Metoprolol Hexal

Italy
Brand name Metoprolol Hexal
Form tablets
Active substance / Dosage
METOPROLOL TARTRATE
Prescription type Prescription only
ATC code
C07AB02
Registration number 032019
Manufacturer SANDOZ S.P.A.

Table of Contents

Patient Information Leaflet

Metoprolol Hexal 100 mg tablets, 200 mg prolonged-release tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Metoprolol Hexal is and what it is used for

Metoprolol Hexal contains the active substance metoprolol, which belongs to a group of medicines called beta-blockers, which work by slowing down the heartbeat and reducing the force of the heart's contractions.
Metoprolol Hexal is indicated in adults for:

  • the treatment of high blood pressure (hypertension), either alone or in combination with other medicines used to treat high blood pressure (antihypertensives), such as diuretics, peripheral vasodilators, and ACE inhibitors;
  • the long-term prevention of chest pain caused by heart problems (angina pectoris);
  • the treatment of confirmed or suspected heart attack, and as secondary prevention in patients who have previously had a heart attack;
  • the treatment of disturbances in heart rhythm (functional cardiac disorders with palpitations);
  • the prevention of recurrent attacks of severe headache (migraine).

Talk to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Metoprolol Hexal

Do not take Metoprolol Hexal

  • if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
  • if you are allergic to other medicines similar to metoprolol (beta-blockers);
  • if you have conduction disorders of the heart (second- or third-degree atrioventricular block, sinoatrial node syndrome);
  • if your heart function is insufficient to ensure adequate blood supply to the body, for example when your heart rate is below 45–50 beats per minute (decompensated heart failure);
  • if you have a very slow heart rate (clinically significant sinus bradycardia);
  • if you have severe circulatory disorders in the limbs (peripheral arterial circulation);
  • if you have a serious heart condition known as cardiogenic shock, which occurs when the heart fails to pump enough blood throughout the body;
  • if you have had a heart attack and have a slow heart rate (45 beats/minute), certain rhythm disturbances (P-R interval longer than 0.24 seconds), very low blood pressure (systolic pressure below 100 mmHg) and/or severe heart dysfunction (severe heart failure);
  • if you suffer from low blood pressure (hypotension);
  • if you have asthma or have experienced breathing problems (bronchospasm);
  • if you have a benign adrenal gland tumor (pheochromocytoma) and are not receiving any treatment.

Warnings and precautions
Talk to your doctor or pharmacist before taking Metoprolol Hexal.
Pay special attention and consult your doctor before taking this medicine:

  • if you have difficulty breathing (obstructive lung diseases);
  • if you have problems metabolizing sugars or suffer from low blood sugar levels (hypoglycemia). Metoprolol may interfere with sugar metabolism or mask the signs and symptoms of hypoglycemia;
  • if your heart function does not ensure adequate blood supply to the body (heart failure);
  • if you have heart conduction disorders (moderate atrioventricular conduction disorder), as metoprolol may worsen your condition (atrioventricular block);
  • if you have a progressively slow heart rate (progressive bradycardia);
  • if you have low blood pressure and have had a heart attack. Your doctor will closely monitor you during treatment.
  • if you have circulatory disorders in the limbs (peripheral arterial circulatory disorders);
  • if you have a tumor of the adrenal gland called pheochromocytoma;
  • if you are scheduled for surgery. In this case, inform the anesthesiologist that you are being treated with this medicine;
  • if you are taking a calcium antagonist (particularly verapamil), another medicine for high blood pressure, especially if administered intravenously;
  • a type of angina (chest pain) called Prinzmetal's angina;
  • overactivity of a gland called the thyroid (thyrotoxicosis);
  • allergies. If you suffer from allergies and take beta-blockers, allergic reactions may be more severe than usual;
  • liver problems (hepatic insufficiency), as your doctor may decide to adjust the dose.

