felodipine / metoprolol tartrate
What Logimax and Logimax forte are and what they are used for
Logimax and Logimax forte are blood pressure-lowering drugs that consist of a combination of two active substances, felodipine, and metoprolol. The modes of action of the two substances complement each other. Felodipine lowers blood pressure by relaxing the tense muscle cells of the small blood vessels (arteries) and dilating the blood vessels so that the blood can pass more easily. Metoprolol lowers blood pressure by reducing the heart rate, which then pumps out less blood per minute. In this way, Logimax and Logimax forte provide a more pronounced blood pressure-lowering effect than with the respective active substance separately. Logimax and Logimax forte is only used when treatment with the substances alone has not had an effect.
What you need to know before taking Logimax or Logimax forte
Do not take Logimax or Logimax forte:
- if you are allergic to felodipine or metoprolol or any of the other ingredients of this medicine (listed in section 6) or other similar medicines ( beta-receptor blockers or dihydropyridine-type calcium channel blockers ).
- during pregnancy
- in acute myocardial infarction
- in heart valve obstruction (obstruction)
- in case of dynamic outflow obstruction in the heart
- in unstable angina
- in severe heart block
- in untreated heart failure
- if you have a slow heartbeat ( bradycardia )
- if you have an irregular heartbeat (sick sinus node)
- if you have very poor blood circulation
- if you have narrowing of the heart valves ( stenosis )
- if you have impaired blood flow from the heart (obstructive cardiomyopathy )
- if you have insufficient blood supply to the tissues ( cardiogenic shock )
Warnings and cautions
Talk to your doctor before using Logimax or Logimax forte if you have any of the following conditions:
- asthma
- diabetes mellitus (Logimax / Logimax forte may mask symptoms of low blood sugar, hypoglycaemia )
- heart failure
- disorders of the cardiac conduction system
- severe metabolic disorders (metabolic acidosis )
- circulatory disorders in fingers, toes, arms or legs
- pheochromocytoma (benign tumor of the adrenal gland that causes high blood pressure )
- Prinzmetal’s angina (a certain type of angina)
If you get a noticeably lower heart rate, you should consult your doctor as dose one of Logimax / Logimax forte may need to be lowered.
If you are going to have surgery, tell your doctor that you are being treated with Logimax or Logimax forte.
Other medicines and Logimax or Logimax forte
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines, or other natural products, including St. John’s wort. Some medicines may affect or be affected by treatment with Logimax and Logimax forte, for example:
- itraconazole and ketoconazole ( antifungal medicines)
- erythromycin ( antibiotic )
- herbal medicine containing St. John’s wort ( hypericum perforatum )
- tacrolimus, ciclosporin (medicines that inhibit the immune system)
- certain drugs against HIV – infection e.g. ritonavir, efavirenz and nevirapine
- propafenone , amiodarone , quinidine , verapamil, diltiazem , digoxin , clonidine , disopyramide and hydralazine (medicines for cardiovascular disease)
- barbituric acid derivatives, carbamazepine and phenytoin ( antiepileptic medicines)
- anti- inflammatory drugs (eg indomethacin and celecoxib)
- adrenaline (medicine for acute shock and severe allergic reaction )
- medicines for allergic conditions, so-called antihistamines , e.g. diphenhydramine
- terbinafine (medicine used to treat fungal infections of the skin)
- rifampicin (medicine for turberculosis)
- other beta-blockers (for example, eye drops )
- MAO inhibitors (antidepressants and Parkinson’s disease )
- inhalation anesthetics (medicines under anesthesia)
- medicines for diabetes in tablet form (oral antidiabetics)
- cimetidine (medicine for heartburn and acid reflux)
- antidepressants ( paroxetine , fluoxetine and sertraline )
- phenylpropanolamine (medicine for nasal congestion)
- medicines for psychosis are so-called antipsychotic medicines
Logimax or Logimax forte with food and drink
Grapefruit juice can in some cases enhance the effect of Logimax and Logimax forte. You should therefore avoid grapefruit juice during treatment.
Pregnancy and breastfeeding
Logimax and Logimax forte should not be used during pregnancy. There is a risk that the fetus and the newborn baby will be affected. During breastfeeding, the drug passes into breast milk, but if the mother uses the usual dosage, the baby is probably not affected. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Dizziness and tiredness may occur when taking Logimax or Logimax forte.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Logimax and Logimax forte contain lactose, macrogolglycerol hydroxystearate and sodium
Lactose; If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Logimax or Logimax forte.
Macrogolglycerol hydroxy stearate; May cause stomach upset and diarrhea.
Sodium; This medicine contains less than 1 mmol (23 mg) sodium per prolonged-release tablet, it is essential ‘sodium-free’.
How to take Logimax and Logimax forte
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 prolonged-release tablet Logimax or Logimax forte daily.
