoprolol succinate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

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

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

Do not take Logimax:

• If you are allergic to felodipine, metoprolol, or any of the other components of this medication (listed in section 6). Inform your doctor if you have had allergic reactions to other medications that are calcium antagonists or beta blockers. Also, inform your doctor if you have had any unusual reactions to other medications, and mention any other health problems, especially those related to the heart, blood circulation, lungs, liver, or kidneys. Remember to mention allergies such as insect bites, food, or other substances.
• If you have uncompensated heart failure, acute myocardial infarction, or angina pectoris that has lasted uninterrupted for 15 minutes or more, or is more severe than usual.
• If you have a heart valve obstruction disorder or a heart output obstruction.
• If you are pregnant.

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Logimax.

Logimax, like other medications that lower blood pressure, may cause, in rare cases, a significantly low blood pressure that in some patients may 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 your Logimax dose or withdraw the medication gradually.

If your dentist puts you under general anesthesia or you need to be hospitalized for a surgical procedure, inform your doctor or dentist that you are taking Logimax.

Inform your doctor if you have had chronic health problems in the past.

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 only for the treatment of your current condition. Do not take this medication for other conditions without your doctor's indication.

Children:

Logimax should not be used in children. See “Do not take Logimax”.

Logimax with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including eye drops, injectables, or those acquired 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 those medications used in the past. Some medications may affect the action of other medications. Especially inform your doctor if you are using any of the following medications:

• Cardiac medications (for treating heart diseases) and vascular medications (such as digitalis/digoxin, calcium antagonists (verapamil, diltiazem), antiarrhythmic agents (quinidine or amiodarone), ganglionic blockers, hydralazine).
• Other medications such as protease inhibitors (ritonavir) or reverse transcriptase inhibitors (efavirenz, nevirapina) (for HIV infection treatment), monoamine oxidase inhibitors (IMAO) (for depression treatment) and other antidepressants (paroxetine, fluoxetine, sertraline), inhalation anesthetics, antibiotics (rifampicin, erythromycin), antifungals (itraconazole, ketoconazole, terbinafine), sedatives (barbiturates), antiulcer medications (cimetidine), anti-inflammatory medications (indomethacin, celecoxib), antiepileptic medications (phenytoin, carbamazepine), St. John's Wort (for depression treatment) and antipsychotics, antihistamines, beta blockers in eye drops, and other substances (e.g. alcohol, some hormones) may also affect the effect of Logimax treatment.
• Logimax treatment may affect tacrolimus levels in the blood (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 together and need to interrupt clonidine treatment, you should stop taking Logimax several days before clonidine. To interrupt Logimax treatment, see “If you interrupt Logimax treatment”.
• If you are taking oral antidiabetic medications (medications for controlling blood sugar), your doctor may need to adjust the dose.

Logimax with food and beverages:

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

Pregnancy and lactation:

Pregnancy:

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

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

Lactation:

Consult your doctor or pharmacist before using any medication.

Inform your doctor if you are breastfeeding. The effect of Logimax on the baby, if breastfeeding, is insignificant if the mother is treated with the recommended normal doses.

Driving and operating machinery:

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

Logimax contains lactose and ricin oil:

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

This medication may cause stomach discomfort and diarrhea because it contains ricin oil.

Logimax contains sodium:

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

Use in athletes:

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

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 taken once a day. If necessary, your doctor will increase the dose to two Logimax tablets taken once a day.

Logimax should be taken in the morning with a little liquid. Tablets should not be divided, crushed, or chewed. 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 the limited available experience.

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 an overdose with some of the following symptoms: slow or irregular heart rate, difficulty breathing, swelling of ankles, sensation of palpitations, dizziness, fainting, chest pain, skin cooling, weak pulse, mental confusion, anxiety, sensation of respiratory tract constriction, total or partial loss of consciousness/coma, nausea, vomiting, blue discoloration of the skin. In extreme cases, cardiac arrest may occur. Therefore, it is very important not to take more doses than prescribed by your doctor.

In case of taking alcohol, antihypertensive medications, quinidine, or sedatives (barbiturates) along with a Logimax 5/50 mg overdose, symptoms may worsen.

The first manifestations of the overdose may be observed between 20 minutes and 2 hours after administration of the medication. In case of presenting 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Logimax

Do not take a double dose to compensate for the missed doses. If 12 hours have passed until your next dose, take the missed dose immediately, then take the next dose at your scheduled time.

If you interrupt treatment with Logimax

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

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

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

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

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

If you experience any of the symptoms described below persistently, inform your doctor.

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

Congestion, peripheral edema.

Common (may affect up to 1 in 10 patients)

Relief or stuffiness, dizziness, headaches, slowing of heart rate, dizziness when changing position (occasionally with fainting), coldness of hands and feet, nausea, abdominal pain, diarrhea, constipation, feeling of suffocation when exerting oneself, palpitations.

Uncommon (may affect up to 1 in 100patients)

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

Rare (may affect up to 1 in1,000 patients)

Dizziness, alterations in cardiac conduction in the electrocardiogram, irregular heart rhythm, nervousness, anxiety, abnormal results from liver function tests, hair loss, appearance of rashes on the skin, nasal discharge or eye redness due to an allergic reaction, vision disturbances, dryness and/or irritation of the eyes, dryness of the mouth, impotence/sexual dysfunction, muscle pain, joint pain.

Very rare (may affect up to 1 in10,000 patients)

Worsening of circulatory problems in the extremities in patients with severe circulatory disorders, loss or deterioration of memory, confusion, hallucinations, hypersensitivity reactions such as fever and swelling, skin rash due to increased sensitivity to the sun, worsening of psoriasis, tinnitus, alterations in taste, increased need to urinate, blood disorders (decrease in platelet count in blood) and hepatitis.

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

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

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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep the blisters in the original packaging until the time of use.

Do not store at a temperature above 30°C.

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

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

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

Composition of Logimax

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

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

Appearance of the product and content of the packaging

Logimax tablets are orange-colored, round, 10 mm in diameter, biconvex, with a pellicular coating, and have the imprint A/FG on one face.

Each package contains 30 prolonged-release tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milan

Italy

Responsible for manufacturing:

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milano

Italy

or

Savio Industrial S.r.l.

Via Emilia, 21

27100 Pavia

Italy

For more information about this medication, please contact the local representative of the marketing authorization holder:

Casen Recordati, S.L.

Autovía de Logroño, km 13,300

50180 Utebo - Zaragoza

Spain

Last review date of this leaflet: January 2021

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/