During treatment with Metoprolol Hexal, you may experience the following conditions:

  • occurrence of particularly severe allergic reactions (anaphylactic reactions) showing increased resistance to normal doses of adrenaline;
  • increased frequency and duration of chest pain episodes (angina) in patients with Prinzmetal's angina;
  • disappearance or reduction of symptoms related to severe thyroid problems (thyrotoxicosis);
  • increased risk of developing eye and skin problems (oculo-muco-cutaneous syndrome).
  • If any of these symptoms occur, it is recommended to discontinue therapy.

For athletes:
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
The efficacy and safety of Metoprolol Hexal in children and adolescents under 18 years of age are limited; therefore, Lopresor is not recommended in this population (0–18 years).

Hepatic impairment
If you suffer from liver problems (hepatic insufficiency), inform your doctor, as dose adjustment may be necessary.

Renal impairment
If your kidney function is impaired, no dose adjustment is required.

Elderly
If you are elderly, take this medicine with great caution, as excessive reduction in blood pressure or heart rate may lead to serious circulatory problems (inadequate perfusion of vital organs).

Other medicines and Metoprolol Hexal
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Interactions with medicines whose concomitant use is not recommended:

  • medicines used to treat certain heart conditions belonging to the class of calcium antagonists (administered intravenously), such as verapamil and diltiazem. This combination may enhance the depressant effects of Metoprolol Hexal on the heart and blood pressure.

Interactions to consider
Pay special attention and consult your doctor if you are taking:

  • other medicines used to treat high blood pressure (antihypertensives), particularly if you are being treated with clonidine. If both medicines are administered simultaneously, treatment with Metoprolol Hexal must be discontinued several days before stopping clonidine;
  • prazosin, a medicine used to facilitate urine elimination;
  • medicines that reduce blood pressure (alpha-adrenergic blockers: guanethidine, betanidine, reserpine, alpha-methyldopa);
  • other medicines similar to metoprolol (beta-blockers), including eye drops (ophthalmic solutions);
  • antidepressants called monoamine oxidase inhibitors (MAOIs), even within 14 days after stopping treatment;
  • nitroglycerin, a medicine used to treat certain heart conditions, as it may cause excessive reduction in blood pressure (hypotensive effect);
  • medicines used to treat heart rhythm disorders (antiarrhythmics such as quinidine or propafenone, tocainide, procainamide, ajmaline, amiodarone, flecainide and disopyramide);
  • medicines used to treat certain heart conditions and high blood pressure belonging to the class of calcium antagonists (such as verapamil and diltiazem), administered orally;
  • medicines used to treat respiratory problems (such as asthma and cough) or to clear nasal congestion (nasal drops) or to treat certain eye disorders (ophthalmic drops), for example: adrenaline, noradrenaline, isoprenaline, ephedrine, phenylephrine, phenylpropanolamine, xanthine derivatives;
  • medicines used to treat diabetes, such as insulin and oral hypoglycemics. Metoprolol Hexal may increase the risk of severe hypoglycemia when used concomitantly with certain types of antidiabetic medicines called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide);
  • rifampicin, a medicine used to treat tuberculosis;
  • lidocaine, a medicine used to reduce pain during procedures, as metoprolol may affect its effects;
  • medicines used to induce anesthesia (see section "Warnings and precautions");
  • medicines used for inflammation and pain (NSAIDs and COX-2 inhibitors), as they may reduce the effects of metoprolol;
  • hydralazine and prazosin, medicines used to treat high blood pressure (antihypertensives);
  • digitalis glycosides, used to treat severe heart problems (heart failure);
  • medicines that may affect metoprolol metabolism, such as those used for depression (fluvoxamine, fluoxetine, paroxetine, sertraline, bupropion, clomipramine, desipramine), psychiatric disorders (chlorpromazine, fluphenazine, haloperidol and thioridazine), HIV therapy (ritonavir), allergy treatment (diphenhydramine), malaria treatment (hydroxychloroquine or quinidine), and fungal infections (terbinafine);
  • medicines used to treat migraine: ergot alkaloids.