Logimax and Logimax forte prolonged-release tablets give an even effect throughout the day and should be taken once a day. Prolonged-release tablets should preferably be taken in the morning on an empty stomach or with a light meal with a low fat and carbohydrate content.
The prolonged-release tablets must not be divided, crushed, or chewed and must be swallowed with at least ½ glass of liquid.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects of Logimax and Logimax forte are related to the dilation of the small blood vessels and are a sign that the drug has a blood pressure-lowering effect. They may occur at the beginning of treatment (the first week) or in connection with a dose increase and usually disappear on their own.
The following side effects have been reported for the individual active substances and may therefore be possible side effects.
Felodipine
Common (affects more than 1 user in 100): Headache, flushing, fluid retention, and swelling of arms/legs.
Uncommon (affects less than 1 in 100 people): Dizziness, abnormal sensations such as tingling, numbness and ant crawling, fatigue, increased heart rate, palpitations, abdominal pain, nausea, rash, itching.
Rare (affects less than 1 user in 1,000): Fainting attacks, vomiting, joint pain, muscle aches, impotence/disturbance of sexual function, hives.
Very rare (affects less than 1 in 10,000 people): Gingival hyperplasia, gingivitis, hepatic exposure, hypersensitivity to sunlight, vasculitis, more frequent urination, hypersensitivity reactions such as fever or swelling of the face and lips, tongue, lips, tongue sometimes with shortness of breath or difficulty swallowing, fever.
Metoprolol
Very common (affects more than 1 user in 10): Fatigue, fluid retention, and swelling of the arms/legs.
Common (affects more than 1 user in 100): Slow heartbeat, dizziness when getting up (rarely with fainting), cold hands and feet, palpitations, dizziness, headache, nausea, abdominal pain, diarrhea, constipation, shortness of breath on exertion.
Uncommon (affects less than 1 in 100 people): Transient worsening of heart failure, heart block (AV block I), chest pain, abnormal sensations such as tingling, numbness, and ant crawling, muscle cramps, vomiting, weight gain, depression, difficulty concentrating, sleep disturbances, nightmares, respiratory problems due to bronchospasm ( bronchospasm ), hypersensitivity reactions (eg hives, psoriasis-like rash, and skin changes), increased sweating and low blood pressure ( hypotension ).
Rare (affects less than 1 user in 1,000): Disorders of heart rhythm or electrical pulse, dry mouth, hepatic impairment, nervousness, anxiety, impotence/disturbance of sexual function, runny nose, visual disturbances, dry and/or irritated eyes, eye inflammation, hair loss.
Very rare (less than 1 in 10 000): Tissue death (gangrene) in patients with severe circulatory disturbances, decreased platelet count, liver inflammation, joint pain, loss of memory/memory disorders, confusion, hallucinations, tinnitus ( tinnitus ), taste alteration, hypersensitivity to sunlight, worsening of psoriasis.
Stop taking Logimax / Logimax forte and contact a doctor immediately if you get the following symptoms ( angioedema ):
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing
In case of gum swelling, the swelling can be avoided and returned with good oral hygiene.
How to store Logimax and Logimax forte
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
Logimax
The active substances are 5 mg felodipine and 50 mg metoprolol tartrate (as metoprolol succinate).
The other ingredients are dyes (titanium dioxide E171, iron oxide E172), 42 mg anhydrous lactose, propyl gallate, anhydrous non- colloidal silicon dioxide, solid paraffin, hypromellose, microcrystalline cellulose, ethylcellulose, hydroxypropyl cellulose, sodium aluminum silicolaricate, macrologaricyl macroglycerol, macroglycerol.
Logimax forte
The active substances are 10 mg felodipine and 100 mg metoprolol tartrate (as metoprolol succinate).
The other ingredients are dyes (titanium dioxide E171, iron oxide E172), 56 mg anhydrous lactose, propyl gallate, anhydrous non- colloidal silicon dioxide, solid paraffin, hypromellose, microcrystalline cellulose, ethylcellulose, hydroxypropyl cellulose, sodium aluminum silicolaricate, macrologlycerol, macroglycerol.
What the medicine looks like and contents of the pack
Logimax: apricot-colored, round, biconvex, marked A / FG, Ø 10 mm.
Logimax forte: reddish-brown, round, biconvex, marked A / FH, Ø 11 mm.
Logimax
28 pcs ( calendar packaging )
98 pcs ( calendar packaging )
Logimax forte
98 pcs ( calendar packaging )
100 pcs (plastic jar)
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sale:
AstraZeneca AB, 151 85 Södertälje
Manufacturer:
AstraZeneca AB, 151 85 Södertälje
or
Savio Industrial Srl, Via Emilia, 21, 27100 Pavia, Italy
or
Caseen Recordati, SL, Autovía de Logroño, km. 13,300, 50180 Utebo (Zaragoza), Spain (only applies to Logimax forte )