Discontinue treatment with this medicine before undergoing a stress test involving injection of dipyridamole; in this case, your doctor will monitor your heart rate after the injection.

Metoprolol Hexal and alcohol
Avoid consuming alcoholic beverages during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary and always under strict medical supervision.
Metoprolol Hexal passes into breast milk; therefore, this medicine is not recommended during breastfeeding.
However, if you are breastfeeding and being treated with Metoprolol Hexal, your doctor must closely monitor your baby.

Driving and using machines
This medicine may impair your ability to drive or operate machinery.

This medicine contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Metoprololo Hexal

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Swallow the tablets whole with a sufficient amount of liquid and without chewing them.
Take the tablets every day at the same time.
Metoprololo Hexal 100 mg tablets should be taken on an empty stomach.
Metoprololo Hexal 200 mg prolonged-release tablets may be taken either with or without food,
preferably in the morning.

Treatment of high blood pressure (hypertension)
The recommended dose of Metoprololo Hexal 100 mg tablets is 1 or 2 tablets (100–200 mg) per day.
This dose may be taken as a single daily dose (in the morning) or divided into two separate doses
(morning and evening).
The recommended dose of Metoprololo Hexal 200 mg prolonged-release tablets is 1 tablet in the morning,
taken as a single dose.

Prevention of chest pain (angina pectoris)
The recommended dose of Metoprololo Hexal 100 mg tablets is 1 or 2 tablets (100–200 mg) per day,
divided into two doses.
If necessary, your doctor may increase the dose up to 4 tablets (400 mg).
The recommended dose of Metoprololo Hexal 200 mg prolonged-release tablets is 1 tablet in the morning,
taken as a single dose.

Treatment of heart attack (myocardial infarction)
Your doctor will determine the dose based on the results of your blood tests (hemodynamic status).
The recommended maintenance dose is 2 tablets (200 mg) per day, divided into two doses.
The duration of treatment is at least 3 months.

Treatment of irregular heartbeat (functional cardiac disorders) with palpitations and prevention of recurrent
severe headaches (migraine)
The recommended dose of Metoprololo Hexal 100 mg tablets is 1 tablet (100 mg) per day,
taken as a single morning dose. If necessary, your doctor may increase the dose to 2 tablets (200 mg),
divided into two daily doses (morning and evening).
The recommended dose of Metoprololo Hexal 200 mg prolonged-release tablets is 1 tablet in the morning,
taken as a single dose.

If you take more Metoprololo Hexal than you should
If you have taken or swallowed too much of this medicine, contact your doctor or the nearest hospital immediately.
If an overdose of this medicine is taken, you may experience the following symptoms:

  • severe drop in blood pressure (hypotension);
  • slowed heart rate (sinus bradycardia);
  • serious heart problems (atrioventricular block, heart failure, cardiogenic shock and cardiac arrest, myocardial infarction);
  • difficulty breathing (bronchospasm);
  • altered state of consciousness, up to coma;
  • nausea, vomiting;
  • seizures;
  • severe circulatory disturbance characterized by bluish discoloration of the skin (cyanosis);
  • death.

These symptoms generally appear within 20 minutes to 2 hours after taking an excessive dose of this
medicine and are more severe if you are simultaneously consuming alcohol, other medicines for high blood pressure (antihypertensives), quinidine (a medicine used for heart rhythm disorders), or barbiturates (medicines used to treat seizures and anxiety).

If you forget to take Metoprololo Hexal
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Metoprololo Hexal
Do not stop treatment with this medicine abruptly without consulting your doctor. Treatment with Metoprololo Hexal must be discontinued gradually and under close medical supervision.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may also occur:

Common (may affect up to 1 in 10 people):

  • dizziness and headache (cephalalgia);
  • slowing of the heartbeat (bradycardia);
  • marked reduction in blood pressure when standing (orthostatic hypotension), occasionally with transient loss of consciousness (syncope);
  • severe difficulty in breathing (exertional dyspnea);
  • nausea, vomiting, abdominal pain;
  • fatigue.

Uncommon (may affect up to 1 in 1,000 people):

  • depression;
  • drowsiness or insomnia;
  • reduced level of consciousness;
  • tingling in the extremities (paraesthesia);
  • muscle cramps;
  • sleep disturbances (nightmares);
  • inadequate heart function (heart failure);
  • changes in heart rhythm (arrhythmias);
  • swelling due to fluid accumulation (oedema);
  • increased awareness of heartbeat (palpitations);
  • tingling and pain in the fingers, followed by a sensation of heat and pain (Raynaud's phenomenon);
  • skin irritation (rash, in the form of urticaria, psoriasiform and dystrophic skin lesions);
  • diarrhoea and constipation;
  • difficulty in breathing (bronchospasm).

Rare (may affect up to 1 in 10,000 people):

  • reduction in the number of platelets in the blood (thrombocytopenia);
  • personality disorders, hallucinations;
  • eye irritation and/or dryness;
  • reduced vision (e.g. blurred vision);
  • ringing in the ears (tinnitus) and hearing disturbances, especially if doses higher than those prescribed by the doctor are taken;
  • heart problems and chest pain (cardiac conduction disturbances, chest pain);
  • tissue damage and death (gangrene) in patients with peripheral blood circulation problems;
  • irritation and inflammation of the nose (rhinitis);
  • dry mouth (dryness of the oral mucosa);
  • formation of a mass in the back of the abdomen (retroperitoneal fibrosis);
  • abnormal results in tests performed to assess liver function;
  • inflammation of the liver (hepatitis);
  • skin sensitivity to light (photosensitivity);
  • increased sweating (hyperhidrosis);
  • hair loss (alopecia);
  • worsening of a skin disease (worsening of psoriasis);
  • inflammation of the joints (arthritis);
  • sexual problems (libido disorders, erectile dysfunction, Peyronie's disease);
  • weight gain.

Not known (frequency cannot be estimated from the available data):

  • confusion;
  • changes in certain diagnostic tests such as increased blood triglycerides (hypertriglyceridaemia) and reduced HDL levels.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metoprololo Hexal

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 “Expiry”.
The expiry date refers to the last day of that month.
Metoprololo Hexal 100 mg tablets:
This medicine requires no special storage conditions.
Metoprololo Hexal 200 mg prolonged-release tablets:
Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Metoprololo Hexal contains
Metoprololo Hexal 100 mg tablets

  • The active substance is: metoprolol (as metoprolol tartrate). Each tablet contains 100 mg of metoprolol tartrate.
  • The other components are: lactose, maize starch, magnesium stearate, colloidal silicon dioxide, hydroxypropylcellulose, calcium monophosphate, crospovidone, microcrystalline cellulose.

Metoprololo Hexal 200 mg prolonged-release tablets

  • The active substance is: metoprolol (as metoprolol tartrate). Each tablet contains 200 mg of metoprolol tartrate.
  • The other components are:
    • Tablet core: Eudragit RS PO, monohydrate lactose, magnesium stearate, maize starch, anhydrous colloidal silicon dioxide.
    • Tablet coating: hypromellose, macrogol 4000, talc, titanium dioxide (E171).

Description of the appearance of Metoprololo Hexal and package contents
Metoprololo Hexal 100 mg tablets
PP/Alu blister pack containing 30 tablets.
Metoprololo Hexal 200 mg prolonged-release tablets
PVC/PVDC/Alu blister pack containing 28 tablets.
Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy
Manufacturer
Salutas Pharma GmbH - Otto-von-Guericke-Allee, 1 - D-39179 Barleben (Germany)
LEK S.A., ul. Podlipie 16, 95-010 Strykow (Poland) (only for Metoprololo Hexal 200 mg prolonged-release tablets)
LEK S.A., ul. Domaniewska 50c, 02-672 Warsaw (Poland) (only for Metoprololo Hexal 200 mg prolonged-release tablets)